17th Annual Outsourcing in Clinical Trials East Coast 2026

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

12 - 13

May

2026
  • Hyatt Regency New Brunswick, New Jersey
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
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Why attend?

WHAT TO EXPECT FOR 2026?

450+

Attendees

70+

Exhibitors

30+

Speakers

450+

Attendees

70+

Exhibitors

30+

Speakers

See What It's All About

Agenda

  • 12 May 2026
  • 13 May 2026
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Streams

Stream one

Stream A - Clinical Operations and Outsourcing

Stream two

Stream B - Clinical Technology and Innovation

11 AM

PANEL DISCUSSION Committing to innovation by moving beyond endless pilots and buzzwords

  • Exploring why innovations stall at pilot stage
  • Supporting organizations to scale meaningful improvements
  • Strengthening alignment and accountability across teams

Speakers

John Seman
Chief Executive Officer, Revitale Pharma
Judy Zahora
Senior Director, Clinical QA and Process Improvement, Zentalis

11:30 AM

Session reserved for event sponsor

12 PM

Strengthening innovation by aligning quality by design and data governance

  • Embedding quality and governance principles earlier in digital and analytics initiatives
  • Understanding how trusted data foundations enable faster, more confident innovation
  • Exploring where governance accelerates innovation rather than slowing it down

12:30 PM

Session reserved for event sponsor

1 PM

Lunch and networking

2 PM

LIVE DEBATE Debating the AI hype – what’s really happening on the ground

  • Questioning whether current AI tools are overpromising and underdelivering in real clinical operations
  • Exploring where AI implementations are stalling due to data quality, integration and change-management challenges
  • Examining regulatory, validation and inspection readiness concerns that are slowing adoption

Speakers

Frank Leu
CEO, Novapeutics,
Chris Adams
Chief Executive Officer, Andarix

2:30 PM

Session reserved for event sponsor

3 PM

Accelerating data flow by integrating AI across the clinical technology stack

  • Exploring automated data cleaning and reconciliation
  • Supporting near real‑time decision‑making
  • Strengthening interoperability across clinical systems

Speakers

Vinod Samala
Director Data Product Lead, Regeneron Pharmaceuticals

3:30 PM

Afternoon refreshments, networking and Prize Draw

4 PM

Session reserved for event sponsor

4:30 PM

Session reserved for Meghan Dierks, Executive Director Advanced Analytics and Technology Assessment, Harvard Medical School

Speakers

Meghan Dierks
Executive Director Advanced Analytics and Technology Assessment, Harvard Medical School

7:30 AM

Registration & Refreshments

8:30 AM

Chairman’s opening remarks

Speakers

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

8:45 AM

Session reserved for Revati Tatake, Global Head of Pharma R&A and Competitive Intelligence, GlobalData

Speakers

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

9:15 AM

Session reserved for ICON

9:45 AM

KEYNOTE PANEL DISCUSSION Strengthening trial resilience by navigating FDA volatility and global uncertainty

  • Exploring how regulatory and economic shifts disrupt timelines
  • Supporting teams to adapt while protecting patient access
  • Strengthening readiness for rapid pivots in study delivery

Moderator Revati Tatake, Global Head of Pharma R&A and Competitive Intelligence, GlobalData

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
Rik Mehta
Co-Founder and CEO, Lactiga & Former FDA
Meghan Dierks
Executive Director Advanced Analytics and Technology Assessment, Harvard Medical School
Jamie Gamerman
Head of Regulatory Policy US, UCB

10:30 AM

Morning refreshments and networking break

11 AM

CASE STUDY Optimizing resourcing models by evolving from full outsourcing to flexible FSP partnerships

  • Exploring lessons from shifting between outsourcing models
  • Supporting clearer expectations between sponsors and CROs
  • Strengthening RBQM alignment across portfolios

Speakers

David Hilfiker
Senior Director, Head of Risk Based Quality Management, Daiichi Sankyo

11:30 AM

Session reserved for EmVenio Clinical Research

Speakers

Ron Ramos
Senior Director, Business Development, EmVenio Clinical Research

12 PM

Accelerating study start‑up by simplifying internal approvals and global partnerships

  • Exploring how internal misalignment delays activation
  • Supporting faster cross-functional decision‑making
  • Strengthening collaboration with regional partners

Speakers

Tia Williamson
Associate Director, Development Operations, Incyte

12:30 PM

Session reserved for event sponsor

1 PM

Lunch and networking

2 PM

PANEL DISCUSSION Rebuilding trust across sponsors, CROs and sites by addressing the human factors behind operational success

