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View Full Agenda 2009 Conference Agenda

  • Wednesday, May 6th
  • Thursday, May 7th
7:30 - 8:30 a.m. Breakfast & Networking Reception
Hosted by Dorsey & Whitney LLP
8:30 - 8:45 a.m.

Welcome & Opening Remarks
Don Gerhardt
President & CEO
LifeScience Alley™

8:45 - 9:00 a.m.

The State of MedTech Venture Capital Trends
PWC will set the stage by presenting tailored data from the quarterly MoneyTree Report specific to investment activity in the medical device market on a regional and national level.

Jay Hare
Partner
PricewaterhouseCoopers
9:00 - 10:00 a.m.

The State of the Public Device Market
A panel of seasoned healthcare investment bankers will share different perspectives on:

  • The current state of the equity markets
  • When we can expect to see a rebound
  • Predictions on the IPO window
  • M&A activity: who’s looking for what
Moderator:
Eric Tardif
Senior Vice President, Corporate Strategy
Gen-Probe Inc.

 
Panelists:
Robert DeSutter
Managing Director, Co-Head of Health Care
Piper Jaffray

Jeff Hoffman
Managing Director
JP Morgan Securities Inc.
Kevin Davies
Managing Director, Co-Head, Healthcare
Investment Banking, RBC Capital Markets
Luke Sarsfield
Managing Director
Goldman, Sachs & Co.

10:00 - 11:00 a.m.

Operationally Building Device Companies in the New Economy
How are CEOs, CFOs and Board Members adjusting their strategies from an operations standpoint during an economic down period?

  • How are they raising capital in a stagnant market?
  • Did they batten down the hatches at the first sign of a vulnerable market?
  • How has the market affected business and what are they doing differently now?
Moderator:
Evan Ng
Partner
Dorsey & Whitney

 
Panelists:
Kadir Kadhiresan
Principal
Johnson & Johnson Development Corp.

Mike Partsch
Founder & CEO
AcceleMed Management, Inc.
Doug Kohrs
CEO
Tornier, Inc.
Howard C. Root
Co-founder & CEO
Vascular Solutions Inc.

11:00 - 11:30 a.m.

Networking & Refreshment Break

11:30 - 12:30 p.m.

Corporate Buyers Shopping List: What are they looking for?
This session is an in-depth conversation with several business development executives at various device companies that have been active on the M&A front. The discussion will explore:

  • What types of technologies are they focused on for investments, alliances, or acquisitions
  • How to get the Buyers attention
  • Pitfalls and strategies for negotiating deals
  • What deals are getting done
  • The impact of discounted valuations
  • Deal structures with lack of debt available
  • At what stage in the company’s development will they evaluate the company for investment or acquisition
  • How would they decide to invest in a venture round versus acquire the company
Moderator:
Sami Hamadé
Partner
Aberdare Ventures

 
Panelists:
Chad Cornell
Vice President, Corporate Development
Medtronic, Inc.

Ann Hickey, MD
VP, New Business Development
Peripheral Vascular Division, ev3 Inc.
Scott R. Miller
Vice President, Corporate Development & Licensing
Covidien Ltd.

12:30 - 2:00 p.m.

Luncheon with Keynote
Stephen N. Oesterle, M.D.
Senior Vice President for Medicine and Technology
Medtronic, Inc.
Hosted By: OPPENHEIMER WOLFF & DONNELLY LLP

2:00 - 3:00 p.m.

Impact of the Economic Meltdown on Private Device Companies
What are the implications of the economic meltdown on device companies, from an operating perspective, as well as relative to funding alternatives ranging from venture capital investments to debt. With longer times to exit, and less availability of capital, what are the implications for weathering the storm for a successful outcome?

Moderator:
Kevin Wasserstein
Managing Director
Versant Ventures

 
Panelists:
Rich Bowman
President
Debt Advisors Group

Jonathan Silverstein
General Partner
OrbiMed Advisors LLC
Carter McNabb
Managing Director
River Cities Capital Funds
Dennis Wahr
President & CEO
Lutonix
Jonathan Norris
Managing Director, Private Equity Group
Silicon Valley Bank

3:00 - 3:30 p.m.

Networking & Refreshment Break

3:30 - 4:30 p.m.

The Serial Way…
In this session, we will interview successful serial entrepreneurs to find out what drives them to keep building companies, what they’ve learned along the way, the difference between building a company today vs. when they first started, what it takes to be a great leader and where they see opportunities going forward?

Moderator:
William Kaufman
Partner, Corporate Finance and Transactions Group
Oppenheimer Wolff & Donnelly LLP
Panelists:
Mike Berman
Medical Device Venture Catalyst
Berman Medical

Dan Sullivan
President & CEO
superDimension Inc.

4:30 - 5:30 p.m.

The Lightning Round
The moderator will ask a variety of candid questions surrounding the current investing landscape and issues relevant to portfolio management.

