BioExec Institute
Deloitte & Touche USA LLP, Prescience International, and the UC Berkeley Center for Executive Education have collaborated to create innovative curriculums that provide Director and VP-level executives with both industry leading skills development and tools for marketing, branding and credibility.
Program Description
The BioExec Institute is an internationally-renowned executive program delivered by leaders in the industry for life sciences directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists, including Deloitte LLP leaders and BioExec Institute faculty and alumni, the Institute offers attendees six-days of interactive programming from September through December 2009, including three evening networking receptions. Participants will have unique opportunities to debate the strategies and tactics of business leadership within biopharma and will complete the program with invaluable insight and powerful networks to help them deliver bottom-line value in this growing industry.
At the end of the program, participants will be awarded a certificate of completion by the UC Berkeley Center for Executive Education.
Product Development and Manufacturing
- Linking strategy and organizational capabilities
- Regulatory and compliance/quality considerations
- Comparability assessment considerations while transferring technologies to new and/or multiple manufacturing sites
- Capacity and facility, supply chain, sourcing decisions and cost of goods
- Manufacturing-marketing interface
Strategy
- Discussion of court cases, intellectual property planning and strategy, protection of space or focus in a certain therapeutic area.
Political and Regulatory Strategies: Understanding the key issues at stake unveils the secrets to getting a drug approved.
- The importance of designing appropriate clinical trials to support a strong product label, DOJ and FDA specific promotional interests, substantial evidence, fair balance, understanding the basics of clinical support, medical affairs organizations and regulatory considerations, pre-approval activities, public relations programs, medical conventions, the EMEA and Japan regulatory requirements, and how to meet those.
- What policy considerations (social, economic, and governmental) drive acceptance from and the challenges faced from a regulatory standpoint for review and approval.
- Roles and advantages that a RiskMap, an 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.
Who Should Attend
- Directors
- VP-level management
Advantages
Industry leaders will join session participants to discuss the trade-offs caused by exploring new R&D models with the goal of creating value for your organizations.
Key Skills
- How to approach business challenges with a different mindset.
- Effective alliance management and post-acquisition integration issues
- Appropriate assessment of the commercial value of your asset
- Recognition of key commercial value drivers
- Valuing appropriate and relevant commercial input in the value chain
- Appreciation of the pre-launch/launch and post-launch marketing activities
- Recognition of the critical commercial input to optimize your asset
