15th Annual Outsourcing in Clinical Trials New England 2023

This year's Outsourcing in Clinical Trials New England event will boast 3 tracks on Clinical Operations and Outsourcing, Clinical Technology and Innovation, and Patient Recruitment and Engagement, meaning for anyone involved in the operational aspects of running a clinical trial, there truly is something for everyone.

1 - 2

November

2023
  • John B. Hynes Veterans Memorial Convention Centre, Boston, USA
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2023 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 15th 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 three streams on Clinical Operations and Outsourcing, Clinical Technology and Innovation, and Patient Recruitment and Engagement, 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, 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

    Agenda

    • 1 Nov 2023
    • 2 Nov 2023
    Expand All

    Streams

    Stream one

    Clinical Outsourcing and Operations

    Stream two

    Clinical Technology and Innovation

    Stream three

    Patient Recruitment and Engagement

    11 AM

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    • The importance of ensuring your patient population is diverse
    • Strategies to improve diversity, equity and inclusion in your trial
    • Building trust and relationships with communities who may not traditionally participate in clinical trials
    • Innovative methods of engaging with the wider patient community
    • Best practice in working closely with patient advocacy groups

    Speakers

    Behtash Bahador
    Director, Health Literacy, CISCRP
    Blake E Wilson
    Partner, Hogan Lovells LLP
    Cathleen Platt
    Vice President, Clinical Operations, Click Therapeutics
    Marilyn Fontaine
    Director, Clinical Operations, AnHeart Therapeutics
    Missy Hansen
    Paediatric Strategy Liaison, ICON Plc

    11:30 AM

    Accelerated performance of complex exploratory patient studies: practical insights from investigational site

    • Global challenges and industry trends
    • Research clinics dedicated to early patient trials
    • Key elements to consider when planning a Phase Ib/IIa patient trial
    • Case studies

    Speakers

    Dr. Claudia Hesselmann
    Founder and CEO, ARENSIA Exploratory Medicine

    12 PM

    Benchmarking patient enrollment and use of recruitment tactics

    • An overview of Tufts CSDD’s study on study and site level metrics on patient enrollment effectiveness and site activation rates
    • Global recruitment and retention tactics
    • Benchmarking results for enrollment and site activation
    • Differences and similarities in cycle times and performance across therapeutic areas

    Speakers

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

    12:30 PM

    Bridging barriers: streamlining oncology study startup in today’s clinical environment

    • Utilizing tactics to attract enthusiastic sites and PIs
    • Mastering the art of streamlined contract and budget negotiations
    • Optimizing vendor selection and oversight
    • Implementing best practices for consistent and committed enrollment

    Speakers

    Nissa Ashenbramer
    Senior Project Manager, Oncology and Hematology, TFS Health Science

    1 PM

    Lunch and networking break

    2 PM

    Working closely with advocacy groups around clinical trial design

    • Key considerations in designing a patient-centric clinical trial
    • How to bring the patient voice into your clinical trial design
    • Engaging patient advocacy groups from the beginning of your design process and benefits of this

    2:30 PM

    How do we make participation in clinical research more patient-friendly

    • Barriers to patient participation in clinical research
    • Pre- and post-pandemic patient expectations
    • Balancing the need for robust data collection and reduced patient burden
    • What does – a potential – future hold?

    Speakers

    Joyce Moore
    Global Head of Patient Engagement, Allucent

    3 PM

    Designing patient engagement strategies to inform clinical trial recruitment

    • An overview of frameworks developed around patient recruitment and engagement
    • How to best engage patients, caregivers and advocacy groups in your clinical trial design
    • Key considerations in ensuring your patient recruitment strategy is as patient-centric as possible

    Speakers

    Deborah Howe
    Global Patient Recruitment and Engagement, Alexion Pharmaceuticals

    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

    FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

    • Culture shift from the inside out: opportunity to briefly immerse yourself in the clinical trial journey from a patient’s perspective
    • What are the main barriers for patients participating in clinical trials and how can these be minimized?
    • Incorporating technology to support patients and increase engagement and retention

    Speakers

    Robert Loll
    Senior Vice President, Business Development and Strategic Planning, Praxis
    Rohita Sharma
    PhD, Global Senior Director, LEAP Lead, Patient Insights and Solutions, Medical Affairs, Alexion Pharmaceuticals
    Deborah Howe
    Global Patient Recruitment and Engagement, Alexion Pharmaceuticals

    4:30 PM

    Improving randomization rates with Machine Learning and AI

    • Learn the key differences between Machine Learning and Artificial Intelligence for patient recruiting
    • Find out why study data is more impactful than patient data on predicting recruitment success
    • Discover how to combine your model's results with your business strategy to create reliable recruitment

    Speakers

    Ivor Clarke
    Chief Innovation Officer, SubjectWell

    5 PM

    CASE STUDY: Working with diverse groups in order to meet achieve DEI in clinical trials

    • How to recruit and engage populations who would not typically participate in clinical trials
    • Ensuring your clinical trial participants are representative of the general population
    • Overcoming common challenges around diversity and inclusion

    Speakers

    Neha Ghosh
    Associate Director, Clinical Research, Fresenius Medical Care

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Jessica Perry
    Director, Patient Centricity, Clinical Innovation, Moderna

    END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

    11 AM

    Incorporating real world evidence into clinical trials: what new opportunities are created?

    • Tapping into the full potential of real world evidence and incorporating this into your trial
    • Barriers to adopting real world evidence: how to address and overcome these
    • Navigating regulations in the USA in relation to the use of real world evidence in clinical trials

    Speakers

    Lisa Kang
    Independent Clinical Trial Expert

    11:30 AM

    TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

    Learn how elluminate and eClinical’s Biometrics Services deliver:

    • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
    • Improved study oversight with a holistic view of risk across all data sources
    • 50 out-of-the-box visualizations to support cross-study analysis for deeper insights with self-service access to clinical and operational analytics
    • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

    Speakers

    Jason Konn
    Solution Consultant, eClinical Solutions

    11:45 AM

    TECHNOLOGY SPOTLIGHT: eSource: auto-populate eCRFs with source data on study Day 1

    Learn how eSource, EHR-to-EDC integration automatically populates eCRFs on study day one with source data. We’ll discuss practicality, implementation and scalability so you can see how we’re keeping patients at the center of clinical trials with proven solutions that lessen the burden for researchers, sponsors and patients alike. Join this session and learn how to:

    • Get source data on study Day 1
    • Ease the burden with smart, automated workflows
    • Simplify enrollment, data sharing and participation
    • Enhance decision support for site and sponsor stakeholders
    • Improve recruitment and retention with engaging digital solutions

    Speakers

    Chris Weiss
    Vice President, Sales, OpenClinica

    12 PM

    PANEL DISCUSSION: Is DCT old news?

