2008年5月1日

7:30-8:30 Workshop Registration and Breakfast

8:30 Pre-Conference Workshop: Best Practices in Licensing and Deal-Making

10:15-10:30 Networking and Refreshment Break

12:00 Workshop concludes / Conference registration begins

12:00 - 1:00 Lunch for Workshop participants

1:00 Chair’s opening remarks

Howard Wachtler, CEO, Actinium Pharmaceuticals

1:10 Presentation TBA

Andrew Forman, Sr. Analyst & Managing Director, WR Hambrecht

1:40 Electroporation as a Clinical Stage Technology for Intracellular Delivery of Nucleic Acids

In general, clinical trials using conventional injection of DNA-based products have produced disappointing results, likely due to inefficient intracellular delivery of the DNA. In comparison to conventional injection, electroporation dramatically enhances both the delivery of nucleic acids into cells and the resultant biological responses. Electroporation mediated DNA delivery is currently being evaluated in a number of clinical trials for DNA vaccines. This session will cover the following topics:

• Ability of electroporation to enhance intracellular DNA and RNA delivery, and resulting biological responses
• Overview of clinical electroporation technologies, including Ichor�fs TriGridTM Delivery System
• Current clinical trials utilizing electroporation to deliver DNA vaccines

Claire Evans, Ph.D., Director Protein Therapeutics, Ichor Medical Systems

2:10 Novel Injectable Delivery Systems for Biologicals

Biological drugs represent one of the most important and fastest growing segments of the pharmaceutical industry. Promising areas for future growth are monoclonal antibodies and vaccines. These agents present considerable delivery challenges. A number of delivery technologies are being investigated that may facilitate administration and improve outcomes.

• New Self-Injecting systems
• Subcutaneous Delivery of Monoclonal antibodies and other drugs requiring high volumes
• Enhancing vaccination using microneedles.
• Lymphatic delivery using microneedles for potential treatment of diseases such as metastatic cancers.

Philip G. Green, Ph.D., Director Alternative Delivery Systems, BD-Medical Pharmaceutical Systems

2:40 The Staccato System: Inhaled Drug Delivery for Rapid Relief of Acute Systemic Medical conditions

The Staccato system technology is the basis of a novel drug delivery via inhalation for treatment of acute and intermittent conditions, such as pain, migraine, panic and agitation. The technology enables precise, drug delivery via the lungs to the systemic circulation, thus generating a rapid onset of effect, comparable to IV. Its core principal is thermal transformation of pure, excipient-free drug into an aerosol that is inhaled by a patient. The Staccato system technology has been proven in 6 product candidates to date, with the most advanced program in Phase III clinical trials.

This session will cover the following:

• Key features of Staccato technology
• Differentiation of Staccato system technology vis a vis other inhalation and drug delivery systems
• Technical, strategic and commercial assessment of compounds for Staccato technology

Tatyana Naranda, Director Business Development, Alexza Pharmaceuticals

3:10 - 3:30 Networking and Refreshment Break

3:30 Protecting Intellectual Property 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 �gsham�h 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 relationships of licensors and licensees. As a result of the changing landscape, life science companies need to reevaluate how they protect their intellectual property.

Topics to be covered in this presentation include:

• Recent decisions on patent validity and the effect on drug delivery patents

• Recent decisions affecting license agreements

• The patent application process under the pending Patent Office rules

• Proposed patent reform legislation in Congress

• Listing drug delivery patents with the FDA: to list or not to list?

Janet Linn, JD, Intellectual Property Expert

4:00 Molecular Imaging and Drug Delivery

This presentation will outline the basics of molecular imaging and how this process can aid with the drug delivery and discovery process.

This presentation will cover the following key areas:

• Lesion detection (diagnosis)
• Patient stratification
• Dose scheduling (pharmacokinetics)
• Treatment monitoring (pharmacodynamics)
• Drug screening/optimization

Shawn Chen, Ph.D., Assistant Professor, Stanford University School of Medicine

4:30 Understanding Regional Bioavailability as a Driver for Realising the Success and Value from Modified Release Oral Formulations

The physicochemical properties of many new chemical entities present significant biopharmaceutical challenges for oral drug delivery. Furthermore, patient-friendly dosage regimens are now seen as a requirement for these new products as well as a driver for traditional life cycle management activities. The mapping of regional bioavailability in humans has been proven as a pivotal tool in providing data-driven decisions for the selection of optimal formulation strategies to achieve desired in vivo performance, thereby offering substantial advantages over historical techniques such as preclinical and in vitro models.

