16th Annual Outsourcing in Clinical Trials New England 2024

This year's Outsourcing in Clinical Trials New England event will boast 4 tracks on Clinical Operations and Outsourcing, Clinical Technology and Innovation, Rare Diseases, and Patient Recruitment and Engagement, meaning for anyone involved in the operational aspects of running a clinical trial, there truly is something for everyone.

23 - 24

October

2024
  • Westin Boston Seaport, Boston, USA
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
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Featured Speakers

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Ken Getz​

Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

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Ankita Deshpande​

Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals

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Leonella Seeley​

Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics

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Janet Peterson​

Associate Director, Patient Insights and Clinical Trial Experience, Biogen

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Charity Roddy​

Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna

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Jay Russak​

Senior Director, Clinical Operations, Keros Therapeutics

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    Sponsors Included:

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    Company Information

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

    To learn more, please visit our website - http://www.iconplc.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 34,000 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 2,200 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

    Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

    Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

    The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

    For more information or to speak to an expert team member visit www.Novotech-CRO.com

    Company Website

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

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    Company Information

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    Company Information

    ARENSIA Exploratory Medicine, a German company, specializes in “first-in-patient” Phase IB and II/PROOF-OF-CONCEPT clinical trials spanning various patient populations. Equipped with 14 proprietary research clinics and advanced Phase I infrastructure, ARENSIA exceptionally accelerates the detection of initial efficacy signals for novel compounds at an unrivalled speed. ARENSIA’s streamlined approach significantly slashes patient recruitment time and costs by at least 50%, as opposed to overcrowded and understaffed conventional trial sites. The company’s remarkable efficiency is underscored by its 93% repeat business rate, propelling its growth and collaborations with leading pharmaceutical companies, biotechs, and global CROs. H3.eadquartered in Düsseldorf, ARENSIA operates with a workforce of over 450 employees across 8 countries.

    Company Website

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

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    Company Information

    Clario is a leading healthcare research and technology company that generates high quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac safety, 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 2019.

    Company Website

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

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    Company Information

    Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. We are known for our superior statistical leadership and data management expertise and proud to have supported  thousands of studies across a diverse range of diseases.  For more than 40 years, Emmes has been dedicated to research for a healthier world.

    Company Website

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

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    Company Information

    PCM Trials has been at the forefront of decentralized clinical research since 2008, leading mobile visits and recently introducing community-based research sites. We are driving the shift to patient-centric clinical trials, giving individuals the flexibility to engage in research studies in ways that work best for them. Our approach expands opportunities for participation, resulting in greater patient diversity, reduced patient dropout, and faster study results.

    Company Website

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

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    Company Information

    Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

    Company Website

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

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    Company Information

    Pro-ficiency converts training from a cost center to a powerful quality improvement system. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. Pro-ficiency ensures that everyone in your study is compliant with all training requirements.

    Company Website

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

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    Company Information

    SubjectWell is the risk-free clinical trials marketplace that only charges for patients who randomize. Our unique approach raises awareness of the benefits of clinical research and engages the public when they are not thinking about their conditions. This gives SubjectWell access to tens of millions of patients and when combined with our high-touch approach, allows us to deliver qualified referrals who randomize at three to five times the rate of other sources.

    Company Website

    To learn more, please visit our website - www.SubjectWell.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

    TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc.), pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement.

    Company Website

    To learn more, please visit our website - https://lifesciences.transperfect.com/

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    Company Information

    Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

    RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

    RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

    RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

    Company Website

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

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    Company Information

    At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

    Company Website

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

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    Company Information

    Viroclinics-DDL, a Cerba Research Company is a leading specialty contract research organization, serving the biopharmaceutical community with a broad range of non-clinical research, clinical diagnostics, assay development, laboratory, and clinical trial logistic services. It offers its clients a global reach through a network of 38 processing laboratories.

    More Info:

    www.viroclinics.com

    www.ddl.nl

    Company Website

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

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    Company Information

    Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

    Company Website

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

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    Company Information

    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

    Company Website

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

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    Company Information

    Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

    Company Website

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

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    Company Information

    IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

     

    Company Website

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

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      Why attend?

      The 16th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations.

      This two day programme will feature four streams on Clinical Operations and Outsourcing, Clinical Technology and Innovation, Patient Recruitment and Engagement, and Rare Diseases, with a mixture of case studies, panel discussions and workshops looking at optimizing your clinical trial strategy. We will explore topics including diversity and inclusion in clinical trials, choosing and working with vendors, the potential uses of AI to increase efficiency in clinical trials, patient centricity in clinical trials, and much much more. Register now to book your place at the conference.

       

      Outsourcing clinical trials can be of particular interest to online casino players. Our Outsourcing in Clinical Trials event in 2023 will consist of 4 tracks, each with something for online casino source link players. In addition, this event will bring together many specialists in clinical trials, who also play in online casinos.

      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

      Agenda

      • 23 Oct 2024
      • 24 Oct 2024
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      Streams

      Stream one

      Stream A: Clinical Outsourcing and Operations

      Stream two

      Stream B: Clinical Technology and Innovation

      Stream three

      Stream C: Patient Recruitment and Engagement

      10:30 AM

      Morning refreshments and networking break

      11 AM

      Best practice for biopharma and advocacy group collaborations in order to boost recruitment for trials

      • How successful collaboration with advocacy groups can boost recruitment and enrolment
      • Strategies for building effective partnerships with advocacy groups
      • Utilizing patient-centric approaches to enhance trial recruitment efforts
      • The impact of a patient-focused trial design on accelerating timelines

      Speakers

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

      11:30 AM

      Diversity Action Plans: preparing, submitting, and receiving regulatory feedback

      • An overview of recent US legislation around diversity in clinical trials
      • Understanding requirements around DAP approval and submission: what should you include?
      • Preparing documentation to demonstrate diversity in your clinical trial
      • Experience with DAPs in view of the received FDA feedback

      Speakers

      Alicia M. Baker McDowell
      Head of Regulatory Strategy and Product Development Consulting, Fortrea

      12 PM

      PANEL: Achieving diversity and inclusion in patient recruitment

      • DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
      • Navigating FDA regulations and devising a strategy for diversity and inclusion
      • Building trust and relationships with communities who may not traditionally participate in clinical trials
      • Working with advocacy groups to increase trial diversity and patient numbers

      MODERATOR:

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

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis
      Patrick Ezeh
      Director, Clinical Trial Diversity Portfolio Lead, Biogen
      Tammy Burke
      Patient Advocate
      Behtash Bahador
      Director, Health Literacy, CISCRP
      Alicia M. Baker McDowell
      Head of Regulatory Strategy and Product Development Consulting, Fortrea

      12:30 PM

      Patient-guided by design: a framework for successful study start-up, informed protocol design and better outcomes

      • Optimizing study-start up for improved timelines and site performance
      • Integrating patient input into protocol design and the impact of patient motivation assessments
      • Case studies: patient-informed protocol design for successful outcomes

      Speakers

      Deborah Jakubowski Russ
      Director, Launch Excellence Leads, Parexel

      1 PM

      Lunch and networking break

      2 PM

      Beyond trial participation: engaging rare disease patients in the long term

      • Biopharma’s role in supporting patients with their disease once no longer study participants
      • Working with advocacy groups on long term patient engagement
      • Where and how can trial sponsors step in to provide long term support for rare disease patients?
      • Bridging the scientific advice gap for patients with rare diseases

      Speakers

      Kate Tith
      Vice President, Head of Clinical Operations, Dyne Therapeutics

      2:30 PM

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      This presentation delves into dynamics of enrollment challenges and underscores the significance of fostering strong site relationships in rare diseases, which often prove instrumental in driving successful outcomes. Beginning with a compelling case study, we navigate key drivers influencing sponsor decision-making processes, creating innovative strategies that positively impact the study. Emphasizing the paramount importance of timelines, we discuss how sponsor decisions are strategically molded to align with project deadlines. Through the lens of the “one team, one approach” philosophy, we highlight collaborative strategies that surmounted our enrollment hurdles effectively. Key takeaways offer actionable insights for stakeholders navigating the complex terrain of rare disease research, paving the way for enhanced enrollment outcomes.

