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Final Program

Complete workshop program (Final)

NONMEM PK/PD modeling course
Sunday Oct 5, Outline & FREE registration

Presentations where authors have still missed to send information

Abstract Book

Cancer research
Any researcher involved in the field of cancer knows the famous “Ehrlich-Ascites-Cells” that are still frequently used. Although Ehrlich’s cancer research did not lead to a Magic Bullet and was not as successful as his other research areas, it was still a considerable part of his research after 1906. The Institute for Chemotherapy (“Georg-Speyer-Haus”) was founded and officially opened on September 3rd, 1906.

The pharmacology of antineoplastic agents will be a major topic this conference: Many new and exciting agents as well as treatment options in antineoplastic therapy will be introduced and discussed. This will include small molecules as well as therapeutic proteins, monoclonal antibodies and other miscellaneous immunotherapies.

Includes symposia with Alexander Levitzki who is known for developing specific chemical inhibitors of cancer-induced protein kinases. He demonstrated that such an inhibitor to Bcr-Abl kinase induces death of chronic myeloid leukemia cells. This is currently used, with great success, for therapy of patients afflicted by this disease. Her received the prestigious Wolf prize in medicine in 2005

JM Goldman, the world’s leading expert in treatment of CML will present and chair a symposium

C. Wani developed paclitaxel, an antineoplastic agent with a great history of efficacy and use in a high number of patients will present

The importance of pharmacokinetic and pharmacodynamic principles, drug uptake and interaction with transporters, as well as resistance issues will be discussed. New drug assays as well as Therapeutic Drug Monitoring (TDM) of antineoplastic agents will be introduced.

A special focus is given to the following agents:

• 5-Fluorouracil
• Mercaptopurine
• All marketed tyrosin kinase inhibitors
• Platin compounds
• Methotrexate
• Gemcitabine and drugs from the same class

The term ‘Drug Resistance’ (in German: “Arzneifestigkeit”) was first coined by Paul Ehrlich in 1904 when testing trypan red. The conference aims at summarizing and discussing the present knowledge on resistance to drugs from a variety of different therapeutic areas.

Resistance has become a major problem for many drug classes. To our knowledge there has been no conference on this issue that brought together investigators from several fields where resistance to a particular drug or drug class was reported. The conference will focus on examples and discuss the mechanisms of resistance and if the term “resistance” is justified in the respective therapeutic area. The concept of having leading scientists from many fields on-site will stimulate an interdisciplinary discussion and present solutions and pitfalls from each field.

The following agents are to be covered:

• Anti-infectives (including antibiotics, antifungals, tuberculostatics, and antivirals)
• Aspirin/clopidogrel as anti-platelet agents
• Diuretics
• Centrally acting drugs
• Antihypertensive agents
• Antineoplastic agents
• Analgesics
• Transporter and metabolism as a mechanism of resistance

Includes a symposium where mechanisms of resistance from different pharmacological groups will be discussed in one session to optimize interdisciplinary aspects and allowing to learn from approached applied in different fields.

Paul Ehrlich and Emil von Behring developed jointly the first antidiphtheritic antiserum. After this great success Ehrlich de-prioritized immunology research to fully focus on chemotherapy, a term that he coined. In many most recent reviews on vaccines and particularly monoclonal antibodies Ehrlich’s work was well cited and his contributions to these new forms of therapy were well appreciated.

Many recombinant proteins are presently marketed and have made a great contribution to drug therapy.

Erythropoietin is among the index compounds of recombinant therapeutic proteins for use in humans. Erythropoietin changed the world of nephrology profoundly as well as it did in oncology. Recently, adverse events were reported that have lead to a reassessment of its use. Earlier the formulation based serious and life threatening adverse event red cell aplasia (RCA) was reported.

The symposium aims at a rational erythropoietin use and at avoiding it’s unintended uses.

Discovery and development of erythropoietin
Physiology of erythropoietin
Pharmacokinetic/pharmacodynamic modeling of erythropoietin
Clinical use in nephrology
Clinical use in oncology
Recent concern on erythropoietin use
Abuse in sports

Includes a symposium on follow-on proteins (Biosimilars) with
C. Schneider ( EMEA / Paul-Ehrlich-Institute – PEI ) ,
Chairman of the Similar Biological (Biosimilar) Medicinal Products Working Party (BMWP)

Many of the first and spectacularly acting and selling therapeutic proteins like erythropoietin, growth hormone and G-CSF have come off-patent and can now be copied by generic manufacturers. However, unlike small molecule generics, these proteins, especially those which have glycosylation, need an extended regulatory approval process. In the US the proteins are called “Follow-on-proteins” and are called “Biosimilars” in Europe. In Europe growth hormone, several erythropoietins and one G-CSF product received approval by the EMEA (European Medicine Evaluation Agency).

