Dr. Vinci is currently Director of Bioprocess Operations at Eli Lilly and Company in Indianapolis, Indiana. As such, he is responsible for process operations focused on bringing new protein therapeutics to market by producing active pharmaceutical ingredients intended for clinical trials. For the last 4 years, his responsibilities have included coordination of teams involved in the design, commissioning and qualification of a new 200,000 sq ft cGMP bulk process facility, developing staffing models, and implementing effective and compliant operational practices. His team is currently engaged in tech transfer for new campaigns, bioprocess operations to produce bulk biologic API, and improving platform operations for bioproducts. He serves as the lead for the Lilly team involved with the CMC Biotech Working Group (industry consortium) which has finished a QbD case study for a monoclonal antibody (Mab). Prior to his current role, he was a scientist and group leader in process development at Eli Lilly for five years. He began his career at Merck where he was a scientist and later section head in an Manufacturing Science and Technology (MS&T) role. Dr. Vinci received his doctorate in Microbiology from The Ohio State University in 1988.

Des Makohon
Senior GMP Inspector, MHRA. Member, PAT Team
EMEA

Gerry DiDonato, Associate Director, Global Regulatory Sciences-CMC, received his PhD in Analytical Chemistry with a specialty in mass spectrometery from Indiana University in 1987. Gerry joined Bristol-Myers Squibb as a Research Investigator solving structure elucidation problems for Discovery, Development and Manufacturing colleagues. He was one of the first to use electrospray mass spectrometry as a routine structure elucidation tool in the Pharmaceutical Industry. Subsequently he managed multidisciplinary analytical groups, and led Development and Manufacturing Teams for new products. Gerry recently chaired the Company's Specification Committre. He saw the light and switched to Regulatory Affairs in 2005, where he currently is the CMC lead for saxagliptin as well as several products in development.

Michael Schousboe holds the title of Senior QbD Manager, Principal Scientist in within the department Manufacturing Science and Quality part of Global Quality of Novo Nordisk
His Main areas of responsibility are Quality by Design and process analytical technology (PAT), Validation Non Conformities Analytical instrument qualification among others. He is currently the project manager of implementing Quality By Design in Novo Nordisk globally. Michael Also serves as the chairman of the internal Focus Group regarding Quality by Design
Michael holds a masters degree in pharmaceutical science (M.Sc. Pharm.) from the Royal Danish School of Pharmacy and has 11 years of experience within the pharmaceutical industry.
With a QC laboratory background and later as a QA professional Michael has worked with qualification and validation within the areas of computerised systems, laboratories, as well as production of drug products and API in different Danish pharmaceutical companies, and he is experienced as a speaker on the aspects of validation, Quality by Design and Quality Management. Furthermore Michael is an experienced auditor and has served as a qualified person. Michael is a member of the ASTM E55 Committee on Pharmaceutical Manufacture, and has participated in writing of the standard “Continuous Quality Verification” and the draft standard “Verification of PAT systems”.

Martin is a Scientific Fellow at Vertex Pharmaceuticals supporting the use of PAT during QbD. Prior to this he provided PAT consultancy services to the Pharmaceutical industry. He has over 17 years experience working in the field having previously lead the PAT Development Team of Pfizer Global Manufacturing.

Before joining Pfizer he worked for Dionex providing application support for liquid and supercritical fluid chromatography, including on-line measurements.

He joined Dionex from Shell Research, where he provided analytical support, developing novel environmental analysis methods and technologies in support of Shell's bio-restoration/bio-remediation projects, and environmental monitoring programs in the North Sea.

He has also worked in academia starting his career at the University of Westminster and unusually for an Analytical Chemist, his bachelor’s degree is in Cell Biochemistry and is a qualified microbiologist.

This provides extensive, cross industry, experience in application identification, solution specification and delivery, as well as the support of systems during product life-cycle and he has experience in a developing and implementing a wide variety of measurement solutions, from spectroscopic, through chromatographic but including acoustic and particle characterisation.

David Sharp
Senior Principal Scientist
Pfizer

Hans obtained a BSc degree in Chemical Engineering, with a specialization in Biotechnology. He has worked for over 18 years in Biopharmaceutical industry. Having worked on many design, scale-up, implementation, and validation projects for both production processes and production lines made him an experienced process- and mechanical engineer.