      Speakers

      Urania Rappo
      Senior Medical Director, Clinical Development, BiomX
      Caitlin Hirschman
      Executive Director, Project Delivery, Rho

      3 PM

      PANEL: How minimizing participant burden leads to on-time enrollment and completion

      • Patient reimbursement: how to relieve financial pressures on patients participating in trials
      • Where are the main hurdles patients face and how can these be removed?
      • Addressing low levels of health literacy in the patient population: how to improve communication
      • Engaging patients and advocacy groups early on in the clinical trial design process

       

      Speakers

      Leticia Tarilonte
      Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics
      Colleen Graham
      Vice President, Head of Clinical Operations, Mediar Therapeutics
      Charity Roddy
      Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna
      Tammy Burke
      Patient Advocate
      G Bernard Wandel
      Clinical Trial Patient

      3:30 PM

      Afternoon refreshments and networking break

      3:50 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 vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      4 PM

      Utilizing technology to improve patient recruitment and retention

      • Methods to streamline patient recruitment and enrolment processes
      • AI and ML as methods of speeding up enrolment timelines in order to reduce overall trial costs
      • Engaging patients through social media and other digital channels

      Speakers

      Jenn Curry
      Head of Patient Engagement Capabilities, Biogen

      4:30 PM

      Clinical site support and patient enabling services

      • Everything starts with strategic site selection and feasibility
      • Understand the value of patient engagement and measuring its impact on the trial successful completion
      • Know your sites, know their needs, customize your support
      • Innovative patient centric approach: defining a set of strategies designed to place the needs, preferences, and experiences of patients at the

      Speakers

      Atalah Haun
      Vice President, Global Medical Affairs, WEP Clinical

      5 PM

      Successful recruitment for a rare disease trial

      • Patient identification: how to find patients who are eligible to participate in your rare disease trial
      • Collaborating with patient advocacy groups to facilitate recruitment
      • How does recruitment in rare diseases differ from other therapeutic areas?

      Speakers

      Chris Adams
      Chief Executive Officer, Andarix

      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

      10:30 AM

      Morning refreshments and networking break

      11 AM

      Applying Lean Six Sigma methodology to reduce the lead-time of clinical contracting

      • Clinical contracting is on the critical path to trial start
      • It is a process where bottlenecks and root causes can be identified via data analysis
      • Lean Six Sigma methodology can help to significantly reduce contracting lead-time

      Speakers

      Alex Bai
      Head of Clinical Contracts, Biogen

      11:30 AM

      Enhancing clinical trial integrity: safeguarding endpoints with patient technology

      • Ensuring data accuracy: utilize eCOA to capture patient-reported outcomes in real-time, reducing errors and enhancing data reliability
      • Streamlining patient enrollment: implement IRT to manage patient randomization and drug supply logistics, ensuring compliance and minimizing risks of bias
      • Enhancing patient compliance: leverage eConsent to provide clear, accessible information to participants, ensuring informed consent and improving retention
      • Strengthening data security: integrate robust encryption and authentication measures across eCOA, IRT, and eConsent platforms to protect sensitive data and maintain trial integrity
      • Facilitating regulatory compliance: ensure all digital tools comply with regulatory standards (eg FDA, EMA) to streamline approval processes and enhance trial credibility

      Speakers

      Anthony Mikulaschek
      VP, Commercial Strategy, IQVIA Technologies

      12 PM

      Study results: using AI in clinical development

      • Results of a collaborative industry survey on the use of AI and machine learning within clinical research and development
      • Mapping AI usage and level of adoption
      • Examine perceptions and attitudes regarding use of AI and machine learning and challenges to implementation

      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

      Accelerating clinical trials with meaningful AI

      Explore how artificial intelligence is revolutionizing the speed, quality, and consistency within clinical trials through innovative technologies and real-world applications. This presentation explores:

      • Preparing your organization
      • How to identify AI opportunities and associated value
      • Real life examples of using AI to accelerate clinical trials

      Speakers

      Brian Wehrle
      Vice President, R&D Imaging, Clario

      1 PM

      Lunch and networking break

      2 PM

      PANEL: How do we work together to deliver GenAI for clinical trials?

      • How AI and digitalization can support streamlining of clinical operations and improve efficiency
      • Simple ways to implement tools such as GPT and GenAI
      • Where can AI be utilized to minimize workloads and increase overall output?
      • The regulatory landscape in the US for the use of AI in clinical trials: what do you need to know?
      • Key limitations of GenAI and how these impact its potential uses for clinical trials in the US

      Speakers

      John J. Seman
      Chief Executive Officer, REVITALE Pharma
      Ankita Deshpande
      Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals
      Maria Florez
      Senior Consultant, Tufts Center for the Study of Drug Development
      Jia Chen
      Senior Director, Medidata AI, Medidata

      2:30 PM

      Oversight for all: achieve data transparency with elluminate

      Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources:

      • How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
      • AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
      • Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
      • Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management

      Speakers

      Jason Konn
      Solution Consultant, eClinical Solutions

      2:45 PM

      Enhancing clinical trial outcomes with a unified eClinical platform

      Speakers

      Stacey Lasser
      Senior Project Manager, Mednet

      3 PM

      Site activation and study start up: making processes more efficient

      • How early should you begin planning study start up and site activation?
      • Tips and tricks to reduce start up timelines for your trial
      • Fostering a strong relationship with sites to accelerate study start up and reduce overall timelines

      Speakers

      Jay Russak
      Senior Director, Clinical Operations, Keros Therapeutics

      3:30 PM

      Afternoon refreshments and networking break

      3:50 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 vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      4 PM

      Assessing patient attitudes to the use of AI in clinical trials

      • Review the results of a public and patient survey on the use of AI to develop clinical trial documents
      • Assess patient level of trust in and comfort with the use of AI to generate patient-facing clinical trial documents
      • Discuss the patient’s views on the importance of human review of AI-generated content and implications for the future

      Speakers

      Shalome Sine
      Senior Manager and Quantitative Insights Specialist, Research Services, CISCRP

      4:30 PM

      Increase trial agility with our integrated reporting tool

      • High-level study metrics and plan
      • Discover data outliers with intuitive dashboards
      • Deep dive into the data with the Data Browser
      • Standard Reports, including Key Risk Indicator to track site trends
      • Create unlimited custom, user generated reports

      Speakers

      Kelsey Buhler
      Product Specialist, Viedoc Technologies

      5 PM

      eConsent and the benefits for patients, sites, investigators and sponsors

      • Using eConsent as a tool to speed up recruitment and thus overall trial timelines
      • The regulatory landscape surrounding eConsent: what challenges are there to this?
      • Maintaining a relationship with patients in order to ensure consent is informed in remote settings

      Speakers

      Meredith Frank-Molnia
      Senior Director, Clinical Operations, Third Pole Therapeutics

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Meredith Frank-Molnia
      Senior Director, Clinical Operations, Third Pole Therapeutics

      END OF DAY 1 AND NETWORKING DRINKS

      7:30 AM

      Registration and refreshments

      8:20 AM

      Chair’s opening remarks

      Speakers

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

      8:30 AM

      OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

      • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
      • Staff turnover and layoffs: handling changes in the industry in order to ensure success
      • New regulations and guidance around clinical trials in the US: how will this impact you?
      • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
      Harry Barnett
      Executive Chairman And Founder, Lubris BioPharma
      Kevin Killeen
      Chief Scientific Officer, Matrivax
      Nick Pelletier
      Head of Clinical Operations and Program Management, Delix Therapeutics
      Manny Lazaro
      Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

      9 AM

      Reducing trial start-up time through an innovative approach to vendor qualification

      • Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help sponsors onboard vendors more quickly leading to a real reduction in clinical trial start-up times
      • Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations strength their compliance practices in a heavily regulated industry
      • Uncover the advantages of a centralized approach to vendor qualification that provides unique benefits to both sponsors and vendors across the globe

      Speakers

      Anthea Dransfield
      Head of Quality, Diligent Pharma

      9:30 AM

      Considerations for successful third party vendor management

      • What degree of oversight should you have over third party vendors?
      • Risks and benefits of handing third party management to CROs
      • Regulatory and quality considerations around outsourcing to third party vendors

      Speakers

      Leticia Tarilonte
      Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics

      10 AM

      Importance of forecasting clinical trial enrollment: an AI enabled approach to increase confidence in feasibility and execution

      • Learn how to pressure-test site footprint through predictive analytics by forecasting enrollment at the country and site level
      • Discover methods to run re-forecasts based on actual study performance for more accurate tracking and adjustments as necessary
      • Gain competitive advantage thru actionable insights to remain agile and avoid costly enrollment delays
      • Learn how to leverage data to identify low-performing sites earlier in the trial process to implement effective risk mitigation tactics

      Speakers

      Chloe Ren
      Lead Data Scientist, Medidata AI, Medidata

      10:30 AM

      Morning refreshments and networking break

      11 AM

      PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

      • Weighing up pros and cons of different outsourcing models: which is best for your trial?
      • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
      • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
      • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?

