Highlights from the Regulatory Affairs Professionals Society (RAPS) 2017 Conference

(September 2017): Boston Strategic Partners, Inc. attended the 2017 Regulatory Affairs Professionals Society Convergence held 9-12 September 2017, in Washington D.C. New FDA Commissioner, Dr. Scott Gotlieb, discussed in his keynote address initiatives at FDA to improve the application process through:

  • Advocating use of ‘seamless’ or combined-phase trials, such as melding dose-finding and proof-of-concept studies to avoid sequential Phase I / Phase II trials, thereby using one patient population (typically reducing patient numbers) to more quickly determine dosing and generate results
  • Accelerated approvals
  • Increased use of biomarkers for surrogate end-points or as a companion diagnostics
  • Improve FDA Information Technology (I.T.) and access to computing algorithms to assist in evaluation of models included in submissions
  • Creation of new Oncology Center of Excellence which promotes discussion of oncology-focused submissions


Hot topics attended by BSP at the conference included sessions on regulatory considerations in clinical trial design and use of surrogate and co-primary endpoints, trends in orphan designations (including demonstration of clinical superiority and strategies to break exclusivity), incorporation of patient-reported outcomes into trial design, and use of Big Data in regulatory strategy [FDA is tasked with creating a framework to allow for real-world evidence utilization within 2 years, through a series of guidances), and the impact and important regulations from PDUFA VI and the 21st Century Cures Act.

Please call us for additional details regarding new topics which may impact your product’s path to market.


About BSP
Founded in 2003, Boston Strategic Partners, Inc. is a dedicated healthcare and life sciences company. We offer five different types of services:

For more information or to schedule a meeting with our team, please email us at info@bostonsp.com


About Regulatory Affairs Professionals Society (RAPS)
RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Shanghai and Singapore and chapters and affiliates worldwide.  (Source: http://www.raps.org/about/)