Sponsored by: 

Dr. Jeremy Levin, CEO of Ovid Therapeutics

Sponsored by: 

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. 

Panelists: 

• 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

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Sponsored by: 

• 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

Panelists: 

• 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

Sponsored by: 

• During our networking sessions, we will utilize the capabilities of Zoom to break attendees into rooms for networking.

Sponsored by: 

Sponsored By: 

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.

Panelists: 

• 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

Sponsored By: 

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

Panelists: 

• Denise Burke, Parnter, Waller
• Dawn Norman, Partner, MRC Global
• Dave White, Partner, MRC Global
• Chris Lyons, Chief Strategy Officer, Ortho Spine Partners

  Sponsored By: 

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.

Panelists

• Gabriel Orsinger, PhD,  PMP / Vice President of Engineering and R&D, Rhythmlink International, LLC 
• Jim Stefansic, Director of Corporate Development,  Cumberland Emerging Technologies
• Kathryn Cole Becker (moderator), Founder & Principal, Translational Science Solutions

Sponsored by: 

Sponsored by: 

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.

Panelists: 

• 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

Sponsored by: 

Michal Preminger, PhD, MBA 
Head, Johnson & Johnson Innovation, East North America

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