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Why Attend?

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

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

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

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

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

Register now to book your place at the conference.

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

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.

700+

Attendees

80+

Exhibitors

50+

Speakers
700+

Attendees

80+

Exhibitors
50+

Speakers

Testimonials

See What It's All About

2025 Sponsors Included:

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Company Information

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

Company Website

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

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Company Information

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

Company Website

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

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Company Information

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

Company Website

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

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Company Information

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

 

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

 

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Company Information

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

Company Website

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

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

Company Website

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

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Company Information

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

Company Website

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

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Company Information

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

Company Website

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

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Company Information

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

Company Website

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

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

Company Website

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

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Company Information

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

Company Website

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

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

trutechnologies.io

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

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

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

Company Website

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

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Company Information

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

www.smurfitwestrock.com

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

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Company Information

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

Company Website

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

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

Company Website

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

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Company Information

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

Company Website

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

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

Company Website

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

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    Agenda

    • 27 Oct 2026
    • 28 Oct 2026
    Expand All

    Streams

    Stream one

    Stream C: Biotech Strategy

    12:30 PM

    Driving innovation in clinical research with master protocols

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

    Speakers

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

    2 PM

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

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

    MODERATOR Rich Polgar, Managing Director, Danforth Health

    Speakers

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

    2:30 PM

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

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

    Speakers

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

    3 PM

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

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

    Speakers

    Chris Adams
    Chief Executive Officer, Andarix

    3:30 PM

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

    3:45 PM

    EXHIBITION APPLE PRIZE DRAW

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

    4 PM

    Choosing the right CRO: key considerations for small biotechs

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

    Speakers

    Dr. Martin Bauer
    Chief Medical Officer, Eleva GmbH

    4:30 PM

    Driving asset value through operational precision

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

    Speakers

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

    5 PM

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

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

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

    Speakers

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

    5:30 PM

    Chairperson’s closing remarks

    Speakers

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

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

    12:30 PM

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

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

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

    Speakers

    Christer Nilsson
    Chief Executive Officer, Replior

    2 PM

    Implementing an EDC system: operational and technical considerations

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

    Speakers

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

    2:30 PM

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

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

    Speakers

    Brad Stefanovic
    Head of Clinical Innovations, Simulations Plus

    2:45 PM

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

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

    Speakers

    Josh Gillum
    Vice President, Business Development, Evotec

    3 PM

    Harnessing real world experience: driving innovation and decision making

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

    Speakers

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

    3:30 PM

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

    3:45 PM

    EXHIBITION APPLE PRIZE DRAW

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

    4 PM

    Opportunities in building AI models for efficiency in outsourcing

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

    Speakers

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

    4:30 PM

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

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

    Speakers

    Emily McInturf
    Director, Feasibility, PSI CRO

    5 PM

    Direct-to-Patient Shipments of Investigational Products

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

    Speakers

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

    5:30 PM

    Chairperson’s closing remarks

    Speakers

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

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

    10:30 AM

    Morning refreshments and networking break sponsored by Suvoda

    12:30 PM

    Beyond the Buzzword: Practical AI strategies for accelerating clinical research

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

    Speakers

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

    2 PM

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

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

    Speakers

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

    2:30 PM

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

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

    Speakers

    Jessica Wessel
    Senior Director, Project Delivery, TFS HealthScience

    3 PM

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

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

    MODERATOR John Seman, Chief Executive Officer, Revitale Pharma

    Speakers

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

    3:30 PM

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

    3:45 PM

    EXHIBITION APPLE PRIZE DRAW

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

    4 PM

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

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

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

    Speakers

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

    4:30 PM

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

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

    Speakers

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

    5 PM

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

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

    Speakers

    Carrie Lewis
    Executive Director, Clinical Program Optimization, Keenova Therapeutics

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    John Seman
    Chief Executive Officer, Revitale Pharma

