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 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 from his work as a clinical pharmacology/PK/PD consultant and corporate R&D adviser to over 300 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 molecules and biologics) across all stages of drug development (discovery through IND, early phase through late phase clinical development, and marketing authorizations [NDA/BLA/MAA/ANDA] 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.”

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. Schmith has 30 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, infectious diseases, 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 25 years of experience in the GLP regulated pharmaceutical industry with 9 years of experience in GCP regulations. Ms. Roach has extensive experience in QC/QA as well as pre-clinical DMPK, nonclinical and clinical PK data analysis/interpretation and report writing. At Nuventra, her main focuses are leading the QA unit, ensuring compliance of regulations and training at Nuventra and staying abreast of regulatory requirements.

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. 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. Higgins has been with Nuventra since June 2016 and has been an R user for over 15 years. Her areas of expertise include using R in a regulated environment for many aspects of clinical trial data analysis including, CDISC dataset generation, creation of TLFs, dataset generation for popPK analyses. She also has experience managing the programming team at Nuventra and she enjoys exploring and developing novel techniques for data manipulation and visualization of NCA and popPK analyses.

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

Dr. Burch has been with Nuventra since May 2014 with a primary focus on regulatory affairs, medical and scientific writing, and project management, and currently oversees Nuventra’s Regulatory Affairs and Scientific Writing department. Dr. Burch has participated in numerous IND, NDA (505(b)(1) and 505(b)(2)), and BLA submissions across a multitude of drug classes, routes of administration, and therapeutic areas. Dr. Burch’s experience includes overall regulatory strategy; client representation at FDA meetings; on-site assessments and gap analyses for client development programs; authoring clinical, nonclinical, quality (i.e., Chemistry, Manufacturing, and Controls), and administrative modules of regulatory submissions; and authoring clinical study reports, manuscripts, and a diverse array of other regulatory, scientific, and technical documents.

Education

• Post-doctoral Fellowship, Department of Medicine (Infectious Diseases)
  • University of North Carolina, Chapel Hill, NC
• Doctor of Philosophy, Genetics and Molecular Biology
  • University of North Carolina, Chapel Hill, NC
• Master of Science, Biology (Cell Biology Concentration)
  • East Carolina University, Greenville, NC
• Bachelor of Science, Biology
  • University of North Carolina, Chapel Hill, NC

Gift has been with Nuventra for over 4 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. Williams has 25 years of experience in clinical pharmacology, 20 of which occurred at the FDA, first as an FDA Primary Reviewer and subsequently as an FDA Team Leader. He specializes in the development of drugs for oncology, medical counter-measures for radiation, and medical imaging.  Dr. Williams worked on over 400 different drugs as an FDA Primary Reviewer and 600 as an FDA Team Leader. Over 150 of these drugs were reviewed as NDAs/BLAs (NMEs and supplements). He was a member of the FDA Working Groups that developed the boilerplate used by FDA Reviewers to complete NME NDA/BLA reviews and the draft FDA Guidance, Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations.

Education

• Doctor of Philosophy, Pharmacology and Toxicology
  • West Virginia University, Morgantown, WV
• Bachelor of Science, Chemistry
  • Gannon University, Erie, PA

Dr. Hussey has over 30 years of extensive leadership and experience in drug development, clinical development, clinical pharmacology, and pharmacokinetics across multiple therapeutic areas and all phases of development. Dr. Hussey’s primary 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 8 approved drugs, 12 NDAs, 3 ANDAs, 18 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

Learn More About Betty

We sat down with Betty to learn more about her drug development experience, discuss her advice for new scientists, favorite projects, and life as a consultant. Listen to the interview:

Listen to the Interview

Anginelle has been with Nuventra since January 2017, and since then has been involved with writing and publishing of over 25 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

Dr. Muthukrishnan has 20 years of broad experience in various stages of drug development with a focus in DMPK, PK/PD modeling and simulations, IVIVC model development, and clinical pharmacology. Dr. Muthukrishnan has also contributed to 2 approved drugs and contributed to 2 clinical development programs entering Phase 3 studies. She also supported few 505b(2) applications involving drug-device combination products. She has authored over 60 PK/TK (GLP) study reports for INDs, several clinical PK study reports and contributed to nonclinical and clinical sections of various international regulatory submissions. Dr. Muthukrishnan has therapeutic expertise in oncology, hematology, immunology, endocrine and metabolic diseases, pain, and inflammation. She is interested in clinical development strategy and translational sciences.

Education

• Doctor of Philosophy, Pharmaceutical Sciences & Pharmacology
  • University of Missouri-Kansas City, Kansas City, MO
• Master of Pharmacy, Pharmaceutics
  • Banaras Hindu University, Varanasi, India
• Bachelor of Pharmacy
  • Andhra University, Visakhapatnam, India