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2014 Agenda

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Detailed Agenda: September 30, 2014

7:00 a.m. - 7:00 p.m.


8:00 a.m.-12:30 p.m.

Biosciences Facilities Tour

12:30-2:00 p.m.

Welcome │ Plenary Luncheon

Joseph Gulfo

Stephen Lanier │ Vice President for Research │ Wayne State University
Joseph V. Gulfo, MD, MBA │ Founder and CEO │ Breakthrough Medical Innovations

Joseph V. Gulfo, MD, MBA, is the author of Innovation Breakdown and CEO of Breakthrough Medical Innovations, a team of biopharma and medtech consultants. An Inc.com contributor, he also teaches graduate cancer biology and business and entrepreneurship classes at Seton Hall University and maintains an educational cancer biology blog. Dr. Gulfo received his MD from University of Medicine and Dentistry of New Jersey and his MBA from Seton Hall University. Follow him @josephgulfo.

Moderator: Stephen T. Rapundalo, PhD │ President and CEO │ MichBio


2:00-7:00 p.m.

Exhibits Hall Open

2:00-3:00 p.m.

Emerging Bioscience Showcase #1

Tom Shehab, MD │ Principal │ Arboretum Ventures
David Strickler │ Vice President │ Cascade Partners

Presenting Companies:
Michigan State University: Novel DNA Deep Sequencing Technologies
Sisu Global Health
Deuwave, LLC

Moderator: Ken Massey, PhD │ Senior Director, Venture Development │ Wayne State University

3:00-3:30 p.m.


3:30-4:30 p.m.

FDA Regulation of Drugs and Devices: What Recent Actions Mean for You (Human Health)

Eileen Dorsey │ Director, Corporate Post-Market Surveillance │ Terumo Cardiovascular Group
Frank Fucile │ Senior Director, Regulatory Affairs │ STERIS Corporation
Stephen Gracon, DVM │ Vice President of Regulatory Affairs │ NanoBio

There’s been a flood of FDA regulatory guidance and policy initiatives – fast track, UDI, accelerated approval, device reclassification, 21st Century Cures, etc. - over the last year that will impact drug and device development significantly. Bio-industry experts will review some of the key programs and how they will impact your drug or device development and manufacturing plans.

Moderator: Kay Fuller │ Founder and Principal │ Medical Device Regulatory Solutions

3:30-4:30 p.m.

Michigan Support Services for Commercialization and Growth (Business Growth)

Dennis Atkinson │ Director of Corporate Engagement │ Wayne State University
Kristin Burgard │ Principal Consultant, FASTCONNECT │ BBCetc.
Sandra Cochrane │ Technology Business Consultant │ Small Business Development Center - Michigan
Bill Mayer │ Vice President, Entrepreneur Services │ Ann Arbor SPARK

Over the last decade Michigan has witnessed the expansion of state-supported programs for bioscience entrepreneurs and established companies, as well as a plethora of contract research and manufacturing organizations. Panelists will review the various entities providing services and discuss what additional resources are needed to help companies throughout their business lifecycle.

Moderator: Margaret McCammon │ Portfolio Manager, Business Development │ Michigan Economic Development Corporation

4:30-5:30 p.m.

Bio-Industry Town Hall │ Legislators of the Year Award

Senator Debbie Stabenow

Jim Eichhorst │ Manager, State Government Relations │ Biotechnology Industry Association
Carrie Hartgen │ Vice President, State Government Affairs │ AdvaMed
Debbie Stabenow │ U.S. Senator │ State of Michigan

Michigan’s U.S. Senator Debbie Stabenow serves on the key economic committees in the Senate, including as a senior member of the Finance, Budget, and Energy Committees, as Chairwoman of the Agriculture Committee, and as Co-Chair of the Senate Manufacturing Caucus. She has a powerful role to play in shaping our nation’s manufacturing, healthcare, energy, and agriculture policies that are so critical to our future.

Moderator: Stephen T. Rapundalo, PhD │ President and CEO │ MichBio

5:30-7:00 p.m.

