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Why Attend?

The 18th Annual Outsourcing in Clinical Trials New England brings together senior clinical trial leaders from across pharma, biotech, CROs, and solution providers to address the most pressing challenges in trial delivery today.

Across two days, attendees will gain practical, real-world insights through three focused streams: Clinical Operations, AI & Technology Innovation, and Biotech Strategy. Designed for those responsible for delivering clinical trials, the programme combines case studies, panel discussions, and highly interactive sessions to ensure tangible takeaways you can implement immediately.

Key themes include navigating evolving regulatory requirements, strengthening quality and compliance frameworks, embedding patient-centric approaches into trial design and delivery, and understanding the impact of geopolitical shifts on global trial execution. From optimising outsourcing partnerships to leveraging AI for efficiency and scale, the event equips you with the strategies needed to deliver faster, smarter, and more resilient clinical trials.

This year’s conference is especially significant as we also celebrate the 50th Anniversary of the Tufts Center for the Study of Drug Development, a globally recognized leading academic center providing evidence-based research informing drug development strategy, performance and collaboration. For five decades, the Centre has played a pivotal role in shaping understanding of factors driving clinical trial innovation, operational and economic efficiency, and the evolving drug development landscape. We are delighted to be working closely with Ken Getz on this year’s agenda and are pleased to have him open the conference with what promises to be an insightful and engaging keynote session.

Join your peers to benchmark approaches, share challenges, and build the partnerships that will drive your clinical programmes forward.

Register now to book your place at the conference.

 

 

 

YOUR CHANCE TO MEET AND CATCH UP WITH COLLEAGUES FROM ACROSS THE INDUSTRY

As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

  • Keynote presentations on the topics affecting you: from COVID to shipping to disruptive technologies
  • Join in with audience discussions, panel debates and add your voice to the conversation

700+

Attendees

80+

Exhibitors

50+

Speakers
700+

Attendees

80+

Exhibitors
50+

Speakers

Testimonials

See What It's All About

Featured Speakers

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Meredith Frank-Molnia​

Vice President, Clinical Affairs, Vericel Corporation

Meredith Frank-Molnia is currently employed as Vice President of Clinical Affairs at Vericel Corporation. Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

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John Seman​

Chief Executive Officer, Revitale Pharma

John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

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Carrie Lewis​

Executive Director, Clinical Program Optimization, Keenova Therapeutics

Carrie Lewis is Executive Director of Clinical Program Optimization at Keenova, where she leads numerous operational teams. With over 20 years of experience across academia, global CROs, and sponsor organizations, she brings deep expertise in multiple therapeutic areas and clinical research strategy. Carrie holds a Master’s in Clinical Research Administration and is known for driving site innovation, reducing burden, and fostering strong partnerships in clinical trial operations.

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Dan Housman​

Chief Executive Officer, Courage Therapeutics

I am interested in acting as an entrepreneur to create companies that can build cultures and products that change the world. I am a versatile player willing to take on many different positions because of my background in both technology (chemistry, biology, software) and business. I prefer the role of visionary and to work to build a team, culture, product, and partnerships. I like the challenge of creating innovative solutions to hard underserved problems.

I am currently focused on my start-up ventures including Graticule (Digital accelerators for Advanced real world data), Courage Therapeutics (medical discovery for eating disorders), and advocacy work towards improving research, treatment, and payment for Anorexia Nervosa.

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Kento Nakamura​

Strategy and Corporate Development, CMIC

Kento Nakamura is a global professional having worked both in the Western and Eastern healthcare landscapes. He has been in various roles, contributing significantly to drug development, market access, and pharmaceutical marketing.

At CMIC, Japan and South Korea’s first CRO, Kento wears multiple hats including helping formulate corporate strategy, creating mutually beneficial partnerships with other companies, and taking initiative to create business development opportunities.

During his tenure at KM Pharmaceutical Consulting, a boutique drug development consulting firm, Kento co-pioneered the market access perspective on drug development, resulting in key additional endpoints in an ongoing phase 2 study. He also played a crucial role in developing the global drug safety plan, ensuring compliance with reporting requirements across multiple continents.

Kento holds an MPH in Health Management from Harvard University and a BS in Biology from Tufts University. He is fluent in English and Japanese. In his free time, Kento enjoys playing tennis, watching football, visiting contemporary art museums, and traveling around the world.

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Andy Liu​

General Manager - China, Novotech

Mr. Andy Liu has strong operational experience in the CRO industry and a deep understanding of the regional market. Andy worked at Covance, Inc., a global CRO, for more than 10 years in a number of executive positions. Before joining PPC group, he was General Manager of Covance’s Central Laboratory Service, Asia Pacific, where he led a large multi-functional team of around 500 employees across multiple sites in APAC. Andy holds an MBA from the Booth School of Business at the University of Chicago, an MS in Electrical Engineering from the Rose-Hulman Institute of Technology, and a BS in Electrical Engineering from Tsinghua University.

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    2025 Sponsors Included:

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    Company Information

    Trustful Clinical Budgeting is a cloud-based SaaS platform designed to streamline and optimize financial management in clinical trials, addressing challenges faced by CROs and biopharmaceutical companies. By integrating budgeting, tracking, and analysis into one platform, it reduces manual effort, minimizes errors, and enhances cost efficiency, making it particularly beneficial for small and growing organizations.

    Company Website

    To learn more, please visit our website - https://www.trustfulclinical.com/

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    Company Information

    Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

    Company Website

    To learn more, please visit our website - www.novotech-cro.com

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    Company Information

    Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2012.

    Company Website

    To learn more, please visit our website - www.Clario.com

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    Company Information

    ICON Biotech is a world leading healthcare intelligence and clinical research organisation, dedicated to the needs of small and mid-sized biopharma companies. We help biotech organisations meet their critical milestones and deliver data and evidence-based results to investors, large pharma partners and regulatory authorities. With over 8,000 staff working exclusively with biotech customers, we support over 500 biotech sponsors annually.

     

    ICON Biotech advances clinical research by offering highly focused, integrated outsourced services and solutions, delivered by tailored teams and management that understand the different pressures faced by biotechs in their drive to solve today’s challenges, without losing sight of their mission to deliver life-changing innovations tomorrow. To learn more, please visit www.iconplc.com/biotech

     

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    Company Information

    EPS Corporation, an EPS Holdings Group Company, a Japanese headquartered company, is a comprehensive provider of clinical research outsourced services. Since 1991, the EPS Group has grown to over 7,800 staff providing quality R&D support to pharmaceutical, biotech, regenerative medicine, and medical device companies. EPS operates in Japan, China, South Korea, and Taiwan. With a business partner, we also support studies in other Asia-Pacific countries.

    Company Website

    To learn more, please visit our website - https://www.eps-holdings.co.jp/en/

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    Company Information

    Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

    Company Website

    To learn more, please visit our website - https://www.fortrea.com/

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    Company Information

    IQVIA Biotech delivers flexible clinical development solutions designed for the specific needs of biotech and emerging biopharma companies. When you partner with our clinical development team you gain expertise from more than two decades of running clinical trials exclusively for biotech companies plus access to IQVIA’s unparalleled data and technology. From drug development strategy to trial design and execution, we draw on this experience to put together the right solution, and the right team, for you.

    Company Website

    To learn more, please visit our website - http://www.iqviabiotech.com/

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    Company Information

    MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps.

    Company Website

    To learn more, please visit our website - www.medpt.com

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    Company Information

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. We work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference.

    Company Website

    To learn more, please visit our website - https://www.parexel.com/

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    Company Information

    Premier Research International LLC (Premier) is a leading global CRO and consulting partner with expertise in driving a smarter, faster path to approval. Our integrated approach helps the life sciences industry turn breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value. 

    Company Website

    To learn more, please visit our website - https://premier-research.com/

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    Company Information

    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

    To learn more, please visit our website - www.tfscro.com.

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    Company Information

    Founded in 2018, TruTechnologies is the leading provider of real-time clinical trial oversight, focused on enabling timely, high-quality data and mitigating risks in drug development. The company partners with six top 20 pharmaceutical companies and numerous biotechnology firms to accelerate patient screening and enrollment, drive protocol adherence, and correct deviations.

    trutechnologies.io

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    Company Information

    Worldwide Clinical Trials (Worldwide) is a global CRO serving development-driven biopharmaceutical companies, with more than 4,400 professionals operating across more than 70 countries. The company delivers therapeutically dedicated expertise in neuroscience, oncology, rare disease, and internal medicine, with comprehensive support across every development phase – from early-stage and first-in-human studies through Phase III registration trials.

    The company’s flexible service model – spanning full-service trial management to functional service partnerships through Worldwide Flex – is powered by a people‑first, partnership‑driven outsourcing approach that strengthens collaboration, enhances data transparency, and supports more informed decision‑making. This provides sponsors with tailored, adaptable solutions that keep pace with the evolving demands of clinical research. Learn more at www.worldwide.com

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

    To learn more, please visit our website - https://www.medidata.com

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    Company Information

    We’re more than a supplier: we’re a partner that can deliver consistent quality and superior service, a partner that fuels innovation to foster real and sustainable results. A deep understanding of the healthcare industry, our customers’ needs, and patient needs is critical to ensure our range of packaging products and services deliver value through the entire product lifecycle. These insights and the experience of the Smurfit Westrock Adherence & Clinicals team enable us to work in tune with regulations and clients to provide a service solution underpinned by an innovative and unparalleled range of packaging solutions that, at their heart, are patient focused. These include Clinical Trial Packaging, specialty labels, literature & booklets, Adherence packaging, component kits and SMART Digital Adherence Technology along with Digital Display Labels. Talk to us.

    www.smurfitwestrock.com

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    Company Information

    AdhereTech is revolutionizing clinical trial adherence with its innovative Aidia System. Unlike traditional methods such as pill counting, journals, or video capture, our patented smart cap technology provides unparalleled accuracy in medication adherence tracking while minimizing patient burden. We address the critical need for increasing medication adherence, helping biotech and pharma companies maximize effect size and demonstrate efficacy. Our solution overcomes limitations of current offerings and doesn’t require additional stability testing. By partnering with AdhereTech, clinical operations teams ensure regulatory compliance, optimize drug accountability, and can avoid significant financial and operational consequences of failed trials due to non-adherence.

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    Company Information

    Quipment is a leading player in clinical trial equipment solutions – rental, sales, and inventory management—for CROs, pharma, and biotech.
    We manage global deployment and support throughout the entire clinical trial process, operating across 110+ countries from our technical service centers in France, the US, and Japan.
    All devices are checked, calibrated, and controlled by in-house experienced biomedical technicians to ensure precision and performance at every stage of the study.
    Our circular model limits waste and reduces the carbon footprint of clinical trials, while our flexible approach adapts to each project’s specific needs. As a mission-driven company, we integrate sustainability, ethical responsibility, and innovation into our operations.
    The underlying force behind every clinical trial, whatever the need, Quipment makes it possible.

    Company Website

    To learn more, please visit our website - https://www.quipment.com/

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    Company Information

    Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and therapeutic areas such as neuroscience, substance abuse, pain, tobacco harm reduction, infectious diseases and many others. CRO services include project management, data management, biostatistics, statistical programming, PK/PD analysis, medical writing, monitoring, site feasibility and management for multi-site trials.

