Although R&D spending on new drugs is high and the number of new INDs for small molecules and biologics continues to increase each year, the number of NDAs/BLAs submitted and approved by FDA has remained on average steady over the last 10 years. This is not limited to the US and speaks to the complexity of drug development and navigating the global regulatory environment. Successful drug development requires a clear plan that starts with the end in mind. A well developed regulatory strategy that takes into account what the global business objectives are and factors in the regulatory needs to achieve those goals compliments a clinical development plan.
The presentation will discuss the importance of having a regulatory strategy, the specific elements that are considered when developing a regulatory strategy and will explore in more detail the value of a Target Product Profile, importance of conducting Agency meetings and the challenges of a global patient database on drug approvals.
Speaker
William Hanlon, PhD, VP, Head of Global Regulatory Affairs, Covance
Dr. Bill Hanlon is Vice President and Head of the Global Regulatory Affairs organization which includes the, Regulatory Strategy, Regulatory Submissions and Medical/Regulatory Writing & Publishing groups. Global Regulatory Affairs at Covance provides clients with a broad array of regulatory services to support the planning, development, reviewing, publishing and submission of regulatory documents to Health Authorities to support clinical trials, agency interactions and marketing applications globally. He and his group are also responsible for advising clients on global, regional or local regulatory strategy associated with pre-clinical or clinical study design, regulatory agency interactions, as well as for complete drug development programs. Bill and his team work with and advise internal cross-functional molecule development teams as well as external clients.
Prior to joining Covance, Dr. Hanlon was Vice President and Head of Global Regulatory Affairs at Archimedes Pharma in Bedminster, NJ where he led a team of regulatory professionals in the US and EU providing complete regulatory support for their flagship pain product, product lifecycle management, and molecules in their development pipeline. Prior to joining Archimedes Pharma, Dr. Hanlon spent more than 23 years at Merck Research Laboratories in Rahway, NJ. The first 14 years were in discovery research working on novel immunological and inflammatory targets, and the remainder of his time was in World-wide Regulatory Affairs developing regulatory strategy and leading Regulatory Authority interactions globally for internal drug development programs. Dr. Hanlon s final position at Merck was as the regulatory Therapeutic Area Co-Leader for the Cardiovascular/Atherosclerosis Franchise developing products for treatment of hypercholesterolemia, hypertension, atrial fibrillation, thrombosis and heart failure. During his tenure at Merck, Dr. Hanlon also led a late stage CV/Athero drug development team advancing double and triple combination products through the drug development process.
Dr. Hanlon received his PhD in biochemistry and cell biology jointly conferred from the University of Medicine and Dentistry of New Jersey (UMDNJ) and Rutgers Graduate School in Piscataway, NJ. He completed his post doctoral training at Merck Research Laboratories in Rahway, NJ.
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Covance
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.
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