Galien Foundation Newsletter
The mission of the Galien Foundation is to serve as a vehicle for the open exchange of ideas that drive science and new innovations. Our Third major forum will be held at the Alexandria Center for Life Science on the morning of October 16, 2012, and will feature round table debates focusing on critical, global healthcare issues and challenges.
PRELIMINARY TOPICS 3rd GALIEN FORUM. October 16th 2012
Innovation and Patient Safety -- Resolving the Conflicts of Need and Risk
This sessions would include chief medical officers, biotech entrepreneurs, patient advocates and Food and Drug Administration regulators to discuss the challenges and urgency of innovation that can change the human condition.
Patents and the Human Genome -- Does Ownership Encourage Innovation
Countries with strong intellectual property systems are drivers for medical innovation. The economic systems and patent protection seem to go hand-in-hand. Will that work going forward, or will it harm broad scientific participation.
Worldwide Comparative Effectiveness: Friend or Foe to Industry?
Value in Drug Development: Is a Third Leg Needed in Pharma R&D?
For decades, pharmaceutical company laboratories produced novel medicines for heart disease, cancers, depression and pain management. At some point, did new stop being a game changer in health care. Now the United States will mirror the European drug approval system with separate decisions for drug review and reimbursement. How will this impact innovation's future?
Capitalizing Innovation at the Academic Level
The university setting is the catalyst for innovation. Endowment funds have long been directed and managed by private-equity teams. Will academia now seek to squeeze-out the middle-men of investment and use its knowledge, due-diligence systems and talent to invest directly in innovation's possibilities. Why would that work and could big pharma be a direct partner?
Innovation and Corporate Responsibility -- Clinical and Social Changes
Ultimately, innovation is dependent on reimbursement and access-to-care. Will the face of the third-world deprivation be the future of American healthcare -- a nation of haves and have nots? What is necessary to prevent this care collision?
Building the R&D Organization: Next Wave Strategies for Portfolio Productivity and Growth
With internal rates of return on investment in R&D falling below the break even level, companies are looking hard for ways to restore the productivity of their in-house operations - or to find a better deal elsewhere through external partnerships. This panel will review (1) whether the current platform is sustainable, (2) the prospects for a new business model for big pharma focused entirely on a service mode focused on distribution, manufacturing and marketing, and (3) explore additional options for managing the cost burden of moving successfully from basic research to final market authorization.
Post Marketing Commitments: Impact on Innovation
Finding the right balance between benefit, safety and risk is leading to more regulatory requirements after a new medicine is cleared for sale. Regulators are conditioning final authorization on a commitment by companies to conduct large-scale follow-up studies based on actual use of the medicine in the field. Timing for many such studies extend beyond the life of the patent and represent an increasing cost exposure for innovative companies. This panel will consider the utility of this approach and the relevance, quality and applicability of the evidence required to furnish proof of clinical value and - increasingly - cost effectiveness.
2011 Galien Forum Topics:
Session I : 8:30 am – 10:30 am.
RoundTable IA -“Funding Innovation - New Trends in the Healthcare M&A Landscape” (Sponsored by Biopharm Insight, part of the Financial Times Group))
RoundTable IB -"What is "Value" and How Can it be Measured and Demonstrated in Therapeutic Innovations? Breaking Down the Barriers of the Past"
Session II : 11:00 am – 1:00 pm.
RoundTable IIA -"The Next Generation of Health and Research Informatics" (Sponsored by Oracle)
RoundTable IIB - “A Global Health Challenge: The Obesity and Diabetes Epidemic Where are the Innovations and Who Will Pay For Them?” (Sponsored by Alexandria Real Estate)
RoundTable IIC -“Perspectives on Innovation, Patient Safety and Global Access” Thinking Beyond Laboratories and Clinical Trials