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

    Streams

    Stream one

    Stream C: Biotech Strategy

    8:50 AM

    Chairperson’s opening remarks

    Speakers

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

    9 AM

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

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

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

    Speakers

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

    10 AM

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

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

    Speakers

    Shailesh Chavan
    Managing Partner, Ingenious Global Venture Partners

    10:30 AM

    Morning refreshments and networking break

    11 AM

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

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

    Speakers

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

    11:30 AM

    PANEL: Driving technology and innovation in a small biotech

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

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

    Speakers

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

    12:30 PM

    Lunch and networking break

    8:50 AM

    Chairperson’s opening remarks

    Speakers

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

    9 AM

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

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

    Speakers

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

    9:30 AM

    Beyond Integration: How AI Creates a Clinical Trial Platform

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

    Speakers

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

    10 AM

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

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

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

    Speakers

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

    10:30 AM

    Morning refreshments and networking break

    11 AM

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

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

    Speakers

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

    11:30 AM

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

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

    Speakers

    Christopher Schoonmaker
    Chief Operating Officer, MMS Holdings

    12 PM

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

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

    Speakers

    Jerrold M. Shapiro
    President, Floelle

    12:30 PM

    Lunch and networking break

    8 AM

    Registration and refreshments sponsored by Catalyst Flex

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    T.J. Sharpe
    Patient Engagement Expert, Sharpe Patient Insights

    9 AM

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

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

    Speakers

    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, Center for Information & Study on Clinical Research Participation (CISCRP)
    Ellyn Getz
    Director, R&D Patient Partnerships, R&D Strategic Operations, CSL Behring

    9:30 AM

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

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

    Speakers

    Louisa Carlse
    Director of Partnerships, TecEx Medical

    10 AM

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

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

    Speakers

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

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Accelerating site activation and study start up

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

    Speakers

    Marilyn Fontaine
    Director of Clinical Operations, Nuvation Bio

    11:30 AM

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

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

    Speakers

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

    12 PM

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

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

    Speakers

    John Smutko
    Head of Oncology Scientific Operations, GSK

    12:30 PM

    Lunch and networking break

    1:30 PM

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

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

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

    Speakers

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

    2:15 PM

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

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

    Speakers

    Vinnette Sallo
    Senior Director, Project Management, Ergomed

    2:45 PM

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

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

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

    Speakers

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

    3:15 PM

    Afternoon refreshments, networking and prize draw sponsored by Andwin Scientific

    3:30 PM

    PRIZE DRAW

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

    3:45 PM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

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

    ROUNDTABLE 1: Navigating biological material regulations

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

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

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

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

    Liza Micioni, Director, Clinical Operations, Tris Pharma

    ROUNDTABLE 4: Negotiation tips for emerging startups

    Speakers

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

    4:45 PM

    Chair’s closing remarks

    End of Conference

    2025 Speakers

    Select a speaker to learn more

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    Ken Getz
    Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development

    Ken Getz is the Executive Director and a research professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded research on pharmaceutical R&D management and execution; protocol design optimization; contract service provider and investigative site management; e-clinical technology and data usage; and patient and community engagement. He is also the chairman of CISCRP – a nonprofit internationally-recognized organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. And the president of the Otsuka Patient Assistance Foundation. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors and serves on the editorial boards of Pharmaceutical Medicine, Life Science Leader and Therapeutic Innovation and Regulatory Science. Ken received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. He is the founder of CenterWatch, a leading publisher in the clinical trials industry, and one of several businesses that he has created and sold.

