Join us on August 21st at 1PM ET for the webinar "Small Size, Big Plans – Product Development Advice for Small Companies."
Today’s drug development industry is comprised of more and more small- to mid-sized biotechnology and pharmaceutical companies and less and less big pharmaceutical giants. As such, companies are charged with making the most out of their finite resources (time, money, and personnel) to successfully bring products to market. This webinar will provide advice on how to set your small company up for long-term success through the use of strategic development plans, purposeful outsourcing, patent protection, partnership strategies, and provide specific examples of success stories and lessons learned.
David Shoemaker, Ph.D.
Senior Vice President, R&D
Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development. He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents. He has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs. He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs. Dr. Shoemaker has moderated dozens of regulatory authority meetings for all stages of development. His primary areas of expertise include clinical study design and regulatory strategy for development of novel drug and biological products.
Lauren Neighbours, Ph.D., R.A.C.
Lauren Neighbours, Research Scientist, is a regulatory program manager with experience leading cross-functional teams for clinical operations and regulatory submissions programs. This experience includes coordinating and overseeing the strategy and operations of full-service clinical studies and multidisciplinary product development programs throughout the development lifecycle. Dr. Neighbours partners with early-, mid-, and late-stage companies to develop and refine strategic development plans, design and execute clinical studies, lead regulatory submissions, and provide support for regulatory authority meetings and other consulting needs. Dr. Neighbours has authored a variety of clinical and regulatory documents, and has contributed as an author to multiple IND/CTA and NDA dossiers.
Sheila Bello-Irizarry, Ph.D., R.A.C.
Integrated Product Associate
Sheila Bello-Irizarry is actively involved in product development in the areas of protocol development, clinical feasibility, regulatory submissions and authoring including INDs, NDAs/BLAs modules, orphan-drug designation applications, among others. Dr. Bello Irizarry was part of the Global Community Advisory Board for the NIH funded HIV Vaccine Trials Network, AIDS Clinical Trials Group, and the Pediatric HIV Program for 8 years. At the local Community Advisory Board in Rochester, NY, she was part of the Outreach Committee contributing to community education and encouraging minorities to participate in clinical trials.