03
June

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 2027

The premier meeting for all East Coast USA CMC professionals

Le Meridien Cambridge

DOWNLOAD THE BROCHURE

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 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.

Abizer Harianawala

Vice President, CMC & Technical Operations Alkeus Pharmaceuticals, Inc.

Annette Bak

Head, Advanced Drug Delivery AstraZeneca

Christoph Winterhalter

Chief Business Officer AGC Biologics

Debasis Patra

Vice President, Head of CMC OliX Pharmaceuticals

Erin O’Brien

Vice President, Pharmaceutical Development Parabilis Medicines

Erin O’Brien is a purpose-driven pharmaceutical executive dedicated to improving patients’ lives while advancing environmentally responsible drug development. She serves as Vice President of Pharmaceutical Development at Parabilis Medicines, where she leads the development of peptide drug substances and drug products, guiding programs from early development through clinical advancement. Her work emphasizes robust CMC strategy, scalable manufacturing, and sustainable process design. Erin brings more than two decades of experience leading multidisciplinary teams across process chemistry, drug product development, technology transfer, and commercial lifecycle management. Prior to joining Parabilis, she held senior leadership roles at Takeda Pharmaceuticals and Biogen, where she directed global organizations responsible for small molecule development and manufacturing innovation. Recognized for integrating green chemistry principles into pharmaceutical development, Erin is committed to building high-performing teams and advancing efficient, high- quality, and environmentally conscious manufacturing solutions. She holds a Ph.D. in Organic Chemistry from the University of Pennsylvania and a B.S. in Chemistry from Mount Allison University.

Gavin Loudfoot

Vice President, Business Development BV Investment Partners

Gopi Vudathala

Global Head, Regulatory Affairs CMC Incyte Corporation

Goldi Kaul

Vice President, Head of External Alternative CMC Development Boehringer Ingelheim

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.

Hagen Cramer

Chief Technology Officer QurAlis

Hagen Cramer, Ph.D., is a renowned expert in all chemistry-related aspects of oligonucleotide therapeutic development. He has been working in the biotech industry for more than 20 years, spanning discovery, development, and manufacturing of oligonucleotide-based therapeutics. Early in his career, Hagen worked with Gemini Technologies and Ridgeway Biosystems on the discovery of 2-5A antisense for the treatment of a variety of cancers and viral diseases. In 2005, Hagen joined Girindus, which was later acquired by Nitto Denko Avecia, where he headed the process development department, eventually becoming director of operations to advance cGMP manufacturing of RNA therapeutics through the clinical stages of development for a variety of sponsors. Just prior to joining QurAlis, Hagen was at Wave Life Sciences, where he was responsible for securing drug substance and drug product for its clinical pipeline of stereodefined oligonucleotide therapeutics targeting diseases affecting the central nervous system. Other responsibilities included heading Wave’s process validation efforts and being a main contributor for writing regulatory documents. Hagen received his PhD in chemistry under the guidance and mentorship of Prof. Dr. Wolfgang Pfleiderer in 1995 from the University of Konstanz, Germany, and then conducted postdoctoral work at the National Institutes of Health. He has published 25 peer-reviewed papers, including four book chapters, holds four patents, and has authored one book.

Hibreniguss Terefe, PhD

Director, Product Development Ardena

Jamie Gillette

Vice President, Head of Regulatory Cullinan Therapeutics

Kristin King Jankiewicz

Head, Group Management Boston Harbor Angels

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.

Melissa Morandi

Vice President and Head, Global Quality Sumitomo Pharma America, Inc.

Neera Jain

Senior Vice President, CMC PureTech Health

Nelly Viseux

Vice President, Cell Therapies Development, Manufacturing, Supply & Quality Regeneron

Olga Paley

Director, Head US Downstream Process Development Late and Bioconjugation Takeda

Paul Peng

Vice President, CMC City Therapeutics

Robert Gabriel

Board Member, Managing Partner Ashur Capital

Rowshon Alam

Vice President, Chemistry and In-Process Analytics Prime Medicine, Inc.

Sean Cumiskey

Head, Investor Relations Omega Funds

Sean joined Omega Funds in 2024. Prior to joining Omega, Sean was a Partner and Chief Strategy Officer at Yiheng Capital Management, an Asia-focused alternative investment manager, where he implemented growth strategies that resulted in an increase of assets under management from an initial base of $350 million to over $3 billion at peak. Previously, Sean was a Director at Farallon Capital Management, with responsibility for new business development, product strategy and investor relations. Before Farallon, Sean was a Managing Director at York Capital Management, a global multi-asset alternative investment firm, where he directed key elements of the firm’s global investor relations efforts. Prior to York, Sean was on the Executive Committee at Ivy Asset Management, overseeing over $16 billion in global alternative investments. In previous years, Sean was Director of Portfolio Strategy at a Silicon Valley wealth management firm and Head of Investment Consulting at Montgomery Securities, a technology-focused investment bank. Sean received his BA from the University of California, Los Angeles, and MBA from Columbia Business School