Evidence will therefore be presented to show how data from human drug absorption (HDA) studies can be utilised to:

• Confirm the potential oral developability of the candidate molecule vrs the proposed target product profile
• Recommend specific Modified Release (MR) formulation technologies to achieve a desired pharmacokinetic (PK) delivery profile
• Generate a proactive �gMR formulation road-map�h to expedite initiation of PoX studies
• Explore enhanced IP protection, particularly in light of MR formulation �gobviousness�h challenges

Peter Scholes, Ph.D., VP Pharmaceutical Sciences, Pharmaceutical Profiles Ltd.

5:00 Transdermal Delivery: Reaching Beyond the Stratum Corneum Through RF MicroChannels

Transdermal delivery, although a preferable route of administration, has always been limited in its applications and growth due to an effective barrier- the Stratum Corneum, the most upper layer of the skin. The ViaDermTM system, a novel, active transdermal drug delivery system is designed to overcome the Stratum Corneum barrier by opening microscopic pores in a precise, effective, and reproducible manner. The pores created enable the systemic delivery of a wide range of molecules, including peptides and proteins.

In today’s pharmaceutical’s pipeline, major growth is expected to come from peptides and proteins based therapeutics and a delivery method which would offer safe and painless administration of such therapeutics is bound to be implemented into many therapeutic compounds, improving patients disease management and quality of life. The ViaDerm was developed to answer this apparent need. It has a significant potential to offer an alternative delivery route which entails many advantages: It avoids the need for injections, it offers a control over the blood drug profile, and increases drug safety. This system is low cost, small, user friendly and aimed to be self used at home especially by chronically ill patients. Examples of products being developed based on the ViaDerm system and the technologies underlying the system will be presented.

Judith Kornfeld, VP Business Development, Transpharma Medical

5:30 Wine and Cheese Reception

2008年5月2日

7:30-8:15 Breakfast

8:15 Chair’s Opening Remarks

Howard Wachtler, CEO, Actinium Pharmaceuticals

8:25 Presentation TBA

Mark Bunger, Research Director, Lux Research

8:55 Delayed Pulse Delivery as a Method to Overcome First Pass Effects

Oral drug delivery is the preferred route for administering drugs and extended release formulations are ideal because they give constant blood levels. However some drugs have a substantial first pass metabolism and extended release formulations exacerbate this problem. Additionally, many drugs are only absorbed in the upper gastrointestinal tract so the dosage form must be retained in this area to be effective. This presentation will focus on a recently developed gastric retentive pulsatile delivery system to over come both the first pass metabolism and the absorption window problems.

Verne Cowles, Ph.D., Sr. Director of Preclinical Studies, Depomed

9:25 Presentation TBA

Mark Matthews, VP Commercial Affairs, Javelin Pharmaceuticals

9:55-10:10 Networking and Refreshment Break

10:10 Collaboration and Licensing as an Approach to Solving Drug Delivery Problems

Yael Weiss, MD, Ph.D., Director Licensing and External Research

10:40 Presentation TBA

Shawn Cross, Managing Director, Investment Banking Healthcare, Thomas Weisel Partners

11:10 Waiting to Inhale: The Prospects for Inhaled Delivery Technologies

Despite the recent terminations by Pfizer/Nektar and Novo Nordisk of their respective inhaled insulin programs, many inhaled drug delivery programs continue to advance. This presentation will provide an overview of these programs and a critique of inhaled delivery technologies and commercialization strategies. At the end of the presentation and discussion, the audience will have an understanding of the opportunity for inhaled drug delivery and which technologies and strategies are best poised to capitalize on that opportunity.

