• Why Attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Why partner?
  • Contact Us

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:

Back

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/

Next Sponsor
Back

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

Next Sponsor
Back

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

Next Sponsor
Back

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

 

Next Sponsor
Back

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/

Next Sponsor
Back

Company Information

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

Company Website

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

Next Sponsor
Back

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/

Next Sponsor
Back

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

Next Sponsor
Back

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/

Next Sponsor
Back

Company Information

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

Company Website

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

Next Sponsor
Back

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.

Next Sponsor
Back

Company Information

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

trutechnologies.io

Next Sponsor
Back

Company Information

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

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

Next Sponsor
Back

Company Information

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

Company Website

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

Next Sponsor
Back

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

Next Sponsor
Back

Company Information

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

Next Sponsor
Back

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/

Next Sponsor
Back

Company Information

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

Company Website

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

Next Sponsor
Back

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

Next Sponsor
Back

Company Information

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

Company Website

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

Next Sponsor

    Agenda

    • 27 Oct 2026
    • 28 Oct 2026
    Expand All

    Streams

    Stream one

    Stream A: Outsourcing & Clinical Operations

    Stream two

    Stream B: Data, AI & Clinical Innovation

    Stream three

    Stream C: Biotech Strategy

    11:15 AM

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

    from early research to clinical delivery under one roof. This session explores the practical realities of building clinical operations and establishing an in-house Phase II unit.

    • Building and scaling a clinical operations function
    • Talent, structure, and service provider strategy
    • Establishing an in-house Phase II unit: key considerations and patient recruitment

    Speakers

    Marissa Volpe
    SVP, Clinical Development, NervGen Pharma

    11:45 AM

    Reserved for Fortrea

    12:15 PM

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

    Biotech clinical operations teams face constant pressure - limited resources, tight timelines, and increasing complexity. This interactive session creates an open forum to share challenges, learn from peers, and uncover practical solutions that work in lean environments. 

    Led by expert facilitators, the discussion will focus on real-world issues submitted anonymously by attendees. From operational bottlenecks to vendor management and resourcing, this is an opportunity to learn from others, avoid common mistakes, and leave with actionable ideas to drive progress. 

    How the Session Will Work:

    • Scene Setting: Experts frame key challenges and trends
    • Anonymous Input (Slido): Attendees submit questions and challenges live
    • Peer Discussion: Open, honest sharing of experiences and solutions, with attendees also able to contribute answers and insights via Slido
    • Expert Takeaways: Key insights and practical actions to implement

    Outcome: A candid, solution-focused discussion designed to help teams move faster and smarter.

     

    Speakers

    Colleen Graham
    SVP, Head of Clinical Operations, Mediar Therapeutics
    Amanda Hayden
    Senior Vice President, Clinical Operations, Amylyx Pharmaceuticals
    Carrie Lewis
    Executive Director, Clinical Program Optimization, Keenova Therapeutics
    Jennifer Burg
    Global Clinical Development Operations Leader, Burg Consulting

    12:45 PM

    Reserved for Parexel Biotech

    1:15 PM

    Lunch and networking

    2:15 PM

    Doing More with Less: Maximizing Resources & Capabilities in Biotech Clinical Trials

    Biotech companies often operate with lean teams and limited resources yet face the same complexities as larger pharma. This session will explore how smaller organisations can maximise internal capabilities, leverage cross-functional talent, and build efficient operating models to successfully deliver clinical trials.

    • Making the most of lean teams: prioritisation and resource allocation strategies
    • Leveraging cross-functional talent and transferable skillsets across departments
    • Building agile operating models to increase efficiency and speed
    • When to outsource vs keep capabilities in-house
    • Empowering individuals to take on broader roles and responsibilities
    • Creating a culture of collaboration and flexibility to drive delivery

    Speakers

    Yanping Kong
    CEO, Kong’s Pharmaceutical

    2:45 PM

    Reserved for IQVIA

    3:15 PM

    INDUSTRY DEBATE Are large CRO operating models equipped to support the agility and priorities of small biotechs?

