ASAP Applications in Generic Products

ASAP Applications in Generic Products Bryan Wicks, Ph.D. Associate Director Boehringer Ingelheim Pharmaceuticals Inc. The typical generic pharmaceutical business model requires ascertaining as much product understanding as possible in a drastically shortened development time.  With ever changing regulatory requirements, product knowledge and robust development processes are critical in the manufacturing of a sustainable quality product.  […]

In-Use and Excursions: Stability Beyond ICH

In-Use and Excursions: Stability Beyond ICH Kenneth C. Waterman Ph.D. President, FreeThink Technologies, Inc. Branford, CT USA While there is a regulatory expectation that in-use shelf-life will be determined for multiuse packaging, there is little definition of what that testing entails. In-use conditions can be from opening of a package (e.g., breaking a heat-induction seal, HIS, […]

ASAP for Non-Traditional Factors: Dissolution, Disintegration & Color

ASAP for Non-Traditional Factors: Dissolution, Disintegration & Color Kenneth C. Waterman, Ph.D. President, FreeThink Technologies, Inc. Branford, CT USA The Accelerated Stability Assessment Program (ASAP) approach of assigning storage times to hit the dissolution failure point at a range of temperatures and relative humidities (RHs) below the critical relative humidity (CRH) at each storage condition […]

ASAP Prime 5.0: Introduction to Latest Version Release

ASAP Prime 5.0: Introduction to Latest Version Release Kenneth C. Waterman, Ph.D. President, FreeThink Technologies, Inc. Branford, CT USA The latest version of ASAPprime® Stability Software will be released shortly. It will have a number of new features: Added the cross-validated R2 (Q2) Ability to see all the isoconversion plots at once Warnings when data involve significant […]

ASAP: Theory and Fundamentals

ASAP: Theory and Fundamentals Sabine Thielges, Ph.D. Analytical Project Leader Novartis, Basel, Switzerland ASAP (Accelerated Stability Assessment Protocol) is gaining acceptance across the pharmaceutical industry as a powerful tool of predicting the effects of temperature and humidity on pharmaceutical stability.  In this presentation the theory and fundamentals of ASAP will be discussed, covering the science […]

In Silico Characterization of Thermodynamic and Kinetic Stability of Amorphous Solid Dispersions

In Silico Characterization of Thermodynamic and Kinetic Stability of Amorphous Solid Dispersions Jeffrey S. Tan, Ph.D. Senior Research Scientist, Eli Lilly and Company Indianapolis, IN, USA Amorphous solid dispersion is an important formulation platform for the delivery of poorly soluble drugs.  The solubility enhancement is achieved by disruption of the highly ordered crystalline lattice into […]

Stress Testing in Solid State: Towards a Realistic Degradation Profile

Stress Testing in Solid State: Towards a Realistic Degradation Profile Peter Persich, Ph.D. Scientist, Janssen Pharmaceuticals (J & J) Beerse, Belgium Stress testing is an important and convenient tool to predict degradation profiles and to understand drug decomposition processes. A thoroughly assessed degradation profile allows the smooth development of stability indicating methods, robust formulations, and […]

The Use of ASAP from Early to Late Pharmaceutical Development

The Use of ASAP from Early to Late Pharmaceutical Development Eduard Luss, Ph.D. Sr. Scientist, Vertex Pharmaceuticals Boston, MA, USA The presentation covers a brief overview of ASAP, experimental design and its advantages in pharmaceutical development when compared to other typical approaches.  Also, ASAP implementation in early development projects is demonstrated; including regulatory implications during […]

Case studies in Drug Packaging: Supporting Stability by Addressing Specific Preservation Challenges

Case studies in Drug Packaging: Supporting Stability by Addressing Specific Preservation Challenges Valère Logel, M.S. Head of Development, Clariant Paris, France Selecting the appropriate packaging to preserve drug products always requires calibration to the conditions specific to the application. In some instances, preservation of moisture sensitive drug products is achieved by combining commonly available packaging […]