    Company Website

    To learn more, please visit our website - www.drvince.com/cro/

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    Company Information

    Putting patients first is in uMotif’s DNA. The uMotif eCOA/ePRO platform delivers faster, quality clinical trials and real-world studies by putting patients at the core of research. Through cloud-hosting in the US, Europe and China, the GCP, 21 CFR Part 11 and GDPR-compliant platform supports any study or trial, from Clinical Phase I, II and III studies through to decentralized or virtual real-world studies. Find out how uMotif can improve your clinical research programs and real-world studies at www.umotif.com

    Company Website

    To learn more, please visit our website - www.umotif.com

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    Company Information

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

    Company Website

    To learn more, please visit our website - https://www.propharmagroup.com/

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      Agenda

      • 15 Oct 2025
      • 16 Oct 2025
      Expand All

      Streams

      Stream one

      Stream A: Clinical Outsourcing and Operations

      Stream two

      Stream B: Clinical Technology and Innovation

      Stream three

      Stream C: Biotech Strategy

      11 AM

      PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

      • Analyzing current market dynamics and funding trends shaping biotech growth in 2025
      • Addressing ongoing talent shortages and evolving workforce strategies
      • Funding and investment for biotechs in and around Boston: how has this shifted in 2025?
      • The impact of national political and economic changes on the biotech landscape in Boston and New England

      MODERATOR: Gregg Beloff, Founder, Danforth Health

      Speakers

      Gregg Beloff
      Founder, Danforth Health
      George Tetz
      Chief Executive Officer, Second Life Therapeutics
      Chris Adams
      Chief Executive Officer, Andarix
      Taiba Quraishi
      Innovation Accelerator Lead, Alexion

      11:30 AM

      Bridging the gaps: Integrating consulting and clinical operations to accelerate biotech development

      • Identify and eliminate “white space”.  Spot gaps between strategic planning and operational execution and apply techniques to streamline transitions across the clinical development lifecycle.
      • Understand how early consulting and clinical pharmacology services work together to enhance strategy and execution. Understand when and how to engage to shape a cohesive development pathway, improve timing, and accelerate decision-making.
      • Align scientific, regulatory, and clinical perspectives from the outset. Explore the benefits of integrated teams in a CRO setting to ensure continuity, reduce delays, and support end-to-end development.
      • Connect strategic and operational elements across development stages. Gain practical insights into bridging planning, execution, and transition phases for smoother progression and better outcomes.

      Speakers

      Stephanie Bolick
      VP Biotech Development Operations, Fortrea

      12 PM

      CASE STUDY: Securing capital: funding strategies for biotechs and start up companies

      • Navigating the evolving VC landscape and investor expectations
      • Leveraging funding options such as grants, strategic partnerships and government programs
      • Building strong enough data to convince investors while managing with limited capital

      Speakers

      Dan Housman
      Chief Executive Officer, Courage Therapeutics

      12:30 PM

      Driving innovation in clinical research with master protocols

      • Understand the benefits, optimal use cases and best scenarios for master protocols
      • Maximize trial operations with improved coordination and more sub-study opportunities
      • Enhance data collection and sharing, broadening patient access to new therapies
      • Navigate strategic relationships for safe and successful master protocol research

      Speakers

      Beth Chamblin
      Senior Director, Project Management, Late Phase Oncology, IQVIA Biotech

      1 PM

      Lunch and networking break sponsored by ProPharma Group

      2 PM

      PANEL: Staying resilient: leading your biotech through political and economic uncertainty

      • Coping with layoffs and budget cuts
      • Are we expecting droughts for research in the biotech space?
      • Diversifying funding and partnership strategies to reduce financial risk
      • Strengthening operational agility to respond quickly to market and policy disruptions

      MODERATOR Rich Polgar, Managing Director, Danforth Health

      Speakers

      Rich Polgar
      Managing Director, Danforth Health
      Ingrid Abrahamsen
      Executive Director, Clinical Operations, Fulcrum Therapeutics
      Daniel Klamer
      Vice President, Business Development & Scientific Strategy, Anavex Life Sciences
      Aditya Kotta
      VP Business Development, Novotech

      2:30 PM

      AI in eCOA: Separating today’s opportunities from tomorrow’s possibilities

      As with all industries, artificial intelligence is generating significant buzz in the clinical research space. But where does it offer meaningful impact today, and where is there still work to be done? In this session, we’ll explore the practical realities of applying AI tools within the context of electronic clinical outcomes assessment data, from operational efficiencies like study setup and translation to the future promise of patient-facing applications. Join us for an honest look at what’s achievable now, what’s emerging, and how to think strategically about this fast-moving future.

      Speakers

      Paul O’Donohoe
      Senior Director, eCOA Product and Science, Medidata

      3 PM

      CASE STUDY: What does it take to start up a biotech company from scratch?

      • An overview of common challenges and how to overcome these
      • Securing initial funding: navigating opportunities available to raise capital
      • Overcoming early stage hurdles
      • Building strategic partnerships to support your biotech

      Speakers

      Chris Adams
      Chief Executive Officer, Andarix

      3:30 PM

      Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research

      3:45 PM

      EXHIBITION APPLE PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      4 PM

      Choosing the right CRO: key considerations for small biotechs

      • Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
      • Balancing cost, quality and timelines within tight budget constraints
      • Negotiating contracts with flexibility to protect your biotech’s goals

      Speakers

      Dr. Martin Bauer
      Chief Medical Officer, Eleva GmbH

      4:30 PM

      Driving asset value through operational precision

      • Operational inefficiencies quietly erode a drug’s Probability of Technical and Regulatory Success (PTRS) and reduce overall asset value
      • Biotechs must shift from reactive oversight to proactive strategies grounded in near-term visibility and actionable data
      • Same-day insights into trial conduct help de-risk execution, protect endpoints, and accelerate development timelines
      • Faster, cleaner data drives confident decisions and signals operational strength to investors and partners
      • Lessons from 25+ years in drug development offer a practical blueprint for embedding operation excellence into biotech strategy

      Speakers

      Richard A. Graham
      Ph.D., Co Founder and Chairman of the Board, TruTechnologies

      5 PM

      PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

      • Developing relationships with advocacy groups and patient communities from early stages
      • How does patient advocacy differ at biotechs vs large pharma?
      • Integrating patient insights into your study to ensure patients remain the priority throughout your trial

      MODERATOR Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

      Speakers

      Hollie Schmidt
      Vice President, Scientific Operations, Accelerated Cure Project for MS
      Rebecca Nordland
      Senior Project Manager, Research Services, CISCRP
      Katerina Chatzi
      Founder and Chief Executive Officer, Promakhos Therapeutics
      T.J. Sharpe
      Patient Advocate

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY DR VINCE CLINICAL RESEARCH

      11 AM

      The Future of Clinical Operations with Generative AI

      • Understanding Gen AI — Why it matters for clinical operations
      • Trends & Barriers — What's driving adoption or impeding progress
      • GenAI in Action — Real world use cases that are transforming clinical ops

      Speakers

      Shwen Gwee
      AI & Digital Innovation Leader and Former VP/Head of Global Digital Strategy, Bristol Myers Squibb

      11:30 AM

      Community first: How local engagement builds better clinical trials

      • Exploring how building authentic relationships with patients and local healthcare providers create meaningful opportunities for research participation
      • Sharing how consistent engagement, education, and community-first strategies foster trust and drive better outcomes in clinical trials through real-world stories and examples from local outreach events.
      • Insights into how inclusive outreach expands trial access, strengthens provider partnerships, and delivers measurable impact for both patients and sponsors

      Speakers

      Jennifer Holloway
      Nurse Practitioner/ Sub-Investigator, EmVenio Clinical Research

      12 PM

      Updates and developments on Tufts CSDD: DIA collaborative study results: using AI and ML in clinical development

      • Focus of the innovation and phase of AI implementation (pilot, partial implementation, full implementation) as well as the organizational resources required to deploy the innovation
      • Impact on cycle times and costs
      • Key challenges to implementation and how they have been addressed by organizations
      • Metrics tracked and outcomes that have resulted

      Speakers

      Mary Jo Lamberti
      Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development
      Maria Florez
      Senior Consultant, Tufts Center for the Study of Drug Development

      12:30 PM

      Gamification in clinical trials: A proven path to better engagement, retention, and data integrity

      Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.

      • Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation
      • See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines
      • Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols

      Speakers

      Christer Nilsson
      Chief Executive Officer, Replior

      1 PM

      Lunch and networking break sponsored by ProPharma Group

      2 PM

      Implementing an EDC system: operational and technical considerations

      • Considerations during EDC vendor selection
      • Operational and technical considerations when implementing Patient Reported Outcomes measures
      • Outsourced/Hybrid/Insourced EDC development models- cost and operational considerations

      Speakers

      Meredith Frank-Molnia
      Vice President, Clinical Affairs, Vericel Corporation

      2:30 PM

      TECHNOLOGY SPOTLIGHT: The impact of Simulation-Based learning on Study Acceleration – Spoken from the Sponsor who converted

      • What forced me to think strategically about clinical research training methodology
      • Gaps & Risks of ‘check-the-box’ training
      • Initial impact of Simulation-Based training on risk mitigation, Site time, Satisfaction, Enrollment and Quality
      • Advances in Simulation-Based training that enhance site and patient engagement as well as optimize protocols

      Speakers

      Brad Stefanovic
      Head of Clinical Innovations, Simulations Plus

      2:45 PM

      TECHNOLOGY SPOTLIGHT: First time in human studies: The Italian experience

      • Combined single and multiple ascending dose studies, with food effect
      • An Evotec Clinical Solution Services case study:
      • Fully integrated approach allowing timelines optimization
      • Authority Approval timelines
      • Timely Study Management

      Speakers

      Josh Gillum
      Vice President, Business Development, Evotec

      3 PM

      Harnessing real world experience: driving innovation and decision making

      • Collecting and integrating supportive data sources for complimentary patient insights
      • Understanding the regulatory landscape around RWE and how to navigate this efficiently
      • Ensuring data quality, privacy and regulatory compliance in RWE initiatives

      Speakers

      Daniel Klamer
      Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

      3:30 PM

      Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research

      3:45 PM

      EXHIBITION APPLE PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      4 PM

      Opportunities in building AI models for efficiency in outsourcing

      • Identifying outsourcing opportunities and pitfalls to avoid that can be addressed through AI driven solutions: timeline standards, document prep and system utilization
      • Developing operationally, process and system driven AI models to support clinical operations and outsourcing: what can be streamlined?
      • Integrating AI insights into outsourcing strategy to drive speed, quality and cost effectiveness: timelines, project management and reconciliation

      Speakers

      Jeannette Villabon
      Associate Director, Clinical Operations and Vendor Management, Alkermes

      4:30 PM

      PSI’s VISIONAL: enhancing feasibility and enrollment predictions with GenAI

      • Explore how PSI integrates GenAI for protocol similarity searches and enrollment rate predictions, improving accuracy and efficiency in clinical trial planning
      • Learn how VISIONAL™ incorporates three new data sources to enhance site performance analysis and offer insights across 56 countries, supporting better decision-making
      • Discover how VISIONAL™ enables sponsors to quickly generate multi-country feasibility scenarios and budgets in under 30 minutes, streamlining the planning process

      Speakers

      Emily McInturf
      Director, Feasibility, PSI CRO

      5 PM

      Direct-to-Patient Shipments of Investigational Products

      • We’ll discuss findings from a recent study on site and patient perspectives on Direct-to-Patient shipments of investigational product.
      • Explore feasibility across different treatment types, and what investigative sites see as the key benefits and drawbacks.
      • Learn how shipping models like site-to-patient (STP) and warehouse-to-patient (WTP) are perceived by sites and how these influence enrollment speed, study start-up, and close-out.
      • Understand how patients perceive direct-to-patient shipments, what has worked well and where common challenges arise from the patient’s perspective.

      Speakers

      Maria Florez
      Senior Consultant, Tufts Center for the Study of Drug Development

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY DR VINCE CLINICAL RESEARCH

      7:30 AM

      Registration and refreshments sponsored by Catalyst Flex

      8:15 AM

      GlobalData opening remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      8:25 AM

      Chairperson’s opening remarks

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      8:30 AM

      PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

      • 10 months in: how has the new administration affected the pharma and biotech industry in New England?
      • Dealing with change and uncertainty: ensuring your clinical trial timelines stay on track
      • Discussing pros and cons of running trials in the US vs overseas considering recent changes
      • How have funding and resources been affected in 2025 and how has this impacted outsourcing and clinical operations?

      MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
      Jay Russak
      Senior Director, Clinical Operations, Keros Therapeutics
      Rita Lemming
      Director, Clinical Operations, Fulcrum Therapeutics
      Harry Barnett
      Executive Chairman, Lubris Biopharma

      9 AM

      Clinical trials in Japan: a new era of opportunity for global sponsors

      • Japan as one of the largest pharmaceutical markets presents unique challenges and opportunities
      • Overview of the current clinical trial environment, government support and major regulatory reforms
      • What’s the reward of running clinical trials in Japan and Japan market entry?

      Speakers

      Kento Nakamura
      Strategy and Corporate Development, CMIC

      9:30 AM

      PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

      • Fostering transparent and constant communication with CROs and other suppliers to minimize delays and ensure timelines stay on track
      • Ensuring your suppliers’ goals align with your study goals
      • Monitoring CRO and supplier performance with clearly defined KPIs
      • Aligning on project timelines, milestones and quality expectations from the beginning

      MODERATOR
      Rich Polgar, Managing Director, Danforth Advisors

      Speakers

      Rich Polgar
      Managing Director, Danforth Health
      Rinaldo Dorman
      Associate Director, R&D Global Procurement and Strategic Sourcing, Sarepta Therapeutics
      Stacey Oppenheimer
      Director, Third Parth Quality Lead, Pfizer
      Nicole McElroy
      Director, Strategic Partnerships and Outsourcing, Takeda
      Kathleen Martyn
      Manager, Vendor and Clinical Operations, Karyopharm Therapeutics

      10 AM

      China as an Early Phase Solution: Opportunities for US Sponsors

      • Why plan your trials in China?
      • Key considerations in evaluating China
      • Key success factors
      • Case studies

      Speakers

      Andy Liu
      General Manager - China, Novotech

      10:30 AM

      Morning refreshments and networking break sponsored by Suvoda

      11 AM

      Leveraging untapped resources: capitalizing on expertise from non-industry professionals

      • The importance of transferrable skills and assessing potential hires based on more than direct industry experience
      • Challenging your mindset to expand your talent pipeline
      • Integrating fresh perspectives and how this can drive innovation and broaden your knowledge
      • Onboarding and supporting cross-sector hires for long term impact and retention

      Speakers

      Nick Pelletier
      Vice President, Clinical Operations, Curis
      Sydney DeCaro
      Clinical Trial Associate, MapLight Therapeutics

      11:30 AM

      Maneuvering with agility in a challenging landscape

      • Why today’s constraints make nimbleness essential
        Innovative approaches to accelerate time to market
      • Creating an ecosystem of collaborations that inspire and enable flexibility

      Speakers

      Stacey Flattery
      Vice President, General Partner, ICON Biotech

      12 PM

      FIRESIDE CHAT: Keeping patients and caregivers at the center of rare disease clinical trials: collaborating with patients, caregivers, and nonprofits for better outcomes

      • Understanding the provider-patient conversations: point-of-patient and provider discussions to shape trial design that is patient centric
      • Survey design: creating questions focused on patient and caregiver needs during the trial and post-trial to keep patients engaged and enrolled leading to better outcomes
      • Share your Rare Action: mention your post-session action to improve your process that includes rare patients, caregivers, and non-profits

      Speakers

      Sarah Woods
      Founder, Serenely Guided Foundation

      12:30 PM

      Beyond the Buzzword: Practical AI strategies for accelerating clinical research

      • Define AI use across the biotech industry
      • Provide a framework for when and how to incorporate AI into clinical trials
      • Uncover areas where AI is relatively easy to use within your current corporate environment
      • Share real-world examples of how rare disease focused companies are leveraging AI to expedite drug development

      Speakers

      Derek Ansel
      Vice President, Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

      1 PM

      Lunch and networking break sponsored by ProPharma Group

      2 PM

      Partnering with patient advocacy groups in order to align clinical trials with patient priorities

      • Engaging with patient advocacy groups to uncover true patient needs
      • Incorporating patient insights early on in design and launch plans
      • Identifying clinical trial design elements that may hinder recruitment and retention
      • De-risking development programs by aligning with patient priorities
      • Real world case studies on how advocacy input shaped treatment selection, clinical trial design, and trial results dessemination

      Speakers

      Hollie Schmidt
      Vice President, Scientific Operations, Accelerated Cure Project for MS

      2:30 PM

      From first step to final outcome: Reframing feasibility as an operational strategy

      • ow integrating cross-functional risk assessment of the feasibility process can enhance site strategy, clinical oversight, system selection(s) product solutions, and long-term trial delivery
      • How to identify feasibility approaches that align with execution, not just enrollment, and how a more connected model helped de-risk a complex study
      • Practical strategies to elevate feasibility from a planning task to a foundational element of trial success
      • Understand the difference between traditional feasibility and true operational feasibility, and why that distinction matters
      • Learn how early cross-functional risk assessments can expose delivery risks before they surface mid-study
      • Discover how to align feasibility insights with cross-functional oversight, site strategy, and fit-for-purpose systems with customized solutions from the outset
      • Explore how an integrated feasibility-to-delivery model can improve performance in high-complexity, high-variability trials

      Speakers

      Jessica Wessel
      Senior Director, Project Delivery, TFS HealthScience

      3 PM

      PANEL: Making a success of FSP models for your clinical trial

      • Weighing up pros and cons of FSP vs other outsourcing models: is FSP right for your clinical trial?
      • Defining the FSP model and understanding when it is the right fit for your organization
      • Selecting the right FSP partners to complement internal capabilities
      • Optimizing cost efficiency and scalability through flexible FSP partnerships

      MODERATOR John Seman, Chief Executive Officer, Revitale Pharma

      Speakers

      John Seman
      Chief Executive Officer, Revitale Pharma
      Leonella Seeley
      Director, Vendor Management and Operations, Karyopharm Therapeutics
      Carrie Lewis
      Executive Director, Clinical Program Optimization, Keenova Therapeutics
      Beth Davis
      Senior Manager, Development Services and Operational Excellence, Vendor and Relationship Management Lead, Regeneron
      Leticia Tarilonte
      Vice President, Head of Global Clinical Operations, Former Pyxis Oncology

      3:30 PM

      Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research

      3:45 PM

      EXHIBITION APPLE PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      4 PM

      PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

      • Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
      • Tips and tricks to ensure you are ready for inspection
      • Simplifying processes in order to prepare for an FDA inspection

      MODERATOR Leticia Tarilonte, Vice President, Head of Global Clinical Operations, Pyxis Oncology

      Speakers

      Kelsey Miller-Torchia
      Senior Vice President, Clinical and Business Development, Intrinsic Therapeutics
      Meredith Frank-Molnia
      Vice President, Clinical Affairs, Vericel Corporation
      Colleen Smith
      Director, Clinical Affairs Operations, Siemens Healthineers Endovascular Robotics
      Katherine Neblett
      Global Program Director, AstraZeneca
      Leticia Tarilonte
      Vice President, Head of Global Clinical Operations, Former Pyxis Oncology

      4:30 PM

      Strategic site selection in early development: Meeting the demands of complex therapies

      • Examining common pitfalls in site selection for complex therapies and how data informed approaches can help sponsors overcome them
      • Exploring strategies to balance sponsor preferred sites, CRO recommendations, KOL influence, and community investigators for stronger performance
      • Understanding how to connect internal knowledge with external databases to drive greater accuracy and efficiency in early development
      • Reviewing real world case studies that highlight innovative solutions to early phase challenges in complex therapies, from timeline management to site readiness

      Speakers

      Amanda Fierro
      Project Manager, Oncology, Premier Research
      Marilyn Kludt
      Senior Project Director, Oncology, Premier Research

      5 PM

      CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

      • Top tips for working with and supporting naïve physicians in order to ensure their success
      • The importance of maintaining and growing the pool of investigator sites
      • Lessons learned for the future: what should you consider when working with naïve doctors?

      Speakers

      Carrie Lewis
      Executive Director, Clinical Program Optimization, Keenova Therapeutics

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      John Seman
      Chief Executive Officer, Revitale Pharma

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY DR VINCE CLINICAL RESEARCH

      Streams

      Stream one

      Stream A: Clinical Outsourcing and Operations

      Stream two

      Stream B: Clinical Technology and Innovation

      Stream three

      Stream C: Biotech Strategy

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      9 AM

      PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

      • Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
      • Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
      • Keeping your clinical budget on track
      • Negotiating prices and contracts in order to ensure maximum benefit without going over budget

      MODERATOR
      Rene Stephens, Managing Director, Clinical Business Operations, Danforth Advisors

      Speakers

      Rene Stephens
      Managing Director, Clinical Business Operations, Danforth Health
      Molly James
      Associate Director, Strategic Sourcing, Beam Therapeutics
      Dan Housman
      Chief Executive Officer, Courage Therapeutics
      Vikas Agarwal
      PhD, Chief Executive Officer, WeaveBio Therapeutics

      10 AM

      INTERACTIVE SESSION: What are investors looking for in a biotech or start up?

      • Outline critical factors biotech investors evaluate before committing their resources, offering actionable insights to help startups stand out in a competitive market.
      • Steps for biotech founders to differentiate, IP strategy and to attract funding
      • Avoiding missteps in budgeting and resource allocation together with prioritization and careful planning.
      • Storytelling about key milestones achieved aligned with operational activities with feasible exit strategy?
      • Does the biotech investor bring strategic expertise beyond capital needs?
      • Does the biotech have the appropriate team and expertise to execute?

      Speakers

      Shailesh Chavan
      Managing Partner, Ingenious Global Venture Partners

      10:30 AM

      Morning refreshments and networking break

      11 AM

      CASE STUDY: Making a strategic success of public-private partnerships

      • Exploring different funding avenues: how to structure fundraising initiatives
      • Working in collaboration with academia: benefits and opportunities
      • The importance of building networks and insights from investors in addition to capital
      • Lessons learned: analyzing both successes and learnings for future biotech initiatives

      Speakers

      Steffen-Sebastian Bolz
      Co-Founder and Chief Scientific Officer, Aphaia Pharma and Executive Board Member and Chief Scientific and Medical Officer, Qanatpharma

      11:30 AM

      PANEL: Driving technology and innovation in a small biotech

      • What is realistic, what isn’t, and how can you stay ahead of the curve?
      • How biotech and pharma differ when it comes to technology and innovation: as a biotech, where should your priorities lie?
      • Staying ahead of competitors when funding and resources are limited for technology investment
      • Leveraging agility and flexibility to adopt technology quickly
      • Balancing innovation with risk management and scalable development

      MODERATOR Jay Russak, Former Senior Director, Clinical Operations, Keros Therapeutics

      Speakers

      Jay Russak
      Senior Director, Clinical Operations, Keros Therapeutics
      Jennifer Sydney Goldman
      Clinical Finance and Business Operation Consultant, ARTBIO
      Marilyn Fontaine
      Director of Clinical Operations, Nuvation Bio
      Taiba Quraishi
      Innovation Accelerator Lead, Alexion
      Katie Norton
      Trial Optimization SME

      12:30 PM

      Lunch and networking break

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      9 AM

      Studies Beyond Borders: Managing the logistics of conducting worldwide clinical trials

      • Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
      • Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
      • Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
      • Addressing concerns at the protocol and ICF development phase

      Speakers

      Michael Murphy
      Director, Legal and Associate General Council, Ionis Pharmaceuticals

      9:30 AM

      Beyond Integration: How AI Creates a Clinical Trial Platform

      • The challenge: Disconnected systems creating blind spots in trial management
      • The opportunity: AI as the connective tissue between documentation and execution
      • The Intelligent Trial Assistant: Natural Language Queries Across ETMF and CTMS
      • AI-Driven Inspection Readiness: Connecting Document Quality to Trial Execution
      • Predictive Trial Health: Using AI to Connect the Dots Between Documents and Operations
      • Smart Document Classification Meets Smart Workflow: End-to-End Trial Automation

      Speakers

      April Mattison-Wolfe
      Senior Manager Technical Services, TransPerfect
      Katherine Cianciarelli
      Senior Product Manager, eTMF and AI, TransPerfect

      10 AM

      PANEL: AI and machine learning in clinical trials: where are we in 2025?

