07
May

08:00 AM EDT

Chemistry, Manufacturing
and
Controls

Name: Medicinal Chemistry Strategy Meeting East Coast 2025 (Boston)
Start: 2025-05-08T08:00
End: 2025-05-08T18:00
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.

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.

Caitlyn Harvey

Vice President, Head of CMC Convergent Therapeutics, Inc.

Daniel Peng

Vice President, Regulatory Affairs CMC Checkpoint Therapeutics

Debasis Patra

Vice President, Head of CMC OliX Pharmaceuticals

Erin O’Brien

Head, Process Chemistry, Synthetic Molecule Process Development Takeda

Erin O’Brien is a collaborative, strategic, and solutions-oriented leader responsible for the development and manufacturing of small molecule drug candidates through clinical development and commercial life cycle management. Currently serving as the Head of Process Chemistry at Takeda Pharmaceuticals, she spearheads the development of synthetic molecule drug substances. Before joining Takeda, Erin held significant roles at Biogen, including Executive Director, Head of Small Molecule Development, where she led initiatives in drug product process development, technology transfer, and strategic collaborations. Erin’s career began as a research scientist at Roche Palo Alto, LLC. She then advanced through various roles at Millennium: The Takeda Oncology Company, eventually becoming a Group Leader. Her leadership expanded further at Biogen, where she oversaw the chemical Process Development group, focusing on innovative manufacturing processes and green chemistry. Erin holds a Ph.D. in Organic Chemistry from the University of Pennsylvania and a B.S. in Chemistry from Mount Allison University. She is active in professional circles, including International Consortium of Quality, contributing to developments in green chemistry and pharmaceutical manufacturing. Her published works span multiple journals and book chapters, reflecting her commitment to advancing sustainable and efficient chemical processes.

Fabien Bonhoure

Global Business Project Director SEQENS

Fue Vang

Director, Analytical Development Candel Therapeutics

Gopi Vudathala

Global Head, Regulatory Affairs CMC Incyte Corporation

Dr. Vudathala, Ph.D., is currently Global Head, RA CMC at Incyte Corporation. He was Formerly Executive Director of RA CMC at Intarcia Therapeutics, Head of Quality Advocacy at GSK Vaccines and Global Head of Regulatory CMC at Novartis Vaccines. He was also Associate Vice President of Regulatory Affairs CMC at Sanofi-Aventis. He has extensive experience in CMC regulatory strategy for Global Development and Life-Cycle Management Projects and contributed to over 30 NDA and BLA approvals and 60 INDs. Dr. Vudathala has had numerous interactions with global regulators on project related CMC matters as well as on key ICH initiatives. He has published extensively on drug development and regulatory CMC topics. He was on the Regulatory and Quality Advisory Board at the Parenteral Drug Association and a member of the PDA core team on ICHQ12/ Post Approval Changes. He was also previously Vice Chair of the Technical Development and Operations Committee at PhRMA and an active member of the PhRMA CTD Quality Task Force, Genotoxic Impurities Task Force, and a working group member of the FDA Subcommittee for Pharmaceutical Sciences on Process Analytical Technologies and Quality-by-Design. He was also the Chair of the Regulatory Sciences Section of AAPS. Dr. Vudathala is a well-recognized expert on Regulatory CMC and Quality matters and has made several presentations at AAPS, PDA, IIR, Barnett & Proventa International workshops and conferences on CMC, Regulatory, CTD, Drug Device Combination Products and Genotoxic Impurities topics. Dr. Vudathala graduated from the University of Alberta with a Ph.D. in Pharmaceutics and held positions with the Health Protection Branch, Canada, and Procter & Gamble Pharmaceuticals

Gregory Papastoitsis

Chief Process and Manufacturing Officer Ankyra Therapeutics

Dr. Gregory Zarbis-Papastoitsis is the Chief Process and Manufacturing Officer at Ankyra Therapeutics, an immune-oncology company, where he is responsible for all CMC activities. Prior to Ankyra, he was the EVP of Process and Manufacturing at Compass Therapeutics where he oversaw all CMC activities for a CD137 agonist, which is currently in Phase 1/2 clinical studies. Before he was the SVP of development and manufacturing at Eleven Biotherapeutics where he worked on an IL-1 inhibitor that reached pivotal clinical studies for Dry Eye Disease, and an anti-IL6 antibody (successful IND), for Macular Edema. Earlier, he was Associate Director of Process and Analytical Development at Syntonix Pharmaceuticals, where he was responsible for the early development of a long-lasting Factor IX (ALPROLIX®). He also worked on the commercial process of HUMIRA® (Abbott/Abbvie), on the purification process of ONTAK® , an IL2-diphtheria toxin fusion protein (Seragen), on the early development of an antibody-toxin conjugate (aPSMA-DM1) that reached Phase I clinical trials for prostate cancer and an aCCR2 antibody that was in Phase II clinical trials for autoimmune diseases (Millenium Pharma). He received his PhD in Biology at Binghamton University followed by 3 years of post-doctoral studies at Boston University School of Medicine investigating proteases in Alzheimer disease.

