BOSTON REGULATORY
AFFAIRS GROUP
Connecting the Boston Regulatory Affairs Community
Welcome
ABOUT BRAG
Boston Regulatory Affairs Group (BRAG), serves as a conduit to bring together local Regulatory Heads and Thought Leaders to innovate and influence the life sciences regulatory landscape. We accomplish this by fostering a collaborative environment between our members and external experts.
LEADERSHIP TEAM
MARY CHRISTIAN, PHARMD, MBA
SVP of Regulatory, C4 Therapeutics
Over two decades in biopharma, Dr Mary Christian has successfully transformed regulatory organizations, built new teams and capabilities across R&D and innovated approaches to drug development leading to the delivery of medicines to patients.
IAN HAWKINS
Global Head of Regulatory Strategy, Vertex Pharmaceuticals
Ian Hawkins serves as the Global Head of Regulatory Strategy at Vertex Pharmaceuticals where he provides global regulatory leadership around clinical research and development and commercialization of Vertex's transformational medicines.
KRISZTINA NEMENYI, PhD
Senior Vice President, Regulatory Affairs & Quality for Cyteir Therapeutics
Krisztina Nemenyi is an experienced R&D regulatory leader with more than 20 years of experience across diverse organizations, regions, and responsibilities. Currently, she serves as the Head of Regulatory Affairs and Quality at Cyteir Therapeutics.
GUILIN HUANG, MBA
SVP, Development, AnHeart Therapeutics
Guilin Huang oversees the regulatory efforts at AnHeart Therapeutics. She brings over 18 years of experience in global regulatory affairs and drug development focusing on oncology and rare diseases, and she was instrumental to delivering successful global simultaneous filings and regulatory approvals for multiple transformative medicines.
ANDREW SLUGG
Sr. Vice President, Global Head of Regulatory Affairs, Alnylam Pharmaceuticals, Inc.
Andrew Slugg is the Global Head of Regulatory Affairs at Alnylam, the leading RNAi therapeutics company. At Alnylam, Andrew has helped usher forth a new class of medicines as a part of the teams that have led to the global approvals of the company’s first four RNAi therapeutics.
PAST MEETINGS
Q2 - 2024
UPCOMING - June 20, 2024
Model Informed Drug Development (MIDD) and Dose Optimization Planning
Guest Speaker: Dr. Joan Korth Bradley
Q1 - 2024
Digital Innovation in Drug Development - Is Your Strategy Aligned?
Guest Speaker: Hui Huang, CEO/Founder of CSD Partners
Q2 - 2023
The Future of the Accelerated Approvals Pathway & Audience Q&A
Guest Speaker: John J. Jenkins, M.D., Principal. Greenleaf Health
Q4 - 2022
Topic 1: Optimizing Your FDA Meeting
Topic 2: EU Clinical Trial Regulations
Guest Speaker: Open Member Forum facilitated by Mary Christian & Guilin Huang
Q1 - 2022
Sharing Insight and Best Practices for Attracting. Developing, and Retaining Staff in Today's Remote Work Environment
Guest Speaker: Open Member Forum
Q2 - 2021
Update from MHRA (Medicines and Healthcare products Regulatory Agency) on Current State of Clinical Trials in the UK and Future Directions
Guest Speaker: Dr. Martine O'Kane, Head of Clinical Trials Unit at Medicines and Healthcare Product
Q1 - 2021
Regulatory Aspects & Requirements for Combination Products in Europe with a Focus on Drug-Delivery Devices
Guest Speaker: Beat U. Steffan, Founder & CEO of Confinis AG
Q3 - 2020
Decentralized Trials 2020
Guest Speaker: Craig Lipset
Q2 - 2020
"Moving Beyond Covid-19: Regulatory in the new normal - virtual agency meetings, stress management, and staying connected"
Q1 - 2020
The path through development and regulatory aspects of gaining approval for a new therapeutic modality; a case study discussion
Guest Speaker: Sara Nochur, Chief Regulatory Officer of Alnylam Pharmaceuticals
Q4 - 2019
Regulators Perspective of PROs
Guest Speaker: Laurie Burke, RPh, MPH
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Q3 - 2019
PDUFA VII
Guest Speaker: Cartier Esham, Executive Vice President for emerging companies of BIO
Q2 - 2019
Finding and Retaining Talent in the Boston Marketplace
Panel discussion
Q1 -Â 2019
Regulatory Affairs and Market Access | Bridging the Gap
Guest Speaker: Dr. Steven Pearson, President of ICER
Participating Organizations
Alkermes
Alnylam Pharmaceuticals
Biogen
Blueprint Medicines
Cerevel Therapeutics
Cyclerion Therapeutics
EMD Serono
Ironwood Pharmaceuticals
Lyndra TherapeuticsÂ
Moderna Therapeutics
Momenta Pharmaceuticals
Obsidian Therapeutics
Ocular Therapeutix
Sage Therapeutics
Sanofi Genzyme
Sarepta Therapeutics
Stoke Therapeutics
Takeda
Tesaro
Vertex Pharmaceuticals
Voyager Therapeutics
Wave Therapeutics
