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DAY 2 ✦ LIVE: Wed, Dec 2 - EST
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DAY 2 ✦ LIVE: Wed, Dec 2 - EST
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10:30am - 10:35am5 mins
Day 2 KICK-OFF
- John Maslowski - Chief Executive Officer, Castle Creek Biosciences
10:35am - 11:05am30 mins
FDA ADDRESS ● NAVIGATING REGULATORY PATHWAYS AND EVIDENTIARY REQUIREMENTS FOR RARE DISEASE THERAPIES
- Kerry Jo Lee, MD - Acting Associate Director for Rare Diseases, FDA/CDER/OND
11:05am - 11:20am15 mins
ADVANCED THERAPIES FOR RARE DISEASE — STATE OF THE INDUSTRY AND THE WAY FORWARD
- Chelsey Hathaway McCarthy - Director, Patient Engagement, Alliance for Regenerative Medicine
11:20am - 2:00pm160 mins
Take Time Throughout the Day for Virtual Networking with Peers and Listen to On-Demand Sessions
2:00pm - 2:30pm30 mins
INNOVATIVE FUNDING SPOTLIGHT ● ACCELERATE RARE DISEASE THERAPEUTIC DEVELOPMENT THROUGH NOVEL FUNDING
- Andrew Lo, PhD - Charles E. and Susan T. Harris Professor, MIT Sloan School of Management
2:35pm - 3:20pm45 mins
EXPLORE NOVEL FUNDING MODELS TO DE-RISK DRUG DEVELOPMENT
- Imran Babar, PhD - Chief Business Officer, Cydan II Inc.
- Sean Ekins - CEO, Collaborations Pharmaceuticals
- Andrew Lo, PhD - Charles E. and Susan T. Harris Professor, MIT Sloan School of Management
CHOOSE BETWEEN FOUR CONCURRENT DEEP-DIVE SESSIONS (1-4):
3:30pm - 4:15pm45 mins
ADDRESS COMMON CHALLENGES IN CREATING AND SUSTAINING IMPACTFUL ADVOCACY ORGANIZATIONS
- Seth Rotberg - Co-Founder and Board President, Our Odyssey
- Keith McArthur - Chief Executive Officer and Head of Science, CureGRIN Foundation
- Jocelyn Duff - Founder & CEO, CureCMT4J
3:30pm - 4:15pm45 mins
NEW LAUNCH & COMMERCIALIZATION — BRIDGE THE GAP BETWEEN THE PATIENT AND HCP FOR MEANINGFUL COMMUNICATION AND LAUNCH SUCCESS
- Katrina Sergeev - Director of Patient Marketing, argenx
- Luis Carlos Sanchez - Director of HCP Marketing, argenx
3:30pm - 4:15pm45 mins
DELVE INTO CHALLENGES IN COLLECTING UTILIZING REAL-WORLD EVIDENCE AND PATIENT REGISTRY DATA
- Monica Weldon - Founder/CEO, Bridge the Gap – SYNGAP Education and Research Foundation
- Christian Rubio - Vice President, Community Development & Engagement, Global Genes
- Stella Stergiopoulos - Associate Director, Health Economic Outcomes Research and Payer Policy, Foundation Medicine, Inc.
3:30pm - 4:15pm45 mins
FDA CLINICAL PROCESS AND U.S. REGULATORY SUBMISSIONS
- Bethany Hills, JD, MPH - Partner, Morrison & Foerster
- Leonide Saad - CEO, Alkeus Pharmaceuticals, Inc.
- Mark A. Rutter - Senior Director, Global Regulatory Policy, Biogen