    • Navigating traditional and niche CRO models as an emerging biotech
    • Understanding the key differences between big pharma and biotech approaches to clinical trial execution and outsourcing strategy
    • Examining how niche and specialist vendors are addressing sponsor pain points with more tailored, flexible solutions
    • Identifying how sponsors and providers can better align expectations, communication models, and operational support for successful partnerships

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Prize Draw in the Exhibition Hall

    4:30 PM

    EXPERT PANEL From Vision to Approval: How Biotech Leader’s Turn Strategy into Clinical Success

    A candid panel sharing real success stories - exploring the decisions, partnerships, and approaches that helped biotech leaders overcome challenges and successfully progress their programmes. 

    • Starting Strong: What it really takes to initiate a study and avoid early-stage delays
    • Building & Backing the Right Team: How to structure, scale, and support clinical operations for growth
    • Making the Right Partnerships: Which vendors to work with, how to select them, and how to get the most value
    • Staying in the Game: How leaders navigated challenges, maintained momentum, and kept programmes on track
    • Operational Excellence that Delivers: Why data quality, oversight, and inspection readiness underpin success

    Moderator: Shailesh Chavan, MD, Ingenious Global Venture Partners

    Speakers

    Shailesh Chavan
    Managing Partner, Ingenious Global Venture Partners
    Fran Brophy
    Senior Director, Clinical Programs, Clinical Product Lead, US WorldMeds
    Yanping Kong
    CEO, Kong’s Pharmaceutical

    5 PM

    INTERACTIVE SESSION Solution Sprint

    • Overview: Opportunities for vendor to address real-world biopharma specific challenges
    • How it runs: Audience/Advisory Board poses a challenge to 3 vendors, and they have to present their company’s solutions.
    • Best for: Sponsor opportunity and Biopharma /Vendor Interaction

    Reserved for Event Sponsors

    5:15 PM

    END OF DAY ONE & DRINKS RECEPTION

    11:15 AM

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

    • A real-world case study demonstrating where AI has tangibly reduced costs or accelerated timelines
    • How AI was implemented in practice (e.g. patient recruitment, data cleaning, site selection) and what made it successful
    • Breaking down the ROI: cost savings, efficiency gains, and operational impact
    • Lessons learned: where AI delivered value vs where it fell short—and how to replicate success in smaller biotech settings

    Speakers

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

    11:45 AM

    Reserved for MedPoint Digital

    12:15 PM

    ASK THE EXPERTS! Clinical Trials in The Age of AI

    Discover how artificial intelligence is transforming clinical research by streamlining processes from protocol design to regulatory submission. This session explores practical AI applications for overcoming recruitment challenges, ensuring ethical implementation, and shaping the future of oncology trials.

    • Overcome Bottlenecks: Learn how AI breaks cycle inefficiencies in trial design and patient screening.
    • Accelerate Recruitment: See how AI-driven models and molecular matching reduce screening time and failures.
    • Implement Ethically: Understand frameworks for bias mitigation, data privacy, and regulatory compliance.
    • Future Trends: Explore next-decade innovations like digital twins and foundation models.

    Outcome: A candid, solution-focused discussion designed to help teams move faster and smarter.

     

    Speakers

    Kevin Anderson
    Founder, Applied AI Strategy and Pharma GTM Advisor
    Anil Tarachandani
    Former Vice President and Head of Translational Medicine, Verge Genomics
    T.J. Sharpe
    Patient Engagement Expert, Sharpe Patient Insights

    12:45 PM

    Reserved for TruTechnologies

    1:15 PM

    Lunch and networking

    2:15 PM

    New insights on how sponsor companies approach change management when adopting new innovations

    • Identify common drivers of change management in drug development
    • Discuss common challenges related to change implementation, including change overload, fatigue, and psychological resistance
    • Explore best approaches for handling different types of challenges

    Speakers

    Dr. Jenny Kim
    Research Associate Professor, Tufts Center for the Study of Drug Development
    Ananya Jain
    Portfolio Management Lead, Research Strategy and Operations, Biogen

    3:15 PM

    INTERACTIVE SESSION The Traps of AI: Misrepresentation, Bias, and the Limits of Existing Data

    Opening Question

    “If your AI is trained on incomplete data, who is it really working for - and who is it leaving behind?” 