Seshu Tummala

Vice President, Drug Substance Process Development and Manufacturing Uniquity Bio

Seshu Tummala, PhD, is the Executive Director, Drug Substance Process Development and Manufacturing Operations in the Technical Operations group at Uniquity Bio. In this role, he is responsible for process development, manufacturing operations, and process/method tech transfer activities for biologics drug substance manufacturing. Dr. Tummala has 20 years of experience in manufacturing and process development in the biotech industry with a broad experience in various drug product modalities including biologics, cell and gene therapies, recombinant protein therapeutics, siRNA, and vaccines. Prior to joining Uniquity Bio, Dr. Tummala was the Vice President of CMC at Mana Therapeutics with CMC stewardship responsibilities for both of Mana Tx’s cell therapy programs. Before Mana Therapeutics, he was a member of CRISPR Therapeutics, where he had responsibilities for external manufacturing and CMC leadership for CRISPR immuno-oncology programs. Prior to that, Dr. Tummala held positions of increasing responsibility in technical operations at multiple biopharmaceutical companies including Abbvie, Lonza, and Shire/Takeda, where he supported biologics process development, technology transfer, analytical testing, and CMC leadership. Dr. Tummala holds a B.S. in chemical engineering from Johns Hopkins University and both an M.S./Ph.D. in chemical engineering from Northwestern University.

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 drink – however you choose to make those important connections, our Strategy Meetings have the solution.

Our Past Agenda

09:00 – 10:00

Roundtable Tracks

Biomanufacturing
Explore How Innovation in CMC Intersects with Regulatory Communication in Biomanufacturing

-Gregory Papastoitsis
Chief Process and Manufacturing Officer
Ankyra Therapeutics

Technology Transfer Analytical
Leveraging Digital Tools for Effective Technology Transfers

-Olga Paley
Director, Head US Downstream Process Development Late and Bioconjugation
Takeda

Outsourcing / Process Research & Scale Up
Integrated Peptide Outsourcing: Aligning Drug Substance, Drug Product & Lifecycle Strategy

-Erin O’Brien
Vice President, Pharmaceutical Development
Parabilis Medicines

Integrated Drug Development
Early CMC-Clinical Integration: Aligning Strategies to Accelerate Development and Mitigate Risks

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

Emerging / New Modalities
Accelerating Oligonucleotide Development Through Integrated CMC Approaches (Topic TBC)

-Debasis Patra
Vice President, Head of CMC
OliX Pharmaceuticals

Drug Substance, Drug Product, Drug Delivery
Cross-Functional Collaboration for API and Intermediate Optimization: Bridging R&D, Manufacturing, and Regulatory

-Gopi Vudathala
Global Head, Regulatory Affairs CMC
Incyte Corporation

Private Equity & Venture Capital
Is Private Equity Quietly Becoming the Dominant Force in Life Sciences?

-Sean Cumiskey
Head, Investor Relations
Omega Funds

11:10 – 12:10

Roundtable Tracks

Biomanufacturing
Scaling Biologics: Managing Comparability and Tech Transfer Risk Across Sites and Phases

-Christoph Winterhalter
Chief Business Officer
AGC Biologics

AGC BIOLOGICS

Technology Transfer Analytical
Tech Transfer Is Not a Handoff — It’s a Lifecycle. A CDMO Perspective on Tech Transfer as a Strategic CMC Enabler

-Hibreniguss Terefe, PhD
Director, Product Development
Ardena

Ardena

Outsourcing / Process Research & Scale Up
Selecting the Right Outsourcing Partners

SPONSOR

Integrated Drug Development
Driving CMC Excellence Through Digital Transformation and Data Integration

SPONSOR

Emerging / New Modalities
Precision and Beyond: The Impact of Emerging Modalities on Drug Development

SPONSOR

Drug Substance, Drug Product, Drug Delivery
Navigating CMC Hurdles in Generic Drug Development: Strategies to Overcome Formulation Challenges

SPONSOR

Private Equity & Venture Capital
How Early Is “Too Early” to Invest in Manufacturing?

SPONSOR

12:15 – 13:15

Roundtable Tracks

Biomanufacturing
Continuous Manufacturing Adoption: A Leadership Checklist for Pharma Sites (Topic TBC)

-Melissa Morandi
Vice President and Head, Global Quality
Sumitomo Pharma America, Inc.

Technology Transfer Analytical
Using Real-Time Data Insights to Drive Faster, More Reliable Bioprocess Tech Transfer

-Seshu Tyagarajan
Chief Technical and Development Officer
Candel Therapeutics

Outsourcing / Process Research & Scale Up
Aligning CMC Strategy to Overcome Scale-Up Challenges and Accelerate Development

-Mahesh Padval
Chief Pharmaceutical Development Officer
Relay Therapeutics

Integrated Drug Development
Integrated CMC Partnerships: Driving Efficiency, Compliance, and Innovation in Drug Development

-Jamie Gillette
Vice President, Head of Regulatory
Cullinan Therapeutics

Emerging / New Modalities
Streamlining CMC Workflows to Accelerate Development of Current and Next-Generation ADC

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

Drug Substance, Drug Product, Drug Delivery
Innovations in Drug Delivery Systems

-Paul Peng
Vice President, CMC
City Therapeutics

Private Equity & Venture Capital
Will AI Create the Next Biotech Giants—or the Next Bubble?

