3rd Annual Conference 2017
3rd – 5th October 2017
Crowne Plaza Hotel – Blanchardstown, Dublin, Ireland

Speakers

Please note that our full and final speaker panel will not be available until circa June 2017

 

Gregory Stephenson, Ph.D.
Senior Scientific Advisor
CrystalPharmatech, USA
Greg Stephenson earned a Ph.D. in Medicinal Chemistry from Purdue University in 1990, in Medicinal Chemistry, specialising in research of solid-state properties of pharmaceuticals compounds under the advisement of Professor Stephen Byrn. He subsequently joined Eli Lilly and Company.During his 27 years in research and development, Greg built teams that interfaced with discovery organic chemists, development analytical scientists, process organic chemists and formulation scientists. He served as Research Advisor in Pharmaceutical Research and Development, Preclinical Formulation development, and Product Design and Development areas. Much of his work focused on the identification and selection of the optimal salt and physical form (crystalline, amorphous, or polymorph) for the pharmaceutical dosage form. The work required navigation of the delicate balance of chemical and physical stability, properties that are commonly at odds in with one another in pharmaceutical selection, (solubility, pH, particle size etc.).Greg continues to serves on the editorial advisory board for a number of pharmaceutical journals, has published 68 peer reviewed journal articles and holds 14 patents, issued in the U.S. and Internationally. In February 2017, Greg transitioned to Crystal Pharmatech, where he serves as senior scientific advisor for the rapidly growing Contract Research Organisation that has headquarters in Suzhou China and Cranberry New Jersey.

 

Dr. Elke Debie
Manager, CMC Regulatory Affairs
Janssen Pharmaceuticals, Belgium
Dr. Elke Debie earned a Ph.D. in Chemistry from the University of Gent. She did her Ph.D. thesis on Vibrational Circular Dichroism (VCD), an analytical technique to determine the absolute configuration of chiral molecules in solution. She did a post-doctoral assignment as a visiting scientist at BioTools in the USA, prior to joining Janssen Pharmaceutica in Beerse in 2010.Dr. Debie is currently working in the Global Chemistry, Manufacturing and Controls Regulatory Affairs (CMCRA) department providing regulatory strategy for projects that transfer from the development through the commercial registration phases. In addition to her project-related responsibilities, she represents CMCRA in discussions related to ASAP initiatives. She is also a member of the International Consortium of Innovation and Quality (IQ consortium), a technically-focused organization of pharmaceutical and biotechnology companies that provides a forum for exchange of ideas within and across technical disciplines. Within the IQ, she is part of the cross-company pharmaceutical regulatory sub-team which discusses the strategies for use of risk-based stability procedures in regulatory filings.

 

Robin Farley
Business Development Manager
MBW Calibration, Switzerland
Robin Farley has more 25 years’ experience in metrology and analytical science with a specific focus on the measurement of humidity, moisture and temperature. He has worked on application support, maintenance, calibration, product and market development for humidity systems within the pharmaceutical, food, automotive, aerospace, semiconductor, climatic test and standards laboratory segments.As a contributing author to the Guide to the Measurement of Humidity, published in 1996, Robin had unique access to many of the world’s leading authorities in humidity measurement and calibration. A regular participant in International Conferences, his knowledge continues to expand alongside the developing and increasingly important humidity industry. He was Chairman of the UK FETA Humidity Group for five years, and continues associations with many humidity working groups, standards laboratories and leading manufacturers.Robin currently works as an independent consultant with clients including the world’s leading chilled mirror dew point manufacturer MBW, dew point generator producer Thunder Scientific, RH instrument manufacturer Rotronic, and the HygroGen RH generator development company VCT Ltd.

 

Alisa Waterman, Ph.D.
Chief Science Officer
FreeThink Technologies Inc., USA
Dr. Alisa Waterman received her B.A. degree in Biology from Wesleyan University, her Ph.D. in Cell Biology from Albert Einstein College of Medicine and completed post-doctoral studies in biochemistry and cell biology as a Jane Coffin Childs Fellow at Yale University School of Medicine. Dr. Waterman worked for 24-years at Boehringer Ingelheim Pharmaceuticals (as a Senior Research Fellow) championing discovery and development of both biological and small molecule drug candidates. In 2015, she joined FreeThink Technologies as Chief Science Officer responsible for both research strategy and leading company projects.FreeThink Technologies produces and licenses the accelerated stability software package ASAPprime® and is a CRO that has Connecticut-based laboratories specializing in stability for pharmaceuticals, generics, OTCs, nutraceuticals and consumer products.