    Session Details:

    KEYNOTE with Q&A Characterizing the high and rising global enrollment challenge and what can be done about it

    2026-10-27, 8:30 AM

    Session Details:

    KEYNOTE PANEL New strategies and tactics driving more agile, feasible, and risk-based operating models

    2026-10-27, 9:30 AM

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    Dr. Jenny Kim
    Research Associate Professor, Tufts Center for the Study of Drug Development
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    Abigail Dirks
    Senior Data Scientist, Tufts Center for the Study of Drug Development

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

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    Madison Ford
    Research Analyst, Tufts Center for the Study of Drug Development
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    Hana Do
    Research Analyst, Tufts Center for the Study of Drug Development
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    Andrea Bottkova
    Senior Director of Procurement and Vendor Management, Karyopharm Therapeutics

    I currently work as Senior Director of Procurement and Vendor Management at Karyopharm Therapeutics Inc. I have been negotiating contracts for little over fifteen years. Working 10 years in the biotech industry I have gained an excellent Understanding of all areas of research and development. In 2019 I helped establish Karyopharm’ s vendor management and procurement department to support vendor oversight, strategic sourcing maximizing financial savings. I am passionate about building partnerships and negotiating business terms of contracts resulting in several million dollar savings annually. I believe that I have perfected my negotiations skills while learning from my very curious 7-year-old son Barton.

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    Leonella Seeley
    Director of Procurement and Vendor Management, Karyopharm Therapeutics
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    Sonal Kalra
    Founder, CONNECT Meditation
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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, Center for Information & Study on Clinical Research Participation (CISCRP)

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

    Session Details:

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

    2025-10-16, 9:00 AM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2025-10-16, 3:45 PM

    View In Agenda
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    Colleen Graham
    SVP, Head of Clinical Operations, Mediar Therapeutics

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

    Session Details:

    ASK THE EXPERTS! Biotech Unlocked: Solving Clinical Operations Challenges Through Peer Insight

    2026-10-27, 12:15 PM

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    Akash Patel
    Sr. Director; Head of Design Assurance, GSK
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    Kevin Anderson
    Founder, Applied AI Strategy and Pharma GTM Advisor

    Session Details:

    ASK THE EXPERTS! Clinical Trials in The Age of AI

    2026-10-27, 12:15 PM

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    Dori Sarkis
    Sr. Director, Strategic Partnerships, Alcanza Clinical Research for all

    Session Details:

    PANEL DISCUSSION Maximizing Site Productivity: Reducing Burden and Strengthening Output

    2026-10-27, 12:15 PM

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    Michael Herman
    Patient Advocate, Founder & Chief Visionary Officer, Cancer CAREs International

    Session Details:

    PANEL DISCUSSION Maximizing Site Productivity: Reducing Burden and Strengthening Output

    2026-10-27, 12:15 PM

    Session Details:

    Why Patients Walk Away from Clinical Trials and What the Industry Still Gets Wrong

    2026-10-27, 11:15 AM

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

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

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    Carrie Lewis
    Executive Director, Clinical Program Optimization, Keenova Therapeutics

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

    Session Details:

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

    2025-10-15, 5:00 PM

    Session Details:

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

    2025-10-15, 3:00 PM

    Session Details:

    ASK THE EXPERTS! Biotech Unlocked: Solving Clinical Operations Challenges Through Peer Insight

    2026-10-27, 12:15 PM

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    Amanda Hayden
    Senior Vice President, Clinical Operations, Amylyx Pharmaceuticals

    Amanda Hayden is an Executive Director of Clinical Operations at Eledon Pharmaceuticals, and has worked for over 20 years in the clinical operations field. Amanda started her career as a CRA with a small CRO, progressing to Lead CRA and Project and Program Management roles at Antigenics (now Agenus) and Millennium Pharmaceuticals (now Takeda). She then transitioned into Clinical Leadership positions at Lantheus Medical Imaging, and at Alkermes, where Amanda spent 8 years overseeing Study Start Up, Clinical Compliance, Clinical Systems and Disclosure and Technical Solutions. She has extensive prior monitoring and project management experience, with more than 10 years focused on Oncology trials. More recently, Amanda has spent significant time dedicated to large scale trial start-up, including global trial submissions and study launches in approximately 20 countries, as well as in overseeing ICH E6 R2 implementation and Inspection Readiness initiatives.

