May
Chemistry, Manufacturing
and
Controls
Strategy Meeting East Coast USA 2025
The premier meeting for all East Coast USA CMC professionals
days
hours
minutes
seconds
What makes our strategy meetings unique?

Roundtable Discussions
Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.

Unrivalled Networking
With senior delegation from big pharma and innovative biotech from across the East Coast, you can network with peers from different locations, all in one place.

Personalised Agenda
Choose the topics that matter to you. Reserve your place at the roundtable discussions and ensure your whole day delivers the insights you need to hear.

Solutions to your Problems
We've partnered with the best solution providers to solve your biggest challenges. Engage in pre-arranged, private meetings to address your specific needs and find a tangible solution.

Industry Researched Topics
We guarantee our agenda is up-to-date and mission critical because its designed by you. We speak to our extended network of senior decision makers to ensure the most important topics are discussed.

Senior Decision Makers
The entire strategy meeting is specifically tailored to the needs and challenges of senior life science professionals. Discover how your peers are dealing with the same challenges as you.
Meet Our Facilitators
Our panel of facilitators plays a key role in shaping the agenda for the day. Whilst we're busy connecting with the best industry experts, take a look at our facilitators.

Blair McNeill
Senior Vice President, Head of Cell Therapy Sumitomo Pharma America
Caitlyn Harvey
Vice President, Head of CMC Convergent Therapeutics, Inc.
Dana Callow
Founder & Managing Partner Boston Millennia Partners
Debasis Patra
Vice President, Head of CMC OliX Pharmaceuticals
Erin O’Brien
VHead, Process Chemistry Synthetic Molecule Process Developmen Takeda
Fabien Bonhoure
Senior Vice President Chemistry & Manufacturing SEQUENS
Gopi Vudathala
Global Head, Regulatory Affairs CMC Incyte
Gregory Papastoitsis
Chief Process and Manufacturing Office Ankyra Therapeutics
Henry Wolfe
Senior Vice President, Biologics CMC Centessa Pharmaceuticals

Jamie Gillette
Vice President, Head of Regulatory Cullinan Oncology

Jeff Chu
Co-Founder and Managing Partner Features Capital

Johan Evenäs
Chief Executive Officer RG Discovery

Jon Seal
Associate Director of Medicinal Chemistry SAI Life Sciences

Kelly Barret
Director of Discovery Business Development Sai Life Sciences

Kimberly Garko
Senior Vice President, Chief Technical Officer Akebia Therapeutics



Kwame Nti-Addae
Executive Director, Head of CMC Frontier Medicines

Mahesh Padval
Chief Pharmaceutical Development Officer Relay Therapeutics

Matt Barrows
Senior Vice President, CMC & Technical Operations Aviceda Therapeutics

Niels Svenstrup
Senior Vice President, Chemistry & Manufacturing PepGen

Paul Peng
Vice President, CMC City Therapeutics

Raj Manchanda
Chief Technical Operations Officer Neumora Therapeutics



Robert Matunas
Head, CMC Zehna Therapeutics

Seshu Tyagarajan
Chief Technical and Development Officer Candel Therapeutics

Stephan Krause
Executive Director, Cell Therapy Global Quality Bristol Myers Squibb

Vikram Sadineni
Vice President, Technical Development & Manufacturing Generate:Biomedicines

Yumiko Mizuno
Head, Plasma-Derived Therapies (PDT) Drug Product Development Takeda

Yu Qian
Director, Head of Analytical Project Leads Cell Therapies NovartisReasons To Attend Our Strategy Meetings


Fully Interactive Format
There's only so much you can learn from presentations and lectures. Instead our interactive Roundtable Discussions let you debate the topics that really matter


Senior Decision Makers
All our Strategy Meetings are aimed at director level and above. Discover how your peers are tackling the industries biggest challenges and have your thoughts heard


Personalised Agendas
Pick the roundtable discussions that you want to be part of. Simply choose your sessions and we'll create a personalised agenda just for you


