Our platform for fostering conversation on product development and product lifecycle management topics of interest with the community.
published on June 13, 2018 by
I was once told by a serial Life Sciences Entrepreneur (with both Biotech & MedTech exits) that when it comes to taking care of their young (early stage ventures) the Biotech industry is “mammalian” and MedTech industry is “reptilian”. In other words, Biotech/Pharma nurtures their young (In-licensing/Out-licensing deals) and MedTech eats their young (acquisition/do not commercialize).
published on March 03, 2017 by
This article was originally published in the March 2017 Issue of Drug, Development, and Delivery
published on March 01, 2017 by
Earlier this month, I attended the Drug Delivery Partnerships (DDP) Conference in Florida. The conference covered a wide range of topics impacting the combination product sector including digital health, mixed reality, risk management, new technologies in manufacturing and molecular development.
published on August 10, 2016 by
This article originally was published in the Combination Corner featured article in Drug Development & Delivery magazine on May 3, 2016
published on April 30, 2015 by
Today's Therapeutic-focused Combination Product (Drug/Biologic & Device) Companies: The Good, The Bad, and The Ugly. Which one are you?
published on March 02, 2015 by
You are a drug/biologic developer and the time has come to select a delivery device (auto-injector, pump, etc.) that will be feasible for clinical trials and ideally commercialization. More than likely you are not interested in developing this device in house and you need to decide whether to develop a custom delivery device or leverage an existing “off-the-shelf” device. The points listed below serve as a guideline to facilitate the decision making process and to assist in selecting the best device for your specific needs.
published on February 28, 2015 by
FDA’s final rule on combination products (21 C.F.R. Part 4) set forth current good manufacturing practice requirements that must be met for the entire product (drug/device or biologic/device), regardless if the device design occurs internally or externally to the Marketing Authorization Holder (MAH). Although many elements of CP cGMPs are well understood, it appears many are focused on understanding design control and supplier evaluation in the context of the new regulation and guidance.