Meet Our Team

Geoffrey Banks, Ph.D., founded Nuventra in 2008 and has led the company as both its CEO and as a principal consultant.  He has nearly 20 years of extensive experience in large pharma, biotechnology, and specialty pharma and an established track record of clinical, regulatory, and entrepreneurial success within the pharmaceutical industry.

Dr. Banks received his Ph.D., in protein biochemistry from Washington State University and transitioned to pharmaceutical drug development following a post-doctoral appointment at NIH.  The first compound worked on in his pharmaceutical career was HUMIRA® (adalimumab) for the treatment of rheumatoid arthritis and, during his work at Salix Pharmaceuticals, he led the Xifaxan® (rifaximin) clinical program that won FDA approval for the Hepatic Encephalopathy indication.

He brings C-level and drug development expertise to Nuventra’s clients from his work as a clinical pharmacology/PK/PD consultant and corporate R&D adviser to over 250 companies that range from venture-backed, start-up biotech companies through large multinational pharmaceutical companies.  He has valuable insight into business and R&D operations as well as R&D strategies for pharma/biotech companies with compounds (small molecule and biologics) across all stages of drug development (discovery through IND, early phase through late phase clinical development, and marketing authorizations [NDA/BLA/MAA] through post-approval commitments).

Dr. Banks is also the co-founder of a virtual drug development company (1st Order Pharmaceuticals, Inc.) that acquired a small molecule potassium channel opener for Kv7 (KCNQ) ion channels for central nervous system hyperexcitability-related disorders in neurology and pain.  In 2017, 1st Order Pharmaceuticals divested the asset as announced  “Xenon Expands Ion Channel Neurology Pipeline with Acquisition of New Potassium Channel Modulator for the Treatment of Epilepsy.”

With Dr. Banks’ track record of drug development and entrepreneurial success in the pharmaceutical industry, he brings unique insight into success strategies and pitfalls for pharmaceutical/biotech companies supported by Nuventra.

Education

• Doctor of Philosophy, Biochemistry
  • Washington State University, Pullman, WA
• Bachelor of Science, Chemistry
  • Linfield College, McMinnville, OR

Dr. Shaw has been involved in basic, applied, and clinical research, with a focus on research with biologics, throughout his 16-year career. Dr. Shaw performed his undergraduate work at Duke University, receiving B.S. degrees in Chemistry and Biology, followed by graduate work at Washington State University. He continued his training as an American Heart Association Post-doctoral fellow at the University of Pennsylvania. Dr. Shaw spent 6 years directing bioanalytical laboratories as a faculty member at Thomas Jefferson University and as the National Applications Laboratory Manager at Hitachi High Technologies America. Dr. Shaw is also an accomplished writer, having contributed to a wide variety of regulatory, scientific, clinical pharmacology, and commercial documents for industry and academia.

Education 

• Doctor of Biochemistry
  • Washington State University, Pullman, WA
• Bachelor of Science, Chemistry
  • Duke University, Durham, NC
• Bachelor of Science, Biology
  • Duke University, Durham, NC

Dr. Wargin has over 30 years of experience working in Clinical Pharmacology, Pharmacokinetics, Biopharmaceutics, and Scientific Writing. Dr. Wargin provides expertise in all aspects of pre-clinical and clinical pharmacokinetics including study design, clinical and toxicokinetic data analysis, report writing, IND and NDA PK section authorship.

Dr. Wargin’s therapeutic area experience includes Oncology, CNS, Cardiovascular disease, and Critical Care relative to Phase 1 studies. Dr. Wargin has worked on over 20 approved drugs, 20 NDAs, 2 BLAs, 5 ANDAs, ~50 INDs, and over 100 PK Analyses. He has authored or co-authored of over 30 journal articles in pharmacokinetics/biopharmaceutics.

Education

• Doctor of Philosophy, Pharmaceutics
  • University of Minnesota, Minneapolis, MN
• Bachelor of Science, Biology
  • University of Minnesota, Minneapolis, MN

Dr. Mitchell has more than 28 years of progressive leadership experience in Clinical Pharmacology and Pharmacokinetics (PK). Dr. Mitchell has extensive expertise in all phases of development. His focus is on protocol design and planning, clinical and nonclinical PK data analysis/simulation, pharmacodynamic data analysis/interpretation, and representation at regulatory meetings. Dr. Mitchell’s therapeutic area experience includes Oncology, Immunology, Rheumatology, and rare diseases. Dr. Mitchell has worked on 10 NDAs, 2 ANDAs, 2 BLAs, 20+ INDs, 100+ PK and Population PK analyses.

