Özlem is full Professor in structural bioinformatics at Rhodes University, South Africa and distinguished adjunct Professor at Saveetha University, Chennai, India.

She received her BSc degree in Physics from Boğaziçi University, Istanbul, Turkey. Then she moved to the Department of Molecular Biology and Genetics at the same University for her MSc degree. She obtained her PhD from Max-Planck Institute for Molecular Genetics and Free University, Berlin, Germany in 2003. While doing her PhD, Özlem became interested in structural biology, and during her postdoctoral positions (Texas University, USA; University of Western Cape and University of Pretoria, South Africa) she gained experience in structural bioinformatics as well as structural biology.

In 2009, Özlem took up an academic position at Rhodes University, South Africa. She established the Research Unit in Bioinformatics (RUBi) in 2013. She has graduated 25 PhD and 38 MSc students since she joined Rhodes University. She received Rhodes University Internationalization award for 2018; Rhodes University Vice Chancellor’s Distinguished Senior Research award for 2020 and South African Society for Bioinformatics (SASBi) Silver Award, 2022.

She serves on the Editorial Board for PLOS Computational Biology, PLOS One and Frontiers in Molecular Biosciences and Frontiers in Applied Mathematics and Statistics, Biological Modeling and Simulation Section, and she is an Advisory Board member of F1000Research Bioinformatics Gateway. Özlem’s broad research interest is structural bioinformatics and its applications to drug design and development. Her recent interest is in the allosteric mechanisms of proteins and understanding the effects of nonsynonymous single nucleotide variations on protein structure and function in the context of drug resistance and drug metabolism. She has published roughly 100 research articles.

Dr. Qin Sun is the Therapeutic Biologics Program (TBP) Biologics Lead in the Office of Clinical Pharmacology (OCP), CDER, FDA. Her job functions include guide and support reviews and policy development for novel biologics and biosimilars. She also serves as vice chair for Biologics Oversight Board in OCP, and chair for several biologics and biosimilar guidance working groups. Qin joined FDA in 2016. Before that, she worked at Pharmaceutical Product Development (PPD) from 2015 to 2016, and at Bristol-Myers Squibb from 2008 to 2014. Qin received her PhD from University of Virginia. Her work experience extends from drug discovery to drug development, and finally to regulatory review, focusing on biologics and biosimilars currently.  

Dr. Venkatesh Pilla Reddy is a distinguished Senior Director in the Global PKPD and Pharmacometrics group at Eli Lilly and Company in the UK. His extensive expertise stems from earning his PhD in Pharmacometrics through a collaborative program involving Pfizer, Janssen Pharmaceuticals, and Merck via TI Pharma in the Netherlands. His doctoral research centred on the PKPD M&S of antipsychotic drugs, and he has since made substantial contributions to the Quantitative Pharmacology and Pharmacometrics groups at Merck and AstraZeneca.

At present, Venkatesh provides invaluable Clinical Pharmacology and Model-Informed Drug Development support for a range of impactful projects in oncology, neuroscience, and immunology. Notably, he played a pivotal role as Deputy Topic Leader position ICH shaping ICH DDI guideline. Furthermore, he plays a leading role in influential cross-industry working groups including IQ TALG, ISOP, ASCPT, and ISSX M&S. He also serves as an esteemed Editorial Board Member for the Biopharmaceutics and Drug Disposition Journal and is a respected reviewer for clinical pharmacology/PKPD M&S-related journals.

Professor Collet Dandara is currently serving as Deputy Dean of Postgraduate Education in the Faculty of Health Sciences, at the University of Cape Town. He is also a Director of the SAMRC/UCT Platform for Pharmacogenomics Research and Translation Unit (PREMED) and is a professor of human genomics. Collet Dandara is principal investigator of the pharmacogenomics & drug metabolism research group at the University of Cape Town. Collet is on the Executive Committee of the African Society for Human Genetics (AfSHG) as well as the African Pharmacogenomics Network (APN) and was Chair of the Southern African Society for Human Genetics (SASHG) (2021-2023).  Professor Dandara serves on the Board of the Sydney Brenner Institute for Molecular Bioscience and served on the South African Medical Research Council (SAMRC) board from 2019 to 2022. Professor Dandara is a biomedical scientist with extensive experience in pharmacogenomics. Professor Dandara’s research covers the understanding of the pharmacogenomics of antiretroviral drugs and cardiovascular diseases including hypertension and cancer. Professor C Dandara is a current HUGO Executive Board Member. He is a Fellow of the Academy of Science of South Africa (ASSAf Fellow), a Fellow of the African Academy of Science (AAS-Fellow) and was part of the inaugural World Academy of Sciences (TWAS) Young Affiliate/Alumni (TYAN) Executive Committee (2016-2021). He has a track record of successful supervision of postgraduate students and has >160 publications in international peer-reviewed journals.

