The Food and Drug Administration Amendments Act of 2007 (FDAAA), effective on October 1, 2007, has been hailed as the most comprehensive change to the Federal Food, Drug, and Cosmetic Act (FDCA) since 1997.

This session will focus on the business and legal implications of key provisions in the new law, including the reauthorization and addition of prescription drug user fees, the FDA's enhanced regulatory authority to monitor the safety of marketed prescription drugs, the new penalties for violations, and the addition of incentives for development and oversight of prescription drugs for pediatric use.

Industry leaders will discuss short-term solutions and long-term strategies to address the fast-paced and uncertain environment created by the FDA's new authority.

Key learnings will examine the law's requirements regarding:

• Post approval safety studies
• Post approval label changes
• Risk Evaluation and Mitigation Strategies (REMS)
• Clinical trial databases
• Advertising

Moderator:

• Paul Woitach, managing partner, Pharmaceutical Advisors LLC

Panelists:

• Edgar Adams, ScD, executive director, epidemiology, Covance Inc.
• Maurice Briggs, Ph.D., former senior director, regulatory affairs, Genmab, Inc.
• Manya Deehr, chief legal officer, Eurand
• Robert Hrubiec, Ph.D., J.D., vice president, intellectual property, Cephalon, Inc.

Different regulations and procedures for initiating clinical trials apply in the US and individual countries throughout Europe. This session will provide a forum to discuss and compare the initiation of studies in the US (IND submission and next steps) versus Clinical Trial Applications (CTAs) in Europe and other countries. This is particularly relevant for Phase 2 and 3 trials that require international studies to achieve expeditious enrollment for proof of concept or rigorous studies to demonstrate efficacy and safety.

Topics to be discussed include:

• Content of an IND vs. CTA
• IMPDs required for each product used in a CTA
• Requirements for national and local Ethics Committee approvals - coordination with Health Authority approval
• Contracts with the sites
• Working with a scientific group (NIH, EORTC, SWOG, etc.)
• Sponsorship of the trial
• Interpretation of the Clinical Trials Directive
• Handling Protocol Amendments

Moderator:

• Robert Pietrusko, Pharm.D., vice president, global regulatory affairs and quality, ViroPharma Incorporated

Panelists:

• Glenn Gormley, M.D., Ph.D., president and CEO, Gemin X Pharmaceuticals, Inc.
• Ross Murdoch, Ph.D., senior vice president, emerging business unit, Shire Pharmaceuticals
• Navaneetha Rao, Sc.D., vice president clinical research and development, Vicus Therapeutics
• Bruce Wagman, RN, MBA, RAC, vice president, regulatory affairs and quality assurance, clinical development services, Covance Inc.

Assuring regulatory compliance during drug development requires a dedicated and focused effort, especially in a small start-up biotech company where personnel and/or financial resources may be limited. 

This session will review the practicalities of, and need for, a structured and compliant infrastructure to manage effectively and support the regulatory drug development process as it pertains to:

• FDA
• Clinical trials - GCP
• Manufacture - GMP
• Internal documentation systems and tracking

The session will also examine how to steer through the complexities of collaborating with CROs and other support organizations to assure quality in late-stage clinical development and the perils and pitfalls experienced by other companies that have built and lived through the evolution from start-up to commercial entity. 

Moderator:

•  Gerard Norton, Ph.D., partner, Fox Rothschild LLP

Panelists:

• Arthur Caplan, Ph.D., chair, department of medical ethics, University of Pennsylvania
• King Lee, Ph.D., R.A.C., vice president, regulatory and clinical affairs, Cornerstone Pharmaceuticals, Inc.
• Julia Lukas, director, regulatory affairs compliance, sanofi pasteur
• Chris Szustkiewicz, Ph.D., MBA, vice president of regulatory affairs & compliance, Lux Biosciences