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

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

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

Dr. Amr Mohamed, MD

Scientific Advisory Board Member

Director, Neuroendocrine Tumors Program, UH Seidman Cancer Center

Assistant Professor, CWRU School of Medicine

 Amr Mohamed, MD, is a board-certified medical oncologist and internal medicine specialist at UH Seidman Cancer Center and an assistant professor of gastrointestinal medical oncology and neuroendocrine tumors at Case Western Reserve University School of Medicine. His special clinical interests include the management of gastrointestinal and neuroendocrine malignancies.

Since joining University Hospitals, Dr. Mohamed has created a comprehensive neuroendocrine tumors program at UH Seidman Cancer Center, which now has more than ten neuroendocrine tumor (NET) experts from different subspecialties. He currently serves as director of the program.

Dr. Mohamed received his medical doctorate from the Cairo University School of Medicine in 2007 followed by three years of internal medicine training at Ministry of Health affiliated hospitals. He then came to the United States to complete a research fellowship at Emory University School of Medicine, after which he finished his internal medicine training at Morehouse School of Medicine in Atlanta, Georgia. He went on to complete a fellowship in medical oncology at the Karmanos Cancer Institute at Wayne State University in Detroit, Michigan, followed by an instructorship year in neuroendocrine tumors and GI malignancies at the Moffitt Cancer Center in Tampa, Florida.

An active member of numerous medical societies, Dr. Mohamed also serves on the educational committee of the North American Neuroendocrine Tumors Society (NANETs). He has authored many peer-reviewed papers and received two merit awards from the American Society of Clinical Oncology (ASCO).

Scientific Advisory Board Member

Director, Neuroendocrine Tumors Program, UH Seidman Cancer Center

Assistant Professor, CWRU School of Medicine

 Amr Mohamed, MD, is a board-certified medical oncologist and internal medicine specialist at UH Seidman Cancer Center and an assistant professor of gastrointestinal medical oncology and neuroendocrine tumors at Case Western Reserve University School of Medicine. His special clinical interests include the management of gastrointestinal and neuroendocrine malignancies.

Since joining University Hospitals, Dr. Mohamed has created a comprehensive neuroendocrine tumors program at UH Seidman Cancer Center, which now has more than ten neuroendocrine tumor (NET) experts from different subspecialties. He currently serves as director of the program.

Dr. Mohamed received his medical doctorate from the Cairo University School of Medicine in 2007 followed by three years of internal medicine training at Ministry of Health affiliated hospitals. He then came to the United States to complete a research fellowship at Emory University School of Medicine, after which he finished his internal medicine training at Morehouse School of Medicine in Atlanta, Georgia. He went on to complete a fellowship in medical oncology at the Karmanos Cancer Institute at Wayne State University in Detroit, Michigan, followed by an instructorship year in neuroendocrine tumors and GI malignancies at the Moffitt Cancer Center in Tampa, Florida.

An active member of numerous medical societies, Dr. Mohamed also serves on the educational committee of the North American Neuroendocrine Tumors Society (NANETs). He has authored many peer-reviewed papers and received two merit awards from the American Society of Clinical Oncology (ASCO).

Dr. Amr Mohamed, MD

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.

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.

NOVATEK PHARMACEUTICALS

Live Healthier

Please contact us