David Shoemaker, Ph.D.
Senior Vice President, Research & Development
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.”
Content by David Shoemaker, Ph.D.
Blog Post
FDA’s Project Orbis: Trendsetter or One-off
With the announcement of Project Orbis, FDA’s Oncology Center of Excellence (OCE) excited both patients and the pharmaceutical industry with the program’s future possibilities for collaborative regulatory authority interaction in accelerating product approvals worldwide. Is this the tip of the iceberg for process improvement?
Blog Post
Revised Draft Guidance: Formal Meetings with the FDA for Drug Products
On 29 December 2017, the FDA released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” This draft guidance replaces the previous draft guidance posted in 2015 on this topic. According to the draft guidance, from this point in time there will be 4 types of formal meetings with FDA staff. Read more to get the details on each one.
Blog Post
Could Your Drug Development Program Benefit from an NDA/BLA/PMA Gap Analysis?
Whether you plan to file a new drug application (NDA), a biologics license application (BLA), or a premarket approval application (PMA) with the FDA or a marketing authorization application (MAA) with the European Medicines Agency, you’ll need an in depth understanding of how the data you have from your clinical studies, nonclinical studies, and Chemistry, Manufacturing and Controls (CMC) / Quality development map to the requirements of the application.
