by Andrea Farr | May 31, 2023 | Blog
How AI and ML can facilitate quality improvements in biopharma Artificial Intelligence (AI) and Machine Learning (ML) are often confused, but they are fundamentally different. AI comprises pre-built products that use established patterns for recognition and...
by Scott Farr | Apr 27, 2023 | Blog, Drug Development Consulting
It’s imperative that biopharma organizations developing innovative treatments for rare diseases navigate the FDA’s Orphan Drug Designation (ODD) program. Since its passage in 1983, the Orphan Drug Act has helped countless individuals living with rare diseases receive...
by Frank Sorce | May 4, 2022 | Blog, Drug Development Consulting
May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and...
by Frank Sorce | Jan 10, 2022 | Blog, Regulatory Affairs
January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer our insight and expertise...
by Frank Sorce | Jun 2, 2020 | Blog, Kathryn Tworkoski, Medical Writing, Regulatory Operations
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of...
by Frank Sorce | Oct 30, 2019 | Blog, Brandi Schuster, Medical Writing
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing – congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing...
