17th Annual Outsourcing in Clinical Trials New England 2025

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

15 - 16

October

2025
  • Encore Boston Harbor, Boston, USA
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
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2024 Sponsors Included:

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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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CMIC Group, founded as Japan’s first CRO over 30 years ago, is now the largest clinical CRO in Japan with a global presence. Our services span non-clinical studies, clinical trial management, GMP manufacturing, regulatory consulting, and sales/marketing solutions. We facilitate market entry in Japan, offer leading clinical trial expertise in APAC region, and bridge drug development between the US and Japan. With 7,000+ employees and 24 global sites, we’re your comprehensive partner in the pharmaceutical, biotech, and medical device sectors.

Company Website

To learn more, please visit our website - https://en.cmicgroup.com/

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

Company Website

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

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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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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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Intrinseque Health is an EN ISO 13485 certified Global Clinical Supply Chain organisation, building & executing complex Clinical Supply Plans for Ancillary, Medicinal products, Clinical Supplies, Equipment and Services required by Pharmaceutical & Biotech companies and CROs for their Clinical Trials.

Company Website

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

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At Praxis, our approach to patient recruitment for clinical trials involves making connections that matter. We connect specialized tools with our team’s talent. Sophisticated data with our insight. And patients with hope. This is how we help the world’s leading pharmaceutical and biotech companies create unique, customized programs to support clinical trial recruitment and patient retention. Learn more at gopraxis.com.

Company Website

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

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

Company Website

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

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Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.

Company Website

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

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Company Website

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

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SGS is a leading life sciences CRO providing clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in Americas, SGS offers clinical trial (Phase I to IV) services encompassing full early phase drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling & simulation and regulatory & medical affairs services. SGS has its own clinical unit in Belgium including a viral challenge testing facility and two phase I patients units based in Belgium and Hungary.

SGS has a wealth of expertise in FIH studies, viral challenge testing, biosimilars and complex PK/PD studies with a high therapeutic focus in Infectious Diseases, Vaccines, and Respiratory.

Company Website

To learn more, please visit our website - http://www.sgs.com/en/life-sciences/clinical-research-services

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Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. For more than 30 years, Rho has been a trusted partner to  leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence,  innovative technologies, and  therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.

Company Website

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

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Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

Company Website

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

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At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval.

Company Website

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

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Company Website

To learn more, please visit our website - www.CentralLabs.urmc.edu

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QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

Company Website

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

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Scout empowers the life sciences industry with people-first solutions: Scout Meetings, Scout Clinical, and Scout Academy. We specialize in face-to-face, virtual, and hybrid clinical meeting planning, patient payment, travel, and logistics support, and virtual collaboration and education. Since 1995, we have been a trusted partner excelling in customer service, regulatory compliance, and project delivery for leading pharmaceutical and biotechnology companies. Our deep understanding of international regulations and adaptable network of resources is built on operational experience in 109 countries. With white-glove attention to detail and a customizable, comprehensive range of services, Scout makes the complex easier. Learn more at scoutclinical.com.

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Endpoint Clinical is a leading clinical trial technology and service partner, delivering adaptable RTSM solutions with a focus on security, stability, and trust. With decades of expertise and a proactive, innovation-driven approach, Endpoint minimizes friction, reduces risk, and enables your teams to focus where it matters most—on trial success.

Company Website

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

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

Company Website

To learn more, please visit our website - https://www.iconplc.com/sectors/biotech

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

Company Website

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

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    Why attend?

    The 17th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations.

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

     

     

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

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

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

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

    700+

    Attendees

    		80+

    Exhibitors

    		50+

    Speakers
    700+

    Attendees

    		80+

    Exhibitors
    50+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 15 Oct 2025
    • 16 Oct 2025
    Expand All

    Streams

    Stream one

    Stream A: Clinical Outsourcing and Operations

    Stream two

    Stream B: Clinical Technology and Innovation

    Stream three

    Stream C: Biotech Strategy

    11 AM

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

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

    Speakers

    Gregg Beloff
    Founder, Danforth Advisors
    Harry Barnett
    Executive Chairman, Lubris Biopharma
    George Tetz
    Chief Executive Officer, Second Life Therapeutics
    Chris Adams
    Chief Executive Officer, Andarix

