Support of preclinical development plan

Eden supports the design of drug development programs from-end-to-end. The focus is on pharmacokinetics/ADME and toxicology (activities and budget). Development plans are based on regulatory guidelines. If requested, Eden can take care of the follow up of the lab work. This includes CRO scouting and selection, study monitoring (protocol review, follow up of data generation and report writing).

Eden is building bridges between preclinical ADME/TOX and clinical pharmacology (input in clinical protocols and trial designs and review of studies), regulatory, CMC, discovery, legal… .

Eden interacts with other stakeholders such as authorities, other pharmaceutical companies, key opinion leaders, scientists at universities

Scientific support

As study monitor Eden takes care of scouting of CRO’s, price and timeline negotiations :

  • The study monitor Eden follows up the study in terms of protocol generation, follow up of results, interpretation of data, review of data, reporting and communication to Eden’s client. Eden is the point of contact between the client and the CRO.
     
  • Eden is experienced in different types of studies:
  • Follow up of label synthesis (3H or 14C) 
  • Caco-2 permeability
  • PK at low dose in relevant animals for toxicology or pharmacology
  • linearity PK
  • toxicokinetics
  • tissue distribution (cold or radioactive)
  • QWBA
  • in vitro metabolism
  • enzyme phenotyping
  • enzyme inhibition
  • mechanism based inhibition
  • enzyme induction 
  • transporter involvement as substrate or inhibitor

  • Strategies on how to deal with high levels of metabolites (> that 10% of drug related material).
  • Calculation of a safe starting dose for a first in human study.
  • Review of the client’s protocols, data calculation and reports, review written assessments or IB’s.
  • Preparation of presentations.

Support in Due dilligence

The aim of the due dilligence is to identify gaps in the development program and identify potential risks for future development. An important factor is the estimated safety range based on pharmacology and the available toxicology studies. A due diligence, if positive, mostly ends with a gap analysis and a mitigation plan for further drug development. The aim of Eden is to identify and to proactively work on gaps before the due dilligence proces starts.

Eden can be part of the due diligence team to evaluate the preclinical studies, The founder has experience in the evaluation of different compounds and companies. She was involved in both, in and out licencing. 

In small pharma, the focus is on out licencing of compounds to large pharma. Eden can work together with the client towards an optimal and budget friendly preclinical package for out-licencing