Steven Baertschi, Ph.D., is President of Baertschi Consulting, LLC, an Indiana-based firm specializing in providing solutions to the most difficult stability, impurity, analytical, solid-state, and formulation issues. Retiring from Eli Lilly and Company in early 2015, he brings more than 33 years of experience in the pharmaceutical industry to his consulting firm, with a demonstrated track record of innovation and problem-solving. He obtained his PhD in Organic Chemistry in 1989 from Vanderbilt University (Nashville, TN) joining Eli Lilly and Co. (Indianapolis, IN) that same year. While at Lilly he was responsible for developing the areas of degradation chemistry, including stress testing, photostability testing, degradation product prediction and identification, mutagenic impurity and analytical control strategies for small molecule drug candidates.
Dr. Baertschi has helped organized / Chair numerous scientific conferences and symposia on stress testing, stability, photostability, and impurities; he has published 60 scientific articles in refereed journals and 30 book chapters. He has edited two editions of a book focused on the topic of pharmaceutical stress testing and has made critical contributions to more than 15 NDA/CTD and dozens of IND/CTA submissions. Dr. Baertschi has been a member of the American Chemical Society since 1980, the American Association of Pharmaceutical Scientists (AAPS) since 1993, was named a Fellow of the AAPS in 2007, and was awarded the Albert Nelson Marquis Lifetime Achievement Award by Marquis Who’s Who.
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Contracts have been established and services provided to more than 60 pharma / biotech / agriscience companies in the last 5 years!
Ph.D.,Organic Chemistry, Minor: Biochemistry, July 1989
Vanderbilt University, Nashville, TN
B.S., Chemistry, Minor: Mathematics, June 1980
CURRENT POSITION
President, Baertschi Consulting, LLC
29 years of in-depth scientific / technical experience in pharmaceutical R&D.
Providing consulting for the following industries:
- Pharmaceutical
- Animal Health
- Agrochemicals
- Consumer Healthcare
- Nutraceutical
- Weathering
On a wide range of topics including:
- Chemical, Physical, and Environmental Stability and Degradation
- Analytical and Impurity (including genotoxic impurity) Control Strategies
- Formulation Development, Excipient Compatibility, Excipient Interactions, and Stabilization
- Photostability / Photochemistry
- Regulatory Issues
- Quality-by-Design
- Scientific / Technical Staff Development
- Legal / Expert Witness / Patent Disputes
EMPLOYMENT HISTORY
Feb 2015 Retired from Lilly
Oct 2012 Promoted to Senior Research Fellow, Small Molecule Design and Development.
Oct 2005 Promoted to Research Fellow, Analytical Sciences R&D
Oct 2004 Promoted to Senior Research Advisor
Jan 2004 Title changed to Research Advisor
Jan 2003 Assumed supervision of Thermal Analysis Group
June 2001 Assumed supervision of Microcalorimetry Group
Jan 2001 Promoted to Senior Research Scientist
Jan 2000 Assumed role as Confirmation of Structure Team Leader
Jan 1994 to Dec 2000 Promoted to Research Scientist
Jan 1991 Assumed leadership for Degradation Chemistry Group
Aug. 1989 to Dec. 1994 Eli Lilly and Company
Senior Chemist, Analytical Development
Pharmaceutical Product Development
- The Albert Nelson Marquis Lifetime Achievement Recipient (2018)
- Fellow, AAPS (2007)
- Scientific Advisor, Journal of Pharmaceutical Sciences (July 2013-present).
- Member of the Editorial Advisory Board, Journal of Pharmaceutical and Biomedical Analysis, January 2010 to present
- Chair, AAPS APQ Fellows Selection Committee, 2010-2012.
- Member, AAPS Executive Fellows Selection Committee, 2010-2012.
- Member, PhRMA Limited Duration Key Initiative Team (LDKIT) for Genotoxic Impurities, ICH M7 Guidance (2010-present)
- Co-Chair, ICH M7 Degradants Subtopic Group LDKIT (2011-2015)
- Member, ICH M7 Quality Subgroup LDKIT (2011-2015)
- Member, USP Expert Panel on Impurities (2011-2015)
- Top Referee Award, 2007, Journal of Pharmaceutical Science
- Top Referee Award, 2006, Journal of Pharmaceutical and Biomedical Analysis
- Top Referee Award, 2008, Journal of Pharmaceutical and Biomedical Analysis
- Scientific Reviewer on Ph.D. Committees
- 2011: Shah Ravi Piyushkumar, National Institute of Pharmaceutical Education and Research, Served as External Reviewer of Dissertation for Ph.D. Committee; Prof. Saranjit Singh, Research Advisor (Ph.D. Pharmaceutical Sciences).
- 2006: Joergen Brustugun, University of. Oslo, Served as First Opponent for Ph.D. Defense (Ph.D. Pharmaceutical Sciences), Prof. Hanne H. Tonnesen, Research Advisor.