    11:30 AM

    Available for event sponsor

    12 PM

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

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

    Speakers

    Dan Housman
    Chief Executive Officer, Courage Therapeutics

    12:30 PM

    Available for event sponsor

    1 PM

    Lunch and networking break

    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

    Speakers

    Rich Polgar
    Managing Director, Danforth Advisors
    Christopher U Missling
    President and Chief Executive Officer, Anavex Life Sciences
    Stefan N. Lukianov
    Founder and Chief Executive Officer, Salve Therapeutics

    2:30 PM

    Available for event sponsor

    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 and networking break

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon 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

    Available for event sponsor

    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

    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

    11 AM

    The state of the biopharmaceutical industry in 2025: emerging technologies and opportunities

    • Emerging themes and technology advancements in biopharma
    • Leveraging data to predict the outlook for 2025 clinical trials
    • Trends, key players, opportunities, and threats in clinical trial outsourcing
    • Latest biopharma investor activity: venturing financing, IPOs, and grants

    Speakers

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

    11:30 AM

    Available for event sponsor

    12 PM

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

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

    Speakers

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

    12:30 PM

    Available for event sponsor

    1 PM

    Lunch and networking break

    2 PM

    Reserved for

    Speakers

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

    2:30 PM

    Available for event sponsor

    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

    Christopher U Missling
    President and Chief Executive Officer, Anavex Life Sciences

    3:30 PM

    Afternoon refreshments and networking break

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

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

    4 PM

    Building AI models for efficiency in outsourcing

    • Identifying outsourcing inefficiencies that can be addressed through AI driven solutions
    • Developing 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

    Speakers

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

    4:30 PM

    Available for event sponsor

    5 PM

    Assessing patient attitudes to the use of AI in clinical trials

    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

    7:30 AM

    Registration and refreshments

    8:15 AM

    GlobalData opening remarks

    Speakers

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

    8:25 AM

    Chairperson’s opening remarks

    8:30 AM

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

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

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

    Speakers

    Revati Tatake
    Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
    Harry Barnett
    Executive Chairman, Lubris Biopharma

    9 AM

    Reserved for Novotech

    9:30 AM

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

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

    MODERATOR
    Rich Polgar, Managing Director, Danforth Advisors

    Speakers

    Rich Polgar
    Managing Director, Danforth Advisors
    Rinaldo Dorman
    Associate Director, R&D Global Procurement and Strategic Sourcing, Sarepta Therapeutics
    Stacey Oppenheimer
    Director, Vendor Lead, Pfizer
    Nicole McElroy
    Director, Partnership Health and Supplier Management, Takeda
    Kathleen Martyn
    Manager, Vendor and Clinical Operations, Karyopharm Therapeutics

    10 AM

    Available for Featured Sponsor

    10:30 AM

    Morning refreshments and networking break

    11 AM

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

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

    Speakers

    Nick Pelletier
    Head of Clinical Operations and Program Management, Delix Therapeutics
    Sydney DeCaro
    Clinical Trial Associate, Delix Therapeutics

    11:30 AM

    Available for event sponsor

    12 PM

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

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

    Speakers

    Sarah Woods
    Founder, Serenely Guided Foundation

    12:30 PM

    Available for event sponsor

    1 PM

    Lunch and networking break

    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

    Available for event sponsor

    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

    Speakers

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

    3:30 PM

    Afternoon refreshments and networking break

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon 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

    Speakers

    Leticia Tarilonte
    Vice President, Head of Global Clinical Operations, Pyxis Oncology
    Kelsey Miller-Torchia
    Senior Vice President, Clinical and Business Development, Intrinsic Therapeutics

    4:30 PM

    Available for event sponsor

    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, Endo

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    John Seman
    Chief Executive Officer, Revitale Pharma

