JP PHARMA Consulting

Regulatory preclinical development

 

Preclinical evaluation is a crucial stage in drug development process. The goal is to demonstrate both efficacy and safety of the candidate drug via preclinical studies mostly defined in regulatory guidelines by major agencies (EMA, FDA, ICH): In vitro and in vivo pharmacology, pharmacokinetics, ADME (absorption, distribution, metabolism and excretion), safety pharmacology, acute to chronic toxicology (general, reproductive, genetic).

 

Overall final evaluation of results of all preclinical studies allows to characterize adverse effects, identify target organ toxicity, determine severity and reversibility of adverse effects, establish a dose response relationship and assist in dose selection for clinical trials. The knowledge leads to determination of NOAEL (no-observed-adverse-effect-level), to identify the specific target organ toxicity and to propose the safe MRSD (maximum recommended starting dose) for the first-in human study.

 

In this stage of development of your product, my expertise can assist you in the following tasks: 

• Proposal for preclinical program (list of studies), study designs

• Verification of the proposed preclinical program by another expert or the Agency

• Selection of preclinical CRO, outsourcing, study conduct and monitoring 

• Summary of all studies, interpretation and correlation of results

• Preparation of relevant parts of regulatory documents such as IMPD, IND, IB.

• Transition to the clinical team.

Corporate services

 

The services I offer to assist in your company efforts include:

 

Project evaluation

What is the stage of your project, are the extent and the results ready for the preclinical regulatory program or are there more studies and  interpretations needed?

 

Organization evaluation and restructuring

To evaluate the composition of your research team, the need for additional expertise, to find balance between internal work versus outsourcing. Allocate the right tasks to the right people.

 

Training

GLP, GCP, regulatory toxicology and clinical monitoring trainings by myself or my network experts.

 

Talent search

Find new staff with the directly relevant expertise from my own professional network or via my network of headhunters.

 

Due diligence

Is your project looking for additional funding or has reached the stage where new strategic partnerships are needed? I will help with the due diligence process.

CRO selection and study monitoring

 

Outsourcing and use of Contract Research Organizations (CRO) is an inevitable step in the drug development process.

 

All or parts of work are conducted at CROs because:

• No test facility in house

• Unusual species or procedures

       (housing, procedures, equipment, staff)

• Insufficient capacity in-house

• Regulatory requirements

       GxP (GLP, GCP, GMP) and regional

 

Selection of your preclinical provider is one of the crucial tasks. They all will claim their wide expertise, experience and high quality at favorable cost. 

 

So what are my criteria for the CRO selection? 

• Accreditations by national and international agencies, history of audits and inspections

• Capacity/Capability: Size, trained personnel, processes compliant to regulatory requirements, equipment, timelines

• Cost - important but should not be the only criterion

• Previous experience with the test facility or a Study Director

• Quality 

• Procedures and training, experience, SOPs, QA​

 

Let me guide you through the complex process of the CRO selection and study monitoring:

• Selection of preclinical CRO: identify candidate providers, visit, evaluation, comparison of selected criteria, final selection

• Work with the CRO on Study Protocols (Study Plans)

• Along with your scientists, co-ordinating the supply of the test substance

• Participation in pre-study meeting, Day 1 of study, during crucial procedures, terminal procedures, troubleshooting, liaisonship between you and the CRO, interim result reporting

• GLP review of study records

• Interpretation of results, work with the CRO on Study Reports

 

Professional network

 

If the advices or services that seek are beyond the limits of my expertise, I will connect you with relevant expert organizations. The recommendations of research or business partners will be based on my previous or current direct interaction with them and on the satisfactory experience.

 

My network expertise covers the following areas:

• GLP Bioanalytical services

• Pharmacokinetics, biodistribution

• GLP Pathology and histopathology services (slide preparation and evaluation)

• Regulatory services

• Clinical CRO selection (Phase I-IV and bioequivalence studies)

• GCP clinical study monitoring, pharmacovigilance

• GMP manufacturing

• GMP QC services

• Medical writing

• Dossier preparation and submission