      Speakers

      John J. Seman
      Chief Executive Officer, REVITALE Pharma
      Rinaldo Dorman
      Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
      Judith Murphy
      Executive Director, Centralized Contracting and Outsourcing, Kura Oncology
      Derek Pu
      Director, R&D Procurement, Servier Pharmaceuticals

      11:30 AM

      Maximizing the consultative partnership between CRO and biotech sponsors

      • How early engagement can improve outcomes
      • Unlocking the value of your pipeline
      • Purposeful partnering with bespoke solutions

      Speakers

      Stacey Flattery
      Vice President, General Partner, ICON Biotech

      12 PM

      FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

      • Importance of retention and growth for your team
      • Openness to junior clinical team members
      • Openness to bridge programs with vendor partner
      • Navigating these challenges in a hybrid environment

      Speakers

      Carrie Lewis
      Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
      Joan Ramella
      Associate Director, Clinical Operations, Endo USA, Inc

      12:30 PM

      Beyond the protocol: crafting expert CRAs for impactful rare disease trials

      • Understanding the role of Key Opinion Leaders beyond data collection
      • Educating CRAs on the impact of safeguarding future customer relationships
      • Prioritizing site satisfaction for patient happiness
      • Enhancing patient outcomes through site relationship building

      Speakers

      Juliane K Mills
      Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

      1 PM

      Lunch and networking break

      2 PM

      From fantasy to function: authentic sponsor-vendor engagement

      • Priorities and strategies for small biotech in partnering with CROs and vendors
      • Breaking down the myths
      • Identifying the right partners
      • Cultivating collaborative relationships
      • Managing the partnership

      Speakers

      Colleen Graham
      Vice President, Head of Clinical Operations, Mediar Therapeutics

      2:30 PM

      Building your toolkit: how to operationalize FDA guidance on diversity today

      • Understand the key points of recent FDA guidance aimed at enhancing diversity and equity in clinical trials
      • Discuss how recent FDA guidance supports patient optionality in clinical trials, especially for underrepresented populations
      • Identify actionable strategies for integrating FDA guidance into clinical trial designs to achieve diversity and innovation goals
      • Explore the potential impact of FDA guidance on future clinical trials, with an emphasis on patient-centricity and inclusivity

      Speakers

      Kris Booth
      Director of Strategic Partnerships, EmVenio
      Stephanie Hitchcock
      Associate Director of Project Management, PCM Trials

      3 PM

      Fostering a productive CRO/Sponsor relationship and factors to consider before undertaking a transition to a new CRO

      • Planning for a successful sponsor/CRO relationship
      • Defining goals, priorities and metrics
      • Considerations when contemplating a CRO transition
      • Overview of common challenges and pitfalls in CRO transitions
      • Developing a detailed transition plan to minimize disruptions and ensure continuity

      Speakers

      Helen Chalk
      Vice President, Clinical Operations, Mythic Therapeutics

      3:30 PM

      Afternoon refreshments and networking break

      3:50 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 vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

      4 PM

      PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

      • Ensuring your trial is both cost-conscious and efficient without compromising on quality
      • Techniques, processes and technology to improve forecasting and budgeting
      • Avoiding common mistakes to keep your clinical trial budget on track

      Speakers

      Harry Barnett
      Executive Chairman And Founder, Lubris BioPharma
      Veronica Ludensky
      Director of Procurement, Clinical, Flagship Pioneering
      Brenda J Boyle
      Senior Director, Clinical Vendor Strategy and Partnerships, Agios
      Derek Pu
      Director, R&D Procurement, Servier Pharmaceuticals
      Jennifer Sydney Goldman
      Clinical Business Operations Consultant, Day One Biopharmaceuticals

      4:30 PM

      Cardiac data matters: keeping patients at the heart of innovation

      • Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology
      • Dive into the transformative power of AI and explore real-world applications reshaping cardiac care
      • Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety
      • Uncover the revolutionary role of AI in interpreting cardiac data
      • Review practical examples and case studies demonstrating effectiveness of continuous cardiac monitoring in clinical settings

      Speakers

      Ana Natera
      Director, Clinical Business Strategy, HeartMetrics Cardiac Monitoring, Medtronic

      5 PM

      The state of the biopharmaceutical industry in 2025

      • Reviewing results from our annual survey: were 2024 predictions correct?
      • Key themes and technology advancements in biopharma
      • Spotlight on clinical trial technologies for drug development
      • Leveraging data to predict the outlook for 2025 clinical trial outsourcing
      • Trends, key players, opportunities and threat in biopharma
      • What the latest investment trends show for small to medium biotechs

      Speakers

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

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Rinaldo Dorman
      Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

      END OF DAY 1 AND NETWORKING DRINKS

      Streams

      Stream one

      Stream A: Clinical Outsourcing and Operations

      Stream two

      Stream B: Clinical Technology and Innovation

      Stream three

      Stream C: Rare Diseases

      9 AM

      Innovation and digital health for rare diseases

      • Challenges and limitations of rare disease research: how new solutions can help to overcome this
      • Embracing a patient centric approach in rare disease trials through digital health
      • Opportunities for innovation for orphan drug trials in the US

      Speakers

      Ankita Deshpande
      Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals

      9:30 AM

      Exploring the UAE’s clinical research landscape: unlocking opportunities and driving innovation

      • The UAE as a prominent hub for research and clinical trials, driven by a focus on healthcare innovation and patient-centric approaches
      • The UAE’s comprehensive regulatory framework that supports and facilitates clinical research
      • Training and upskilling local researchers and clinicians in research methodologies
      • Prioritizing patient-centric approach, engaging patient communities and advocacy groups

      Speakers

      Rohan Simon
      Associate Director, Business Development, IROS by M42

      10 AM

      PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

      • Working closely with patients, caregivers and advocacy groups in clinical trial design
      • The importance of building a close relationship with patients for trials where patients are the expert in their disease
      • Reducing the financial burden of clinical trial participation on patients
      • How to make trial participation easier on patients: where are the main hurdles impacting enrolment?
      • Building long term relationships with patients post clinical trials

      Speakers

      Nan Doyle
      Patient Advocate
      Leticia Tarilonte
      Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics
      Lily Cappalletti
      Director, Patient Experience, Alexion Pharmaceuticals
      Janet Peterson
      Associate Director, Patient Insights and Clinical Trial Experience, Biogen
      Sue Kahn
      Board Member, IFOPA

      10:30 AM

      Morning refreshments and networking break

      11 AM

      CASE STUDY: Improving patient and site experience for rare disease trials

      • Sponsors’ roles in supporting sites in order to increase trial efficiency and decrease overall timelines
      • Where can clinical trial sponsors better support patients with rare diseases both during trials and in the long term?
      • Lessons learned from Moderna’s experience of site and patient engagement during clinical trials

       

      Speakers

      Charity Roddy
      Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna

      11:30 AM

      Rare disease studies: benefits of a hybrid outsourcing strategy

      A look at the pros and cons of various outsourcing models including Full-Service Outsourcing (FSO), Functional Service Provision (FSP), and single service. A discussion of the benefits of a hybrid approach are explored.

