IND Readiness Team

IND Readiness Team

Aside from InClinica's strength in clinical trial management and project direction, we have deep and extensive experience in the post-discovery/pre-development evaluation of research programs or, more granularly, of a compound, a device, or a diagnostic assay.

Specifically, for small molecules, InClinica has the experience to help a small company or a virtual company sift through its leads or its IND-track candidates and identify the chemical structure with the best chance of advancing to clinical trials.

The leaders of InClinica's pre-clinical evaluation team are trained pharmaceutical chemists, who are responsible for evaluating the “drug-likeness” of clients’ novel compounds as IND-track candidates, as patentable structures, or as optimizable chemical leads.

Of particular interest to university technology transfer offices, our chemists can review your records of invention and perform a drug-likeness assessment based on standard metrics that will help these offices perform a risk assessment of filing a patent, of filing a patent with just with the USPTO, or of filing a PCT application and bearing the downstream expenses of the national filing phase.

Workplan Development InClinica Service... We Use
CMC Industry-capable, cost-efficient vendors to scale-up drug substance and drug product, develop analytical methods and related protocols
DMPK Experienced laboratories performing well-designed PK and metabolic studies
Toxicology Experienced laboratories performing well-designed pilot and GLP studies identifying appropriate dosing brackets
Pharmacology Industry-standard laboratories able to perform POC studies or PK/PD studies
Clinical Experienced clinical management professionals to design industry-standard protocols, protocol outlines, investigator brochures
Project Management ... We organize these tasks into a logical, coherent flow of experiments, results, and reports

 

Direction and Management of Studies InClinica Service... We
Direction of drug substance and drug product scale-up, analytical studies and related CMC data, e.g., stability plan and testing Review all protocols, data, and reports; timely communication to you
Direction of DMPK studies Review all protocols, data, and reports; timely communication to you
Direction of in vitro/in vivo pharmacology studies Review all protocols, data, and reports; timely communication to you
Direction of toxicology studies Review all protocols, data, and reports; timely communication to you
Clinical protocol and investigator brochure Work with Sponsor to finalize protocol and investigator brochure to be submitted with IND. Iterative process.
Regulatory Support and IND Preparation and submission via eCTD Conform submission to new eCTD document requirements and submission
Project management and coordination (up to IND submission) Keep you informed regularly of progress and data for decision-making
Clinical trial management and tasks related to study start and site management of Phase 1A and 1B only Provide classic clinical trial management through experienced clinical trial management professionals

InClinica’s team supports several key drug development activities summarized below:

 

Chemistry

 

 

Key Drug Development Activities

 

 

Regulatory

 

Chemistry

InClinica has access 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.

Marketing/Positioning

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.

Pricing

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.

Regulatory

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.

PK/ADME Toxicology

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.

Pharmacology

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 team.

In combination with our staff experience, InClinica has access to a robust network of technical advisors, who span the major functional areas of preclinical development. Our commercial advisors, complementing our clinical and preclinical expertise, provide sound consulting on pricing, positioning, and reimbursement issues — at the early stages of development.

All of this work “maps” into a pre-IND meeting package and ultimately the IND’s sections for pharmacology, pharmacokinetics, metabolism, toxicology, and chemistry manufacturing controls.

InClinica orchestrates this work through its strong project management staff, its network of laboratories and manufacturing partners to perform the necessary studies, and its medical writing and quality assurance staff to prepare and review regulatory submissions.

Let us help you lay the groundwork that will increase your chances of moving your molecule or compound successfully toward Phase I or First-in-Man studies.