Currently, Hans is Senior Process Engineer in the Production Department of DSM Biologics. Here he is responsible for technology transfer, scale-up and validation of new manufacturing processes. In this position he is involved in optimizing processes regarding efficiency, costs and quality.

He took the degree in Organic Chemistry at the University of Milan (Italy) in 1991. In 1992 he joined GlaxoSmithKline (Glaxo at that time) in the Chemical Development Department (R&D Verona Research Center, Italy) as a process chemist. He was involved in the discovery and optimization of new manufacturing routes. In his role he worked on projects in the antibacterial, psychiatric and oncology area where he led the development of several molecules in the different phases of development (from early phase to the market). Working on projects in late phase he was able to apply the QbD concepts on some molecules in development.

Philippe Cappuyns is an Industrial Pharmacist from the University of Louvain, Belgium. He began his career at Warner-Lambert as a QA/QC Manager of the Belgian manufacturing facility. He joined later Janssen Pharmaceutica, part of Johnson & Johnson, as a QA manager supporting the manufacturing plant in Beerse, Belgium. He moved on to Packaging Technical Support and Package Development functions and became head of Technical Services of the Beerse plant. Later on, he assumed a Technology and Innovation role in the European Technical Services group of Johnson & Johnson before to join Global Technical Services where he acts as a Pharmaceutical Technology expert. Currently, he is actively involved with the deployment of Quality by Design and Design for Manufacturability in the Pharma commercial manufacturing environment of Johnson & Johnson.

Héðinn Valþórsson comes from Hafnarfjörður in Iceland. He moved to Braunschweig, Germany 1996 where he studied pharmacy at the Technische Universität zu Carolo Wilhelmina. Prior to his current activities Hedinn was a PhD student at Novartis Pharmaceuticals in Stein, Switzerland for 3 years. There he conducted his thesis on PAT and Quality by Design in collaboration with the University of Basel under the tutorial of Professor Hans Leuenberger.

January 2006 to April 2008, Hedinn was working in the Global Q&IT group at Novartis in East Hanover, NJ. He was the project manager for the Drug Product part of the QbD / PAT pilot project within Novartis.

Since April 2008 Hedinn works as a Facilitator / manufacturing manager of solid dosages in Novartis Stein, Switzerland, leading the implementation of QbD / PAT into manufacturing and acts as a link to manufacturing for QbD projects from development.

Barry Gujral recently joined Noven Pharmaceuticals, Inc. in January of 2009 as Associate Director of Quality Engineering. Prior to joining Noven, Barry had over 17 years of diverse pharmaceutical and biotechnology industry experience. He previously served DSM Pharmaceuticals, Inc. in various roles. In his most recent position at DSM, Barry worked as Coordinator, Process Analytical Technology, Where he completed two projects with the FDA on Statistical Modeling and Quality by Design.

Barry holds a Master of Chemistry degree from Illinois Institute of Technology, Chicago and PhD in Chemistry from Meerut University. Barry also holds Global MBA degree from Fuqua School of Business, Duke University. He has authored several scientific publications in the areas of Process Analytical Technology and Quality by Design. In addition, Barry is a Six Sigma black belt trained at the NC State University Raleigh and is author of three textbooks in Chemistry besides a US Patent that was awarded to him in 1999.

Ayub Khan
Senior Process Technologist
Napp Pharmaceuticals

Branko Vranic graduated from the Faculty of Pharmacy, University of Belgrade, Serbia in June 2008. In September 2008 Branko joined the Department of Pharmaceutical Sciences, the Industrial Pharmacy Lab research group and started his PhD research on near-infrared quantification for solid dosage forms.