    • How we should be thinking about decentralization in the long term
    • Hybrid vs decentralized vs traditional clinical trial models: the pros and cons of each
    • Which indications and therapeutic areas does DCT have potential in?
    • FDA regulations and guidance around DCT
    • Incorporating elements of DCT into your clinical trial: is this now commonplace or are we moving away from this?
    • Working with vendors and CROs in order to deliver decentralized and hybrid clinical trials

    Speakers

    Christine Hurley
    Vice President, Clinical Business Operations and Innovation, Relay Therapeutics
    Harry Barnett
    Executive Chairman And Founder, Lubris BioPharma
    Mackenzie Johnson
    Senior Manager, Patient Centricity, Moderna
    Kelly McKee
    Vice President of Patient Registries and Recruitment

    12:30 PM

    Digitalization in clinical trials: a 360 view

    • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
    • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
    • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
    • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
    • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

    Speakers

    Sverre Bengtsson
    Co-Founder, Viedoc

    1 PM

    Lunch and networking break

    2 PM

    PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

    • ChatGPT and its potential in supporting clinical trials
    • What risks and potential pitfalls are there when using AI?
    • Does AI eliminate the need for a human, or is it simply a tool?
    • How FDA guidelines impact the use of AI and machine learning in clinical trials

    Speakers

    Blake E Wilson
    Partner, Hogan Lovells LLP
    Lisa Kang
    Independent Clinical Trial Expert
    Vikas Agarwal
    Vice President, Head of Program Development, Greenfire Bio

    2:30 PM

    Re-imagining IRT for modern clinical development

    • The majority of clinical studies are being run on technology that is over 10 years old, which limits the ability to innovate and optimally support modern trials
    • IRT as a driver of innovation and not a constraint when advances in the technology landscape are applied to allow for more flexible solutions
    • Deliver scalable, robust, and future-proof IRT solutions by applying lessons learned from other industries
    • Examples include: A.I.-enabled datasets, no-code study deployment, automated excursion reviews, rapid prototyping, reduced (or removed) need for change orders, and ability to adapt to unforeseen challenges

    Speakers

    Evan Hahn
    Senior Vice President, IRT Solutions, YPrime

    3 PM

    Finances and managing your clinical trial budget as a small or medium sized biotech company

    • Cutting down your expenses without compromising on the quality of your trial
    • Forecasting and budgeting costs for your clinical trial
    • Solutions in order to ensure your trial budget stays on track

    Speakers

    Marilyn Fontaine
    Director, Clinical Operations, AnHeart 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

    CASE STUDY: Implementing eClinical technology in a medical device setting

    • Implementing EDC, CTMS and eTMF for a medical device trial and what benefits these can bring
    • Choosing between technology providers: what are the main factors in decision-making?
    • Common challenges and hurdles when introducing new systems to your medical device clinical trial
    • Considerations for medical device trials compared to drug trials in EDC, CTMS and eTMF

    Speakers

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

    4:30 PM

    Clarity in the complex: the untapped potential of simulation-based training in clinical research

    • Explore the future state of performance-based training
    • Discuss how to interpret and apply learning results to optimize and de-risk your study
    • Discover how simulation-based training improves study performance

    Speakers

    David Hadden
    President, Founder and Chief Game Changer, Pro-ficiency

    5 PM

    Key considerations when choosing vendors and partners as a small biotech

    • How specialized should your CRO be in your therapeutic area: is this the most important factor?
    • As a small biotech, what are the benefits of working with a large global CRO vs a small specialized organization?
    • Working with and collaborating with multiple vendors: considerations and best practice

    Speakers

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

    5:30 PM

    Chairperson’s closing remarks

    Speakers

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

    END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

    7:30 AM

    Registration and refreshments

    8:20 AM

    Chair’s opening remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    8:30 AM

    OPENING KEYNOTE: Innovation in the US pharma industry: uncovering challenges and opportunities

    • Harnessing the power of language models such as GPT to revolutionize pharma innovation
    • The potential of advanced technology to drive advancements in drug discovery, optimize clinical trials and enable personalized medicine
    • Practical takeaways: how you can leverage AI and Generative AI to achieve transformative innovation in your clinical trial

    Speakers

    Prasanna Rao
    Senior Director, Global Head of AI and ML, Pfizer

    9 AM

    Solving the clinical data challenge

    Patient centricity requires data centricity to integrate and manage a growing variety of data sources. The challenge lies in integrating and managing those sources to deliver high-quality data. How do we overcome this?

    • Moving from manual, reactive data review and cleaning to proactive, risk-based approaches based on integrated data
    • Providing clinical data management and monitoring teams with workflows and analytics that support their day-to-day functions
    • Leveraging technologies that incorporate AI to automate manual tasks and identify potential issues sooner

    Speakers

    Ken Hamill
    Senior Director, Clinical Operations Portfolio, Medidata Solutions

    9:30 AM

    PATIENT ADVOCACY KEYNOTE: Patient experience in oncology trials: lessons learned from a patient advocacy-driven, decentralized clinical trial

    • How easy and accessible are oncology trials to patients, and where are the main hurdles?
    • What do pharma and biotech sponsors need to be doing in order to ensure a reduced burden on patients participating in clinical trials?
    • Decentralized clinical trials: and what are the benefits and challenges of incorporating elements of decentralization into your clinical trial from a patient perspective?

    Speakers

    Jim Palma
    Executive Director, TargetCancer Foundation

    10 AM

    Perspectives on the biotech/CRO investment landscape

    • Perspective on investment landscape
    • Biotech workforce current trends and the implications for clinical trials
    • M&A activity in the CRO landscape and how that impacts sponsors

    Speakers

    Alyce King
    Senior Business Development Manager

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Choosing a vendor as a small biotech: creating a hierarchy of considerations

    • What are the most important factors when selecting vendors and CROs for your clinical trial?
    • Is it always crucial to have trial partners with expertise in your therapeutic area?
    • Should cost be the primary factor in vendor selection?

    Speakers

    Jodi Coughlin
    Director, Vendor Relationship Management, Deciphera Pharmaceuticals
    Stacey Limauro
    Executive Director, Clinical Operations, Deciphera Pharmaceuticals

    11:30 AM

    Lessons learned in Topaz: incorporating mobile visits in DCT

    • Easier for patients with chronic disease or limited mobility
    • Siteless design to reach more eligible patients
    • Simplified to reduce costs of trial

    Speakers

    Jonathan Ernst
    Senior Director, In Home Solutions, DCT, PCM Trials

    12 PM

    The state of the biopharmaceutical industry: mid-year update and 2024 outlook

    • Reviewing results from our annual survey - were the 2023 predictions correct?
    • Key themes and technology advancements in the biopharma industry that are expected to have the largest (positive and negative) impacts on the industry
    • Spotlight on clinical trial technologies: trends of cell and gene therapies, virtual trials and ai used in drug development
    • Leveraging data to predict the outlook for 2024 clinical trial outsourcing
    • Trends, key players, opportunities and threat in biopharma, focusing on AI, DCTs, cell and gene therapy, etc.
    • What the latest investment trends show for small and medium biotechs

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    12:30 PM

    Assessing risk in your clinical trial using the Pediatric Risk Assessment Map (PRAM):

    • An interactive, reusable, and shareable tool that helps to identify common risks that may exist in a pediatric clinical trial
    • Populates with risk category and mitigation strategies for consideration when risk is identified
    • Tallies and populates key risks and categories identified

    Speakers

    Missy Hansen
    Paediatric Strategy Liaison, ICON Plc

    1 PM

    Lunch and networking break

    2 PM

    CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

    • Communicating and liaising effectively with CROs: overcoming common challenges
    • Creating and fostering a long term relationship with vendors
    • Balancing levels of vendor oversight in your clinical trial

    Speakers

    Christine Hurley
    Vice President, Clinical Business Operations and Innovation, Relay Therapeutics
    Emily Matthews
    Senior Manager, Clinical Business Operations, Relay Therapeutics

    2:30 PM

    Continued evolution of cell and gene therapy development programs

    • Technology-based development trends
    • Driving success in either unexplored settings or in saturated market settings
    • Context-dependent stakeholder engagement

    Speakers

    Amy Raymond
    Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials

    3 PM

    Biomarker opportunities in FiH and clinical pharmacology studies run in an outsourcing model

    • Introduction: history of “fully outsourced” studies at Novartis
    • Personalized medicine and the shift in clinical trial goals
    • CRO relationships with biomarkers
    • Lessons learned from biomarkers
    • Balancing risks vs benefits

    Speakers

    Kathryn Duschean
    Senior Scientist, Laboratory Excellence and Operations, Novartis

    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 and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    4 PM

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    • Establishing upfront communication on responsibilities and escalation processes
    • What do vendors expect from sponsors in terms of oversight?
    • Best practice in building a strong relationship with vendors
    • Regulatory guidance for sponsors around vendor communications and oversight: what do you need to be doing as a sponsor?