Johan Evenäs

Chief Executive Officer RG Discovery

Kwame Nti-Addae

Executive Director, Head of CMC Frontier Medicines

Mahesh Padval

Chief Pharmaceutical Development Officer Relay Therapeutics

As Chief Pharmaceutical Development Officer, Mahesh Padval guides transition of the Company’s late research assets into development and oversees pharmaceutical development activities to support regulatory filings and product commercialization. Mahesh brings to Relay Therapeutics nearly 30 years of product development experience in the pharmaceutical industry. Prior to joining Relay Therapeutics, Mahesh was vice president of pharmaceutical sciences and product development at Verastem, Inc. There, he was responsible for preclinical development, CMC and clinical pharmacology activities in support of the company’s development programs through non-clinical, clinical development and regulatory filings, including the approval and commercial launch of COPIKTRA TM. Prior to Verastem, Mahesh held roles of increasing responsibility at Zalicus, Inc., culminating in his role as vice president of preclinical development and formulations. He also held roles at Charles River Discovery and Development Services and Genzyme Transgenics Corporation. Mahesh holds a Ph.D. and M.S. in industrial pharmacy from Massachusetts College of Pharmacy, CSS in administration and management from Harvard University and a Bachelor of Pharmacy from the University of Bombay, India.

Matt Barrows

Senior Vice President, CMC & Technical Operations Aviceda Therapeutics

Niels Svenstrup

Senior Vice President, Chemistry & Manufacturing PepGen

Niels Svenstrup has over 20 years of experience in the pharma and biotech industry across various leadership roles in chemistry and manufacturing. He recently founded Creative Molecular Consulting, where he is advising early-stage companies on navigating the transition from discovery to preclinical and clinical development from a CMC, regulatory, and business perspective. Niels has a master’s in cell biology and chemistry, a Ph.D. in organic chemistry, and did his postdoctoral training at The Scripps Research Institute in La Jolla, CA. He joined the pharmaceutical industry as a laboratory leader in medicinal chemistry at Bayer Pharma in Germany in 2000. He later went on to become Head of Department, Medicinal Chemistry at H. Lundbeck’s Neuroscience Drug Discovery Center in Copenhagen, Denmark, before joining Ascendis Pharma as Director of CMC and leader of the team that invented and developed TransCon PTH (now YorviPath), an approved drug in the EU and US for the treatment of hypoparathyroidism. Niels moved to the U.S. in 2017 to take on the role of Senior Vice President, Development at Cydan, a rare disease accelerator located in Cambridge, MA. Most recently, Niels was SVP of Chemistry and Manufacturing at PepGen Inc. from 2021 to 2025

Paul Peng

Vice President, CMC City Therapeutics

Robert Gabriel

Board Member, Managing Partner Ashur Capital

Stephan Krause

Executive Director, Cell Therapy Global Quality Bristol Myers Squibb

Suresh Tipparaju

Director, Product Development and Clinical Supply Alexion-AstraZeneca Rare Disease

Dr. Suresh Tipparaju is Director of Product Development and Clinical Supply at Alexion-AstraZeneca Rare Disease. He leads development strategy for a portfolio of APIs comprising small molecules, synthetic peptides, and oligonucleotides from early clinical stages up to commercial validation. Over his 15 years of experience in pharmaceutical development and CMC, Suresh was a key contributor and author of marketing applications for four approved medicines currently helping patients in need: Onivyde, Livtencity, Voydeya, and Beyonttra. Before joining AstraZeneca, Suresh worked at Takeda, Shire, and Merrimack Pharmaceuticals. Dr. Tipparaju obtained his PhD in organometallics from the National Chemical Laboratory, India, and was a postdoctoral associate in Nobel laureate (late) Prof. Herbert C. Brown’s lab at the Herbert C. Brown Center for Borane Research at Purdue University, IN. Dr. Tipparaju published over 20 research articles in prestigious peer-reviewed journals and is an inventor on 10 patents. His research interests are in all aspects of CMC and pharmaceutical development.

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 Novartis

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 Agenda

See Which Topics Are Up For Discussion

09:00 - 10:00

Roundtable Tracks

Intermediates & API
The 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

-Fue Vang
Director, Analytical Development
Candel Therapeutics

Emerging / New Modalities
Navigating CMC for Biologic/Small Molecule Hybrid Therapies

-Caitlyn Harvey
Vice President, Head of CMC
Convergent Therapeutics, Inc.

