NOVATEK PHARMACEUTICALS

WHO WE ARE

Meet the Scientific Advisory Board team

Scientific Advisory Board Member​

Dr. Ahmed Kaseb is a Professor and Program Director of Hepatocellular Carcinoma (HCC), in the Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Dr. Kaseb received his medical degree from Cairo University, and worked as a research fellow at University of Michigan, in Ann Arbor for two years focusing on cancer biomarkers before starting Internal Medicine Residency at Wayne State University, in Detroit, Michigan where he excelled in clinical training and was the recipient of The Best Resident Award in 2003-2004. He then finished Medical oncology fellowship at Henry Ford Hospital, in Detroit, Michigan where he continued his translational research work which led to three major publications presenting circulating biomarkers for early cancer detection in the area of bladder and prostate cancers and his work on HCC biomarkers was subsequently initiated. Dr. Kaseb’s work received international awards from the American Society of Clinical Oncology (ASCO) an American College of Physicians (ACP).

Dr. Kaseb joined the department of Gastrointestinal Medical Oncology, at the University of Texas MD Anderson Cancer Center in 2007 to lead the HCC program. Dr. Kaseb is heavily involved in HCC clinical research where he has served as principal investigator on multiple clinical trials. Dr. Kaseb’s principal research interests include HCC systemic and multi-disciplinary therapies, in addition to molecular staging studies. His research also examines the differential effects of demographics and hepatitis status on treatment outcome in HCC. Based on his interest and research, he has developed several protocols in the treatment and staging of HCC. His published studies have yielded impressive results. Dr. Kaseb’s work has contributed greatly to the understanding of HCC interdisciplinary therapies and molecular staging, and has received governmental and pharmaceutical funding for several projects and clinical trials.

Dr. Kaseb has extensively authored and co-authored dozens of papers and books. Dr. Kaseb serves as an Editor and Scientific Reviewer for several international medical journals, and has received several national and international awards throughout his career. He is an active member of several international societies and has served on several committees and advisory boards at the national and international levels, and has participated in several international expert consensus conferences in the area of HCC.

Consulting Team: RGP has been partnered to build out Novatek’s initial operating structure and provide support in all key areas that will support years 1-3 of operations

Dr. Ahmed Kaseb

Dr. Ahmed Kaseb

Scientific Advisory Board Member

Dr. Ahmed Kaseb is a Professor and Program Director of Hepatocellular Carcinoma (HCC), in the Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Dr. Kaseb received his medical degree from Cairo University, and worked as a research fellow at University of Michigan, in Ann Arbor for two years focusing on cancer biomarkers before starting Internal Medicine Residency at Wayne State University, in Detroit, Michigan where he excelled in clinical training and was the recipient of The Best Resident Award in 2003-2004. He then finished Medical oncology fellowship at Henry Ford Hospital, in Detroit, Michigan where he continued his translational research work which led to three major publications presenting circulating biomarkers for early cancer detection in the area of bladder and prostate cancers and his work on HCC biomarkers was subsequently initiated. Dr. Kaseb’s work received international awards from the American Society of Clinical Oncology (ASCO) an American College of Physicians (ACP).

Dr. Kaseb joined the department of Gastrointestinal Medical Oncology, at the University of Texas MD Anderson Cancer Center in 2007 to lead the HCC program. Dr. Kaseb is heavily involved in HCC clinical research where he has served as principal investigator on multiple clinical trials. Dr. Kaseb’s principal research interests include HCC systemic and multi-disciplinary therapies, in addition to molecular staging studies. His research also examines the differential effects of demographics and hepatitis status on treatment outcome in HCC. Based on his interest and research, he has developed several protocols in the treatment and staging of HCC. His published studies have yielded impressive results. Dr. Kaseb’s work has contributed greatly to the understanding of HCC interdisciplinary therapies and molecular staging, and has received governmental and pharmaceutical funding for several projects and clinical trials.

Dr. Kaseb has extensively authored and co-authored dozens of papers and books. Dr. Kaseb serves as an Editor and Scientific Reviewer for several international medical journals, and has received several national and international awards throughout his career. He is an active member of several international societies and has served on several committees and advisory boards at the national and international levels, and has participated in several international expert consensus conferences in the area of HCC.

Consulting Team: RGP has been partnered to build out Novatek’s initial operating structure and provide support in all key areas that will support years 1-3 of operations

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

Dr. Mehmet Kocak

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 Pondell

Scientific Advisory Board Member

Steve Pondell is a Principal at Integrated BioTech Solutions.  He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production.  As an expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, Phase I product development programs, cGMP compliance and supplier audits, and business development activities for a global logistics provider.  He has experience at working with small biotech companies as well as multi-national pharmaceutical companies.  He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager.  His particular specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis.

Scientific Advisory Board Member

Steve Pondell is a Principal at Integrated BioTech Solutions.  He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production.  As an expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, Phase I product development programs, cGMP compliance and supplier audits, and business development activities for a global logistics provider.  He has experience at working with small biotech companies as well as multi-national pharmaceutical companies.  He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager.  His particular specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis.

Steve Pondell

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.

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