Signals Blog


9am, Day 1: IBC Cell Therapy Bioprocessing Conference (Bethesda, MD, USA): Attempting to sharpen tie, and my welcome isolation is interrupted by a lady entering the elevator and fighting for mirror space. Cue small talk:

“That’s a nice tie.”

“Erm, thank you.”

“And what is ‘bio…processing?’” [staring at name badge]. “Oh, I thought that it was a medical conference?”

“Well it sort of is. They are closely related…now that I think of it…”

The woman was not attending the IBC event, an event focused on cell therapy biomanufacturing and regulatory challenges, so she did not have a reason to be embarrassed. However, the early encounter very much set the tone for the rest of the day.

Frequently, the enthusiasm and passion of those within the cell therapy industry is not matched by their ability to effectively communicate, often highly esoteric information, to a multi-stakeholder audience. Consequently, vocation specific terminology often impedes biomedical translation and fails to adequately manage stakeholder expectation, including that held by investors and patients. Which, in today’s highly connected world, can influence a significantly broader audience than initially intended. (Something that I am particularly conscious of in my posts.)

No two groups are more critical to industry development, or arguably guiltier of failing to communicate effectively with each other, than clinicians and bioprocess engineers. Both groups have their own specialist languages, broadly different scopes – patient(s) vs. process(es). However, one key shared relationship is an obligation to regulators.

Today’s ‘Regulatory Roundtable’ asserted that, unlike biologics, the majority of cell-based therapeutics have their basic scientific and early clinical trial activities rooted in academia, as opposed to industry. Consequently, they are clinician led, and focused on discrete patient outcomes, as opposed to long-term commercial success.

Similarly, a large proportion of bioprocess engineers operating in the cell therapy space are academically focused, with subtly different objectives to their industrial counterparts – whose principal objectives are regulatory compliance and commercial viability. However, as stressed by Nick Timmins, of the Centre for Commercialization of Regenerative Medicine, in his excellent presentation regarding automated, scale-down bioprocessing technologies, one shared challenge relates to awareness of appropriate regulatory guidance.

Historically, most clinicians are well versed in regulatory expectations around Good Clinical Practice and for bioprocess engineers, Good Manufacturing Practice – neither of which considers critical commercial aspects relating to product development. Nevertheless, improved understanding of Good Regulatory Practice (and its commercial implications) is critical for both groups as they seek to contribute to sustainable industry development.

But for those of you who were unable to attend the IBC event, perhaps because you were heading to Banff on cramped United Flight 1560, what are the key precepts to absorb and apply from discussions in DC?  

  1. “Quality is a living thing” Anthony Davies, Capricor (Los Angeles, CA, USA)
  2. “[Process] reliability is inversely proportional to complexity” Brian Hampson, Aastrom (Ann Harbor, MI, USA)
  3. “You all have the same ingredients, but different cooks” Margardia Menezes Ferreira, National Authority of Medicines and Health Products (Lisbon, Portugal)

The effective integration of clinical, bioprocessing and regulatory strategies is not optional. It is essential.

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David Brindley
David is an international thought-leader in the translation of life-science innovations into commercially viable products and services. His expertise spans the ‘Valley of Death,’ encompassing regulation, basic science, process engineering and finance. This distinctive skill set positions David at the forefront of socially responsible investments – in particular initiatives that make impactful contributions to global health. David currently holds a joint appointment between the University of Oxford and the Harvard Stem Cell Institute and is an active Fellow of the Royal Institution of Great Britain and the Royal Society for the Advancement of Arts and Manufacturing. In addition to being an Editorial Board member of a range of international academic and industrial journals, David is also a founder of Translation Ventures, a boutique consultancy that is actively engaged in maximizing the financial and societal value realized from cutting edge scientific innovations. Disclosure: David A Brindley has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in any postings apart from those disclosed. D.A.B. is subject to the CFA Institute’s Codes, Standards, and Guidelines, and as such, the author must stress that his contributions to this site are provided for academic interest only and must not be construed in any way as an investment recommendation.