    Session Details:

    ASK THE EXPERTS! Biotech Unlocked: Solving Clinical Operations Challenges Through Peer Insight

    2026-10-27, 12:15 PM

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    Jennifer Burg
    Global Clinical Development Operations Leader, Burg Consulting

    Session Details:

    ASK THE EXPERTS! Biotech Unlocked: Solving Clinical Operations Challenges Through Peer Insight

    2026-10-27, 12:15 PM

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    Ananya Jain
    Portfolio Management Lead, Research Strategy and Operations, Biogen
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    Fran Brophy
    Senior Director, Clinical Programs, Clinical Product Lead, US WorldMeds

    Session Details:

    KEYNOTE PANEL New strategies and tactics driving more agile, feasible, and risk-based operating models

    2026-10-27, 9:30 AM

    View In Agenda
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    Anil Tarachandani
    Former Vice President and Head of Translational Medicine, Verge Genomics

    Biotech executive with 20+ years of experience driving innovation at the intersection of science, medicine, and technology. Currently VP, Head of Translational Medicine at Verge Genomics, where I built the function from the ground up and advanced neurology programs through Phase 2/3 readiness using FDA-validated biomarkers. Previously at Pfizer, I led cross-functional teams delivering novel digital endpoints, secured FDA/EMA alignment, and helped advance Ponsegromab from Phase 1 to Phase 2/3. At Biogen, I drove digital diagnostics initiatives, advanced technologies in Alzheimer’s and stroke, and helped spin out a new venture. I also founded a digital diagnostics startup, Usin’Life, which exited with a few assets. Passionate about advancing therapies for patients with high unmet medical needs, I bring expertise in translational medicine, biomarker strategy (digital & fluid), regulatory engagement, using technology ( including AI/ML !) and partnerships across biotech, pharma, and academia.

    Session Details:

    ASK THE EXPERTS! Clinical Trials in The Age of AI

    2026-10-27, 12:15 PM

    Session Details:

    Proving the Value of AI in Clinical Trials: Real-World Use Cases Delivering Measurable ROI

    2026-10-27, 11:15 AM

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    T.J. Sharpe
    Patient Engagement Expert, Sharpe Patient Insights

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

    Session Details:

    ASK THE EXPERTS! Clinical Trials in The Age of AI

    2026-10-27, 12:15 PM

    Session Details:

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

    2025-10-15, 5:00 PM

    Session Details:

    Chairperson’s opening remarks

    2025-10-16, 8:50 AM

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    Yanping Kong
    CEO, Kong’s Pharmaceutical
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    Kelly Knippel Butler
    JD, Ethics & Compliance Business Partner, Data & Digital Innovation, Takeda
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    Marissa Volpe
    SVP, Clinical Development, NervGen Pharma

    Session Details:

    CASE STUDY From Bench to Bedside: Building an End-to-End Biotech

    2026-10-27, 11:15 AM

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    Bob Loll
    SVP, Business Development & Strategic Planning, Praxis

    Session Details:

    Chairperson’s opening remarks

    2026-10-27, 8:20 AM

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    OCT Advisory Board

    Select a member to learn more

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    Dr Alison McMorn
    Head of Clinical Strategy and Development, LifeArc

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

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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, Center for Information & Study on Clinical Research Participation (CISCRP)

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

    Session Details:

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

    2025-10-16, 9:00 AM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2025-10-16, 3:45 PM

    View In Agenda
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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

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

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    Aditya Kotta
    VP Business Development, Novotech

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

    Session Details:

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

    2025-10-15, 2:00 PM

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

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

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

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

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

     

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

     

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

     

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

     

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

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    Edwin van Vulpen
    Executive Director and Head of Clinical Business Development Euro-Asia
    Next

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    SPONSORSHIP ENQUIRIES

    Head of OCT events

    Nicholas McCudden


    +61 280 978 126

    SPEAKER ENQUIRIES

    Head of Production

    Maya Hudson


     

    MARKETING ENQUIRIES

    Head of Marketing

    Valentina Sidore


     

    DELEGATE ENQUIRIES

    VIP Delegate Manager

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