      • Opportunities for incorporating AI into clinical research: where should the industry be focusing?
      • Why has pharma been relatively slow to utilize AI in clinical research?
      • Understanding limitations of GenAI: what do you need to be wary of?
      • Real case studies on AI in the clinical trial industry: where has there been progress and success?
      • What does the future hold for AI in clinical trials?

      MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
      Jeannette Villabon
      Associate Director, Clinical Operations and Vendor Management, Alkermes
      Bailey Willis
      Associate Director, Medical Operations and Sourcing, Click Therapeutics
      Diane Fortune
      Associate Director, Clinical Outsourcing, Neurocrine

      10:30 AM

      Morning refreshments and networking break

      11 AM

      Digital health innovations in cardiovascular clinical trials: assessing Apple Watch as a sensor-based digital health technology for atrial fibrillation

      • Harnessing Apple Watch technology: key features for detecting heart arrhythmias
      • What the evidence says: insights from published cardiovascular studies
      • From wrist to research: smart distribution models for clinical trial success
      • Making it work: tackling operational and data management hurdles for clinical trial success

      Speakers

      Amir M. Behdani
      PharmD, Biomarker Development Postdoctoral Fellow, Novartis

      11:30 AM

      3 technology use cases shaping the future of trial design and implementation

      • Optimizing and de-risking trial design and feasibility: how data-driven modeling and simulation tools are helping sponsors design smarter, more efficient trials from the outset
      • Enabling in-stream decision-making during execution: using real-time insights to adapt trial operations dynamically, improving quality, timelines, and decision confidence
      • AI's transformative impact on trial delivery: from reshaping how we plan and run trials to redefining roles and workflows, AI is set to re-engineer every stage of clinical development

      Speakers

      Christopher Schoonmaker
      Chief Operating Officer, MMS Holdings

      12 PM

      The Early Feasibility Study: getting it right for a medical device

      • Designing the study and getting IRB permission to run it
      • Site selection
      • The importance of electronic data capture
      • Why a sponsor's representative must be there
      • The physician's or surgeon's muscle memory

      Speakers

      Jerrold M. Shapiro
      President, Floelle

      12:30 PM

      Lunch and networking break

      8 AM

      Registration and refreshments sponsored by Catalyst Flex

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      T.J. Sharpe
      Patient Advocate

      9 AM

      From insight to impact: translating patient voices into study materials that matter

      • Maximize the value of existing patient involvement efforts by “translating” patient advisory board insights into participant-facing materials
      • Meet growing regulatory expectations for patient involvement in participant materials development
      • Implement a co-development approach with patients and advisors review
      • Internal planning tips for timelines, stakeholder engagement, and IRB submission strategies
      • Best practices in health literacy to ensure clarity, trust, and accessibility

      Speakers

      Behtash Bahador
      Senior Director, Community Engagement & Partnerships, CISCRP
      Ellyn Getz
      Director, R&D Patient Partnerships, R&D Strategic Operations, CSL Behring

      9:30 AM

      Beyond the Middleman: Strategic Outsourcing of IOR/EOR for Global Clinical Trials

      • Demystifying the Importer of Record (IOR) and Exporter of Record (EOR) functions and reframing it as a strategic enabler of cost efficiency, regulatory compliance, and accelerated timelines in global clinical trial logistics
      • What IOR/EOR really means in a clinical context: Role in customs declarations, tax responsibility, and compliance.
      • IOR providers' responsibilities through HS classification, valuation review, and pre-clearance planning.
      • Best-fit model: When and where to outsource vs. manage in-house.
      • Tax pitfalls in outsourced IOR: Misclassification of goods (e.g., placebo vs. commercial drug), overpaying duties or VAT due to poor documentation control, and ignoring the available tax saving opportunities.
      • Tax planning by design: The importance of implementing a sound IOR strategy to avoid the highlighted tax pitfalls.
      • Walk away with a deeper understanding of IOR/EOR as a strategic lever for improved global clinical execution, guidance on how to incorporate an outsourced IOR for global clinical trials and a “Red Flag Checklist” with critical questions to vet vendors for outsourcing IOR/EOR

      Speakers

      Louisa Carlse
      Director of Partnerships, TecEx Medical

      10 AM

      Reimagining the clinical trials infrastructure for Inclusive and accessible rare diseases and orphan therapies

      • Uncovering the invisible: a 20-year analysis of medically underrepresented populations in clinical trials
      • Benchmarking against the US census reveals structural gaps and needs
      • Adopt a six-pillar architecture to embed equity from the ground up

      Speakers

      Harsha K. Rajasimha
      MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
      Jenifer Waldrop
      Executive Director, Rare Disease Diversity Coalition

      10:30 AM

      Morning refreshments and networking break

      11 AM

      Accelerating site activation and study start up

      • Streamlining feasibility, site selection and qualification processes to minimize delays
      • Leveraging technology to manage documents, workflows and communication
      • Identifying common bottlenecks and strategies to overcome them proactively
      • Aligning sponsor, CRO and site teams to ensure clarity from day one

      Speakers

      Marilyn Fontaine
      Director of Clinical Operations, Nuvation Bio

      11:30 AM

      Strength meets agility: Co-developing a framework for seamless FSO to FSP transition

      • Big pharma is a battleship in a speedboat world. FSP outsourcing offers the agility to cut through traditional development timelines and chart a faster course to patients.
      • In this presentation, Parexel will share how they partnered with Bristol Myers Squibb (BMS) to make a strategic shift, transitioning from a predominantly full-service outsourcing model to a functional service provider model. This involved redefining traditional roles, innovating tasks and responsibilities, and talent redeployment in support of pipeline priorities.
      • The presenters will discuss the strategic considerations and benefits of this transition, demonstrating how through a collaborative partnership, they worked to enhance BMS’ clinical trial operations, creating resource efficiencies, increasing agility, and optimizing clinical operations across their global portfolio. This presentation will offer valuable insights for companies seeking to adapt their outsourcing strategies to meet the demands of today's complex and rapidly changing drug development environment.

      Speakers

      Kerri McCaul-Claus
      Vice President, Head of FSP Biometrics, Parexel
      Allison Covucci
      Senior Director, Statistical Programming, Bristol Myers Squibb

      12 PM

      The importance of accurate and consistent sample collection and management in clinical trials

      • Biospecimens are foundational for all clinical trial data: they are data at an early stage
      • Errors in collection, logistics, or analysis can have major impacts.
      • Pre-analysis processes (requirements, collection, logistics, lab contracting, analysis, data transfer) are critical and should not be left to chance.
      • Clinical Trial logistical design is increasingly complex, and errors can occur at any stage
      • Compliance with evolving regulations is essential.
      • Informed consent, ownership rights, and privacy are key issues.
      • Transparent policies, ethical oversight, and robust tracking of samples and data are necessary
      • We need to Focus on the entire lifecycle to ensure compliance and trust.

      Speakers

      John Smutko
      Head of Oncology Scientific Operations, GSK

      12:30 PM

      Lunch and networking break

      1:30 PM

      PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

      • With uncertainty and constant change in the US, is the solution to look overseas for clinical trial sites?
      • Working with CROs and partners overseas: assessing benefits as well as potential challenges
      • Positive and negative impacts of trials abroad on clinical trial finances and budgeting
      • What advantages are there of keeping trials inside the US?

      MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
      Hyun Kim
      Senior Vice President, Clinical Development, AOBiome Therapeutics
      Yolanda Wan
      Head of Clinical Operations, Orna Therapeutics
      Kento Nakamura
      Strategy and Corporate Development, CMIC

      2:15 PM

      I’ve chosen my CRO – Now what? Preparing for success in the first 90 days of your strategic partnership

      • How to build a strong CRO onboarding plan that sets your study up for success
      • Making your kickoff meeting count: aligning teams, timelines, and expectations
      • Fast-tracking your study start-up — from project plan to site activation
      • Anticipating and mitigating early risks to protect your study timelines

      Speakers

      Vinnette Sallo
      Senior Director, Project Management, Ergomed

      2:45 PM

      Clinical trials surged in H1 2025! Where was the growth, will it continue and how to stay ahead

      GlobalData’s clinical trials data indicates that trials initiations in H1 2025 increased significantly over previous years. Public reporting of clinical trials make it easy to miss when and where the real growth is happening. In addition to surprising Wall Street, this has shaken up the competitive landscape and created major opportunities for CROs, CDMOs and Pharma Tech.

      • What drove the surge
      • Where the next wave is coming from
      • How can early signals give you the edge
      • Whether you run trials, manufacture at scale, or partner with life sciences companies, this is about being prepared.

      Speakers

      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare

      3:15 PM

      Afternoon refreshments, networking and prize draw sponsored by Andwin Scientific

      3:30 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the conference and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      3:45 PM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.

      ROUNDTABLE 1: Navigating biological material regulations

      Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection

      ROUNDTABLE 2: Keeping patients at the heart of your clinical trial

      Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

      ROUNDTABLE 3: Fostering a positive relationship with your CRO and vendor partners

      Liza Micioni, Director, Clinical Operations, Tris Pharma

      ROUNDTABLE 4: Negotiation tips for emerging startups

      Speakers

      Liza Micioni
      Director, Clinical Operations, Tris Pharma
      Behtash Bahador
      Senior Director, Community Engagement & Partnerships, CISCRP
      Sean Smith
      Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations,
      U.S. Customs and Border Protection

      4:45 PM

      Chair’s closing remarks

      End of Conference

      2025 Speakers

      Select a speaker to learn more

      Back
      Hollie Schmidt
      Vice President, Scientific Operations, Accelerated Cure Project for MS

      Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

      Session Details:

      Partnering with patient advocacy groups in order to align clinical trials with patient priorities

      2025-10-15, 2:00 PM

      Session Details:

      PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

      2025-10-15, 5:00 PM

      View In Agenda
      Next speaker
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      Shwen Gwee
      AI & Digital Innovation Leader and Former VP/Head of Global Digital Strategy, Bristol Myers Squibb

      AI & Digital Innovation Leader | Biopharma Executive | Startup Advisor & Investor
      → I help biopharma companies navigate and lead the future of healthcare through AI, digital strategy, and innovation.
      → With nearly 20 years of experience across commercial, clinical, and enterprise functions, I’ve held senior leadership roles at top pharma companies, including BMS, Novartis, and Biogen.
      → Most recently, I served as VP and Head of Global Digital Strategy at Bristol Myers Squibb, where I was accountable to the Executive Leadership Team and Board of Directors for driving enterprise-wide digital innovation. Prior to that, I was a founding member of the Novartis BIOME, a global network of digital innovation hubs.

      Session Details:

      The Future of Clinical Operations with Generative AI

      2025-10-15, 11:00 AM

      View In Agenda
      Next speaker
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      Taiba Quraishi
      Innovation Accelerator Lead, Alexion

      Session Details:

      PANEL: Driving technology and innovation in a small biotech

      2025-10-16, 11:30 AM

      Session Details:

      PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

      2025-10-15, 11:00 AM

      View In Agenda
      Next speaker
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      Jeannette Villabon
      Associate Director, Clinical Operations and Vendor Management, Alkermes

      Session Details:

      Opportunities in building AI models for efficiency in outsourcing

      2025-10-15, 4:00 PM

      Session Details:

      PANEL: AI and machine learning in clinical trials: where are we in 2025?

      2025-10-16, 10:00 AM

      View In Agenda
      Next speaker
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      Chris Adams
      Chief Executive Officer, Andarix

      Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection.

      Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

      Session Details:

      CASE STUDY: What does it take to start up a biotech company from scratch?

