60 SECONDSWITH...

THOMASCHATTAWAYOn Chairing the Biopharmaceutical School

THOMAS CHATTAWAY

Thomas Chattaway is a Senior Life Sciences Consultantand has expertise in providing innovative solutions forpatient needs and addressing manufacturing challenges.He has over 20 years’ experience leading biotechnology-based product and process development projects and hasworked in various countries serving customers in thepharmaceutical, biotech, medical device and health careindustries.

First, maybe you could tell us a little about yourbackground and how you came to end up working in thebiopharmaceutical industry.

I studied Engineering first and did a PhD in Biotechnology,then spent the first third of my career in industrialbiotechnology. I then moved into biopharmaceuticals,where the technology was quite similar, although at asmaller scale and with GMP and regulatory constraintsadded. After this, I became an independent consultantsupporting Biopharma and Biotech companies in thevarious aspects of CMC drug development as well asmanufacturing.

How have you witnessed the industry change overyour career, and how do you predict it to evolve goingforward?

When I started my career, biotechnology was still relativelyin its infancy, with the first biotech products (recombinantinsulin, TPA etc.) just being marketed and cell culturetechnology finding its way. In fact, traditional pharmacompanies were often doubtful of the future ofbiopharmaceuticals, let alone of the preponderant part theyplay today.

What has been incredible is the medical needs met bybiopharmaceuticals, both the breadth of diseasesaddressed and the improvements enabled and, ofcourse, the extraordinary science that goes with this!   What is a strange paradox, is that despitesuch medical progress, the manufacturing technologyremains relatively conservative compared with otherindustries, embracing incremental rather than disruptiveinnovation.  As an illustration, the regulators areadvocating continuous manufacturing almost harderthan the industry. I think one might see massiveimprovements for ATMPs (cell and gene therapies) wherecurrent COGs are not sustainable.

Why do you believe Big Pharma are becoming increasinglymore interested in the biopharmaceutical industry?

The first reason is the shift in the industry from primary tosecondary, specialised care, where biologics have a naturalposition. The second is the innovation deficit which affectssmall molecules much more than biologicals. Coupled withthe progress in science, this makes biologicals muchmore natural and accessible leads.

Thirdly, biologicals have become more ‘accessible’, interms of the technology to make them, analyse them andunderstand them, and this goes with a more predictableregulatory landscape.

Do you believe that new industry entrants havesufficient knowledge and skills to work in this evolvingindustry?

Yes and no... The biopharmaceutical industry is relativelyunique in requiring such a broad range of disciplines tobring a product to market. So new entrants need tobecome conversant with this range, as well as applyingmore specialised knowledge and even deepening it. As an example science and engineering graduates (evenpharmacists) usually know very little about GMPs orregulatory matters.  This must be learnt in the work-place.So the ability to learn from others and work with them is asimportant as the ability to apply what you have learned,and to further it.

It seems to me it can help in two ways. First, this coursecovers a wide breadth of topics. Recent entrants to theindustry will be able to consolidate core knowledge, as wellas fill in the gaps in less familiar areas. Second, the course is also a really good platform fornetworking and sharing experience, as well as makingcontacts for the future. This is important in whatremains a relatively small industry.

How does the Biopharmaceutical School help toaddress this?

The Biopharmaceutical School is a 3-day coursechaired by 3 different experts Find out more >>

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