ADME, DMPK, and DDI Consulting Services for Nonclinical Drug Development
Our DDI Consulting Services connect clients with top-tier experts and facilitate exhaustive analysis of the critical components of absorption, distribution, metabolism, and excretion (ADME) properties and risk related to drug-drug interaction (DDI) potential of their drug candidate. This input allows for the optimization of your data package for regulatory submission and minimizes the risk of costly or dangerous unexpected circumstances in clinical trials leading to late-stage failure.
Your Goals, Our Expertise
When a drug is being developed, it goes through a rigorous battery of safety assessments to prove it poses minimal risks to participants in clinical trials. However, there are many options for preclinical testing, from which studies to perform or contract to when and where. Although there is some regulatory guidance, it requires expert interpretation, and approval is only granted when exhaustive information is presented to detail and support a risk-based approach.
To assist with these decisions, we have assembled a network of internal and external consultants with diverse and deep-rooted experience in evaluating drug-drug interaction risk of investigational drugs in the development pipeline. Our experts are trusted by 98% of top pharma companies in the United States as well as research institutions and countless others worldwide to provide high-caliber advice and solutions to DDI-related challenges.
Our consulting offerings can help you not only be prepared for regulatory submission, but also to better understand the intricacies of your compound and use data proactively to design effective follow-up DDI investigations and first in-human (FIH) studies. Each client walks a unique path with challenges, data sets, and strategic development plans that set them apart from others. Depending on your specific needs and position, we can match you to one or a combination of our DDI consulting experts qualified to help you succeed.
Gain trusted insight from the experts to meet your needs, including:
- Gap analyses for in vitro victim and perpetrator studies (DDI and drug metabolism)
- Recommendations for planning risk-based approach (including strategic study timing advice)
- Response to regulatory questions
- Introductory in vitro DDI study package design
- Mechanistic static modeling for DDIs (i.e., AUCR calculations)
- Basic IVIVE scaling for CLint
- Synthesis of in vitro DDI data including commentary as needed
- Expert opinions or commentary on in vitro DDI and metabolism data
- Written summaries of guidance provided in consulting calls
- Relevant written sections of applications for IND, NDA, and IB
- Manuscript writing
- Custom drug metabolism lectures or workshops at client’s site
Our consultants give you the confidence to prepare your in vitro ADME / PK and DDI data for regulatory submission.
With so many moving parts, drug developers often need external guidance to examine all available data with a fine-tooth comb to answer questions, identify potential issues, and minimize the risk of unexpected outcomes in clinical trials. That extra set of eyes and knowledgeable expertise could mean the difference between successful risk management and late-stage failure.
We provide that comfort.
In addition to our signature consultative approach we provide with every contracted study, we offer top-tier consultancy through a team of professionals from SEKISUI XenoTech and highly-qualified independent contractors who can equip our clients with highly specialized insight borne of years of experience in the industry and extensive scholarship. The ADME, DMPK, and DDI consulting team is led by Brian Ogilvie who serves as SEKISUI XenoTech’s Vice President of Scientific Consulting and has over 20 years of specialized experience in ADME and DDI, working with clients to evaluate their compounds’ pharmacokinetic properties and associated risks.
Our Network of DDI Consultant & Internal Support
Each member of our team is hand-picked to bring something unique and valuable to the table. In addition to our designated Scientific Consulting department, we maintain strong ties to a variety of external experts with complementary areas of expertise. This network allows us to best meet the needs of our clients, whether they are directly related to our specialized in vitro and in vivo work or could benefit from tangential fields. The team is further supported by experts in our own Scientific Operations department, who can lend additional insight to drug metabolism- and drug interaction-related concerns.
Brian Ogilvie, Ph.D., Vice President, Scientific Consulting
Brian Ogilvie currently serves as Vice President of Scientific Consulting at SEKISUI XenoTech. Dr. Ogilvie obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. He joined XenoTech in 1997. From 1999 to 2006 Dr. Ogilvie was the head of the CYP Inhibition Department at SEKISUI XenoTech. Dr. Ogilvie is an author or co-author on over 50 scientific posters, peer-reviewed publications and book chapters on the topics of drug metabolism, transport, and drug-drug interactions and regularly consults on these subjects. In April 2006, Dr. Ogilvie became a member of the SEKISUI XenoTech Consulting Department, which he now leads as Vice President. Dr. Ogilvie also manages new and ongoing drug-drug interaction-related R&D projects, authors various publications, and is regularly featured as an invited expert speaker at trade shows and seminars around the world. As Vice President of Scientific Consulting, Dr. Ogilvie is additionally involved in quality management and strategic planning for the company in scientifically relevant areas.