    END OF DAY 1 AND NETWORKING DRINKS

    Streams

    Stream one

    Stream A: Clinical Outsourcing and Operations

    Stream two

    Stream B: Clinical Technology and Innovation

    Stream three

    Stream C: 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 Advisors
    Veronica Ludensky
    Director of Procurement, Clinical, Flagship Pioneering
    Molly James
    Associate Director, Strategic Sourcing, Beam Therapeutics
    Dan Housman
    Chief Executive Officer, Courage Therapeutics

    9:30 AM

    Available for event sponsor

    10 AM

    Reserved for investor/venture capitalist

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

    10:30 AM

    Morning refreshments and networking break

    11 AM

    BIOTECH CASE STUDY

    11:30 AM

    Available for event sponsor

    12 PM

    PANEL: Driving technology and innovation in a small biotec

    • 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

    Speakers

    Harry Barnett
    Executive Chairman, Lubris Biopharma
    Veronica Ludensky
    Director of Procurement, Clinical, Flagship Pioneering

    8:50 AM

    Chairperson’s opening remarks

    Speakers

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

    9 AM

    Successfully planning a clinical supply chain for new drug modalities

    • Overviewing trends and developments in drug modalities to evaluate differences in supply management
    • Strategizing an effective trial supply plan to minimize setbacks
    • Implementing changes in supply chain management across teams to best facilitate a new modality

    Speakers

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

    9:30 AM

    Available for event sponsor

    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

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Topic TBC

    Speakers

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

    11:30 AM

    Available for event sponsor

    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

    8:50 AM

    Chairperson’s opening remarks

    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
    Director, Health Literacy, CISCRP

    9:30 AM

    Available for event sponsor

    10 AM

    Topic TBC

    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

    CASE STUDY: Management of tumor biomarker testing to boost study enrolment

    Speakers

    Helen Chalk
    Vice President, Clinical Operations, Mythic Therapeutics
    Malina Traianova
    Director, Lab and Vendor Management, Mythic Therapeutics

    11:30 AM

    Available for event sponsor

    12 PM

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

    Speakers

    John Smutko
    Head of Oncology Scientific Operations, GSK
    Ben Laiviere
    Associate Director, Scientific Operations, GSK

    12:30 PM

    Lunch and networking break

    1:30 PM

    KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

    • What’s stopping us from using AI?
    • How to overcome barriers to AI: creative starter ideas
    • AI case studies, stories and key takeaways

    Speakers

    Dan Seewald
    Co-Founder and COO, LiviWell and Founder and Chief Executive Officer, Deliberate Innovation

    2:20 PM

    Available for event sponsor

    2:20 PM

    Available for event sponsor

    2:50 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?

    Speakers

    Hyun Kim
    Senior Vice President, Clinical Development, AOBiome Therapeutics
    Yolanda Wan
    Head of Clinical Operations, Orna Therapeutics

    3:20 PM

    Afternoon refreshments and networking break

    3:40 PM

    EXHIBITION APPLE PRIZE DRAW

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

    3:50 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: Negotiation tips
    Leonella Seeley, Director, Vendor Management and Operations, Karyopharm Therapeutics

    ROUNDTABLE 2: Practical applications of AI in a clinical setting

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

    ROUNDTABLE 4: Keeping patients at the heart of your clinical trial

    End of Conference

    12:30 PM

    Lunch and networking break

    Speakers

    Select a speaker to learn more

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

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

    Session Details:

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

    2025-10-15, 2:00 PM

    Session Details:

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

    2025-10-15, 5:00 PM

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

    Session Details:

    Building AI models for efficiency in outsourcing

    2025-10-15, 4:00 PM

    Session Details:

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

    2025-10-16, 10:00 AM

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    Christopher U Missling
    President and Chief Executive Officer, Anavex Life Sciences

    Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi),  Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.

