18
May

08:00 AM EDT

Chemistry, Manufacturing
and
Controls

Name: Regulatory CMC Conferences 2023
Start: 2023-05-18T08:00
End: 2023-05-18T16:50
Location: Le Méridien Boston Cambridge

Strategy Meeting East Coast USA 2023

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.

Meet Our 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

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

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 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

Ian O’Reilly

Vice President, Quality Tessera Therapeutics

Jamie Gillette

Vice President, Head of Regulatory Cullinan Therapeutics

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

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.

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

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

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
Art	Faulkner	Vice President, Regulatory CMC	TG Therapeutics, Inc.	https://proventainternational.com/wp-content/uploads/2020/01/Art-Faulkner-new2.jpg	Session – Strategies to manage differing country-specific requirements for submissions Art Faulkner has worked in the pharmaceutical industry for over 30 years, with more than 20 years experience in regulatory CMC. He is currently the head of regulatory CMC at TG Therapeutics in New York. He has also worked at Edge Therapeutics, Pfizer and worked at Merck He has global experience in Regulatory CMC for initial registrations and post approval changes. He attended University of Scranton (B.S), Bucknell University (M.S.) and Rutgers University (graduate coursework).
Ganfeng	Cao	Vice President and Head of Process Chemistry, CMC	Prelude Therapeutics	https://proventainternational.com/wp-content/uploads/2023/04/Ganfeng-Cao.jpg
George	Wu	Vice President, CMC	Enanta Pharmaceuticals	https://proventainternational.com/wp-content/uploads/2023/03/George-Wu.jpg
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. 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
Ian	O’Reilly	Vice President, Quality	Tessera Therapeutics	https://proventainternational.com/wp-content/uploads/2023/04/Ian-OReilly.jpg
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, Head of Regulatory Affairs at Cullinan Oncology of Cambridge, Massachusetts. She is responsible for Regulatory strategy and operations for all Cullinan pipeline products. Jamie possesses 20+ years of global drug development, clinical trials, and Regulatory experience and has held leadership positions at multiple organizations in the biopharmaceutical industry. She has experience throughout the product life cycle, from INDs through Marketing Applications and across multiple therapeutic areas including oncology, inflammation, and vaccines. As a community leader, Jamie has been an instructor and avid student in Budo Taijutsu for over 10 years. She is also Vice President of the Howard County Veterans Foundation whose mission is to develop and construct the Howard County Veterans Monument in Columbia, Maryland.
Kelly	Neelon	Vice President, CMC and Technical Operations	Vigil Neuroscience	https://proventainternational.com/wp-content/uploads/2020/01/Kelly-Neelon-1.jpg	Kelly Neelon is a product development professional with over 15 years of industry experience in biotech and pharma. Technical expertise in analytical development, formulation development, drug product development and manufacturing across the program lifecycle.
Kristen	Manion	Vice President, Head of Regulatory Affairs, Quality and Manufacturing	Paratek Pharmaceuticals	https://proventainternational.com/wp-content/uploads/2022/10/Kristen-Manion.jpg
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.
Niels	Svenstrup	Senior Vice President, Chemistry & Manufacturing	PepGen	https://proventainternational.com/wp-content/uploads/2023/02/Niels-Svenstrup-1.jpg	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
Pradeep	Sharma	Global Head, Pharmaceutical & Technical Ops, Small Molecule & Oligonucleotides	Takeda	https://proventainternational.com/wp-content/uploads/2023/03/Pradeep-Sharma.jpg	Pradeep Sharma is an accomplished CMC leader in pharmaceutical industry with experience in CDMOs, Generic drug manufacturing, New Chemical entities (NCEs) including commercial process development, preformulation studies, solid oral dosage development, optimization, managing product life cycle etc. Authored multiple DMFs, INDs, IMPDs, CTAs, NDAs, MAAs, PMDAs, etc. for Global market approvals. Recently led CMC teams for submissions and approvals of multiple NCEs: Ridaforolimus, ponatinib, brigatinib, mobocertinib, maribavir. Presently employed at Takeda Pharmaceuticals Co. Intl. Co. Ltd., Cambridge, MA.
Seshu	Tyagarajan	Chief Technical and Development Officer	Candel Therapeutics	https://proventainternational.com/wp-content/uploads/2023/02/Seshu-Tyagarajan-2.jpg	Dr. Seshu Tyagarajan is the Chief Technical and Development Officer at Candel Therapeutics. She has two decades of technical, manufacturing and development experience in Biologics and Cell & Gene therapies. Prior to Candel, she was Global Head, CMC Strategy for CGT at Novartis where she developed the clinical and commercial manufacturing strategy for T-Charge™(CAR-T). She successfully led several BLAs and INDs and was a key contributor to the groundbreaking BLA submission for Kymriah®. Seshu held roles of increasing responsibility at Merck, Roche, Phyton, Biogen and Lilly. She holds a Ph.D. in Chemical and Biochemical Engineering (Rutgers), and MS in Bioengineering (Purdue).
Sheila	Mathias	Chief Scientific Officer	Virpax Pharmaceuticals, Inc.	https://proventainternational.com/wp-content/uploads/2023/02/Virpax_Mathias.jpg	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	https://proventainternational.com/wp-content/uploads/2023/03/Yanhuai-Ding.jpg
Vimal	Patel	Vice President, Head of CMC	Orum Therapeutics	https://proventainternational.com/wp-content/uploads/2023/05/Vimal-Patel.jpg	Vimal is currently Vice President, Head of CMC at Orum Therapeutics. Orum is a clinical-stage biotechnology company whose goal is to bring life-changing therapies to patients by combining the power of the emerging field of protein degraders with precision of antibodies to generate a broad portfolio of highly differentiated product candidates.Vimal brings over 20 years of experience in development and manufacturing of mAbs, ADCs, radiopharmaceuticals and small molecules. Previously, Vimal held roles of increasing responsibility with Process Development and Manufacturing Sciences at Daiichi Sankyo, Actinium Pharmaceuticals, Pfizer and Progenics Pharmaceuticals.

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

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 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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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 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

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

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