      Speakers

      Ajay Sadhwani
      Senior Vice President, Operations, Harbor Clinic

      12 PM

      Insights into barriers to care in the rare disease community

      • Insights on the differences between represented and underrepresents populations on their barriers to care
      • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
      • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers
      • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement

      Speakers

      Jenifer Waldrop
      Executive Director, Rare Disease Diversity Coalition

      12:30 PM

      Lunch and networking break

      9 AM

      Uncovering RBQM adoption levels and mapping implementation: a novel comprehensive assessment

      • Learn about a new comprehensive approach to assessing RBQM adoption
      • See recent data on current and future levels of RBQM adoption among industry sponsors and CROs
      • Discuss a maturity model that characterizes levels of adoption among industry sponsors
      • Discuss perceived challenges associated with the implementation of RBQM components
      • Discuss opportunities and benefits of RBQM implementation

      Speakers

      Abigail S Dirks
      Data Scientist, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

      9:30 AM

      Biometrics considerations in implementing new technology

      • How to keep up with rapid changes in technology?
      • How do all the systems interact with each other?
      • What is the ultimate goal?

      Speakers

      David Ng
      Vice President, Global Biometrics, Novotech

      10 AM

      FIRESIDE CHAT: Deploying an effective monitoring strategy

      • Budget considerations
      • In house vs outsourced
      • Site relationship management
      • Effective risk-based approach
      • Remote vs on-site

      Speakers

      Suzanne Murphy
      Director, Clinical Operations, Compliance and Oversight, Editas Med
      Matt Weinberg
      Director, Clinical Outsourcing and Alliance Management, Intellia Therapeutics

      10:30 AM

      Morning refreshments and networking break

      11 AM

      Next generation biotherapeutics: bacteria as a novel drug delivery device

      • Non-pathogenic, non-replicative, immune protected bacteria engineered to safely deliver biologic therapeutic payloads intracellular to targeted tissues
      • Bacteria capable of delivering biologics as in mRNA, siRNA, proteins/nanobodies, and CRISPR/Cas, independent of size
      • Reaches tissues that cannot be targeted by viral vectors or lipid nanoparticles
      • Efficiently target even hard-to-reach tissues and tumors
      • Revolutionizes future of treatment by ensuring better outcomes for patients

      Speakers

      David Sherris
      Board Member, SiVEC Biotherapeutics

      11:30 AM

      Leveraging technology to ease patient burden: the right solutions for better clinical trials

      • Discover the technology behind patient-centric trials: explore the cutting-edge tools that streamline trial processes and minimize patient burden, improving both retention and outcomes
      • The smart use of tech in clinical trials: learn how to strategically implement technology to enhance patient experiences without compromising data integrity or trial efficiency.
      • Balancing innovation with human touch: understand when technology empowers clinical trials and when human intervention remains critical, ensuring the right blend for successful studies.
      • Practical insights on reducing patient burden: gain actionable insights into how technology can be applied to simplify patient participation, from remote monitoring to decentralized trial designs
      • Where tech truly makes an impact: explore specific phases and aspects of clinical trials where technology transforms patient engagement and drives trial success

      Speakers

      Kris O’Brien
      Vice President, Oncology and Rare Diseases, TFS HealthScience

      12 PM

      Clinical supply chain procurement challenges in 2024

      • Overview of evolving challenges and solutions in clinical supply chain procurement
      • Examination of the impact of the geopolitical and geoeconomic climate on procurement
      • Regulatory considerations and compliance challenges in clinical supply chain management

      Speakers

      Heng Liu
      Director of Procurement, I-Mab Biopharma

      12:30 PM

      Lunch and networking break

      8 AM

      Registration and Refreshments

      9 AM

      Site relationship management: key ways to develop and maintain effective partnerships with sites

      • How sponsors can support and reduce burden on sites in order to shorten overall trial timelines
      • Top tips for training site staff with new processes and technology
      • Managing relationships with short staffed and under resourced sites to ensure your trial stays on track

      Speakers

      Marilyn Fontaine
      Director of Clinical Operations, Nuvation Bio

      9:30 AM

      Driving success through well-planned study start-up

      • Defining a start-up plan based on key study objectives
      • Using a data driven approach for effective start-up planning, including data from regulatory intelligence, site intelligence, and KPIs to support start-up planning
      • How effective start-up execution drives a successful trial

      Speakers

      Ashley Sullivan
      Director, Study Start-Up, Allucent

      10 AM

      Navigating multiple regulatory agencies to help expedite supply chain times

      • Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
      • Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
      • Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
      • Learning about valuable resources and contacts for assistance

      Speakers

      Sean Smith
      Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
      Baljeet Kaur
      Agriculture Operations Manager, US Customs and Border Protection

      10:30 AM

      Morning refreshments and networking break

      11 AM

      PANEL: Fostering a strong relationship with your CRO to make your trial a success

      • Technology and new developments when it comes to managing CRO relationships
      • How to ensure your study is prioritized
      • Maintaining a strong relationship with vendors in remote and hybrid work settings
      • How to blend a CRO team with your internal team in order to foster communication and overall success of your trial
      • CRO monitoring and oversight: how to make processes efficient and effective

      Speakers

      Leonella Seeley
      Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics
      Yolanda Wan
      Head of Clinical Operations, Orna Therapeutics
      Molly James
      Associate Director, Strategic Sourcing, Beam Therapeutics
      Brenda J Boyle
      Senior Director, Clinical Vendor Strategy and Partnerships, Agios
      Judith Murphy
      Executive Director, Centralized Contracting and Outsourcing, Kura Oncology

      11:30 AM

      Propelling asset development through integrated regulatory, clinical, and medical expertise

      • Discover the benefits this model brings to strategic asset development
      • Understand the optimal timepoints for CRO engagement
      • Discuss tips for maximizing your CRO’s expertise to support a comprehensive development plan
      • Review real-world examples demonstrating the advantages of this approach

      Speakers

      Elaina Haeuber
      Senior Vice President, Oncology, Premier Research

      12 PM

      Frustrations of a CRO sales guy, or, a guided tour of the clinical trial outsourcing world, from both sides of the negotiation table

      Speakers

      David Gibboni
      Independent Clinical Outsourcing Expert

      12:30 PM

      Lunch and networking break

      1:30 PM

      KEYNOTE PRESENTATION: Report Card on the use and impact of patient engagement practices in drug development

      • Overview of the value proposition and expected financial return of patient engagement practices
      • Review of current adoption levels of patient engagement practices
      • Assessment of the impact of patient engagement practices on performance and quality
      • Discussion of opportunities to optimize patient engagement and its impact

      Speakers

      Ken Getz
      Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

      2:15 PM

      Efficient data orchestration in clinical trials

      • Advantages of using a data-focused CRO and technology to manage data related activities
      • Simplifying process and leveraging efficiencies to reduce risk and cost
      • Understand key gateways to ensure quality and coordination
      • Sponsor perspective and benefits of outsourcing models

      Speakers

      Amy Manley
      Vice President, Clinical and Medical Operations, Paratek Pharmaceuticals
      Ben Dudley
      Chief Commercial Officer, MMS Holdings Inc
      Michelle Gayari
      Executive Vice President, Global Operational Excellence and Innovation, MMS Holdings Inc

      2:45 PM

      KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

      • Navigating new regulations around clinical trials smoothly and successfully
      • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
      • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
      • How may geopolitical and geoeconomic events including the financial crisis, the Inflation Reduction Act and the upcoming election impact clinical trials in the US?
      • Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5 years?

