Aside from InClinica’s strength in clinical trial management and project direction, we have access to a robust network of advisors. Our scientific advisors span the major functional areas of preclinical development. Our commercial advisors, complementing our clinical expertise, provide sound consulting on pricing, positioning, and reimbursement issues — at the early stages of development.
InClinica relies on the accumulated expertise and experience of synthetic medicinal chemists who have managed chemistry programs for major pharmaceutical companies. We have recourse to chemists expert in process chemistry development – going from benchtop to industrial scale synthesis — and preparation of the CMC sections of IND’s. We have worked with several GMP manufacturers who can offer assistance to virtual and small biotech companies who are seeking solutions for scale-up challenges.
InClinica uses the talents of consulting pharmacologists who have extensive industry experience in cell biology, in vitro biology, and in vivo models of efficacy. Ways to demonstrate target engagement and the design of in vivo proof of concept studies are two areas of strength for this consulting team.
We have a strong advisory team in pharmacokinetics and ADME, who are adept in drug metabolism and PK models and simulations and who have worked in biotechnology companies and large pharma. Coupled with our toxicology advisors, who specialize in the toxicology studies necessary for IND submission, this early development team has seen and solved diverse problems in ADME and toxicology.
Our regulatory advisors have held positions in the FDA and EMA, have worked in industry, and can provide strong strategic regulatory guidance to early stage programs in drugs or devices.
Given the evolution of patients’ access to healthcare insurance, questions about reimbursement and other payor issues are fundamental drivers of clinical and commercial development. InClinica has an entrée to experts who have worked at high levels in the insurance industry and can provide well-informed recommendations on how to develop a program clinically for optimal pricing.
InClinica works with several well-known firms who offer an incisive method for determining the optimal match-ups of target product profile, clinical indication, and market positioning. In addition, InClinica works with analysts who can advise our clients on various product pricing strategies.