Ed Cannon, Ph.D, CEO Aerovectrx

11:40 Prefilled Products, Platforms for Today and the Future

Prefilled products have gained significant acceptance in the market and are projected to continue to grow. Drivers for this growth include product differentiation, the impact of the age wave on medical facilities and staff, and the increased trend in home administration. The session will examine the current platforms, their flexibility, the need for improved cycle time for innovation and cost reduction, and a glimpse of what future platforms may have to evolve to in order to meet industries needs and customer�fs requirements.

Dr. Ron Forster, Director of Advanced Product and Materials Engineering, Amgen

12:10-12:55 Lunch

12:55 Key Factors in Ensuring Early Commercial Success in Specialty Pharma: Planning to �gGo it alone�h

While the biotech and specialty pharma sector have traditionally capitalized on late and lucrative partnerships from Big-Pharma to launch their products, tougher market conditions and a desire to return higher rewards to shareholders are paving a new �ggo it alone�h model in our industry. In recent times our industry has faced anemic and selective deal flow, increased competitive pressure, and a riskier regulatory environment laying the ground for young biotech companies to deploy their own commercial infrastructure and launch capabilities. It should be seen as a positive that a company�fs heavy R&D lifting can be rewarded commercially by launching a product and keeping 100% of the revenues.

However developing turnkey late-stage drug development capabilities- financially and operationally- while assessing M&A and in-licensing activity in parallel is a fine line to walk but ensures leaders seize the best opportunity and at the right time. Discover how leaders in biotech and specialty pharma market can achieve high returns partner or no-partner, benchmark your launch preparedness against those of the industry�fs leaders and identify an appropriate plan of action for your company. Ultimately regardless of whether a dream deal comes to fruition, it is best to put your company in the best negotiating position with a launch ready asset. Never build a company to sell and always launch a product right the first time.

Meghan Fitzgerald, Chief Business Officer, Vion Pharmaceuticals

1:25 Keys to a Successful and Profitable Contract Manufacturing Partnership

As drug manufacturers plan for the commercialization of their products, they will need to determine how their drugs will be delivered to the patient. Many drugs will require a separate delivery device. These devices may range from a simple syringe, to a complex device designed to deliver one or multiple doses to very specific sites in the body. In many cases, drug manufacturers will partner with a contract manufacturer to build these devices. Choosing the right contract manufacturing partner may make the difference between successful commercial launch or failure. The numerous considerations to take into account include: quality and regulatory status, core competencies, design for manufacturability, scalability and effective use of capital.

Topics to be discussed in this presentation include:

• Design and Development
• Manufacturing and Assembly
• Supply Chain Management
• Packaging and Sterilization
• Order Fulfillment

Walter Gacek, Director of Business Development, Accellent

1:55 Intracellular Drug Delivery Mediated by High Intensity Focused Ultrasound (HIFU)

Cell and tissue specific intracellular drug delivery in vivo is now possible, mediated by ultrasonic energy applied externally to specific regions of the patient. This is accomplished first by using novel, self-assembling polymeric nanocarriers to safely deliver therapeutics to the target site of the patient. Because of their multifunctionality, these therapeutic carrying vesicles may be passively or actively targeted using, for example, ligands such as antibody fragments or nucleic acid aptamers. Once the therapeutic containing nanocarriers are in treatment area, drug delivery commences following cell membrane disruption and nanocarrier disassociation by high intensity focused ultrasound (HIFU). Thus, non-invasive sonic energy being applied to the patient, directly and indirectly results in both therapeutic release and drug delivery to specific organs and tissues inside the body of the patient. Preferred therapeutics for use with this new drug delivery platform include the modern therapeutics of biotechnology, such as: nucleic acids, proteins, peptides, and other compounds.

This presentation will include the following:

• An overview of ultrasound�fs use in medicine including diagnostics and drug delivery applications.

• A discussion of the complex and competitive nature of ultrasound intellectual property

• An overview of acoustic cavitation, which is integral to the successful development of this new technology

• A summary of the future therapeutic applications for ultrasound drug delivery

Charles Hardy, President, Biovaluation and Analysis

2:25 Presentation TBA

2:55 End of Conference