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.

 

Anders Broo has a PhD in theoretical and physical chemistry from University of Gothenburg, Sweden (1991). He did a post-doc at University of Uppsala (1992) and a second post-doc at University of Florida (1993-94). After the post-doc’s he returned to Sweden for an assistant professor position at Chalmers Technical University, Gothenburg, Sweden.

The research interest was focused on electron transfer in biological systems, molecular devices, self- assembling systems, spectroscopy of DNA bases. In 1997 Anders transitioned to the automotive industry. In 2001 he moved to a computational chemist role at AstraZeneca. Since then he has held several different scientific, management and project leader positions within the discovery and development part to the AstraZeneca organization.

His current role is to lead a science program in Modeling and Simulation at Pharmaceutical Development.

Dill,_Allison

Allison Dill, Ph.D. is a Research Scientist Small Molecule Design and Development at Eli Lilly and Company, Indianapolis, IN.  She received a BS in Chemistry from Indiana University in 2001, and worked for 4 years as an analytical chemist in Product Research and Development before attending graduate school.

She received her Ph.D. in Analytical Chemistry in 2011 from Purdue University, studying imaging mass spectrometry for disease state characterization.  While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to several regulatory submissions.

She has experience developing the analytical control strategy for pediatric dosage forms.  Her recent contributions have focused on enabling the delivery of the early phase portfolio within a complex global network with responsibility for the analytical control strategy of both the active pharmaceutical ingredient and the drug product.

PatrickJansen

Patrick Jansen is a Principal Research Scientist in the Analytical Sciences Research and Development division of Lilly Research Laboratories, Eli Lilly and Company. Mr. Jansen obtained a BS degree in Chemistry from the University of Minnesota in 1989 and joined Lilly in 1989. His current responsibilities include leading a team responsible for the design and implementation of ICH stress testing studies for drug substances and drug products, isolation and characterization of degradation products and impurities, and preparation of regulatory documents describing the degradation chemistry of molecules in late-phase development. Previous responsibilities included development and validation of analytical methods for drug products.

 

Jennifer_Lewis_CircleDr. Jennifer Lewis received her B.A. degree in chemistry from Berea College and her Ph.D. in bioanalytical chemistry from the University of Kentucky. She has extensive experience acting as an analytical lead on multidisciplinary teams to support new product development and existing product optimization in the pharmaceutical industry.

Dr. Lewis also has expertise in a wide-range of analytical methodologies to support product release testing, stability testing, new product formulation, patent protection and unknown impurity/degradant identification.  She has developed and validated test methods, particularly chromatography methods, for both small molecule drugs and biologics in a cGMP environment.

Most recently, Dr. Lewis fulfilled an administrative role as an Assistant Dean of Strategic Initiatives, creating new professional degree programs at the College of Arts and Sciences, University of Miami.

Dr. Lewis is currently an Associate Director at FreeThink Technologies Inc. and is responsible for all aspects of laboratory management, direct client-sponsored project work, and helps develop and spearhead FreeThink’s R&D strategy.

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.

Llurellyn Malcolm, Principal Scientist, Pfizer Inc.

Llurellyn Malcolm is currently employed at Pfizer Pharmaceutical Inc. as a Principal Scientist at the Pearl River site in New York.

He joined Pfizer Inc. in 2000 providing analytical support within the Product and Process Development group in Brooklyn, New York. In 2004 he joined the analytical team at the Morris Plain site, New Jersey to support new technology development projects and pilot plant operations. Focus areas entailed FT-IR and NIR spectroscopy, NIR chemical mapping and imaging applications linked to product quality and design. Major activities involved utilizing material characterization tools (e.g. spectroscopy, differential scanning calorimetry and particle size distribution) in the investigation and troubleshooting of API, excipients and oral solid drug products.

