NOVATEK PHARMACEUTICALS
WHO WE ARE
Meet the Scientific Advisory Board team
Scientific Advisory Board Member
James L. Hinson is a senior level regulatory affairs and drug development professional with over 30 years of experience and expertise in leading regulatory affairs and drug development teams in the planning, executing and reporting of clinical, nonclinical and manufacturing studies to U.S. and international regulatory agencies. Expertise includes preparation, submission and approval of numerous IND’s, CTA’s, ANDA’s and NDA’s along with strong scientific skills. Recognized for providing leadership and creativity to shape strategic direction and long-term vision in both start-up and established business ventures.
James L. Hinson
Scientific Advisory Board Member
Bassel F. El-Rayes, M.D. is the Director of the Division of Hematology and Oncology and the Deputy Cancer Center Director of the O’Neal Comprehensive Cancer Center of the University of Alabama at Birmingham. Dr. El-Rayes earned his bachelor’s degree in biology and doctoral degree from the American University of Beirut. He then completed his residency in internal medicine and fellowship in hematology and medical oncology at Wayne State University, Detroit. He was on faculty at Wayne State University Karmanos Cancer Institute from 2003-2009. He joined Emory University as Director of the GI Oncology Clinical and Translational Research Program, Associate Director for Clinical Research at Winship Cancer and Vice Chair for Clinical Research of Hematology and Oncology at Emory University School of Medicine. Dr. El-Rayes clinical interests include gastrointestinal malignancies specifically pancreatobiliary and neuroendocrine cancers. He is principle investigator on multiple investigator-initiated trials. He has peer-reviewed funding including from National Cancer Institute. He has served on the gastrointestinal committee for Southwest Oncology Group (SWOG) and Radiation Oncology Cooperative Group (RTOG). He currently serves on the Alliance Oncology. He also serves as Co-chair of Hoosier Cancer Research Network (HCRN) – Gastrointestinal Clinical Trials Working Group. Dr. El-Rayes has published over 250 peer reviewed articles in elite journals including Journal of Clinical Oncology and Cancer Research.
Bassel F. El-Rayes, M.D.
Scientific Advisory Board Member
Hagop Kantarjian, M.D. is professor and chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, where he is also the Samsung Distinguished Leukemia Chair in Cancer Medicine. He is also a non-resident fellow in health policy at the Rice University Baker Institute.
Doctor Kantarjian has received several prestigious honors and awards including the 37th Jeffrey A Gottlieb Memorial Award (2012), the John Mendelsohn Lifetime Scientific Achievement Award (2008), the Joseph H. Burchenal Memorial Award (2013), the Charles A. LeMaistre, M.D. Outstanding Achievement Award in Cancer (2014), and America’s Top Doctors, Castle Connolly Medical (2003-present). He was also selected the top Castle Connolly National Physician of the Year Award for Lifetime Achievement (2014).
Doctor Kantarjian’s research focuses on translational-clinical developmental therapeutics in leukemia. In the past four decades, he has made several contributions that improved prognosis and survival in patients with chronic myeloid leukemia (tyrosine kinase inhibitors, e.g. imatinib, dasatinib, nilotinib, bosutinib which improved the 10-year survival from 20% to 90%), in acute lymphocytic leukemia (HPER-CVAD regimen and its derivatives which improved cure rates from 20% to 60+%), the discovery of decitabine for the treatment of myelodysplastic syndrome, and of clofarabine for the treatment of leukemias, among others.
His research and collaborations were the basis for the FDA approvals of over 25 drugs in leukemia. He is an author on over 2,200 peer-reviewed publications.