Xiaomin Liang, Ph.D., is a Senior Scientist II in the Department of Drug Metabolism at Gilead Sciences Inc. She obtained her B.S. degree in molecular toxicology from the University of California, Berkeley in 2011, and her Ph.D. degree in pharmaceutical sciences with a focus on membrane transporters, transporter-mediated drug disposition, and pharmacokinetics (PK) from the University of California, San Francisco in 2016. Following a brief fellowship at the Office of Clinical Pharmacology at the FDA, she joined Gilead in 2017. Her primary research interests are in the applications of transporter biology, in vitro methodologies, and mechanism-based PK/PBPK modeling to understand the ADME of compounds and translate preclinical data to predict human PK.

Dr. Ying-Hong Wang is a senior reviewer in the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences (OTS)/CDER. Prior to joining the FDA, she worked for 14 years at Merck, where she was responsible for preclinical and clinical development of numerous compounds in multiple therapeutic areas. She chaired the Quantitative Prediction of Drug Interaction Working Group and developed the internal guidelines for DDI prediction. Her modeling work on predicting and characterizing enzyme and transporter-mediated DDI and hepatic impairment contributed to the NDA approvals of grazoprevir/elbasvir and letermovir. Dr. Wang earned her Ph.D. from the Oregon Health Science University and completed her Clinical Pharmacology Fellowship training at the Indiana University-Purdue University Indianapolis. Her current research focuses on applications of PBPK modeling in CYP induction, transporter-mediated DDI, and hepatic impairment.

Kunal Taskar, Ph.D., is currently working as Director, Global Head of PBPK Modelling at GSK. Kunal completed his doctorate more than a decade ago and postdoctoral research at Texas Tech University Health Sciences department, USA, in Quentin Smith’s lab with research focused on Neuropharmacokinetics and role of transporters in drug delivery across the blood-brain barrier (BBB).

Kunal’s experience and research focus include: PBPK modeling of small/large molecules and new modalities for PK and dose predictions, drug-drug interaction predictions and mechanistic understanding of the clinically occurring drug–drug interactions; and application of PBPK modeling in special populations including pediatrics, pregnancy, and organ impairment. His expertise also includes transporter mediated drug delivery and intracellular drug concentrations, especially the role of uptake and efflux transporters in drug pharmacokinetics-pharmacodynamics in disease and toxicology; novel transporters and role in drug disposition and use of endogenous probes and modeling for drug mediated transporter modulations.

Kunal is a member of American Society of Clinical Pharmacology and Therapeutics (ASCPT), International Society for the Study of Xenobiotics (ISSX) and the International Brain Barriers Society. Kunal is a member of several IQ consortiums including MIDD Pilot Program WG, Transporters, Induction PBPK and Pediatric PBPK. He is the founder member and Chair of the ASCPT QP PBPK Community. He received the 2014 AAPS Pharmaceutical Research Meritorious Manuscript Award for a manuscript that was published in the same journal in 2012. He has actively published and given invited talks and conducted workshops at international conferences.

Christine Bowman is a Principal Scientist in the Drug Metabolism and Pharmacokinetics Department at Genentech, Inc.  She is a DMPK project lead for discovery and development projects and her research interests include improving in vitro to in vivo extrapolation with new in vitro methods and PBPK modeling, with a specific focus on transporters.  Prior to joining Genentech, Christine received her PhD from the University of California, San Francisco under Dr. Leslie Benet.

Dr. Xiaoyan Chu is a Senior Director in the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics at Merck & Co., Inc. in West Point, PA, USA. She obtained her PhD from the Department of Molecular Pharmacokinetics at the Graduate School of Pharmaceutical Sciences, University of Tokyo, Japan. After completing her post-doctoral research at the Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan., she joined the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck & Co., Inc.   As the leader for the Transporter Science Group, her main responsibilities are to develop transporter related research and operational strategies to support Merck’s discovery and development portfolio, and to evaluate and establish new technologies and approaches to study the role of transporters in pharmacokinetics, efficacy, and toxicity of drugs. She has authored over 80 peer-reviewed research papers, book chapters, and has been invited to speak at over 40 national/international scientific conferences.  She is the member of the International Transport Consortium (ITC) and serves as the Chair of the ISSX Transporter Focus Group from 2019 to 2022. She is also a member of the Editorial Board of Drug Metabolism & Disposition (DMD) and serves on the Industry Advisory Board at the College of Pharmacy & Pharmaceutical Sciences, Washington State University.

Dr. Bridget Morse is currently a Senior Director in PK/PD and scientific lead of Quantitative Clinical Pharmacology at Lilly Research Laboratories. She received her Pharm.D. from Butler University and her Ph.D. in Pharmaceutical Sciences from the University at Buffalo. Bridget has served in the pharmaceutical industry for 10 years as a subject matter expert in pharmacokinetics, transporters, clinical pharmacology and drug-drug interactions, particularly in the use of modeling for substrates of hepatic transporters. She chaired the IQ OATP1B Biomarkers Working Group from 2020-2023, is current Chair of the AAPS Drug Transporter Community and sits on the Editorial Advisory Board for the AAPS Journal. She has over 30 published journal articles and co-authors a recurring book chapter on drug transporters in Foye’s Principles of Medicinal Chemistry.

