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.

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Webinar

Expedited US FDA Development and Approval Programs for Serious Conditions

The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately.  Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program.

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Webinar

Regulatory Agency Meetings – Your guide to EOP2 meeting preparation

The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission.  Companies nearing completion of their phase 2 studies or who are planning phase 3 programs will benefit from this webinar.

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Webinar

Understanding New Drug Applications (NDAs)

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market.  This webinar will help you understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and provide tips that can help you avoid common pitfalls in the submissions process.

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Webinar

Development Advice for Gene Therapy Products

In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy.  The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products.  This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development.

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Webinar

Tips for a Successful NDA Submission

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market.  This webinar will share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.