Within the past five years, Llurellyn has shifted his focus area to supporting the development of science based approaches to stability studies within a commercial space. This involves utilizing the Accelerated Stability Assessment Program (ASAP) as root cause investigative and risk assessment tool. Other areas of application Llurellyn has explored using the statistical methodology include supporting drug product packaging design, excursion studies and gaining an improved understanding of product stability with respect to ICH storage conditions.

Llurellyn holds a B.S. in Forensics Science from John Jay College, a M.S. in Pharmaceutical Chemistry from Lehigh University. Llurellyn is also an affiliate of the American Association of Pharmaceutical Scientist (AAPS).

Brian W. Pack, Ph.D. is a Sr. Research Advisor in Small Molecule Design and Development at Eli Lilly and Company, Indianapolis, IN

Brian W. Pack, Ph.D. is a Sr. Research Advisor in Small Molecule Design and Development at Eli Lilly and Company, Indianapolis, IN.  While at Lilly, he has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to several regulatory submissions.  He is recognized for his contributions to raw material control strategy, cleaning validation, and HPLC method development.  He has over 20 publications, including three book chapters, mainly on the topics of cleaning verification and chromatographic applications.  He has given invited presentation on the topics of HILIC, analytical color determinations for pharmaceuticals, and genotoxic impurity control and testing in drug products.   His undergraduate degree is from Ohio University and his doctorate in analytical chemistry is from Indiana University.

Peter_Persich_Circle

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.

Science of Stability (SOS-2015) Speaker Fenghe Qui<a href="http://www.scienceofstability.com">www.scienceofstability.com</a>

Dr. Fenghe Qiu is a Senior Principal Scientist in the Material and Analytical Sciences Department, Boehringer Ingelheim. He also serves as a member of the Development US GTI Advisory Council, Head of QC for Synthesis Materials and DEA Controlled Substance Monitor.

Fenghe received a BS degree in Chemistry from Shandong University and a Ph.D. degree in Physical Chemistry from Chinese Academy of Sciences. He authored/co-authored over 50 peer reviewed papers/book chapters, and made many presentations including over 25 invited presentations at various international/national conferences.

Prior to BI, Fenghe had several academic assignments including: Mass Spectrometry Lab Manager, Department of Chemistry, Northwestern University; Associate Professor, National Center of Biomedical Analysis of China. He also received a diploma from the First Artillery Academy in China and was an army captain prior to entering graduate school.

Garry_Scrivens_CircleGarry Scrivens, Ph.D.
Senior Principal Scientist
Pfizer Pharmaceuticals

Dr. 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 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 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, for instance understanding causes of poor stability and improving product design.

Dr. Thomas Sharp -TRS_2003Dr. Thomas Sharp is associate research fellow (emeritus), retired from Pfizer Global Research and Development, Groton, CT, in 2009. During his 18-year tenure, he headed a mass spectrometry resource laboratory focusing on the structural characterization of drug substance molecules and of impurities and degradants of interest to the company for 13 years. He served as a member of the research analytical co-discovery group for the last 5 years, providing analytical chemical support for early development candidate molecules, while focusing on investigations into computational chemistry aspects of molecule stability evaluation and expert systems development.

He received his B.S., zoology, Western Illinois University (1972), Ph.D., biological chemistry, Indiana University (1977), and has held postdoctoral appointments at The Pennsylvania State University and Case Western Reserve University School of Medicine, faculty/staff appointments at the University of Utah and Texas A&M University before joining Pfizer in 1991. Dr. Sharp received his M.S., computer science (1999) from Rensselaer Polytechnic Institute at Hartford, CT.

Since retirement, he has held teaching appointments at the University of Connecticut-Storrs, Quinebaug Valley Community College, University of New Haven and South University Online, and has recently joined FreeThink Technologies Inc. as a senior scientist. He has been a member of the American Chemical Society since 1972 and of the American Society for Mass Spectrometry since 1982.

Carlos Daniel StagnaroCarlos Daniel Stagnaro, Director, Global Business Development, Klöckner Pentaplast Pharmaceutical Films Division.