      2025-10-15, 3:00 PM

      Session Details:

      PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

      2025-10-15, 11:00 AM

      View In Agenda
      Next speaker
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      Hyun Kim
      Senior Vice President, Clinical Development, AOBiome Therapeutics

      Hyun has been a part of AOBiome's clinical pipeline leadership since 2016. Hyun brings over 25 years of drug development experience in the pharma and biotech industry.  Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech.  He started his career at Genetics Institute and Wyeth, advancing R&D programs into the clinic.  He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

      AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company focused on transforming human health by developing microbiome-based therapies for local, nasal and systemic inflammatory conditions. Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline of multiple, clinical-stage therapeutic candidates. The company's portfolio includes multiple clinical-stage programs in atopic dermatitis, rosacea, and acne, as well as additional programs targeting diverse inflammatory indications.

      Session Details:

      PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

      2025-10-16, 1:30 PM

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      Steffen-Sebastian Bolz
      Co-Founder and Chief Scientific Officer, Aphaia Pharma and Executive Board Member and Chief Scientific and Medical Officer, Qanatpharma

      Session Details:

      CASE STUDY: Making a strategic success of public-private partnerships

      2025-10-16, 11:00 AM

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      Katherine Neblett
      Global Program Director, AstraZeneca

      Session Details:

      PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

      2025-10-15, 4:00 PM

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      Jennifer Sydney Goldman
      Clinical Finance and Business Operation Consultant, ARTBIO

      I’m a clinical finance and operations leader with 20+ years of experience driving global strategies for clinical trial financial planning, strategic outsourcing, vendor management, site contracts and budgets, and investigator grant payments.

      I specialize in optimizing systems and workflows to ensure accuracy, compliance, and audit readiness, while building strong cross-functional partnerships across Clinical Operations, Finance, Legal, and Outsourcing.

      My experience is predominantly with early-stage biotech, preparing for Phase 1 trials and IPO in 1-3 years. While hands on, as the portfolio grows, I’ve built and led Clinical Business Operations teams.

      I enjoy solving complex problems, mentoring teams, implementing automation tools, and working at the intersection of data, people, and purpose-ultimately enabling faster, more transparent trials that serve patients and sites alike, while ensuring financial control and compliance with regulatory requirements.

      Session Details:

      PANEL: Driving technology and innovation in a small biotech

      2025-10-16, 11:30 AM

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      Molly James
      Associate Director, Strategic Sourcing, Beam Therapeutics

      Molly James is the Associate Director of Strategic Sourcing at Beam Therapeutics. In this role she manages all vendors and leads strategic partnerships for the development organization within Beam. She has over 10 years of experience in strategic sourcing and vendor management within the pharmaceutical industry.

      Session Details:

      PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

      2025-10-16, 9:00 AM

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      Allison Covucci
      Senior Director, Statistical Programming, Bristol Myers Squibb

      Session Details:

      Strength meets agility: Co-developing a framework for seamless FSO to FSP transition

      2025-10-16, 11:30 AM

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      Dan Housman
      Chief Executive Officer, Courage Therapeutics

      I am interested in acting as an entrepreneur to create companies that can build cultures and products that change the world. I am a versatile player willing to take on many different positions because of my background in both technology (chemistry, biology, software) and business. I prefer the role of visionary and to work to build a team, culture, product, and partnerships. I like the challenge of creating innovative solutions to hard underserved problems.

      I am currently focused on my start-up ventures including Graticule (Digital accelerators for Advanced real world data), Courage Therapeutics (medical discovery for eating disorders), and advocacy work towards improving research, treatment, and payment for Anorexia Nervosa.

      Session Details:

      CASE STUDY: Securing capital: funding strategies for biotechs and start up companies

      2025-10-15, 12:00 PM

      Session Details:

      PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

      2025-10-16, 9:00 AM

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      Behtash Bahador
      Senior Director, Community Engagement & Partnerships, CISCRP

      Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

      Session Details:

      From insight to impact: translating patient voices into study materials that matter

      2025-10-16, 9:00 AM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2025-10-16, 3:45 PM

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      Rebecca Nordland
      Senior Project Manager, Research Services, CISCRP

      Session Details:

      PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

      2025-10-15, 5:00 PM

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      Bailey Willis
      Associate Director, Medical Operations and Sourcing, Click Therapeutics

      Session Details:

      PANEL: AI and machine learning in clinical trials: where are we in 2025?

      2025-10-16, 10:00 AM

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      Kento Nakamura
      Strategy and Corporate Development, CMIC

      Kento Nakamura is a global professional having worked both in the Western and Eastern healthcare landscapes. He has been in various roles, contributing significantly to drug development, market access, and pharmaceutical marketing.

      At CMIC, Japan and South Korea’s first CRO, Kento wears multiple hats including helping formulate corporate strategy, creating mutually beneficial partnerships with other companies, and taking initiative to create business development opportunities.

      During his tenure at KM Pharmaceutical Consulting, a boutique drug development consulting firm, Kento co-pioneered the market access perspective on drug development, resulting in key additional endpoints in an ongoing phase 2 study. He also played a crucial role in developing the global drug safety plan, ensuring compliance with reporting requirements across multiple continents.

      Kento holds an MPH in Health Management from Harvard University and a BS in Biology from Tufts University. He is fluent in English and Japanese. In his free time, Kento enjoys playing tennis, watching football, visiting contemporary art museums, and traveling around the world.

      Session Details:

      PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

      2025-10-16, 1:30 PM

      Session Details:

      Clinical trials in Japan: a new era of opportunity for global sponsors

      2025-10-15, 9:00 AM

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      Ellyn Getz
      Director, R&D Patient Partnerships, R&D Strategic Operations, CSL Behring

      Session Details:

      From insight to impact: translating patient voices into study materials that matter

      2025-10-16, 9:00 AM

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      Gregg Beloff
      Founder, Danforth Health

      A business professional who has served as an executive officer in both privately held and publicly traded companies, an investment banker and a corporate attorney. Demonstrated experience in all aspects of financial and business management, strategy and operations including operations management, strategic planning, technology outlicensing, legal, mergers and acquisitions, IPO’s, private placements, finance and accounting, facilities, human resources, IT systems and corporate communications.

      Specialties: As CFO raised over $2 billion in equity and debt financings for emerging public and private companies
      Designed and executed financial and corporate development strategies
      Built and managed operational departments including finance and accounting, human resources, facilities, corporate communications and information systems
      Worked as both an investment banker and corporate attorney

      Session Details:

      PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

      2025-10-15, 11:00 AM

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      Rene Stephens
      Managing Director, Clinical Business Operations, Danforth Health

      Réne Stephens is a biopharmaceutical research and development industry consultant with over 25 years of business operations and outsourcing experience. He has worked within pharmaceutical, CRO, SMO, medical imaging, academic CRO, and EDC companies, and private consultation. Réne understands the critical path of development and has a wealth of experience in outsourcing/procurement strategies, practices and negotiations, vendor relationship management, oversight and governance, clinical operations, finance, contracting, process development and improvement, and technology solutions. He holds a BA in Corporate & Organizational Communications (WKU), and an MSHS in Clinical Research Administration (GWU). While at Astellas Pharma Global Development as Executive Director and global head of Contracts & Outsourcing, Réne also served as the Global Procurement Lead for TransCelerate Biopharma, Inc., acting on behalf of and supporting the 20 biopharmaceutical company consortium for vendor selection, negotiation, and governance. He is the former moderator for the quarterly Linking Leaders Outsourcing Roundtable meeting, where current issues are discussed among development outsourcing heads; and, he is a regular speaker at conferences and symposia on business operations topics as related to drug development, outsourcing, vendor and site contracting, and oversight/governance. Since 2017, he has been supporting biopharmaceutical companies in this function as the Managing Member and founder of Renatus Consulting, LLC.

      Session Details:

      PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

      2025-10-16, 9:00 AM

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      Rich Polgar
      Managing Director, Danforth Health

      Steering the helm for biotechs at Danforth Advisors, my strategic procurement proficiency shapes the landscape of clinical development. With a laser focus on sourcing strategy and risk mitigation, my contribution has been pivotal in advising organizations through critical transitions, including mergers and acquisitions. The expertise I honed while advising on operational growth strategies and variabilizing workforces underscores my current mission to optimize our clients' partnerships and exit strategies.

      My tenure as a Senior Director at Danforth Advisors cultivated a deep understanding of clinical sourcing, from preclinical and translational stages to real-world evidence and late-phase data analysis. This comprehensive background facilitates my current role, where I'm committed to advancing sourcing of trials & digital health through robust supplier and stakeholder engagement, thereby empowering the acceleration of our clients' portfolio growth and fostering strategic partnerships.

      Session Details:

      PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

      2025-10-15, 9:30 AM

      Session Details:

      PANEL: Staying resilient: leading your biotech through political and economic uncertainty

      2025-10-15, 2:00 PM

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      Nick Pelletier
      Vice President, Clinical Operations, Curis

      Session Details:

      Leveraging untapped resources: capitalizing on expertise from non-industry professionals

      2025-10-15, 11:00 AM

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      Sydney DeCaro
      Clinical Trial Associate, MapLight Therapeutics

      Clinical Operations and research professional with 5 years of clinical research experience, including greater than one year of experience in the biotechnology sector and multiple years leading trials and teams at academic medical research centers. I leverage my deep understanding of the patient journey and site-level operations to bring a site- and patient-centeric perspective to sponsor-side clinical trial execution, driving high-quality studies delivered on time, on budget, and with meaningful impact.

      Session Details:

      Leveraging untapped resources: capitalizing on expertise from non-industry professionals

      2025-10-15, 11:00 AM

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      Dr. Martin Bauer
      Chief Medical Officer, Eleva GmbH

      Session Details:

      Choosing the right CRO: key considerations for small biotechs

      2025-10-15, 4:00 PM

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      Jennifer Holloway
      Nurse Practitioner/ Sub-Investigator, EmVenio Clinical Research

      Jennifer Holloway is a board-certified Nurse Practitioner with a Doctor of Nursing Practice and over 10 years of experience in critical care and clinical research. Her career has focused on delivering high-acuity care while advancing evidence-based practices through research and quality improvement initiatives. Mrs. Holloway is passionate about bridging the gap between bedside care and clinical inquiry, and she continues to advocate for innovative, patient-centered approaches within interdisciplinary teams. Her work reflects a deep commitment to clinical excellence, research integration, and the ongoing advancement of nursing practice.

      Session Details:

      Community first: How local engagement builds better clinical trials

      2025-10-15, 11:30 AM

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      Carrie Lewis
      Executive Director, Clinical Program Optimization, Keenova Therapeutics

      Carrie Lewis is Executive Director of Clinical Program Optimization at Keenova, where she leads numerous operational teams. With over 20 years of experience across academia, global CROs, and sponsor organizations, she brings deep expertise in multiple therapeutic areas and clinical research strategy. Carrie holds a Master’s in Clinical Research Administration and is known for driving site innovation, reducing burden, and fostering strong partnerships in clinical trial operations.

      Session Details:

      CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

      2025-10-15, 5:00 PM

      Session Details:

      PANEL: Making a success of FSP models for your clinical trial

      2025-10-15, 3:00 PM

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      Vinnette Sallo
      Senior Director, Project Management, Ergomed

      Vinnette Sallo is a pharmaceutical professional with over 25 years of experience, currently serving as the Head of Project Management for North America at Ergomed CRO. A strategic, problem-solving leader committed to successful project delivery, fostering employee development, and ensuring customer satisfaction. She started her career in large pharma, progressing from development labs to managing clinical research studies from Phase I-IV. Her clinical research experience includes multiple therapeutic areas working in Clinical Development, Early Phase Oncology, Oncology Global Medical Affairs, and with Investigator Initiated Programs. Vinnette has also successfully supported FDA inspections throughout the development process leading to FDA approvals and has contributed to publications presented at international oncology symposiums.

