Recommended Pre-Conference Short Course (SC)*

SC4: Protecting Your Pharmaceutical Inventions with Patents  Patents are at the very core of strategic decision making at pharmaceutical companies, large and small. They impact research and development, commercial products and investor financing. Very often, patent applications are written and filed with the USPTO and issued long before FDA approval and commercial production. Given the nature of  pharmaceutical development, patents need to be forward-thinking and cast a broad net not only to cover your own eventual commercial embodiments but also your competitors’ commercial embodiments. Once a patent issues, goals of enforcement and/or licensing come into play. Every company that relies on innovation should have a sound patent strategy to protect the fruits of its labors. This requires at the outset, an effective recording and reporting program to maximize the benefits of scientific discoveries. Is an electronic recording system the best choice? Once the discoveries are recorded and reported, there are many questions that require answers, such as:  How do you decide which inventions merit a patent application and when do you file? What are the best strategies for seeking and obtaining patent protection in view of shifting standards of patentability?  How do you ensure that your patent portfolio prote cts your commercial products and methods and provides you with a competitive edge in the marketplace?  When do you examine your competitors’ patents and patent applications?  Do you need product clearance opinions?  What do your issued patent claims mean? Can you or your issued patents withstand litigation?  And even if you win, can you still stop your competitor?  Our expert instructors will lead an interactive workshop into the cutting edge areas of patent law of most interest to corporate executives, whether in-house counsel, technology officers or CEOs. Short Course Leader: John P. Iwanicki, Esq., Senior Partner, Banner & Witcoff, Ltd.  Instructors: Peter D. McDermott, Esq.                   Sarah A. Kagan, Esq.                   Ernest V. Linek, Esq.                   Joseph M. Skerpon, Esq.                   Jon O. Nelson, Esq. Our expert instructors will lead an interactive workshop into the cutting-edge areas of patent law of most interest to corporate executives, whether in-house counsel, technology officers or CEOs.

7:30 am Registration & Morning Coffee

8:30 Chairperson: John P. Iwanicki, Esq., Senior Partner, Banner & Witcoff, Ltd

8:40 Utilizing Biomarkers for Decision Making in Early Stage Discovery & Development

• Biomarkers represent tools to improve target identification and target validation, and identify beneficial and adverse drug effects and a way of segmenting patient populations for personalized medicine approaches. 
• Biomarkers also represent ways of accelerating R&D, improving decision making, and gaining greater insight into novel mechanisms in diseases processes. 
• Integrating biomarkers across R&D improves quality and has the potential to 
  improve productivity, addressing the declining number of new drug approvals in the US, EU and Japan. 
• Biomarkers are an important and integral component of many of the new initiatives in industry and the regulatory agencies, such as the Critical Path Initiative at the FDA. 
• This presentation will describe a new conceptual framework with specific worked examples of how we can improve in R&D.

Harsukh Parmar, Ph.D..Executive Director, Global Discovery Medicine, Respiratory & Inflammation Therapy Area, AstraZeneca

9:25 Safety Evaluation Strategies - Can They Be Standardized in Early Stages?

• Sources of safety information related to target
• A tiered strategic approach to evaluation
• Evaluating toxicity signals related to targets

Michael W. Leach, DVM, Ph.D., DACVP, Senior Director, Exploratory Drug Safety, Wyeth Research

10:10 Networking Coffee Break

11:00 Systems Biology: A New Hope for Drug Discovery? 

• The explosion of biomedical information following the mapping of the human genome has contributed to significant advances in understanding disease mechanisms at the molecular level, and raised the hope and expectation that novel therapies would rapidly emerge. This has proven not to be the case. 
• The increased focus on studying specific molecular targets and single chemical 
  entities in isolation may be misleading and may contribute to the failures seen in development, once the target is seen to operate in its natural physiological networks.
• There is increasing interest in the use of systems-based, as opposed to    target-driven, approaches to tackle this problem. Systems Biology offers the hope that issues arising from a lack of understanding of the target in its true context may be addressed through a combination of modelling and experimentation. 
• This talk will present a current perspective on Systems Biology and its application  to drug discovery & development. 

Adriano M. Henney, Ph.D., Director, Global Discovery Enabling Capabilities & Sciences, AstraZeneca

2:00 Chairperson: Peter D. McDermott, Esq., Partner, Banner & Witcoff, Ltd

2:05 Licensing Early-Stage Programs from Academia and Biotech - a View from the Inside

• Comparing the types of opportunities available in academia and early stage  
  companies - targets, technologies and compounds 
• Deal structures and collaboration opportunities 
• Contrasting approaches to marketing - how to find the nuggets if you are the 
  licensor 
• Dealmaking priorities on both sides 
• Alliances and alliance management

O. Prem Das, Ph.D., Senior Vice President, Technology Partnerships, Praecis Pharmaceuticals Incorporated; formerly Director, Office of Technology Licensing, Harvard Medical School and Associate Director, Office of Industrial Affairs, Memorial Sloan-Kettering Cancer Center

2:50 Patents: The Sword and the Shield in the High Stakes World of Pharmaceuticals

• Your company has already spent years of research and development followed by the FDA approval process, and not to mention substantial financial    resources to finally get your company’s next pharmaceutical to market. 
• As soon as your company’s drug product enters the market, your company receives a threatening letter from your competitor demanding that your  company pull your drug product from the market or suffer an immediate injunction and money damages because they say your company infringes on a patent they obtained a few years ago. 
• At the same time, your company learns that the same competitor has announced a new product that claims to have the same therapeutic effect as your company’s product. 
• To make matters worse, your company’s successful drug product is about to come off patent and a competitor has just filed an abbreviated new drug application so they can market a generic version. 
• Can they do that? 
• How does your company enhance its position and strength in a highly competitive market? How can patents be used as both a sword and a shield to help your company attain its business objectives?
  John P. Iwanicki, Esq., Senior Partner, Banner & Witcoff., Ltd.

3:35 Networking Refreshment Break

5:30 Happy Hour in the Exhibit Hall
Enter to win and iPod® nano!  
Enter at the CHI registration desk. Winner will be announced in the exhibit hall. You must be present to win.*

7:00 am Registration & Morning Coffee 

KEYNOTE SESSION

8:30 Keynote Introduction 8:40 Target Discovery: Seeking Innovation and the Role of Collaboration with Biotech and Academia Jeremy Levin, D. Phil, MB. Bchir, Global Head, Business Development and Strategic Alliances, Novartis 9:10 Reducing Clinical Attrition through Efficiencies in Discovery Joseph Bolen, Ph.D., Senior Vice President, Research & Drug Discovery, Millennium Pharmaceuticals