David Shoemaker, Ph.D.

Senior Vice President, Research & Development

David Shoemaker

David Shoemaker, Ph.D.

Senior Vice President, Research & Development

Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas.  Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities.  At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents destined for regulatory authorities and as an advisor to integrated product development program teams.  For the past 10 years, Dr. Shoemaker has also served as the Vice Chair of the Product Development Review Counsel and as a Product Development Review Committee Study Section Chair for the Cancer Prevention and Research Institute of Texas. He has helped oversee the distribution and management of over $440 million dollars in grants to 46 early stage pharmaceutical, biotechnology, and medical device companies.  Dr. Shoemaker’s primary areas of interest focus on the development of clinical protocols and clinical development plans for novel therapeutic products.

Why clinical research?

“I’m passionate about helping companies find the most expedient regulatory path to marketing approval. Ninety percent of products entering human studies fail to reach the market either because the product is not safe and efficacious or because a program is mismanaged with inappropriate priorities. I enjoy being able to craft a proactive integrated product development plan and to provide good program management and sound regulatory judgment to help ensure products will not fail due to mismanagement.” 

This is what drives David:

“My greatest pleasures derived from my work come when Rho gets a product on the market that will help patients fight off disease for the long-term. The more serious the disease the better! Recently, we were able to help a company get a product for multi-drug resistant tuberculosis approved in the US and EU which improved patients’ chances of survival from around fifty percent to close to ninety percent. That is when the work is most satisfying.”