Dear Colleague:

I am pleased to announce the production of Cambridge Healthtech Institute’s and the BioPharma Strategy Series’ fifth annual executive forum Post-Approval Drug Safety Strategies being held November 8-9, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia, PA.

Improving products’ clinical safety will increase the industry’s fundamental value proposition to patients, healthcare providers, payors and regulators. The program will focus on pharmacovigilance program implementation and specific strategies and approaches to creating true value from a peri- and post-approval drug safety program. The approach of this conference is not to look at safety in the silos of early-phase safety or post-approval safety but to view safety holistically, across the lifecycle, especially at the transition from approval to broader use in the marketplace.

The special, two-day executive forum entitled Post-Approval Drug Safety Strategies will tackle many of the pressing issues that executives are facing today. Topics include:

• Optimizing the allocation of an organization's drug safety assessment, evaluation and minimization resources and costs
• Doing drug safety on a tight budget and with other fiscal, personnel and travel restraints
• Challenges and opportunities for outsourcing and off-shoring some or all safety functions
• Designing and executing a proactive risk management plan and driving your business for the best benefit-risk ratio
• Strategies to place risk management more in connection with benefits: A focus on the positive
• Integrating drug safety knowledge longitudinally across a compound's lifecycle; practical approaches to Lifecycle Signal Detection
• Understanding global regulatory authorities' evolving drug safety risk management expectations, demands and “nice-to-haves”
• Practical case studies in REMS, EU RMPs; unifying the European RMP with the FDA REMS to avoid work duplication
• Proactive risk communication (out and in) as a part of risk benefit management strategy with a look at the new “Social Media”; approaches to handling safety information and patient communications through Social Media
• Best practices for managing product/patient safety in partial or staged divestitures for late-patent life products
• Using quantitative and qualitative methods to better balance benefit-risk
• Registries and observational studies: Analyzing and incorporating drug/condition information for overall population and subgroups to demonstrate your product's true value and improve decision making
• Understanding new labels and labeling requirements
• How to negotiate with regulators to avoid costly and, in some cases, unnecessary, risk management plans

In addition, once again in 2010 we will be dedicating time to the informal breakout discussion groups wherein attendees and faculty will continue sharing ideas on the topics above.

You can view last year’s agenda at: 2009 program.

If you are interested in presenting, please submit a speaking proposal for review. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. We are looking for case study-based presentations. Additionally, as per BPSS policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. The deadline for submissions is March 26, 2010. 

The BioPharma Strategy Series (BPSS) mission is to assist in improving the overall health of the pharmaceutical industry by producing high-level meetings that bring together R&D leaders to discuss and debate potential solutions to overcoming the most pressing challenges facing their organizations. I hope you can join us on November 8-9, 2010 in Philadelphia, PA to discuss and debate this emerging drug safety paradigm and how innovative drug safety risk assessment, management and mitigation hold the promise of creating considerable value for the industry.

I look forward to seeing you in November!

Very sincerely,

Micah Lieberman

For questions or suggestions about the meeting, please contact:
Micah Lieberman
Executive Director, Conferences
BioPharma Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@healthtech.com 

For exhibit, partnering and sponsorship information, please contact:
Arnold Wolfson
Business Development Manager
BioPharma Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5431
E: awolfson@healthtech.com

For media and association partnerships, please contact:
James Prudhomme
Manager, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5486
E: jprudhomme@healthtech.com