JP PHARMA Consulting
Expertise in Drug Development
Jan Praslicka DVM PhD
In science: Drug efficacy/resistance since 1989
Pharma R&D: Preclinical safety/efficacy since 2001
SERVICES IN THE FOLLOWING AREAS
Regulatory Preclinical Development
Project evaluation, design of preclinical safety program, study designs, interpretation of results, overall summaries, regulatory documents (study reports, pre-IND document, IND, IMPD, IB, etc.), medical writing, transition to Phase I
CRO Selection/Monitoring
Selection of preclinical provider(s), study plans and amendments, monitoring of study procedures and compliance, troubleshooting, data review, interpretation of results, study report comments and finalization
Corporate Services
Trainings (GLP, toxicology), evaluation of the research organization, restructuring, talent search, business development, due diligence
Professional Network
Link to: GLP analytical and bioanalytical, pharmacokinetics, biodistribution, pathology and histopathology, regulatory services, clinical CRO selection, GCP clinical study monitoring, pharmacovigilance, GMP QC services, writing of dossiers
CONSULTING AND PARTNERSHIPS TOWARDS PHASE 1
So you've got this perfect idea, the discovery, the original new approach to tackle and disrupt a pathological process leading to the disease development. You have managed to provide the theoretical justification for your hypothesis, for the new mechanism of action, based on your best knowledge and current status of science. You even demonstrated the desired action in vitro. Congratulations!
After the exciting discovery and creative science, you are now facing guidelines, regulations, new steps and milestones to test your new drug candidate for in vivo efficacy and preclinical safety. You need to a preclinical program, to select the best external partners, to design, monitor and interprete the preclinical studies, to assure their GLP compliance, to prepare regulatory documents and regulatory submissions, communicate with Agencies, and get ready for the first clinical trial.
The mission in this stage of drug development is to demonstrate the preclinical efficacy and safety of your drug candidate, to determine the preclinical 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. I am here to help.
About
A career of 25 years in science including last 13 years in pharmaceutical R&D. Experience in Slovakia, Denmark, Canada, USA. Worked in Canadian, American, Japanese, German and Slovak companies. Study Director and senior manager at CRO, responsible for conduct of over 75 studies. Senior, principal and executive scientific positions at large pharma and biotech, designed, outsourced, monitored numerous studies at preclinical CROs as a Sponsor's Representative...
Services
Regulatory preclinical development, design of preclinical program, study design, protocols, monitoring, summaries and study reports, liaison to clinical researchteams, transition to Phase I. Outsourcing, CRO selection, external collaborations. Regulatory writing, interaction with Agencies. Partnerships, due diligence. Project evaluation, identification of in-house versus outsourced ratio, training, talent search, restructuring, talent search, linking to other expert services and providers within my broad professional network...
Testimonials
"Jan and I worked together between 2001 and 2003 as Study Directors at a CRO in Canada and we have kept in close touch since. Through our continued interactions and numerous scientific discussions, I have always found Jan to be a dedicated and well-rounded professional who understands issues and talks to the point, is proactive and pragmatic in problem solving. He has a rich repertoire of experience in both the CRO and pharma/biotech sides of the preclinical business."