7:45-8:30 Breakfast
8:30 Chair’s Opening Remarks
Hans F.W. Hoogkamer, Senior Director, Strategic Portfolio Planning, Actelion Pharmaceuticals
8:45 Keys to Successfully Commercializing a New Pharma / Biotech Product
A successful launch is crucial to the long term success of any product. In today’s competitive environment, it is critical for a new product to establish a steep sales growth curve at launch. To do so requires strong focus on all elements related to launch including clinical, regulatory, sales, marketing, logistics, and others. Often organizations primarily focus on the clinical and regulatory aspects of commercialization which can lead to ineffective planning of required sales and marketing activities. A rush at the last minute to establish a commercial strategy and infrastructure leads to unsuccessful launches, lost opportunities, and unhappy customers. This presentation will contain insights on:
Participants will obtain a clear view of the complexity of the commercialization process and the various decisions involved.
Samrat Shenbaga, MBA, MS, Principal, ZS Associates and Paul Darling, Ph.D., Associate Principal, ZS Associates
9:25 Integrated Product Lifecycle and Portfolio Management Process
Lifecycle (or project) management is about doing products right and portfolio management is about doing the right products. Actelion Pharmaceuticals has designed and implemented a process linking these two critical activities. It enables Actelion to both efficiently (on time within budget) develop their growing pipeline of new compounds in R&D and at the same time ensure that ongoing and planned projects in the portfolio are aligned with corporate strategy.
This presentation will cover the following:
The process is supported by an internet based software tool that provides timely and accurate cost and timeline information for all R&D projects. It is a quite efficient and transparent process that does not require large number of resources, therefore especially suitable for small/mid size companies that deal with multiple projects.
Hans F.W. Hoogkamer, Senior Director, Strategic Portfolio Planning, Actelion Pharmaceuticals
10:05 Morning Refreshment Break
10:25 Optimizing Early Product Value via Indication Expansion
A key strategy of Product Life Cycle Management is the optimization of product value via the expansion of possible indications. This strategy is critical to improving the value of each product in your portfolio. If carried out properly each product can be found to have multiple potential disease applications. Whether your company can optimize this value itself or you require a partner, the optimized value should not go unnoticed. Good diligence to your Executive Management should include a thorough review of this strategic exercise for each product asset in your portfolio. This session will help provide some basic tools to carry out this exercise.
Debra K. Bowes, MT, Principal, Chevy Chase BioPartners, LLC
11:05 Utilization of Drug Delivery Technologies in Product Lifecycle Management
With the slow down in productivity from big pharma’s R&D efforts and the significant growth in numbers of specialty pharma companies, the number and the value of deals involving drug delivery technologies are growing. Many companies are seeing the opportunity to incorporate delivery technologies into their product line as a low risk, relatively low cost way to shore up their pipelines and grow revenues. This presentation will review a number of examples of how this strategy was successfully implemented and discuss the role that drug delivery can play in managing pharmaceutical brand lifecycles and the value that can be captured by doing so.
John Taylor, Director Business Development, Eurand Pharmaceuticals
11:45 Expanding Markets and Expanding Margins: India as Part of Life Cycle Planning
Big Pharma has been turning to India for everything from discovery research to global supply manufacturing, but small and mid-sized pharmaceutical and biotechnology companies have been much slower to make similar moves. Clinical trials, formulation development, manufacturing and regional licensing are some of the “Indian options” that small and medium sized companies can use to reduce the costs of life cycle management and to expand their market in both current and future indications.
While every situation is different, this presentation will focus on the opportunities (and some of the challenges) that smaller companies should consider when thinking about India as part of an overall product life cycle management strategy.
Mark Ravera, Principal and Managing Director, Strategic Pharma Consulting
12:25 Lunch
1:25 Pharmaceutical Life Cycle Management in the Changing Patent Landscape
In the past few years, there has been much public debate about the quality of patents, and pressure to make patents harder to obtain and enforce based on the perception that competition is being stifled by worthless patents. Recently, the Supreme Court, the Federal Circuit (the patent appeals court), the legislature, and the Patent Office have modified or sought to modify long standing patent law and procedure in apparent response to this pressure. Both class action lawyers and the government are aggressively suing pharmaceutical companies for antitrust violations arising from alleged “sham” patent litigations and settlement agreements.
This presentation will summarize recent court decisions and pending legislation and regulations that may significantly alter what is patentable and how patents are obtained, as well as the viability of certain agreements with generic companies. As a result of the changing landscape, pharmaceutical and biotech companies need to reevaluate their life cycle management strategies.
Topics to be covered in this presentation include:
Janet Linn, Partner, Morgan, Lewis & Bockius LLP
2:05 Regulatory Strategies for Product Lifecycle Management
Pharmaceutical product lifecycle management can be used to further extend the value of a product by meeting unmet medical needs of patients. Early development of an effective regulatory strategy is essential to bringing such innovations to market.
Understanding the regulatory landscape is an important first step in product lifecycle management as this can guide the decision making process. With pharmaceutical research and development becoming increasingly global, it is necessary to keep the regulatory requirements of multiple countries in mind along with the marketing needs of each of these countries, in order to develop a viable product lifecycle management plan.
This presentation will include case studies of drug development programs that were able to successfully manage their product lifecycle by focusing on delivering additional value to the patient. Regulatory strategies used in each case study will be discussed.
