12:00 - 1:00 Private Equity, Proximity and a Pandemic: Raising Funds in Today’s Environment
Despite conferences being cancelled and roadshows going fully virtual, fundraising for life sciences companies has arguably never been better. In 2Q 2020, VCs pumped $6.4 Billion into the life sciences industry, the most in one quarter EVER. And the IPO window remains open; four dozen biotech IPOs combined for $11 billion-plus in August.
How are these deals happening, and what can companies located outside of America’s traditional capital centers do to access these firms and funds? This panel will ask recent raisers and investors to assess today’s fundraising marketplace and share tips and best practices for networking and fundraising in the virtual age.
2:00 - 3:00 General Session: Are you about to board the Titanic?
Too many promising medtech & biopharma innovations and early stage companies fail unnecessarily because they run out of funding before achieving milestones required for next-round investments. Is it possible to know earlier in the process when innovators are burning cash at too high a rate and failure is nearly certain? Can disaster be averted? In many cases, yes.
It is possible to know earlier in the process when innovators are burning cash at too high a rate and failure is nearly certain.
How can innovators and investors avoid crippling mistakes like premature preclinical work or endless prototyping cycles? Proper sequencing of activities in the commercialization pathway is critical to mitigating risk and should allow more capital to flow into innovations with higher potential for successful entry into patient care.
Attendees will learn:
Top ways innovators burn cash unnecessarily
How innovators can know they are wasting time and money
How to know when an innovation is ready for preclinical work
The critical importance of activity sequencing in the innovation pathway
Critical questions to ask prospective partners in regulatory, IP, engineering and reimbursement.
Sarah Cohen, Medical Development Engineer & Senior Project Manager, GCMI
Paul J. Fitzpatrick, CEO, Advanced Catheter Therapies
Andrew Krouse, Entrepreneur-in-Residence at University of Virginia Licensing & Ventures Group
Kamil Makhnejia, MBID, COO, VP of Clinical Development, Jackson Medical
Paul Snyder (Moderator), Vice President of Healthcare, Write2Market
3:00 - 3:30 Break
3:30 - 4:30 General Session: Allowable activities when raising Money
As the saying goes, cash is king. That’s never truer than in healthcare innovation where millions of dollars are needed to get a product from bench to bedside. But in a high-risk industry such ours, all bets are not off and entrepreneurs need to balance the dilemma of needing to raise funds without over-promising. This panel features senior executives who have tread this line successfully at multiple companies. The panelists will draw from years of experience to provide tips and advice on how to avoid the pitfalls that can ultimately doom a deal.
Attendees will learn:
How to approach investors during fund raising, from seed to Phases A, B, & C
The “gotcha” moments and how to avoid them
How to be transparent without over-promising
What guidance and back-up information is necessary when working on a deal
The differences between these topics in a private vs. public company
Celia Economedes, SVP, Strategy & External Affairs, Kezar Life Sciences
Dan O’Korn, Partner, Hutchison PLLC
Richard Shea, CEO, Basking Biosciences
Fred Kornahrens, Executive Mentor-in-Residence, Duke University Office of Licensing & Ventures
4:30 - 5:30 Networking Breakouts
During our networking sessions, we will utilize the capabilities of Zoom to break attendees into rooms for networking.
Thursday, November 12
8:00 PARTNERING OPENS
8:00 - 9:00 Biopharma Breakfast: Covid-19 Where we are, Where we're Going
This panel will provide an overview of where we’ve been, where we are currently, and where we are headed in the future. The immediate impact of Covid-19 is known, with nearly 1.3 million deaths worldwide, but the long-term impact won’t be known for years. The panel will look back and forward, from the health systems and physicians taking care of patients, to the public health organizations tasked with tracking data and communities, to clinical trials and pharma and vaccine development, and distribution of these both nationally and internationally.
Bronwen Garner, M.D., Infectious Disease expert at Piedmont Healthcare and Head of the Piedmont Covid Testing Committee
Amy Finan, CEO of Sabin Vaccines
Jayne Morgan, M.D., Director of the Covid Task Force at Piedmont Healthcare Adjunct Clinical Assistant Professor of Medicine at The Morehouse School of Medicine
Amber Schmidtke, GA Covid Task Force
Ryan O’Quinn, Partner, Finnegan
9:00 - 10:00 Medtech Breakfast: Partnering with Focused Experts to Scale Your Business
Partnering with Focused Experts to Scale Your Business
Whether start up, small but mighty or mid-size in nature there is a life cycle to medical device and pharma business. Working with experts can accelerate your process, better allocate expenses and lower your corporate risk. This panel discussion will share insight on working with focused resources, share tips on contracting and minimizing mistakes as well as discuss examples of situations that created significant value for clients.
