19
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 2026

The premier meeting for all East Coast USA CMC professionals

Le Meridien Cambridge

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 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

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

Jennifer Taillie

Vice President, Business Development US AGC Biologics

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

First name	Last name	Job title	Company name	Photo URL	Bio Position
Abizer	Harianawala	Vice President, CMC & Technical Operations	Alkeus Pharmaceuticals, Inc.	https://proventainternational.com/wp-content/uploads/2020/01/Abizer-Harianawala-2.jpg	Abizer is a strategic pharmaceutical executive with over 25 years of global leadership in CMC, technical operations, and end‑to‑end drug development for small‑molecule therapeutics. He has led the development and commercialization of ten globally marketed products, integrating drug substance, drug product, analytical, quality, and supply chain functions into cohesive, high‑performing operating models. Known for advancing programs from preclinical through commercial launch, he brings deep expertise in biopharmaceutics, solubility‑enhancement technologies, and scalable manufacturing. Abizer is recognized for aligning technical rigor with enterprise strategy and for championing integrated drug development approaches that accelerate timelines, reduce risk, and strengthen regulatory success.
Annette	Bak	Head, Advanced Drug Delivery	AstraZeneca	https://proventainternational.com/wp-content/uploads/2022/05/avatar.jpg
Debasis	Patra	Vice President, Head of CMC	OliX Pharmaceuticals	https://proventainternational.com/wp-content/uploads/2024/12/DEBASIS-PATRA-1.jpg	Dr. Debasis Patra has doctoral and post-doctoral research experience in novel method development and total synthesis of natural products. He has been working in the pharma/biotech industry for the last 25 years, leading teams of scientists and engineers for the process development and manufacturing of small molecules, peptides, oligonucleotides, etc. Currently he is heading the CMC team at OliX Pharmaceuticals and is responsible for all activities related to drug substance and drug product development and manufacturing to support multiple clinical stage programs (Phase 1/2) in several disease areas, such as ophthalmology, metabolic, dermatology, hair loss, etc.
Erin	O’Brien	Vice President, Pharmaceutical Development	Parabilis Medicines	https://proventainternational.com/wp-content/uploads/2025/04/Erin-OBrien.jpg	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	https://proventainternational.com/wp-content/uploads/2026/05/Gavin-Loudfoot.jpg	Gavin Loudfoot is currently a Vice President at Boston Ventures, previously with OpenView Venture Partners, investing in software and tech-enabled services across several sectors, including healthcare IT. After a decade in investment roles, Gavin is joining Lila Sciences, a Flagship Pioneering-backed AI platform company, where he will help commercialize the concept of scientific superintelligence—using AI and autonomous laboratories to compress R&D timelines across life sciences, materials, and energy. Compressed version (from what I see on the site)—VP at Boston Ventures, previously at OpenView Ventures. Soon to join Lila Sciences to help commercialize the concept of scientific superintelligence— deploying AI and autonomous laboratories to life sciences.
Gopi	Vudathala	Global Head, Regulatory Affairs CMC	Incyte Corporation	https://proventainternational.com/wp-content/uploads/2022/08/Gopi-Vudathala-1.jpg	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.
Goldi	Kaul	Vice President, Head of External Alternative CMC Development	Boehringer Ingelheim	https://proventainternational.com/wp-content/uploads/2026/02/Goldi-Kaul.png	Goldi Kaul, PhD, is a pharmaceutical executive with over 15 years of experience driving global CMC development, manufacturing, and commercialization. She currently serves as Vice President of External Alternative CMC Development at Boehringer Ingelheim, where she leads drug substance, drug product, and analytical development through strategic external partnerships. Dr. Kaul has played a critical role in delivering first‑in‑class and breakthrough therapies, including multiple oncology products and the world’s first FDA‑approved digital medicine. Known for her decisive leadership and execution focus, she bridges science, strategy, and operations to deliver scalable, regulator‑ready medicines worldwide.
Gregory	Papastoitsis	Chief Process and Manufacturing Officer	Ankyra Therapeutics	https://proventainternational.com/wp-content/uploads/2025/02/Gregory-Papastoitsis.jpg	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	https://proventainternational.com/wp-content/uploads/2026/02/Hagen-Cramer.png	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	https://proventainternational.com/wp-content/uploads/2026/05/Hibreniguss-Teref.jpg	With over 27 years of experience in pharmaceutical research, development, and manufacturing, he leads the development of preclinical and clinical solid oral dosage forms at Ardena’s site in Somerset, NJ. Previously, he served as Director of R&D at Catalent Pharma Solutions and Vice President of R&D at ExxPharma Therapeutics. He specializes in drug product development, commercial manufacturing, and CMC, with deep expertise in solubility enhancement, modified-release formulations, and twin-screw extrusion processes. Holding a Ph.D. in Pharmaceutical Chemistry and a Pharmacy degree from Westfälische Wilhelms-Universität Münster, Germany, he was also a Fulbright Visiting Scholar at UC Berkeley.
