Outsourcing in Clinical Trials East Coast

Other · Clinical Operations and Outsourcing

Registration & Refreshments

Other · Clinical Operations and Outsourcing

GlobalData opening remarks

John Rose, GlobalData

Talk · Clinical Operations and Outsourcing

Evolving sourcing needs and models in clinical R&D

Mohan Bangalore, Summit Therapeutics

Talk · Clinical Operations and Outsourcing

Smarter, faster, autonomous: the future of clinical data management with generative and agentic AI

Prasanna Rao, Saama

Panel · Clinical Operations and Outsourcing

PANEL: Diversity in clinical trials: how to ensure your clinical study has diverse representation

Ram Raju, Northwell Health · Patrick Floody, Global Clinical Trial Services · Lucas Goren, CISCRP · Kathleen Cohen, Marinus Pharmaceuticals

Break · Clinical Operations and Outsourcing

Morning refreshments and networking break

Talk · Clinical Operations and Outsourcing

Innovative approaches to measure your performance and identify areas for improvement in supplier relationships

Jim Mordaga, Novartis

Panel · Clinical Technology and Innovation

PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

Rich Polgar, Bristol-Myers Squibb · Ashlyn Jose, Inc · Ram Raju, Northwell Health · Kristen Olszyk, Neuraptive Therapeutics · Stefanie Kuhner, Bristol Myers Squibb

Talk · Clinical Operations and Outsourcing

Maximizing the consultative partnership between CRO and biotech partners

John Kamin, KCR (an ICON PLC company)

Talk · Clinical Technology and Innovation

Community is the new site: redefining trial footprints to expand access

Nancy Lizzul, EmVenio Research

Panel · Clinical Operations and Outsourcing

PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

John Seman, REVITALE Pharma · Albert A Siha, Pfizer · Nupur Modi Murali, Bausch Health · Kathleen Cohen, Marinus Pharmaceuticals · Susan Neal, Novavax

Talk · Clinical Technology and Innovation

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

Carrie Lewis, Endo Pharmaceuticals · Suzy Montanye, Endo Pharmaceuticals

Talk · Clinical Operations and Outsourcing

Trump Administration effect on healthcare through the lens of a former regulator

Patrick Ronan, Symbio Research

Talk · Clinical Technology and Innovation

Achieving submission excellence with Certara’s regulatory operations solutions

Evan Richardson, Certara

Break · Clinical Operations and Outsourcing · Clinical Technology and Innovation

Lunch and networking

Talk · Clinical Operations and Outsourcing

Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

Linda Miller, Incyte · Todd Nicklas, Incyte

Panel · Clinical Technology and Innovation

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

Judyth Zahora, Agenus · Bryan Clayton, Endpoint Clinical · Paresh Patel, Otsuka · Cole Eshbach, Endo · Prasanna Rao, Saama

Talk · Clinical Operations and Outsourcing

Built different: how a BioA-rooted central lab delivers precision in a dynamic clinical landscape

Nan Zhang, Frontage Laboratories

Talk · Clinical Technology and Innovation

Expanding the patient universe: transforming clinical trials through inclusive, data-driven design

Chris Riley, H1 Clinical

Panel · Clinical Operations and Outsourcing

PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

Rich Polgar, Bristol-Myers Squibb · Lauren Colfer, MapLight Therapeutics · Amber Knight, Organon · Rick O’Hara, OncoC4

Talk · Clinical Technology and Innovation

Leveraging innovative AI solutions to improve the efficiency and effectiveness of clinical trials

Thomas Hopkins, AccuVein

Break · Clinical Operations and Outsourcing · Clinical Technology and Innovation

Afternoon refreshments, networking

Other · Clinical Operations and Outsourcing

Exhibition Apple prize draw

Talk · Clinical Operations and Outsourcing

What does patient centricity mean in an outsourcing context?