    Session Details:

    Harnessing real world experience: driving innovation and decision making

    2025-10-15, 3:00 PM

    Session Details:

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

    2025-10-15, 2:00 PM

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    Chris Adams
    Chief Executive Officer, Andarix

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

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

    Session Details:

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

    2025-10-15, 3:00 PM

    Session Details:

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

    2025-10-15, 11:00 AM

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    Hyun Kim
    Senior Vice President, Clinical Development, AOBiome Therapeutics

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

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

    Session Details:

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

    2025-10-16, 2:50 PM

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    Molly James
    Associate Director, Strategic Sourcing, Beam Therapeutics

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

    Session Details:

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

    2025-10-16, 9:00 AM

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    Dan Housman
    Chief Executive Officer, Courage Therapeutics

    Session Details:

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

    2025-10-15, 12:00 PM

    Session Details:

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

    2025-10-16, 9:00 AM

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    Behtash Bahador
    Director, Health Literacy, CISCRP

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

    Session Details:

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

    2025-10-16, 9:00 AM

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    Rebecca Nordland
    Senior Project Manager, Research Services, CISCRP

    Session Details:

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

    2025-10-15, 5:00 PM

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    Gregg Beloff
    Founder, Danforth Advisors

    Session Details:

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

    2025-10-15, 11:00 AM

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    Rene Stephens
    Managing Director, Clinical Business Operations, Danforth Advisors

    Session Details:

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

    2025-10-16, 9:00 AM

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    Rich Polgar
    Managing Director, Danforth Advisors

    Session Details:

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

    2025-10-15, 9:30 AM

    Session Details:

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

    2025-10-15, 2:00 PM

    View In Agenda
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    Dan Seewald
    Co-Founder and COO, LiviWell and Founder and Chief Executive Officer, Deliberate Innovation

    Session Details:

    KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

    2025-10-16, 1:30 PM

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

    Session Details:

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

    2025-10-15, 11:00 AM

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    Sydney DeCaro
    Clinical Trial Associate, Delix Therapeutics

    Session Details:

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

    2025-10-15, 11:00 AM

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    Dr. Martin Bauer
    Chief Medical Officer, Eleva GmbH

    Session Details:

    Choosing the right CRO: key considerations for small biotechs

    2025-10-15, 4:00 PM

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    Carrie Lewis
    Executive Director, Clinical Program Optimization, Endo

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

    Session Details:

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

    2025-10-15, 5:00 PM

    Session Details:

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

    2025-10-15, 3:00 PM

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    Veronica Ludensky
    Director of Procurement, Clinical, Flagship Pioneering

    Veronica Ludensky is the Director of Procurement, Clinical. She is responsible for establishing and growing the procurement function for clinical services to leverage the Flagship ecosystem to advance companies’ clinical development goals.

    Veronica has almost two decades of experience in clinical sourcing functions for multiple compounds from Phase 1 through 4, in small biotech, large pharma and CROs. During her career, Veronica was responsible for supporting project teams across multiple therapeutic areas in selecting, negotiating costs, contracting and business oversight of CROs, laboratories and all other vendor types in support of clinical programs at AstraZeneca, Alexion Pharmaceuticals, Millenium Pharmaceuticals and Takeda.

    Session Details:

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

    2025-10-16, 9:00 AM

    Session Details:

    PANEL: Driving technology and innovation in a small biotec

    2025-10-16, 12:00 PM

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    Jerrold M. Shapiro
    President, Floelle

    Session Details:

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

    2025-10-16, 12:00 PM

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

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

    Session Details:

    Chairperson’s closing remarks

    2025-10-15, 5:30 PM

    Session Details:

    GlobalData opening remarks

    2025-10-15, 8:15 AM

    Session Details:

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

    2025-10-16, 10:00 AM

    Session Details:

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

    2025-10-15, 8:30 AM

    Session Details:

    The state of the biopharmaceutical industry in 2025: emerging technologies and opportunities

    2025-10-15, 11:00 AM

    Session Details:

    Chairperson’s opening remarks

    2025-10-16, 8:50 AM

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    John Smutko
    Head of Oncology Scientific Operations, GSK

    Session Details:

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

    2025-10-16, 12:00 PM

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    Ben Laiviere
    Associate Director, Scientific Operations, GSK

    Session Details:

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

    2025-10-16, 12:00 PM

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

    Session Details:

    Topic TBC

    2025-10-16, 10:00 AM

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

    Session Details:

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

    2025-10-15, 4:00 PM

    View In Agenda
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    Leonella Seeley
    Director, Vendor Management and Operations, Karyopharm Therapeutics

    Session Details:

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

    2025-10-15, 3:00 PM

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    Kathleen Martyn
    Manager, Vendor and Clinical Operations, Karyopharm Therapeutics

    Session Details:

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

    2025-10-15, 9:30 AM

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    Harry Barnett
    Executive Chairman, Lubris Biopharma

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

    Session Details:

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

    2025-10-15, 8:30 AM

    Session Details:

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

    2025-10-15, 11:00 AM

    Session Details:

    PANEL: Driving technology and innovation in a small biotec

    2025-10-16, 12:00 PM

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    Helen Chalk
    Vice President, Clinical Operations, Mythic Therapeutics

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

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

    Session Details:

    CASE STUDY: Management of tumor biomarker testing to boost study enrolment

    2025-10-16, 11:00 AM

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    Malina Traianova
    Director, Lab and Vendor Management, Mythic Therapeutics

    Session Details:

    CASE STUDY: Management of tumor biomarker testing to boost study enrolment

    2025-10-16, 11:00 AM

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

    Session Details:

    Topic TBC

    2025-10-16, 11:00 AM

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    Yolanda Wan
    Head of Clinical Operations, Orna Therapeutics

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

    Session Details:

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

    2025-10-16, 2:50 PM

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    Stacey Oppenheimer
    Director, Vendor Lead, Pfizer

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

    Session Details:

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

    2025-10-15, 9:30 AM

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

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

    Session Details:

    Chairperson’s closing remarks

    2025-10-15, 5:30 PM

    Session Details:

    Chairperson’s opening remarks

    2025-10-16, 8:50 AM

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

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

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

    Session Details:

    Successfully planning a clinical supply chain for new drug modalities

    2025-10-16, 9:00 AM

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    Katerina Chatzi
    Founder and Chief Executive Officer, Promakhos Therapeutics

    Session Details:

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

    2025-10-15, 5:00 PM

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

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

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

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

    Session Details:

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

    2025-10-15, 4:00 PM

    Session Details:

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

    2025-10-15, 3:00 PM

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    Jenifer Waldrop
    Executive Director, Rare Disease Diversity Coalition

    Session Details:

    Topic TBC

    2025-10-16, 10:00 AM

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

    Session Details:

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

    2025-10-15, 3:00 PM

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    John Seman
    Chief Executive Officer, Revitale Pharma

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

    Session Details:

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

    2025-10-15, 3:00 PM

    Session Details:

    Chairperson’s closing remarks

    2025-10-15, 5:30 PM

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    Stefan N. Lukianov
    Founder and Chief Executive Officer, Salve Therapeutics

    Stefan N. Lukianov, AM MS is the first-time JHU grad student founder of Salve Therapeutics, Inc. of Los Angeles, CA.  He has undergraduate degrees from the University of Maine and masters from the University of Pittsburgh and Harvard University in the biomedical sciences.  He has worked in reputable labs at Boston Children’s Hospital, Brigham and Women’s Hospital, McLean Hospital and the UPMC Hillman Cancer Center. He also has extensive experience in science journalism and education that contribute to his company leadership and vision.

    Session Details:

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

    2025-10-15, 2:00 PM

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

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

    Session Details:

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

    2025-10-15, 9:30 AM

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    George Tetz
    Chief Executive Officer, Second Life Therapeutics

    Session Details:

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

    2025-10-15, 11:00 AM

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    Sarah Woods
    Founder, Serenely Guided Foundation

    Session Details:

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

    2025-10-15, 12:00 PM

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    Nicole McElroy
    Director, Partnership Health and Supplier Management, Takeda

    Session Details:

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

    2025-10-15, 9:30 AM

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

    Session Details:

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

    2025-10-15, 12:00 PM

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

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

    Session Details:

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

    2025-10-15, 12:00 PM

    Session Details:

    Assessing patient attitudes to the use of AI in clinical trials

    2025-10-15, 5:00 PM

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

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

    Session Details:

    Reserved for

    2025-10-15, 2:00 PM

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    OCT Advisory Board

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

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

     

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

     

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

     

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

     

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

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

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

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

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

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    Bao Dinh
    Global Development Business Operation, Takeda

    With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

    Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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