Moderator:
Bill Harrington
Partner
Three Arch Partners

 
Panelists:
Nathan Every MD, MPH
General Partner
Frazier Healthcare Ventures

Peter McNerney
Partner
Thomas McNerney Partners
Richard Ferrari
Managing Director
De Novo Ventures
Thomas D. Weldon
Chairman, Managing Director
Accuitive Medical Ventures

5:30 - 6:30 p.m.

Cocktail Reception
Hosted By: OPPENHEIMER WOLFF & DONNELLY LLP

8:00 - 9:00 a.m.

Breakfast & Networking Reception

9:00 - 10:00 a.m.

Health Plan & How Medical Directors Establish Medical Policy
The panel will discuss the roles of evidence based medicine and comparative effectiveness in developing Medical Policy. What is the difference? Will Comparative Effectiveness impact they way they establish Medical Policy? What are the challenges and key issues Medical Directors face today? What are the best strategies for communicating with them and what should be avoided.

Moderator:
Brent O’Connell

Chief Medical Officer
Argenta TEC Advisors
Panelists:
Fredrik P. Tolin, MD, MBA, FACS
Medical Director
Chicago Commercial Market

Elizabeth Brown, MD
Board Certified Pathologist

Fiona Wilmot, MD MPH
Glas Group Consulting
10:00 - 11:00 a.m.

The New Administration
What impact will the new administration have on reimbursement and healthcare coverage over the next 4 years? What are the restrictions of the sunshine act?

Todd Evans
Director, Pharmaceuticals and Life Sciences
PricewaterhouseCoopers

11:00 - 11:30 a.m.

Networking & Reception Break

11:30 - 12:30 p.m.

FDA Fireside Chat: The 510(k) Program Under Siege
This session will be feature CDRH's Don St. Pierre who has a distinguished career with CDRH starting as field engineer testing medical devices in CDRH laboratories, then he progressed to a reviewer in two divisions (Cardiovascular Devices and Reproductive, Abdominal, Ear, Nose, Throat and Radiological Devices). He has been a Branch Chief and Deputy Director of the Division of Clinical Laboratory Device and was Deputy Director for New Device Evaluation in the office of OIVD and is currently Associate Director for Policy in OIVD. Mr. St. Pierre's education as an engineer and experience as a reviewer and manager within FDA make him well qualified to discuss what is happening within the Agency as it relates to the 510(k) program.
 
In this fireside chat, we will explore the contours of the 510(k) program and ask Mr. St. Pierre questions about whether he believes the scientific requirements are on the rise, do new employees understand and employ the substantial equivalence standard for clearance and what is CDRH doing to address these issues? We will ask his views about the 510(k) program generally and ask for an update on political developments.

Interviewer:
Mark DuVal
President
DuVal & Associates
Special Guest:
Don St. Pierre
Associate Director for Policy and Operations
Office of In Vitro Diagnostic Device Evaluation and Safety
12:30 - 2:00 p.m.

Luncheon with Keynote
"Research that Can Pay for the Lab Rat"
The Medical Devices Center is a new interdisciplinary center at the University of Minnesota where physicians and engineers work to develop commercializable products. The Innovation Fellows program, within the Medical Devices Center, is an example of this collaboration on steroids. A four-person team composed of postdoctoral level engineers and medical doctors are 100% immersed in "smart innovation" for a year. The goal of the program is to train leaders, improve health care, save lives and create intellectual property. Marie Johnson, Ph.D., Director of the Fellows program will discuss the program model and Benjamin Arcand, Ph.D., Innovation Fellow, will describe one of the medical devices created in the program.

Marie Guion Johnson, PhD
Director
Medical Devices Center Innovation Fellows Program University of Minnesota

2:00 - 4:00 p.m.

Master Class – New!
Managing the Burn Rate While Meeting the Regs —
A Who, What, When, Where, & Why of the Major Tasks you’ll Encounter in Medical Device Development
As the FDA demands more data and testing requirements become increasingly rigorous, the structure of today’s start-up must adapt in order to more efficiently capture speed-to-market. Rules, regulations, and guidelines still drive successful medical device development and the secret to meeting key milestones remains knowing how to plan for multiple endpoints up front. However, in response to external forces, the models for successful start-up development are undergoing major changes.

This Master Class will provide tools and information for investors and entrepreneurs to successfully manage and lead a product through development in today's startup medical device world. A panel of seasoned project leaders will discuss the process of bringing a medical device to market by setting appropriate clinical, regulatory, reimbursement, marketing and technical strategies on the front end, followed by early discovery and risk management. This coordinated approach affords investors and entrepreneurs greater assurance in meeting company milestones – both cost-effectively and time-efficiently.

Moderator:
Randall Nelson

President
Evergreen Medical Technologies
Panelists:
J. Robert Paulson
President & CEO
NxtThera, Inc.

Paula R. Skjefte
President & CEO
Waterford Consulting

Tom Waddell
Principal
Project Leadership Services

 
* The workshop is included with the conference registration or you may register for it separately here.
4:00 p.m.

Program Adjourns


 
 
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