      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 Plc
      Jay Russak
      Senior Director, Clinical Operations, Keros Therapeutics
      Harry Barnett
      Executive Chairman And Founder, Lubris BioPharma
      RINALDO DORMAN, MBA, CPSM
      Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
      Manny Lazaro
      Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

      3:15 PM

      Afternoon refreshments and networking break

      3:35 PM

      EXHIBITION APPLE 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: Importing and exporting biological materials to or from the U.S

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

      Baljeet Kaur, Agriculture Operations Manager, U.S. Customs and Border Protection
      ROUNDTABLE 2: Pros and cons of different outsourcing models: FSO vs FSP vs inhouse

      Yolanda Wan, Head of Clinical Operations, Orna Therapeutics
      ROUNDTABLE 3: Enabling the most inclusive approach to patient engagement

      Lily Cappalletti, Director, Patient Experience, Alexion Pharmaceuticals
      ROUNDTABLE 4: Topic TBC

      Kate Tith, Vice President, Head of Clinical Operations, Dyne Therapeutics
      ROUNDTABLE 5: Building efficient and effective relationships with sites

      Peter Koefler, Director, Study Site Engagement, Takeda

      Speakers

      Sean Smith
      Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
      Yolanda Wan
      Head of Clinical Operations, Orna Therapeutics
      Lily Cappalletti
      Director, Patient Experience, Alexion Pharmaceuticals
      Kate Tith
      Vice President, Head of Clinical Operations, Dyne Therapeutics
      Peter Koefler
      Director, Study Site Engagement, Takeda
      Cory Burke
      Executive Director, Head of Biometrics and Data Management, Black Diamond Therapeutics
      Baljeet Kaur
      Agriculture Operations Manager, US Customs and Border Protection

      End of Conference

      Speakers

      Select a speaker to learn more

      Back
      Ken Getz
      Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

      Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

      Session Details:

      KEYNOTE PRESENTATION: Report Card on the use and impact of patient engagement practices in drug development

      2024-10-24, 1:30 PM

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      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:

      Best practice for biopharma and advocacy group collaborations in order to boost recruitment for trials

      2024-10-23, 11:00 AM

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      Brenda J Boyle
      Senior Director, Clinical Vendor Strategy and Partnerships, Agios

      Session Details:

      PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

      2024-10-23, 4:00 PM

      Session Details:

      PANEL: Fostering a strong relationship with your CRO to make your trial a success

      2024-10-24, 11:00 AM

      View In Agenda
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      Ankita Deshpande
      Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals

      Session Details:

      PANEL: How do we work together to deliver GenAI for clinical trials?

      2024-10-23, 2:00 PM

      Session Details:

      Innovation and digital health for rare diseases

      2024-10-24, 9:00 AM

      View In Agenda
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      Lily Cappalletti
      Director, Patient Experience, Alexion Pharmaceuticals

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

      Session Details:

      PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

      2024-10-24, 10:00 AM

      View In Agenda
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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:

      Successful recruitment for a rare disease trial

      2024-10-23, 5:00 PM

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      Marilyn Fontaine
      Director of Clinical Operations, Nuvation Bio

      Marilyn has dedicated the past 11 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:

      Site relationship management: key ways to develop and maintain effective partnerships with sites

      2024-10-24, 9:00 AM

      View In Agenda
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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: Fostering a strong relationship with your CRO to make your trial a success

      2024-10-24, 11:00 AM

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      Hasim Khorakiwala
      Associate Director, Global R&D Sourcing, BeiGene
      Next speaker
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      Patrick Ezeh
      Director, Clinical Trial Diversity Portfolio Lead, Biogen

      Session Details:

      PANEL: Achieving diversity and inclusion in patient recruitment

      2024-10-23, 12:00 PM

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      Jenn Curry
      Head of Patient Engagement Capabilities, Biogen

      Session Details:

      Utilizing technology to improve patient recruitment and retention

      2024-10-23, 4:00 PM

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      Janet Peterson
      Associate Director, Patient Insights and Clinical Trial Experience, Biogen

      Session Details:

      PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

      2024-10-24, 10:00 AM

      View In Agenda
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      Cory Burke
      Executive Director, Head of Biometrics and Data Management, Black Diamond Therapeutics

      Cory Burke is the Executive Director Head of Biometrics and Data Management at Black Diamond Therapeutics. Cory has over 25 years of experience in the pharmaceutical industry in both CRO and Sponsor side. She has worked in many aspects of data management, database programming and SAS programming in the industry. She works collaboratively with Clinical Operations, Medical, Translational Medicine and many other cross functional teams. She has worked on a wide range of therapeutic areas (Oncology, Dermatology, Cardiology, Gastrologic,etc) from Phase I-IV.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

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      Leticia Tarilonte
      Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics

      Session Details:

      PANEL: How minimizing participant burden leads to on-time enrollment and completion

      2024-10-23, 3:00 PM

      Session Details:

      Considerations for successful third party vendor management

      2024-10-23, 9:30 AM

      Session Details:

      PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

      2024-10-24, 10:00 AM

      View In Agenda
      Next speaker
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      Rebecca Nordland
      Senior Project Manager, CISCRP
      Next speaker
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      Laura Taraboanta
      Director, Medical Operations and Strategy, Click Therapeutics

      Laura Taraboanta, MS is a clinical strategy and development professional with a demonstrated history in health care and clinical trials. She is currently the of Head Clinical Innovation at Click Therapeutics, with a focus on improving speed, efficiency, and cost of prescription digital therapeutics discovery, development and implementation. Prior to Click, Laura was leading clinical operations at Woebot Health, a mental health company focused on delivering evidence-based treatment through an AI chatbot. Laura has been part of two successful FDA Breakthrough Designations for software as medical devices and has overseen numerous research projects in CNS and oncology, tapping into the potential of virtual trials to empower patients. Laura is keen on tackling health disparities by accelerating digital therapeutic development so that clinically-proven, safe and effective solutions can be universally available to patients and their providers.

      Next speaker
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      Shaheen Lakhan
      Chief Medical Officer, Click Therapeutics
      Next speaker
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      Manny Lazaro
      Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

      Session Details:

      OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

      2024-10-23, 8:30 AM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

      2024-10-24, 2:45 PM

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      Nick Pelletier
      Head of Clinical Operations and Program Management, Delix Therapeutics

      Nick is a globally experienced Clinical Operations, Program and Vendor Management professional with greater than 15 years of experience across the biotech/pharmaceutical industry. He is currently the Head of Clinical Operations and Program Management at Delix Therapeutics. Prior to Delix, Nick has spent time at CRO’s and both small and large Biotech, in roles of increasing responsibility across Research and Development. Nick holds both a Bachelor of Science degree and MBA from the University of Massachusetts Amherst.

      Session Details:

      OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

      2024-10-23, 8:30 AM

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      Kate Tith
      Vice President, Head of Clinical Operations, Dyne Therapeutics

      Session Details:

      Beyond trial participation: engaging rare disease patients in the long term

      2024-10-23, 2:00 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

      View In Agenda
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      Suzanne Murphy
      Director, Clinical Operations, Compliance and Oversight, Editas Med

      Session Details:

      FIRESIDE CHAT: Deploying an effective monitoring strategy

      2024-10-24, 10:00 AM

      View In Agenda
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      Veronica Ludensky
      Director of Procurement, Clinical, Flagship Pioneering

      Session Details:

      PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

      2024-10-23, 4:00 PM

      View In Agenda
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      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

      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:

      OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

      2024-10-23, 8:30 AM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

      2024-10-24, 2:45 PM

      Session Details:

      The state of the biopharmaceutical industry in 2025

      2024-10-23, 5:00 PM

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      Ajay Sadhwani
      Senior Vice President, Operations, Harbor Clinic

      Ajay Sadhwani is an executive Life Science Professional with over 25 years of clinical research experience. Proven leader of cross functional teams and people management of large and small functional groups with a track record of successfully leading teams and motivating individuals to perform at their highest level.