      Session Details:

      I’ve chosen my CRO – Now what? Preparing for success in the first 90 days of your strategic partnership

      2025-10-16, 2:15 PM

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      Jerrold M. Shapiro
      President, Floelle

      An effective team-building leader who takes new medical devices from concept through design, pilot & production manufacturing, clinical trial, FDA regulatory approval, production and service. As an associate professor of medicine, surgery and ophthalmology at the Boston University School of Medicine, led interdisciplinary teams in creating, designing, developing, implementing and testing innovative biomedical instrumentation. Wrote proposals which secured over $1 million in federal research grants. Commercialized one of four patented inventions, designed and ran clinical trial and secured FDA 510(k) clearance. Used over 30 years of laser experience to develop diagnostic and therapeutic instrumentation.

      Current goals are to take Floelle Inc.'s patented small medical device through its Early Feasibility Study, pivotal clinical trial and FDA de novo 510(k) process (and the equivalent in Europe) into the market to restore the quality of life to one billion incontinent women worldwide, and to bring high value to physicians, third party payers, investors and governments, and well as removing trillions of absorbent products from landfills.

      Specialties: Development of new product concepts, taking concepts all the way to servicing the finished product in the field, regulatory affairs, all aspects of medical device manufacturing, purchasing, program management, engineering management, operations management, ophthalmology, dermatology, gynecology, urology, laser surgery, 3-D imaging, image processing, pharmacodynamics, among many others.

      Session Details:

      The Early Feasibility Study: getting it right for a medical device

      2025-10-16, 12:00 PM

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      Stephanie Bolick
      VP Biotech Development Operations, Fortrea

      Stephanie has nearly 3 decades of experience in the global biopharmaceutical industry specializing in end-to-end clinical development operations and delivery, strategic planning, and client management.  She leads the team of biotech portfolio leaders focused on delivery excellence, functional connectivity, and customer partnership – ensuring programs move with the speed, flexibility and expertise biotech clients require.  Stephanie’s core focus is to strengthen and evolve Fortrea’s biotech delivery strategy to stay ahead of industry needs, deliver with optimal agility and operational excellence, and consistently enhance the experience for our customers and their programs. She is passionate about cultivating strong, collaborative relationships – both within teams and with customers – and about equipping organizations to think entrepreneurially, move decisively, and deliver with accountability.  As a biotech-focused leader within Global Project Delivery, Stephanie offers executive-level engagement for biotech customers to support success and achieve business objectives.

      Session Details:

      Bridging the gaps: Integrating consulting and clinical operations to accelerate biotech development

      2025-10-15, 11:30 AM

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      Ingrid Abrahamsen
      Executive Director, Clinical Operations, Fulcrum Therapeutics

      Ingrid Abrahamsen is an experienced clinical research leader with a focus on clinical trial management and clinical operations. Her 15 years of experience have been concentrated in early and late phase rare disease and oncology clinical research. Her experience in the span of  the last 5 years has been focused in the cell and gene therapy (CGT) industry, contributing to the clinical development of multiple autologous cell and gene therapies. Most recently, Ingrid was leading clinical operations at Editas Medicine in the development of reni-cel, an AsCas12a gene-edited cell therapy in severe sickle cell disease (SCD).

      In her Clinical Operations leadership roles, Ingrid has formed and led teams to optimize clinical trial execution and build cross-functional relationships. Ingrid is currently the Head of Clinical Operations at Fulcrum Therapeutics, leading the advancement of their small molecule pipeline with their lead clinical program in SCD. Ingrid holds an MS and BS from Penn State University and is a Certified Clinical Research Professional (CCRP) via the Society of Clinical Research Associates (SOCRA).

      Session Details:

      PANEL: Staying resilient: leading your biotech through political and economic uncertainty

      2025-10-15, 2:00 PM

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      Rita Lemming
      Director, Clinical Operations, Fulcrum Therapeutics

      Clinical Research Leader with extensive experience overseeing pharmaceutical trials within oncological, central nervous system, rare disease, and infectious disease therapies, leveraging an intuitive blend of interpersonal skills to maintain cross-functional collaboration across internal and external stakeholders.
      Knowledgeable and respectful team player adept at building trust and mutual respect among vendors
      and team members to ensure quality execution. Highly motivated clinical operations specialist
      employing dedication, work ethic, flexibility, and an unwavering drive to improve patient lives through
      research trials.

      Session Details:

      PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

      2025-10-15, 8:30 AM

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      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

      Session Details:

      PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

      2025-10-16, 1:30 PM

      Session Details:

      Chairperson’s closing remarks

      2025-10-15, 5:30 PM

      Session Details:

      GlobalData opening remarks

      2025-10-15, 8:15 AM

      Session Details:

      PANEL: AI and machine learning in clinical trials: where are we in 2025?

      2025-10-16, 10:00 AM

      Session Details:

      PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

      2025-10-15, 8:30 AM

      Session Details:

      Chairperson’s opening remarks

      2025-10-16, 8:50 AM

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      Amanda Murphy
      Senior Director, Data Intelligence and Solutions,
      GlobalData Healthcare

      Session Details:

      Clinical trials surged in H1 2025! Where was the growth, will it continue and how to stay ahead

      2025-10-16, 2:45 PM

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      John Smutko
      Head of Oncology Scientific Operations, GSK

      Experienced BioPharma professional with a strong background in Genomics, Technical Support, Training, and Clinical Biomarker Operations.

      Session Details:

      The importance of accurate and consistent sample collection and management in clinical trials

      2025-10-16, 12:00 PM

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      Stacey Flattery
      Vice President, General Partner, ICON Biotech

      Session Details:

      Maneuvering with agility in a challenging landscape

      2025-10-15, 11:30 AM

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      Harsha K. Rajasimha
      MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

      Harsha K Rajasimha, Ph.D., is a serial entrepreneur, scientist, patient advocate, and philanthropist. Harsha is Founder and CEO of Jeeva Clinical Trials Inc.(https://jeevatrials.com) a AI-driven unified platform for sponsors to execute modern clinical trials with efficiency and universal accessibility. Harsha serves as the founder chairperson of the Indo US Organization for Rare Diseases (https://indousrare.org), where he is forging a new era of cross-border cooperation among various stakeholders of rare diseases in the US, India, and globally by convening the annual Indo US bridging RARE Summit (https://summit.indousrare.org) and the Abbey Meyers Khushi Bridging RARE Awards Gala.
      Harsha’s 20 years of experience in precision medicine data research spans academia, federally funded research, healthcare and life science consulting, and multiple startups. Harsha made bold career moves after losing a newborn child to a rare congenital disease in 2012 and his younger brother with juvenile diabetes in 2017. He decided to apply his years of postdoctoral training at NIH and FDA to combat rare diseases. At Jeeva, Harsha leads the development of a unified software platform for efficient clinical trials for rare and common conditions that are universally accessible. He knew that technology is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would be critical ingredients of the continuously learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to diverse patients who need them anywhere by over 3x faster.
      Harsha maintains academic affiliation at George Mason University since 2012 and has authored 17+ publications, book chapters, and patents. Harsha’s work has been recognized by Lead India Foundation 2020 Award for leadership and outstanding achievement in rare diseases, a travel award to join the NGO Committee on Rare Diseases at the United Nations headquarters, New York City in Feb 2019, NTT DATA Healthcare Life Sciences Silver award for outstanding achievement 2017, Sanofi Genzyme patient advocacy leadership award 2016, Bioscience company of the year 2014, NEI director’s innovation award 2012 for building their genomics data infrastructure. Harsha earned his M.S. in Computer Science (2004) and Ph.D. in Genetics, Bioinformatics and Computational Biology (2007) from Virginia Tech.

      Session Details:

      Reimagining the clinical trials infrastructure for Inclusive and accessible rare diseases and orphan therapies

      2025-10-16, 10:00 AM

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      Shailesh Chavan
      Managing Partner, Ingenious Global Venture Partners

      Physician-scientist executive with experience in the industry (pharma, biotech & CRO). Leadership role with focus on patient centric innovation, building and leading high performing teams in Early to Late Phase Product development, launch and life-cycle management, business development, due diligence and integration. Ability to integrate development and operations experience in various TA's including Immunology, Oncology, Neurology and Transplantation.
      All opinions and views are my own.

      Session Details:

      INTERACTIVE SESSION: What are investors looking for in a biotech or start up?

      2025-10-16, 10:00 AM

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      Kelsey Miller-Torchia
      Senior Vice President, Clinical and Business Development, Intrinsic Therapeutics

      Session Details:

      PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

      2025-10-15, 4:00 PM

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      Michael Murphy
      Director, Legal and Associate General Council, Ionis Pharmaceuticals

      Session Details:

      Studies Beyond Borders: Managing the logistics of conducting worldwide clinical trials

      2025-10-16, 9:00 AM

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      Beth Chamblin
      Senior Director, Project Management, Late Phase Oncology, IQVIA Biotech

      Beth Chamblin has 25 years of experience in Pharmaceutical/BioPharmaceutical development, including over 15 years in global clinical project management and 4 years in oncology project management. At IQVIA Biotech, she specializes in strategic oversight of late-phase global clinical programs, supporting emerging biotech companies. Beth has managed global Phase I-III studies across multiple regions and has expertise in novel trial designs. She also leads a team of 10 project managers/directors, providing mentoring and support. Her broad experience allows her to align each study with a company's long-term goals, ensuring project success.

      Session Details:

      Driving innovation in clinical research with master protocols

      2025-10-15, 12:30 PM

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      Leonella Seeley
      Director, Vendor Management and Operations, Karyopharm Therapeutics

      Session Details:

      PANEL: Making a success of FSP models for your clinical trial

      2025-10-15, 3:00 PM

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      Kathleen Martyn
      Manager, Vendor and Clinical Operations, Karyopharm Therapeutics

      Session Details:

      PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

      2025-10-15, 9:30 AM

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      Jay Russak
      Senior Director, Clinical Operations, Keros Therapeutics

      Jay has over 17 years of clinical development experience.  He currently is the clinical lead for the PAH program at Keros Therapeutics.  He has been working at smaller biotech companies for the last 8 plus years.  In addition, he is an adjunct faculty member at Northeastern University teaching in the Masters of Regulatory Affairs program.

      Session Details:

      PANEL: Driving technology and innovation in a small biotech

      2025-10-16, 11:30 AM

      Session Details:

      PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

      2025-10-15, 8:30 AM

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      Harry Barnett
      Executive Chairman, Lubris Biopharma

      Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

      Session Details:

      PANEL: Assessing the impact of the political and economic landscape in the US on outsourcing decisions in pharma

      2025-10-15, 8:30 AM

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      Paul O’Donohoe
      Senior Director, eCOA Product and Science, Medidata

      Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health, and is responsible for ensuring internal teams, partners and Sponsors are following industry, regulatory and scientific best practices when it comes to integrating technology into clinical trials. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium. Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.

      Session Details:

      AI in eCOA: Separating today’s opportunities from tomorrow’s possibilities

      2025-10-15, 2:30 PM

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      Christopher Schoonmaker
      Chief Operating Officer, MMS Holdings

      A biostatistician by training, Chris is an executive leader with the technical and business experience required to lead in the clinical research industry. He held executive and senior leadership roles before MMS, including management of biometrics operations as well as oversight of key customer accounts. His key strengths include his statistical and data expertise, building and maintaining required operational delivery models to ensure quality delivery, implementing effective governance to ensure successful client collaborations and relationships, and providing statistical consultation.  Throughout his career, Chris has been a statistical lead for hundreds of clinical studies, served as a voting member on data monitoring committees, and guided the statistical strategy for regulatory submissions.

      As Chief Operating Officer, Chris has global responsibility for operations across all MMS service lines globally as well as business strategies for growth. Chris is responsible for driving corporate operational excellence, including talent planning, productivity improvements and cost management across the organization.