Dr. Hagop Kantarjian, MD
Scientific Advisory Board Member
John M Vierling MD, FACP, FAASLD, AGAF is Professor of Medicine and Surgery, Chief of Hepatology and Director of Baylor Liver Health at the Baylor College of Medicine in Houston, Texas. He also serves as Director of Advanced Liver Therapies (a clinical research unit) and Program Director of the Hepatology and Liver Transplantation Fellowship. He obtained his undergraduate degree in Biology with Great Distinction from Stanford University and his MD degree from Stanford University School of Medicine. His broad clinical interests and translational research interest in immunologic mechanisms of hepatobiliary injury have facilitated his goal of advancing science to enhance healthcare and education. He has authored over 290 manuscripts and chapters. He is co-editor of Liver Immunology: Principles and Practice, now in its 3rd edition. He is an active member of the International Autoimmune Hepatitis Group. He has served on the Editorial Boards of Hepatology, Liver Transplantation and Gastroenterology. Honors include Phi Beta Kappa, Alpha Omega Alpha, Best Doctors in America for the past 21 years, Top 1% physician rating by U.S. News and World Report, Who’s Who in America, in the World, in Science and Engineering, in Healthcare, the Albert Nelson Marquis Lifetime Achievement Award and the 2021 AASLD Distinguished Service Award. He currently serves on the NIH NIDDK’s Liver Tissue and Cell Distribution System Coordinating Committee and on their DILI Network’s DSMB. He is a former President of the American Association for the Study of Liver Diseases, Secretary-Treasurer of Digestive Disease Week® and Chairman of the National Board of Directors of the American Liver Foundation
Dr. John M Vierling MD
Scientific Advisory Board Member
Dr. Mehmet Kocak earned his MSc degree in applied statistics from Michigan State University and a PhD in applied statistics from the University of Memphis. He has been a study biostatistician for numerous Phase-I and Phase-II brain tumor clinical trials conducted by St. Jude Children’s Research Hospital from 2002-2011 and by Pediatric Brain Tumor Consortium (PBTC) from 2002-2021. He joined the Department of Preventive Medicine at the University of Tennessee Health Science Center (UTHSC) in 2011 and supported clinical and observational studies conducted by UTHSC. Since 2021, he is serving as the professor of Biostatistics in the International School of Medicine at Istanbul Medipol University and he is the chair of the department of biostatistics and medical informatics and the director of Biostatistics and Bioinformatics Analysis Unit. His areas of research have been time-course gene expression data analysis, meta-analysis of p-values, Phase-I/II clinical trial design, Survival analysis, and categorical data analysis. He is an expert in the SAS programming language as well as Statistical Simulations and Graphics.
Dr. Mehmet Kocak
James L. Hinson
Scientific Advisory Board Member
James L. Hinson is a senior level regulatory affairs and drug development professional with over 30 years of experience and expertise in leading regulatory affairs and drug development teams in the planning, executing and reporting of clinical, nonclinical and manufacturing studies to U.S. and international regulatory agencies. Expertise includes preparation, submission and approval of numerous IND’s, CTA’s, ANDA’s and NDA’s along with strong scientific skills. Recognized for providing leadership and creativity to shape strategic direction and long-term vision in both start-up and established business ventures.
Bassel F. El-Rayes, M.D.
Scientific Advisory Board Member
Bassel F. El-Rayes, M.D. is the Director of the Division of Hematology and Oncology and the Deputy Cancer Center Director of the O’Neal Comprehensive Cancer Center of the University of Alabama at Birmingham. Dr. El-Rayes earned his bachelor’s degree in biology and doctoral degree from the American University of Beirut. He then completed his residency in internal medicine and fellowship in hematology and medical oncology at Wayne State University, Detroit. He was on faculty at Wayne State University Karmanos Cancer Institute from 2003-2009. He joined Emory University as Director of the GI Oncology Clinical and Translational Research Program, Associate Director for Clinical Research at Winship Cancer and Vice Chair for Clinical Research of Hematology and Oncology at Emory University School of Medicine. Dr. El-Rayes clinical interests include gastrointestinal malignancies specifically pancreatobiliary and neuroendocrine cancers. He is principle investigator on multiple investigator-initiated trials. He has peer-reviewed funding including from National Cancer Institute. He has served on the gastrointestinal committee for Southwest Oncology Group (SWOG) and Radiation Oncology Cooperative Group (RTOG). He currently serves on the Alliance Oncology. He also serves as Co-chair of Hoosier Cancer Research Network (HCRN) – Gastrointestinal Clinical Trials Working Group. Dr. El-Rayes has published over 250 peer reviewed articles in elite journals including Journal of Clinical Oncology and Cancer Research.