Opening Reception │ Good to Great Award

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Detailed Agenda: October 1, 2014

7:30 a.m. - 12:00 p.m.


7:30-8:30 a.m.

Continental Breakfast

7:30 a.m. - 3:00 p.m.

Exhibits Hall Open

8:30-9:30 a.m.

Emerging Bioscience Showcase #2

Tom Shehab, MD │ Principal │ Arboretum Ventures
David Strickler │ Vice President │ Cascade Partners

Presenting Companies:
Functional Fluidics, LLC
Exo Dynamics
ONL Therapeutics, Inc.

Moderator: Ken Massey, PhD │ Senior Director, Venture Development │ Wayne State University

9:30 a.m. - 12:00 p.m.

College Program

Kristyn Aalto │ Director of Innovations │ Henry Ford Health System
Gloria Chou │ Clinical Research Operations Manager │ SRI International
Art Czabaniuk │ District Director │ U.S. Food & Drug Administration
Nicole Heinz │ Business Development Director │ Asterand
Stephen Munk, PhD │ President and CEO │ Ash Stevens
Christopher Sanders │ Vice President, Engineering │ Delphinus Medical Technologies
Kinnari Saraiya │ District Manager │ Kelly Scientific
Michael Woolliscroft │ Director, Technology and Research Operations │ ProNAi Therapeutics

Moderator: Karen Weist │ Director, Graduate School Career Services Office │ Wayne State University

View College Program flier. (PDF)
Learn more about all student programming.

9:30-10:30 a.m.

Payment Reform: Implications for R&D and Commercialization (Human Health)

Robert Reinhardt, MD │ U.S. Medical Director, Immunodiagnostics │ Thermo Fisher Scientific, Phadia U.S.
Kristin Viswanathan │ Manager, Reimbursement and Health Policy │ Biotechnology Industry Organization (BIO)
Leslie Wise │ Global Director of Reimbursement │ Biomet Inc.

The ACA has transformed the healthcare environment and challenged medical device, diagnostic, and drug manufacturers to rethink reimbursement and market access strategies. All companies today need a thorough understanding of policy changes related to Medicare/Medicaid, CPT coding, and CLIA, as well as those invoked by ACOs, health plans, and benefits managers. Learn what all these changes mean for product commercialization and development.

Moderator: Andrea Bare │ Affiliate Consultant │ bioStrategies Group

9:30-10:30 a.m.

Effective Disease Foundation and Bio-Industry R&D Collaborations (Business Growth)

Derek Gavin │ Director of Development and Corporate Outreach │ National Organization for Rare Diseases
Mitch Seymour, PhD │ Scientific Advisory Board │ Cures Within Reach

Disease foundations are playing an increasingly important role in advancing research and helping to bring new treatments to market. Such groups can bring expertise to developing research tools, technologies and clinical protocols, an understanding of patient needs and access to clinical thought leaders. Industry and foundation executives share what they view as the key opportunities and challenges.

Moderator: Molly Williams │ Director, Alliance Development │ Pfizer, Inc.

10:30-11:00 a.m.


11:00 a.m. - 12:00 p.m.

CEOs Unplugged: Strategically Building Michigan's Bio-Industry

Michael Graham, MD │ President and CEO │ GraMedica
Jeff Mason │ Executive Director │ University Research Corridor
David Olson, PhD │ President and CEO │ Swift Biosciences
Tom Ross │ President and CEO │ Grand River Aseptic Manufacturing

Moderator: Stephen T. Rapundalo, PhD │ President and CEO │ MichBio

12:00-1:00 p.m.


1:00-2:00 p.m.

Emerging Bioscience Showcase #3

Tom Shehab, MD │ Principal │ Arboretum Ventures
David Strickler │ Vice President │ Cascade Partners

Presenting Companies:
Advanced Interactive Response Systems (AIRS)
Fluition, LLC

Moderator: Ken Massey, PhD │ Senior Director, Venture Development │ Wayne State University

2:00-3:00 p.m.