      Chris received his Master of Public Health in Epidemiology and Biostatistics from Boston University.

      Session Details:

      3 technology use cases shaping the future of trial design and implementation

      2025-10-16, 11:30 AM

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      Amir M. Behdani
      PharmD, Biomarker Development Postdoctoral Fellow, Novartis

      Session Details:

      Digital health innovations in cardiovascular clinical trials: assessing Apple Watch as a sensor-based digital health technology for atrial fibrillation

      2025-10-16, 11:00 AM

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      Andy Liu
      General Manager - China, Novotech

      Mr. Andy Liu has strong operational experience in the CRO industry and a deep understanding of the regional market. Andy worked at Covance, Inc., a global CRO, for more than 10 years in a number of executive positions. Before joining PPC group, he was General Manager of Covance’s Central Laboratory Service, Asia Pacific, where he led a large multi-functional team of around 500 employees across multiple sites in APAC. Andy holds an MBA from the Booth School of Business at the University of Chicago, an MS in Electrical Engineering from the Rose-Hulman Institute of Technology, and a BS in Electrical Engineering from Tsinghua University.

      Session Details:

      China as an Early Phase Solution: Opportunities for US Sponsors

      2025-10-15, 10:00 AM

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      Marilyn Fontaine
      Director of Clinical Operations, Nuvation Bio

      Marilyn is currently Director of Clinical Operations at Nuvation Bio. She has dedicated the past 12 years to clinical development and operations, with a sole focus in oncology drugs. She is passionate about executing clinical trials with agile and innovative teams and enjoys working with emerging biotech companies to establish flexible, best practice processes.

      Session Details:

      Accelerating site activation and study start up

      2025-10-16, 11:00 AM

      Session Details:

      PANEL: Driving technology and innovation in a small biotech

      2025-10-16, 11:30 AM

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      Yolanda Wan
      Head of Clinical Operations, Orna Therapeutics

      Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

      Session Details:

      PANEL: Running clinical trials in different geographical regions: benefits of running trials inside vs outside the US

      2025-10-16, 1:30 PM

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      Kerri McCaul-Claus
      Vice President, Head of FSP Biometrics, Parexel

      Kerri oversees the global Functional Service Provider (FSP) biometrics team at Parexel, spanning North America, South America, EMEA, and APAC.

      With tenure at Parexel of more than 28 years, Kerri has also overseen Parexel’s team of FSP solution consultants, and served in a commercial and sales support role and as a solution consultant herself. Kerri’s career at Parexel spans more than 19 years in operational management in statistical programming. She brings a wealth of expertise, a deep understanding of client needs, and a passion for operational excellence. Kerri holds a master’s degree in health studies from Brock University.

      Session Details:

      Strength meets agility: Co-developing a framework for seamless FSO to FSP transition

      2025-10-16, 11:30 AM

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      T.J. Sharpe
      Patient Advocate

      T.J. Sharpe is a Stage IV melanoma survivor who began sharing his journey through cancer as a blogger and later a keynote speaker. Diagnosed in August 2012 and given two years to live, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials. His story of overcoming numerous issues to find, select, enroll, and complete two trials illustrates the hurdles many patients encounter when faced with a difficult diagnosis.
      Taking his personal journey and the insights gleaned from a decade+ of listening to and working with leaders in healthcare, clinical research, digital medicine technologies, and patient advocacy, he speaks frankly about and works tirelessly towards creating advanced patient engagement to benefit all.
      Now a speaker, writer, and patient expert consultant, he has worked with top pharmaceutical companies and clinical research stakeholders to address the power imbalance in patient care through sustained, ingrained, and consistent patient engagement. A South Jersey native, T.J. lives in Fort Lauderdale with his wife Jennifer and two children, Josie and Tommy. He is active on Twitter at @TeamTJSharpe and LinkedIn at https://www.linkedin.com/in/tjsharpe/.

      Session Details:

      PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

      2025-10-15, 5:00 PM

      Session Details:

      Chairperson’s opening remarks

      2025-10-16, 8:50 AM

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      Stacey Oppenheimer
      Director, Third Parth Quality Lead, Pfizer

      Stacey Oppenheimer is in the Clinical Imaging group at Pfizer in Cambridge, MA, where she is the Head of Vendor Oversight and Sourcing for Pfizer’s clinical trials with imaging.  In this role, she specializes in alliance management, issue resolution, auditing and providing scientific guidance for clinical study teams.  Prior to this role, she was an imaging lab head at Pfizer in the Drug Metabolism and Medicinal Chemistry Departments. She has a PhD in Chemistry from Vanderbilt University and an MBA from Northeastern University.

      Session Details:

      PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

      2025-10-15, 9:30 AM

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      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

      Session Details:

      Chairperson’s closing remarks

      2025-10-15, 5:30 PM

      Session Details:

      Chairperson’s opening remarks

      2025-10-16, 8:50 AM

      Session Details:

      Chairperson’s opening remarks

      2025-10-15, 8:25 AM

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      Marilyn Kludt
      Senior Project Director, Oncology, Premier Research

      Marilyn Kludt, Senior Project Director, Oncology, at Premier Research is highly experienced in clinical development within the CRO, pharmaceutical, and biotech environments. Her emphasis is in Global Project Management, Strategic Alliances, Functional Service Provisioning, and Global Clinical Operations. Marilyn has experience in Phases I-IV across extensive therapeutic areas with the most recent 12 years focused on early phase international programs in oncology and haematology. Her unique experience includes FIH, Head and Neck TIL infusion, CAR T-cell therapy, and Richter’s Transformation.

      Session Details:

      Strategic site selection in early development: Meeting the demands of complex therapies

      2025-10-15, 4:30 PM

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      Amanda Fierro
      Project Manager, Oncology, Premier Research

      Amanda Fierro, Project Manager, Oncology, at Premier Research is leading cross-functional teams to support the planning and launch of clinical trials. She ensures the on-time delivery of key study milestones by working closely with internal teams, sponsors, and vendors. Amanda brings expertise in clinical project management and imaging. She previously served as a Clinical Project Manager at an imaging vendor, and she is committed to fostering strong collaboration across all stakeholders to drive successful study outcomes.

      Session Details:

      Strategic site selection in early development: Meeting the demands of complex therapies

      2025-10-15, 4:30 PM

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      Matthew Birmingham
      Head, Supply Chain and External Manufacturing, Prime Medicine

      Matt Birmingham is a seasoned operations leader with over 24 years of experience managing clinical and commercial operations in the biologics and cell and gene therapy (CGT) industries. His career includes extensive experience leading teams and operations at Genentech where he oversaw quality engineering and validation of computerized systems and laboratory equipment, clinical and commercial production planning and commercial product distribution and logistics for high-value biologics and small-molecule products.  Matt has spent the last 10 years playing pivotal roles in building and strengthening supply chains for leading CGT companies, contributing to the successful launch of four commercial CGT products. As Senior Director of Supply Chain and External Manufacturing at Prime Medicine, Matt leads all clinical manufacturing and supply chain operations for autologous cell and in vivo gene therapies.

      Matt holds an MBA from the University of Maryland, a Bachelor of Science in Business Administration from the University of Vermont, and is APICS Certified in Production and Inventory Management.

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      Katerina Chatzi
      Founder and Chief Executive Officer, Promakhos Therapeutics

      Session Details:

      PANEL: Patient advocacy and incorporating patient perspectives early on in a small biotech

      2025-10-15, 5:00 PM

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      Emily McInturf
      Director, Feasibility, PSI CRO

      Emily McInturf, Director of Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

      Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives. As a director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

      Session Details:

      PSI’s VISIONAL: enhancing feasibility and enrollment predictions with GenAI

      2025-10-15, 4:30 PM

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      Leticia Tarilonte
      Vice President, Head of Global Clinical Operations, Former Pyxis Oncology

      Leticia has over 23 years of industry experience managing several research projects and clinical studies in various roles. She started her career in Pharma at Biogen, working collaboratively in an integrated monoclonal antibody research team and then moving to development in clinical operations, where she managed numerous phase I-III clinical trials in diverse therapeutic areas including, gastroenterology, immunology, neurology, and neuropathic pain.

      She continued her career at Merck/EMD Serono where she provided strategic and operational expertise in the planning and conduct of several Phase I-III clinical studies in oncology and immuno-oncology, which led to the FDA accelerated approval of BAVENCIO® in merkel cell carcinoma and in urothelial carcinoma. Later she served as a Chief of Staff to the Sr. VP and Head of Development in Oncology, where she partnered with executive sponsors to identify and promote projects that are of strategic importance to the company and translating the function strategy into operational plans.
      After many years in big Pharma, Leticia continued her career at various biotech companies: first at Kiniksa Pharmaceuticals, where she was responsible for various programs with high complexity in rare diseases, consisting of numerous global clinical trials in 10 different indications. Followed by Black Diamond Therapeutics, a biotech company addressing the significant unmet need for novel precision oncology therapies for patients with genetically defined cancers. In her last role, Leticia served as the Clinical Operations Lead at Nimbus Therapeutics, a biotech company working on the development of a HPK1 inhibitor in solid tumors.

      Leticia also serves as an IRB Member at Yale University and is the Chair and President of the Association of Clinical Research Professionals (ACRP) - New England Chapter.
      Leticia earned her Bachelor’s Degree in Biomedical Laboratory and Clinical Sciences from the School of Medicine at Boston University, followed by a Master’s Degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences in Boston.

      Session Details:

      PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

      2025-10-15, 4:00 PM

      Session Details:

      PANEL: Making a success of FSP models for your clinical trial

      2025-10-15, 3:00 PM

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      Jenifer Waldrop
      Executive Director, Rare Disease Diversity Coalition

      I am a results-driven healthcare executive with a proven track record of fostering organizational excellence and advancing initiatives that strengthen communities. By promoting fairness, opportunity, and innovation, I create meaningful solutions that improve access to care for underserved populations while supporting the success of organizations and fostering a culture of collaboration and shared purpose. My niche is taking complex ideas, analyzing and communicating them effectively to the respective audiences. My key skills include leading teams, fostering global perspectives, facilitating, coaching, providing consultative services, and managing budgets. I thrive in a team-oriented organization where everyone feels welcome. I believe in having authentic and transparent relationships, in promoting an inclusive environment with a diverse group of multi-cultural thinkers to promote innovation and creativity in obtaining targets. I have been described as “the consummate professional who is warm and approachable." #ONO

      Session Details:

      Reimagining the clinical trials infrastructure for Inclusive and accessible rare diseases and orphan therapies

      2025-10-16, 10:00 AM

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      Beth Davis
      Senior Manager, Development Services and Operational Excellence, Vendor and Relationship Management Lead, Regeneron

      Session Details:

      PANEL: Making a success of FSP models for your clinical trial

      2025-10-15, 3:00 PM

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      Christer Nilsson
      Chief Executive Officer, Replior

      Christer Nilsson is a dynamic entrepreneur and the CEO of Replior, bringing over 30 years of leadership experience in IT, Finance, and Life Sciences. Throughout his career, he has successfully launched and managed several businesses with a strong focus on innovation and customer satisfaction. At Replior, Mr. Nilsson is committed to a transparent and honest approach, ensuring that clients’ needs are at the heart of every decision. He leads the integration of cutting-edge digital endpoints, sensor technology, and gamification strategies into clinical research solutions, aimed at reducing patient dropout and increasing compliance. Under his leadership, Replior is pioneering a more patient-centric and effective model for clinical trials.

      Session Details:

      Gamification in clinical trials: A proven path to better engagement, retention, and data integrity

      2025-10-15, 12:30 PM

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      John Seman
      Chief Executive Officer, Revitale Pharma

      John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

      Session Details:

      PANEL: Making a success of FSP models for your clinical trial

      2025-10-15, 3:00 PM

      Session Details:

      Chairperson’s closing remarks

      2025-10-15, 5:30 PM

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      George Tetz
      Chief Executive Officer, Second Life Therapeutics

      George Tetz, MD, PhD, and CEO/Cofounder of Second Life Group, has dedicated his life’s work to addressing some of medicine’s most unmet needs.