    Speakers

    Stacey Oppenheimer
    Imaging Vendor Oversight and Sourcing Strategy Lead, Pfizer
    Shari Coslett
    Vice President, Clinical Operations, Rhythm Pharmaceuticals
    Shelby Abel-Kilmartin
    Director, Data Management Strategic Outsourcing and Vendor Management, Alexion, AstraZeneca Rare Disease
    Leonella Seeley
    Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics

    4:30 PM

    Innovative processes to better address today’s trial dynamics

    • Supply chain efficiency: why do extra work and spend more money than necessary?
    • Payment process efficient: leverage an existing workflow process that sites use everyday
    • Understanding the total value a vendor can provide
    • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

    Speakers

    5 PM

    Designing a vendor strategy that works for your clinical trial

    • Choosing between one full service CRO and working with multiple vendors: what are the main advantages and disadvantages?
    • Ensuring sponsors, vendors and sites are aligned under one shared goal
    • Overcoming challenges around communication with vendors in order to create strong relationships

    Speakers

    Siddharth Parulkar
    Senior Director, Head of Clinical Operations, Independent

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

    Streams

    Stream one

    Clinical Outsourcing and Operations

    Stream two

    Clinical Technology and Innovation

    Stream three

    Patient Recruitment and Engagement

    9 AM

    Patient centricity through health literacy

    • Sponsor funded initiatives that incorporate Health Literacy into the clinical trial lifecycle
    • Beginning patient involvement before the study: building awareness of clinical research
    • The importance of partnership and co-development throughout the research lifecycle
    • Tools and resources available to assist research organizations in effective patient centricity planning

    Speakers

    Behtash Bahador
    Director, Health Literacy, CISCRP

    9:30 AM

    The importance of scientific validation and data integrity when using accessibility features

    • FDA recommendation for accessible features and designs to increase clinical trial inclusivity eg zoom in/zoom out functionality
    • Importance for patients who may have visual impairments, hearing, motor and dexterity, or cognitive difficulties that may impact inclusivity into clinical trials
    • Significance of deploying these functionalities where the drug under study may cause visual impairment such as certain oncology treatments or population under study, eg older adults, may have one or more impairments
    • Results of an industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences

    Speakers

    Sarah Tressel Gary
    Ph.D., Senior Scientific Advisor, eCOA Clinical Science and Consulting, Clario

    10 AM

    CASE STUDY: Recruiting for a rare disease trial

    • Identifying eligible patients for an orphan drug trial: designing your recruitment campaign
    • Best practice in collaborating with patient advocacy groups for rare diseases
    • The role of social media and other online tools to drive patient recruitment for a rare disease trial

    Speakers

    Christine Slater
    Associate Director, Patient Recruitment, Editas Medicine
    Dima Hendricks
    Sickle Cell Patient Advocate

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Engaging patients in a rare disease clinical trial

    • How rare disease trials are unique when it comes to building and fostering relationships with patients
    • Reasons and tactics to engage longitudinally with rare disease patients
    • Working with patients, carers and advocacy groups for a successful patient engagement strategy

    Speakers

    Nan Doyle
    Patient Advocate

    11:30 AM

    The innovations of decentralized clinical trials

    • Decentralized clinical trial numbers grow and are forecast to continue, even after the accelerated adoption driven by the Covid-19 global pandemic
    • A view on the next steps of innovations within decentralized clinical trials
    • Why “consumerisation of clinical trials” continues to be key when considering patient centricity
    • How multi-channel data collection is at the heart of clinical trials – and the need to integrate data sources to maximise the value of this powerful by-product of decentralised clinical trial methodologies

    Speakers

    TOLA OLORUNNISOLA
    VP, Strategy, Innovation, Marketing And Digital, Avantor

    12 PM

    Utilizing technology to accelerate clinical trial enrolment

    Kevin will be sharing his experience of using tools such as a patient engagement website, a strategic partnership and social media to impact patient enrolment across the portfolio of Biogen clinical trials. Join him to hear more about how to optimize your patient enrolment, with Kevin’s top tips and lessons learned.

    Speakers

    Kevin Ahonen
    Former Head of Digital Engagement, Biogen

    12:30 PM

    Lunch and networking break

    9 AM

    PANEL DISCUSSION: How to choose technology vendors for your study

    • Key questions to ask when selecting clinical trial technology
    • Building relationships with vendors in order to deliver a seamless and efficient clinical trial
    • Working with patients and advocacy groups to ensure all new technology is for the ultimate benefit of the patient
    • Making technology and systems easy for sites to adopt
    • Balancing cost and opportunity when weighing up benefits of new technology

    Speakers

    Christine Hurley
    Vice President, Clinical Business Operations and Innovation, Relay Therapeutics
    Jessica Perry
    Director, Patient Centricity, Clinical Innovation, Moderna

    9:30 AM

    Find a cure for your complex technology headaches

    Join Emmes’ Chief Innovation Officer, Ching Tian as she addresses how the technology we are accustomed to in clinical trials are getting more complex while not meeting today’s clinical research needs.  Ching will provide a peek  into a new paradigm of the next-gen solutions with the goal to achieve an ‘iphone’ like experience. In this session, you will learn:

    • How technology is negatively disrupting clinical research
    • What a new paradigm needs to look like to turn technology into an enabler for all users
    • An example of the next-gen that’s already available for use today

    Speakers

    Ching Tian
    Chief Innovation Officer, Emmes

    10 AM

    CASE STUDY: Revolutionizing drug delivery devices: paving the way for clinical success

    • Overview: the potential from using nose-to-brain technology to treat complex CNS disorders
    • Learnings and outcomes from running a clinical trial on a drug delivery device
    • Advancing treatment for neurogenerative diseases: how Kurve is reshaping this

    Speakers

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Innovating your data management strategy: how to stay ahead of the curve

    • Developing efficient infrastructures and processes for clinical data management
    • Navigating changing regulatory requirements around data in clinical trials
    • Key drivers for innovation: considerations for 2024

    Speakers

    Holly Huang
    Vice President, Head of Biometrics, Denovo Biopharma

    11:30 AM

    The importance of real-time forecasting in biotech trials

    • Review the challenges of forecasting clinical trial costs and its impact on cash flow
    • Understand how a data-driven and automated approach can produce more accurate forecasts quickly
    • Learn how a biotech company can apply these methodologies

    Speakers

    Stuart Thiede
    VP & Global Head Financial Lifecycle, IQVIA

    12 PM

    Revolutionizing clinical trials with accelerating clinical evidence models

    • Novel approaches for drug approvals with accelerated approval pathway to streamline processes
    • Enhancing collaboration between the FDA and CMS in developing new payment methods for drugs approved via accelerated approval
    • Improving patient access to post-market safety and efficacy data

    Speakers

    Blake E Wilson
    Partner, Hogan Lovells LLP

    12:30 PM

    Lunch and networking break

    8 AM

    Registration and Refreshments

    9 AM

    Innovating and introducing new technology while ensuring patients remain at the heart of your clinical trial

    • Ensuring any new technology is for the benefit of the patient: the importance of involving the patient voice and advocacy groups in innovation
    • Where are the main difficulties for patients when participating in a clinical trial?
    • Decentralized and remote elements of clinical trials to ease the burden on patients

    Speakers

    Leticia Tarilonte
    Senior Director, Clinical Operations Consultant, Nimbus Therapeutics

    9:30 AM

    Modernizing site management and monitoring roles to meet the dynamic needs of clinical research

    • The purpose of a Site Manager and how they interact with other monitors on the study to avoid duplicate efforts and contain costs
    • When to use a Site Manager for optimal study conduct
    • The benefits a Site Manager can bring to studies with highly complex logistics, such as cell and gene therapies or rare disease trials
    • How technology drives efficiencies and streamlines communications across the various resources on a study

    Speakers

    Nicole Stansbury
    Senior Vice President and Head of Global Clinical Operations, Premier Research

    10 AM

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    • Benefits and opportunities of running clinical trials outside of the US including Latin America, Europe, Asia and Australia
    • Do the challenges and risks outweigh the benefits of running trials internationally?
    • Understanding and navigating clinical trial regulations in different geographical regions
    • What factors are most important when choosing a location for your clinical trial?

