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Clinical Pharmacology Consultants Ready to Work with You
Need a clinical pharmacologist on your team? Patel Kwan’s clinical pharmacology consultants can work in an integrated manner with your team throughout your drug development program. We are able to work in your environment to fit seamlessly into your current process.
Gina Patel, MPharm, Ph.D., President and CEO
Gina founded a clinical pharmacology consultancy organization, Patel Kwan Consultancy. In 2021 she was selected as one of Madison’s 40 under 40. Gina is a Clinical pharmacologist with over 13 years experience in the pharmaceutical industry and contract research organizations. As a clinical pharmacologist she has experience in multiple therapeutic areas including rare disease, oncology, antimicrobials, neurology for both biologics and small molecules. Gina has extensive experience with designing clinical pharmacology studies, conducting and reporting Pharmacokinetic (PK) analyses with over 300 non-compartmental analyses (NCA) across all phases of drug development from preclinical to all stages of clinical development and post-marketing. She is experienced with regulatory filings and interactions and has provided clinical pharmacology gap analyses for existing drug development programs as well as development of the clinical pharmacology strategy. Gina is an adjunct Associate Professor at the University of Wisconsin, School of Pharmacy where she teaches Pharmacokinetics and Pharmacometrics to graduate students.
Wallace Chan, BS, MS, Associate Pharmacokineticist
Wallace Chan is an Associate Pharmacokineticist. He obtained his MS degree in Pharmaceutical Sciences and BS in Chemical and Biological Engineering from the University of Wisconsin-Madison. He received training in many aspects of the drug development process, such as drug formulation development, PK/PD, drug manufacturing, as well as regulatory practices. His comprehensive knowledge of drug development equips him with the skills to be able to handle different projects and better advise clients. He is skilled in analyzing data using Phoenix, R, Matlab and Excel. Wallace also speaks five languages, including English, Mandarin, Cantonese, Malay and Basic Japanese, which allow him to promote international business relations.
Kantakarn (Mick) Thadavitchayapat, BS, MS
Kantakarn (Mick) Thadavitchayapat, B.S. and M.S., is an Associate Pharmacokineticist and responsible for supporting the development and submission of project deliverables to Patel Kwan Consultancy LLC’s clients. He earned formal education in Biology (B.S.) and Pharmaceutical Sciences (M.S.) from the University of Wisconsin-Madison School of Pharmacy. He received trainings in most relevant aspects of drug development, including clinical pharmacology, biostatistics, regulatory practice, pharmacokinetics. As an associate pharmacokineticist, Mick supports a wide range of PK-focused works, including TK, PK, PK/PD analyses using Phoenix WinNonlin® for both preclinical and clinical studies as well as IMPD and IND regulatory filings. He is well‑equipped to contribute to client projects from initiation to regulatory filings.
Grace Liew, MS, BS, Intern Pharmacokineticist
Ian Miller, Ph.D., Data Scientist
Ian is data scientist and entrepreneur with a PhD in Pharmaceutical Sciences from the University of Wisconsin–Madison, where his research focused on the assembly, annotation, and taxonomic analysis of novel biosynthetic pathways in symbiotic microbial communities. He has nearly ten years of experience in analytical chemistry and molecular biology and a consistent track record of data-driven solutions via computational and molecular techniques. He is skilled in analyzing Next Generation Sequencing and Mass Spectrometry data and has developed custom and scalable bioinformatics software and machine learning algorithms using Python, R, Unix/Linux, and High-Performance Computing. Ian has co-authored ten peer-reviewed publications with international teams involving the analysis of diverse samples and datasets including: human and microbial genomics, transcriptomics, metabolomics, and proteomics. He has also studied more than four years of college-level Mandarin, has lived abroad in France and China, and is passionate about fostering international scientific partnerships.
Anthony J. DeStefano, Ph.D., Senior Consultant
Tony DeStefano obtained his BS in Chemistry from Villanova University and his MS and PhD degrees in Physical Chemistry from Cornell University. He was employed by Procter & Gamble for 31 years, initially as a mass spectroscopist, supporting the consumer products divisions. After P&G purchased Norwich Eaton Pharmaceuticals, he transferred to the pharmaceuticals area, working in and managing physical measurements, reference standard, method development and bioanalytical groups, and serving as a clinical project team member for several drugs, representing the analytical and bioanalytical functions. He has been actively involved in bioanalytical method validation for many years and was a co-author on the Crystal City 3 and 4 white papers that serve as part of the foundation of the current FDA guidance on this topic. In 2008 he joined the US Pharmacopeia as its Vice President of General Chapters, later becoming Sr. VP of General Chapters and Healthcare Quality Standards. At USP, he led the initiatives to maintain, update and redesign the General Chapters. He was a member of the ICH Q3D Expert Working Group on elemental impurities. He is currently a consultant in analytical, compendial, bioanalytical and quality-related issues with emphasis on bioanalysis as a consultant. He is past-president (2013) of the American Association of Pharmaceutical Scientists (AAPS), a member of the American Chemical Society (ACS), and Past-Chair of the Technical Steering Committee and the Board of the Product Quality Research Institute (PQRI).
