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:

• You thought the Indian companies were taking a hammering. Better look to the US Pharmacies

  26 Apr 2014 in audits & GMP & inspections & News & regulatory citations & Warning Letter

  In the first quarter of 2014, 3 Indian companies were issued warning letter (see my posting on the blog) whereas 7 pharmacies were hit.  Statistically significant?  Perhaps. After the debacle of the New England Compounding Center about a year ago, the FDA has been on a rampage in the Pharmacy world.  I am no lawyer […]

• Biosimilars are taking hold in Europe at least

  08 Apr 2014 in Biosimilars & Commercial Manufacturing & GMP & News

  Both the EU and US have passed regulations allowing biosimilars.  You know what they are.  They are the copies of licensed drugs that have been developed by others.  Somewhat akin to the generics of the drug world.  The path to licensure of these biosimilars  is more complicated than classic drugs.  None have been licensed in […]

• Indian Companies get hammered in Q1 2014

  01 Apr 2014 in Commercial Manufacturing & GMP & News & Warning Letter

  In the first quarter of 2014, there are 3 warning letters for Indian Companies.  Add to that the travails of Wockhardt and Ranbaxy over the last couple of years and it looks bleak for Indian Companies in general.  I regularly read LinkedIn Groups and I noticed a thread related the question of reliability of Indian […]

• Not just telling you your faults but how to rectify

  30 Mar 2014 in Commercial Manufacturing & FDA Guidance & GMP & inspections & News & regulatory citations & Warning Letter

  When I read FDA Warning Letters and I do often, most take the format of telling you the observations and then indicating that this is not a complete list. However, about 10% go one step further and basically read you the riot act suggesting that you need to hire a consultant to “educate you” on […]

• A new FDA Paradigm? Citing Guidances

  28 Feb 2014 in GMP & Warning Letter

  Just when you thought you had it straight, the FDA throws you a fast ball – or is it a slider, a spit ball. Not being a baseball fan, never quite certain what the saying is. Had I used the cricket analogy, I would have said a googly. But I digress. Reading the new batch […]