17
May

08:00 AM EDT

Regulatory Affairs

Name: Regulatory Affairs Conferences
Start: 2023-05-17T08:00
End: 2023-05-17T16:50
Location: Le Méridien Boston Cambridge

Strategy Meeting East Coast USA 2023

The premier meeting for all East Coast USA Regulatory Affairs professionals

Le Meridien Cambridge Boston

A MEETING EXPERIENCE UNLIKE ANY OTHER

Fresh Regulatory Affairs 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 Regulatory Affairs 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 2023’s facilitators

Art Faulkner

Vice President, Regulatory CMC TG Therapeutics, Inc.

Chitkala Kalidas

Vice President, Global Head Oncology & IVD Regulatory Affairs and Oncology Sustainability Bayer

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

Guilin Huang

Vice President, Head of Regulatory Affairs Relay Therapeutics

Guilin Huang oversees the regulatory efforts at Relay Tx. She brings over 18 years of experience in global regulatory affairs and drug development focusing on oncology and rare diseases. Prior to Relay Tx, Guilin accumulated and enriched her drug development expertise as an accomplished regulatory strategist at <a href="https://www.takeda.com/">Takeda</a>, ARIAD, Chugai and Vertex. She contributed to global clinical development of several breakthrough therapies from early stage through global approvals, and she was instrumental to delivering successful global simultaneous filings and regulatory approvals of Kalydeco® (ivacaftor) for cystic fibrosis with gating mutations and R117H mutation, Alunbrig® (brigatinib) for ALK-positive non-small cell lung cancer (NSCLC), and Exkivity™ (mobocertinib) for NSCLC with EGFR exon20 insertion mutations. Additionally, Guilin played a key role to secure successful approvals of companion diagnostics for Alunbrig® and Exkivity™ .
Guilin holds a B.S. in Pharmacy and Japanese from Shenyang Pharmaceutical University, and she received her MBA in Health Sector Management from Boston University. Guilin also graduated from the WOMEN Unlimited LEAD Program.

Jamie Gillette

Vice President, Head of Regulatory Cullinan Therapeutics

Joe McLaughlin

Head, Regulatory Business Process & Innovation Sanofi

Kristen Manion

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

Lauren DiPetrillo

Vice President, Head of Regulatory Affairs Keros Therapeutics

Margaret Woo

Vice President, Head of Regulatory Affairs and Quality Scorpion Therapeutics

Ramola Bhandarkar

Vice President, Head of Regulatory Affairs Omega 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

Stan Russell

Former Vice President, Quality TCR2 Therapeutics Inc.