      Second Life Group includes three different clinical-stage entities, including Second Life Therapeutics, Second Life Diagnostics, and Second Life Vaccines. Together, these companies address some of the most critical, unmet needs in medicine, including advanced solid tumors, antibiotic resistance and longevity with first-in-class personalized medicines and medical devices.

      Throughout his career as both a medical practitioner and researcher, Dr. Tetz has focused on applying cutting-edge multifactorial approaches to a variety of medical problems. One of his most groundbreaking findings is the existence of the previously unknown Universal Receptive System and Teazeled receptors. With this discovery, Dr. Tetz is modulating cellular memory for the first time, bringing cell control to a new and unprecedented level.

      Dr. Tetz began his career as a medical practitioner, then earned his PhD in molecular microbiology. He serves as Director of the Department of Systems Biology at the Human Microbiology Institute, where he played an integral role in groundbreaking studies. Dr. Tetz is also a member of the American Society for Microbiology, Society for Neurosciences, and New York Academy of Sciences.

       

      Session Details:

      PANEL: The New England biotech landscape in 2025: growths, shifts and strategic outlook

      2025-10-15, 11:00 AM

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      Sarah Woods
      Founder, Serenely Guided Foundation

      Session Details:

      FIRESIDE CHAT: Keeping patients and caregivers at the center of rare disease clinical trials: collaborating with patients, caregivers, and nonprofits for better outcomes

      2025-10-15, 12:00 PM

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      Colleen Smith
      Director, Clinical Affairs Operations, Siemens Healthineers Endovascular Robotics

      Session Details:

      PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

      2025-10-15, 4:00 PM

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      Brad Stefanovic
      Head of Clinical Innovations, Simulations Plus

      Clinical Research, Bio-Tech, expert with over 18 years of experience working in the Life Sciences Industry. Brings a unique blend of clinical trial expertise, safety management, scientific and technology consulting. Possesses strong team-working, leadership, communication skills and attention to detail. Enthusiastic and excited about furthering the cause of clinical research.

      I was born in Australia and reside in New York City, NY and I am fortunate to be in an extremely active family. Being from this environment with active siblings had thrust me into a leadership position early in my life and I have embraced that leadership mentality ever since. I wake every morning thankful for the great family and friends I now call family.

      Session Details:

      TECHNOLOGY SPOTLIGHT: The impact of Simulation-Based learning on Study Acceleration – Spoken from the Sponsor who converted

      2025-10-15, 2:30 PM

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      Nicole McElroy
      Director, Strategic Partnerships and Outsourcing, Takeda

      Customer-focused healthcare manager with 20+ years of experience (11 years at Takeda/Shire, 7 years at Pfizer/Wyeth) in Clinical Research and Pharmaceutical industries. Expertise managing teams (up to 6 employees); overseeing complex vendor relationships; and negotiating clinical vendor and investigator contracts, and phase I–IV master service agreements. Proven record implementing innovative tools, processes, metrics, strategic practices, and global trainings to improve supplier and site management, outsourcing management, vendor qualification, vendor accountability, contract negotiations, compliance, and profitability. Earned numerous awards for exceeding goals and work excellence.

      Session Details:

      PANEL: Strengthening supplier relationships: strategies for positive collaboration and communication

      2025-10-15, 9:30 AM

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      Rinaldo Dorman
      Global Category Manager, Clinical Development Services, Takeda
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      Louisa Carlse
      Director of Partnerships, TecEx Medical

      Proven success in supporting the Health and Lifesciences industry as Partnership Director.   Fostering B2B partnerships, and driving customer success initiatives for overall efficiency across clinical trials in support of timely delivery of supplies to sites and patients. Recognized for implementing key projects, reducing compliance risks, and leading Importer of Record initiatives. Leader with a visionary and strategic mindset, fostering innovation, inclusivity, and continuous improvement.

      Session Details:

      Beyond the Middleman: Strategic Outsourcing of IOR/EOR for Global Clinical Trials

      2025-10-16, 9:30 AM

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      Jessica Wessel
      Senior Director, Project Delivery, TFS HealthScience

      Session Details:

      From first step to final outcome: Reframing feasibility as an operational strategy

      2025-10-15, 2:30 PM

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      April Mattison-Wolfe
      Senior Manager Technical Services, TransPerfect

      April Mattison-Wolfe brings 24 years of Clinical Operations experience to TransPerfect’s Trial Interactive (TI) Technical Services, including 7+ years as a Clinical Operations Trainer and Clinical Business Systems Analyst. With expertise from both sponsors and CROs, she helps TI clients identify CTMS needs and configure tailored solutions. April’s deep understanding of clinical systems requirements and pharmaceutical business practices ensures clients optimize their clinical trial management systems for efficiency and compliance.

      Session Details:

      Beyond Integration: How AI Creates a Clinical Trial Platform

      2025-10-16, 9:30 AM

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      Katherine Cianciarelli
      Senior Product Manager, eTMF and AI, TransPerfect

      Katherine Cianciarelli is a senior product manager with almost a decade of experience in eClinical technology. An engineer by trade, she focuses on building practical AI tools that improve clinical research workflows. Her work centers on finding smart ways to optimize processes while ensuring responsible and compliant technology use, always seeking to bridge the gap between technical innovation and real-world research needs.

      Session Details:

      Beyond Integration: How AI Creates a Clinical Trial Platform

      2025-10-16, 9:30 AM

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      Katie Norton
      Trial Optimization SME

      Katie Norton is a transformational leader with over 20 years of experience building and scaling patient recruitment, feasibility, and engagement functions for global clinical trials. She has led high-impact organizational change at companies including Moderna, EMD Serono, and Takeda, creating innovative, patient-centered strategies that accelerate development and deliver meaningful results.

      Session Details:

      PANEL: Driving technology and innovation in a small biotech

      2025-10-16, 11:30 AM

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      Liza Micioni
      Director, Clinical Operations, Tris Pharma

      With over 25 years of progressive experience in clinical operations, project management, and medical affairs, Liza Micioni brings a deep understanding of the clinical development lifecycle. Her expertise spans early- to late-phase clinical trials across a broad spectrum of therapeutic areas, including rare diseases, CNS disorders including pain management, and immunology. Liza consistently demonstrates the ability to translate complex scientific and regulatory requirements into actionable strategies that drive operational excellence and accelerate timelines.

      Throughout her career, Liza has successfully led global cross-functional teams, managed multimillion-dollar clinical programs, and built high-performing clinical operations departments from the ground up. She is known for her collaborative leadership style, strategic foresight, and unwavering commitment to quality and compliance. Her ability to foster strong partnerships with investigators, CROs, vendors, and internal stakeholders has been instrumental in delivering multiple clinical trials on time and within budget.

      Liza is passionate about advancing innovation in clinical research by embracing emerging technologies and championing patient-centric solutions that improve trial accessibility, efficiency, and overall impact. She is a strong advocate for continuous improvement and operational agility, consistently seeking new ways to elevate patient engagement and optimize outcomes. Her work is driven by a deep sense of purpose: to contribute meaningfully to the development of life-changing therapies that improve the lives of patients.

       

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2025-10-16, 3:45 PM

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      Richard A. Graham
      Ph.D., Co Founder and Chairman of the Board, TruTechnologies

      Richard Graham, founder of Mirador Therapeutics and TruTechnologies, is a seasoned leader with extensive experience in business operations, corporate strategy, fundraising, scientific research, and therapeutics development. He excels at aligning corporate strategy with scientific expertise and building partnerships with executives, board members, and investors.

      A proven leader in global team management, Rick has successfully driven large-scale R&D programs from concept to completion, consistently achieving ambitious milestones. His work has advanced therapeutics through late-stage development, contributing to the approvals of Erivedge™, Kadcyla™, Kyprolis™, Perjeta™, and Yupelri™.

      Session Details:

      Driving asset value through operational precision

      2025-10-15, 4:30 PM

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      Mary Jo Lamberti
      Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development

      Research Assistant Professor at Tufts University School of Medicine and Director of Sponsored Projects at Tufts CSDD.
      Expertise in benchmarking drug development operating practices.
      Research focus includes outsourcing and partnerships; clinical supplies; investigative site initiation and management; patient recruitment and retention; and the use of technologies and digital solutions in clinical trials.
      Published extensively and is a frequent speaker at global conferences.
      Current Initiatives Include:
      • Study volunteer diversity in clinical trials
      • Benchmarking patient recruitment and retention practices
      • Industry use of automation, IT technologies and applications

      Session Details:

      Updates and developments on Tufts CSDD: DIA collaborative study results: using AI and ML in clinical development

      2025-10-15, 12:00 PM

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      Maria Florez
      Senior Consultant, Tufts Center for the Study of Drug Development

      Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

      Session Details:

      Updates and developments on Tufts CSDD: DIA collaborative study results: using AI and ML in clinical development

      2025-10-15, 12:00 PM

      Session Details:

      Direct-to-Patient Shipments of Investigational Products

      2025-10-15, 5:00 PM

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      Sean D. Smith
      Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection
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      Meredith Frank-Molnia
      Vice President, Clinical Affairs, Vericel Corporation

      Meredith Frank-Molnia is currently employed as Vice President of Clinical Affairs at Vericel Corporation. Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

      Session Details:

      PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

      2025-10-15, 4:00 PM

      Session Details:

      Implementing an EDC system: operational and technical considerations

      2025-10-15, 2:00 PM

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      Vikas Agarwal
      PhD, Chief Executive Officer, WeaveBio Therapeutics

      Session Details:

      PANEL: Handling finances for your biotech: tips for managing funding, investment and budgets

      2025-10-16, 9:00 AM

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      Derek Ansel
      Vice President, Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

      Derek Ansel is the Vice President, Therapeutic Strategy Lead, Rare Disease at Worldwide Clinical Trials.  Mr. Ansel has worked in clinical research for more than a decade with a focus almost exclusively in rare and pediatric diseases, including non-malignant hematology, autoimmune diseases, metabolic disorders, movement disorders, and other genetic conditions. At Worldwide, he leads and supports corporate initiatives within rare and pediatric diseases and maintains relationships with over 60 patient-focused advocacy organizations. He holds a master’s degree in Pharmacology and Toxicology from Michigan State University and is pursuing a master’s degree in Genetic Counseling from Bay Path University.

      Session Details:

      Beyond the Buzzword: Practical AI strategies for accelerating clinical research

      2025-10-15, 12:30 PM

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      Daniel Klamer
      Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

      Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development.

      Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

      Session Details:

      Harnessing real world experience: driving innovation and decision making

      2025-10-15, 3:00 PM

      Session Details:

      PANEL: Staying resilient: leading your biotech through political and economic uncertainty

      2025-10-15, 2:00 PM

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      Aditya Kotta
      VP Business Development, Novotech

      Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

      Session Details:

      PANEL: Staying resilient: leading your biotech through political and economic uncertainty

      2025-10-15, 2:00 PM

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      OCT Advisory Board

      Select a member to learn more

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      Dr Alison McMorn
      Head of Clinical Strategy and Development, LifeArc

      Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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      Behtash Bahador
      Senior Director, Community Engagement & Partnerships, CISCRP

      Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

      Session Details:

      From insight to impact: translating patient voices into study materials that matter

      2025-10-16, 9:00 AM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2025-10-16, 3:45 PM

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

      Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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      Aditya Kotta
      VP Business Development, Novotech

      Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

      Session Details:

      PANEL: Staying resilient: leading your biotech through political and economic uncertainty

      2025-10-15, 2:00 PM

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      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Opella

      Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

      I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, Keenova

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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      Edwin van Vulpen
      Executive Director and Head of Clinical Business Development Euro-Asia
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      +61 280 978 126

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      Valentina Sidore


       

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