What you’ll learn:
Areas that make sense to contract rather than employ full time
Understanding shared responsibilities that optimize value
Pitfalls to avoid
Through discussion of real world examples, create better relationships on focused support areas
Denise Burke, Parnter, Waller
Dawn Norman, Partner, MRC Global
Dave White, Partner, MRC Global
Chris Lyons, Chief Strategy Officer, Ortho Spine Partners
10:00 - 10:45 General Session: Hold That Thought: FDA Promotion of Medical Products
Hold That Thought: FDA Promotion of Medical Products
How do you differentiate your product from competitors, but also stay within the boundaries established by FDA for the advertising and promotion of life science products? What can you say before your product is on the market – or even in a journal publication – and what can you say once FDA has authorized its marketing? And what about that doctor who wants to tell everyone about a new way to use your product? Join us for perspectives from the perspectives of pharma, medical device, and a regulatory consultant to try to find the right words to promote your product without provoking regulators.
Gabriel Orsinger, PhD, PMP / Vice President of Engineering and R&D, Rhythmlink International, LLC
Jim Stefansic, Director of Corporate Development, Cumberland Emerging Technologies
11:15 - 12:00 General Session: The business landscape is changing: Value-Based Care Safe Harbors: What Life Science Companies Need to Know
Life Sciences companies are not simply manufacturers, but instead full solutions providers able to bring comprehensive advice, guidance, technical support, and assurances to solve complex health problems. New risk based arrangements are emerging in the private market place and last fall, the HHS Office of the Inspector General proposed modernizations to enable new value based care arrangements among health industry participants. Final regulations are expected this fall. Once promulgated, these regulations would reshape the business and care environment, presenting new opportunities for life sciences innovators. This panel will review the developments and provide insights on implications for life sciences companies.
Todd Gillenwater, Senior Director US Government Affairs, Medtronic
Julie Ritchie Wagner, Sr. Assistant General Counsel, PhRMA
Chris White, General Counsel & COO, AdvaMed
Kristen McDermott Woodrum, Partner, Baker & Hostetler
12:00 - 1:00 Keynote Address: Michal Preminger: The changing innovation landscape particularly during this time of the COVID-19 pandemic
Michal Preminger, PhD, MBA Head, Johnson & Johnson Innovation, East North America
Friday, November 13
9:00 PARTNERING OPENS
9:00 - 10:00 PitchRounds Finalists Presentation
10:00 - 11:00 General Session, sponsored by Silicon Valley Bank
11:00 - 11:30 Awards Presentations
11:30 - 12:30 Keynote: Tuskegee Experiment? Clinical Trials for “The Culture”
Clinical Trials for “The Culture”
“Wherever I go, I bring the culture with me, so that they can understand…” Jay- Z (American businessman)
Join us for a discussion on ways to secure more minority participation in clinical trials.
Our culture defines our beliefs, knowledge, arts, and the way we move. Communities of color cultural norms provide opportunities to better address health disparities. In this panel discussion we will discuss the cultural objections to clinical research and the need for culturally relevant /effective medical innovations in communities of color.
The COVID19 pandemic has clearly revealed health disparities exist within communities of color. The CDC reports, “African Americans ages 18-49 are 2 times as likely to die from heart disease than whites”. “Participants in clinical trials should represent the patients that will use the medical products. This is often not the case— racial and ethnic minorities are underrepresented in clinical research.” – Source www.fda.gov
Luther T. Clark, MD, FACC, FACP, Deputy Chief Patient Officer, Global Director, Scientific, Medical and Patient Perspective, Merck & Co
Dr. Jayne Morgan, Head Covid Task Force, Piedmont Healthcare
Felix Sogade, Cardiac Surgeon & Researcher, Georgia Arrhythmia Consultants
Gerren Wilson, PharmD, Head of Inclusion Strategy & Partnering, Chief Diversity Officer, Genentech
Tiffany Jordan, Co-Founder & Chief Development Officer, Acclinate