URGenT Project Consultants
URGenT Project Consultants support the translational development of ultra-rare disease therapeutics through technical recommendations and advice to PI and her/his team. Consultants provide feedback and guidance on project milestones, development strategy, study design, and data interpretation. Each Multidisciplinary Project Team (MPT) receives support from URGenT consultants. Consultants are assigned to a project with consideration of the project team's individual needs and consultants' expertise.
Current NIH-contracted URGenT Consultants
Voisin Consulting Life Sciences (VCLS)
![Voisin Consulting Life Sciences (VCLS) logo](/sites/default/files/styles/half_width_small/public/2022-05/VCLS.png?itok=q2mzvM-t)
Voisin Consulting Life Sciences (VCLS) is a regulatory science and market access advisory consulting firm assisting Biotechnology, Pharmaceutical, and MedTech companies and manufacturers throughout product development, market access, and life cycle management. Voisin Consulting assists innovative Healthtech developers in designing regulatory strategies, supporting and implementing clinical trials and vigilance plans, obtaining regulatory authorizations, as well as in elaborating market access strategies. With close to 24 years of experience, long-standing relationships with regulators and payers, a presence in seven locations across Europe, USA, and India, and with over 200 employees including in house ex-agency experts and excellent preferred partnerships, Voisin Consulting assembles one of the world's largest multidisciplinary groups of scientific and medical experts devoted to Regulatory Science.
Shabas Solutions, LLC
![Shabas Solutions logo](/sites/default/files/styles/half_width_small/public/2022-05/Shabas.png?itok=8ebrj7f-)
Shabas Solutions, LLC is a Virginia-based, minority and women-owned, Small Disadvantaged Business providing management consulting services.
Shabas offers scientific and technical services, management advisory services, medical logistics and supply chain management support, financial management support, technology integration, training, and communication and outreach to Federal Government Agencies. The company’s experts convey deep knowledge in full lifecycle of drug development including pre-clinical, clinical, scale-up and tech-transfer, licensure and pharmacovigilance covering small molecules, biologics, combination products and medical devices. Shabas’ consultants also have in-depth industry experience in CBRN medical countermeasures and biological therapeutics development.
Dr. Clyde Schultz, Ph.D. (CMC and Quality Assurance)
Dr. Schultz has 40+ years of experience in the field of microbiology with expertise in manufacturing of multiple biological therapeutics platforms, including modalities such as purified proteins and antibody-based therapies. His experience includes research in infectious diseases (Meningitis, Dengue, and Leishmaniasis), international regulatory expertise (bringing 10 products to the market), has seven patents and 100+ publications/posters/invitations to his credit. He is experienced with IP matters as a founder of two biotech ophthalmologic products (CNS agents).
Dr. Schultz has expertise in a range of best practices and processes: from large scale experiment design, FDA’s GLP and relevant animal testing rules, to conducting bio-assays, toxicology studies, in-vitro and in-vivo testing, and manufacturing process design including validation practices. Dr. Schultz earned his Ph.D. focused on Microbiology and Immunology, from University of Maryland. He completed his Master’s degree in Biology and received two undergraduate degrees – in Biology and in Chemistry.
Pharmalex
![Pharmalex logo](/sites/default/files/styles/half_width_small/public/2022-05/PharmaLex.png?itok=jH8JoTsj)
Pharmalex specializes in providing advisory services to scientific and biomedical product developers.
Bio-Val Consulting (BVC)
![Bio-Val Consulting logo: Assay Development & Method Validation](/sites/default/files/styles/half_width_small/public/2022-09/Bio-Val.jpg?itok=ry09PjZY)
Bio-Val Consulting (BVC), a woman-owned small business established in 2013 committed to helping clients meet today's demands for regulatory compliance with their bioanalytical needs. BVC's mission is to assist clients to condense drug development timelines and get products to market efficiently without compromising quality or budget.
Quality Services, LLC
Contract Research/Manufacturing Organizations
URGenT awardees receive no-cost access to the network's Contract Research Organizations (CROs). LDTs plan and coordinate studies conducted by URGenT and BPN CROs.