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 Oncology

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

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

DOWNLOAD THE BROCHURE

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

There’s only so much you can learn from presentations and lectures. Instead our interactive Roundtable Discussions let you debate the topics that really matter

Senior Decision Makers

All our Strategy Meetings are aimed at director level and above. Discover how your peers are tackling the industries biggest challenges and have your thoughts heard

Personalised Agendas

Pick the roundtable discussions that you want to be part of. Simply choose your sessions and we’ll create a personalised agenda just for you

Private and Intimate Networking

Small group discussions, private meetings, networking drinks – however you choose to make those important connections our Strategy Meetings have the solution

Our Agenda