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

NOTE: BayBio2008 has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.


Track Sponsors:



With Support From:

Three Paths, One Goal: Preparing for Regulatory Submission Compliance
9:45am – 11:00am

For many companies, an NDA may be years off. As the current regulatory climate shifts, agencies are changing the required formats to submit data and documentation. In the face of more stringent standards, companies need to collect, analyze and report data in various formats depending on regulatory specifications. A compliance-driven approach to managing the business will become a strategic priority for many organizations in the coming years. A panel of three California-based companies will discuss various paths to compliance – from building an IT infrastructure and compliance knowledge base internally, to “renting” software so as to keep the company’s operations lean, to outsourcing all non-core functions such as submission compilation. This panel will also discuss the technology and process requirements of emerging companies, as well as apparent disconnect between emerging companies thinking about globalizing their clinical development processes while still using “paper” regulatory submission processes.

Panel Moderator:

Annette Nilsen
Senior Regulatory Consultant / Professional Services, Image Solutions, Inc.

Panel Speakers:

Nilda Badea-Patterson
Operations Specialist, Regulatory Affairs, CEREXA, Inc.

Emily Onkka
Associate Director, Regulatory Operations and Submissions, Cadence Pharmaceuticals, Inc.

Steven Sharkey
Senior IT Program Manager for Development Informatics, Theravance, Inc., Theravance, Inc.

Changing Landscape of the Regulatory Pathway for Follow-on Biologics
11:30am – 12:45pm

This session will discuss the changing landscape of the regulatory pathway for follow-on or generic biologics. The session will discuss current lack of an approval pathway for follow-on biologics under the Public Health Service Act, which provides the statutory framework for marketing approval of biologics via a Biologics License Application, or BLA. This is in contrast to the Federal Food, Drug, and Cosmetic Act, which specifically provides for marketing approval of generic drugs through an Abbreviated New Drug Application. This session will discuss current legislative activity in Congress that is aimed at giving FDA the authority to approve follow-on biologics. The session will focus on the regulatory and scientific challenges in demonstrating comparability for biologics, the size and scope of clinical data required for approval, “substitutability” or bioequivalence rating of the generic biologic, marketing exclusivity for innovator products, and intellectual property concerns. The session will discuss the consequences for innovator products of a new regulatory pathway for follow-on biologics in the US.

Panel Moderator:

Joyce L Morrison
Vice President, Intellectual Property, Xencor, Inc.

Panel Speakers:

Sandra J.P. Dennis, Esq.
Deputy General Counsel for Health Care Regulatory Affairs, Biotechnology Industry Organization (BIO)

Renee Kosslak, PhD
General Patent Counsel, PDL BioPharma, Inc.

Phoebe Mounts, Esq.
Morgan, Lewis & Bockius, LLP

Global Clinical Trials: Potential Pitfalls of Offshore Trials
2:15pm – 3:30pm

In 2005, nearly half of the 1,200 clinical trials conducted by the 12 largest US pharmaceutical companies included an offshore location, according to an analysis by consulting firm AT Kearney. Large enrollee populations and lower costs have induced an increasing number of early-stage life science companies to conduct clinical trials overseas in such far flung jurisdictions as China, India and Eastern Europe. However, conducting a clinical trial overseas also entails risks, and a sponsor must address myriad legal, regulatory, ethical and practical considerations in ensuring that timelines and budgets are met, and that data collected from foreign sites are suitable for use in US FDA submissions. This session will evaluate the key business and regulatory issues associated with foreign studies, and the common pitfalls encountered by US companies in conducting offshore trials: Ensuring compliance with US regulatory requirements (IND v. non-IND studies); Ensuring compliance with local requirements; Effective utilization and management of CROs and other vendors; Managing budgets and resources; Managing foreign sites and investigators; Common pitfalls and roadblocks (e.g., contracts, timely regulatory approvals, dealing with cultural issues).

Panel Moderator:

John Manthei
Partner, Latham & Watkins LLP

Panel Speakers:

Eric Humphriss
Senior Director for Clinical Affairs, ChemGenex Pharmaceuticals

Kent Thoelke
Senior Vice President, Scientific & Medical Affairs, PRA International

Getting Paid: Managing Your Downstream Risk
3:45pm – 5:00pm

This session would be devoted to helping companies with medical products on the way to market understand how regulation by U.S. federal government agencies may affect their prospects. After approval for marketing by the Food and Drug Administration, the post-approval picture presents another whole world. Medicare and other payers must wrestle with whether to pay for products and how to add them to the benefit packages of their insurance products. Speakers in this session will explore the basics of approval and payment, focusing on the pitfalls and potential problems companies should be aware of early in their planning processes.

Panel Moderator:

Thomas A. Gustafson, PhD
Senior Health Policy Advisor, Arent Fox LLP

Panel Speakers:

Jon Freudman, MD
PrFreudman Healthcare Consulting LLC
Former Director, Medical Policy Department, Blue Shield of California

Peter Hardovic
Vice President for Business Development and General Counsel, Laserscope, Inc.

Susanne Machacz, MPH
Senior Director, Xcenda