Dr. Hagop Kantarjian, MD
Scientific Advisory Board Member
Hagop Kantarjian, M.D. is professor and chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, where he is also the Samsung Distinguished Leukemia Chair in Cancer Medicine. He is also a non-resident fellow in health policy at the Rice University Baker Institute.
Doctor Kantarjian has received several prestigious honors and awards including the 37th Jeffrey A Gottlieb Memorial Award (2012), the John Mendelsohn Lifetime Scientific Achievement Award (2008), the Joseph H. Burchenal Memorial Award (2013), the Charles A. LeMaistre, M.D. Outstanding Achievement Award in Cancer (2014), and America’s Top Doctors, Castle Connolly Medical (2003-present). He was also selected the top Castle Connolly National Physician of the Year Award for Lifetime Achievement (2014).
Doctor Kantarjian’s research focuses on translational-clinical developmental therapeutics in leukemia. In the past four decades, he has made several contributions that improved prognosis and survival in patients with chronic myeloid leukemia (tyrosine kinase inhibitors, e.g. imatinib, dasatinib, nilotinib, bosutinib which improved the 10-year survival from 20% to 90%), in acute lymphocytic leukemia (HPER-CVAD regimen and its derivatives which improved cure rates from 20% to 60+%), the discovery of decitabine for the treatment of myelodysplastic syndrome, and of clofarabine for the treatment of leukemias, among others.
His research and collaborations were the basis for the FDA approvals of over 25 drugs in leukemia. He is an author on over 2,200 peer-reviewed publications.
Dr. John M Vierling MD
Scientific Advisory Board Member
John M Vierling MD, FACP, FAASLD, AGAF is Professor of Medicine and Surgery, Chief of Hepatology and Director of Baylor Liver Health at the Baylor College of Medicine in Houston, Texas. He also serves as Director of Advanced Liver Therapies (a clinical research unit) and Program Director of the Hepatology and Liver Transplantation Fellowship. He obtained his undergraduate degree in Biology with Great Distinction from Stanford University and his MD degree from Stanford University School of Medicine. His broad clinical interests and translational research interest in immunologic mechanisms of hepatobiliary injury have facilitated his goal of advancing science to enhance healthcare and education. He has authored over 290 manuscripts and chapters. He is co-editor of Liver Immunology: Principles and Practice, now in its 3rd edition. He is an active member of the International Autoimmune Hepatitis Group. He has served on the Editorial Boards of Hepatology, Liver Transplantation and Gastroenterology. Honors include Phi Beta Kappa, Alpha Omega Alpha, Best Doctors in America for the past 21 years, Top 1% physician rating by U.S. News and World Report, Who’s Who in America, in the World, in Science and Engineering, in Healthcare, the Albert Nelson Marquis Lifetime Achievement Award and the 2021 AASLD Distinguished Service Award. He currently serves on the NIH NIDDK’s Liver Tissue and Cell Distribution System Coordinating Committee and on their DILI Network’s DSMB. He is a former President of the American Association for the Study of Liver Diseases, Secretary-Treasurer of Digestive Disease Week® and Chairman of the National Board of Directors of the American Liver Foundation
Dr. Mehmet Kocak
Scientific Advisory Board Member
Dr. Mehmet Kocak earned his MSc degree in applied statistics from Michigan State University and a PhD in applied statistics from the University of Memphis. He has been a study biostatistician for numerous Phase-I and Phase-II clinical trials conducted by St. Jude Children’s Research Hospital from 2002-2011 and by Pediatric Brain Tumor Consortium (PBTC) from 2002-present, and for clinical and observational studies conducted by the University of Tennessee Health Science Center (UTHSC) since 2011. His areas of research have been time-course gene expression data analysis, meta-analysis of p-values, Phase-I clinical trial design, Survival analysis, and categorical data analysis. He is an expert in the SAS programming language as well as Statistical Graphics
Steve Newsholme
Scientific Advisory Board Member
Steve Newsholme is a freelance drug-development consultant with 30 years of previous experience in a large pharmaceutical company as a pathologist and director of non-clinical safety. He brings to the table a deep and broad knowledge of non-clinical safety aspects of drug development at all stages. He has worked with a wide variety of chemical and biologic therapeutic agents, including natural oil-derived products, and has participated in selecting many new drug candidate molecules and in the planning, preparation, review and submission of numerous regulatory filings.
