The PDA Annual Meeting was held in New Orleans on April 3-5, 2023.  It was a great conference with the theme of “Back to the Future: Learning from the Past in a Patient‑Centric World.”  The plenary and breakout sessions truly held to that theme.

The first plenary session started off with a discussion of Rare Diseases (RDs) from EveryLife Foundation for Rare Diseases, which focuses on the impact of the patient voice in public policy, including an impactful patient‑speaker who gave firsthand knowledge of her RD experience.

The second plenary was intriguing in a different way.  With a title of “Digitization of Pharma: Achieving Cybersecurity in Healthcare,” the speakers from Siemens Industry discussed IT versus OT, or Operational Technology essentially being anything used to run manufacturing equipment, and the impact of network security on each of these.  A key point from one of the slides was “The ROI for OT cybersecurity is much more than an avoided incident,” and when justifying the cost for needed upgrades to network security to management, ask “what are the cost-savings of manufacturing not being down for two weeks?”  The next speaker, from GxP-CC, followed with a discussion of how to manage risk in the world of data that the pharmaceutical industry lives in.  His key message was that you need to determine how to balance your risk, to manage your risk by identifying vulnerabilities, creating scenarios to protect them, and then challenging those scenarios.

The third plenary was on emerging technologies, specifically discussing Advanced Therapy Medicinal Products (ATMPs).  The two speakers discussed how their companies are pushing boundaries to accelerate the development of new drugs.  The first speaker, from Tessera, spoke of editing genomes using mobile genetic genomes that occur naturally in DNA and how they have been successful in doing this type of editing in primates to modify disease states.  In contrast, Adicet Bio is using gamma‑delta T‑cells as a modality for therapeutic treatment to improve cancer immunotherapy, with a goal of producing an “off‑the‑shelf” product administered to patients in several target immunotherapy areas.

The fourth plenary focused on the supply chain with the first presentation from the Coalition for Epidemic Preparedness and Innovation (CEPI) about its 100 Days Mission to provide speed and access for vaccine development within a Quality and regulatory framework by using a platform development and geo‑diversified manufacturing network.  It sees lack of thermostability as a main hurdle in getting vaccines to the geographical areas where they are needed.  This was followed by a presentation by the U.S. Pharmacopeia (USP) which has been working on a data platform it calls the USP Medicine Supply Map to identify and evaluate supply chain risks to try to predict drug shortages.  The study focused on antimicrobials and what information could be uncovered from mapping by labels and searching the master file database for APIs.  A key finding was that greater upstream supply‑chain transparency (where and how much volume of APIs and key excipients come from a particular geographic area) could help healthcare practitioners to safeguard patient health better proactively.

In between the plenary sessions, there were many great presentations and discussions with a focus on Annex 1 changes and implications, data integrity, risk management, supply chain, and innovation.  Stay tuned for more updates from this meeting.