Free whitepapers on Pharmacogenomics and Drug Transporters

Access free whitepapers on Pharma Imaging and Modelling for Optimized Translational Research; for example articles on Pharmacogenomics and Drug Transporters:


Pharmacogenomics - Drug Disposition, Drug Targets, and Side Effects
It is well recognized that different patients respond in different ways to the same medication. These differences are often greater among members of a population than they are within the same person at different times (or between monozygotic twins).

Drug Transporters in ADME
Pharmaceutical companies are investing research time into understanding and modelling of drug transporters to better predict drug-drug interactions and toxicities. Whilst understanding drug-drug interactions can enhance study efficiency and drug efficacy, the challenges presented by drug transporters are complex.

Access more at:  Imaging and Modelling for Optimized Translational Research

Exclusive Podcast Series: Preclinical to clinical translation - the "tool" box

In our exclusive three-part podcast series, Prof. Martin Wehling, Managing Director at the University of Heidelberg’s Institute for Experimental & Clinical Pharmacology, speaks about current developments and challenges in translational medicine today.

Follow the links to download the podcast or to listen online:

Preclinical to clinical translation - the “tool box” (Part 1) In part one of our three-part podcast series, Prof. Martin Wehling, Managing Director at the University of Heidelberg’s Institute for Experimental & Clinical Pharmacology, speaks about current developments and challenges in translational medicine today.


Preclinical to clinical translation - the “tool box” (Part 2) In part two of our three-part podcast series, Prof. Wehling speaks about the standardized translational “tool box”, the current efficacy of physiologically based pharmacokinetic modelling (PBPK), and the relevance of biomarkers to translational processes.


Preclinical to clinical translation - the “tool box” (Part 3) In the third and final part of our podcast series on the preclinical to clinical translation tool box, Prof. Wehling gives insight into the role of pharmaceutical industry, joint public-private ventures and the future of Preclinical to clinical translation.

Guideline on Clinical Investigation of Immunosuppressants for solid Organ Transplantation

The aim of this guideline is to provide guidance on the clinical development of compounds for the prevention and treatment of allograft rejection in solid organ transplantation.

The immune system is vital for the human body and immunosuppression in organ transplantation should be as selective as possible, to minimise the risk of over-immunosuppression which can cause increased risks of infections and malignancies. Many problems exist in currently approved regimens: Treatments are often very complex, e.g. quadruple immunosuppression, and vary over time for each patient. This complexity also increases the risk for low patient compliance. Therapeutic margins can be very narrow and there are considerable risks of over- as well as of under immunosuppression. The pharmacokinetic interaction potential is high and causes problems (decreased efficacy, increased toxicity) as transplant patients are often on multiple other drugs. Many widely used immunosuppressive protocols in transplants performed in low numbers,  i.e., lung, bowel and islet transplantation, are not approved for that indication.

Different treatment settings and modalities, such as type of organ transplantation (renal, liver, heart, lung, etc.) type of therapy (induction, initial, maintenance, tolerance induction), type of allograft rejection (hyperacute, acute, subacute, ‘chronic’ and/or (steroid) resistant) and type of pathophysiology (cellular or humoral type of rejection) are distinguished. Many different immunosuppressive drugs and a number of different combinations are currently available and new agents are under development. Other treatment concepts that are explored include steroid withdrawal or total avoidance of steroids, drug minimisation and induction of tolerance.

This document considers these circumstances and provides guidance for proper development of new immunosuppressant for solid organ transplantation. Potential claims provided reflect principal aims of management of transplanted allograft with immunosuppressant. Baseline subject characteristics and selection criteria of subjects considers immunological and global transplantation risk assessment; both of donor/transplant and recipient. Primary efficacy criteria are provided in general terms and are seen as constructed by composed and/or co-primary endpoints only. Guidance on pharmacokinetic and pharmacodynamic investigations reflects mainly specific pathophysiology during peri-transplantation period, co-therapies and monitoring strategies. Exploratory trials should reflect concepts of immunosuppression for investigated agent or process and base strong rationale for confirmative investigations. Guidance on confirmatory trials is provided mainly for  major transplantation areas, such as renal, liver, heart, lung and pancreas transplantation. Specific areas with limited experience gathered
up till now, such as development of minor transplantation areas as well as choice of non-approved comparators are recommended to be guided by European regulatory advice procedures. Special issues in paediatric, elderly population and in case of certain infections during peri-transplantation period are advised to be investigated by tailored trials. Clinical safety investigation should reflect certain essential
characteristics of immunosuppression in solid organ transplantation, such as life-long lasting treatment in a population with extensive co-morbidity. Specific factors to be considered include proper time for assessment of infectogenic and cancerogenic potential, risk of premature death due to primary disease and overlapping safety signals.

This document should be conceived as general guidance and should be read in conjunction with other EU and ICH guidelines that apply to the subject (see Section 3 ‘Legal basis’). Due to the dynamics of the field, frequent revisions and amendments are foreseen.
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This document provides guidance for proper development of new immunosuppressant for solid organ transplantation. Potential claims provided reflect principal aims of management of transplanted allograft with immunosuppressant. Baseline subject characteristics and selection criteria of subjects considers immunological and global transplantation risk assessment; both of donor/transplant and recipient.

The 15-page Guideline on clinical investigation of immunosuppressants for solid organ transplantation can be downloaded here: Guideline on clinical investigation of immunosuppressants for solid organ transplantation