Session Descriptions:
Plenary Sessions:
9:00 Opening Plenary: "Just What the Doctor Ordered: CEOs and Their Prescription for Success in a Changing Economy
This exceptional forum assembles CEOs from some of Upstate New York’s most interesting bioscience companies for an intimate conversation on what strategies they’re employing to captain their organizations through these unsettled times. How do these leaders manage market uncertainty while promoting a culture of innovation? What does healthcare reform mean for their businesses and the industry as a whole? How do international markets shape growth and risk management strategies? And, what keeps a successful executive up at night?
Featuring:
> David Gately, Managing Partner, Global Healthcare Investment Banking, UBS
Investment Bank (moderator)
> Joseph Corasanti, President and CEO, ConMed
> Thomas D'Ambra, Chairman, President and CEO, AMRI Global
> Thomas Hook, CEO, Greatbatch
> Daniel Kerpelman, President and CEO, Bio-Optronics
> Peter Robinson, Vice President and COO, University of
Rochester Medical Center
> Julie Shimer, President and CEO, Welch Allyn
Session sponsored by Welch Allyn
1:00 Luncheon Keynote: “FDA at a Crossroads?
Mr. Heller will discuss the recent past and present at the FDA, the agency's new leadership and its early stated goals, and Congressional attention, its effect on FDA, and possible legislative change. His focus will be on the agency generally and medical device regulation in particular.
> Mark Heller, Partner, Goodwin Proctor and former Associate Chief Counsel,
United States Food and Drug Administration
Session sponsored by ConMed
3:10 Closing Plenary: “Navigating Turbulent Economic Crosscurrents
What crosscurrents are likely to affect the economy and the financial markets in the months ahead? How will the impact of influences such as global business trends, Federal Reserve monetary policy, the availability of credit, and healthcare reform shape the bioscience industry? Although the economy often takes unanticipated twists and turns, Mr. Goloven will tap his extensive career in developing economic strategies to elucidate the path being traveled by the New York State economy and assess the especially challenging environment confronting businesses large and small.
> Marc Goloven, former Vice President and Sr. Regional Economist, JP Morgan
Chase
Government Updates Track:
11:40 Surveys from the Capitols – where are Albany and Washington headed and how can you get out in front of their priorities?
Tom Tremble, AdvaMed’s Vice President, Government and Regional Affairs, will
provide an update of key federal legislative issues, including health care reform
and preemption, with the potential to impact the medical products industry. He will
also discuss state level initiatives, from across the country, which could impact all
manufacturers in this space. Paul Powers from Empire Advocates will then provide an
overview of where New York State fits into the national picture, including a discussion
of legislative activity in 2009 and an update on the current fiscal year’s budget deficit
and likely impact on businesses. He will also address recent activity surrounding NYS
economic development programs and their restructuring.
> Paul Powers, Senior Business Advisor, Empire Advocates
> Tom Tremble, Associate Vice President, State Government Relations
and Regional Affairs, AdvaMed
Track sponsored by AMRI Global, Excell Partners
Science, Technology, R&D Track:
10:20 Innovative versus Iterative Change: how to best fill the pipeline in challenging times
Innovation is always a driver for creating value. In the current environment, there are serious economic pressures, changing expectations for healthcare, and increasing regulatory scrutiny. On the other hand, there are also promising new business models like open innovation, and orders of magnitude more data and technology available to solve challenging problems. Is the current environment a call to action for bold changes in the way that new medical products are developed, or a time for caution and incremental improvement?
Featuring:
> John Boger, Patent Attorney, Heslin Rothenberg Farley & Mesiti P.C.
> Al Di Rienzo, President and CEO, Blue Highway
> Micheal Dwyer, Director, Research Relations Office,
Rochester Institute of Technology
> Ted Farrell, Group Director, Systems R&D, Ortho Clinical Diagnostics
> Bruce Kirk, Director, Corporate Innovation Effectiveness, Corning
2:00 The Best of NY: lessons from the field in translational research
Tapping the best of our assets and leveraging publically-funded research can be a great way to move exciting discoveries from the bench to marketplace. Where can state resources help to connect your business to the research support you need? Learn about new efforts that integrate very different technologies to improve disease management. Explore where the worlds of semiconductors and healthcare intersect. How have NYS companies successfully collaborated with our universities and where can you employ their lessons to solve complex problems in your own business?
Featuring:
> John Demarest, NYSTAR (moderator)
> Todd Krauss, University of Rochester
> Shaker Mousa, Albany College of Pharmacy
Track sponsored by Greatbatch Medical, Heslin Rothenberg Farley & Mesiti, Hiscock & Barclay, The Tech Garden
Private Equity and Finance Track:
10:20 Raising Capital to Fund Your Company: Benefits and Drawbacks to Tapping the Various Capital Markets and Taking a Company Public
Growth capital is an essential part of starting and building a technology company. In the bioscience industry, capital requirements can be significant, as can the returns. Join a panel of seasoned entrepreneurs who have raised capital from angels, venture capitalist, and in the public markets, as they highlight the funding practices that have allowed them and their businesses to thrive both in fat times and in lean. How should you approach investors and are there options to raise capital in the current economic climate?
Featuring:
> Bela Musits, Managing Director, High Peaks Venture Partners (moderator)
> Tom D'Ambra, Chairman, President and CEO, AMRI Global
> Tony Eisenhut, Founder and President, Kensa Group
2:00 Keys to Accessing Capital Markets During Difficult Times: Critical Indicators and Trends In Market Finance
With credit markets having dried up to a degree not seen in decades, there is a renewed focus on heightened credit reviews by lenders and other liquidity sources in the credit markets. What are the current trends, how can companies manage the current environment’s impact on available cash, and how can you position your business as a potential borrower in order to tap into today’s domestic and international capital markets.
