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.
White paper
Accelerated Approval with Inadequate CMC Program Development
This white paper examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s […]
White paper
Understanding Right-to-Try and FDA’s Expanded Access
You may be familiar with Right-to-Try, but what does it actually mean for product sponsors? This white paper explores both Right-to-Try legislation and existing Expanded Access Programs, including: Understanding sponsor […]
White paper
To SPA or Not to SPA: That is the Question
In this white paper, “To SPA or Not to SPA: That is the Question. Understanding Special Protocol Assessments,” David Shoemaker, SVP of Research and Development at Rho, provides strategic recommendations […]
Webinar
Protocol Design: What You Need to Know to Ensure a Successful Study
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this webinar, Dr. Shoemaker and Dr. Kesler
Webinar
Get Your Development Program Started on the Right Foot
This webinar will review the content of both the Target Product Profile (TPP) and the Integrated Product Development Plan (IPDP), demonstrate how they are written, and provide specific examples of decisions that
Webinar
Small Size, Big Plans – Product Development Advice for Small Companies
Pursuing big pharma dreams on a small budget? This webinar will discuss product development strategies for small biotechnology and pharmaceutical companies.
Webinar
Right-to-Try or Right-to-Ask? Understanding Right-to-Try and FDA’s Expanded Access
This webinar explores both Right-to-Try legislation and existing FDA Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs,
White paper
Accelerating Regulatory Product Development and Approvals in the US
The FDA’s Accelerated Approval, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations were created to help speed up the approval of drugs and biologics that effectively […]
Blog
Is a Target Product Profile Worth the Effort?
Perhaps the greatest value of the TPP is as a communication tool. The ultimate goal of the development program is shared clearly and continually with all the company disciplines, e.g., clinical, preclinical, chemistry manufacturing and controls, regulatory, and marketing. The TPP is also able to be used as an external communication tool that facilitates interactions with regulatory authorities, investors, and the media.