Iftekhar Mahmood, Ph.D., Senior Consultant
Dr. Mahmood has more than 25 years of experience in clinical pharmacology at FDA. He worked both in Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). During this period, Dr. Mahmood worked on neurological products, therapeutic proteins (antibodies and non-antibodies), coagulation factors (hemophilia), immunoglobulins, and cell and gene therapy. Dr. Mahmood helped in establishing a robust clinical pharmacology program in the Office of Blood Review and Research and the Office of Tissue & Advanced Therapeutics (OTAT), CBER. In CBER, he led a team of clinical and preclinical pharmacologists for two years. Dr. Mahmood was the member of several working groups in CDER and CBER which wrote the guidance for pharmaceutical industry. He Received three research grants from CDER for conducting research in the area of anti-epilepsy drugs, pediatric clinical pharmacology, and drug-drug interaction. At the FDA, besides his review duties, Dr. Mahmood was involved with clinical pharmacology research (both small and large molecules) and published more than 120 research papers in peer-reviewed scientific journals. His research mainly focused in allometric scaling, modeling, sparse sampling, and pediatric drug development. Dr. Mahmood also edited and wrote several scientific books.
Magdy Abdelhameed, MPharm, Ph.D., Senior Consultant
Magdy has over 25 years of experience in drug development working for a world leader CROs. He created and/or managed the pharmacokinetic group at different CROs. Extensive experience in designing and executing Phase I/II clinical programs. Overseen the development and execution of study protocols, clinical study reports (CSR) and pharmacokinetic (PK) reports for hundreds of small and large molecules in different therapeutic areas. Hands on experience with the PK data analysis from Phase I and II studies. Supported GLP preclinical drug safety studies, that included design and review of study protocols and completion of PK and toxicokinetics (TK) reports for toxicity, exploratory and regulatory studies. Comprehensive and solid understanding of GLP, GCP, ICH and applicable regulatory requirements with respect to preclinical TK studies to clinical pharmacology and pharmacokinetics. Authored necessary SOPs that address quality assurance and FDA audits of TK and PK preclinical and clinical studies. Managed a global group of 10 to 12 PK scientists consisting of BS through PhD level scientists. Provided hands-on consultation for clients seeking to design preclinical as well as Phase I/II clinical programs. Provided and executed strategies around business development in support of Early Clinical Biometrics group. Set and implemented the strategy for revenue and margin growth for the global PK business, including new scientific service offerings.
Jennifer O’Donnell, Medical Writing Consultant
Jennifer O’Donnell, CEO of Synergy Writing LLC, is a senior regulatory medical writer with 10+ years of experience in the industry. She has diverse cross-therapeutic authoring experience in areas including diabetes, oncology, neuroscience, sleep, gastroenterology and rare diseases.
Scott Akers, PharmD, Ph.D., Senior Consultant
Dr. Akers research expertise as a clinical pharmaceutical scientist over the past 25 years bridges the pre-clinical and clinical phases of small molecule drug development in the areas of pre-formulation and formulation development, drug metabolism and drug transporter assessment, and the analysis of pharmacokinetic and pharmacodynamics relationships in cell-based assays, isolated organs, whole animal models, and humans. Collectively, he has conducted and participated in investigator initiated and pharmaceutical industry sponsored pre‐clinical and clinical research trials at all levels of drug development with a particular emphasis on pharmacokinetic-pharmacodynamic study design, execution, and analysis. He remains active as a clinical and translational research scientist and serves as a research mentor for undergraduate students, graduate students, and junior faculty members as they transition into independent research careers.
Ongoing clinical and translational research projects in collaboration with investigators at Vanderbilt University and colleagues within the pharmaceutical industry include pre-clinical in vitro drug metabolism experiments, pharmacokinetic modeling and simulation, and execution of first-in-human studies. He is the director of the Pharmaceutical Sciences Research Center and Research Training Programs at Lipscomb University and co-director of the cross institutional Pharm.D.-to-Ph.D. Pathway Program between Lipscomb University and the Department of Pharmacology at Vanderbilt University.
As the director of the Pharmaceutical Sciences Research Center at Lipscomb University, he oversees the operations of a state-of-art Bioanalytical Core Laboratory that provides HPLC, LC-MS, LC-MS/MS analytical instrumentation to develop and validate quantitative drug assays in both the preclinical and clinical phases of drug development. He has also established in vitro cellular permeability studies in cell lines to support drug transport studies in Caco-2, MDCK, and renal proximal tubular epithelial cell lines. Additional priorities include establishing protocols and methods to evaluate vehicle selection, drug stability, and co-solvent precipitation studies to support formulation development capable of producing adequate drug exposure for Investigational New Drug-enabling nonclinical studies.
As an adjunct professor in the Department of Pharmacology at Vanderbilt University, he is the co-coordinator of the Drug Metabolism and Pharmacokinetics Course in the graduate program and serves as a member of the senior advisory committee for the NIGMS T32 Graduate Training Program in Pharmacology, the AHA Atrial Fibrillation – Strategically Focused Research Network, and the AHA Sudden Cardiac Death – Strategically Focused Research Network.