  • Exploring how communication styles, cultural mismatches and unspoken assumptions derail trials more than processes or systems
  • Supporting teams by aligning expectations, roles and behaviour before contracting, not after issues emerge
  • Strengthening long-term partnerships with transparent conflict resolution models and joint decision-making practices

Moderator Revati Tatake, Global Head of Pharma R&A and Competitive Intelligence, GlobalData

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
Judy Zahora
Senior Director, Clinical QA and Process Improvement, Zentalis
Rick O’Hara
Director, R&D Business Operations, OncoC4
Nupur Murali
Director of Clinical Operations, Bausch Health

2:30 PM

Session reserved for event sponsor

3 PM

Designing trials for success: becoming the sponsor sites choose

  • Why be a sponsor of choice in the ever changing landscape
  • What we do to elevate our site partnerships
  • Always keep pushing through curiosity to drive innovation to ensure the health of our industry

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Keenova Therapeutics
Cole Eshbach
Senior Clinical Trial Manager, Clinical Operations, Keenova Therapeutics

3:30 PM

Afternoon refreshments, networking and Prize Draw

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

Session reserved for event sponsor

4:30 PM

Staying inspection-ready while policy is still taking shape

  • Demonstrating good faith compliance with emerging expectations
  • Documenting rationale and regulatory intelligence in trial files
  • Engaging with FDA proactively to validate regulatory strategy

Speakers

Jamie Gamerman
Head of Regulatory Policy US, UCB

NETWORKING DRINKS RECEPTION AND END OF DAY 1

5 PM

Chairperson’s closing remarks

Speakers

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

Streams

Stream one

Stream A - Clinical Operations and Outsourcing

Stream two

Stream B - Clinical Technology and Innovation

9 AM

What patients really think about clinical research and AI

Turning large-scale perception data into smarter engagement strategies

  • Sharing insights from CISCRP’s 2025 survey of 12,000+ individuals, including 4,000+ past trial participants, to unpack patient and public perceptions of AI in clinical research
  • Exploring what the data means in practice, highlighting concrete actions researchers, sponsors, and sites should take to build trust, improve communication, and use AI responsibly
  • Applying engagement and communication findings to recruitment and retention, including trial information-seeking behaviors, DCT preferences, results sharing expectations, and demographic-specific insights

 

Speakers

Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP

9:30 AM

Session reserved for event sponsor

10 AM

PANEL DISCUSSION Inspection readiness in the era of AI, automation & digital systems

  • Discussing how digital workflows impact inspections
  • Preparing AI-related documentation and audit trails
  • Strengthening quality systems for evolving expectations

Speakers

PARESH PATEL
Director Data Science & Technologies,Otsuka

10:30 AM

Morning Refreshments & Networking

11:15 AM

Transforming trial design by using AI to optimise protocols and feasibility

  • Exploring AI‑driven modelling of eligibility and visit schedules
  • Supporting accurate feasibility predictions
  • Strengthening cross-functional design collaboration

Speakers

Chris Adams
Chief Executive Officer, Andarix

11:45 AM

Session reserved for Technology Spotlight Sponsor

Session reserved for Technology Spotlight Sponsor

12:15 PM

Empowering small and mid‑size sponsors by adopting practical AI tools

  • Exploring accessible AI options suitable for SMEs
  • Supporting feasibility, documentation and data review workflows
  • Strengthening competitiveness with budget‑friendly innovation

Speakers

PARESH PATEL
Director Data Science & Technologies,Otsuka

12:45 PM

Lunch and networking

8 AM

Registration and Refreshments

9 AM

The treatment works — now what? Navigating post-trial access between patient need and operational reality

  • Understanding patient expectations when a treatment shows clear benefit during a trial
  • Managing continuation pathways once a study ends and the therapy is not yet commercially available
  • Exploring where sponsors, sites, and physicians struggle to align on responsibility and feasibility

Speakers

Mel Mann
Patient Advocate

9:30 AM

Session reserved for event sponsor

10 AM

PANEL DISCUSSION Debating ownership and risk sharing in sponsor and vendor partnerships

  • Exploring the meaning of risk sharing across roles
  • Supporting balance between procurement and R&D priorities
  • Strengthening partnership models through transparency

Moderator Rosie Filling, Vice President, Senior Global Head R&D Operations, Keenova Therapeutics

Speakers

Rosie Filling
Vice President, Senior Global Head R&D Operations, Keenova Therapeutics
Linda Kerrigan
Director, R&D Agile Sourcing, Bristol Myers Squibb
Bryan Fulop
Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals

10:30 AM

Morning refreshments and networking

11:15 AM

Rebuilding patient recruitment in the US amid trust, access, and site constraints

  • Understanding why traditional recruitment approaches are no longer delivering consistent enrollment
  • Recognizing the impact of trust, awareness, and misinformation on patient participation
  • Sharing practical adjustments sponsors and sites are making to recruit more effectively

Speakers

John Gregg
Chairman and CEO at BalinBac Therapeutics, Inc.

