Steve_Baertschi_CircleSteven Baertschi, Ph.D. 
President
Baertschi Consulting, LLC

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.

 

Chandan_Bhugra_CircleChandan Bhugra, Ph.D.
Sr. Principal Scientist
Boehringer-Ingelheim Pharmaceuticals

Dr. Chandan Bhugra received his PhD in Pharmaceutical Sciences from University of Connecticut with emphasis on stabilization of amorphous state. Chandan joined the Pharmaceutical Development department at Boehringer Ingelheim in 2007. He led various pharmaceutics teams responsible for formulation development and scale-up to support up to Phase II clinical trials. He has been actively involved in advancing new technology within Pharmaceutics such as understanding stability of amorphous dosage systems, implementing platform formulation concepts utilizing API sparing dry granulation approaches (FAST approach), and has led academic collaborations focusing on super-saturated systems. More recently Chandan has been leading R&D project teams for various development candidates. Chandan has published 14 peer reviewed research papers and has over 25 poster/podium presentations.

Dan_Burnet_CircleDaniel Burnett, Ph.D.
Director of Science Strategy
Surface Measurement Systems, Ltd.

Dr. Dan Burnett is the Director of Science Strategy for Surface Measurement Systems, Ltd. located at SMS’s North American headquarters in Allentown, PA.  He received his bachelor’s degree in Professional Chemistry from Eastern Michigan University in 1997.  He received his Ph.D. degree in Chemical Engineering from the University of Michigan in 2001.  Since joining SMS in 2001, he has continued his interests in sorption science and surface chemistry on a range of materials including: pharmaceutical powders, natural and man-made fibers, polymers, films, and food/flavor systems.  Dr. Burnett has authored or co-authored over 25 papers in peer-reviewed journals and presented at numerous national and international conferences. 

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John M. Campbell, Ph.D.
Investigator
GlaxoSmithKline

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.

Jonathan Clark, Ph.D.
Scientist
Procter & Gamble

A native of Dayton, OH, Jonathan received his B.S. in Chemistry from Butler University in Indianapolis before pursuing his Ph.D. in Analytical Chemistry (separation science) under Dr. Susan Olesik at the Ohio State University.  After receiving his Ph.D. in the fall of 2010, he continued his training in the field of biological mass spectrometry at the Vanderbilt-Ingram Cancer Center.

His passion for the untapped potential of separation science to solve impactful problems led him to a career in industry; first at Dow AgroSciences (2012-2015) and currently with Procter & Gamble (2015-present).

He is currently leading analytical technology for upstream OTC product development as well as the strategy for new chromatographic technologies in the changing regulatory landscape.

Dr. Elke Debie, Ph.D.
Manager, CMC Regulatory Affairs
Janssen Pharmaceuticals

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.

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Rodney J. Ketner, Ph.D.
Director, Pharmaceutical Alliances
Bend Research, a division of Capsugel

Dr. Rod Ketner has 17 years of experience developing novel drug-delivery technologies for new and existing pharmaceuticals.  Rod has worked on more than 500 client compounds, addressing multiple challenges including: improving the bioavailability of drugs with low aqueous solubility, mitigating chemical instability in amorphous and crystalline formulations, mapping and predicting the physical stability of amorphous dispersions, and masking the taste of bitter drugs.

Dr. Ketner received his Ph.D. in Physical Organic Chemistry at the University of California-Santa Cruz and conducted post-doctoral research at the University of California-Berkeley with Andrew Streitwieser. Dr. Ketner coordinates charitable outreach programs at Bend Research and actively promotes science education in Central Oregon.

Valère Logel, M.S.
Head of Development
Clariant Healthcare Packaging

Since 2005 Valère Logel has been the Head of Development for Clariant Healthcare Packaging, a globally active manufacturer of controlled atmosphere packaging.

He holds master’s degrees in Engineering and Polymer Science and has nearly 20 years of experience in research, development, production and market introduction of pharmaceutical and diagnostic packaging technologies.