 

Steven Baertschi, Ph.D.
President
Baertschi Consulting LLC, USA
Dr. Steven Baertschi is President of Baertschi Consulting, LLC, a firm specializing in providing solutions to the most difficult stability, impurity, and formulation issues. Dr. Baertschi has more than 27 years of experience in the pharmaceutical industry, with a demonstrated track record of innovation and problem-solving. He received his B.S. degree in Chemistry from Lipscomb University (Nashville, TN) in 1980. He obtained his Ph.D. in Organic Chemistry in 1989 from Vanderbilt University (Nashville, TN) joining Eli Lilly and Co. (Indianapolis, IN) that same year. Research interests are impurity isolation / structure elucidation, photostability and photochemistry of drugs, mechanisms of drug degradation, reactive intermediates, mass balance investigations, degradation-derived genotoxic (mutagenic) impurities, and drug-excipient interactions. Dr. Baertschi is internationally renowned, organizing / chairing numerous scientific conferences and symposia; he has published more than 50 scientific articles in refereed journals, more than 25 book chapters, and has edited two editions of a book focused on the topic of pharmaceutical stress testing. He has been a member of the American Chemical Society since 1980, the American Association of Pharmaceutical Scientists (AAPS) since 1993, and was named a Fellow of the AAPS in 2007.

 

Sabine Thielges, Ph.D.
Analytical Project Leader
Novartis, Switzerland
In 2005, Dr. Sabine Thielges obtained her Ph.D. from Mulhouse University Ph.D. in Organic and Medicinal Chemistry under the supervision of Prof. J. Eustache on new approaches towards the treatment of mycobacterial infections. Sabine then spent 3 years as a postdoctoral fellow, at McGill University, Quebec with Prof. N. Moitessier on the computer-aided design and synthesis of asymmetric catalysts. After finishing her post-doctorate stage, Sabine worked for 2 years as a Research Associate at the NRC (National Council of Canada) working in parallel on modeling of dopamine D2/D4 receptors and the development of eye drop formulation using Design of Experiment (DoE).In 2012, Dr. Thielges worked at Janssen, Pharmaceutical Companies of Johnson and Johnson in Belgium where she built and supervised a Stability Science Group focused on early development, stability investigation and the use of ASAP (Accelerated Stability Assessment Program) in the company. Since 2016, Sabine works for Novartis as an analytical project leader.

 

Helen Williams, M.S.
Associate Principal Scientist
AstraZeneca, UK
Helen Williams graduated from Southampton University with a master degree in Chemistry in the summer of 1998, after which she started working at Astra-Zeneca in Macclesfield, UK, where she has spent the last 18 years working as an analytical chemist in the pharmaceutical development department.For 14 years she specialised as an expert in Electron Paramagnetic Resonance (EPR) spectroscopy, and she has most recently been working in the area of predictive stability. She is also a member of the IQ Risk-Based Predictive Stability working group. In 2014, she became a Chartered Chemist with the Royal Society of Chemistry.

 

Garry Scrivens, Ph.D.
Senior Principal Chemist
Pfizer, UK
Garry Scrivens is a Senior Principal Chemist at Pfizer in Sandwich, UK.He has a B.Sc. in Chemistry and a D.Phil in the application of magnetic resonance spectroscopy (ESR and NMR) to determine the mechanisms and kinetics of organic oxidation reactions.He has over 20 years’ experience in analytical chemistry in the pharmaceutical industry, working in a wide diversity of areas ranging from inhalation and dissolution and has authored numerous regulatory submissions. Garry has recently focused on pharmaceutical stability and in particular, has helped to develop, refine and apply accelerated studies for the prediction of long-term stability performance. Garry’s role at Pfizer also includes troubleshooting pharmaceutical product problems, understanding causes of poor stability and improving product design.

