Pearls of Wisdom
Women in Leadership in the Life Sciences – Gretchen Bowker will speak during IHIF Life Sciences Lunch
Gretchen Bowker, CEO of Pearl Pathways, will share insights during an Indiana Health Industry Forum (IHIF) lunch event on Tuesday, September 18, 2018. The lunch event, "Women in Leadership in the Life Sciences", is part of IHIF's recurring Life Sciences...
Pearl Pathways hires accomplished biopharma, medical device leader as Director of Business Development
Pearl Pathways announces the hiring of Cara Frosch, MBA, PA as Director of Business Development. Frosch brings over 35 years of diversified biopharmaceutical and medical device experience in human and animal health to Pearl Pathways. After a short stint in...
FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics
A new draft guidance issued by the U.S. Food and Drug Administration (FDA) provides advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials for cancer drugs and biologics. The draft guidance, issued in August 2018,...
New FDA draft guidance for gene therapy requests more CMC information earlier in initial IND process
In July 2018, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for Industry, on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). Since the initial FDA gene...
Biosimilar Competition Development
After the US Food and Drug Administration (FDA) released its 11-part biosimilar action plan, FDA has now announced that it will hold a public hearing to gather input “on how it can facilitate the development of biosimilars and ensure they enter the market...