Featuring:
> David Gately, Managing Partner, UBS Investment Bank
> Joseph Serbun, Vice President of Commercial Banking, Community Bank N.A.
Track sponsored by Gilroy Kernan & Gilroy
Operations & Manufacturing Track:
11:40 The Future of Manufacturing In Upstate New York: Proven Strategies to Compete Worldwide And the Keys to Future Success
Companies face even tougher competition in a difficult economy, and there is increasing pressure to increase manufacturing efficiencies. With Healthcare Reform on the horizon, and the pressures of globalization making it difficult to continue manufacturing products with high labor content in the United States, what types of products and processes can companies produce on a competitive basis in Upstate New York? What strategies have Upstate New York companies successfully employed? What does the future of bioscience manufacturing look like in Upstate New York?
Featuring:
> Bill Schwartz, Executive Vice President, TBM Consulting Group (moderator)
> Andy Clapper, Sr. VP WW Operations, Welch Allyn
> David Johnson, Vice President Global Operations & Supply Chain, ConMed
> Bill Willick, Director, Lean Enterprise Center of Excellence, Greatbatch
Track sponsored by AMRI Global, Carestream Health, Tessy Plastics, Laboratory Alliance
Regulatory, Legal & Risk Management Track:
10:20 Tracking the Currents: Understanding and responding to the regulatory priorities at home and abroad
Companies are constants striving to understand domestic and international regulatory agencies’ current priorities. What are the current and forthcoming shifts in focus and resources that bioscience professionals should expect in the US given the leadership changes? Industry experts will explore how companies can better understand and respond to product oversight priorities and emerging trends in imported products and components. Discussion will include recent changes that may impact the 510(k) Premarket Notification process, especially in light of recent congressional attention to this process. Speakers will also explore the FDA’s approach to international harmonization efforts and recent regulatory changes, particularly in Europe.
Featuring:
> Greg Jones, Vice President Regulatory Affairs and Quality Assurance, Livantec
11:40 Conducting International Clinical Trials
Medical product development is going global! What are some of the advantages and challenges in planning and executing international clinical trials? Will your development plans result in clinical trials that provide quality data and meet regulations so the product will gain approval? Will your clinical trial pass an FDA audit so the data will be considered by FDA? All these answers plus additional information about international clinical trials will be provided during this session.
Featuring:
> Lorraine Ellis, President and CEO, Research Dynamics Consulting
Group (moderator)
> Amer El-Kerdi, Director, Clinical Affairs, Carestream Health
> Shirley Isbill, Consultant
2:00 Know the intellectual property that you have & why you have it
Explore strategies for cost effective management of your intellectual property portfolio and maintaining rights to your IP during external collaboration. What practices best align internal patenting activities with a business’s growth strategy? Are there general guidelines for building effective external IP agreements?
Featuring:
> Laurel Baum, Partner, Hancock & Estabrook (moderator)
> Tim Evans, Partner, Marjama Muldoon Blasiak & Sullivan LLP
> Donna Rankin-Parobek, Intellectual Property Director, Carestream Health
Track sponsored by Marjama Muldoon
Sales & Marketing Track:
10:20 "New Restrictions on Sales and Marketing to Health Care Providers: How to Manage Manufacturer-Physician Relationships in the Current Climate"
After a series of high profile stories chronicling how some companies have been paying physicians hundreds of thousands of dollars for “consulting” services, new laws have been passed in several states, including Massachusetts and Vermont, to crack down on abuses. Other states are similarly looking to restrict clinician-industry interactions. Has this legislative trend gone too far? Not far enough? How are companies and hospitals responding and are there appropriate models for interaction between these components of the healthcare industry?
Featuring:
> Nancy Nussmeier, Professor and Chair of the Department of Anesthesiology,
Upstate Medical University (moderator)
> Joseph Darling, President, Livantec
> Holly Hoehner, Counsel, Hiscock & Barclay
2:00 Exploring Export Opportunities in the Flat World
Often the biggest growth opportunities are far from home. How do companies successfully "go international" and tap into the potential of foreign markets and customers? When should a company consider entering a new country? Learn how local experts tackle tough questions related to varying cultural mores, increasingly complex logistics, and even basic business communications. Each panelist will draw from an extensive career in navigating import/export regulations, international financing options, economic development incentives, and the legal considerations of a global business.
Featuring:
> Brian Bechard, Director of Operations, InfiMed (moderator)
> Steve Lescohier, Senior Vice President, JP Morgan Securities, Inc.
> Richard Paul, Partner, Hiscock & Barclay
> Gerald Shaye, Director of International Trade, Empire State Development
> John Tracy, International Trade Specialist, US Department of Commerce
Track sponsored by Accellent, Polymer Conversions
Human Resources Track:
11:40 Compensation and Recruiting in an Era of Changing Economics and Regulatory Pressures
Following public outrage over excessive compensation to Wall Street executives, compensation strategies are now being questioned across the economy. How is the landscape of acceptable pay practices changing? National and regional experts will explore the challenges of recruiting, motivating and retaining talent in light of this new environment and the current economy.
Featuring:
> Steve Daley, BSK (moderator)
> John Adams, Principal, Towers Perrin
> Dan Fisher, Sr. VP Human Resources, Welch Allyn
> Gary Pease, HR Director, International, Corning, Inc.
> Compensation and Recruiting in an Era of Changing Economics and
Regulatory Pressures