07
May

08:00 AM EDT

Chemistry, Manufacturing
and
Controls

Name: CMC Conferences 2025
Start: 2025-05-7T08:00
End: 2023-05-7T16:50
Location: Le Méridien Boston Cambridge

Strategy Meeting East Coast USA 2025

The premier meeting for all East Coast USA CMC professionals

Le Meridien Cambridge

Our Event Starts In

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A MEETING EXPERIENCE UNLIKE ANY OTHER

Fresh CMC Insights

Tired of the same conference experience? Real discussions and genuine networking are often promised, but not always delivered. Proventa International’s Manufacturing Strategy Meetings are designed to avoid the pitfalls of a typical conference, by providing the right environment to make those important connections through interactive roundtable discussions, exclusive networking and keynote panel debates. Join CMC professionals from across the East Coast, in Boston MA, to discover new insights and take your company’s mission to the next level.

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.

Our Past Facilitator

Our panel of facilitators play 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

Abizer Harianawala

Senior Director, Product Development and Technical Operations TARIS Biomedical

Art Faulkner

Vice President, Regulatory CMC TG Therapeutics, Inc.

Ganfeng Cao

Vice President and Head of Process Chemistry, CMC Prelude Therapeutics

George Wu

Vice President, CMC Enanta Pharmaceuticals

Gopi Vudathala

Global Head, Regulatory Affairs CMC Incyte

Ian O’Reilly

Vice President, Quality Tessera Therapeutics

Jamie Gillette

Vice President, Head of Regulatory Cullinan Oncology

Kelly Neelon

Vice President, CMC and Technical Operations Vigil Neuroscience

Kristen Manion

Vice President, Head of Regulatory Affairs, Quality and Manufacturing Paratek Pharmaceuticals

Mahesh Padval

Chief Pharmaceutical Development Officer Relay Therapeutics

Niels Svenstrup

Senior Vice President, Chemistry & Manufacturing PepGen

Pradeep Sharma

Global Head, Pharmaceutical & Technical Ops, Small Molecule & Oligonucleotides Takeda

Seshu Tyagarajan

Chief Technical and Development Officer Candel Therapeutics

Sheila Mathias

Chief Scientific Officer Virpax Pharmaceuticals, Inc.

Dr. Sheila A. Mathias has more than 20 years of leadership experience in the pharmaceutical industry accelerating drug development. She brings extensive global regulatory affairs strategic guidance and clinical development experience having worked across a range of therapeutics areas, including pain management, addiction medicine, and dermatology. This experience has spanned across big pharma, mid-sized, to start-up biotechnology companies. Most recently, she held the position Senior Director Global Regulatory Affairs at Sun Pharma Advanced Research Company. Sheila has held increasing roles of responsibilities, entering the pharmaceutical industry at Merck US Human Health in the position of Medical Science Liaison. Dr. Mathias transitioned into Regulatory Affairs at Aventis Pharmaceuticals and has successfully brought multiple products through regulatory approval.
Dr. Mathas received a B.S in Zoology from Howard University, a PhD in Neurophysiology from Meharry Medical College, an executive MBA from Saint Joseph’s University, and a JD from Northwestern California University School of Law. Since 2018 she has served on the Advisory Board for Tennessee State University Department of Biology

Yanhuai (Richard) Ding

Head, Purification Process Development, Gene Therapy Biogen

Vimal Patel

Vice President, Head of CMC Orum Therapeutics

See the agenda and facilitator line-up. Download the strategy meeting brochure for full details.

DOWNLOAD THE BROCHURE

Reasons 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 Past Agenda

See Which Topics Are Up For Discussion

08:30

Opening Keynote and Welcome Address Proactive Leadership In The Sciences PRESENTER: Ian O’Reilly Vice President, Head of Quality, Tessera Therapeutics