      Session Details:

      Rare disease studies: benefits of a hybrid outsourcing strategy

      2024-10-24, 11:30 AM

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      Sue Kahn
      Board Member, IFOPA

      Session Details:

      PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

      2024-10-24, 10:00 AM

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      Heng Liu
      Director of Procurement, I-Mab Biopharma

      Session Details:

      Clinical supply chain procurement challenges in 2024

      2024-10-24, 12:00 PM

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      Matt Weinberg
      Director, Clinical Outsourcing and Alliance Management, Intellia Therapeutics

      Session Details:

      FIRESIDE CHAT: Deploying an effective monitoring strategy

      2024-10-24, 10:00 AM

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      Leonella Seeley
      Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics

      Session Details:

      PANEL: Fostering a strong relationship with your CRO to make your trial a success

      2024-10-24, 11:00 AM

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      Jay Russak
      Senior Director, Clinical Operations, Keros Therapeutics

      Session Details:

      Site activation and study start up: making processes more efficient

      2024-10-23, 3:00 PM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

      2024-10-24, 2:45 PM

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      Judith Murphy
      Executive Director, Centralized Contracting and Outsourcing, Kura Oncology

      Session Details:

      PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2024-10-23, 11:00 AM

      Session Details:

      PANEL: Fostering a strong relationship with your CRO to make your trial a success

      2024-10-24, 11:00 AM

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      Harry Barnett
      Executive Chairman And Founder, 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:

      OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

      2024-10-23, 8:30 AM

      Session Details:

      PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

      2024-10-23, 4:00 PM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

      2024-10-24, 2:45 PM

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      Kevin Killeen
      Chief Scientific Officer, Matrivax

      Session Details:

      OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

      2024-10-23, 8:30 AM

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      Colleen Graham
      Vice President, Head of Clinical Operations, Mediar Therapeutics

      Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes Phases I-IV drugs, biologics and device studies across a variety of therapeutic areas working with companies such as Biogen, Pfizer, and Takeda Pharmaceuticals. Her operational experience includes resource management, process development and she has managed large-scale global studies. Colleen is currently Director of Clinical Development Operations at Momenta Pharmaceuticals, where she responsible for clinical development of M281 in rare immune-mediated diseases.

      Session Details:

      From fantasy to function: authentic sponsor-vendor engagement

      2024-10-23, 2:00 PM

      Session Details:

      PANEL: How minimizing participant burden leads to on-time enrollment and completion

      2024-10-23, 3:00 PM

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      Eric Harvey
      Senior Director, Biometrics and Data Science, MMS

      Eric Harvey is the Senior Director of Biometrics and Data Science at MMS. He has over 20 years of experience in pharmaceutical research, spanning pre-clinical through phase IV clinical trials, device and diagnostic studies. Prior to MMS, he led biostatistics, programming, data management, data science and information technology groups at various CROs. He also led a clinical research department at a large hospital system. Eric is a problem solver at heart whose focus is to identify data driven opportunities to increase efficiency and improve quality.

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      Helen Chalk
      Vice President, Clinical Operations, Mythic Therapeutics

      Helen Chalk is a Clinical Development leader who has worked in Clinical and Program Management roles across the pharmaceutical, biotechnology and CRO sectors for over 25 years.  She has a breadth of global industry experience including oversight of Phase 1-4 clinical trials, medical affairs and global managed access programs in indications including oncology, autoimmune disorders, respiratory disorders, cardiovascular and infectious diseases.  Fueled by opportunities to build effective, cohesive teams and processes, Helen enjoys the challenges and daily risk management required to develop drugs and bring them to market.

      Beyond work, Helen loves to travel with her family and spend time with her two dogs.  Helen relishes any opportunity to ride horses and to volunteer in a therapeutic riding program in Norfolk, MA.

      Session Details:

      Fostering a productive CRO/Sponsor relationship and factors to consider before undertaking a transition to a new CRO

      2024-10-23, 3:00 PM

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      Maria de Assis
      Senior Director, Clinical Operations, OriCell Therapeutics
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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:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

      Session Details:

      PANEL: Fostering a strong relationship with your CRO to make your trial a success

      2024-10-24, 11:00 AM

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      Nan Doyle
      Patient Advocate

      Nan Doyle is a patient engagement catalyst with a passion to strengthen access to diagnosis and treatment for people living with rare genetic conditions. She has deep roots in medicines development, and is known for building durable relationships based on a foundation of active listening and inquiry.
      Most recently, Nan established and built the Rare Disease Patient Engagement function for Takeda Pharmaceuticals. The role required strategy-driven partnerships with patient organizations; and tight, de-siloed collaboration with R&D, Clinical Development, Commercial, Regulatory, Access, and other colleagues around the world.
      Nan is also a board-certified genetic counselor, where she developed front-line understanding of patient and care partner practical, emotional, financial and policy needs.

      Session Details:

      PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

      2024-10-24, 10:00 AM

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      Tammy Burke
      Patient Advocate

      Session Details:

      PANEL: Achieving diversity and inclusion in patient recruitment

      2024-10-23, 12:00 PM

      Session Details:

      PANEL: How minimizing participant burden leads to on-time enrollment and completion

      2024-10-23, 3:00 PM

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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:

      Chair’s opening remarks

      2024-10-23, 8:20 AM

      Session Details:

      PANEL: Achieving diversity and inclusion in patient recruitment

      2024-10-23, 12:00 PM

      Session Details:

      Chairperson’s closing remarks

      2024-10-23, 5:30 PM

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      Jenifer Waldrop
      Executive Director, Rare Disease Diversity Coalition

      Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

      Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

      Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

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      John J. 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: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2024-10-23, 11:00 AM

      Session Details:

      PANEL: How do we work together to deliver GenAI for clinical trials?

      2024-10-23, 2:00 PM

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      Rinaldo Dorman
      Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

      Rinaldo leads the Clinical Procurement team at Sarepta Therapeutics; which focuses on the clinical trial outsourcing for phases 1 through 3. His tenure as a Procurement professional includes roles at large and small organizations across both pharmaceuticals as well as biotech organizations. He has an MBA from Northeastern University and is a Certified Professional of Supply Management.

      Session Details:

      PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2024-10-23, 11:00 AM

      Session Details:

      Chairperson’s closing remarks

      2024-10-23, 5:30 PM

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      Derek Pu
      Director, R&D Procurement, Servier Pharmaceuticals

      Session Details:

      PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2024-10-23, 11:00 AM

      Session Details:

      PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

      2024-10-23, 4:00 PM

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      David Sherris
      Board Member, SiVEC Biotherapeutics

      Session Details:

      Next generation biotherapeutics: bacteria as a novel drug delivery device

      2024-10-24, 11:00 AM

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      Peter Koefler
      Director, Study Site Engagement, Takeda

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

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      Meredith Frank-Molnia
      Senior Director, Clinical Operations, Third Pole Therapeutics

      Meredith Frank-Molnia is currently employed at Third Pole Therapeutics as Senior Director of Clinical Operations. Third Pole is a medical device company producing electrically generated nitric oxide for treatment of hypoxic respiratory failure and lung disease.  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:

      eConsent and the benefits for patients, sites, investigators and sponsors

      2024-10-23, 5:00 PM

      Session Details:

      Chairperson’s closing remarks

      2024-10-23, 5:30 PM

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

      Mary Jo Lamberti is a Research Associate Professor at Tufts University Medical School and Director of Sponsored Research at the Tufts Center for the Study of Drug Development. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical research workforce issues, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

      Session Details:

      Study results: using AI in clinical development

      2024-10-23, 12:00 PM

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      Abigail S Dirks
      Data Scientist, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

      Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to industry drug development performance, including clinical research associate (CRA) performance, impact of decentralized clinical trials (DCT), and investigative site burden. She recently received her Master’s in Health Informatics and Analytics from Tufts University and has a BS in Data Science and Mathematics from St. Michael’s College. She also has experience in web development for North Shore Nurse Practitioner Associates, a psychopharmacology practice.

      Session Details:

      Uncovering RBQM adoption levels and mapping implementation: a novel comprehensive assessment

      2024-10-24, 9:00 AM

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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:

      Study results: using AI in clinical development

      2024-10-23, 12:00 PM

      Session Details:

      PANEL: How do we work together to deliver GenAI for clinical trials?

      2024-10-23, 2:00 PM

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      Sean Smith
      Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection

      Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.

      Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

      Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

      Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

      Session Details:

      Navigating multiple regulatory agencies to help expedite supply chain times

      2024-10-24, 10:00 AM

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      G Bernard Wandel
      Clinical Trial Patient

      Session Details:

      PANEL: How minimizing participant burden leads to on-time enrollment and completion

      2024-10-23, 3:00 PM

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      Jennifer Sydney Goldman
      Clinical Business Operations Consultant, Day One Biopharmaceuticals

      Session Details:

      PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

      2024-10-23, 4:00 PM

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      Charity Roddy
      Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna

      Session Details:

      PANEL: How minimizing participant burden leads to on-time enrollment and completion

      2024-10-23, 3:00 PM

      Session Details:

      CASE STUDY: Improving patient and site experience for rare disease trials

      2024-10-24, 11:00 AM

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      Ashley Sullivan
      Director, Study Start-Up, Allucent

      Ashley Sullivan has more than 13 years’ experience in clinical research. As Director of Study Start-up at Allucent, Ashley is responsible for leading, developing and coordinating activities and staff within Study Start-up & Site Intelligence and developing and implementing business strategies to ensure quality and timely performance of all start-up activities. She guided the overhaul and implementation of a specialized SSU module within CTMS allowing for improved metric tracking and reporting. Ashley also focuses on collaborating across functional areas to ensure a smooth working relationship between Study Start-up and other departments for overall successful trial conduct and delivery for clients.

