Regulatory Affairs Compliance and Review
The management of science requires many converging forces that impact basic research, preclinical studies, clinical research and the broader development and operations of the research enterprise. Most graduate programs do not train bench scientists in these areas. However, many scientists transition into careers that allow them to take a central role in the oversight of science. The Regulatory Affairs, Compliance and Review Pathway holds three tracks that form the foundation of the management of science. All three tracks feed into positions found within all sectors of industry, various levels of government and academia. Dr. Joan Adamo, Associate Director, Regulatory Support Services and Assistant Professor of Biomedical Engineering, will coordinate this Pathway. Dr. Adamo currently manages University-wide Regulatory and Review issues, and teaches at the undergraduate and graduate levels. Prior to her position at UR, she spent five years in a Researcher / Regulator position in the Center for Biologics Evaluation and Research at the FDA.
Discuss ideas you have about gaining experience in Regulatory Affairs, Compliance and Review with Dr. Joan Adamo
Regulatory Affairs Track
As scientists move from academic training to an industry or a government research setting, bench research may still be a component, but layered upon this is the need to understand Regulatory Affairs that deal with current regulations that govern development, manufacturing and testing. Current regulations cover a wide swath of work from preclinical studies, clinical trials, product testing and data analysis all the way through labeling, marketing and distribution of regulated product. While US FDA or US Environmental Protection Agency (EPA) regulations would be most applicable to students moving through a biomedical or scientific training program, regulations flow from other sources such as Health Canada and the European Medicines Agency. This track will offer trainees foundational training in management and leadership through the Spring IND 494 Leadership and Management for Scientists or the Online AAAS Career Development Portal. Trainees will obtain formal instruction and networking opportunities through Fall BME 431 FDA & Intellectual Property and Spring BME 432 FDA & IP Commercialization. Top trainees interested in exploring independent study and research opportunities can also pursue a range of projects in regulatory science here at UR with Joan Adamo, Director of Regulatory Support Services or at outside agencies. We have had past trainees intern at FDA for a few months or a few weeks. Another great way to meet leaders at FDA is be crown winner of UR's America's Got Regulatory Talent Competition. If you think you have what it takes, contact Dr. Joan Adamo to learn more. You might also consider applying for a Regulatory Science Fellowship through PhRMA Foundation, which works with Sanofi, Johnson & Johnson, and Janessen. We’ve also had two URBEST trainees participate in Bayer’s Global Regulatory Affairs Internship.
Translational research brings research scientists closer to more highly-regulated fields. However, the jump from academic bench research to work in a regulated arena requires significant training and education. This program will provide students with the knowledge and practical skills to effectively support organizations performing Good Laboratory Practice (GLP)-, Good Clinical Practice (GCP)- and Good Manufacturing Practice (GMP)-compliant preclinical safety and toxicology studies, where controlled processes that ensure the validity and integrity of the data are mandatory. UR's Upstate Stem Cell cGMP (Good Manufacturing Practice) Facility has a quality system, is capable of producing stem cell-derived products, monoclonal antibodies and other materials for the purpose of pre-clinical and clinical trials and will provide a vibrant and hands-on environment for URBEST trainees to learn the fundamentals of compliance. The basis for compliance with any of these highly regulated fields is the ability to write, understand and follow Standard Operating Procedures. In addition to mastery of SOPs, the validation of processes and equipment used in a GMP facility will be a key component in this track. This track will offer trainees foundational training in management and leadership through the Spring IND 494 Leadership and Management for Scientists or the Online AAAS Career Development Portal. Top trainees interested in exploring independent study and research opportunities can also pursue a range of projects in research quality and compliance here at UR with Sharyl Zaccaglino, Director of Research Quality and Compliance at the Upstate Stem Cell cGMP Facility.
Programs, projects and grant proposals all require careful review by individuals who have a scientific background that enables them to make informed decisions about the potential success of each application. Whether the application is at the University review level or being evaluated for funding by a federal program, knowledge of core competencies is required for a successful review. Administration of funding programs requires a skill set beyond the solid foundation of writing and reviewing grants applications. It includes the ability to ascertain and clearly communicate pertinent information such as the merit of the project, potential risks and fit within the agency’s overall plans. Within this program, mastering skills such as writing study protocols, preparing applications and the ability to parse critical information must be developed concurrent with scientific expertise to enable scientists to hone their review skills.