Jamie	Gillette	Vice President, Head of Regulatory	Cullinan Therapeutics	https://proventainternational.com/wp-content/uploads/2022/07/Jamie-Gillette-2.jpg	Jamie Gillette is Vice President of Regulatory Affairs at Cullinan Therapeutics, where she leads global regulatory strategy and oversees all aspects of regulatory affairs across the company’s full portfolio of oncology and autoimmune/ immunology programs. With 25 years of experience spanning clinical trial and marketing applications across global jurisdictions, she has led regulatory teams at AstraZeneca, BeiGene, and Amgen. Jamie holds an MS in Biomedical Science and a Graduate Certification in Regulatory Compliance from Hood College. She serves as VP of the Howard County Veterans Foundation and is dedicated to lifelong community service through veterans advocacy, mentorship, and charitable fundraising.
Jennifer	Taillie	Vice President, Business Development US	AGC Biologics	https://proventainternational.com/wp-content/uploads/2026/01/Jennifer-Taillie.jpg	Jennifer Taillie is the Vice President of Business Development, US at AGC Biologics, where she is responsible for driving strategic commercial growth, expanding market presence, and leading high-impact client engagements for US-based biologics customers. With over 20 years of experience in healthcare and life sciences, she has spent the majority of her career in management and strategy consulting, helping her clients define strategies and improve operational performance. She holds a BS in Health Science from Georgetown University and an MHA from Johns Hopkins University.
Kristin	King Jankiewicz	Head, Group Management	Boston Harbor Angels	https://proventainternational.com/wp-content/uploads/2026/05/ristin-King-Jankiewicz.jpg	Kristin King-Jankiewicz brings 25 years life science operator and investor experience. She is Head of Group Management, Boston Harbor Angels, an investment group focusing on seed and early stage growth companies. Over the past 2 decades Boston Harbor Angels organization has cultivated a dynamic network of investors, industry experts, and most importantly their entrepreneurs fostering a network of visionaries and nurturing the growth of promising startups continuing our mission of investing for a better world.
Kwame	Nti-Addae	Executive Director, Head of CMC	Frontier Medicines	https://proventainternational.com/wp-content/uploads/2025/04/Kwame-Nti-Addae.jpg	Kwame is a pharmaceutical executive with over 15 years of experience in CMC, formulation, and process development. As Executive Director at Frontier Medicines, he leads Drug Substance, Drug Product, Analytical, and Supply Chain functions. At Lyndra Therapeutics, he played a key role in advancing long-acting oral dosage forms through pivotal trials. He has also held key roles at Ironwood, Cyclerion, and Vertex, driving preclinical and clinical programs and regulatory submissions. Known for his technical expertise, strategic leadership, and dedication to innovation and inclusion, Kwame delivers impactful results across early-stage development through to commercial readiness.
Mahesh	Padval	Chief Pharmaceutical Development Officer	Relay Therapeutics	https://proventainternational.com/wp-content/uploads/2023/03/Mahesh-Padval-1.jpg	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.	https://proventainternational.com/wp-content/uploads/2020/02/Melissa-Morandi.jpeg	Track: Outsourcing
Neera	Jain	Senior Vice President, CMC	PureTech Health	https://proventainternational.com/wp-content/uploads/2026/01/Neera-Jain.jpg
Nelly	Viseux	Vice President, Cell Therapies Development, Manufacturing, Supply & Quality	Regeneron	https://proventainternational.com/wp-content/uploads/2026/03/Nelly-Viseux.jpg
Olga	Paley	Director, Head US Downstream Process Development Late and Bioconjugation	Takeda	https://proventainternational.com/wp-content/uploads/2026/04/Olga-Paley.jpg	Olga currently leads a Takeda Pharmaceuticals development team responsible for establishing robust and scalable biotherapeutic purification processes in support of late-stage pipeline programs along with bioconjugation processes for early and late-stage projects. Olga’s prior experience includes oversight for the development of upstream, downstream, and bioconjugation processes for antibodies and antibody-derived products spanning the pre-clinical stage through launch (along with life-cycle management). She holds a BS in Chemical Engineering from UC Berkeley and a PhD in Chemical Engineering from UT Austin, where her research focused on therapeutic enzyme engineering for oncology applications. Prior to Takeda and her graduate work, Olga also spent time at Genentech in the late-stage purification process development group.
Paul	Peng	Vice President, CMC	City Therapeutics	https://proventainternational.com/wp-content/uploads/2025/01/Paul-Peng.jpg	Paul Peng, Ph.D., has about 20 years of experience in the oligonucleotide industry. Dr. Peng is currently leading the CMC function at City Therapeutics for second generation siRNA therapeutics. In his previous roles he made key CMC contributions to support early and late stage development and regulatory filings for oligonucleotide therapeutics (siRNAs, ASOs and RNA editing oligonucleotides) in small and large biotechnology companies including Alnylam, Stoke, Biogen and Korro. With a Ph.D. in nucleoside/nucleotide chemistry from McGill University, he is dedicated to his profession and finds relaxation in biking, swimming, hiking and gardening.