Steve’s experience is international in scope: he obtained degrees in physiology and veterinary medicine from the University of London and a pathology degree from the University of Pretoria as well as being a Diplomate of the American College of Veterinary Pathologists. He has also chaired international, multidisciplinary research teams to investigate and resolve drug safety issues. He is a member of the American College of Veterinary Pathologists, Society of Toxicologic Pathologists, American Society for Investigative Pathology, the Royal College of Veterinary Surgeons and the Roundtable of Toxicology Consultants, and is a former member of ILSI/HESI where he chaired the Emerging Issues Committee. He has authored or co-authored more than 50 publications relating to pathology, toxicology and safety assessment.
Scientific Advisory Board Member
Steve Newsholme is a freelance drug-development consultant with 30 years of previous experience in a large pharmaceutical company as a pathologist and director of non-clinical safety. He brings to the table a deep and broad knowledge of non-clinical safety aspects of drug development at all stages. He has worked with a wide variety of chemical and biologic therapeutic agents, including natural oil-derived products, and has participated in selecting many new drug candidate molecules and in the planning, preparation, review and submission of numerous regulatory filings.
Steve’s experience is international in scope: he obtained degrees in physiology and veterinary medicine from the University of London and a pathology degree from the University of Pretoria as well as being a Diplomate of the American College of Veterinary Pathologists. He has also chaired international, multidisciplinary research teams to investigate and resolve drug safety issues. He is a member of the American College of Veterinary Pathologists, Society of Toxicologic Pathologists, American Society for Investigative Pathology, the Royal College of Veterinary Surgeons and the Roundtable of Toxicology Consultants, and is a former member of ILSI/HESI where he chaired the Emerging Issues Committee. He has authored or co-authored more than 50 publications relating to pathology, toxicology and safety assessment.
Steve Newsholme
Scientific Advisory Board Member
Archie Thurston is the President / CEO of ADME Solutions, Inc., a consulting firm focused on providing effective DMPK (drug metabolism and pharmacokinetic) solutions to pharmaceutical organizations faced with challenges in their preclinical to early clinical programs. These include providing non-GLP and GLP PK (pharmacokinetic) and TK (toxicokinetic) services, human pharmacokinetic and dose predictions, basic PK/PD models, and FIH PK support. Experience is based on 25+ years in characterizing the Absorption, Distribution, Metabolism and Elimination (ADME) properties of molecules following oral, subcutaneous, topical, and inhaled routes of administration
Prior to consulting, Archie worked 25 years in the pharmaceutical industry starting at Rhone-Poulenc Rorer as a research scientist where he began applying in vitro models to predicting in vivo parameters in a drug discovery setting. Later, Archie moved to Solvay Pharmaceuticals where he built a group focused on developing drug metabolism methodologies to support the ADME drug discovery effort and was then promoted into a leadership role. Later, Archie moved to Pfizer Global Research and Development where he continued to develop his scientific experiences as a Director of a PDM (pharmacokinetics, dynamics and metabolism) group providing ADME support to drug discovery research programs for topical and inhalation drug projects. After Pfizer, Archie managed the PDM (Pharmacokinetics / Drug Metabolism) Group at Seventh Wave Laboratories where managed bioanalytical (both non-GLP and GLP), PK/TK (non-GLP and GLP), and drug metabolism groups. While managing these groups, Archie served as a Principal Investigator for both preclinical PK/TK and clinical PK studies in support of both small molecule and large molecule programs. In October of 2016, Archie started ADME Solutions, Inc. and started independent consultingArchie earned both his Doctorate of Philosophy in Pharmacology and his Master of Science in Pharmacology from the University of Missouri – Columbia. He completed his Bachelor of Science in Zoology from Southeast Missouri State University.
Archie W. Thurston, Jr., Ph.D.
