Gawayne Mahboubian-Jones currently works for Philip Morris International as Program Manager – Quality by Design. His primary responsibilities in this role are the implementation of QbD and PAT across the R&D facility and in early phase manufacturing.

Gawayne’s initial degree work was in Electronics and Physics, followed by doctoral work studying Bioelectronics. Since then he has worked in a variety of industry sectors, mainly applying complex instrumentation to the design and control of complex processes. Prior to joining PMI earlier this year, he worked for 7 years for Optimal Industrial Automation, providing PAT solutions to a wide range of pharmaceutical companies. He has trained the FDA PAT inspectors on control aspects of PAT, repeatedly spoken for the FDA on the subjects of PAT and QbD, served on the ISPE PAT Community of Practice Steering Committee, and has worked extensively with ASTM E55 to create international standards to support the application of PAT.

Brett Cooper is currently a Research Fellow within the Analytical Sciences Department within Pharmaceutical Sciences at MSD, with 15 years Pharmaceutical industrial experience in the areas of Analytical Development, Physical Measurements, Preformulation and Basic Research Support. Within MSD he is a member of the Controlled Release Centre of Excellence at Devlab UK, and a member of the Pharmaceutical Sciences Quality by Design team. Externally he is a Member of the Royal Society of Chemistry and currently Secretary of the Industrial Group of the British Crystallographic Association.

Nuno Matos is a PAT Specialist at Hovione who supports the development and implementation of PAT tools during development and commercial manufacturing of API and pre-formulated pharmaceutical products. PAT tools developed and implemented include near infrared spectroscopy, mass spectroscopy, particle characterization technologies, and multivariate analysis. Prior to joining Hovione, Nuno co-developed microbial identification and typing methods based on infrared spectroscopy and classification algorithms at the BioSystems Engineering Lab – IST, Technical University of Lisbon. Nuno holds a bachelor degree in biologic engineering from IST – Technical University of Lisbon.

Tom Cochrane has worked in the Pharmaceutical Industry for 30 years, holding positions of Quality Control Analyst, Quality Control Laboratory Manager and Quality Assurance manager. For the last 10 years he worked as Business Process Development Manager with NAPP Pharmaceutical Group in Cambridge where he tasked with embedding quality principles throughout business processes. This has seen him apply improvement techniques not only in the traditional areas of manufacturing and Quality Control but in other business functions such as Sales, Finance, Drug Development, Regulatory Affairs, Human Resource and Supply Chain Security

Tom has recently worked on developing a methodology for transferring processes from R&D to production and from the UK site to an Indian site. He led a team to get MHRA approval for a manufacturing site in northern India and is currently working on supply chain security across all business processes.

In January 2011 he was appointed Head of Security Operations and Process Development, this has seen him develop security systems across the global supply chain.

Marie Calame is a Pharmacist from french Faculty of Tours. She graduated in 2004 and then oriented her education towards chemical and process engineering studies. She obtained her Engineer diploma from Ecole des Mines d'Albi-Carmaux in 2006.

Marie was first an outsourcing manager in Pharmaceutical Sciences Department - Sanofi-Aventis R&D Montpellier site (2006 - 2010). The main purpose of the activity was to coordinate outsourced manufactures of clinical batches, review contracts, define technical requirements, review manufacturing instructions and follow-up supplies. Thanks to this experience, she faced a wide range of process technologies, process issues and could acquire a great technological knowledge from supplier site visits, discussions and batch record analysis.

After this great wide experience, she joined the Pharmaceutical Engineering team as a Manager in Pharmaceutical Sciences Department - Sanofi-aventis R&D Montpellier site (since April 2010). The main objective of the function is to support the development of the clinical batches manufacturing processes, to be involved in the definition of scale-up strategies for transfer across scales, to contribute to the development of tools for the improvement of process understanding and monitoring, to be involved in the definition of Quality by Design approaches.

Cécile is a Engineer from a chemical engineering school (Ecole Nationnale Supérieure des Industries Chimiques, Nancy), she graduated in 1995 with a combined Master degree in Process Integration obtained at UMIST (University of Manchester 1994-1995). She then studied specifically the compression process and obtained her Ph.D. in 1999.

After 10 years experience on drug product development, she developed a specific activity dedicated to process understanding in Pharmaceutical Sciences Department on Sanofi-Aventis R&D Montpellier site (since beginning 2009). The main objective is to improve process knowledge from R&D to GMP and final scale-up to industrial site by implementing new Process Analytical Tools (PAT) to follow-up processes and to control them in the end, in order to ensure drug products are developed and submitted within Quality By Design (QbD) approach.

Dr. Ali Afnan was recruited in May 2003 by CDER, FDA to join the Agency’s PAT and Drug Product Quality initiatives. He was a member of the PAT steering team and a co-author of the PAT Guidance. He had also been a member of the core team responsible for drafting, and finalizing, the most recent Guidance from FDA on process Validation. Dr. Afnan has received several FDA and CDER level awards. He left the FDA in March 2010.

He holds a degree in industrial chemistry, and a PhD in instrumentation for analytical science. He began his career in ICI Engineering as a control-electrical engineer, and then joined the Engineering group in AstraZeneca. His responsibilities included working with development, manufacturing and quality functions: problem solving, development and implementation of PAT, devising regulatory strategy, undertaking feasibility studies, equipment specification, and project management.

He lead the design, development and implementation of a Process Analytical Technology system and network encompassing an entire solid dosage facility- the first such facility in the pharmaceutical industry. Ali is the president of Step Change Pharma, Inc. which offers a range of consultancy services targeting the development and delivery of Pharmaceutical Manufacturing Excellence. He is also an editor and columnist on pharmaqbd.com and Pharmaceutical Manufacturing.

Peter Boogaard, founder of Industrial Lab Automation Consultancy, studied analytical chemistry in Delft (The Netherlands). Here he was introduced to computer software during his research on inductively couples plasma (ICP) technology, now a de-facto standard in many analytical analysis methods. Peter started his international professional career with Perkin-Elmer Corporation. Thanks to his first employer, who understood very early on, the importance of the end-user experience, he created many application programs to for fill the client needs. Peter has been able to adopt and expand this behaviour successfully with great companies including Applied Biosystems, Oracle, Informix, Symyx, Life Technology and LabVantage. Peter has published several white papers and contributes in industry advisory boards.