Robert	Gabriel	Board Member, Managing Partner	Ashur Capital	https://proventainternational.com/wp-content/uploads/2025/04/Robert-Gabriel-2.jpg	Dr. Robert Gabriel has broad experience in technology and business development. He founded Genesis Aromatique and led the company for over 15 years. Prior to that, Gabriel led technology and business development initiatives at Unilever, Gillette, Clorox, and Rhone-Poulenc. In his current role as Ashur Capital’s managing partner and board member, Dr. Gabriel provides strategic direction for asset allocation and capital deployment. He is also an investor and board member at Clear Protocol, a digital health startup. Dr. Gabriel earned a Ph.D. from the University of Illinois and an MBA from the Wharton School of Business. Dr. Gabriel is married and has 4 sons.
Rowshon	Alam	Vice President, Chemistry and In-Process Analytics	Prime Medicine, Inc.	https://proventainternational.com/wp-content/uploads/2026/02/Rowshon-Alam.jpg	Dr. Rowshon Alam is Vice President of Chemistry and In-Process Analytics at Prime Medicine, where he guides RNA screening and discovery, process development, analytics, scale-up, and CMC readiness for advanced genetic medicines. An oligonucleotide chemist by training, he brings over 25 years of experience spanning discovery, process optimization, technology transfer, and GLP/cGMP manufacturing of complex oligonucleotide therapeutics, including gRNA, siRNA, antisense modalities, and conjugates. Prior to joining Prime Medicine, Dr. Alam held leadership and scientific roles at Wave Life Sciences, Nitto Denko Avecia, and Alnylam Pharmaceuticals. He holds a PhD in Synthetic and BioOrganic Chemistry from Kyushu University and is an author of 20+ peer-reviewed publications and patents.
Sean	Cumiskey	Head, Investor Relations	Omega Funds	https://proventainternational.com/wp-content/uploads/2026/05/Sean-Cumiskey.jpg	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	https://proventainternational.com/wp-content/uploads/2026/01/Seshu-Tummala.jpg	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	https://proventainternational.com/wp-content/uploads/2025/04/Yumiko-Mizuno.jpg	Dr. Yumiko Mizuno is the Head of Plasma-Derived Therapies Drug Product Development at Takeda, where she is responsible for all activities related to drug product and combination product development, as well as leading the early-stage portfolio. With over 14 years of experience in R&D CMC at Takeda, she brings deep expertise across all phases of development for a range of modalities. Dr. Mizuno has a proven track record of successfully leading diverse cross-functional and cross-regional teams, fostering collaboration, innovation, and excellence. Previously, she led global R&D strategic planning and change management at Takeda, developing practical skill sets in portfolio strategy and management.
Yu	Qian	Director, Head of Analytical Project Leads & Cell Therapies	Novartis	https://proventainternational.com/wp-content/uploads/2025/04/Yu-Qian.jpg	Yu is the Head of the Cell Therapy Analytical Project team at Novartis. With a background in Immunology and Cancer Immunology, Yu has extensive experience in Analytical Development for Cell Therapies. Yu has a proven track record in developing integrated analytical strategies and guiding teams in creating fit-for- purpose assays to drive innovation and support various cell therapy modalities at different stages. Before joining Novartis, Yu was the Director of Cell Therapy CMC Analytical Innovation and Product Sciences at Takeda Pharmaceuticals and co-founded a start-up prior to joining Takeda.

Abizer Harianawala, Annette Bak, Debasis Patra, Erin O’Brien, Gavin Loudfoot, Gopi Vudathala, Goldi Kaul, Gregory Papastoitsis, Hagen Cramer, Hibreniguss Terefe, PhD, Jamie Gillette, Jennifer Taillie, 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

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

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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 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

-Jennifer Taillie
Vice President, Business Development US
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 (Topic TBC)

-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
How VCs Are Pacing Capital amid Longer Timelines?

-Robert Gabriel
Board Member, Managing Partner
Ashur Capital

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 (Topic TBC)

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

Private Equity & Venture Capital
How VCs Are Pacing Capital amid Longer Timelines?

-Gavin Loudfoot
Vice President, Business Development
BV Investment Partners

16:30 – 17:00

MODERATOR: Nelly Viseux, Vice President, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron

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Hibreniguss Terefe, PhD

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Mahesh Padval

Melissa Morandi

Neera Jain

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Opening Keynote Presentation

Roundtable

Roundtable Tracks

Refreshment Break

Networking/1-1 Meetings

Roundtable

Roundtable Tracks

AGC BIOLOGICS

Ardena

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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

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