Expert guidance for your
drug development ventures

Geoffrey Banks, Ph.D., founded Nuventra in 2008 and has led the company as both its CEO and as a principal consultant.  He has over 16 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 (1^st Order Pharmaceuticals, Inc.) that purchased a small molecule potassium channel opener for Kv7 (KCNQ) ion channels for central nervous system hyperexcitability-related disorders in neurology and pain.  In 2017, the following was announced “Xenon Expands Ion Channel Neurology Pipeline with Acquisition of New Potassium Channel Modulator for the Treatment of Epilepsy,”giving Dr. Banks insight into start-up pharmaceutical and biotech companies seeking funding and development partners while progressing drug development in parallel.

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. 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

Dr. Higgins has been with Nuventra since June 2016 and has been an R user for over 10 years. Her areas of expertise include management of the programming team at Nuventra and exploring how to use R in a regulated environment. She enjoys working with data manipulation and visualization for NCA and popPK analysis in addition to providing support for bioequivalence testing using R.

Education

• Doctor of Philosophy, Biology
  • University of North Carolina-Chapel Hill, Chapel Hill, NC
• Bachelor of Science, Environmental Sciences
  • University of Notre Dame, Notre Dame, IN

Since 2014, Dr. Williams has supported Nuventra’s clients working in Clinical Pharmacology, PK/PD, and Clinical and Regulatory Operations. He has extensive experience with medical/scientific writing, study design, and program oversight. In addition, Dr. Williams conducts analytical activities to support clinical data management, noncompartmental analyses, and simulations. His primary focus has been in early phase clinical development and regulatory operations. Dr. Williams has assisted with and led the authorship of clinical study protocols, analysis plans, clinical study reports, INDs, and briefing packets for several regulatory and steering committee meetings.

Education

• Doctor of Philosophy, Genetics and Molecular Biology
  • University of North Carolina, Chapel Hill, NC
• Bachelor of Science, Biochemistry
  • Texas A&M University, College Station, TX

Gift has been with Nuventra for 2+ years. Before joining Nuventra, Gift acquired specialized training through NC State’s Biomanufacturing Training and Education Center in the areas of Biopharmaceutical Product Development, Process Automation, and Regulatory Science. Gift now applies those skills to her work at Nuventra in Quality Assurance through SOP development, computer system validation, GxP compliance auditing, management of training and training programs, and involvement with a variety of other quality procedures.

Education

• Bachelor of Science, Bioprocessing Science
  • North Carolina State University, Raleigh, NC

Dr. Furmanski has over 8 years of experience in the development of small molecule, oligonucleotide, radiopharmaceutical, and biologic therapeutics from an industrial and regulatory perspective.  He has provided expert guidance on the design and interpretation of human clinical pharmacology, toxicokinetic, drug metabolism, bioanalytical and biopharmaceutical quality findings through the examination of pharmacokinetic and pharmacodynamic analyses across multiple therapeutic areas.

While at the FDA, Dr. Furmanski reviewed and provided regulatory advice on 3 NDAs, 1 BLA, 6 sNDAs, 11 sBLAs, 2 505b2s, and 1 biosimilar application.  He has also reviewed over 200 INDs spanning across all phases of development (pre-IND, IND, meeting packages, breakthrough designation, pre-NDA/BLA), along with briefing packages, product labeling, and post-marketing commitment and requirement studies.

He has presented key regulatory findings at an oncology drug advisory committee meeting, scientific conferences and to other health agencies (EMA, Health Canada, PMDA, TGA and Swissmedic). His therapeutic focus areas are oncology, immuno-oncology, muscular disorders, and infectious diseases. Dr. Furmanski has been recognized for his work using model informed drug development tools for regulatory decision making and evaluation of the effect of immunogenicity on clinical efficacy and safety.

Education

• Doctor of Philosophy, Biochemistry
  • University of South Carolina, Columbia, SC
• Bachelor of Science, Chemistry & Biology
  • University of South Carolina, Columbia, SC

Dr. Hussey has over 31 years of extensive leadership and experience in clinical development, clinical pharmacology, and pharmacokinetics across multiple therapeutic areas and all phases of development. Dr. Hussey’s therapeutic area experience includes dermatology, metabolic diseases, CNS (headaches), antivirals, anti-infectives with focus on early proof-of-concept.  Dr. Hussey has worked on approximately 6 approved drugs, 12 NDAs, 3 ANDAs, 14 INDs, and over 50 PK analyses.

Education

• Post-Doctorate Fellowship, Clinical Research/Drug Development
  • UNC School of Pharmacy/Glaxo Inc.
• Doctor of Pharmacy
  • University of North Carolina, Chapel Hill, NC
• Bachelor of Science, Pharmacy
  • University of North Carolina, Chapel Hill, NC

Anginelle has been with Nuventra since January 2017, and since then has been involved with writing and publishing of over 13 INDs, BLAs, and NDAs. In particular, Anginelle has a strong interest in writing both about bioanalytical methods and validation, as well as pharmacokinetic modeling and simulation.

Education

• Master of Science, Chemistry
  • The University of North Carolina at Chapel Hill, Chapel Hill, NC
• Bachelor of Science, Chemistry
  • The College of New Jersey, Ewing, NJ