ASAP Regulatory Strategy: Acceptance and Feedback

ASAP Regulatory Strategy: Acceptance and Feedback Elke Debie, Ph.D. Manager, CMC Regulatory Affairs, Janssen Pharmaceuticals Beerse, Belgium During this presentation the use of ASAP stability in regulatory filings will be discussed. Companies have been utilizing ASAP tools to enable development.  However, the perception is that the application of these tools has been inconsistent across the […]

Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development

Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development Jonathan Clark Scientist, Procter & Gamble Cincinnati, OH, USA The Over the Counter (OTC) drug market is changing. USP OTC Drug Product monographs are evolving to contain better control of API degradation products. OTC products are complex formulations, often containing solvents, dyes, flavors, […]

Analysis of Unstable Degradation Impurities and their Quantification without Isolation using Multiple Linear Regression

Analysis of Unstable Degradation Impurities and their Quantification without Isolation using Multiple Linear Regression John M. Campbell, Ph.D. Investigator, GlaxoSmithKline Philadelphia, PA, USA This presentation discusses a novel methodology developed for calculating the relative response factors (RRFs) of two highly unstable degradation impurities without isolation using only HPLC-UV data. Subsequent correction of HPLC peak areas […]

Understanding Importance of Water Sorption Isotherm Shape, Hysteresis, and Models on Pharmaceutical Materials

Understanding Importance of Water Sorption Isotherm Shape, Hysteresis, and Models on Pharmaceutical Materials Daniel Burnett, Ph.D. Director of Science Strategy, Surface Measurement Systems, Ltd. Allentown, PA, USA This educational seminar will focus on the interactions of water vapor and understanding physicochemical water sorption isotherms on pharmaceutical ingredients.  Moisture and/or humidity has significant importance for pharmaceutical […]

Drug Degradation Mechanisms

Drug Degradation Mechanisms Steven Baertschi, Ph.D. President, Baertschi Consulting, LLC Indianapolis, IN, USA Developing an understanding of the degradation pathways available to drug substances and associated formulated products is an important part of establishing the “intrinsic stability” characteristics of a drug.  This talk will focus on several case studies of degradation mechanisms, highlighting the importance of […]

Dr. Steven Baertschi

Steven 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. […]

Dr. Chandan Bhugra

Chandan 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 […]

Dr. Ricardo Borjas

Dr. Ricardo Borjas, Ph.D. Scientific Fellow II Vertex Pharmaceuticals Ricardo Borjas received his BSc and PhD in chemistry (Dr. Robert J. Gale) from Louisiana State University, Baton Rouge, LA. After completion of the PhD, he held postdoctoral positions at the Fritz Haber Institut in Berlin, Germany (Prof. Heinz Gerisher), and the University of Wyoming (Dr. […]

Dr. Anders Broo

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 […]

Dr. Daniel Burnett

Daniel 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 […]

Dr. John Campbell

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 […]

Dr. Jonathan Clark

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 […]

Dr. Allison Dill

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 […]

Dr. Debbie Elke

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 […]

Patrick Jansen

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 […]

Dr. Rodney Ketner

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 […]

Dr. Jennifer Lewis

Dr. 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 […]

Mr. Valère Logel

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 […]

Dr. Eduard Luss

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 […]

Llurellyn Malcolm

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 […]

Dr. Brian Pack

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 […]

Dr. Peter Persich

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 […]

Dr. Fenghe Qiu

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 […]

Dr. Garry Scrivens

Garry 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 […]

Dr. Thomas Sharp

Dr. 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 […]

Carlos Daniel Stagnaro, M.B.A.

Carlos 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 […]

Dr. Jeffrey Tan

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 […]

Dr. Jason Teckoe

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 […]

Dr. Sabine Thielges

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. […]

Jerusha Thompson

Jerusha 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 […]

Steven Warakomski

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 […]

Dr. Alisa Waterman

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 […]

Dr. Kenneth Waterman

Kenneth 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 […]

Dr. Bryan Wicks

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 […]

Helen Williams, M.S.

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 […]