Presentations

“ Preparation and Evaluation of pH – Independent Sustained – Release Matrix Tablets of Verapamil Hydrochloride Using Kollidon® SR ”; S. Ibrić, B. Vranić, J. Parojčić, Z. Đurić. The 1st Conference on “ Innovation in Drug Delivery: From Biomaterials to Devices ”, Naples, Italy, 30 September – 3 October, 2007

“ Optimization of drug release from compressed multiparticulate units using generalized regression neural network ”; B. Ivic, S. Ibric, G.Betz, B. Vranić, Z. Djuric. The 7 th Central European Symposium on Pharmaceutical Technology and Biodelivery Systems, Ljubljana, Slovenia, 18-20 September, 2008

Julian Morris is Emeritus Professor of Process Control at Newcastle University and Visiting
Professor in the Department of Pure and Applied Chemistry at the University of Strathclyde and Director of the Centre for Process Analytics and Control Technology (CPACT). He is the immediate past Head of the School of Chemical Engineering and Advanced Materials at Newcastle University, head of the Department of Chemical and Process Engineering between 1990 and 1995, and has spent some time as Professor of Chemical Engineering at the University of Alberta in Canada. He holds positions of Associate Director of the data mining company AJM Consulting and is a member of the UK Centre for Process Innovation (CPI) Advisory Committee and has been since CPI’s inception. He is a Chartered Engineer and Fellow of the Institution of Chemical Engineers, the Institute of Measurement and Control and a past Fellow of the IEE. His research interests include process diagnostics and condition monitoring, process performance monitoring, Process Analytical Technologies, neural networks, and advanced process control and optimisation. His contributions to process control are recognised by the co-receipt of a number of Paper prizes and awards. He has authored/co-authored over 190 articles in scientific journals, conferences and books, given over 70 invited lectures, and 50 Plenary and Keynote presentations. He is a Fellow of the Britain’s Royal Academy of Engineering.

Petter has a M.Sc. in technical chemistry with a specialization towards chemometrics. After his M.Sc. Petter joined Umetrics in 1999, as an application specialist and has for the last 8 years worked towards PAT and QbD. Petter is since November 2007 Director of On-line products for Umetrics, this responsibility also incorporates the growing OEM business where Umetrics products successfully generates value in third party systems. Petters goals with the growing On-Line business is to get a substantial increase based on customer value. To achieve customer value the On-Line business needs to work in close relation with existing and potential customers.

Previously he was sales manager in Germany with a good network in major pharmaceutical companies.

Peter Amanatides joined Noven Pharmaceuticals, Inc. in September of 2008 as Vice President of Quality Assurance and Quality Control. Prior to joining Noven, Peter had over 20 years of diverse pharmaceutical and biotechnology industry experience. He previously served DSM Pharmaceuticals, Inc. (a global contract manufacturer of oral and topical dosage forms, sterile products and active pharmaceutical ingredients) in several senior quality roles. In his most recent position at DSM, Peter held the Senior Director of Quality Operations at the DSM Greenville, NC site with responsibility for all quality operations, including quality assurance, quality control, analytical development and regulatory affairs. Prior to his career at DSM, he was Director of Quality Systems at Celera Genomics, a human genome sequencing company affiliated with Applera Corporation. Peter worked for several pharmaceutical and biotechnology companies holding positions of increasing responsibility in Quality Assurance and Quality Control functions.

Peter holds a Master of Science degree in biotechnology and molecular biology from Hood College and a Bachelor of Science Degree in biology from Regents College. He has authored and co-authored several scientific publications in the areas of genome sequencing and biotoxic compounds for a variety of magazines including Science, Nature and Hybridoma. In addition, Peter is a Six Sigma black belt trained at the University of Texas- Austin. He has created and managed several six sigma programs in the pharmaceutical and biotech industry during his career.

Martin has extensive experience in developing and implementing Quality by Design (QbD) techniques on a wide portfolio of GSK products. He has led other transformationional change initiatives such as the introduction of chemistry automation and experimental design.

His pioneering work within Chemical Development at GSK has enabled him to develop and fine tune sequential experimental design techniques which deliver increased process understanding leading to robust optimized processes.

He has led the experimental design learning program across fourteen GSK R&D and manufacturing sites. He also runs an external learning program on “Understanding Chemical Processes” involving twenty leading UK universities.

Patrick is the PAT Sales Executive in the Industrial IT division of Siemens. He has a Master degree in Chemical Engineering, with a specialization in Biochemistry. Patrick has 7 years of experience in LIMS (Laboratory Information Management System), PLM (Product Lifecycle Management solution) and quality management systems. Today he focuses on the application of PAT/QbD in the pharmaceutical sector, designing PAT / QbD infrastructures and consulting companies on their project approach.

Dr Per Vase
Senior Specialist, Consulting
NNE Pharmaplan