Education

• Post-doctoral Fellowship, Department of Pharmacology, Toxicology, & Therapeutics
  • University of Kansas School of Medicine, Kansas City, KS
• Doctor of Philosophy, Pharmaceutical
  • University of Colorado, Boulder, CO
• Bachelor of Science, Biological Sciences
  • University of Northern Colorado, Greeley, CO

Mark Sale received his MD in 1985 from The Ohio State University and an MS in biostatistics from Georgetown University in 1995. Between completing his two graduate degrees, Dr. Sale completed a Fellowship in Clinical Pharmacology at Stanford University and became an Assistant Professor of Medicine and Pharmacology at Georgetown University. In 1998 Dr. Sale joined GlaxoSmithKline and rose to level of Global Director, Research Modeling and Simulation prior to starting an independent consultancy in 2006 in population pharmacokinetics, modeling, and simulation. Dr. Sale has extensive experience conducting complex population PK analyses across diverse therapeutic areas and is one of the pharmaceutical industry’s thought leaders in modeling and simulation.

Education

• Bachelor of Science, Zoology
  • Ohio State University, Columbus, Ohio
• Doctor of Medicine
  • Ohio State University, Columbus, Ohio
• Post-doctoral Fellowship, Clinical Pharmacology
  • Stanford University, Stanford, California
• Master of Arts, Biostatistics
  • Georgetown University, Washington, D.C.

Dr. Schmith has 29 years of leadership and experience in Clinical Pharmacology and Pharmacometrics. Dr. Schmith provides expert consulting in clinical development and pharmacometric strategies for compounds from candidate selection through registration and beyond; development, implementation, and interpretation of strategies (e.g. protocols, analyses, reports, briefing documents, IND, NDA/MAAs) for pharmacokinetics/ pharmacodynamics and modeling and simulation, participating in regulatory meetings (including Advisory Committees), and evaluating the probability of successful differentiation from competitors. Her therapeutic area experience includes Anesthesia, Dermatology, CNS, Antiviral, Gastrointestinal, Cardiovascular, Hematology, Duchenne Muscular Dystrophy, Respiratory, and Inflammation. Dr. Schmith has worked on approximately 10+ NDAs/MAAs, 10+ INDs, 50+ PK/PD or Population PK/PD analyses.

Education

• Doctor of Philosophy, Pharmacy (Clinical Pharmaceutical Sciences)
  • University of Pittsburgh, Pittsburgh, PA
• Bachelor of Science, Pharmacy
  • University of Pittsburgh, Pittsburgh, PA

Ms. Roach has more than 21 years of experience in the GLP regulated pharmaceutical industry and 5 years of experience under GCP regulations.  Ms. Roach has extensive experience in QC/QA as well as pre-clinical DMPK, nonclinical and clinical PK data analysis/interpretation (50+) and report writing.  At Nuventra, her main focuses are in QA/QC functions, SOP development, software validation, and training.

Education

• Master of Science, Biological Sciences with a focus in Microbiology
  • Western Michigan University, Kalamazoo, MI
• Bachelor of Science, Biological Sciences
  • Aquinas College, Grand Rapids, MI

Daniel has 15 years of experience in marketing and business development strategy and alignment. For the past 11 years, he has focused on helping entrepreneurial organizations in the health industry succeed by developing and implementing strategic growth and process improvement initiatives.

While at Nuventra, he has built out a successful marketing and business development team that helps to communicate the value Nuventra offers, develops fit for purpose proposals and matches the expertise of our consultants with the needs of our global client base. As part of the Executive Team, Daniel works to ensure the ways in which Nuventra operates continue to be sustainable and scalable as we continue to experience growth.

Education

• Masters, Healthcare Administration
  • Ohio University, Athens, Ohio
• Bachelor of Arts, Communication
  • East Carolina University, Greenville, NC