 

Kenneth C. Waterman, Ph.D.
President
FreeThink Technologies Inc., USA
Dr. Ken Waterman received his B.S. degree with honors in chemistry from UCLA, his Ph.D. in Physical Organic Chemistry from UC Berkeley and conducted post-doctoral studies in physical and photo-chemistry as an NIH research fellow at Columbia University. Dr. Waterman worked 12-years at Polaroid (as a distinguished scientist) developing imaging products, then 13 years at Pfizer (as a Research Fellow) working on drug stability, drug delivery, biopharmaceutics and prodrugs. He is the author of over 70 journal articles, and was made an AAPS Fellow in 2011.In 2011, he started FreeThink Technologies which both produces and licenses the accelerated stability software package ASAPprime ®, and is a CRO that has Connecticut-based laboratories specializing in stability for pharmaceuticals, generics, OTCs, nutraceuticals and consumer products.

 

Dr Paul G. Royall
Lecturer in Pharmaceutics & Programme Director of the MSc in Pharmaceutical Analysis and Quality Control.
King’s College London, UK
Dr Paul G. Royall’s research focuses on the use of materials science for the development of new dosage forms, especially freeze-dried and amorphous formulations to be administered via the oral route.

 

Thomas Andersson
Associate Principal Scientist
AstraZeneca, Sweden
Thomas Andersson, PhD, is an Associate Principal Scientist in Pharmaceutical Technology and Development at AstraZeneca R&D Gothenburg, Sweden. He received a PhD degree in organic chemistry at Chalmers University of Technology in 1996. He has spent two years at Columbia University, New York, as a postdoctoral fellow. He joined AstraZeneca in 2000 and in his current position he support drug projects within development with organic chemistry knowledge. This knowledge is mainly used to predict chemical degradation of the active ingredient and assist in the design of drug formulations. Another area of interest is pharmacopeia related issues. Thomas is a member of an expert group at EDQM, Strasbourg, working with active synthetic substances.

 

Prof. Zenon Foltynowicz
Department of Industrial Products Quality and Ecology
Poznan University, Poland
Professor Dr. Zenon Foltynowicz has over 35 years’ experience in science and engineering, management of technology and innovation, environmental sciences and sustainability. He currently works as a full professor in the Department of Industrial Products Quality and Ecology at Poznan University of Economics and Business/Poland. He published more than 120 papers, nearly 50 publications in journals with Impact Factor as well as delivered a number of lectures at international conferences. His research interests cover a wide range of topics, from materials science through industrial ecology to protection of intellectual property. He patented over 30 inventions. He has supervised 12 PhDs and more than 160 master’s theses. For two terms, he served as deputy dean and then dean of the Faculty of Commodity Science. Member of advisory board of 5 scientific journals.

 

Prof. Anne Marie Healy
Professor in Pharmaceutics and Pharmaceutical Technology, School of Pharmacy and Pharmaceutical Sciences
Trinity College Dublin, Ireland
Anne Marie Healy is a Professor in Pharmaceutics and Pharmaceutical Technology in the School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin (TCD) and is currently Head of School. She has a B.Sc. in Pharmacy and a Ph.D. in Pharmaceutics, both from the University of Dublin. She joined the School of Pharmacy, TCD in 1992 as a Lecturer in Pharmaceutics. In 2010 she was elected Fellow of Trinity College. Professor Healy has over 70 peer reviewed publications; she has given over 100 presentations at national and international conferences, graduated 15 PhD students and mentored 15 postdoctoral researchers. Her research interests include pharmaceutical material science, preformulation and formulation of pharmaceuticals, amorphous solids, co-crystals, formulating poorly soluble drugs, pharmaceutical processing, pulmonary drug delivery and formulation stability. She is currently Co-Principal Investigator of the Synthesis and Solid State Pharmaceutical Centre (SSPC: www.sspc.ie) and a Funded Investigator in the Advanced Materials and Bioengineering Research Centre (AMBER: www.ambercentre.ie). She was awarded a Special Visiting Research Fellowship by CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brazil) in 2014 to further her collaborative research with the Faculty of Pharmacy of the Federal University of Rio de Janeiro. This research focuses on single and combination dosage forms and on the re-formulation of “old” drugs to improve treatment by either the pulmonary or oral route.

