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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?
- “Quality is a living thing” Anthony Davies, Capricor (Los Angeles, CA, USA)
- “[Process] reliability is inversely proportional to complexity” Brian Hampson, Aastrom (Ann Harbor, MI, USA)
- “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.
David Brindley
Latest posts by David Brindley (see all)
- If cell therapy isn’t about the cells or the therapy, what is it about? - November 19, 2014
- Revolution and reimbursement in the cell therapy industry - November 13, 2014
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