Hot Topics in Business | Biotech 2010: Imagine. Collaborate. Innovate.

Hot Topics in Business

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Wednesday, October 27, 2010

Session I: 9:00 a.m. - 10:15 a.m.

Global Collaboration: Opportunities in Emerging Markets

Emerging markets, most notably the BRIC countries, are increasingly important to bioscience companies, covering a spectrum ranging from sources of low-cost R&D and manufacturing to high-growth markets for products. Pharmaceutical companies are shifting resources and investment to these markets and smaller biotech firms will only be able to participate with pharma’s help. There are risks and unknowns that biotechs will need to work through and understand. The panel of pioneering companies will share their perspectives on:

The current state of R&D in the BRIC countries
The regulatory and legal environment in these countries
The risks (IP, regulatory, legal) associated with emerging markets
Tactics that help mitigate risks
The opportunities (licensing/commercialization) that exist for small biotechs
How small biotechs can team up and capitalize on inroads made by pharmaceutical companies
What should be expected with the evolution of domestic firms within these markets?

Moderator:

Donna Tempel, Ph.D.
President & CEO
Drais Pharmaceuticals

Panelists:

Sanjay Batra, Ph.D., FACC
President and Chief Executive Officer
Aesthetic Factors, LLC

Geert Cauwenbergh, Ph.D. (Presentation)
Managing Director, Phases 123
Chairman, BioNJ

Alex Howarth (Presentation)
Chief Business Officer
moksha8 Pharmaceuticals, Inc.

Sanjiv Sharma (Presentation)
Former Head of NicOx Inc. and Senior Vice President Worldwide Commercial Affairs

Session II: 10:30 a.m. - 11:45 a.m.

Commercialization Strategies for Development-Stage Companies

Despite embracing new or emerging therapies and technologies, the evolving market is becoming ever more challenging for small bioscience companies. The cost to capitalize, commercialize, and compete in these industries present operational risks that are magnified in today’s changing environment. The strategy a company undertakes to bring its product to market is one of the more critical decisions an early-stage company will make.

This panel will provide insights based upon personal experiences of those who have been through this critical process, offering early-stage entrepreneurs and managers an opportunity to learn about key issues, potential hurdles, and rationales behind the decision-making process.

Moderator:

Christopher Cashman

Chairman

MBF Therapeutics Inc., JDP Therapeutics, Inc.

Panelists:

John Fraher

Chief Commercial Officer

Eurand

Ashleigh Palmer
President & CEO
Unigene Laboratories, Inc.

James Sapirstein, RPh, MBA
President and CEO

Tobira Therapeutics

Session III: 1:45 p.m. - 3:00 p.m.

Health Care Reform: Bottom Line Perspectives

The Patient Protection and Affordable Care Act of 2010 will have significant effects on a company’s activities to develop, promote, obtain reimbursement, and report data regarding its products and services.

Our panel of experts will provide an overview, from a business perspective, of the most up-to-date information from this Act and how it will impact our industry now that we have moved from the legislative to implementation phase, including:

Incentives to develop new treatments and devices
FDA approval processes including any new requirements for demonstrating economic as well as medical benefits
Reimbursement bases and calculations for sales to federal and state governments
Criteria to receive Tier 1 or Tier 2 formulary placement with MCO plans
Incentives for payors
Promotion and advertising practices directed at publicly-funded individuals or groups
Market exclusivity parameters arising from IP law, biosimilar designations, orphan drug status, and other issues
Reporting requirements regarding medicine and device development, consultants, lobbyists, and promotion

Moderator:

Jonathon Kellerman
Principal
PricewaterhouseCoopers

Panelists:

Ray Frost
Executive Director, Government Affairs & Public Policy
Eisai Inc.

Dennis Jackman
Senior Vice President Public Affairs
CSL Behring

Michael Pollard (Presentation)
Senior Advisor
Pharmaceutical Care Management Association

Joel Slackman
Managing Director, Policy
BlueCross BlueShield Association