Chitkala Kalidas, Ph.D., Director, Global Strategic Regulatory Development, Merck & Co.
2:45 Afternoon Refreshment Break / Networking Session
3:15 Targeted Drug Delivery as a Means to Improve Drugs and Manage Product Life Cycle - A Case Study of the Lung
Drug delivery has long been an approach to improve safety and efficacy of new and existing drugs and to extend the patent life. One specific strategy is to use drug delivery approaches to target specific organs (or compartments) in the human body. By doing so, the drug can be concentrated in the target organ, thus improving efficacy, reducing systemic toxicity and extending patent life. The presentation will contain discussion on:
Paulo Rangel, Partner, ProPharma Partners International
3:55 Enhancing Product Value Through Early Commercial Input and Improved Management of Project Risk Structure
This presentation will cover the following:
Dr. Kerstin M. Bode-Greuel, Managing Partner, Bioscience Valuation LLC
4:35 Wine and Cheese Reception
7:45-8:30 Breakfast
8:30 Chair’s Opening Remarks
Tariq Arshad, MD, Senior Manager, Commercial Development, Pfizer
8:45 State of the Industry: An Overview of the Fundamental Shifts in Biopharmaceutical Commercialization
The biopharmaceutical industry is experiencing a time of great upheaval and unprecedented change on almost every front. Over the last few years we have seen fundamental shifts in key areas of the industry, such as pricing & reimbursement, regulatory, marketing, strategic business planning, licensing etc. As we enter 2008, this rate of change is only increasing and is now assailing us at breakneck speed. In his presentation, Dr Arshad will provide an overview of these fundamental shifts, contextualize their impact on the industry and provide a framework to evaluate how these trends will continue in 2008 and onwards.
Tariq Arshad, MD, Senior Manager Commercial Development, Pfizer
9:25 Crystalline Form Screening to Optimize Patent Protection and Life Cycle Management
Preclinical stage polymorph screening and salt screening services can assist in identifying the optimal solid form for a given compound to be used for further development and clinical trials. For compounds that are difficult to crystallize, alternative routes can be investigated such as co-crystallization and stabilization of the amorphous form. Typically during phase II clinical trials, increased attention is placed on enhancing patent protection. Comprehensive screening programs are the basis for a successful patent strategy and potential patent extension.
This presentation will cover the following:
Gus Scheefhals, Chief Business Officer, Avantium Technologies
10:05 Morning Refreshment Break / Networking Session
10:35 Lifecycle Management Strategies: Opportunities and Pitfalls
This session will explore the latest developments affecting pharmaceutical lifecycle managements strategies, including patent certification, non-patent exclusivity and the new provisions added by the Food and Drug Administration Amendments Act of 2007 creating additional exclusivity opportunities but also limitations on the filing of Citizen Petitions to protect exclusive marketing rights.
Scott Lassman, Partner, Wilmer Cutler Pickering Hale and Dorr, LLP
11:15 Life Cycle Management via Transdermal Delivery
Life cycle management of injectables and other products currently delivered in sub-optimal administration routes may benefit from innovative drug delivery methods. The ViaDerm, a novel, active transdermal drug delivery system is designed to improve the effectiveness of both small and large molecules, such as high molecular weight proteins. TransPharma’s technologies and the dry protein patch are incorporated into the system. The RF-MicroChannels is a new innovative electronic based technology that creates microscopic controlled passageways on the very outer layer of the skin.
This presentation will:
Judith Kornfeld, Vice President of Business Development, TransPharma Medical
11:55 Payer Considerations and Value Assessment in Pharma / Biotech Product Development
Value creation—for any product lifecycle management strategy—depends on a compelling value story for the product. Traditionally, product value in the pharmaceutical and biotechnology industry has depended primarily on evidence of safety and efficacy. Today, evidence-based medicine and coverage and reimbursement evaluations increasingly require direct evidence of patient benefit and economic impact.
Quantitative assessment of scenarios around the likely value story for payers early in the product development cycle may change development plans, ultimately affect a product’s uptake trajectory, and consequently have implications for NPV. Increasingly, partners, investors, and bankers are assessing these attributes in their own valuation assessments. Portfolio and individual product assessment must fully integrate payer considerations into commercial analysis, which is critical for licensing strategy and negotiations. This presentation will assess the role that payer considerations can play in a strategic valuation and focus on approaches for integrating their implications in quantitative assessment.
Anita Chawla, Ph.D., Vice President, Analysis Group
12:35 Lunch
1:35 Data and Analysis of Partnering Deals and Alliances
This presentation will cover the following:
Chris Dokomajilar, Business Development Analyst, Recombinant Capital
2:15 Emerging Distribution Models for Small Market Products
Typically, manufacturers of small market biotech products look to specialty pharmacies and specialty wholesalers for distribution of their products. However, an accelerated move towards ASP-based reimbursement is eliminating much of the margin that these channel providers have enjoyed in the past.This will drive a move toward fee for service distribution models. One such model treats pharmacy distribution services (direct to patient) as simply the final link in an overall 3PL strategy. In this session, participants will hear and discuss the following topics:
Craig L. Kephart, Chief Executive Officer, Centric Health Resources
2:55 Close of conference