With nearly 25 years of experience developing packaging solutions for the pharmaceutical industry, Daniel has been with Klöckner Pentaplast since 1990. Prior to promotion to his new role, Daniel served as Pharma Business Director for the Americas based at the site in Gordonsville, Virginia. Between 2000 and 2005 Daniel actively participated in the founding of Klöckner Pentaplast Brazil, where he was the Technical and Commercial Director in Sao Paulo. Between 1997 and 2000 he served as Manager of Marketing and Sales for Latin America and was based in Buenos Aires, Argentina. Between 1990 and 1997 he was the Business Manager for additives and fluorinated polymers in Argentina.

Currently, as Director, Global Business Development, Daniel leads the newly launched kp i.center in Charlottesville, Virginia. The kp i.center provides a collaborative space to help customers bring products to market more quickly and economically. The center officially opens to the public on April 1, 2015. Daniel is a graduate of the National Technical University of Argentina with a degree in Chemical Engineering. In 2011 he was awarded his MBA from the University Of Virginia Darden School Of Business. He is an Eagle Scout and actively participates as an adult leader of the Scout Troop 111 in Charlottesville VA.

Science of Stability (SOS-2015) Speaker Jason Teckoe<a href="http://www.scienceofstability.com">www.scienceofstability.com</a>
Dr. Jason Teckoe received his B.Sc in chemistry from the University of Warwick (UK), his M.Sc in polymer science from the University of Lancaster (UK) and his PhD. in polymer physics from the University of Reading (UK).

Jason has over 15 years’ experience formulating novel solid oral dosage forms and film coatings systems, and is a named inventor on 15 patents/applications.  He is an active member of the Royal Society of Chemistry, Society of Chemical Industry and American Association of Pharmaceutical Scientists.  Jason joined Colorcon in 2007, and is Senior Manager in the New Product Development group, based in Harleysville, PA, U.S.A

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.

THOMPSON%20JERUSHA%20RJerusha Thompson is an established analytical scientist with 20 years of diverse R&D experience in the pharmaceutical industry.   Jerusha’s experience in drug product development ranges from product initiation through commercialization. Jerusha received a B.S. in Chemistry from University of California San Diego

Jerusha has been with Upsher-Smith Laboratories since 2005 and is currently a Senior Scientist in the Chemistry and Analytical Sciences department.   Prior to Upsher-Smith Laboratories, Jerusha held positions of increasing responsibility at Allergan, ranging from early phase method development to establishment of extractable/leachable programs.

Jerusha has extensive working knowledge on method development, validation, raw material selection/qualification, packaging selection, ICH stability studies, FDA submissions and regulatory requirements.

 

Steven Warakomski Technology & Innovation, Pharmaceutical Packaging Klöckner Pentaplast

Steven Warakomski, Technology & Innovation, Pharmaceutical Packaging, Klöckner Pentaplast.  For over 18 years, Steven has worked in a variety of technical areas in pharmaceutical packaging and polymer processing. Steven currently works in the Technology & Innovation group of Klöckner Pentaplast with a focus on pharmaceutical packaging. He has served as Technical Manager, Pharmaceutical Film from 2006 until present date and has recently shifting focus to more of a research and development role. Prior the focus on pharmaceutical films, he worked as an extrusion process engineer for both Klöckner Pentaplast and Penn Fibre & Specialty, Co.

As Technical Manager, Steven has played a key role in the development and support of Klöckner Pentaplast’s BlisterPro™ services. He provides support to the recently established i.Center located in UVA Research Park in Charlottesville, VA. Form the i.Center, he supervises a team of design engineers to develop and support the newly expanded BlisterPro™ Xcel services. Other areas of focus include development of packaging that requires high barrier, chemical resistance, or other unique features that arise from customer and market needs.

Steven is a graduate of Bucknell University, Lewisburg, PA with a degree in Chemical Engineering. In 2013, Steven was awarded a patent titled “Configuration of Multiple Thermoformable Film Layers for Rigid Packaging Requiring Moisture and Oxygen Protection.”

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.