“Understanding the challenges and avoiding the pitfalls is key to successfully bringing bioproducts from research through development.”

Biopharmaceuticals, medical devices, and other biological products face a plethora of regulatory and safety issues in addition to the major challenges all products face in moving from concept to reality. Understanding the requirements for and the inter-relation between manufacturing, clinical trials, regulatory approvals, and safety testing is essential to success. 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.

Featured topics:

• Operational challenges of the product development process
• Selection and analysis of new projects and how to optimize their movement through the project pipeline
• Outsourcing for product development
• Key principles in product development that project teams must implement: linking strategy and organizational capabilities

Day 2 - October 8, 2010
Managing Innovation

"Biologics and biopharmaceuticals manufacturing is a linchpin between product development and commercialization.”

New product development demands technology-specific manufacturing assets and upfront capital investment. Evaluation of innovative designs for manufacturing necessitates an ongoing assessment and alignment with commercial strategy. While manufacturing activities and organizations may be viewed as singular and insular, executives must have an integrated knowledge of the biologics industry environment, pre-clinical through clinical development, economics and science, and stakeholder requirements. Continuous evaluation of product life cycle management, technology, manufacturing options, and infrastructure are critical to maximizing production flexibility and asset utilization. Further, a dynamic regulatory and compliance/quality environment mandates ongoing assessment and implementation of new requirements and systems to minimize business risks.

Featured topics:

• Product development and manufacturing interface creating the foundation for successful technology transfer and clinical trial strategies
• Manufacturing process development and technologies
• Regulatory and compliance/quality considerations in product development and manufacturing
• Comparability assessment considerations while transferring technologies to new and/or multiple manufacturing sites
• Manufacturing Strategies: capacity and facility, supply chain, sourcing decisions and cost of goods
• Manufacturing-marketing interface

Module B - Managing Value

Day 3 - November 4, 2010
Managing the FDA in Today’s Environment

“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.”

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. Topics covered in this session include, but not limited to, 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.

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

Day 4 - November 5, 2010
Strategic Product Positioning

“Creation of commercial value for any asset starts at the research stage and parallels the entire R&D process.”

Companies often start development on new or improved products because of great technological innovations in the lab. But, ultimately, it is the market - the customer - who decides whether your product is valuable or not. Planning for commercial success starts at the research stage and parallels the entire R&D process. During this session, industry leaders will explore product commercialization, second generation products and potential exit strategies, all in an effort to determine the best way to optimize the value of innovation over time. The content in this session will range from high-level strategic trade-offs to detailed calculations of value (both quantitative and qualitative) and from debating options to understanding the path for optimizing your company's assets.

Featured Topics:

• Critical commercial decision points during the research and development phase of drugs
• Research and development decisions that have substantial commercial impact in the future
• Benefits and risks associated with commercial decisions during the development process
• Appropriate assessment of the commercial value of your asset
• Recognizing key commercial value drivers
• Value appropriate and relevant commercial input in the value chain
• Gain an appreciation for the pre-launch/launch and post-launch marketing activities
• Recognizing the critical commercial input to optimize your asset

Module C - Growing Value

Day 5 - December 7, 2010
Deal-Maker for a Day

"How do different stakeholder's needs and roles shape the deal, the price and the commercialization pathway for a new therapy?”

Licensing and partnering are an integral part of the Biopharmaceutical industry. The formerly distinct pharmaceutical and biotechnology industries are merging into one interdependent Biopharmaceutical Industry. Partnered products are the future of innovation leading to a significant increase in attempts to acquire and/or license innovation from others. Big pharmaceutical companies will control fewer and fewer of their new products from discovery through line extension or OTC. This Day explores the underlying economics of deals; the different strategies for measuring risk; and how decisions are made amidst uncertainty.

Featured Topics:

• Financial trends in and pressures on the biopharma industry
• The deal market today and coming up
• The Buy-Side: What gets Big Pharma excited about an NME, regardless of who currently owns it?
• The Sell-Side: How to prepare an asset and a biotech company to get the best deal possible?
• De-risking the commercial prospects of a molecule
• How the molecule's commercial value impacts the deal
• Getting it in Writing: Making sure the contract reflects the business
• Success after the deal closes: Effective alliance management and post-acquisition integration issues

Day 6 - December 8, 2010
CEO for a Day

"Making science into a company then scaling and selling ”

Depending on the stage of a company CEO's face different challenges. This session will explore the different stages of a company from pre-clinical, pre/post IND, in-human through to commercial. CEOs from BioPharma will be be on hand to discuss their first-hand experience.