    Key Focus Areas

    • How reliance on historical datasets creates systemic gaps, leaving underrepresented groups without sufficient data to ensure accurate AI outputs
    • Exploring the real-world impact of misrepresentation through live audience polling and scenario-based discussions
    • Challenging assumptions: where do we overtrust AI, and how aware are organisations of its limitations?
    • Practical steps to improve outcomes, including how to identify bias and push for more inclusive, representative data

    Format

    This session will be highly interactive, using live polling, audience Q&A, and scenario-led discussion to test perceptions and uncover blind spots. Attendees will respond to real-world scenarios, compare perspectives across the room, and collectively explore how bias and data gaps influence decision-making in practice.

    Speakers

    Kelly Knippel Butler
    JD, Ethics & Compliance Business Partner, Data & Digital Innovation, Takeda

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Prize Draw in the Exhibition Hall

    4:30 PM

    Impacts of the “One, Big Beautiful Bill Act” on Clinical Research and Trial Access

    The “One, Big Beautiful Bill” introduces statutory changes that affect healthcare coverage and funding, with implications for patient access and participation in clinical research.

    This session examines:

    • Key provisions of the law from Medicaid and Tax reform to Orphan Drug Exclusion expansion
    • Projected and potential impacts on patients and patient access, community based care settings, and equitable trial enrollment
    • Practical perspectives on adapting to policy driven change and maintaining clinical research infrastructure

    Speakers

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

    5 PM

    INTERACTIVE SESSION Solution Sprint

    • Overview: Opportunities for vendor to address real-world biopharma specific challenges
    • How it runs: Audience/Advisory Board poses a challenge to 3 vendors, and they have to present their company’s solutions.
    • Best for: Sponsor opportunity and Biopharma /Vendor Interaction

    Reserved for Event Sponsors

    5:15 PM

    END OF DAY ONE & DRINKS RECEPTION

    7:30 AM

    Registration and Refreshments

    8:20 AM

    Chairperson’s opening remarks

    Speakers

    Bob Loll
    SVP, Business Development & Strategic Planning, Praxis

    8:30 AM

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

    • Review off recent data quantifying the magnitude of the problem
    • Presentation of empirical evidence capturing underlying factors contributing to the problem
    • Discussion of opportunities to optimise protocol design and improve clinical trial performance

    Speakers

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

    9 AM

    Reserved for ICON

    9:30 AM

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

    • Overview of how companies are accommodating increasingly customized clinical trial design and execution
    • Discussion of approaches most resonating with panel member companies
    • Review of implementation challenges and how they have been overcome
    • Discussion of downstream opportunities being pursued

    2 X Biopharma panel positions available

    1 x Vendor panel position available

    Speakers

    Ken Getz
    Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development
    Fran Brophy
    Senior Director, Clinical Programs, Clinical Product Lead, US WorldMeds

    10 AM

    Reserved for Novotech

    10:30 AM

    Morning refreshments and networking break

    11:15 AM

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

    • Understanding the key factors that influence patients' decisions to decline or withdraw from oncology clinical trials
    • Exploring what sponsors, sites, and research teams can do to build greater trust, support, and engagement throughout the patient journey
    • Case Study: Insights from Cancer CAREs International's Next-Generation Trials project on reducing patient burden and creating more patient-centered trial experiences
    • Sharing practical lessons learned and real-world examples of strategies that have improved patient participation, retention, and overall trial experience

    Speakers

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

    11:45 AM

    Reserved for Worldwide Clinical Trials

    12:15 PM

    PANEL DISCUSSION Maximizing Site Productivity: Reducing Burden and Strengthening Output

    • Addressing site burden during study start-up, recognising that sponsors often assume infrastructure and systems are already in place, when the reality can vary significantly between sites.
    • Exploring how increasing protocol complexity is driving operational challenges and requiring sites to develop more creative and adaptable approaches to trial execution.
    • Strengthening collaboration between sites, sponsors, and CROs to improve communication, efficiency, and study delivery.
    • Creating an environment of trust where sites feel comfortable raising concerns around timelines, resources, and operational complexities without fear of losing future opportunities.
    • Identifying practical strategies to reduce administrative burden while maintaining quality, compliance, and patient-focused outcomes.