Scientific Advisory Board Member
Shivani Kaushal Maffi, PhD, MSCI
Doctor Maffi has a Bachelor and Master of Science (Hons) in Biophysics
Doctor Maffi has a Master of Science in Clinical Investigation (Chief areas covered: Responsible conduct of patient-oriented clinical research, study design, Real World Evidence (RWE) data interpretation, epidemiology and biostatistics, data management, regulatory & quality control, bioethics, integrating basic biomedical science, grantsmanship scientific communications, health services research, instrument development and validation).
Doctor Maffi has a PhD in Experimental Medicine and Biotechnology (Pulmonary neonatal respiratory distress).
She is a Goal-oriented medical writer with a proven record of leading teams in medical and scientific communications (end-to-end); manuscripts, abstracts and slide deck presentations, federal and state grants, collaborate with editors, KOLs and vendors, extract and summarize data from clinical reports and protocols, publication planning, editing, and proofreading, create training materials and layman summaries, leading cross functional teams to successfully complete projects on time.
Oncology | Immunology | Neurological Disorders | substance use disorders | Pulmonary | Neonatology | Diabetes | Stem Cells | Orthopedic | Regenerative Medicine | Physiology | Biophysics | Molecular Cellular Biology | Preclinical and Clinical Reports | CROs.
Shivani Kaushal Maffi, PhD, MSCI
Scientific Advisory Board Member
Mr. Prohaska has more than 27 years of experience in all facets of nonclinical drug development with small and large molecules and gene-editing therapies. He has a long track record of successful FDA submissions with multiple drug approvals.
Mr. David Prohaska has more than 27 years of experience in all aspects of preclinical drug development with small and large molecules and gene-editing therapies including the scientific, technical and operational aspects and on-site monitoring of non-GLP and GLP animal metabolism, pharmacokinetic, toxicology, genotoxicity, photosafety, safety pharmacology and carcinogenicity studies. In addition.
He has managed the coordination of these studies with regulatory and clinical teams, including production of submission documents, due diligence activities, client consultation, data interpretation and client report preparation.
Previously, he has worked for Furiex, PPD and Covance. During his time at Furiex he managed the nonclinical development of several compounds, including eluxadoline. Similarly, while at PPD he managed the nonclinical development of alogliptin.
Mr. Prohaska has a long track record of successful FDA submissions with multiple drug approvals.
Mr. Prohaska
Archie W. Thurston, Jr., Ph.D.
Scientific Advisory Board Member
Archie Thurston is the President / CEO of ADME Solutions, Inc., a consulting firm focused on providing effective DMPK (drug metabolism and pharmacokinetic) solutions to pharmaceutical organizations faced with challenges in their preclinical to early clinical programs. These include providing non-GLP and GLP PK (pharmacokinetic) and TK (toxicokinetic) services, human pharmacokinetic and dose predictions, basic PK/PD models, and FIH PK support. Experience is based on 25+ years in characterizing the Absorption, Distribution, Metabolism and Elimination (ADME) properties of molecules following oral, subcutaneous, topical, and inhaled routes of administration
Prior to consulting, Archie worked 25 years in the pharmaceutical industry starting at Rhone-Poulenc Rorer as a research scientist where he began applying in vitro models to predicting in vivo parameters in a drug discovery setting. Later, Archie moved to Solvay Pharmaceuticals where he built a group focused on developing drug metabolism methodologies to support the ADME drug discovery effort and was then promoted into a leadership role. Later, Archie moved to Pfizer Global Research and Development where he continued to develop his scientific experiences as a Director of a PDM (pharmacokinetics, dynamics and metabolism) group providing ADME support to drug discovery research programs for topical and inhalation drug projects. After Pfizer, Archie managed the PDM (Pharmacokinetics / Drug Metabolism) Group at Seventh Wave Laboratories where managed bioanalytical (both non-GLP and GLP), PK/TK (non-GLP and GLP), and drug metabolism groups. While managing these groups, Archie served as a Principal Investigator for both preclinical PK/TK and clinical PK studies in support of both small molecule and large molecule programs. In October of 2016, Archie started ADME Solutions, Inc. and started independent consulting.
Archie earned both his Doctorate of Philosophy in Pharmacology and his Master of Science in Pharmacology from the University of Missouri – Columbia. He completed his Bachelor of Science in Zoology from Southeast Missouri State University.