Planning for the Regulatory Environment of your Life Sciences Startup
Entrepreneurs’ Network
Start-ups are hard work. Launching a start-up is difficult, time consuming and fraught with challenges and risks. Operating an emerging company to achieve financial success is also difficult and risky, with untold obstacles to success in product R&D, financing, operations, business development…and the list goes on.
If the day to day challenges of entrepreneurship seem daunting, life sciences entrepreneurs often have another (not so small) detail to contend with. Regulatory approval, through government agencies like the U.S. FDA and the EU’s EMA, may be required before a product reaches the market – requiring rigorous (and expensive) clinical trials and highly regulated manufacturing processes, among other details.
ENET is here to help; we’re all about offering practical insights, from experienced industry veterans, to help entrepreneurs to succeed. Tonight’s panel will offer insights on how to prepare for meeting rigorous regulatory requirements and even when to get started thinking about regulatory affairs.
Agenda:
7:00 – 7:15 PM – ENET Chairperson’s announcements
7:15 – 7:30 PM – eMinute – Up to 3 Startup companies’ presentations
7:30 – 8:15 PM – 2 expert speakers on the night’s topic
A question and answer session follow the presentations
Panel
Gail Radcliffe, President Radcliffe Consulting, Inc.
Gail E. Radcliffe has more than 20 years experience assisting medical device and diagnostics companies with technical assessment, market research and clinical/regulatory issues. Gail founded Radcliffe Consulting in 1998 after having worked at GENE-TRAK, where she developed IVD assays for several infectious disease organisms including HIV, CMV, TB and Chlamydia and was responsible for instituting the clinical affairs group.
As a consultant, Gail has provided assistance to start-up and established medical device companies with market research, regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development and clinical trial support. Consulting engagements have encompassed a wide range of products including cutting edge digital pathology instruments, stem cell laser dissection devices, companion diagnostics, and multiplex molecular, NGS, POC and CLIA Waived in vitro diagnostic devices.
Gail obtained a Ph.D. in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School.
She is a member of the Regulatory Affairs Professional Society (RAPS), American Society of Microbiology (ASM) and Sigma Xi. She is on the Board of Trustees of the Massachusetts Biomedical Initiatives and acts as an advisor to venture capital companies. https://www.linkedin.com/in/gail-radcliffe-13a0891/
Kevin J. Slatkavitz, President and Founder, ThinkQuality, LLC
Kevin is President/Founder of ThinkQuality, LLC – a strategic consulting firm providing clients across the life sciences with practical customized strategies, solutions and coaching to address a range of quality and regulatory compliance challenges and opportunities from early stage discovery through critical development milestones to product approval/launch and beyond.
He has over 30 years of real world, boots-on-the-ground experience/insights into the complex and global rigors of small and large organizations and draws on over 10 regulatory product approvals (from Lipitor to Linzess) and many more investigational and commercial products from numerous therapeutic categories and delivery systems.
What differentiates Kevin is his “fit-first-time” approach to integrating quality and regulatory compliance proactively and strategically with the science/technology into a client’s business plan as a means to demonstrate value to investors, regulators, patients and other key stakeholders.
Kevin serves as a MassBio/MassConnect mentor for start-up companies.
https://www.linkedin.com/in/kevinslatkavitz/
PRAVIN R. CHATURVEDI, CEO and Co-Founder, Oceanyx Pharmaceuticals
Pravin Chaturvedi is an experienced drug developer and a seasoned biotech entrepreneur. He is the Chairman of the Scientific Advisory Board for Napo Pharmaceuticals/Jaguar Health. He is the CEO of IndUS Pharmaceuticals and Oceanyx Pharmaceuticals. He is the Chairman of the Board of Cellanyx and also serves on the boards of IndUS, Oceanyx, ResoluteBio, Enlivity, MAG Optics, FuelEd Schools and Sindu Research Laboratories. He has previously served as the President and CEO of Pivot Pharmaceuticals and Scion Pharmaceuticals, and served on the boards of Pivot, Scion, Bach Pharma, PRADAN USA, Sindu Pharmaceuticals and TiE Boston. He was the Head of Lead Evaluation at Vertex Pharmaceuticals; and previously was at Alkermes and Parke-Davis/Warner-Lambert (now Pfizer). He has participated in the successful drug approval and commercialization of seven drugs indicated for the treatment of CNS, viral and gastrointestinal disorders. He is as an adjunct faculty member at Georgetown Medical School. https://www.linkedin.com/in/pravin-chaturvedi-a329392/
Moderator/Meeting Organizer
Roger Frechette, Life Science Business Executive / Entrepreneur / Mentor – NEPAssociates, LLC
My daily purpose is to exercise an innate drive to transform ideas and projects into life-changing commercial assets. In the life science business, this is the long game, requiring boundless energy and creativity, coupled with knowledge, experience, and patience.
In my consulting work, I help clients as a business adviser or on-demand, fractional executive. I leverage an extensive global network and insights derived from >20 years of experience in business development, calibrated with an extensive science background. My career has encompassed success as a business executive, project and strategic alliance manager, entrepreneur, and also as a scientist, including leadership of discovery/preclinical development teams resulting in successful drug candidates NUZYRA (omadacycline) and SEYSARA (sarecycline), FDA approved Oct 2018.
https://www.linkedin.com/in/rogerfrechette/
eMinute PITCH Presentations will be given at the start of each meeting. These 90-second elevator-style presentations enable early-stage startup entrepreneurs to gain experience in presenting a summary of their business plans to expert panels and audiences.