Notice:
NextGen will not be able to post acquaintances or people we don’t know well. We are open to suggestion on how we might provide another type of resource that allows consultants we might not know or know well a way to gain exposure, perhaps an Angie’s list of pharma/biotech consultants. Please let us know your thoughts on how we might be able to assist you.
Consultants
This page has been created as a resource for our website guests to find consultants with expertise in drug discovery and development. These Consultants are ‘friends and family’ sorts that we at NextGen Pharma have worked with or have known for long periods of time. NextGen does not charge consultants for the referral service and does not receive compensation for making introductions. However we do ask our consultant friends to consider NextGen client companies for projects they might place for their clients.
| Kelly Byrnes-Blake, PhD - Dr. Byrnes-Blake is an independent PK consultant located in the Seattle area. She obtained a PhD in pharmacology, with specific training in pharmacokinetics in 2001. She has worked for large pharma, as well as a mid-sized biotech company, with the primary focus of her work being the development of protein therapeutics. She is experienced in the designing, monitoring, and reporting of PK, PK/PD, TK, and biodistribution studies, providing support for early-stage preclinical research through Phase 1 and 2 clinical studies. |
| Ronald J. (Ron) Gerson, PhD, DABT - Gerson Pharma Solutions is devoted to helping pharmaceutical companies design and execute their preclinical drug development programs. Ron has 25 years of preclinical drug development experience having overseen ~20 IND and “First in Man” packages for HIV, CNS, CV, medical imaging and cancer therapeutics and have progressed several drugs from discovery through worldwide registration. He also has experience in the development of medical and drug delivery devices. His core competency is Toxicology and in placing Toxicology findings into perspective. He can design and oversee preclinical Toxicology programs to support clinical trials and registration, write pertinent sections of regulatory submissions and has had extensive direct interaction with FDA and worldwide regulatory bodies. |
| Marta Hamilton, PhD - The Hamilton Consulting Group (HCG) LLC offers Pharmaceutical/Biotech Companies, University Researchers, Venture Capital Firms, and Diagnostic Companies services in Pharmaceutical Development, ranging from strategic program development to individual study design, analysis and interpretation. Marta brings over 25 years of pharmaceutical development experience gained from leadership and technical positions at Eli Lilly, Amgen, NeXstar Pharmaceuticals and Gilead Sciences, serving most recently as Vice President, Preclinical Development & Clinical Pharmacology, OSI Pharmaceuticals. Services include: preclinical PK/TK/ADME and clinical pharmacology study design, analysis and reporting; clinical implementation of biomarker assays; and preparation of documents, summaries and presentations for regulatory and grant submissions. HCG also provides critical scientific reviews of potential drug acquisition candidates and offers scientific guidance to the investment community regarding investment and M&A activity. Therapeutic area experience includes oncology, inflammation, antivirals and diabetes. |
 | Dennis M. Miller, Ph.D., D.A.B.T. - President, CPTxBio |
| Robert (Bob) Pollock - Quality Assurance Consultant. Bob has demonstrated ability to improve quality systems and ensure compliance. He has extensive experience leading, developing, and managing QA programs. The services he offers include auditing preclinical and analytical systems and study documentation for protocol review, critical phase study audits, data audits, and report audits. He also performs audits of outsourced investigator sites, CROs, and suppliers for facility pre-study placement, protocol review, critical phase study audits, data audits, report audits, and conducts “for cause” audits. Other services provided are: QA management, audit program design and implementation; SOP drafting, review, revision, and finalization; and QA training for groups and one-on one. |
Frank Richardson, DVM, PhD, DABT- As President of FC Richardson Consulting LTD., Frank provides a variety of services which include: Strategic planning for biomarker development and implementation from discovery to companion diagnostics; Tactical planning for biomarker implementation and evaluation in preclinical and clinical studies; Design and coordination of contract work between preclinical and clinical contract research organizations and biomarker/diagnostic companies; Designing, coordinating and conducting of regulatory and mechanistic toxicology studiesfor discovery compound screening and IND and NDA applications; and Consultation on animal care and use programs focusing on the role of the Attending Veterinarian. Frank will also provide continued guidance and administrative services in the areas above on an as needed basis. You can contact Frank at frichar214@msn.com | |
| Werner Rubas, PhD – As the Founder, President and CEO of PK/ADME Consulting, LLC, Werner’s mission is to accelerate and reduce the cost of drug development in the most responsive manner. Since graduating as a Pharmacist, Werner has been working on diverse projects including drug delivery, formulation, PK/PD and PK/ADME in Academia, Start-up’s, Biotech and Fortune 500 companies. He has contributed to numerous IND’s, Phase 1 and Phase 2 projects. Werner has overseen lead optimization for small molecules, conducted and analyzed PK/TK studies for small molecules and biologics. Areas of expertise include: all aspects of pre-clinical development; managing contract studies; PK/TK analysis, modeling and simulation; due diligence; and expert report writing. |
| Robert D. (Bob) Schultek - Bob is Founder & Managing Principal of GrowthPointe Group, an organization of former owners and senior business development executives who partner with clients to differentiate their business and accelerate their revenue growth. GrowthPointe identifies and develops new growth opportunities that leverage client competencies and achievements. Using customer-partnering strategies, GrowthPointe strengthens clients’ value propositions, competitive advantages and selling strategies that increase sales and build enduring customer relationships. |
| George Shopp, PhD, DABT - George is a private consultant assisting clients in the nonclinical discovery and development of small molecule and biological therapeutics. He has 33 years experience in the fields of toxicology, pharmacology, pharmacokinetics and drug development. This includes 2 years at toxicology contract research organizations; 12 years in grant and contract supported basic and applied research; 14 years in industrial drug development. Areas of expertise include global nonclinical development of small molecule and protein drugs, regulatory toxicology (FDA, EU and Japan), performing due diligence, conducting in-house and contract GLP pharmacology, toxicology, ADME, and PK studies, in vitro toxicity testing and screening, in vivo disease models, and investigational toxicology. George was President of the Board of Directors for the American Board of Toxicology in 2003. |
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