    Speakers

    Dori Sarkis
    Sr. Director, Strategic Partnerships, Alcanza Clinical Research for all
    Michael Herman
    Patient Advocate, Founder & Chief Visionary Officer, Cancer CAREs International

    12:45 PM

    Reserved for Premier Research

    1:15 PM

    Lunch and networking

    2:15 PM

    New Benchmarks on Clinical Trial Sourcing Models and their Association with Trial Performance

    During the past four decades, reliance and use of contract research service providers for drug development capacity and expertise have increased dramatically.  During this period, sourcing models have evolved due to rising protocol scientific and executional demands and company-specific outsourcing strategies and preferences. Despite the long-time horizon and extensive collaboration with CRO partners, until now virtually no research has assessed the impact of various sourcing models on drug development program and clinical trial performance, cost and quality.

    In 2026, the Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a robust study in collaboration with 13 pharmaceutical companies to gather empirical evidence characterizing outsourcing strategies and practices and their relationship with drug development performance, quality and cost.  This session presents the results of this research and offers insights into optimizing drug development performance, cost and quality through more effective, fit-for-purpose use of sourcing models.  This study also examined the relationship between sponsor choice of sourcing model and clinical trial performance; functions and capabilities typically outsourced, and clinical trial performance and number of vendors engaged.

    Reserved for Biopharma

    Speakers

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

    2:45 PM

    Reserved for EPS Corporation

    3:15 PM

    Updated Benchmarks on Protocol Design Practices And Their Impact On Site And Participant Burden

    Reserved for Biopharma

     

    Speakers

    Abigail Dirks
    Senior Data Scientist, Tufts Center for the Study of Drug Development

    3:45 PM

    Afternoon refreshments and networking

    4:15 PM

    Prize Draw in the Exhibition Hall

    4:30 PM

    ASK THE EXPERTS! Sponsor Responsibility Under ICH E6(R3) – Driving Quality Through Strong Central Lab Collaboration

    • Implementing ICH E6(R3) expectations
    • Defining effective oversight and KPIs
    • Strengthening sponsor - lab partnerships
    • Managing compliance and quality risks
    • Lessons learned and future priorities

    Speakers

    Akash Patel
    Sr. Director; Head of Design Assurance, GSK

    5 PM

    Technology Spotlight A Demonstration of Digital Display Labels in Clinical Trials Operations & Supply Chain

    • Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
    • A demonstration of the functionality of DDLs; just in time labelling, lot & expiry update, multiple page count.
    • Understanding the operational ability to securely & remotely update content & language.
    • Integrating across IMP profiles, vials, bottles, blisters

    Speakers

    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    5:15 PM

    END OF DAY ONE & DRINKS RECEPTION

    Streams

    Stream one

    Stream A: Outsourcing & Clinical Operations

    Stream two

    Stream B: Data, AI & Clinical Innovation

    Stream three

    Stream C: Biotech Strategy

    10 AM

    Reserved for Event Sponsor

    10:30 AM

    Morning refreshments and networking break

    11:15 AM

    Reserved for Event Sponsor

    11:45 AM

    Choosing The Right CRO: Key Considerations for Small Biotech’s

    • 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

    12:15 PM

    Lunch and networking

    9 AM

    Resilient Clinical Trial Teams: Using Mindfulness to Improve Focus, Communication, and Quality Under Pressure

    Clinical trial teams today operate in increasingly complex, high-pressure environments involving cross-functional coordination, tight timelines, regulatory demands, vendor management, and constant operational decision-making. Over time, sustained cognitive overload and communication strain can impact focus, collaboration, leadership presence, decision-making, and overall quality of execution. This session explores how mindfulness can be practically applied within clinical operations environments to support more effective ways of working in high-demand, fast-paced clinical environments.