    Speakers

    Harry Barnett
    Executive Chairman And Founder, Lubris BioPharma
    Chris Cain
    Vice President, Clinical and Regulatory Affairs, Hyalex Orthopaedics
    Kelsey Miller
    Director, Clinical Development, Intrinsic Therapeutics
    Judith Murphy
    Executive Director, Centralized Contracting and Outsourcing, Kura Oncology
    Donna Fraser
    Director, Client Operations, Novotech

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Strengthening the CRO/sponsor relationship: a deep dive into studies

    • Maintaining and tracking the CRO/sponsor partnership
    • Exploring tools and metrics that can be put in place
    • How best to utilize these in order to strengthen partnerships with CROs to ensure trial success

    Speakers

    Rana Said
    Biomarker Study Coordinator, Novartis

    11:30 AM

    An agile approach to PBMC collection in vaccine trials

    • Critical aspects of PBMC processing in the context of clinical trials
    • Challenges of sample handling flows
    • Importance of consistent isolation protocols
    • Main quality control aspects of PBMC handling
    • Upscaling capacity planning for sample collection
    • Importance of accessibility to an established global network

    Speakers

    Mike Waters
    Global Vice President, Biopharma Business Development, Cerba Research

    12 PM

    CASE STUDY: Running a clinical trial when repurposing an existing drug

    • An overview of benefits, challenges and key considerations in drug repurposing clinical trials
    • FDA regulations and guidance when it comes to drug repurposing
    • Utilizing existing safety studies to speed up your trial timeline

    Speakers

    12:30 PM

    Lunch and networking break

    1:30 PM

    Operating conditions and trends impacting global clinical trial performance

    • Review macro-level drug development trends
    • Characterize the current operating environment for planning and executing clinical trials
    • Discuss underlying drivers of inefficiency and poor performance
    • Explore new strategies to address and counter the effect of underlying drivers

    Speakers

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

    2:15 PM

    Forging the future with CTMS

    Clinical trials play a crucial role in medical advancements. With increasing challenges, it is essential for our tools to adapt. CTMS represents a significant step forward in how we manage these trials, and by utilizing it effectively, we can improve the healthcare landscape for everyone.

    Speakers

    Hope Weisser
    Senior Product Manager, TransPerfect
    April Mattison-Wolfe
    Senior Solutions Architect, TransPerfect

    2:45 PM

    KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    • How will new and upcoming regulations affect clinical trials, and how can sponsor companies best navigate these?
    • The impact of emerging AI tools such as ChatGPT on clinical trials: are these a challenge or an opportunity?
    • Should we still be discussing decentralization as a long term clinical trial model?
    • Where are the primary opportunities to make clinical trial participation easier on patients and thus improve recruitment, engagement and retention?

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData
    Hollie Schmidt
    Vice President, Scientific Operations, Accelerated Cure Project for MS
    Prasanna Rao
    Senior Director, Global Head of AI and ML, Pfizer
    Rinaldo Dorman
    Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
    Behtash Bahador
    Director, Health Literacy, CISCRP

    3 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 and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    End of Conference

    3:45 PM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into three ‘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 B conference room.

    ROUNDTABLE 1: US vs international CROs: which is best for your trial?
    Vikas Agarwal, Vice President, Head of Program Development, Greenfire Bio

    ---------------------------------------------------------------------------------------------------

    ROUNDTABLE 2: Managing clinical trial budgets effectively
    Marilyn Fontaine, Director, Clinical Operations, AnHeart Therapeutics

    ---------------------------------------------------------------------------------------------------

    ROUNDTABLE 3: Delivering large and complex clinical trials with cross functional teams
    Jenny Bentsen Gordon, Vice President, Head of Clinical Operations, Editas Medicine

    ---------------------------------------------------------------------------------------------------

    ROUNDTABLE 4: Maximizing your CRO relationship and building a solid partnership

    Ritu Mehta, DP Clinical

    Douglas Henry, President, Phazemos

    ---------------------------------------------------------------------------------------------------

    Speakers

    Vikas Agarwal
    Vice President, Head of Program Development, Greenfire Bio
    Marilyn Fontaine
    Director, Clinical Operations, AnHeart Therapeutics
    Jenny Bentsen Gordon
    Vice President, Head of Clinical Operations, Editas Medicine
    Douglas Henry
    President, Phazemos

    Speakers

    Select a speaker to learn more

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

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

    Session Details:

    KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    2023-11-02, 2:45 PM

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    Adrienne Gaggi
    Associate Director, Clinical Development, Aldeyra Therapeutics
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    Deborah Howe
    Global Patient Recruitment and Engagement, Alexion Pharmaceuticals

    Deborah Howe is Director, Global Patient Recruitment and Engagement at Alexion, Astra Zeneca Rare Disease.  In this role, she leads the strategic development and implementation of a framework to support planning and delivery of global patient finding and engagement strategies for Alexion Rare Disease studies that leverage patient voice, strategic partnerships, healthcare data, and technologies.

    Session Details:

    FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

    2023-11-01, 4:00 PM

    Session Details:

    Designing patient engagement strategies to inform clinical trial recruitment

    2023-11-01, 3:00 PM

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    Rohita Sharma
    PhD, Global Senior Director, LEAP Lead, Patient Insights and Solutions, Medical Affairs, Alexion Pharmaceuticals

    Rohita Sharma, PhD, is a Global Sr. Director in the Patient Insights & Solutions team at Alexion AstraZeneca Rare Disease.  In this role, Rohita leads the development and implementation of the LEAP platform – a unique series of immersive patient journeys across the organization, and geographies to ensure that strategies, tactics, and initiatives are grounded in the patients’ lived experience.

    Rohita has more than 15 years’ experience in the pharmaceutical industry mainly in medical affairs. She has worked across commercial, medical affairs and corporate functions, both in country and at the global level. She has broad therapeutic area experience including rare diseases, vaccines, respiratory, and diabetes. She has extensive experience in leading and executing strategic medical plans, partnering with key external experts, presenting scientific and clinical data to advisory and HTA bodies as part of pre-launch, launch and life cycle management of medicines.

    Rohita earned an Honors Bachelor of Science and a Master’s in Science from the University of Toronto and a PhD in Neuroscience from McMaster University. She also completed a one-year post-doctoral fellowship at the Toronto Hospital for Sick Children. She has published several peer-reviewed publications, most recently one on patient centricity and the importance of partnering with patients in the development of medicines.

    Session Details:

    FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

    2023-11-01, 4:00 PM

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    Shelby Abel-Kilmartin
    Director, Data Management Strategic Outsourcing and Vendor Management, Alexion, AstraZeneca Rare Disease

    Shelby L. Abel is the Director of Clinical Data Management - Strategic Outsourcing and Vendor Management at Alexion Pharmaceuticals, where she drives the overall strategy, processes, and governance to effectively oversee CROs and vendors performing data management (DM) activities She provides operational and strategic DM outsourcing leadership and acts as the primary focal point across Global Clinical Data Management (GCDM),  ensuring vendors perform according to agreed requirements to deliver on time, within budget, and with the highest quality.

    She has 20 + years experience in the Biotechnology/Pharmaceutical industry, at various levels and positions within Clinical Data Management. She has over 13 years of Rare Disease experience and is considered an eCOA SME, possessing a vast knowledge of dosing eDiary data collection.

    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 PM

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    Dr. Claudia Hesselmann
    Founder and CEO, ARENSIA Exploratory Medicine

    Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

    Session Details:

    Accelerated performance of complex exploratory patient studies: practical insights from investigational site

    2023-11-01, 11:30 AM

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    TOLA OLORUNNISOLA
    VP, Strategy, Innovation, Marketing And Digital, Avantor

    Ms. Olorunnisola is currently VP – Innovation, Marketing & Digital in the Avantor Services business unit. She leads Innovation, Marketing and Digital Solutions for the Supply Chain (Lab) Services and Clinical Services. She has over 15 years of experience in the Medical Device and Life Science industry developing and executing digital and go-to-market strategies. Additionally, she has led the development and deployment of large-scale enterprise solutions. Ms. Olorunnisola received her BA in Electrical Engineering from the University of Illinois at Chicago.