Communicating and Marketing Your Product or Technology in Today’s Healthcare Environment (Human Health)

Katherine Norris │ Senior Director, Compliance and Integrity Systems │ NSF International
Lee Tumminelo │ Partner │ Faegre Baker Daniels

What you say about products in development or marketed, how you say it, and to whom are being scrutinized increasingly by regulators, investors, and others. The Physician Payments Sunshine Act, use of social media and digital apps, and product labeling, among other areas are changing the healthcare landscape. Experts will address the rules, pitfalls, and approaches to effectively manage information flow.

Moderator: Joan Bradley, PharmD │ Founder, President, and CEO │ JB Ashtin

2:00-3:00 p.m.

Physician, Hospital, and Payer Think: Understanding Healthcare Strategic Decision-Making (Business Growth)

Andrea Bare │ Affiliate Consultant │ bioStrategies Group
Stephen Bartol, MD │ Founder and CEO │ Sentio LLC
Gregory Buran, MD │ VP and Senior Medical Director │ Health Alliance Plan

Ever wonder how providers and payers approach the availability and promise of new products and technologies? Typically, those decision-makers are buried within the hospitals and health plans. Hear from Michigan-based thought leaders on how they evaluate the relative reimbursement, profitability, and innovative potential of prospective treatments on patient outcomes.

Moderator: Molly Hoult │ Director │ Fletcher Spaght

3:00-4:00 p.m.

Keynote Speaker │ Emerging Bioscience Showcase Awards

Margaret Hamburg Speaker:
Margaret A. Hamburg, MD │ Commissioner │ U.S. Food and Drug Administration

Margaret A. Hamburg, MD is the 21st Commissioner of the U.S. Food and Drug Administration. As the top official at the FDA, Dr. Hamburg is committed to strengthening programs and policies that enable the agency to carry out its fundamental mission — to protect and promote the public health.

Only the second woman ever to serve as Commissioner, Dr. Hamburg earned her MD from Harvard Medical School and completed her residency at what is now New York Presbyterian Hospital-Weill Cornell Medical Center. She conducted neuroscience research at Rockefeller University in New York and at the National Institute of Mental Health, and later focused on AIDS research as Assistant Director of the National Institute of Allergy and Infectious Diseases.

In 1991, after just a year in the New York City Department of Health, Dr. Hamburg was named its Commissioner. During her six-year tenure, she implemented rigorous public health initiatives that tackled the city’s most pressing crises head-on — including improved services for women and children, a needle-exchange program to combat HIV transmission, and the nation’s first public health bio-terrorism defense program. The most celebrated achievement during her leadership was her aggressive approach to the city’s tuberculosis epidemic, which led to an 86% decline in drug-resistant TB in just five years.

In 1997, three years after she was elected one of the youngest-ever members of the Institute of Medicine, President Bill Clinton named Dr. Hamburg Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services, where she served until the end of the Clinton Administration. She then became founding Vice President for Biological Programs at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons.

President Barack Obama nominated Dr. Hamburg for the post of FDA Commissioner on March 14, 2009.

As the Commissioner of Food and Drugs, Dr. Hamburg has emphasized the critical role of innovation in meeting the nation’s rapidly growing public health needs. She provided leadership for the implementation of three groundbreaking measures: the Family Smoking Prevention and Tobacco Control Act, a 2009 law that gives FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products; the Food Safety Modernization Act of 2011, which changed the focus of food safety measures from responding to food-borne outbreaks of illness to preventing them; and a thorough review of the system for the evaluation and approval of medical devices.

Beyond these specific undertakings, Dr. Hamburg has set the agency's paramount course for fulfilling two central public health tasks. She has launched a nation-wide public-private effort to strengthen regulatory science as a means for advancing the development and evaluation of innovative, breakthrough medical products; and she is leading FDA’s transformation into a global regulatory agency capable of ensuring the safety and quality of imported food, drugs and medical devices. Commissioner Hamburg is committed to ensuring that FDA is poised to meet the public health challenges of the 21st century.

Moderator: Stephen T. Rapundalo, PhD │ President and CEO │ MichBio


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