Harry Chopra

Chief Client Officer ADLIB

Tara Baer

Former Global Head, Labeling Quality and Excellence Takeda

Samantha Thompson

Strategic Account Manager Esko

Jackie Leslie

Category Specialist Life Sciences ESKO

Jamie Morisco

Vice President, Sales, Marketing & Operations Glemser Technologies

Anthony Vigliotti

Chief Product Officer ADLIB

Pawan Gandhi

Director, R&D Glemser

First name	Last name	Job title	Company name	Photo URL	Bio Position
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).
Chitkala	Kalidas	Vice President, Global Head Oncology & IVD Regulatory Affairs and Oncology Sustainability	Bayer	https://proventainternational.com/wp-content/uploads/2023/03/Chitkala-Kalida.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
Guilin	Huang	Vice President, Head of Regulatory Affairs	Relay Therapeutics	https://proventainternational.com/wp-content/uploads/2020/01/Guilin-Huang-1.jpg	Guilin Huang oversees the regulatory efforts at Relay Tx. She brings over 18 years of experience in global regulatory affairs and drug development focusing on oncology and rare diseases. Prior to Relay Tx, Guilin accumulated and enriched her drug development expertise as an accomplished regulatory strategist at Takeda, ARIAD, Chugai and Vertex. She contributed to global clinical development of several breakthrough therapies from early stage through global approvals, and she was instrumental to delivering successful global simultaneous filings and regulatory approvals of Kalydeco® (ivacaftor) for cystic fibrosis with gating mutations and R117H mutation, Alunbrig® (brigatinib) for ALK-positive non-small cell lung cancer (NSCLC), and Exkivity™ (mobocertinib) for NSCLC with EGFR exon20 insertion mutations. Additionally, Guilin played a key role to secure successful approvals of companion diagnostics for Alunbrig® and Exkivity™ . Guilin holds a B.S. in Pharmacy and Japanese from Shenyang Pharmaceutical University, and she received her MBA in Health Sector Management from Boston University. Guilin also graduated from the WOMEN Unlimited LEAD Program.
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.
Joe	McLaughlin	Head, Regulatory Business Process & Innovation	Sanofi	https://proventainternational.com/wp-content/uploads/2023/03/Joe-McLaughlin.jpg
Kristen	Manion	Vice President, Head of Regulatory Affairs, Quality and Manufacturing	Paratek Pharmaceuticals	https://proventainternational.com/wp-content/uploads/2022/10/Kristen-Manion.jpg
Lauren	DiPetrillo	Vice President, Head of Regulatory Affairs	Keros Therapeutics	https://proventainternational.com/wp-content/uploads/2022/10/Lauren.jpg
Margaret	Woo	Vice President, Head of Regulatory Affairs and Quality	Scorpion Therapeutics	https://proventainternational.com/wp-content/uploads/2022/09/Margaret-Woo.jpg	Margaret is Vice President, Head of Regulatory Affairs of C4 Therapeutics Inc. Prior to C4T, she worked as a Sr. Director of Global Regulatory Affairs to bring early immuno-oncology assets to market with EMD Serono. Her pharmaceutical career began as a clinical pharmacologist before transitioning to a regulatory affairs’ role at Novartis Oncology.She completed her post-doctoral training at St. Jude Children’s Research Hospital, followed by being a Research Associate at Washington University in St Louis. She earned a Master’s in Bioscience Regulatory Affairs from Johns Hopkins University, a PharmD from University of Southern California, and went to college at UC Berkeley majoring in Molecular and Cell Biology.
Ramola	Bhandarkar	Vice President, Head of Regulatory Affairs	Omega Therapeutics	https://proventainternational.com/wp-content/uploads/2022/09/Ramola-Bhandarkar.jpg	Ramola Bhandarkar is Vice President and Head of Regulatory Affairs at Omega Therapeutics, which is pioneering a new class of epigenomic medicines using mRNA-based therapeutics. Prior to Omega, she was the Head of Regulatory Strategy for bluebird bio’s Oncology Business Unit and was the bluebird bio global regulatory lead for ABECMA®, which is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma. Prior to bluebird bio, Ramola held positions of increasing responsibility at ImmunoGen, Inc., an antibody drug conjugate company to treat cancer, where she led the regulatory strategy group. Ramola received her M.S., Regulatory Affairs from Temple University, M.S., Pharmaceutical Sciences from University of Missouri-Kansas City, and Bachelor of Pharmacy from Pune University, India.
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
Stan	Russell	Former Vice President, Quality	TCR2 Therapeutics Inc.	https://proventainternational.com/wp-content/uploads/2020/01/Stan-Russel.jpg	Stan Russell is a 30+ year Life Sciences veteran, working in Engineering, Manufacturing, Quality, Supply Chain, and IT. He has advanced formulations, technologies, and therapeutic areas from discovery through commercial production; playing critical roles in submission, approval, and launch of therapies, diagnostics, and nutritionals. His career progression includes individual contributor roles at Abbott Laboratories and management to executive positions with Automated Systems, Baxter/Baxalta/Shire, Alexion, Sebela, and TCR2.Stan serves on the board of Playworks and will soon take a short-term missionary trip supporting Children’s Impact Network in Honduras. He holds both BSChemical Engineering and Executive MBA degrees from Northwestern University
Harry	Chopra	Chief Client Officer	ADLIB	https://proventainternational.com/wp-content/uploads/2023/05/Harry-Chopra.jpg	Harry Chopra is the Chief Client Officer of Adlib Software and brings over 30 years of experience in a sales and marketing function across multiple industries. Harry’s background spans, manufacturing, telecommunications, financial services, financial market intelligence, and regulatory reporting. Over the last five years Harry has been involved in regulatory reporting and understands the exacting requirements of regulatory bodies across the globe.
Tara	Baer	Former Global Head, Labeling Quality and Excellence	Takeda	https://proventainternational.com/wp-content/uploads/2022/10/Taer-Baer.jpg
Samantha	Thompson	Strategic Account Manager	Esko	https://proventainternational.com/wp-content/uploads/2022/11/Samantha-Thompson.jpg
Jackie	Leslie	Category Specialist Life Sciences	ESKO	https://proventainternational.com/wp-content/uploads/2023/05/Jackie-leslie-1.jpg
Jamie	Morisco	Vice President, Sales, Marketing & Operations	Glemser Technologies	https://proventainternational.com/wp-content/uploads/2023/05/Jamie-Morisco.jpg	Jamie serves as a Director of Sales for Glemser. In this role, Jamie draws from his extensive background in technology and business transformation to assist clients along their modernization journey. Jamie has a proven track record leading clients and team through complex technology enabled transformations delivering benefits across time, quality, cost and compliance.
Anthony	Vigliotti	Chief Product Officer	ADLIB	https://proventainternational.com/wp-content/uploads/2023/05/Anthony-Vigliotti.jpg	Anthony Vigliotti is the Chief Product Officer of Adlib Software and has 20+ years of experience in the Business Workflow and Intelligent Document Processing segment with prior roles at Kofax, Nuance, Notable Solutions (NSi), and Xerox. Anthony brings a well-rounded set of experiences with solution-related roles in Product Management, Alliance and Partner Management, and Product Development. He holds a bachelor’s degree in Mechanical Engineering and a Master’s Degree in Information Technology, both from the Rochester Institute of Technology.
Pawan	Gandhi	Director, R&D	Glemser	https://proventainternational.com/wp-content/uploads/2023/05/Pawan-Gandhi.jpg	Pawan serves clients as the Director of Global Research and Development. He brings along extensive experience in designing and implementing enterprise compliance solutions for life sciences clients. Pawan directs and coordinates development activities for organizational products to deliver quality solutions catering to complex regulated use cases.

Art Faulkner, Chitkala Kalidas, Gopi Vudathala, Guilin Huang, Jamie Gillette, Joe McLaughlin, Kristen Manion, Lauren DiPetrillo, Margaret Woo, Ramola Bhandarkar, Sheila Mathias, Stan Russell, Harry Chopra, Tara Baer, Samantha Thompson, Jackie Leslie, Jamie Morisco, Anthony Vigliotti, Pawan Gandhi

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