    Session Details:

    The innovations of decentralized clinical trials

    2023-11-02, 11:30 AM

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    Siddharth Parulkar
    Senior Director, Head of Clinical Operations, Independent

    Session Details:

    Designing a vendor strategy that works for your clinical trial

    2023-11-01, 5:00 PM

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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:

    KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    2023-11-02, 2:45 PM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

    Session Details:

    Patient centricity through health literacy

    2023-11-02, 9:00 AM

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    Sarah Tressel Gary
    Ph.D., Senior Scientific Advisor, eCOA Clinical Science and Consulting, Clario

    Sarah Tressel Gary is a senior scientific advisor with Clario.  She has over 12 years of experience in clinical trial design and strategy and more than 11 years of experience in eCOA and the development and validation of PROs in support of labeling claims. She has significant experience working with PRO development and validation studies, eCOA design and best practices, and cognitive debriefing and usability testing.  She earned a B.S. in Biomedical Engineering from Worcester Polytechnic Institute, and an M.S. in Mechanical Engineering and Ph.D. in Bioengineering both from Georgia Tech. To date, Dr. Sarah Tressel Gary has co-authored 18 publications and has numerous conference abstracts and presentations.

    Session Details:

    The importance of scientific validation and data integrity when using accessibility features

    2023-11-02, 9:30 AM

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    Cathleen Platt
    Vice President, Clinical Operations, Click Therapeutics

    Former Associate Vice President, Global Clinical Trial Management at Allergan Former Executive Director, Global Clinical Trial Management at Actavis plc Former Executive Director, Clinical Operations at Warner Chilcott Former Senior Director, Technical Services at Consumer Product Testing Company Former Section Head, Toxicology at Leberco Testing A., Biology, Rutgers University

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

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    Marilyn Fontaine
    Director, Clinical Operations, AnHeart Therapeutics

    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:

    Finances and managing your clinical trial budget as a small or medium sized biotech company

    2023-11-01, 3:00 PM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

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    Jodi Coughlin
    Director, Vendor Relationship Management, Deciphera Pharmaceuticals

    Jodi Coughlin, Director of Vendor Relationship Management at Deciphera Pharmaceuticals has over 15 years of industry experience spanning across small to large CRO and Sponsor organizations.  She attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, Jodi transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials.  Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams.  With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations.  She is highly passionate about establishing internal and external cross-functional communication processes and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

    Session Details:

    Choosing a vendor as a small biotech: creating a hierarchy of considerations

    2023-11-01, 11:00 AM

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    Stacey Limauro
    Executive Director, Clinical Operations, Deciphera Pharmaceuticals

    Stacey Limauro, Executive Director of Clinical Operations at Deciphera Pharmaceuticals has over 25 years of industry experience across all Phases of clinical development in both small and large Pharma organizations.  In her current role, she provides leadership and oversight for the entire clinical development operations team and portfolio at Deciphera, including contributing to the operational strategy and implementation of process development and improvement within the department.  One of Stacey’s most influential accomplishments was leading the successful approval of Deciphera’s first drug, QUINLOCK in 2020 for the treatment of GIST.  She enjoys working with high performing cross-functional teams to bring therapeutic treatments to patients in need. She received her BS in Chemistry from Trinity College in CT, and an MS in Biochemistry from Boston College in MA.

    Session Details:

    Choosing a vendor as a small biotech: creating a hierarchy of considerations

    2023-11-01, 11:00 AM

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    Holly Huang
    Vice President, Head of Biometrics, Denovo Biopharma

    Session Details:

    Innovating your data management strategy: how to stay ahead of the curve

    2023-11-02, 11:00 AM

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    Jenny Bentsen Gordon
    Vice President, Head of Clinical Operations, Editas Medicine

    Jennifer (Jenny) Gordon has over 20 years of experience working in Clinical Operations, as a study lead, program lead and head of clinical operations. She has both large, mid and small biotech experience working on biologics and gene therapy in immunology and hematology indications. She loves leading and developing high functioning teams, including partnerships with CROs.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

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    Session Details:

    PANEL DISCUSSION: How to choose technology vendors for your study

    2023-11-02, 9:00 AM

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    Neha Ghosh
    Associate Director, Clinical Research, Fresenius Medical Care

    Neha Ghosh is an Associate Director of Clinical Research at Fresenius Medical Care North America, where she led and manage clinical studies and related activities, from design to conduct to analysis, for various dialysis products and services. She had a PhD in Biological Sciences and multiple certifications in remote work, personal branding, and career development. She is also certified Clinical Professional by ACRP. She had also contributed to several scientific and medical literature in several areas of research and presented her findings internally and externally.

    Session Details:

    CASE STUDY: Working with diverse groups in order to meet achieve DEI in clinical trials

    2023-11-01, 5:00 PM

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    Amanda Murphy
    Senior Director, Data Intelligence & Solutions, GlobalData

    Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

    Session Details:

    Chair’s opening remarks

    2023-11-01, 8:20 AM

    Session Details:

    The state of the biopharmaceutical industry: mid-year update and 2024 outlook

    2023-11-01, 12:00 PM

    Session Details:

    KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    2023-11-02, 2:45 PM

    Session Details:

    Chairperson’s closing remarks

    2023-11-01, 5:30 PM

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    Vikas Agarwal
    Vice President, Head of Program Development, Greenfire Bio

    Session Details:

    PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

    2023-11-01, 2:00 PM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

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    Blake E Wilson
    Partner, Hogan Lovells LLP

    Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group.  He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University.  Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University.  His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry.  He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough.  In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters.  By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

    Session Details:

    PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

    2023-11-01, 2:00 PM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

    Session Details:

    Revolutionizing clinical trials with accelerating clinical evidence models

    2023-11-02, 12:00 PM

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    Chris Cain
    Vice President, Clinical and Regulatory Affairs, Hyalex Orthopaedics

    Chris Cain serves as Vice President, Clinical and Regulatory Affairs at Hyalex Orthopaedics, Inc., a start-up in Lexington, MA.  In this role, he has global responsibility for all aspects of clinical research and regulatory affairs for Hyalex’s cartilage technology.  Chris is currently working on a FIH in Europe, a FIH in Australia and an Early Feasibility Study here in the US. Prior to joining Hyalex, Chris was VP, Clinical and Regulatory Affairs at De Voro Medical, Inc., Conformal Medical, Inc., and Corindus Vascular Robotics. Chris is a member of the Regulatory Affairs Professionals Society (RAPS) and Association of Clinical Research Professional (ACRP); he holds ACRP’s Certification for Clinical Research Associates (CCRA).

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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    Missy Hansen
    Paediatric Strategy Liaison, ICON Plc

    Missy Hansen MSN, CPNP, joined ICON in 2019 as a paediatric strategy liaison (PSL) . As a PSL, Missy considers the patient and family throughout the study and is a resource to both internal and external teams. Missy has 25+ years of experience as a paediatric nurse practitioner, including 17+ years in paediatric haematology/oncology at Children’s Minnesota, the largest haematology/oncology service line in the region providing care for infants through young adults diagnosed with haematologic and/or oncology conditions

    Session Details:

    Assessing risk in your clinical trial using the Pediatric Risk Assessment Map (PRAM):

    2023-11-01, 12:30 PM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

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    Kelsey Miller
    Director, Clinical Development, Intrinsic Therapeutics

    Kelsey started her career in academics with The Boston Spine Group at the renowned New England Baptist Hospital. There she developed and managed their patient registries as well as their investigator and IDE clinical trials.  After 7 years at the Baptist she joined Impliant (a start-up medical device company), where she served as their Clinical Marketing Manager overseeing their US IDE, as well as post-market clinical trials in Brazil, Israel and Belgium. Since 2011 Kelsey has been with Intrinsic Therapeutics in their Clinical department successfully guiding the company’s flagship product through PMA approval.