-Gavin Loudfoot
Vice President, Business Development
BV Investment Partners

14:40 – 15:10

Beyond the Myths: Hot Melt Extrusion and the Evolution of Solubility Enhancement Technologies

Presenter: Hibreniguss Terefe, PhD, Director, Product Development, Ardena’s Somerset, NJ

15:10 – 16:10

Roundtable Tracks

Biomanufacturing
Future-Ready Biomanufacturing Teams: Challenges and Strategies in Workforce Development

-Neera Jain
Senior Vice President, CMC
PureTech Health

Technology Transfer Analytical
Challenges in Technology Transfer for Oligonucleotide Therapeutics: Analytical Complexity, Process Robustness, and CMC Readiness

-Rowshon Alam
Vice President, Chemistry and In-Process Analytics
Prime Medicine, Inc.

Outsourcing / Process Research & Scale Up
How CMC Considerations Are Increasingly Shaping Investor Confidence and Funding Decisions in Biotech

-Seshu Tummala
Vice President, Drug Substance Process Development and Manufacturing
Uniquity Bio

Integrated Drug Development
Leveraging Integrated CMC to Streamline Early-Stage Small Molecule Development

-Abizer Harianawala
Vice President, CMC & Technical Operations
Alkeus Pharmaceuticals, Inc.

Emerging / New Modalities
Breaking CMC Bottlenecks in RNA Therapeutics: The Strategic Role of Early Planning and Outsourcing

-Hagen Cramer
Chief Technology Officer
QurAlis

Drug Substance, Drug Product, Drug Delivery
Enabling Personalized Medicine: Optimizing CMC for Specialized Drug Product Manufacturing

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

Private Equity & Venture Capital
Biotech Funding: How Are Investors Pacing Capital amid Longer Timelines?

-Kristin King Jankiewicz
Head, Group Management
Boston Harbor Angels

16:30 – 17:00

CMC Is Now a Board-Level Risk Category. Are We Ready to Lead at That Level?

MODERATOR: Nelly Viseux, Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron PANELIST: Greg Papastoitsis, Chief Process and Manufacturing Officer, Ankyra Therapeutics PANELIST: Jamie Gillette, Vice President, Head of Regulatory, Cullinan Therapeutics PANELIST: Gopi Vudathala, Global Head, Regulatory Affairs CMC, Incyte

Become an official strategy meeting partner. Whatever your business needs, we can help. Get in touch for partnering opportunities.

Partner With US

Explore Highlight From The Past Events

Gain valuable insights, discover innovative solutions and connect with industry leaders through snapshots of our most successful gatherings.

May
2023

Jun
2020

Oct
2020

Watch to hear what your colleagues had to say...

Hotel & Venue

Le Méridien Boston Cambridge

Hotel Details Map & Directions Parking

Quick Links

Want to find out more?

Find out more details about our Strategy Meetings and other news and events.

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.

Europe

USA East

USA West

Webinars

Dinners & Spotlights

R&D

Manufacturing Boston

Clinical Operations & Clinical Trial Supply Chain Strategy Meeting East Coast – Boston 2024

Chemistry, Manufacturing and Controls

Strategy Meeting East Coast USA 2027

<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 Facilitators

Abizer Harianawala

Annette Bak

Christoph Winterhalter

Debasis Patra

Erin O’Brien

Gavin Loudfoot

Gopi Vudathala

Goldi Kaul

Gregory Papastoitsis

Hagen Cramer

Hibreniguss Terefe, PhD

Jamie Gillette

Kristin King Jankiewicz

Kwame Nti-Addae

Mahesh Padval

Melissa Morandi

Neera Jain

Nelly Viseux

Olga Paley

Paul Peng

Robert Gabriel

Rowshon Alam

Sean Cumiskey

Seshu Tummala

Yumiko Mizuno

Yu Qian

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

Senior Decision Makers

Personalised Agendas

Private and Intimate Networking

Our Past Agenda

Registration Welcoming

Opening Keynote Presentation

Roundtable

Roundtable Tracks

Refreshment Break

Networking/1-1 Meetings

Roundtable

Roundtable Tracks

AGC BIOLOGICS

Ardena

SPONSOR

SPONSOR

SPONSOR

SPONSOR

SPONSOR

Roundtable

Roundtable Tracks

Networking Lunch

Networking / 1-1 Meetings

Afternoon Keynote Presentation

Beyond the Myths: Hot Melt Extrusion and the Evolution of Solubility Enhancement Technologies

Roundtable

Roundtable Tracks

AFTERNOON REFRESHMENT BREAK

Panel Discussion

CMC Is Now a Board-Level Risk Category. Are We Ready to Lead at That Level?

Drinks Canapes & Reception

Our Past Sponsor

Le Meridien Cambridge