May
Chemistry, Manufacturing
and
Controls
Strategy Meeting East Coast USA 2025
The premier meeting for all East Coast USA CMC professionals
days
hours
minutes
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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.
Art Faulkner
Vice President, Regulatory CMC TG Therapeutics, Inc.Debasis Patra
Vice President, Head of CMC OliX PharmaceuticalsGopi Vudathala
Global Head, Regulatory Affairs CMC IncyteHenry Wolfe
Senior Vice President, Biologics CMC Centessa PharmaceuticalsJamie Gillette
Vice President, Head of Regulatory Cullinan OncologyMahesh Padval
Chief Pharmaceutical Development Officer Relay TherapeuticsMichael Tolentino
Co-Founder, Chief Innovation Officer Aviceda TherapeuticsPaul Hanson
Head Vice President, Life Cycle Management, Innovation, and Strategy TakedaRobert Matunas
Head, CMC Zehna TherapeuticsSeshu Tyagarajan
Chief Technical and Development Officer Candel TherapeuticsReasons 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
See Which Topics Are Up For Discussion
Roundtable Tracks
1The Role of Intermediates in API Synthesis and Their Impact on CMC Regulatory Submissions
Technology Transfer Analytical
Key CMC Considerations for Effective Planning and Collaboration in Complex Site Transfers
Outsourcing / Process Research & Scale Up
Evaluating the Pros and Cons of Outsourcing CMC Activities
Integrated Drug Development
Developing Robust Analytical Methods for Integrated CMC
Emerging / New Modalities
Exploring Future Innovations in Manufacturing Platforms (e.g., modular facilities, bioreactors) and How CMC Strategies will Evolve as the Landscape for New Modalities Matures
Drug Substance, Drug Product, Drug Delivery
Understanding the Growing Role of Drug-Device Combination Products and Delivery Systems
Roundtable Tracks
2Complex Chemical Synthesis and Leveraging Advanced Technology
Technology Transfer Analytical
Seamless Technology and Knowledge Transfer From The Bench To The Plant
Outsourcing / Process Research & Scale Up
Complex Chemistry, Formulation, Scalability, and Reproducibility
Integrated Drug Development
Accelerating Time To Market Through Integrated Services
Emerging / New Modalities
Precision and Beyond: The Impact of Emerging Modalities on Drug Development
Drug Substance, Drug Product, Drug Delivery
Enhancing Drug Solubility, Stability, and Drug Delivery
Roundtable Tracks
3Building a Successful Overall Development Plan for Producing Sufficiently Formulated API
Technology Transfer Analytical
Identifying Key Success Factors for Effective Biologics Technology Transfer
Outsourcing / Process Research & Scale Up
Global Outsourcing: Navigating Regulatory Differences
Integrated Drug Development
Collaboration Between CMC and Clinical Teams for Seamless Development
Emerging / New Modalities
What Are the Unique Regulatory Challenges for Gene and Cell Therapies, and How do they Differ from Traditional Biologics?
Drug Substance, Drug Product, Drug Delivery
Tackling the Challenges and Innovations in Oral Drug Delivery
Roundtable Tracks
4Implementing Robust Strategies to Mitigate Risks in the Supply Chain
Technology Transfer Analytical
Innovations and Challenges in Analytical Method Transfer During Technology Transfer: Ensuring Consistency and Compliance Across Global Sites
Outsourcing / Process Research & Scale Up
Optimizing Process Research & Scale-Up in CMC: From EarlyStage Development to Commercial Production
Integrated Drug Development
Leveraging Digital Tools for Integrated CMC
Emerging / New Modalities
Gene Therapies: Overcoming CMC Challenges and Finding Solutions (Topic TBC)
-Debasis Patra
Vice President, Head of CMC
OliX Pharmaceuticals
Drug Substance, Drug Product, Drug Delivery
Innovation in Drug Delivery Systems
Press play to hear what your colleagues had to say...
Hotel & Venue
Le Méridien Boston Cambridge
Le Méridien Cambridge-MIT’s elegant guest rooms and suites offer a place of luxurious sanctuary and unmatched comfort. Explore unique programs inspired by the brand’s European heritage. Born in a glamorous era of travel, Le Méridien believes everyone should explore the world in style.
Here To Help
Want to know more? Interested in sponsoring the event? Need help registering your team? Just get in touch and a member of the team will be happy to help.