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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

    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 PM

    Session Details:

    Key considerations when choosing vendors and partners as a small biotech

    2023-11-01, 5:00 PM

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

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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    David Sherris, Ph.D.
    Board Member, SiVEC Biotherapeutics, Inc.

    Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics. Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition. Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies. Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease. Dr. Sherris has held positions of increasing responsibility in public and private companies. Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.

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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:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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    Mackenzie Johnson
    Senior Manager, Patient Centricity, Moderna

    Mackenzie Johnson brings over 10 years of experience in Health Care, Project Management, and Clinical Research as a Senior Manager of Patient Centricity at Moderna. In her current role, she leads the delivery of innovative clinical trial solutions, focusing on enhancing the participant and site experience. Her expertise spans various areas, including Mobile Health, eConsent, eCOA, and Travel Concierge services.

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

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    Rana Said
    Biomarker Study Coordinator, Novartis

    Rana Said is a second year Biomarker Development fellow at Novartis in conjunction with MCPHS. She graduated from Rutgers with her PharmD in May 2022. At Novartis her primary focus is operational support for biomarker sampling on early clinical trials including setting up CRO support for studies. In addition, she works closely on the team that manages the CRO relationship for the Translational Medicine group, with a focus on managing issues.

    Session Details:

    Strengthening the CRO/sponsor relationship: a deep dive into studies

    2023-11-02, 11:00 AM

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    Kathryn Duschean
    Senior Scientist, Laboratory Excellence and Operations, Novartis

    Dr. Kathryn Duschean is a Senior Scientist in Biomarker Development at Novartis Institutes for Biomedical Research in Cambridge, MA, following a 2-year post-doctoral fellowship. She is currently involved in biomarker operational planning, focusing on streamlining fully outsourced studies containing biomarkers. She is also involved in the implementation, and validation of novel patient-centric sampling techniques across a variety of therapeutic areas. Her deep personal passions and former research in autoimmune and related conditions heavily influence and progress her interests and projects in this area. She believes that engaging with internal and external partners is critical to advancing the capabilities of clinical trials, including recruitment and decentralization. Kathryn received both bachelors in English, and in Health Sciences from the University of Iowa, and her PharmD from the University of Colorado.

    Session Details:

    Biomarker opportunities in FiH and clinical pharmacology studies run in an outsourcing model

    2023-11-01, 3:00 PM

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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:

    Engaging patients in a rare disease clinical trial

    2023-11-02, 11:00 AM

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    Prasanna Rao
    Senior Director, Global Head of AI and ML, Pfizer

    Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is Head of Artificial Intelligence and Data Science for Data Management at Pfizer. He has 30 years of experience in Information technology and Analytics, with 10+ years in Healthcare and Life Sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, Machine Learning developers, and Data Scientists to deliver innovation and drive adoption of AI. He has presented at several industry conferences including SCDM, DIA and SCOPE.

    Session Details:

    OPENING KEYNOTE: Innovation in the US pharma industry: uncovering challenges and opportunities

    2023-11-01, 8:30 AM

    Session Details:

    KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    2023-11-02, 2:45 PM

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    Stacey Oppenheimer
    Imaging Vendor Oversight and Sourcing Strategy Lead, Pfizer

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

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    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 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:

    FIRESIDE CHAT: Reducing the burden of clinical trials on patients: what tools are available?

    2023-11-01, 4:00 PM

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    Nicole Stansbury
    Senior Vice President and Head of Global Clinical Operations, Premier Research

    Nicole Stansbury joined Premier Research in May 2023 as the Senior Vice President and Head of Global Clinical Operations. Prior to joining Premier, Nicole spent 25 years in the CRO industry where she served in leadership roles including Global Head of Clinical Trial Management, Global Head of Central Monitoring, and Head of Global Clinical Performance, a team responsible for SOPs, metrics, training, clinical systems, and clinical quality. Nicole’s 30 years of industry experience has included positions at the site level and other CRO roles such as CRA and Project Manager.

    Nicole’s therapeutic experience has primarily been in Dermatology, Gastroenterology, Urology and Women’s Health; however, Nicole has leadership experience overseeing trials in Oncology, Neuroscience and General Medicine.

    Nicole has a Bachelor’s in Animal Science from Texas A&M University and has a Lean Six Sigma Yellow Belt. Nicole has served as Co-Lead for the Association of Clinical Research Organization’s (ACRO) Risk-Based Monitoring (RBM) Working Group since 2014 where she works with TransCelerate and global regulatory authorities on driving RBM adoption in the industry.

    Nicole is a member of PhUSE, collaborates regularly in industry publications, and is a frequent presenter and panelist at SCOPE, DIA, and other industry conferences.

    Session Details:

    Modernizing site management and monitoring roles to meet the dynamic needs of clinical research

    2023-11-02, 9:30 AM

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    Christine Hurley
    Vice President, Clinical Business Operations and Innovation, Relay Therapeutics

    Christine has worked in leadership roles in biotech for the last twenty-five years, with experience in process improvement, outsourcing, partnership strategies and clinical technology leadership. Christine is currently Vice President of Clinical Business Operations and Innovation at Relay Therapeutics.

    Session Details:

    CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

    2023-11-01, 2:00 PM

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

    Session Details:

    PANEL DISCUSSION: How to choose technology vendors for your study

    2023-11-02, 9:00 AM

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    Emily Matthews
    Senior Manager, Clinical Business Operations, Relay Therapeutics

    Emily has been working at Relay Tx for almost 3 years in the Clinical Business Operations group focusing on contracting, budgeting as well as site and vendor management.  Prior to Relay Tx, she worked at bluebird bio in a similar capacity within the Clinical Business Operations team.

    Session Details:

    CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

    2023-11-01, 2:00 PM

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    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 PM

    Session Details:

    CASE STUDY: Running a clinical trial when repurposing an existing drug

    2023-11-02, 12:00 PM

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    Shari Coslett
    Vice President, Clinical Operations, Rhythm Pharmaceuticals

    Shari has over 25 years experience of operational experience mostly in the CNS space.  She has been with midsized companies such as Eisia, where she headed up the Global CNS Operations team, as well as small biotech, such as Axovant where she built a team from scratch.  She is currently at Rhythm Pharmaceuticals, where she heads up Clinical and Laboratory Operations, Medical Writing, and Procurement and Outsourcing.

    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 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:

    KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    2023-11-02, 2:45 PM

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    Nancy Goodman
    Associate Director, Clinical Operations Program Leader, Takeda

    Nancy Goodman is a Registered Nurse, RN, BSN Nancy has 24 years in Clinical Operations, Ph. 1-4, with a focus in Early Phase, working in multiple therapeutic areas in small, medium and large biotech/pharmaceutical companies in the Boston area.  She has worked on a successful sNDA in Oncology.  Currently, Nancy is at Takeda Pharmaceuticals as an Associate Director, Clinical Operations Program Leader, COPL, Early Clinical Development.  Prior to this remit, she assumed COPL responsibilities in the Neuroscience Therapeutic area working on Neurodegenerative diseases.

    Outside of work, Nancy enjoys spending time with her husband, being outdoors, cycling, hiking, kayaking and playing tennis and travel.  She is located in the Boston area.

