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:

• Managing a CMO can be tricky

  15 Jun 2015 in Clinical Manufacturing & Commercial Manufacturing & Contract Manufacturing & GMP & Quality Agreements & Vendor Qualification

  Much has been talked about choosing a CMO, developing contracts and establishing a quality agreement.  But that is not all.  It involves the establishment of operations and the development of a relationship and developing trust between both parties.  I have just written and had published an article on this topic.  It’s in the May issue […]

• QA and Manufacturing should be working on the same team

  15 May 2015 in Clinical Manufacturing & Commercial Manufacturing & GMP & News & Quality Management Systems & Risk Management

  During the last couple of months I have been working with a company that is undergoing a transition as products move through their pipeline – quite a radical shift in strategy.  Over the years, their Quality Management System (QMS) has evolved.  But as with all evolution, the small incremental changes that occur might lead along […]

• Effective auditing – one size does not fit all

  15 Apr 2015 in audits & Commercial Manufacturing & Contract Manufacturing & FDA Guidance & GMP & News & Quality Agreements

  Every company I work with has a problem with their auditing program.  Some believe they are overdoing it and others feel they are not doing enough.  In a sense, they are both right.  In actual fact, they are all overdoing it in certain areas and underdoing in others. Back when I started in Industry, and […]

• How to handle metrics that drive the wrong behavior

  17 Mar 2015 in Commercial Manufacturing & Contract Manufacturing & GMP & News & Quality Management Systems & regulatory citations

  Over my career I have lived and, unfortunately, died by Metrics.  What do I mean by that?  Metrics if developed carefully, and with thought, can help us attain our goals.  However, badly thought out metrics don’t just not help us from attaining our goals, they can actually prevent us from attaining them.  Because they can […]

• Organisational change is a challenge

  11 Oct 2014 in Clinical Manufacturing & Commercial Manufacturing & News & Quality Management Systems

  Just recently published an article in a new Magazine “Medicine Maker” on this topic. Enjoy the read.  The article   organisational challenges005