BioExec Institute
Module B - Managing Value
Day 3: Life Cycle Management
"A company's success or failure increasingly is linked to its intellectual property planning and strategy." |
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The goal of this day will be to address the various stages during the life cycle of a product or service within a biopharma company with the goal of optimizing the value of a portfolio with a minimal amount of risk. Some issues that can be addressed will be the strategies around expanding into new indications and IP value, acquisition and management, when to use a trade secret, how to protect your IP in collaborations. This session will also discuss on patent reform and how that may change strategies around portfolio management. By focusing on the all the implications of the decisions made along a product life cycle participants will gain a better understanding of how to avoid legal issues.
Day 4: Political and Regulatory Strategies
"From initial product launch to re-launch, and from personalized medicine to pandemic prevention, elected officials, other policymakers and the general public, are counting on the biotechnology industry in the coming decades." |
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Bringing products to market requires overcoming significant regulatory challenges for the goal of delivering on the safety and efficacy of the product. This session deals with the many gray areas of moving the product through the regulatory process, and understanding the various stakeholders' goals and political trade-offs in making the decision of whether or not to approve the product. Understanding the key questions that are core to each of the stakeholders unveils the secrets to getting a drug approved and plays an important role to a company's commercialization strategy. Join Dr. David Kessler, former FDA Commissioner and current Dean and Vice Chancellor of Medical Affairs for UCSF, to "live and understand" the stakeholders, the processes and the resulting impacts on your bottom line.
Featured Topics:
- Discussion on how policy and regulation works in the FDA
- Expand on our policy and regulation discussion using actual examples from food labeling, the approval of drugs for serious and life threatening diseases, and tobacco regulation
- Engage participants in the current state and thinking regarding targeted therapies as a variation of personalized medicine and what it will take for adoption
- Aspects and considerations on how targeted therapies are chosen for development and what considerations go into driving the acceptance from a policy standpoint (social, economic, and governmental) as well as the challenges faced from a regulatory standpoint for review and approval
- Examine how companies can drive the re-launch of a product that has encountered difficulties using actual examples
- Provide and solicit views on the future leading practices for driving product acceptance from a safety perspective
- Discussion around the potential roles and advantages that a RiskMap, evaluative strategy could play in a proactive, pharmacodiligent approach to new product introduction
- Consideration of risk-based approaches that could help define and develop processes and procedures that address potential or unknown drug safety issues prior to launch