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    Jim Palma
    Executive Director, TargetCancer Foundation

    Jim Palma is the Executive Director of TargetCancer Foundation. Since joining TargetCancer Foundation in 2010, Jim has overseen its growth from a small start-up to a nationally recognized foundation supporting comprehensive rare cancer research programs and patient support services. Prior to joining TargetCancer Foundation, he spent eleven years at Fidelity Investments in Boston, MA. Jim is a member of the Board of Directors of the National Organization for Rare Disorders (NORD), and is a founding Co-Chair of the NORD Rare Cancers Coalition. In addition, Jim is a Steering Committee member at the GI Cancers Alliance and the Global Cholangiocarcinoma Alliance. Jim completed studies at the Institute for Nonprofit Management and Leadership at the Questrom School of Business at Boston University, and received his B.A. from Loyola University Maryland.

    Session Details:

    PATIENT ADVOCACY KEYNOTE: Patient experience in oncology trials: lessons learned from a patient advocacy-driven, decentralized clinical trial

    2023-11-01, 9:30 AM

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

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

    Session Details:

    CASE STUDY: Implementing eClinical technology in a medical device setting

    2023-11-01, 4:00 PM

    Session Details:

    Chairperson’s closing remarks

    2023-11-01, 5:30 PM

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    Session Details:

    Innovative processes to better address today’s trial dynamics

    2023-11-01, 4:30 PM

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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.

    Session Details:

    Operating conditions and trends impacting global clinical trial performance

    2023-11-02, 1:30 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:

    Benchmarking patient enrollment and use of recruitment tactics

    2023-11-01, 12:00 PM

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    Amy Raymond
    Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials

    Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances.

    In addition to her grasp of the unique dynamics of developing novel treatments for rare and complex diseases, Amy also leverages her combination of training and experience leading the Cell and Gene Therapy Hub at Worldwide Clinical Trials. This experience includes gene therapy, cell therapy, gene-modified cell therapy, and gene editing treatments for oncology and rare disease patient communities. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders – payers, regulators, patients, families, and sites – is a critical success factor for efficient development programs.

    Session Details:

    Continued evolution of cell and gene therapy development programs

    2023-11-01, 2:30 PM

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    Lisa Kang
    Independent Clinical Trial Expert

    Lisa brings extensive experience in oncology and CNS drug development to the table. She is especially enthusiastic about the industry's increasing emphasis on data-driven approaches to deliver impactful results

    Session Details:

    PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

    2023-11-01, 2:00 PM

    Session Details:

    Incorporating real world evidence into clinical trials: what new opportunities are created?

    2023-11-01, 11:00 AM

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    Sverre Bengtsson
    Co-Founder, Viedoc

    Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

    Session Details:

    Digitalization in clinical trials: a 360 view

    2023-11-01, 12:30 PM

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    Evan Hahn
    Senior Vice President, IRT Solutions, YPrime

    Evan Hahn is Senior Vice President of IRT Solutions at YPrime, a global leader in eClinical systems that provides cloud-based solutions for clinical trials. He has over 20 years of experience in the life sciences industry promoting innovative approaches to drug development. Evan leads a team with a particular focus on applying technology and sophisticated applications of data to drive insights and efficiencies to trial design and execution.

    Session Details:

    Re-imagining IRT for modern clinical development

    2023-11-01, 2:30 PM

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    April Mattison-Wolfe
    Senior Solutions Architect, TransPerfect

    April Mattison-Wolfe came to TransPerfect’s Trial Interactive (TI) Technical Services group with 24 years of Clinical Operations experience, including more than 7 years as a Clinical Operations Trainer and Clinical Business Systems Analyst.  With experience at both Sponsor companies and CROs, April applies her extensive knowledge of clinical systems requirements and pharmaceutical business practices to help TI clients pinpoint their CTMS needs and configure a solution that is right for them.

    Session Details:

    Forging the future with CTMS

    2023-11-02, 2:15 PM

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    Hope Weisser
    Senior Product Manager, TransPerfect

    Hope formally joined TransPerfect in 2021 after nearly two years of working as a contractor with TransPerfect’s Trial Interactive (TI) team developing our Clinical Trial Management System (CTMS). Hope brings 16 years of life science experience, including a vast knowledge of CTMS-related information and systems utilized across the industry in pharmaceutical and clinical research organizations. Trial Interactive officially launched its CTMS at the end of 2021 under Hope’s direction as the Product Owner.  Since the launch, TI’s CTMS solution has continued to incorporate over 50% of customer-requested improvements within each release.

    Session Details:

    Forging the future with CTMS

    2023-11-02, 2:15 PM

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    Ivor Clarke
    Chief Innovation Officer, SubjectWell

    Ivor Clarke is Chief Innovation Officer and co-founder of SubjectWell, the largest patient marketplace connecting people with chronic health conditions to new care options. Since 2012, SubjectWell has been raising awareness about the benefits of clinical research, registering over 10 million healthcare-motivated patients. Ivor has over 15 years of C-suite experience with a background in online marketing and the creation and operation of enterprise SaaS solutions. Before SubjectWell, Ivor served as President of Brightfire, a digital marketing startup.

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    Improving randomization rates with Machine Learning and AI

    2023-11-01, 4:30 PM

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    Steven Cummings
    Executive Director, San Francisco Coordinating Center at California Pacific Medical Center Research Institute

    Dr. Cummings is the Executive Director of the San Francisco Coordinating Center (SFCC) that he founded in 1979. He is also a professor of medicine, epidemiology, and biostatistics emeritus at the University of California, San Francisco (UCSF).  He is an internationally renowned expert in research on aging and osteoporosis.

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    David Hadden
    President, Founder and Chief Game Changer, Pro-ficiency

    David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach.

    Session Details:

    Clarity in the complex: the untapped potential of simulation-based training in clinical research

    2023-11-01, 4:30 PM

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    Ken Hamill
    Senior Director, Clinical Operations Portfolio, Medidata Solutions

    Ken Hamill is the Senior Director, Clinical Operations Portfolio, at Medidata, a Dassault Systèmes company. Ken works across the organization and with customers in their adoption of clinical operations technologies that help automate trial quality workflows. Ken also leads the development and execution of strategic marketing programs for Clinical Operations at Medidata. Prior to Medidata, Ken had over 15 years of experience in life science product management, most recently at PerkinElmer where he led the strategy team for drug discovery assay development. Ken holds an MBA in Health Sector Management from Boston University, and an BS in Chemistry from Tufts University.

    Session Details:

    Solving the clinical data challenge

    2023-11-01, 9:00 AM

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    Ching Tian
    Chief Innovation Officer, Emmes

    Session Details:

    Find a cure for your complex technology headaches

    2023-11-02, 9:30 AM

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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:

    TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

    2023-11-01, 11:30 AM

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    Joyce Moore
    Global Head of Patient Engagement, Allucent

    Joyce brings over 20 years of industry expertise spanning multiple disciplines and a diverse range of therapeutic areas.  For the past 15 years, Joyce has focused on Patient Engagement, Recruitment, and Retention; she is passionate about widening participation in clinical research and developing and deploying technology approaches to engage with both sites and patients, including decentralized approaches.

    In her current position as Global Head of Patient Engagement at Allucent, she is part of the Clinical Trial Organizations leadership team. She is responsible for leading, managing, and overseeing Patient Recruitment activities and Allucent’s Decentralized Trial offering known as Patient Direct Trials.

    Session Details:

    How do we make participation in clinical research more patient-friendly

    2023-11-01, 2:30 PM

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    Kelly McKee
    Vice President of Patient Registries and Recruitment

    Kelly McKee is the Vice President of Patient Registries and Recruitment at Medidata with 20 years of experience in clinical trial operations, patient recruitment and innovation. She is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012.

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

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    Douglas Henry
    President, Phazemos

    Douglas has spent 24 years building a global career in finance, strategy, and corporate and business development.

    Prior to co-founding Phazemos, Douglas was the Vice President of Corporate Development for a full-service CRO headquartered in Boston.  Douglas also worked as a management consultant at Alvarez & Marsal in New York.  He started his career as a Transaction Advisor for Ernst & Young in Chicago.