Areas of Expertise: Drug-metabolizing enzyme inhibition, metabolism, transport, DDI Consulting, regulatory response
Maciej Czerwinski, Ph.D., Director, Scientific Consulting
Maciej Czerwinski currently serves as Director of Consulting at SEKISUI XenoTech. Maciej received his PhD from the University of Maryland at Baltimore Medical School in the Department of Pathology. He conducted his doctoral thesis research in the Laboratory of Dr. Frank Gonzalez at National Cancer Institute in Bethesda, followed by a postdoctoral fellowship at the Department of Pharmaceutics, University of Washington in Seattle. He has been with SEKISUI XenoTech since 1999 and guides the development of products and services for the in vitro analysis of drug safety. Among numerous scientific pursuits, Dr. Czerwinski designed a patented method to analyze the in vitro cytokine-mediated drug-drug interactions between biologics and small molecule drugs. Dr. Czerwinski is also the inventor of XenoTech’s CryostaX® single-freeze pooled hepatocytes.
Areas of Expertise: Cytokine-release assay for immunomodulatory DDIs, products, tissue biobank, disease models
Pallavi Limaye, Ph.D., DABT, Director, Scientific Consulting
Pallavi Limaye completed her Ph.D. in Toxicology from The University of Louisiana in 2004 under the mentorship of Dr. Harihara Mehendale. She did her postdoctoral research in the Department of Pathology at University of Pittsburgh under the direction of Dr. George Michalopoulos and subsequently at the Department of Pharmacology, Toxicology, and Therapeutics at University of Kansas Medical Center under the mentorship of Dr. Curtis Klaassen. Dr. Limaye originally joined SEKISUI XenoTech in 2011 as a Research Scientist and served as a study director for in vitro drug metabolism studies. In 2013, she joined Xenometrics LLC, as a Senior Scientist and served as a study director for regulated nonclinical IND- and NDA-enabling toxicology studies. From 2018 to 2020 Dr. Limaye worked at MRIGlobal as a Principal Scientist and oversaw nonclinical toxicology and animal health studies, as well as contributed to containment research with select chemical agents. Recently Dr. Limaye joined SEKISUI XenoTech’s consulting team and provides input on drug-drug interaction study needs for sponsors. Dr. Limaye has published several original research articles in various journals (Hepatology, Toxicological Sciences among others) and has also contributed many book chapters in the field of toxicology and liver pathobiology. Dr. Limaye is also actively involved in scientific societies and currently serves on the Program Committee of The American College of Toxicology and is the Vice President of the Central States regional chapter of The Society of Toxicology.
Areas of Expertise: Drug metabolism, DDI Consulting, nonclinical IND- and NDA-enabling toxicology studies
Griff Humphreys, Ph.D., External Consultant
Griff Humphreys is currently Principal with Aranmore Pharma Consulting. Prior to that he spent 26 years at Bristol-Myers Squibb Pharmaceutical Company, with the last 12 years leading the Biotransformation Department. He received his graduate training at the University of Virginia in chemistry and completed a postdoctoral fellowship at Vanderbilt University in the Center in Molecular Toxicology. His research interests include the consequences of reactive metabolite formation, development of new analytical methodologies for metabolite detection, reaction phenotyping of CYP- and UGT-catalyzed biotransformations, predictive metabolism and toxicology models, in vitro–in vivo correlations, and strategies for candidate optimization. He has co-authored over 120 refereed manuscripts and numerous reviews and book chapters. Dr. Humphreys is a member of the ISSX and the ACS Chemical Toxicology Division (TOXI). He is on the Editorial Advisory Boards of Drug Metabolism and Disposition and serves as reviewer for multiple additional journals. He has served on the Executive Committee of TOXI since 2008 and most recently as Program Chair for the 2013-2014 National meetings. He is currently a member of the ISSX Council and was a member of the Meeting Organizing Committee for the 22nd NA ISSX Meeting.
