Dr Michael Gamlen has had an extensive career spanning over 40 years in scientific research and tablet development in a range of contexts including Development, Clinical Trials Manufacturing and Production. Formally the Head of Tablet Development at the Wellcome Foundation Ltd for 15 years. Author of pharmaceutical contributions to at least 20 successful INDs and CTXs and at least 6 successful NDAs/MAAs. Experienced and successful in FDA interactions with reviewers and inspectors. Organised and fronted two successful PreApproval Inspections by FDA. Dr Gamlen has developed hundreds of successful tablet formulations at all scales from gram to Production. He has worked with many of the world’s leading pharma companies including GSK, J and J, Pfizer, Teva and Astellas.
Dr Gamlen and his team can support you with:
- Compaction analysis of your formulation using either Heckel or Kawakita plots. Precise measurement of punch displacement on the Gamlen D Series PCA (formerly GTP-1) has now enabled us to provide this service along with true density measurement using helium pycnometry.
- Make tablets for your R&D and product development purposes, tablet manufacturability problem solving and for non-human use (eg medical device diagnostics) to the following specification:
- Manufacturability Assessment by making an assessment of your powder properties based on small batches of tablets compressed under tightly controlled conditions using the Gamlen D series Powder Compaction Analyzer.
- Formulation development – tablet, capsule and formulation development, manufacturing and production transfer.
- Assessment and evaluation of regulatory and manufacturing dossiers and resources during due diligence evaluations and the outsourcer evaluation process
- Expert auditing with international experience in the Middle East, India, Europe and the USA.
- Develop and implement Chemistry and Pharmacy regulatory strategy for compounds from preClinical phase to NDA/MAA approval.
- Tablet development, stability testing, CMC project and regulatory strategy and implementation.
- Audit clinical and production manufacturing and packaging operations including Europe, USA, India and the Middle East
- Technical due diligence and Pharmaceutical Expert Witness in tablet and product development, and the development of controlled release products.
- Teach you on a 3 day course designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility
- 1973 Studied Pharmaceutical Engineering at Sunderland Polytechnic, gaining a First Class Honours degree and the Year Prize for Pharmaceutics.
- 1976 Studied tableting for PhD at Nottingham University with Professor J M Newton (Pharmacy) and Professor P Stanley (Mechanical Engineering). PhD topic was the relationship between material properties and compaction
- 1980 Joined Beechams Pharmaceutical to work on the instrumentation of rotary tablet press, with Peter Ridgway Watt, author of the only book published on tablet machine instrumentation.
- 1981 Joined the Wellcome Foundation Ltd under Professor Trevor Jones, as Head of Solid Dosage Form Development. His section was responsible for development of an entire generation of new and revolutionary drug substances which remain of key importance to GSK including acyclovir, vacyclovir, bupoprion, zidovudine, lamotrigine, atovaquone and atovaquote proguanil
- 1981-1995 Developed a wide range of techniques for studying tablet properties at the formulation development scale including the use of compaction simulators as a drug development tool.
- 1993 Successfully led the UK’s first ever Pre-Approval Inspection by FDA for a treatment IND.
- 1990-1995 Established and developed the role of Physical Pharmacy in the Research environment to assist Research in identifying drug substance which were more likely to be successful as products
- 1995 Joined the Glaxo Wellcome integration team as Dartford Site representative and assisted with the GW integration.
- 1996 Joined Vanguard Medica (now Vernalis) as Manager of Pharmaceutical Development. Managed the CMC aspects of frovatriptan development which included a successful
- 2000 Started Pharmaceutical Development Services regulatory consultancy in 2000.
- 2010 Started Gamlen Tableting Ltd to exploit the development of the Gamlen Tablet Press (now the Gamlen Powder Compaction Analyzer product range).