09:00

Roundtable Tracks

Intermediates & API Evolution of CMC: Tackling the Challenges and Opportunities of Rare Disease Drug Development -Niels Svenstrup Senior Vice President, Chemistry & Manufacturing, PepGen Technology Transfer & Analytical Finding Tactical Approaches in Accelerating CMC Filing and Review Activities -Seshu Tyagarajan Chief Technical and Development Officer, Candel Therapeutics Integrated Drug Development Lessons Learned and Ongoing Effort: Development of Vaccines and Therapeutics in Response to Covid-19 -Gopi Vudathala Global Head, Regulatory Affairs CMC, Incyte Corporation Process Research & Scale-up Key Considerations For Sterile Drug Product Development For The Marketplace -Vimal Patel Vice President, Head of CMC, Orum Therapeutics Outsourcing Strategies For Monitoring The Quality Of Outsourced Work The Vulnerabilities Involved And How To Identify New Strategic Partnership -Kelly Neelon Vice President, CMC and Technical Operations, Vigil Neuroscience

11:10

Roundtable Tracks

Intermediates & API Mitigating Risks Associated With Api Suppliers -Pradeep Sharma Global Head, Pharmaceutical & Technical Ops, Small Molecule & Oligonucleotides, Takeda Technology Transfer & Analytical What Are The Key Success Factors For A Timely And Successful Technology Transfer -Abizer Harianawala Vice President, CMC, Cyteir Therapeutics Integrated Drug Development Early Stage CMC Development Strategy To Speed IND -Sheila Mathias Chief Scientific Officer, Virpax Pharmaceuticals, Inc. Process Research & Scale-up Building An Effective Cmc Strategy For Commercial Readiness In Clinical Stage Companies -Mahesh Padval Chief Pharmaceutical Development Officer, Relay Therapeutics Outsourcing How to Create a Partnership for “OneStop-Shop” with a CDMO in the Current Landscape (considering post-COVID,etc.) -Kristen Manion Vice President, Head of Regulatory Affairs, Quality and Manufacturing, Paratek Pharmaceuticals

13:10

Roundtable Tracks

Intermediates & API What is “Fit for Purpose” Process Research & Scale-Up of Small Molecule API? -Ganfeng Cao Vice President and Head of Process Chemistry, CMC, Prelude Therapeutics Technology Transfer & Analytical Innovations in Quality Technology -What’s Worth Investing In and What Isn’t? -Jamie Gillette Vice President, Head of Regulatory, Cullinan Oncology Integrated Drug Development Exploring CMC Regulatory Challenges in Accelerated Product Development and Commercialization -Art Faulkner Vice President, Regulatory CMC, TG Therapeutics, Inc. Process Research & Scale-up Effective Scale-Up Strategies for Transition from Development to Manufacturing Scale -Yanhuai (Richard) Ding Head, Purification Process Development, Gene Therapy, Biogen Outsourcing Speeding Up Discovery with the Right CRO Partner -George Wu Vice President, CMC, Enanta Pharmaceuticals

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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.

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<img class="lazy" decoding="async" src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%201%201'%3E%3C/svg%3E" data-src="https://proventainternational.com/wp-content/uploads/2020/12/location.png" >Le Meridien Cambridge

Fresh CMC Insights

What makes our strategy meetings unique?

Roundtable Discussions

Unrivalled Networking

Personalised Agenda

Solutions to your Problems

Industry Researched Topics

Senior Decision Makers

Our Past Facilitator

Abizer Harianawala

Art Faulkner

Ganfeng Cao

George Wu

Gopi Vudathala

Ian O’Reilly

Jamie Gillette

Kelly Neelon

Kristen Manion

Mahesh Padval

Niels Svenstrup

Pradeep Sharma

Seshu Tyagarajan

Sheila Mathias

Yanhuai (Richard) Ding

Vimal Patel

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

Senior Decision Makers

Personalised Agendas

Private and Intimate Networking

Our Past Agenda

See Which Topics Are Up For Discussion

Opening Keynote Presentation

Roundtable

Roundtable Tracks

Networking/1-1 Meetings

Roundtable

Roundtable Tracks

Networking Lunch

Roundtable

Roundtable Tracks

Networking/1-1 Meetings

Closing Keynote Presentation

Drinks Reception

Our Sponsors

Past Co-Host Sponsors

Past Key Opinion Leaders

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Hotel & Venue

Le Méridien Boston Cambridge

Want to find out more?

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Chemistry, Manufacturing
and
Controls

Le Meridien Cambridge