Amber Knight, Organon

Talk · Clinical Technology and Innovation

Health literacy in clinical trials: ensuring information is clear and accessible to patients

Lucas Goren, CISCRP

Talk · Clinical Operations and Outsourcing

Clinical agility: conducting early phase trials in times of regulatory uncertainties

Alex Baldridge, Harvest Integrated Research Organization (HiRO)

Talk · Clinical Technology and Innovation

CASE STUDY: Practical aspects of running a clinical trial when repurposing an existing drug

John Seman, REVITALE Pharma

Keynote · Clinical Operations and Outsourcing

Keynote presentation and workshop: Applying AI to our clinical operations challenges

Dan Seewald, Deliberate Innovation

Other · Clinical Operations and Outsourcing

Chairperson’s closing remarks

Rosalie Filling, Endo

Networking · Clinical Operations and Outsourcing

Networking drinks reception sponsored by GlobalData

Other · Clinical Operations and Outsourcing

Registration and Refreshments

Panel · Clinical Operations and Outsourcing

PANEL: Ensuring your FSP model is a success: what do you need to know?

Rich Polgar, Bristol-Myers Squibb · Melanie Goodwin, Immunocore · Russell Bland, Jazz Pharmaceuticals · Terry Katz, Daiichi Sankyo

Talk · Clinical Technology and Innovation

Medically underserved populations and the impact on rare disease clinical trials

Harsha K. Rajasimha, Indo US Organization for Rare Diseases

Talk · Clinical Operations and Outsourcing

What do you mean you need equipment? Demystifying the complexities of the equipment supply chain

Jonathan Raven, Emsere · Bryan Dunlap, Emsere

Talk · Clinical Technology and Innovation

The innovation mandate: how to thrive in a rapidly evolving world of data and analytics

Walter Boyle, Biostatistics and Programming

Panel · Clinical Operations and Outsourcing

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

Judyth Zahora, Agenus · Samantha Beddows, AstraZeneca · Jessica Truscello, Lava Therapeutics · Bryan Fulop, Teva Pharmaceuticals · Haifa Tyler, RiboX Therapeutics

Talk · Clinical Technology and Innovation

A year on update: Critical to quality factors Part 2: operationalization of the concept in a pilot study

Jehan Poco, Inc · Kevin Douglass, Inc

Break · Clinical Operations and Outsourcing

Morning refreshments and networking

Break · Clinical Technology and Innovation

Morning Refreshments & Networking

Talk · Clinical Operations and Outsourcing

Choosing CRO and vendor partners as a small biotech sponsor: priorities and key considerations

Susan Neal, Novavax

Panel · Clinical Technology and Innovation

PANEL: Optimizing remote data capture: new trends and technology in data acquisition

Robert Besthof, RiboNova · Terry Katz, Daiichi Sankyo · TJ Sharpe · Jay Madan, SGN Nanopharma · Mario D’Achille, Jazz Pharmaceuticals

Talk · Clinical Operations and Outsourcing

Driving success: strategies for optimal site support

Eleanor Miller, PSI CRO

Talk · Clinical Technology and Innovation

Leveraging technology for seamless collaboration

Jamie Russo, AG Mednet

Keynote · Clinical Operations and Outsourcing

Keynote: Establishing a Center of Excellence for gene therapy and vaccines

Gurdyal Kalsi, Asklepion Pharmaceuticals

Break · Clinical Operations and Outsourcing

Lunch and Networking

Talk · Clinical Operations and Outsourcing

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

Panel · Clinical Operations and Outsourcing

PANEL: Navigating the outsourcing landscape for emerging therapy areas

Judyth Zahora, Agenus · Gurdyal Kalsi, Asklepion Pharmaceuticals · Harsha K. Rajasimha, Indo US Organization for Rare Diseases · Priya Marreddy, OnCusp Therapeutics · Mohan Bangalore, Summit Therapeutics

Break · Clinical Operations and Outsourcing

Afternoon refreshments and networking

Other · Clinical Operations and Outsourcing

Exhibition Apple prize draw

Roundtable · Clinical Operations and Outsourcing

Problem-solving roundtable discussions

Other · Clinical Operations and Outsourcing

End of conference