    This session explores:

    • The science behind mindfulness and its relevance in high-pressure professional environments
    • What mindfulness is and how it supports focus, resilience, communication, and emotional regulation
    • Practical, doable, and immediately applicable mindfulness-based tools that can help clinical operations professionals strengthen focus, communication quality, resilience, decision-making, and sustained performance under pressure
    • This session will end with a group meditation

    Speakers

    Sonal Kalra
    Founder, CONNECT Meditation

    10 AM

    Reserved for Event Sponsor

    10:30 AM

    Morning refreshments and networking break

    11:15 AM

    Reserved for Event Sponsor

    11:45 AM

    INTERACTIVE SESSION Evolving sponsor operating models to accommodate the shift to risk-based, centralized, and AI-enabled study monitoring

    The clinical trial monitoring function has been transforming as sponsor companies move beyond traditional monitoring to accommodate risk-based, centralized, and AI-enabled approaches. This session explores specific organizational changes that have been made to support this transformation and its impact workforce capacity, timelines and efficiency. Attendees will gain practical insights into building monitoring models that enhance study quality, operational efficiency, and regulatory readiness. 

    Reserved for Biopharma

    Speakers

    Hana Do
    Research Analyst, Tufts Center for the Study of Drug Development

    12:15 PM

    Lunch and networking

    8 AM

    Tufts 50 Years of Impact Breakfast Roundtable’s

    8:00 – 8:45 AM | Exhibition Hall

    Start the day by joining colleagues for an informal breakfast roundtable’s celebrating 50 Years of Impact from Tufts Center for the Study of Drug Development. These interactive discussions will bring together industry peers to reflect on the evolution of clinical research, share lessons learned over the past five decades, and explore the innovations shaping the future of drug development.

    With breakfast served in the exhibition hall during registration, this is an excellent opportunity to network, exchange ideas, and be part of the conversation before the main conference begins.

    Roundtable 1 

    Roundtable 2 

    Roundtable 3

    8 AM

    Registration and Refreshments

    8:45 AM

    Chairperson’s Opening Remarks & Early Bird Prize Draw

    Speakers

    Bob Loll
    SVP, Business Development & Strategic Planning, Praxis

    9 AM

    WORKSHOP Clinical Trial Negotiation & Budgeting: Securing the Right Deal Without Overspending

    For many biotech companies, clinical trial costs spiral beyond initial projections due to ineffective negotiation, unclear contracts, and overly optimistic budgeting. This practical, interactive workshop is designed to equip attendees with the tools and confidence to negotiate stronger contracts, build realistic budgets, and maintain financial discipline throughout the trial lifecycle. 

    Through real-world examples and peer discussion, participants will learn how to secure value from CROs and vendors, avoid hidden costs, and ensure they only commit to spend that aligns with available funding, protecting both timelines and long-term viability. 

    Key Learning Points

    • How to build a robust, realistic clinical trial budget that reflects true operational costs
    • Practical strategies to negotiate favourable contracts with CROs and vendors
    • Identifying and managing hidden costs, scope creep, and change orders
    • Techniques to ensure financial discipline - spending within available capital, not projections
    • How to align finance, clinical operations, and procurement for stronger decision-making

    Moderators will split the room into small groups, assign real-world tasks, guide discussions, and reconvene the audience to share key insights and approaches.