 

Paul Whiteside, Ph.D
Principal Scientist
Pfizer, UK
Paul Whiteside is a Principal Scientist at Pfizer in Sandwich, UK and has over 10 years’ experience working in the pharmaceutical sector. Since joining Pfizer in 2014 Paul has been working within the Material Sciences team as a subject matter expert in vibrational spectroscopy. During this time he has focussed on developing an understanding of physical instability of API within solid dosage forms, as well as creating and implementing strategies to mitigate risk earlier in the drug development process. Paul’s role at Pfizer also involves the application of spectroscopic tools in order to secure the best solid form, support the design of a drug product, and to troubleshoot during the development process.
Paul has a MSci in Chemistry and Molecular Physics, and a Ph.D in the application of photoelectron spectroscopy to understand molecular dynamics, both from The University of Nottingham.

 

John M. Campbell, Ph.D.
Investigator
GlaxoSmithKline, USA
Dr. John M. Campbell received his Ph.D. from Washington University in St. Louis in Physical Organic Chemistry. He has worked at GlaxoSmithKline in the Philadelphia area since 2014 as a spectroscopist and subject matter expert in stress testing and forced degradation of small molecule pharmaceuticals. He specializes in forced degradation experiment design and execution, degradation prediction, impurity identification, and mechanism elucidation. He is passionate about good science and enjoys working on challenging problems.

 

Dr. Jürgen Adolphs
General Manager
Porotec GmbH, Germany
Studies of Physics and Mathematics at the University of Göttingen, Physics Diploma.
Lecturer in Building Physics and Materials Science / Civil Engineering at University Duisburg-Essen.
PhD in Physical Chemistry 1994 University Essen.
1999 – 2000 USA: Northwestern University, SAXS at synchrotron facility Argonne and SANS at NIST Gaithersburg.
From 2001 CEO and co-owner of Porotec GmbH (founded 1994).
Since 2012 Convener of DIN committee / Porosity, member of ISO.
PI of ZIM research projects about water vapor sorption and swelling/shrinkage.
Member of various advisory boards. Co-organiser of international workshops and conferences e.g. EUROMAT 2007
More than 60 publications.

 

Jonathan Bright, MA, MSc
Associate Principal Statistician
AstraZeneca, UK
After studying at the Universities of Cambridge (Natural Sciences) and Sheffield (Statistics), Jonathan Bright has worked as a statistician at the Medical Research Council, at Sheffield University and, since 2000, at AstraZeneca. Based at Alderley Park from 2000 to 2014 in support of Discovery, and based at Macclesfield from 2014 to present in support of Development, he has seen a wide variety of settings within which statistical ideas may be usefully applied – most recently in the area of predictive stability.

 

Ellen Verheyen
Senior Scientist – Stability Expert
Janssen Pharmaceuticals, Belgium
Ellen Verheyen obtained a PhD in Pharmaceutical Sciences at Utrecht university in 2011. She worked for three years as formulation scientist in the animal feed industry, before she started working at Janssen Pharmaceutica in Beerse, Belgium as Material Scientist. In this role, Ellen supported multidisciplinary teams during the development of oral solid drug products. She was responsible for excipient characterization and qualification, and identification of potential risks towards drug substance-excipient interactions. Currently she is working as stability expert in the analytical development organization with a strong focus on accelerated stability studies to identify and understand the chemical as well as physical (in)stability of drug substances and drug product formulations. She is responsible for the set-up of API-excipient compatibility studies, and experimental designs for risk based predictive stability studies. In addition, she is a key member of the investigational team for stability related challenges.

 

Amrit Paudel
Principal Scientist & Department Head for Advanced Products & Delivery
Research Center Pharmaceutical Engineering (RCPE), Austria
Assistant Professor at the University of Technology, Institute of Process and Particle Engineering, Graz, Austria and Principal Scientist / Department Head, Advanced Products and Delivery at Research Center Pharmaceutical Engineering (RCPE), Graz, Austria. Amrit is trained in pharmaceutics, and has a broad interest in physical chemistry of formulations and pharmaceutical material engineering. He has long standing activities and an interest in screening, engineering, stabilization and characterization of pharmaceutical solids intended for oral and inhalation routes. His current work also involves predictive knowledge/model development for physical and chemical stability of pharmaceutical solids utilizing material science principles. Recently, he is working towards advancing the predictive knowledge of in vitro biopharmaceutics methodologies via elucidation of multi-factorial physical and chemical process governing drug dissolution and release from conventional to advanced solid dosage forms.