Modern pharmaceutical development is expensive, time consuming, risky and has a very high attrition rate. However, historically, governmental regulation used to be far more lax.
The presentation will discuss the unique aspects of pharmaceutical development while emphasizing that it is critical at all development stages to keep the end goal in mind. The development process itself is rarely linear. Factors that may increase the overall risk of a program will be discussed with examples from successful and unsuccessful programs that have dealt with these issues. Finally, the modalities by which a CRO can offer support to de-risk the overall development program will be discussed.
Eric Lang, MD, VP, Molecule Development Group, Covance
Dr. Eric Lang is Vice President with the Molecule Development Group (MDG), a dedicated globally-focused drug development group that can work with clients through the various stages of drug development. MDG is focused on molecules entering into or already in the clinical phases of drug development and creates value by providing strategy and navigating to achieve drug development milestones.
Dr. Lang has more than 17 years of experience in drug development in the Pharmaceutical industry in both large and small pharma. His experience includes leading drug development teams that have successfully filed NDAs, directing clinical operations, clinical development, Pharmaceutical business development, and designing, planning, and directing regulatory strategies. Dr. Lang has negotiated with the FDA regarding clinical and regulatory development programs for drug and device approvals.
Prior to working at Covance, Dr. Lang was Vice President, Head of Clinical Development for Grünenthal USA Inc. Before that he was Vice President of Clinical Research at Javelin Pharmaceuticals and also held positions of Head of Clinical Research and Development at Novartis Consumer Health, Pain and Executive Director of Licensing and New Business Development at Johnson and Johnson.
Dr. Lang received his M.D. from Ben Gurion University of the Negev in Beer Sheba, Israel. He completed a fellowship in Clinical Research and in Acute and Chronic Pain at Emory University Medical School in Atlanta, Georgia. He is a board certified Anesthesiologist and Pain Management Specialist and has been published in many peer-reviewing research papers as well as book chapters and review articles.
Who Should Attend?
Chief Medical Officers, Chief Scientific Officers, Research & Development, Preclinical or Clinical Outsourcing, Medical/Regulatory Affairs and Business Development
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 12,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and Pharmaceutical clients’ toughest drug development challenges.