Areas of Expertise: CYP- and UGT-catalyzed biotransformations, predictive metabolism, strategies for candidate optimization
Larry Wienkers, Ph.D., External Consultant
Larry C. Wienkers received his BS in Chemistry and Biology in 1986 and his MS in Chemistry in 1988 from Western Washington University. He then earned his PhD in Medicinal Chemistry from the University of Washington in 1993 under the direction of Dr William F. Trager. He performed postdoctoral work in the department of Drug Metabolism at the Upjohn Company and subsequently joined the company as a Research Scientist in 1995. In 1998, Dr. Wienkers became Director of Drug Metabolism Enabling Technologies at Pharmacia & Upjohn and in 2002 became Executive Director of Pharmacokinetics, Dynamics and Metabolism at Pfizer. In 2004 Dr. Wienkers moved to Amgen and recently retired as Vice President and Global Head of the Department of Pharmacokinetics and Drug Metabolism. He is an American Association of Pharmaceutical Scientists (AAPS) Fellow with over 80 peer reviewed manuscripts and book chapters. One of Dr. Wienkers’ long standing research interests is focused on exploring bioactivation pathways associated with small molecule drug metabolism with particular focus on the prospective application of this information to predict drug-drug interactions in the clinic. To this end, he and collaborators apply a multidisciplinary approach using organic chemistry, biochemistry and biophysical techniques to study cytochrome P450 mechanism-based inactivation and the characterization of biotransformation pathways of novel therapeutics.
Areas of Expertise: Drug metabolism and bioactivation, medicinal chemistry, CYP mechanism-based inhibition (MBI), certain types of biologics
Etsuko Usuki, Ph.D., Division Director, Core Services
Etsuko Usuki currently serves as Director of Core Services at SEKISUI XenoTech. Dr. Usuki received her PhD in Analytical Chemistry from Virginia Polytechnic Institute and State University, and BS in Pharmaceutical Sciences from Kobegakuin University in Japan. After working as an Analytical Chemist at Takeda and a Postdoctoral Research Associate at the Harvey W. Peters Center for the Study of Parkinson’s Disease (VA Tech), she joined SEKISUI XenoTech as a Senior Scientist for the Drug Metabolism Department in 1998. Dr. Usuki is responsible for directing the implementation of SEKISUI XenoTech’s quality vision throughout the Program Execution, Program Oversight and Lab Operations teams, with a focus on scientific quality in the lab, interpretation of data and study oversight.
Areas of Expertise: Drug metabolism, reaction phenotyping
Andrea Wolff, Director, Services Logistics
Andrea received her Bachelors of Science with a double major in Chemistry and Biology at Baker University and joined the SEKISUI XenoTech team in 1999. She has more than 20 years of experience with GLP and non-GLP in vitro metabolism and transporter studies at SEKISUI XenoTech. Her experience started as an analyst and then Study Director focusing on in vitro drug metabolism studies. After over 10 years focusing on in vitro metabolism, her focus shifted to in vitro drug transporter studies, serving as a Study Director and then Manager for 5 years. She then expanded her focus, managing drug interaction studies across multiple disciplines (in vitro drug metabolism, drug transporters, enzyme induction and enzyme inhibition) and providing guidance to clients on the regulatory requirements for performing in vitro drug interaction studies. Andrea is now serving as the Director of Service Logistics at SEKISUI XenoTech, managing several core service support teams that cover protocol writing, report writing, data processing and project management. She is responsible for the quality and timelines associated with all contract study deliverables executed at SEKISUI XenoTech.
Areas of Expertise: Drug metabolism, drug transport
Lois Haupt, Principal Scientist, Program Oversight
Lois has been a scientist with SEKISUI XenoTech since 2000. Prior to joining SEKISUI XenoTech, she obtained her B.S. in Chemistry from Creighton University in Omaha, Nebraska. Lois has extensive experience in in vitro CYP inhibition studies, regulatory compliance, and project management. As a Principal Scientist in Scientific Operations, she is responsible for the conduct and oversight of the nonclinical, drug interaction-related contract studies in the Program Oversight Department of SEKISUI XenoTech’s Scientific Division.
Areas of Expertise: CYP inhibition
Becky Campbell, Principal Scientist, Program Oversight
Becky has been a scientist with SEKISUI XenoTech since 2001. Prior to joining SEKISUI XenoTech, she obtained her B.S. in Biology and B.A. in Chemistry from the University of Central Missouri and studied toxicology and pharmaceutical sciences at the University of Missouri-Kansas City School of Pharmacy. Rebecca has extensive experience in in vitro CYP induction studies, regulatory compliance, and project management. As a Principal Scientist in Scientific Operations, she is responsible for the conduct and oversight of the nonclinical, drug interaction-related contract studies in the Program Oversight Department of SEKISUI XenoTech’s Scientific Division.
Areas of Expertise: CYP Induction