11:45 AM

Session reserved for event sponsor

12:15 PM

Navigating FDA policy & politics in drug development under the Trump Administration

Speakers

Rik Mehta
Co-Founder and CEO, Lactiga & Former FDA

12:45 PM

Lunch and Networking

1:45 PM

Designing trials for everyone: the untapped opportunity in sex-aware clinical research

  • How historical male-centric assumptions shaped clinical research — and how this affected evidence generation, safety signals, and patient outcomes
  • What has changed in prioritizing sex and gender today — including regulatory focus, better data capture, and new enabling tools
  • How sex differences appear across the research lifecycle — using real-world case studies to show impacts on trial interpretation and success
  • Why this is a pivotal moment for clinical research — with sex-aware data driving better insights, outcomes, and more representative evidence

Speakers

Brittany Barreto
Co-Founder, Executive Director, Podcast Host, Femtech Focus

2:15 PM

PANEL DISCUSSION Implementing ICH E6(R3) six months on – turning updated GCP expectations into practice

  • Interpreting what has materially changed under ICH E6(R3), including governance, risk-based quality management, and sponsor oversight expectations
  • Sharing how companies are operationalizing the updated guidance six months in—what has actually changed in trial design, conduct, and oversight
  • Identifying common implementation challenges, grey areas, and lessons learned when aligning internal processes, CRO partnerships, and inspection readiness

Moderator Rosie Filling, Vice President, Senior Global Head R&D Operations, Keenova Therapeutics

Speakers

Rosie Filling
Vice President, Senior Global Head R&D Operations, Keenova Therapeutics
Amanda Eiler
Senior Quality Operations Lead, Incyte
Priya Chaturvedi
VP, Head of Global Clinical Quality, Eisai

2:45 PM

Afternoon refreshments and networking

3:05 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 0ut!

3:15 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 focus on a different challenge within clinical operations.

ROUNDTABLE 1: Outsourcing and vendor models that fit today’s trials

ROUNDTABLE 2: Strengthening sponsor–site relationships in 2026

ROUNDTABLE 3: Making digital tools work for real teams

ROUNDTABLE 4: Fixing the hidden bottlenecks in study start-up

4:15 PM

End of conference

END OF CONFERENCE – SEE YOU NEXT YEAR!

Speakers

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Judy Zahora
Senior Director, Clinical QA and Process Improvement, Zentalis

My goals are to support and drive process understanding, improvements and compliance.

I have been involved with QA, Continuous Improvement activities, both Lean and Six Sigma, contracts, projects, and compliance management, for over 30 years. I have worked in both large multi-national corporations and small private companies. My experience includes GxP controlled process documentation, QA analytics, process engineering, IT Finance Contracts and Revenue and CRO Corporate Lean Sigma mentoring and project support. Throughout these various organizations, I have facilitated continuous improvement projects focusing on cycle time and cost reduction as well as quality. My MBA has provided me with the skills to gain a rapid understanding of transactional processes, the important of effective change management, and the ability to implement efficient, long-term improvements

Specialties: Experienced Quality Assurance Operational Analytics Program Manager looking for a position integrating my contract and project management, compliance review, and Lean/Six Sigma skills with my Finance process development/management experience.

Session Details:

PANEL DISCUSSION Committing to innovation by moving beyond endless pilots and buzzwords

2026-05-12, 11:00 AM

Session Details:

PANEL DISCUSSION Rebuilding trust across sponsors, CROs and sites by addressing the human factors behind operational success

2026-05-12, 2:00 PM

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David Hilfiker
Senior Director, Head of Risk Based Quality Management, Daiichi Sankyo

David Hilfiker (Dave) is an experienced leader in the pharmaceutical industry, currently serving as Senior Director, Head of RBQM at Daiichi Sankyo. He is known for applying his experience to optimize quality and speed during clinical development, leading to successful regulatory submissions and inspections. Dave stands out for his combined experiences in new drug review at the FDA and in industry regulatory affairs and R&D quality and compliance, making him a unique communicator within the field.

