THURSDAY, SEP 29, 2016

Keynote Speaker

Howard Root, CEO of Vascular Solutions, was criminally prosecuted over an FDA-cleared medical device that constituted only 0.1% of the company’s sales and never harmed a single patient, yet required a defense team of 121 lawyers at a cost of $25 million to defeat. He will discuss the wide-ranging and critical lessons he learned in his successful defense against criminal prosecution brought by federal prosecutors.

Companies Represented in Panels:

2016 Agenda

9:10 – 9:40 a.m.

Prescription for Change

Brian Adams, General Counsel, Keryx Biopharmaceuticals, Inc.
David Walker, Partner – Patent, Dorsey & Whitney

This fireside chat delves into the natural evolution of mid-sized life sciences companies and strategies for growth in the marketplace. Keryx Biopharmaceuticals will divulge reasons for their decision to shift from the initial R&D phase to commercialization phase, and the benefits of commercializing their primary drug product with new management.

9:40 – 10:20 a.m.

Digital Health Fireside Chat

Ted Driscoll, PhD, Partner – Digital Healthcare Lead, Claremont Creek Ventures

Kurt Waltenbaugh, Founder & CEO, Carrot Health
Shira Hauschen, Lead Consultant – Dorsey Health Strategies

By its very nature, in merging ever-evolving technology with the ever-changing needs in healthcare, digital health is at the forefront of healthcare innovation. Digital healthcare providers and stakeholders encounter regulations that are not written with their models in mind, and they must either adapt or rewrite the rules. They’re also highly attuned to consumer desires and concerns, which adds an additional layer of complexity to their strategic plans.  Join us as we discuss the regulatory and business hurdles that face the industry. 

10:40 – 11:20 a.m.

Successfully Navigating IP Diligence

Josh Baltzell, Venture Partner, SightLine Partners

Tom Ressemann, President and CEO, Amphora Medical, Inc

Scott Smith, Partner – Patent, Dorsey & Whitney

Serial medical device entrepreneur Tom Ressemann will walk through a hypothetical IP due diligence with venture capital partner Josh Baltzell and Dorsey Patent Partner Scott Smith. What do investors look for when conducting IP diligence? What red flags most commonly occur? How can startups not only avoid the red flags but also position their “IP story” for massive success during financing and acquisition? Panelists will address the ways this important part of financing diligence can go wrong and share concrete information as to how to avoid the pitfalls.

12:10– 1:10 p.m.

Keynote: Cardiac Arrest – Five Heart-Stopping Years on DOJ’s Medical Device Company Hit List

Howard Root, CEO, Vascular Solutions, Inc.

It started as a false accusation of off-label promotion by a disgruntled former employee, and culminated five years later in a San Antonio courtroom with “not guilty” verdicts on all 10 criminal charges. Even a single guilty verdict would have resulted in exclusion of Vascular Solutions from the U.S. market and sent its CEO Howard Root to prison for years. This was a felony criminal prosecution over an FDA-cleared medical device that constituted only 0.1% of the company’s sales and never harmed a single patient, yet required a defense team of 121 lawyers at a cost of $25 million to defeat. In his keynote address, Howard Root will discuss the wide-ranging and critical lessons he learned in his successful defense against a criminal prosecution brought by federal prosecutors in a culture that increasingly distorts vague federal regulations to manufacture criminal charges against medical device companies and their employees.

1:20 – 2:00 p.m.

Leadership Matters

Catherine Jennings, Director of Business Development, Peripheral Interventions Division – Boston Scientific Corporation
Mark Myhra, Senior Corporate Counsel, Boston Scientific Corporation

Tamara Sniffen, Vice President of Operations, Stryker
John Marti, Partner – Govt. Enforcement & Corp Investigation, Dorsey & Whitney

Leading a growing Med-Tech organization is challenging – the operational tempo is quick, the competition is fierce and the environment is heavily regulated. When your company hits a hard spot (and it will), leadership challenges may overwhelm your ability to assess, respond, and succeed. Join experienced business and government leaders who have emerged from the crucible as they discuss surviving and thriving through crises, including major regulatory, economic, and operational disruptions.

2:00– 2:40 p.m.

Cross-Border Life Sciences Deal Making: A Buyer and Seller Perspective

Dr. Steve Allen, CEO, DNA Electronics

Victor Esch, CEO, nanoMR Inc.
Frances Doherty, Partner – Corporate, Dorsey & Whitney

DNA Electronics (DNAe), a leading developer of semiconductor-based DNA sequencing technology, was looking to gain a U.S. presence to facilitate its various initiatives. It sought and executed on an acquisition of nanoMR Inc. in the U.S.  The transaction enabled an immediate U.S. presence and at the same time enhanced their product offering through the complete ownership of blood-to-result-diagnostics. DNAe has since completed a number of operational activities in the U.S. that will allow the company to double its headcount and build a clinical diagnostic manufacturing facility, clinical testing laboratories and a commercial team. In this chat, nanoMR CEO, Victor Esch, will discuss the acquisition process from the seller’s viewpoint, and Steve Allen, CEO of DNAe will share his perspective as a foreign buyer and discuss the decision to expand to the U.S., the type of opportunities they were seeking and insights into what prompted them to look here.

2:55 – 3:35 p.m.

Public Eye on Drug Pricing Practices

Stephen Hurst, President & CEO, Savant HWP
Evan Ng, Co-Chair of Life Sciences and Healthcare Practice, Dorsey & Whitney

In 2015, the overnight price increase of the anti-parasitic drug Daraprim and subsequent arrest of then KaloBios CEO, Martin Shkreli, thrust the pharmaceutical industry into the limelight. Following the removal of Shkreli and as a condition of its restructuring, KaloBios completed a transaction with Savant HWP for the acquisition of its benznidazole program. As one can imagine, drug pricing was a key point of discussion. As a unique condition to closing the transaction, Savant secured fair access for patients who are unable to pay for future drug products. Stephen Hurst, CEO of Savant, will share the parties’ goals, the ongoing spotlight in the industry regarding drug pricing, and the lessons other life sciences companies can learn about their pricing practices.

3:45 – 5:00 p.m.

Networking Reception

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agenda subject to change

© 2016 Dorsey & Whitney LLP