Under the guidance of Ira Gupta, M.D., and Shanthi Ganeshan, Ph.D., GSK has a few breakthrough therapy designations (BTDs) under its belt. Dr. Gupta is VP of medicine development at GSK, and Dr. Ganeshan recently joined Gilead as head of regulatory for oncology. On this Business of Biotech podcast we discuss how to apply for — and win — BTDs with two women who couldn't be more qualified for the discussion. Listen now and subscribe so you never miss an episode.
Payers and health plans handle digital therapeutics inconsistently. They sometimes treat them as medications. The manufacturer would have a role in this determination. This article delves into what digital therapeutics are and are not, and why the industry should not be categorizing them as drugs.
Executives must take an early and active role in vetting potential partners by using a deeper understanding of the capabilities and characteristics a CDMO should have to successfully bring a product to market.
By Oliver Stauffer,PTI Packaging and Inspection Systems
This presentation covers various forms of positive control samples for parenteral products as they relate to validating a leak test method, including which are best suited for each test method and technology.
This compact arrangement of pharmaceutical feeders supplied by Coperion K-Tron accurately delivers ingredients into the continuous mixing process, guaranteeing consistent and high-quality end products.
This online event offers insights on process innovation, occupational health and safety questions, and technologies available to overcome the many challenges in high containment manufacturing facilities.
This presentation addresses the changing needs for the manufacturing of biologics and the rationale for the use of robotics and automation in aseptic fill/finish processing of these products. The webinar covers industry drivers and manufacturing challenges for biologics and provides an introduction to robots and the specific advantages they provide.
Pharmaceutical Online and Techceuticals, in collaboration with Federal Equipment Company, are excited to announce Virtual Pharma Expo: Pharmaceutical Packaging. Join us for this FREE LIVE event September 1 and 2, 2021, to see presentations focusing on aseptic fill/finish and sterile manufacturing.