Peter Calcott

A native of the UK, Dr. Calcott has a career spanning 4 decades and has worked for Pharma companies such as SmithKline Beecham, Monsanto and Bayer as well as biotechnology companies such as Immunex, Chiron and PDL. He has held positions in R&D, Manufacturing, QA & QC, Process Development, Corporate Compliance, Business Development, and Government Affairs. He has worked on biologics (vaccines, recombinant proteins, monoclonal antibodies, blood products), drugs and generics from early development to commercial. Prior to entering industry he taught at university. He is a member of the Board for BayBio and is chairman of the RAC committee of BIO. Dr. Calcott has a BS from University of East Anglia and D.Phil from University of Sussex in the UK. While in Academia he was a consultant to University, government and industry. He has published over 90 research articles, reviews and books.

Posts by Peter Calcott:

• Designing your QMS

  04 Sep 2012 in Clinical Manufacturing & Commercial Manufacturing & GMP & News & Webinars

  At a recent webinar I presented for Tungsten Shield on the topic of Lot Disposition, I had an interesting question.  It occurred when I was discussing review of investigation reports and it went like this: What regulation calls for the Lot Disposition group in the US to review the technical content of an investigation before […]

• Quality by Design: is it only for the big guys?

  06 Jun 2012 in Clinical Manufacturing & Commercial Manufacturing & News & Process Validation & Quality by Design & Risk Management

  There has been a lot of discussion at conferences and on LinkedIn as to whether QbD is just for big Pharma and Biotech and whether smaller companies are being discriminated against.  This triggered me to write an article for Metric Streams, GXP Lifeline.  Enjoy

• Finally, the FDA enforces some post approval commitments

  23 Mar 2012 in Clinical Manufacturing & Commercial Manufacturing & GMP & News & Warning Letter

  Over the last several years I have read in the trade press reports on post approval commitments of companies with respect to clinical studies and the frequency at which they have been initiated.  The reports vary but they appear to be in the 20-30% range.  What does that mean? We all know the situation.  We make […]

• Quality by Design and the new FDA Process Validation Guidance. How do they fit together?

  12 Mar 2012 in Clinical Manufacturing & Commercial Manufacturing & GMP & News & Process Validation & Quality by Design

  At a recent IBC conference on Product and Process Validation, I moderated a panel discussion on this topic with four panelists in addition to myself.  They included two from Pfizer, and one each from Genentech/Roche and Shire Pharmaceuticals.  What were the conclusions: All companies were finding the efforts of QbD painful and laborious and were […]

• Contract Manufacturing and the challenges of developing and maintaining a successful relationship

  12 Feb 2012 in Clinical Manufacturing & Commercial Manufacturing & GMP & News

  Developing and managing a relationship with a Contract Manufactring Organisation (CMO) is difficult and fraught with challenges.  Read an article I wrote on the topic recently that appeared in the European Biopharmaceutical Review.  Pleasant reading.