Drug Substance, Drug Product, Drug Delivery
Enhancing Drug Solubility, Stability, and Drug Delivery

-Mahesh Padval
Chief Pharmaceutical Development Officer
Relay Therapeutics

11:10 - 12:10

Roundtable Tracks

Intermediates & API
De-Risking Small Molecule Development: Strategies to Maximize Success and Boost Your Company’s Value

-Fabien Bonhoure
Global Business Project Director
SEQENS

SEQENS

Technology Transfer Analytical
Seamless Technology and Knowledge Transfer From The Bench To The Plant

Sponsor

Outsourcing / Process Research & Scale Up
Effective Strategies for Managing Impurities during API production of peptides and macrocycles

-Johan Evenäs
Chief Executive Officer
RG Discovery

RG Discovery

Integrated Drug Development
Accelerating Time To Market Through Integrated Services

Sponsor

Emerging / New Modalities
Exploring Emerging Oligonucleotide Modalities and Their Implications for Therapeutic Development

-Debasis Patra
Vice President, Head of CMC
OliX Pharmaceuticals

Sponsor

Drug Substance, Drug Product, Drug Delivery
Understanding the Growing Role of Drug-Device Combination Products and Delivery Systems

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

12:15 - 13:15

Roundtable Tracks

Intermediates & API
Implementing Robust Strategies to Mitigate Risks in the Supply Chain

-Erin O’Brien
Head, Process Chemistry, Synthetic Molecule Process Development
Takeda

Technology Transfer Analytical
Identifying Key Success Factors for Effective Biologics Technology Transfer

-Gopi Vudathala
Global Head, Regulatory Affairs CMC
Incyte Corporation

Outsourcing / Process Research & Scale Up
Evaluating the Pros and Cons of Outsourcing CMC Activities

-Gregory Papastoitsis
Chief Process and Manufacturing Officer
Ankyra Therapeutics

Integrated Drug Development
Collaboration Between CMC and Clinical Teams for Seamless Development

-Daniel Peng
Vice President, Regulatory Affairs CMC
Checkpoint Therapeutics

Emerging / New Modalities
Cell and Gene Therapies: CMC Challenges and Potential Solutions

-Yu Qian
Director, Head of Analytical Project Leads, Cell Therapies
Novartis

Drug Substance, Drug Product, Drug Delivery
CMC for Oral Drug Delivery: Navigating the Challenges of Bioavailability and Controlled Release

-Suresh Tipparaju
Director, Product Development and Clinical Supply
Alexion-AstraZeneca Rare Disease

15:10 - 16:10

Roundtable Tracks

Intermediates & API
Building a Successful Overall Development Plan for Producing Sufficiently Formulated API

-Suresh Tipparaju
Director, Product Development and Clinical Supply
Alexion-AstraZeneca Rare Disease

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
Optimizing Process Research & Scale-Up in CMC: From Early-Stage Development to Commercial Production

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

Integrated Drug Development
Digital Transformation in CMC: Revolutionizing Drug Development & Manufacturing

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

Emerging / New Modalities

Drug Substance, Drug Product, Drug Delivery
CMC Strategies to Reduce Dosing Frequency: Overcoming Challenges in Drug Substance Formulation and Delivery

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

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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.

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Pass includes:

Access to all delegate led roundtable discussions across the agenda to understand and benchmark your solutions against current strategic challenges from within the industry.

The Key Opinion Leader Pass includes full hospitality, access to all networking sessions (excluding Sponsor led Roundtable Discussions unless built into an existing package), breakfast, networking lunch and evening drinks & canape reception

Be amongst 10-15 delegates from a mix of emerging to large Pharma, Biotech & Academic Institutions in a closed boardroom environment as a thought leader to share your best practice and ideas from your own personal experience

A consultative approach to commercially approaching C-Suite, VP and Director level budget holders with thought provoking discussion.

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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

Meet Our Facilitators

Caitlyn Harvey

Daniel Peng

Debasis Patra

Erin O’Brien

Fabien Bonhoure

Fue Vang

Gopi Vudathala

Gregory Papastoitsis

Johan Evenäs

Kwame Nti-Addae

Mahesh Padval

Matt Barrows

Niels Svenstrup

Paul Peng

Robert Gabriel

Stephan Krause

Suresh Tipparaju

Vikram Sadineni

Yumiko Mizuno

Yu Qian

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

Senior Decision Makers

Personalised Agendas

Private and Intimate Networking

Our Agenda

See Which Topics Are Up For Discussion

Registration Welcoming

Opening Keynote Presentation

Roundtable

Roundtable Tracks

Refreshment Break

Networking/1-1 Meetings

Roundtable

Roundtable Tracks

SEQENS

Sponsor

RG Discovery

Sponsor

Sponsor

Roundtable

Roundtable Tracks

Networking Lunch

Networking / 1-1 Meetings

Afternoon Keynote Presentation

Roundtable

Roundtable Tracks

Networking Lunch

Panel Discussion

Drinks Canapes & Reception

Our Sponsors

Co-Host Sponsors

Partnering Sponsor

Key Opinion Leader

Exhibitor

Explore Highlight From The Past Events

Press play to hear what your colleagues had to say...

Hotel & Venue

Le Méridien Boston Cambridge

Want to find out more?

Chemistry, Manufacturing
and
Controls

Le Meridien Cambridge