Insights on Improving Global Drug Development from Bench to Commercialization

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Speaker:
William Hanlon, PhD, VP, Head of Global Regulatory Affairs, Covance

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.