    He holds a BS from the University of Arkansas and an MBA from Harvard Business School.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

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    Kevin Ahonen
    Former Head of Digital Engagement, Biogen

    Kevin Ahonen is an independent consultant with 25 years of experience in the biotechnology industry.  Most recently he was the Head of Digital Patient Engagement within Global Clinical Operations for Biogen where he used digital assets like websites and social media ads to educate patients about clinical trials.  He holds an MBA from Babson College and an undergraduate degree in Engineering Management from the University of Vermont.

    Session Details:

    Utilizing technology to accelerate clinical trial enrolment

    2023-11-02, 12:00 PM

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    Dima Hendricks
    Sickle Cell Patient Advocate

    Dima Hendricks is the Founder and Executive Director of Through The Pain, a non-profit organization that provides patient-centered services for sickle cell warriors and caregivers.

    Dima is a wife, mom of two boys, an author, and has an extensive pageant resume that includes: Mrs. Massachusetts International, Miss Black Dorchester USA, and Miss Black Massachusetts USA. She also lives with sickle cell disease.

    Session Details:

    CASE STUDY: Recruiting for a rare disease trial

    2023-11-02, 10:00 AM

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    Christine Slater
    Associate Director, Patient Recruitment, Editas Medicine

    Christine Slater is the Associate Director of Patient Recruitment at Editas Medicine, where she oversees the strategy and execution of patient recruitment and retention for rare diseases including sickle cell disease and beta thalassemia. Prior to joining the biotech industry, she spent nearly a decade recruiting and training women from underrepresented areas how to run for elected office.

    Session Details:

    CASE STUDY: Recruiting for a rare disease trial

    2023-11-02, 10:00 AM

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    Jessica Perry
    Director, Patient Centricity, Clinical Innovation, Moderna

    Session Details:

    Chairperson’s closing remarks

    2023-11-01, 5:30 PM

    Session Details:

    PANEL DISCUSSION: How to choose technology vendors for your study

    2023-11-02, 9:00 AM

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    Alyce King
    Senior Business Development Manager

    Alyce King is a business development professional with 15+ years of experience in health care. She has been with Novotech for seven years working both in Australia and the United States. She holds a Bachelor of Science in Chemistry and Physiology from Monash University in Melbourne, Australia.

    Session Details:

    Perspectives on the biotech/CRO investment landscape

    2023-11-01, 10:00 AM

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    Nissa Ashenbramer
    Senior Project Manager, Oncology and Hematology, TFS Health Science

    Nissa Ashenbramer, Senior Project Manager, Oncology & Hematology
    Nissa Ashenbramer brings over 25 years of industry expertise to her role as a Senior Project Manager. Her primary focus has been in oncology, with 15 years dedicated to project management and an additional ten years as a Clinical Research Associate (CRA).

    Having engaged on both the pharmaceutical and CRO fronts, Nissa has a strong emphasis on early-phase I and II oncology studies, especially in advanced solid tumors. Throughout her career, she has also made significant contributions to oncology indications in Phases III and IV.

    In addition to her primary role, Nissa has taken on various responsibilities, such as a clinicaltrials.gov administrator, Investigator Sponsored Trial facilitator, and Independent Response Review moderator. Her expertise further extends to budget negotiations, IRB submission specializations, and her role as a CTMS Super User. Passionate about nurturing talent, Nissa takes pride in mentoring both Project Managers and CRAs.

    Session Details:

    Bridging barriers: streamlining oncology study startup in today’s clinical environment

    2023-11-01, 12:30 PM

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    Leticia Tarilonte
    Senior Director, Clinical Operations Consultant, Nimbus Therapeutics

    Leticia has over 23 years of industry experience managing several research projects and clinical studies in various roles. She started her career in Pharma at Biogen, working collaboratively in an integrated monoclonal antibody research team and then moving to development in clinical operations, where she managed numerous phase I-III clinical trials in diverse therapeutic areas including, gastroenterology, immunology, neurology, and neuropathic pain.
    She continued her career at Merck/EMD Serono where she provided strategic and operational expertise in the planning and conduct of several Phase I-III clinical studies in oncology and immuno-oncology, which led to the FDA accelerated approval of BAVENCIO® in merkel cell carcinoma and in urothelial carcinoma. Later she served as a Chief of Staff to the Sr. VP and Head of Development in Oncology, where she partnered with executive sponsors to identify and promote projects that are of strategic importance to the company and translating the function strategy into operational plans.
    After many years in big Pharma, Leticia continued her career at various biotech companies: first at Kiniksa Pharmaceuticals, where she was responsible for various programs with high complexity in rare diseases, consisting of numerous global clinical trials in 10 different indications. Followed by Black Diamond Therapeutics, a biotech company addressing the significant unmet need for novel precision oncology therapies for patients with genetically defined cancers. In her last role, Leticia served as the Clinical Operations Lead at Nimbus Therapeutics, a biotech company working on the development of a HPK1 inhibitor in solid tumors.
    Leticia also serves as an IRB Member at Yale University and is the Chair and President of the Association of Clinical Research Professionals (ACRP) - New England Chapter.
    Leticia earned her Bachelor’s Degree in Biomedical Laboratory and Clinical Sciences from the School of Medicine at Boston University, followed by a Master’s Degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences in Boston.

    Session Details:

    Innovating and introducing new technology while ensuring patients remain at the heart of your clinical trial

    2023-11-02, 9:00 AM

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    Donna Fraser
    Director, Client Operations, Novotech

    Donna Fraser, Therapeutic Strategy Director, US based.
    25 years in Industry with the past 18 years at Novotech.
    Donna is a NZ Comprehensive Registered Nurse with a clinical background in Nursing, Certified Medical Case Management, Project Management and Clinical Operations.
    As Director of Therapeutic Strategy, Donna partners with the Novotech Business Development team to provide strategic oversight across an extensive range of therapeutic areas by leveraging her clinical experience, investigator site relationships and specialist knowledge.
    Established in 1997, Novotech is a global CRO recognized for its partnership with Sponsors clinical trial development and management.
    With its presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide. Novotech supports clinical trials across Asia Pacific, United States and Europe.
    www.novotech-cro.com

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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    Stuart Thiede
    VP & Global Head Financial Lifecycle, IQVIA

    Stuart is responsible for leading the international team of professionals that delivers investigator grant payment solutions to clinical trial sponsors and CROs. He was Senior VP of Global Payment Services at CFS Clinical when it was acquired by DrugDev in 2014, and continued to lead and grow the Clinical Trial Payments offering after DrugDev was acquired by IQVIA in 2017. Stuart’s diverse background includes executive roles in finance, operations, service delivery, and account management in enterprises ranging from Fortune 500 technology companies to start-ups. He has significant international experience, including an expatriate assignment in Europe and a finance director role for a Latin American division of Unisys Corporation. Stuart has a B.S. in Accounting and an M.B.A. from Bowling Green State University.

    Session Details:

    The importance of real-time forecasting in biotech trials

    2023-11-02, 11:30 AM

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    Chris Weiss
    Vice President, Sales, OpenClinica

    Since 2020, Chris’s deep, hands-on experience with the OpenClinica suite of solutions has made him a key member of our team. He has over 20 years of experience in leadership roles across clinical research and data analytics organizations spanning public companies, startups, consulting firms and academia. Chris earned a bachelor of arts in computer science from Dartmouth College.

    Session Details:

    TECHNOLOGY SPOTLIGHT: eSource: auto-populate eCRFs with source data on study Day 1

    2023-11-01, 11:45 AM

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    Mike Waters
    Global Vice President, Biopharma Business Development, Cerba Research

    Mike Waters is the Global VP Biopharma Business Development for Cerba Research.  Mike has spent over 25 years in various roles supporting the drug development industry which has seen him work across central & esoteric labs, oncology and virology specialty labs, preclinical development, diagnostics, medical device, and data/technology organizations. Mike Waters holds a Bachelor of Science degree in Medical Technology and is MT(ASCP) certified.

    Session Details:

    An agile approach to PBMC collection in vaccine trials

    2023-11-02, 11:30 AM

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