His expertise includes material engineering, product design, and process validation, with specific focus on healthcare packaging systems that protect drugs from moisture and oxygen.

Eduard Luss, Ph.D.
Sr. Scientist
Vertex Pharmaceuticals

Dr. Eduard Luss received his BSc and PhD in Organic Chemistry under the supervision of Dr. Craig Forsyth, from the University of Minnesota, Twin Cities, MN. After completion of his PhD, he held a postdoctoral position at the Massachusetts Institute of Technology (Prof. Stephen L. Buchwald). Postdoctoral studies were followed by a move to the industry. After working in the area of radiopharmaceuticals for three years at Molecular Insight Pharmaceuticals he moved to Vertex Pharmaceuticals in Boston, MA where he has worked for the last five years.

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Peter Persich, Ph.D.
Scientist
Janssen Pharmaceuticals (J & J)

Dr. Peter Persich obtained his diploma in Chemistry from the University of Münster (Germany) in 2010 and his Ph.D. from the Max-Planck-Institute for Coal Research in Mülheim/Ruhr (Germany) in 2014 under the supervision of Prof. Alois Fürstner. Peter`s research work focused on the total synthesis of bioactive natural products and the development of transition metal catalyzed reactions in organic synthesis.

Since 2014, Peter Persich has held a position as scientist in the department of analytical development at Janssen Pharmaceuticals in Beerse (Belgium). In his current role, he is mainly working on the assessment of drug stability, the investigation of decomposition pathways, and the development of novel strategies to evaluate drug degradation.

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Jeffrey S. Tan, Ph.D.
Senior Research Scientist, Small Molecule Design and Development
Eli Lilly and Company

Dr. Jeffrey S. Tan obtained his Ph.D. at Purdue University in the Department of Industrial and Physical Pharmacy under the supervision of Professor Kenneth R. Morris. His research focused on developing novel algorithms for quantum mechanically derived partial atomic charges with a level of accuracy suitable for use in solid-state calculations.

Dr. Tan joined Eli Lilly and Company in 2007 in the pre-formulation group as the pharmaceutical development scientist in the discovery-development interface. He is currently a member of the Small Molecule Design and Development Modeling and Simulations group where he is actively developing and applying in silico and in silicoin vitro hybrid tools to study mechanisms affecting drug product performance such as drug absorption, in vivo dissolution and precipitation, solubility, and stability in an effort to better design and optimize pre-clinical and early phase clinical trial formulations.

 

Sabine Thielges, Ph.D.
Analytical Project Leader
Novartis

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.

Alisa Waterman, Ph.D.
Chief Science Officer
FreeThink Technologies, Inc.

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.

Ken_Waterman_CircleKenneth C. Waterman, Ph.D.
President 
FreeThink Technologies, Inc.

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.

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Bryan Wicks, Ph.D.
Associate Director
Boehringer Ingelheim Pharmaceuticals Inc.  

Dr. Bryan Wicks is an Associate Director of Launch Analytics in the Third Party Management (3PM)/ Launch and Transfer Group at Boehringer Ingelheim Pharmaceuticals Inc.

Bryan has over 20 years of experience in Analytical Chemistry in the pharmaceutical industry and has held numerous positions at increasing levels of responsibility.

His technical areas of expertise include Raman, FTIR, and NMR spectroscopies, mass spectrometry, Gas Chromatography and HPLC.

His experience in the application of these techniques ranges from early stage drug development through product launch and lifecycle. Bryan has extensive working knowledge of method development, validation and transfer, and has authored numerous regulatory submission documents. In his previous role at Boehringer Ingelheim Roxane Inc., he led the development and application of ASAP to address challenges related to long term stability prediction of generic products.

Dr. Wicks received his B.S. degree in Chemistry and his Ph.D. in Physical Chemistry from The University of Toledo.

Helen Williams, M.S.
Associate Principal Scientist
AstraZeneca, Macclesfield, 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 specialized 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.