Dave is passionate about the pursuit of balance between competing forces (e.g., work and play, innovation and execution, art and science), incorporating this pursuit into personal and professional interests. He is above all family first – proud to be a husband and father to three fantastic young adults, a dog and a cat.

Session Details:

CASE STUDY Optimizing resourcing models by evolving from full outsourcing to flexible FSP partnerships

2026-05-12, 11:00 AM

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Linda Kerrigan
Director, R&D Agile Sourcing, Bristol Myers Squibb

Linda Kerrigan is Director of R&D Agile Sourcing at Bristol Myers Squibb, where she leverages over twenty years of pharmaceutical drug development expertise spanning clinical development and research. Her unique blend of procurement excellence, scientific training, and passion for continuous improvement drives strategic sourcing initiatives across BMS's R&D portfolio. Linda's career includes progressive roles at BMS and more than a decade at Celgene supporting clinical trial sourcing and contracting. She began her pharmaceutical career as a Research Scientist at Wyeth Vaccines Research, providing her with a scientific foundation for R&D procurement. She holds a degree in Biotechnology and an MBA in Technology Management from Rochester Institute of Technology, where she also serves on the RIT College of Science National Council, providing industry insights and advising on strategic initiatives for scientific education.

Session Details:

PANEL DISCUSSION Debating ownership and risk sharing in sponsor and vendor partnerships

2026-05-13, 10:00 AM

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Mel Mann
Patient Advocate

Mel Mann is a retired U.S. Army major who was diagnosed with chronic myeloid leukemia in 1995, while on active duty, and given three years to live. Mel began organizing bone marrow drives, working with communities, churches, and the Department of Defense to add tens of thousands of donors to the national registry. Each donor represented hope for patients like him, though Mel never found a match for himself.

Mel was able to join a clinical trial for Gleevec, a new targeted therapy that saved his life and millions of others. As the longest-living Gleevec and Tyrosine Kinase Inhibitor survivor, Mel remains grateful for every day and continues to share his journey so others might find hope. Through speaking at conferences and community events, he encourages equal access to care, marrow donor donation, and participation in clinical trials. Mel believes that even small efforts can make a difference for someone in need.

Session Details:

The treatment works — now what? Navigating post-trial access between patient need and operational reality

2026-05-13, 9:00 AM

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Vinod Samala
Director Data Product Lead, Regeneron Pharmaceuticals

Session Details:

Accelerating data flow by integrating AI across the clinical technology stack

2026-05-12, 3:00 PM

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Rick O’Hara
Director, R&D Business Operations, OncoC4

Session Details:

PANEL DISCUSSION Rebuilding trust across sponsors, CROs and sites by addressing the human factors behind operational success

2026-05-12, 2:00 PM

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Bryan Fulop
Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals

Session Details:

PANEL DISCUSSION Debating ownership and risk sharing in sponsor and vendor partnerships

2026-05-13, 10:00 AM

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Meghan Dierks
Executive Director Advanced Analytics and Technology Assessment, Harvard Medical School

Session Details:

KEYNOTE PANEL DISCUSSION Strengthening trial resilience by navigating FDA volatility and global uncertainty

2026-05-12, 9:45 AM

Session Details:

Session reserved for Meghan Dierks, Executive Director Advanced Analytics and Technology Assessment, Harvard Medical School

2026-05-12, 4:30 PM

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Nupur Murali
Director of Clinical Operations, Bausch Health

Session Details:

PANEL DISCUSSION Rebuilding trust across sponsors, CROs and sites by addressing the human factors behind operational success

2026-05-12, 2:00 PM

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Frank Leu
CEO, Novapeutics,

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

Session Details:

LIVE DEBATE Debating the AI hype – what’s really happening on the ground

2026-05-12, 2:00 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:

KEYNOTE PANEL DISCUSSION Strengthening trial resilience by navigating FDA volatility and global uncertainty

2026-05-12, 9:45 AM

Session Details:

Session reserved for Revati Tatake, Global Head of Pharma R&A and Competitive Intelligence, GlobalData

2026-05-12, 8:45 AM

Session Details:

Chairman’s opening remarks

2026-05-12, 8:30 AM

Session Details:

PANEL DISCUSSION Rebuilding trust across sponsors, CROs and sites by addressing the human factors behind operational success

2026-05-12, 2:00 PM

Session Details:

Chairperson’s closing remarks

2026-05-12, 5:00 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:

LIVE DEBATE Debating the AI hype – what’s really happening on the ground

2026-05-12, 2:00 PM

Session Details:

Transforming trial design by using AI to optimise protocols and feasibility

2026-05-13, 11:15 AM

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Brittany Barreto
Co-Founder, Executive Director, Podcast Host, Femtech Focus

Best-selling author, leading researcher, and global speaker: Dr. Brittany Barreto dedicates her work to advancing women’s health innovation by equipping key stakeholders with data-driven insights and strategic advice on the femhealth market. She earned a doctorate in Molecular and Human Genetics from Baylor College of Medicine, founded several tech startups, and championed dozens of investments while in senior leadership at Capital Factory and Coyote Ventures. In 2020, Dr. Barreto noticed the underserved state of the women's health (femtech) industry and set out to raise awareness, provide resources, and invest capital in it. She hosts the #1 femtech podcast, FemTech Focus, leads FemHealth Insights, a boutique consulting firm specializing in women's health innovation, and authored the best-selling book “Unlocking Women’s Health, FemTech and the Quest for Gender Equity.”

Session Details:

Designing trials for everyone: the untapped opportunity in sex-aware clinical research

2026-05-13, 1:45 PM

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Priya Chaturvedi
VP, Head of Global Clinical Quality, Eisai

Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai Pharmaceutical based in USA. She has responsibility for Global Clinical Quality Assurance and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director, CQA at Merck. Before Merck, she was at Pfizer in Quality roles within clinical and medical affairs. Prior to joining Pfizer, Priya spent 12 years at GSK in different clinical, project management and discovery roles.

She received her doctorate from Temple University, School of Medicine, PA.

Session Details:

PANEL DISCUSSION Implementing ICH E6(R3) six months on – turning updated GCP expectations into practice

2026-05-13, 2:15 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 DISCUSSION Committing to innovation by moving beyond endless pilots and buzzwords

2026-05-12, 11:00 AM

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Tia Williamson
Associate Director, Development Operations, Incyte

Session Details:

Accelerating study start‑up by simplifying internal approvals and global partnerships

2026-05-12, 12:00 PM

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Rikin “Rik” Mehta
CEO & Co-Founder, Lactiga US, Inc.

Rikin “Rik” Mehta—CEO & Co-Founder of Lactiga, a biotechnology company developing therapies from human milk antibodies for rare immunodeficiencies. Rik also teaches international drug law and regulation at Georgetown University Law Center and Mount St. Mary’s University, is a former FDA official, and made history as the first Indian-American nominee for U.S. Senate in New Jersey, where he also set a record for the highest number of votes ever received by his party’s candidate.

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Carrie Lewis
Executive Director, Clinical Program Optimization, Keenova Therapeutics

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:

Designing trials for success: becoming the sponsor sites choose

2026-05-12, 3:00 PM

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Cole Eshbach
Senior Clinical Trial Manager, Clinical Operations, Keenova Therapeutics

Cole Eshbach is a clinical research professional with experience managing Phase 1-4 trials, driving innovation, and fostering collaboration.  With over six years dedicated to Endo projects, along with previous roles at Global CROs, have further enriched his skill set.  Before entering the clinical research industry, Cole conducted assessments for Autism (ADOS-II) in the greater Philadelphia area and completed behavioral consulting.

Session Details:

Designing trials for success: becoming the sponsor sites choose

2026-05-12, 3:00 PM

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, 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:

What patients really think about clinical research and AI

2026-05-13, 9:00 AM

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Jamie Gamerman
Head of Regulatory Policy US, UCB

Jamie Gamerman, J.D., is a Senior Policy Advisor at the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research, Office of Medical Policy, where she advises on regulatory policy issues. Jamie has worked at the FDA since 2014 and is also a member of the Food and Drug Law Institute’s Food and Drug Law Journal Editorial Advisory Board.

Session Details:

Staying inspection-ready while policy is still taking shape

2026-05-12, 4:30 PM

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Peter O’Neill
Vice President, Clinical Operations, TuHURA Biosciences
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Paresh Patel
Director Data Science & Technologies, Otsuka
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Advisory Board

Select a member to learn more

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

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

 

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

 

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

 

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

 

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

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Dr Alison McMorn
Head of Clinical Strategy and Development, LifeArc

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

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, 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:

What patients really think about clinical research and AI

2026-05-13, 9:00 AM

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

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

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Aditya Kotta
VP Business Development, Novotech

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

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

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

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

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