- Lilly Research Laboratories, President’s Recognition Award, 1999
- Lilly Research Laboratories, President’s Recognition Award, 2001
- Lilly Research Laboratories, Change the World Award, 2001/Q1
- Lilly Research Laboratories, Change the World Award, 2001/Q4
- Lilly Research Laboratories, Change the World Award, 2002/Q4
- Lilly Research Laboratories, Quality Advocate Award, 2003
Member of the American Chemical Society since 1980.- Member of the American Association of Pharmaceutical Scientists since 1991; Steering Committee Member for APQ Stability Focus Group, 2007-present; Steering Committee Member for APQ Impurities Focus Group, 2011-present.
- Commission Internationale de l’Eclairage (CIE), Topic Chair for Pharmaceutical Photostability, 2003-2009; Committee Member, Expert Working Group for “In-Use Photostability”, 2009-present.
- Pharmaceutical Photostability of Drugs Interest Group, Steering Committee Member since 1999.
- Member of the American Society for Photobiology (ASP)
- Member of the Customer Advisory Council (Weathering / Photostability) for Atlas Materials and Testing (Mount Prospect, IL).
Marvin M. Hansen, Ph.D, is an independent consultant with expertise in process chemistry and CMC issues in the pharmaceutical industry. He has 29 years of experience in drug development, including 28 years at Eli Lilly where he was a Senior Research Advisor. Key areas of expertise include early phase process development (synthetic route design, synthetic route development), development of API and intermediate impurity control strategies, development of the final API crystallization to deliver appropriate API physical properties, and a special emphasis on Genotoxic Impurity control. He has extensive experience delivering API for clinical trials using both Lilly internal and outsourced external resources. He also has experience working at the interface of process development and discovery chemistry. Dr. Hansen received a B.S. in chemistry from the University of Nebraska-Lincoln, and a Ph.D. in organic chemistry from the University of California-Berkeley.
Greg Stephenson is the President of PharmaFormFinders (pharmaformfinders.com). He offers services ranging from oversight of the screening for the optimal form for your API or pharmaceutical product by searching its “solid-form landscape” for physical forms by screening for salts, co-crystals, and amorphous forms. Services also include oversight of the collection and interpretation of characterization data and chemical and physical stability (polymorphic, hydrate, or disproportionation/dissociation) data leading to the optimal physical form selection for your product’s presentation.
Greg Stephenson has significant experience solving the most challenging problems of physical form, having solved numerous serious problems in drug development involving control of physical forms that impact dissolution rate, control of crystal morphology that impact flow characteristics and the processing/tableting of materials. He also offers services with respect to evaluation of patents, the structuring of claims for crystal forms in patents and their defense or questions of validity through litigation.
Bernard A. Olsen, Ph.D., is an independent consultant providing expertise in chemistry, manufacturing, and control issues to the pharmaceutical industry. He has over 37 years of experience in drug development including 29 years at Eli Lilly where he was a Senior Research Fellow. Specific areas of experience include control strategy development, analytical method development, method validation and transfer, HPLC, spectroscopy, impurity investigations, genotoxic impurity strategies, specification development, stability studies, drug substance physical properties, CRO direction and interactions, and regulatory filing preparation. Dr. Olsen also has experience as an expert witness in patent litigation. Dr. Olsen received a B.S. in chemistry from Nebraska Wesleyan University and a Ph.D. in analytical chemistry from the University of Wisconsin-Madison.
Dr. Henry Havel is a skilled pharmaceutical development scientist with more than 35 years experience working on projects from discovery to launch. He recently retired from his position as a Senior Research Fellow at Lilly and is now a CMC consultant to small and large companies. During Dr. Havel’s career, he applied his knowledge and expertise to characterization, delivery, and development of small molecule, peptide and protein therapeutics. He has considerable experience in due diligence, intellectual property and the emerging field of nanomedicine. Prior to joining Lilly, Dr. Havel worked at The Upjohn Company (now Pfizer), Kalamazoo, Michigan. He has a Ph.D. from the University of Minnesota and a B.S. from the University of Rochester, both in chemistry.
Dinesh Mishra, Ph.D. has over 25 years of experience in commercial drug product formulation and manufacturing process development, scale-up & tech transfer, and global regulatory submission for synthetic small molecule, peptides, and biologics. He led formulation development and commercialization of currently marketed injectable drug products by Eli Lilly. Dr. Mishra has been involved in multiple due diligences for projects at all stages in development, preclinical to products ready for launch. He recently retired from Lilly after 23 years where he was Senior Research Advisor in Bioproduct Research & Development. Dr. Mishra received his B.S. in pharmacy from University of Bombay and Ph.D. in pharmaceutical chemistry from University of Arizona.
Contact Information
Dinesh S. Mishra, Ph.D.
Email: dsmishra@gmail.com; dmishra@purdue.edu
Mobile: 317-997-0699