Current track and session postings reflect confirmed speakers only.
Session information and speakers are updated on daily basis and are subject to change.


Track Sponsors:

Strategies and Best Practices for Outsourcing Preclinical R&D
9:45am – 11:00am

The pharma industry continues to downsize, and life sciences companies are often too small to handle research, discovery, development, manufacturing, and commercialization activities in-house. Increased use of collaboration, licensing, and outsourcing venues provide an attractive option that enables companies to focus on their highest value-added assets and leverage the experience and knowledge of others. Companies of all sizes, from virtual start-ups to large multi-national pharmaceuticals, are using everything from strategic alliances to fee-for-service models to support their drug and biologic development programs at all stages of R&D. This session aims to help those considering outsourcing to make educated decisions and find the right partners and CROs.

Panel Moderator:

Nathan Collins
Executive Director, Biosciences Division, SRI International

Panel Speakers:

Michael J Green, PhD
Senior VP, Research and Development, ViroBay, Inc.

Milan T. Tomic
Program Director, XOMA LLC

Ronald Wolff
Executive Director, Preclinical Safety Assessment, Novartis Institute for Biomedical Research

Accelerated Virtual Drug Development
11:30am – 12:45pm

Given the current and foreseeable economic environment, companies from early stage and emerging biotech's to large pharmaceutical firms are being forced to do more with less. In an effort to reduce and/or minimize direct expenditures, outsourcing has become part of many a company’s development strategy, which eliminates the need to incur long term funding commitments for infrastructure. Numerous options now exist for outsourcing but too often lack integration, which results in limited productivity gains. To address this issue there is a paradigm shift underway in drug development by some in the pharmaceutical industry from what was a FIPCO (fully-integrated pharmaceutical company) model to a VIPNET (virtually-integrated pharmaceutical network) model. Creation of novel business arrangements between sponsors and vendors are giving rise to accelerated development in a virtual world where realizations of both time and cost savings is clearly apparent. This seminar will describe the benefits and challenges of virtual drug development from the perspective of a virtual company along with a novel approach accomplished through a Virtual Drug Development Agent and show how it is created, and operated along with its features and benefits. This Session will bring together a panel of experts with different perspectives from biotech, venture capital and virtual organizations from the Bay Area - with experience and understanding of how to employ new business arrangements and strategies to sustain growth and drive value in a virtual world.

Panel Moderator:

Bill Kerns, DVM, MS, DACVP
President, Aptuit Consulting

Panel Speakers:

Kenneth M Ferguson, PhD
President and CEO, Imvaxyn, Inc.

Johnson Y.N. Lau, MB, BS, MD, FRCP
Chairman, XenoBiotic Laboratories; Chairman, Kinex Pharmaceuticals; Chairman, XBL China

Andrew Protter, PhD,
Vice President, Preclinical Development, Medivation, Inc.

Robert G. Urban, PhD
Executive Director, David H. Koch Institute for Integrative Cancer Research
The Massachusetts Institute of Technology

Essentials of a Strategic Clinical Development Plan
2:15pm – 3:30pm

Designing a well constructed development program has always been considered a useful step in the process for an emerging life sciences company, however not always considered a critical item for success. In the past, with ample venture funding and willing pharmaceutical suitors, companies had more time and resources to conduct pre-clinical or clinical studies and often had substantial margin for error. It is an entirely different story today. With considerably less funding to go around, record lows in drug approvals by the FDA and financial markets teetering on the edge of meltdown, an emerging company may only have one shot on goal. The development program must be well planned and executed flawlessly from the beginning. This means considering options for business models, regulatory pathways and exits strategies early. Having the right science is no longer enough for the emerging life sciences company – they need to have the right execution as well. This lecture will discuss how companies should match their development plans to their business models and exit strategies, while considering the best regulatory pathways and growth strategies for the life sciences company. It will examine case studies of what contributed to some companies’ success and choices that may have led other companies to failure. In this troubled financial market, emerging companies and executives cannot afford to learn as they go; rather they need to have the right strategies in place from the inception.

Panel Moderator:

Greg Dombal
Vice President, Regulatory and Clinical Affairs, Halloran Consulting Group

Panel Speakers:

Janice S. Drew, MPH
Senior Director, Clinical Development, Peplin Operations USA, Inc.

Mikhail Gishizky, PhD
Chief Scientific Officer, Entelos, Inc.

Brent Treiger, MD
Consultant

Matthew A. Wikler, MD, MBA, FIDSA
Chief Medical Officer, Institute for OneWorld Health

Stretching the Clinical Dollar in Challenging Financial Times
3:45pm – 5:00pm

Many people in the industry are talking about the problems with drug development, namely how expensive it is and how few regulatory approvals there are. Generally the conversation ends there, with high level theorizing on how to reduce spending and bring more drugs successfully through the approval process. The industry, as a whole, continues to search for changes in development methodology that lead to tangible outcomes, such as lower costs or increased speed. A disciplined approach to clinical and development decision-making is key to stretching the clinical dollar. This means making the investment in the right people and infrastructure while spending wisely, if not conservatively, on other aspects of development process. For example, designing and implementing an efficient study start-up process can position a study for rapid completion; a well thought out and executed development program can reduce delays in decision making; maximizing the data collected from each clinical patient and streamlining data monitoring and analytical processes may reduce the need for additional studies.

Panel Moderator:

Laurie Halloran
President and Chief Executive Officer, Halloran Consulting Group

Panel Speakers:

Connie Andrews
Director, Clinical Outsourcing, Exelixis Pharmaceuticals, Inc.

Bruno Gagnon
Senior Director, Clinical Operations, Roche Molecular Systems

Mari Maurer
Director, Clinical Operations, BioMarin Pharmaceutical Inc.

Bob Webber
Chief Executive Officer, TranSenda International, LLC

May Yau
Director, Clinical Operations, CardioDx