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Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
A skilled workforce is needed to deliver on technology’s promising medical advances.
Trade shows are a good opportunity to assess where an industry stands on new technologies, ongoing challenges, and future opportunities. It also is a good time to assess attitudes about prospects for the road ahead. As I write this, I am half way through three consecutive weeks of industry events, each with a unique market focus, revealing the potential of biopharma to address patient needs and the work that must be done to achieve that goal.
Continuous manufacturing, which has gained momentum for small-molecule drugs with FDA approval of several therapies, was a popular discussion topic at INTERPHEX in New York, NY in mid-April. The strong interest is an indication that the pharma industry may be looking to consider advanced technologies that are common in other industries. In the biologics arena, the move to continuous manufacturing will be more difficult; experts on a panel hosted by Pharmaceutical Technology magazine noted that while some segments of a bioprocess may have continuous operations, an end-to-end continuous process will be difficult to achieve.
At CPhI North America in Philadelphia, PA, medical futurist Bertalan Mesko shared his vision of bringing science fiction to medical reality through the use of digital technologies and data management and identified actions that must be taken today to get the most out of future technologies. Smartphone-based monitoring, drone delivery of medications to remote regions, use of blockchain for data security of drug products, and Internet-based monitoring of patient medical conditions in their homes are a few advances he identified.
In another keynote address at CPhI North America, Nik Leist, senior director of ingestible sensor manufacturing and site leader at Proteus Digital Health, demonstrated how some digital technologies are currently available for monitoring patient adherence. In November 2017, Proteus and Otsuka Pharmaceutical Co. received FDA approval for the first digital medicine system, a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an ingestible event marker (IEM) sensor. Leist explained how the sensor, the size of a grain of sand, can be incorporated into a conventional drug tablet production system with some modifications. Regulatory approval could pave the way for other sensor-based applications.
Mesko noted, however, that the lack of doctors, money, and patient trust in medicine can hinder the acceptance of innovation for medical applications. New digital technologies will generate vast amounts of data that must be managed by artificial intelligence (AI), he said, but fear of the power of AI is a hurdle that must be overcome.
The cost of new technologies may be high, creating a divide between those that can afford it and those that cannot, Mesko warned, and including the patient in the design of the medical advances-by asking them what they want-is crucial.
Mesko also noted that technology is only part of the solution; people are needed to implement this vision. The lack of a trained, qualified workforce to operate bioprocessing facilities spurred a partnership between Philadelphia-based Thomas Jefferson University and the National Institute for Bioprocessing Research and Training (NIBRT) of Dublin, Ireland to establish the Jefferson Institute for Bioprocessing, the first education and training institute for biopharmaceutical processing in North America. The partnership was announced in February 2018; further details were provided during the CPhI North America event by Mary Lynne Bercik, founder and CEO, GenZinnovation, and Ronald G. Kander, Dean, Kanbar College of Design, Engineering & Commerce Associate Provost for Applied Research at Jefferson.
When operational in 2019, the Jefferson Institute for Bioprocessing is expected to serve 2500 people annually, including an academic program for bioprocessing engineering from undergraduate through doctorate levels, industry training, workforce training through community college partnerships, and bioprocessing certifications through regional university partnerships.
Vol. 42, No. 5
When referring to this article, please cite it as R. Peters, " Key Ingredients to Healthcare’s Future" Pharmaceutical Technology 42 (5) 2018.