    Speakers

    Andrea Bottkova
    Senior Director of Procurement and Vendor Management, Karyopharm Therapeutics
    Leonella Seeley
    Director of Procurement and Vendor Management, Karyopharm Therapeutics

    10 AM

    Reserved for Event Sponsor

    10:30 AM

    Morning refreshments and networking break

    11:15 AM

    Reserved for Event Sponsor

    11:45 AM

    Recognizing And Addressing a Global Patient Enrollment Crisis

    Reserved for Biopharma 

    Reserved for Patient Advocate

    Speakers

    Madison Ford
    Research Analyst, Tufts Center for the Study of Drug Development

    12:15 PM

    Lunch and networking

    1:30 PM

    SPOTLIGHT ON CHINA Biotech Power Shift: Navigating China’s Rise in Global Clinical Development

    • The surge of high-quality assets from China: what’s driving the acceleration?
    • Licensing trends: why Western pharma is increasingly looking East
    • Regulatory implications: how the FDA and global bodies are adapting
    • Geopolitics vs innovation: balancing risk, access, and opportunity in trial strategy

    China’s life sciences sector is rapidly reshaping the global biotech landscape, with a growing pipeline of high-quality assets attracting significant international investment and licensing activity. This session will explore how this shift is impacting clinical development strategies, regulatory frameworks, and competitive dynamics. From navigating cross-border partnerships to understanding evolving FDA perspectives, join industry leaders as they unpack what this means for outsourcing, trial design, and the future of global collaboration.

    2 PM

    Reserved for Event Sponsor

    2:30 PM

    SPOTLIGHT ON THE FDA The State of Emerging Biotechnology: FDA Responses, Industry Impact, and Future Priorities

    Speakers

    Caitlin Gearen Frazer
    Executive Director, National Security Commission on Emerging Biotechnology (NSCEB)

    3 PM

    Afternoon refreshments and networking

    3:20 PM

    Prize Draw in Exhibition Hall

    3:30 PM

    END OF CONFERENCE

    Speakers

    Select a speaker to learn more

    Back
    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

    View In Agenda
    Next speaker
    Back
    Dr. Jenny Kim
    Research Associate Professor, Tufts Center for the Study of Drug Development

    Session Details:

    New insights on how sponsor companies approach change management when adopting new innovations

    2026-10-27, 2:15 PM

    View In Agenda
    Next speaker
    Back
    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.

    Session Details:

    Updated Benchmarks on Protocol Design Practices And Their Impact On Site And Participant Burden

    2026-10-27, 3:15 PM

    View In Agenda
    Next speaker
    Back
    Madison Ford
    Research Analyst, Tufts Center for the Study of Drug Development

    Session Details:

    Recognizing And Addressing a Global Patient Enrollment Crisis

    2026-10-28, 11:45 AM

    View In Agenda
    Next speaker
    Back
    Hana Do
    Research Analyst, Tufts Center for the Study of Drug Development

    Session Details:

    INTERACTIVE SESSION Evolving sponsor operating models to accommodate the shift to risk-based, centralized, and AI-enabled study monitoring

    2026-10-28, 11:45 AM

    View In Agenda
    Next speaker
    Back
    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.

    Session Details:

    WORKSHOP Clinical Trial Negotiation & Budgeting: Securing the Right Deal Without Overspending

    2026-10-28, 9:00 AM

    View In Agenda
    Next speaker
    Back
    Leonella Seeley
    Director of Procurement and Vendor Management, Karyopharm Therapeutics

    Session Details:

    WORKSHOP Clinical Trial Negotiation & Budgeting: Securing the Right Deal Without Overspending

    2026-10-28, 9:00 AM

    View In Agenda
    Next speaker
    Back
    Sonal Kalra
    Founder, CONNECT Meditation

    Session Details:

    Resilient Clinical Trial Teams: Using Mindfulness to Improve Focus, Communication, and Quality Under Pressure

    2026-10-28, 9:00 AM

    View In Agenda
    Next speaker
    Back
    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:

    Impacts of the “One, Big Beautiful Bill Act” on Clinical Research and Trial Access

    2026-10-27, 4:30 PM

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    Akash Patel
    Sr. Director; Head of Design Assurance, GSK

    Session Details:

    ASK THE EXPERTS! Sponsor Responsibility Under ICH E6(R3) – Driving Quality Through Strong Central Lab Collaboration

    2026-10-27, 4:30 PM

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    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

    Session Details:

    New Benchmarks on Clinical Trial Sourcing Models and their Association with Trial Performance

    2026-10-27, 2:15 PM

    View In Agenda
    Next speaker
    Back
    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:

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

    2026-10-27, 12:15 PM

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    Ananya Jain
    Portfolio Management Lead, Research Strategy and Operations, Biogen

    Session Details:

    New insights on how sponsor companies approach change management when adopting new innovations

    2026-10-27, 2:15 PM

    View In Agenda
    Next speaker
    Back
    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

    Session Details:

    EXPERT PANEL From Vision to Approval: How Biotech Leader’s Turn Strategy into Clinical Success

    2026-10-27, 4:30 PM

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    Yanping Kong
    CEO, Kong’s Pharmaceutical

    Session Details:

    Doing More with Less: Maximizing Resources & Capabilities in Biotech Clinical Trials

    2026-10-27, 2:15 PM

    Session Details:

    EXPERT PANEL From Vision to Approval: How Biotech Leader’s Turn Strategy into Clinical Success

    2026-10-27, 4:30 PM

    View In Agenda
    Next speaker
    Back
    Kelly Knippel Butler
    JD, Ethics & Compliance Business Partner, Data & Digital Innovation, Takeda

    Session Details:

    INTERACTIVE SESSION The Traps of AI: Misrepresentation, Bias, and the Limits of Existing Data

    2026-10-27, 3:15 PM

    View In Agenda
    Next speaker
    Back
    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

    View In Agenda
    Next speaker
    Back
    Bob Loll
    SVP, Business Development & Strategic Planning, Praxis

    Session Details:

    Chairperson’s Opening Remarks & Early Bird Prize Draw

    2026-10-28, 8:45 AM

    Session Details:

    Chairperson’s opening remarks

    2026-10-27, 8:20 AM

    View In Agenda
    Next speaker

    OCT Advisory Board

    Select a member to learn more

    Back
    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.

    Next
    Back
    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:

    Impacts of the “One, Big Beautiful Bill Act” on Clinical Research and Trial Access

    2026-10-27, 4:30 PM

    View In Agenda
    Next
    Back
    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.

    Next
    Back
    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.

    Next
    Back
    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 .

    Next
    Back
    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.

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

    Plan Your Visit

    Venue

    Encore Boston Harbor One Broadway Everett, MA 02149, US

    Parking: Self-parking is complimentary

    Book Your Stay

    Arena International Events Group “(Arena”) is aware of numerous third-party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings, events attendee lists and selling unsolicited services. It is unclear whether the agencies in question are in possession of such information, or whether they intend to scam unsuspecting customers. Whilst Arena International Events Group pursues such third-party companies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third-party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group..

    Sponsors

    Select a sponsor to learn more

    featured sponsor

    Session sponsors

    TECHNOLOGY SHOWCASE SPONSOR

    Registration Sponsor

    Prize Draw Sponsor

    Lanyards Sponsor

    Lunch Sponsor

    Associate Sponsor

    Pens & Notepad Sponsor

    EXHIBITORS

    co-sponsor

    Event Partner

    Why partner?

    Contact us to become a partner

    Partnership Opportunities

    We work with you to design a bespoke package to meet your business needs, where you could:

    • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
    • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
      Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
    • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

    Event reach

    • 700+ attendees each year
    • 80% attendees C-suite level

     

    Take a look at our current sponsors

    Become A Media Partner

    Your chance to meet and catch up with colleagues from across the industry

    As this event 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 ▶️ Join in with audience discussions, panel debates and add your voice to the conversation    

    See What It's All About

    Enquiry

    Contact Us

    SPONSORSHIP ENQUIRIES

    Nicholas McCudden

    Head of OCT events

    +61 280 978 126

    SPEAKER ENQUIRIES

    Maya Hudson

    Head of Production

    MARKETING ENQUIRIES

    Valentina Sidore

    Head of Marketing

    DELEGATE ENQUIRIES

    Sunny Saikia

    VIP Delegate Manager

    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

    Sunny Saikia