      Session Details:

      Driving success through well-planned study start-up

      2024-10-24, 9:30 AM

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      Rohan Simon
      Associate Director, Business Development, IROS by M42

      Session Details:

      Exploring the UAE’s clinical research landscape: unlocking opportunities and driving innovation

      2024-10-24, 9:30 AM

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      Urania Rappo
      Senior Medical Director, Clinical Development, BiomX

      Dr Rappo is Senior Director of clinical development at BiomX, a biotech company developing phage cocktails designed to target and destroy harmful bacteria. Prior to joining BiomX in 2020, Dr Rappo worked on the clinical development of dalbavancin and other anti-infectives at Durata Therapeutics, Actavis and Allergan. As an adult infectious disease physician, she focuses on developing safer and more effective treatment options for difficult to treat infections.

      Session Details:

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      2024-10-23, 2:30 PM

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      Shalome Sine
      Senior Manager and Quantitative Insights Specialist, Research Services, CISCRP

      Shalome Sine is a Senior Manager and Quantitative Insights Specialist at the Center for Information and Study on Clinical Research Participation (CISCRP).

       

      Shalome believes that the patient's voice can be a powerful force toward building inclusive, efficient clinical trials. Through her work, she hopes to help clinical trial sponsors and teams bring actionable patient insights into practice to improve clinical trial operational processes. 

       

      Shalome manages both quantitative and qualitative patient voice projects, specializing in quantitative, survey-based patient insights projects. She holds a Master of Public Health from Tufts University and a Bachelor of Science from Penn State University.

      Session Details:

      Assessing patient attitudes to the use of AI in clinical trials

      2024-10-23, 4:00 PM

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      Brian Wehrle
      Vice President, R&D Imaging, Clario

      Brian Wehrle is the Vice President of Research and Development for Medical Imaging at Clario, where he spearheads efforts to push the boundaries of medical imaging technology. With over 25 years of dedicated experience in medical imaging, Brian is passionate about delivering innovative solutions that exceed client expectations. Under his leadership, Clario has seen the successful buildup of its Medical Imaging AI team, significantly enhancing its capabilities in this critical area. Additionally, Brian played a pivotal role in driving the creation of a Generative AI team, further solidifying Clario’s position at the forefront of AI in healthcare. His commitment to innovation and excellence in medical imaging makes him a respected leader and a visionary in the field.

      Session Details:

      Accelerating clinical trials with meaningful AI

      2024-10-23, 12:30 PM

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      Kris Booth
      Director of Strategic Partnerships, EmVenio

      Session Details:

      Building your toolkit: how to operationalize FDA guidance on diversity today

      2024-10-23, 2:30 PM

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      Nina Samra
      Executive Director, Project Delivery, ICON

      Nina is an experienced executive director of clinical services with over 25 years in the pharmaceutical/biotechnology and clinical research organization industry. She oversees US and EU Project Services teams including project management, client partnerships, team and portfolio management. She has demonstrated success in managing first-in-human through large, international clinical programs with multiple protocols in Phase I-III drug development resulting in several NDAs/BLAs. Before joining ICON, Nina served as Project Director focusing on Neuroscience, Immunology & Infectious Disease at Covance and held several PM roles at Takeda, TAP Pharmaceuticals, Gilead and Genentech. Nina holds a BS in Cellular Molecular Biology and a Masters in Biomedical Laboratory Science.

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      Ana Natera
      Director, Clinical Business Strategy, HeartMetrics Cardiac Monitoring, Medtronic

      Ana Natera is a highly accomplished Clinical Director with extensive experience in clinical research and cardiac monitoring. She has been instrumental in driving innovative solutions and expanding the integration of technology in clinical trials. Her dedication to patient-centered care is evident in her commitment to improving cardiac monitoring through technological advancements. In addition to her professional achievements, she is an advocate for fostering connection within the industry and contributes to advancing technology in clinical trials. She is also passionate about increasing diversity, equity, and inclusion in the clinical space.

      Ana holds a Bachelor’s in Biomedical Electrical Engineering, a Master of Science in Forensic Science, and an MBA, bringing a unique blend of technical expertise and business acumen to her role.

      Session Details:

      Cardiac data matters: keeping patients at the heart of innovation

      2024-10-23, 4:30 PM

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      David Gibboni
      Independent Clinical Outsourcing Expert

      Dr David Gibboni has been part of the clinical research community for 15 years, with experience on the vendor side of outsourcing selling services to pharma clients, and on the sponsor side as a senior manager for an oncology-focused global pharma company. His consulting business, DJGibboni Consulting LLC, offers sales. business development, and outsourcing consultation for vendors in the clinical research arena, tapping his vast network of industry connections.

      Session Details:

      Frustrations of a CRO sales guy, or, a guided tour of the clinical trial outsourcing world, from both sides of the negotiation table

      2024-10-24, 12:00 PM

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      Caitlin Hirschman
      Executive Director, Project Delivery, Rho

      Caitlin Hirschman has more than 20 years of clinical research experience across Phase 1-4 studies in a variety of therapeutic areas including pulmonology and has spent the last 12 years working with cystic fibrosis. She has successfully provided oversight and clinical trial management support for more than 14 cystic fibrosis studies, including multiple U.S. and global programs. Ms. Hirschman supports teams to ensure high-quality and timely program delivery, providing extensive knowledge of clinical operations, including trial implementation, monitoring and delivery. Ms. Hirschman has managed trials through the clinical development lifecycle from first-in-human to large 200+ center multinational phase 3 trials.

      Session Details:

      Overcoming the challenges of enrollment in the changing landscape of a rare disease

      2024-10-23, 2:30 PM

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      Baljeet Kaur
      Agriculture Operations Manager, US Customs and Border Protection

      Baljeet Kaur is an Agriculture Operations Manager (AOM) for U.S. Customs and Border Protection (CBP) at the Boston Field Office (BFO) consisting of six New England States (MA, ME, VT, NH, CT, and RI).  As an AOM, Ms. Kaur is charged with providing guidance to personnel within the BFO on various agriculture matters including, but not limited to: regulated garbage compliance, regulation of biological material, and entry requirements for regulated agriculture commodities.  Ms. Kaur has more than 15 years of public service with CBP, and has worked in a variety of environments including, air passenger, air cargo, and maritime.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2024-10-24, 3:45 PM

      Session Details:

      Navigating multiple regulatory agencies to help expedite supply chain times

      2024-10-24, 10:00 AM

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      Atalah Haun
      Vice President, Global Medical Affairs, WEP Clinical

      Dr. Haun is an experienced medical doctor, trained in internal medicine and emergency medicine, with 10+ years of clinical practice. He has a high-quality 10+ years’ work history in the drug development and research industry. Among his previous experiences, he was the head of a global medical affairs department for 4 years, acted as primary medical monitor in 30+ clinical trials, mainly in complex studies in a variety of therapeutic areas including oncology, rare diseases, and advanced therapies (gene, cell, chaperone therapies, etc.). He joined WEP Clinical bringing his expertise in applying knowledge and skills in epidemiology, internal medicine and different medical specialties in drug development, clinical trials, and drug safety. He has successfully implemented several techniques to improve site identification and selection and patient centric solutions to ensure timely enrolment and high retention in challenging patient populations with rare and ultra-rare diseases. He is also experienced in elaborating study plans (medical monitoring, clinical monitoring, safety management etc.) and tools (site reference manual, pharmacy manual, treatment manual etc.).