Private and Intimate Networking
Small group discussions, private meetings, networking drinks - however you choose to make those important connections our Strategy Meetings have the solution
Our Agenda
See Which Topics Are Up For Discussion
Roundtable Tracks
1The Role of Intermediates in API Synthesis and Their Impact on CMC Regulatory Submissions (Topic TBC)
-Niels Svenstrup
Senior Vice President, Chemistry & Manufacturing
PepGen
Technology Transfer Analytical
Key CMC Considerations for Effective Planning and Collaboration in Complex Site Transfers (Topic TBC)
-Paul Peng
Vice President, CMC
City Therapeutics
Outsourcing / Process Research & Scale Up
Global Outsourcing: Navigating Regulatory Differences (Topic TBC)
-Matt Barrows
Senior Vice President, CMC & Technical Operations
Aviceda Therapeutics
Integrated Drug Development
Developing Robust Analytical Methods for Integrated CMC (Topic TBC)
-Seshu Tyagarajan
Chief Technical and Development Officer
Candel Therapeutics
Emerging / New Modalities
Discovering Future Innovations in Manufacturing Platforms (e.g., modular facilities, bioreactors) and How CMC Strategies will Evolve as the Landscape for New Modalities Matures (Topic TBC)
-Henry Wolfe
Senior Vice President, Biologics CMC
Centessa Pharmaceuticals
Drug Substance, Drug Product, Drug Delivery
Enhancing Drug Solubility, Stability, and Drug Delivery
-Mahesh Padval
Chief Pharmaceutical Development Officer
Relay Therapeutics
Roundtable Tracks
2CMC Strategies for Highly Potent Compounds: From Development to Commercialization
Sponsor
Technology Transfer AnalyticalSeamless Technology and Knowledge Transfer From The Bench To The Plant
Sponsor
Outsourcing / Process Research & Scale UpEffective Strategies for Managing Impurities during API production of peptides and macrocycles
-Dr. Kyryl Popov
Senior, Business Development
RG Discovery
RG Discovery
Integrated Drug DevelopmentAccelerating Time To Market Through Integrated Services
Sponsor
Emerging / New ModalitiesEssential Process Methodologies, Analytical Techniques, and Manufacturing Considerations Critical for Success in Emerging Modalities
Sponsor
Drug Substance, Drug Product, Drug DeliveryUnderstanding the Growing Role of Drug-Device Combination Products and Delivery Systems
Roundtable Tracks
3Implementing Robust Strategies to Mitigate Risks in the Supply Chain
-Erin O’Brien
VHead, Process Chemistry
Synthetic Molecule Process Developmen Takeda
Technology Transfer Analytical
Identifying Key Success Factors for Effective Biologics Technology Transfer (Topic TBC)
-Gopi Vudathala
Global Head, Regulatory Affairs CMC
Incyte
Outsourcing / Process Research & Scale Up
Evaluating the Pros and Cons of Outsourcing CMC Activities
-Gregory Papastoitsis
Chief Process and Manufacturing Office
Ankyra Therapeutics
Integrated Drug Development
Collaboration Between CMC and Clinical Teams for Seamless Development
-Blair McNeill
Senior Vice President, Head of Cell Therapy
Sumitomo Pharma America
Emerging / New Modalities
Gene Therapies: Overcoming CMC Challenges and Finding Solutions (Topic TBC)
-Yu Qian
Director, Head of Analytical Project Leads
Cell Therapies Novartis
Drug Substance, Drug Product, Drug Delivery
Tackling the Challenges and Innovations in Oral Drug Delivery (Topic TBC)
-Kwame Nti-Addae
Executive Director, Head of CMC
Frontier Medicines
Roundtable Tracks
4Building a Successful Overall Development Plan for Producing Sufficiently Formulated API (Topic TBC)
-Jamie Gillette
Vice President, Head of Regulatory
Cullinan Oncology
Technology Transfer Analytical
Best Industry Practice for Late-Stage and Commercial Analytical Method Transfer (AMT)
-Stephan Krause
Executive Director, Cell Therapy Global Quality
Bristol Myers Squibb
Outsourcing / Process Research & Scale Up
Building Scalable and Flexible CMC Strategies: Leveraging CDMO Partnerships and Digital Tools from Early Development to Commercialization
-Vikram Sadineni
Vice President, Technical Development & Manufacturing
Generate:Biomedicines
Integrated Drug Development
Leveraging Digital Tools for Integrated CMC (Topic TBC)
-Art Faulkner
Vice President, Regulatory CMC
TG Therapeutics, Inc.
Emerging / New Modalities
Exploring Emerging Oligonucleotide Modalities and Their Implications for Therapeutic Development
-Debasis Patra
Vice President, Head of CMC
OliX Pharmaceuticals
Drug Substance, Drug Product, Drug Delivery
Innovation in Drug Delivery Systems (Topic TBC)
-Robert Matunas
Head, CMC
Zehna Therapeutics
Explore Highlight From The Past Events
Gain valuable insights, discover innovative solutions and connect with industry leaders through snapshots of our most successful gatherings.
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