Dr. Manthena Varma, PhD is Research Fellow, at Pfizer Inc, Groton, CT. Dr. Varma received his B. Pharm. degree from the Kakatiya University, India, and an M.S. degree and PhD in Pharmaceutics, from the National Institute of Pharmaceutical Education and research (NIPER), Punjab, India.  Later, Dr. Varma worked as a Post Doctoral Fellow at the Department of Pharmaceutics, University of Minnesota (Minneapolis). Dr. Varma holds an Adjunct faculty position in the Department of Pharmacy at the University of Rhode Island. His research focus include ADME/PK technologies and strategies in drug discovery and development, role of drug transporters and transporter-enzyme interplay (extended clearance) in ADME/PK, clinical pharmacokinetics and DDI predictions via mechanistic (PBPK) modeling. Varma supported preclinical and clinical development of several Pfizer compounds in the oncology, diabetes, and in NAFLD/obesity areas. He published about 150 original articles/reviews on a variety of ADME/PK topics.

Megan Turski received her B.A. in Biology from University of Wisconsin-Madison. She has over 10 years of experience in bioanalysis working in the pharmaceutical industry. She began her career working in an FDA-regulated bioanalytical laboratory using LC-MS/MS and continued on to quantitative method validation and development for ligand binding assays and qPCR. She is currently a Scientist in the Drug Metabolism and Pharmacokinetics group at Takeda Pharmaceuticals in San Diego, CA. She primarily supports the bioanalysis for oligonucleotide drug candidates as well as the delivery platform development. Her current research focuses on developing PCR methods for oligonucleotides to determine pharmacokinetics and biodistribution of these drug candidates.

John D. Schuetz received his Ph.D. from the Medical College of Virginia-Virginia/Virgina Commonwealth University with Robert Diasio (his lab identified the genetic basis of DPD deficiency); and conducted postdoctoral training with I. David Goldman (an SLC19A focused lab) and then wirh Philip Guzelian (identified Cyp3) cloned CYP3A5 and 7 at the same institution. He joined St. Jude Children’s Research Hospital as an Assistant Member (1992). He is a Member and former Vice Chair (2005-2022) of the Pharmaceutical Sciences Department. His lab reveals how transporters contribute to pathophysiology, drug response, and metabolism and has defined and functionally “deorphaned” transporters: ABCB6, ABCG2, and ABCC4 with over 175 articles in peerreviewed journals. He was nominated to membership in ASBMB. He is an Associate Editor for Pharmacological Reviews, Drug Resistance Updates, Drug Metabolism and Disposition and serves on the editorial boards of other journals. He was elected to the AAAS Electorate nominating committee and recently chair of the AAAS Pharmaceutical Sciences section S, elected Chair of the Toxicology Division of American Society for Pharmacology and Experimental Therapeutics (ASPET), Councilor and then ASPET’s President and nominated as an ASPET Fellow.

Dr. Yu Feng is an associate principal scientist at Merck in the Nonclinical Drug Safety (NDS) department. Dr. Feng received his doctoral degree in pharmaceutical sciences from the University of Wisconsin-Madison under the supervision of Dr. Lingjun Li. Yu also holds Bachelor's degree in both organic chemistry and economics from Peking University, and completes MBA program at University of Illinois Urbana-Champaign. His research in Merck focuses on utilizing mass spectrometry techniques to advance the understanding mechanisms of toxicity and evaluate drug candidates. Dr. Feng has contributed significantly to the field, with more than 20 peer-reviewed publications and patents in biomolecule characterization, quantitative proteomics/glycomics and natural product synthesis.

Joe Cannon received his PhD in Biochemistry at the University of Maryland under Catherine Fenselau in 2012, and proceeded to consecutive post doctoral appointments at the University of Texas at Austin with Jennifer Brodbelt and Harvard Medical School with Wade Harper and Steve Gygi. He then joined Merck in 2018 and put his mass spectrometry skills to work with the biotransformation group and later as an ADME PI.  He is currently an Associate Director of Biotransformation at Bristol Myers Squibb and supports company wide efforts in biotransformation, DMPK, and ADME across modalities.

Dr. Kedia received her Bachelors in Pharmaceutical Sciences from the Delhi University in New Delhi, India and her Ph.D. in Analytical Chemistry from Brigham Young University (BYU) under Dr. Steven Graves. Her work in Dr. Graves’s lab focused on identifying biomarkers (including proteins, peptides, lipids and other small molecules) of Preeclampsia, from placental tissue and blood to better understand the pathogenesis of this disorder. Following graduation, Dr. Kedia joined Pacific Northwest National Lab (PNNL) in Dr. Richard Smith’s group where she participated in multiple projects starting from biomarker discovery for several diseases, to method development for xenobiotics, specifically using LCMS and IMMS based approaches. She is currently an Associate Principal Scientist at Merck within PDMB group, where her responsibilities include supporting PK/PD studies and biomarker analysis across various internal programs. Additionally, Dr. Kedia is the project lead for the development and evaluation of different applications on a state-of-the-art, high-resolution ion mobility instrument based on SLIM technology, with the goal of providing program support across different modalities, especially for challenging analytes such as cyclic peptides and lipids.