Wednesday, May 29, 2019 | The Loews Hotel
4:30 - 5:30 PM
1. Avoiding Gilligan’s Island: How to Keep a Three-Hour Pre-Sub Meeting From Turning Into a Shipwreck
Pre-sub meetings have become commonplace at FDA and escalating dramatically in number. We will explore what you think of FDA’s pre-submission process. A pre-submission meeting can be used proactively well before any submission to seek FDA’s input, and hopefully agreement, upon a regulatory path (510(k), de novo or PMA) for your device. It is also used to obtain FDA’s input on the amount and quality of testing required and/or the type of clinical study(s), if any, are agreed upon. A pre-sub can also be suggested by FDA after a submission is filed putting the company in a reactive position.
Mark Duval, JD, President & CEO - DuVal & Associates
John Nealon, President & CEO - UroCure
J. Robert Paulson, President & CEO - VentureMed Group
Tom Ressemann, CEO - Amphora Medical
2. IPO Outlook for Life Sciences: Company Demand and Investor Sentiment
How have recent global economic conditions affected investment in life sciences companies? This session will explain how economic concerns have influenced investors and what the IPO outlook will be for biotech, pharma, and med device companies.
Matt Wolf, Director, Health Care Senior Analyst - RSM
5:30 - 8:00 PM
Opening Reception at Relevé Lounge and Cosmos Restaurant in The Loews Hotel
Thursday, May 30, 2019 | The Loews Hotel
7:15 - 8:00 AM
Registration & Networking Breakfast
8:50 - 9:25 AM
Launching Companies in the Current Environment
9:25 - 9:55 AM
How Coverage Decisions Are Made … Really
10:00 - 10:40 AM
1. US vs OUS Early Commercialization - Which Path Maximizes Enterprise Value?
Is investing the time & resources to gain limited OUS commercial experience justified? This insightful break-out session led by Navigant will share first-hand experiences from two CEOs, one who went OUS and one who went US-only. What drove those decisions? We will also explore whether exit data supports one path over the other.
Ross Meisner, Managing Director - Navigant
Milton Morris, PhD, President & CEO - NeuSpera Medical
Dennis Wahr, MD, CEO - Nuvaira
2. PREVENTING THE PREVENTABLE: What Medical Device Executives Need to Know
Far too many medical device companies ASSUME they are “Fully” covered only to find out after it’s too late they have to come out of pocket millions of dollars for UNEXPECTED unfunded or underfunded claims. This discussion will address a broad range of common mistakes and pitfalls in selecting the right insurance broker/carrier relationships as well as common large dollar uninsured exposures. Alliant Insurance Life Sciences Leader Matt Cohn, through client case study with Jeremy Livianu, General Counsel for silicone breast implant manufacturer Establishment Labs Holdings Inc. (July 2018 IPO - Nasdaq ESTA) will recommend best practices for preventing multi-million dollar gaps in coverage and will address the most optimal methods to reduce the likelihood of your balance sheet and profitability being adversely impacted.
Matt Cohn, Senior Vice President - Alliant
Jeremy Livianu, General Counsel - Establishment Labs
3. What GDPR and CCPA Mean for Your Business and Clinical Trials
Having come into effect on May 25, 2018 with sweeping extraterritorial jurisdiction and large potential fines, the European General Data Protection Regulation (GDPR) imposes obligations on medtech companies and how they process the data of their patients, customers, and clinical trial subjects, even if they do not have an EU subsidiary or parent company. Fast on the heels of GDPR, comes the California Consumer Privacy Act (CCPA), which starting in 2020, will impose expanded disclosure rights and grant individuals rights in their data. In this breakout session we will discuss how GDPR applies to you, what are the risks involved, how to mitigate them, how does this all affect your EU clinical trials and how CCPA will fit in the picture.
Odia Kagan, Partner - Fox Rothschild
Jon Stechmann, Partner - Fox Rothschild
4. Don’t Be a Digital Dinosaur: Be Ready When Digital Technology & Mindsets Transform the Medtech World
Many Medtech leaders dismiss the growing role digital technology and data will play in future product development, quality control and market creation at their own peril. Patients, Payers, Providers even the FDA all see change is on the way. In this penetrating discussion, David L. Vied, Global Sector Leader for the Medical Devices and Diagnostics practice for Korn Ferry, will lead panelists and audience members through a spirited discussion about how digital technology can speed product development, introduce significant - rather than incremental - jumps, and better connect Medtech companies with the information necessary to ensure their products enter the market with the power to truly transform healthcare.
Michael Harsh, Co-Founder & Chief Product Officer - Terapede Systems
Huzefa Neemuchwala, PhD, MBA, VP, Global Education Solution - Johnson & Johnson Medical Devices
David Vied, Global Sector Leader, Medical Devices & Diagnostics - Korn Ferry
5. Real World Evidence of a Successful Coverage Campaign From Aetna’s Former Medical Policy Advisor
Baker Tilly will continue the conversation on payer coverage with best practice tips and recommendations on how to approach payers and how to come armed with the right evidence. This discussion will build on the previous panel with a discussion with Dr.Cross the former Aetna Medical Policy Advisor. We will give insight into how real-world evidence can best be used, and answer questions like "Will claims and medical record analyses ever replace clinical trials?" We will also discuss the recent trends in risk agreements and coverage with evidence development and leave time for the audience to ask questions of Dr.Cross.
Christina Cool, Senior Manager - Baker Tilly
Jim Cross, MD, President - Jim Cross, MD Consulting, LLC
David Gregory, Principal, Healthcare & Life Sciences Consulting Leader - Baker Tilly
10:40 – 11:00 AM
Networking & Refreshment Break
11:35 – 12:10 PM
Fueling Up: Finding the Right Late-Stage Investors
1:15 - 1:50 PM
Anatomy of a Medtech M&A
Charlie Attlan, SVP, Corporate Strategy & Business Development - Boston Scientific
Jan Garfinkle, Managing Partner - Arboretum Ventures
Chris Kaster, VP, Business Development, Venture Capital Investing - Boston Scientific
J. Robert Paulson, President & CEO - VentureMed Group
J.P. Peltier, Managing Director, Global Head, Healthcare Investment Banking - Piper Jaffray
1:50 - 2:00 PM
IPO Outlook for Life Sciences: Company Demand and Investor Sentiment
Erin Peterson, Partner, Senior Manager, Health Care Senior Analyst - RSM