      Session Details:

      Clinical site support and patient enabling services

      2024-10-23, 4:30 PM

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      Juliane K Mills
      Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

      Juliane K. Mills is a seasoned explorer in the world of clinical research with over 20 years of experience. Juliane's mission is simple but powerful: to make a real difference for people battling rare diseases. At Worldwide, she's the go-to person for creating smart, streamlined plans that help bring new treatments to those in need, without forgetting the real people behind the diagnoses – the patients, their loved ones, and their caregivers. Juliane's work is all about connecting the dots between cutting-edge science and the everyday lives of those affected by rare conditions. She's not just a researcher; she's a champion for better health, working tirelessly to ensure that new, life-changing treatments move from the lab bench to the bedside as smoothly and swiftly as possible.

      Session Details:

      Beyond the protocol: crafting expert CRAs for impactful rare disease trials

      2024-10-23, 12:30 PM

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      Carrie Lewis
      Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

      Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

      Session Details:

      FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

      2024-10-23, 12:00 PM

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      Jason Konn
      Solution Consultant, eClinical Solutions

      As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

      Session Details:

      Oversight for all: achieve data transparency with elluminate

      2024-10-23, 2:30 PM

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      David Ng
      Vice President, Global Biometrics, Novotech

      David Ng is Vice President, Global Biometrics at Novotech, a global CRO.   David has over 30 years of experience in global data management, statistics, and regulatory interactions; and has worked on numerous treatments for rare diseases, from proof of concept to submission and ultimate regulatory approval.   David has also collaborated with various organization and vendors to optimize data access and collection, from early EDC and ePRO systems to the use of EMR in clinical development.

      Session Details:

      Biometrics considerations in implementing new technology

      2024-10-24, 9:30 AM

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      Kelsey Buhler
      Product Specialist, Viedoc Technologies

      Kelsey Buhler has been a Product Specialist at Viedoc Technologies since 2021, and specializes in providing technical demos, support, and project management for Viedoc study builds. Prior to her role at Viedoc, she has 7 years combined experience as a Data Manager/Project Manager at a Medical Device CRO, a Data Entry Specialist, and a Clinical Subjects Associate, where she would obtain consent from subjects in clinical trials. All these experiences drive her passion for user-friendly Electronic Data Capture (EDC) systems that increase efficiencies for the subjects, site, and all other study users.

      Session Details:

      Increase trial agility with our integrated reporting tool

      2024-10-23, 4:30 PM

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      Kris O’Brien
      Vice President, Oncology and Rare Diseases, TFS HealthScience

      Kris joined TFS in August 2024, bringing nearly 40 years of clinical research experience to the Oncology and Rare Diseases business unit. Within her role, Kris manages a global team of experts ranging from physicians to clinical specialists and is responsible for supporting the project delivery of all oncology and rare disease programs.

      Kris's diverse experience spans working with CROs, pharmaceutical companies, and academic institutions, with more than half of her career focusing on oncology and rare diseases. Her extensive background includes leadership positions as Vice President of Operations, Executive Director of Strategy, and Head of Project Management, among other clinical roles across the industry.

      She is deeply committed to improving the patient's journey, particularly for those seeking life-altering and life-saving therapies through clinical trials. Her expertise in patient recruitment, retention, and study visit design allows her to provide valuable guidance to her team and sponsors, ensuring the highest quality in operational execution and deliverables in these complex therapeutic areas.

      Session Details:

      Leveraging technology to ease patient burden: the right solutions for better clinical trials

      2024-10-24, 11:30 AM

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      Stephanie Hitchcock
      Director of Project Management, PCM Trials

      Stephanie Hitchcock is an Director of Project Management at PCM Trials. Stephanie specializes in adapting trial designs for mobile visit services. She is passionate about expanding the use of high-quality, patient-centric models to drive clinical development. Stephanie is an expert in establishing logistics and procedures on a global scale for complex visit schedules and expanding the scope of what mobile visits can support globally.

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      Elaina Haeuber
      Senior Vice President, Oncology, Premier Research

      Elaina Haeuber, M.S., Senior Vice President, Head of Oncology, has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

      In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

      Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry through positions at large pharma, small biotech, and CROs. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

      Session Details:

      Propelling asset development through integrated regulatory, clinical, and medical expertise

      2024-10-24, 11:30 AM

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      Alex Bai
      Head of Clinical Contracts, Biogen

      Session Details:

      Applying Lean Six Sigma methodology to reduce the lead-time of clinical contracting

      2024-10-23, 11:00 AM

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      Behtash Bahador
      Director, Health Literacy, CISCRP

      Behtash Bahador is the Director of Health Literacy 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:

      PANEL: Achieving diversity and inclusion in patient recruitment

      2024-10-23, 12:00 PM

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      Anthea Dransfield
      Head of Quality, Diligent Pharma

      Anthea has over 30 years of experience within operational and recruitment leadership for clinical sites, technical validation, analytical and manufacturing aspects of cGMP, and quality oversight spanning GxPs.  She advocates for risk-based, phase-appropriate approaches designed to enable compliance, and has a drive for process and attention to detail with a focus on using technology to ease the quality burden.

      Session Details:

      Reducing trial start-up time through an innovative approach to vendor qualification

      2024-10-23, 9:00 AM

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      Kristofer Booth
      Director, Strategic Partnerships, Emvenio Research
      Next speaker
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      Joan Ramella
      Associate Director, Clinical Operations, Endo USA, Inc

      Session Details:

      FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

      2024-10-23, 12:00 PM

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      Alicia M. Baker McDowell
      Head of Regulatory Strategy and Product Development Consulting, Fortrea

      Session Details:

      PANEL: Achieving diversity and inclusion in patient recruitment

      2024-10-23, 12:00 PM

      Session Details:

      Diversity Action Plans: preparing, submitting, and receiving regulatory feedback

      2024-10-23, 11:30 AM

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      Anthony Mikulaschek
      VP, Commercial Strategy, IQVIA Technologies

      As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

      Session Details:

      Enhancing clinical trial integrity: safeguarding endpoints with patient technology

      2024-10-23, 11:30 AM

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      Stacey Lasser
      Senior Project Manager, Mednet

      Session Details:

      Enhancing clinical trial outcomes with a unified eClinical platform

      2024-10-23, 2:45 PM

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      Ben Dudley
      Chief Commercial Officer, MMS Holdings Inc

      Ben Dudley is the Chief Commercial Officer at MMS. He is a seasoned executive with experience gained over a 27-year career in the industry, in both the biopharma and clinical development services sectors. Ben’s deep, broad expertise spans drug development, sales and customer relationship management, operational leadership, and process optimization. His impressive career includes leadership roles at Parexel, Covance and AstraZeneca, where he consistently demonstrated his ability to lead and innovate across various operational, functional, and commercial domains.

      Session Details:

      Efficient data orchestration in clinical trials

      2024-10-24, 2:15 PM

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      Amy Manley
      Vice President, Clinical and Medical Operations, Paratek Pharmaceuticals

      Amy Manley is the Vice President, Clinical and Medical Operations at Paratek Pharmaceuticals.  She has over 25 years of experience in the pharmaceutical industry in roles of increasing leadership.  Prior to joining Paratek, she worked at Wyeth, Pfizer, and Shire.  Amy has worked in numerous therapeutic areas including Neuroscience, GI, Ophthalmology, and Infectious Disease.  She’s been fortunate to have been part of the development and approval of 6 globally marketed products.  She is a solution focused, proven leader who loves working with high performing teams and has thrived in the small biotech environment.

      Session Details:

      Efficient data orchestration in clinical trials

      2024-10-24, 2:15 PM

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      Deborah Jakubowski Russ
      Director, Launch Excellence Leads, Parexel

      Session Details:

      Patient-guided by design: a framework for successful study start-up, informed protocol design and better outcomes

      2024-10-23, 12:30 PM

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      OCT Advisory Board

      Select a member to learn more

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

      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.

      Next
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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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      THOMAS M TREMBLAY
      Vice President Of Clinical Development, Trefoil Therapeutics, Inc

      Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

      Next
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      Behtash Bahador
      Director, Health Literacy, CISCRP

      Behtash Bahador is the Director of Health Literacy 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:

      PANEL: Achieving diversity and inclusion in patient recruitment

      2024-10-23, 12:00 PM

      View In Agenda
      Next

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