TOPICS to be covered:

• “The process is the product”
• Developing a follow-on / biosimilar protein
• The importance of toxicological investigations
• Assay methodology and Phase I – studies to assess pharmacokinetics and pharmacodynamics
• When is a difference in pharmacokinetics/pharmacodynamics clinically relevant and which criteria should be used to define therapeutic equivalence?
• The EMEA regulatory process for biosimilars
• Pharmacovigilance of biosimilars

Many contributions have been submitted to this large field and will allow a vivid interdisciplinary discussion between physicians and life scientists.

Steroids, pulmonary diseases, other uses of steroids

Includes a state-of-the-art presentation by Professor William Jusko, Buffalo, NY, USA, the leading expert in pharmacokinetics and pharmacodynamics of steroids.

Steroid receptor – Elwood Jensen Symposium

From 1947 Elwood Jensen studied steroid hormones at Chicago, where he isolated estrogen receptors and discovered their importance in breast cancer. He won the Albert Lasker – Award for basic medical research in 2004. 75 Lasker Award recipients have gone on to win a Nobel Prize.

Illicit drugs and doping agents

Several contributions highlight and discuss the main issues of these therapeutic groups.

Appropriate drug, appropriate dose, appropriate patient, appropriate time”. The tremendous progress in this area will be well represented by excellent contributions from researchers who submitted to EHRLICH II.

The drug development and approval process is presently under scrutiny. The pharmaceutical companies need to streamline their development timelines and reduce costs and so have the regulatory authorities. Recently in Europe and the US critics have pinpointed this trend fostered by the increased number of drug removals. The symposium analyzes the present situation and discusses the “How to” of developing and registering a new drug entity. Generic drug development and “Added value” development of generic compounds will be introduced.

The understanding of drug transport has become one of the most promising areas in drug development and use of drugs in patient therapy. A 3/4-day symposium will be held to acknowledge and introduce this important area.
Includes symposia with Professor L. Z. Benet, San Francisco, Professor Kroemer, Greifswald, and Professor Cascorby, Kiel, Germany.

Similarly to the symposium on drug transporters the fascinating findings on cytochrome P450 dependent metabolism and the influence by genetics will be discussed in excellent contributions by EHRLICH II submitters.

This session Includes presentations by Professor I. Cascorbi, Kiel, and Professor U. Fuhr, Köln, Germany.

In this symposium human studies describing drug-drug-interactions and other physiological interactions will be presented and discussed. Their clinical relevance as well as the predictability from in vitro data and the genetic influence on drug interactions are other topics to be covered by the presentations submitted.

In this section many aspects of diseases that affect the immune system as well as drugs with stimulating, inhibitory, or modulating effects on the immune system will be discussed by many contributions submitted.

We received excellent presentations in this field that describe innovative approaches to improving drug delivery and bioavailability, adverse effects, computational studies, and systematic research for pharmacologically active agents from plants.

Ehrlich was the first to describe the blood brain barrier by – at the time – ingenious experiments. Blood brain barrier (BBB): drug penetration into brain and diseases affected by BBB will be discussed.
Our understanding of the BBB on a molecular level today and the many superb contributions to EHRLICH II would make Paul Ehrlich very happy if he heard about it. But maybe you meet him in the theatre play …

Includes several contributions on modern aspects of pharmacokinetics and pharmacodynamics.

Includes several contributions on latest bioanalytical methods, workshops and demonstrations by manufacturers.

Protein binding symposium

Another attempt will be made to summarize a topic that has been around ever since protein binding was measured. Protagonists and antagonists will be discussing this topic.

New / known targets and mechanisms

Endocrinology and drugs acting on or related to the endocrine system

TDM has become an accepted and valuable tool in clinical medicine to optimize effectiveness and safety by tailoring dosage regimens to each individual patient. World class scientists will review our present knowledge and also critically analyze the unresolved question and pitfalls.

This symposium includes a presentation by Alexander Vinks, Cincinnati, OH, USA, on TDM of immunosuppressants and
Includes a discussion group of clinical cases with Tyrosine Kinase Inhibitors.

Part I The following drugs will be covered in Part I of the symposium:

• Ciclosporine
• Mycophenolic acid
• Tacrolimus
• Digoxin
• Phenytoin
• Anti-infectives such as aminoglycosides and glycopeptides

Part II Where is an (unmet) need for TDM?

• Antineoplastic agents
• 5-Fluorouracil, mercaptopurine, methotrexate
• Tyrosine Kinase Inhibitors: Dasatinib, Erlotinib, Imatinib, Nilotinib, Sorafenib, Sunitinib
• Platin compounds
• Methotrexate
• Gemcitabine
• Psychoactive drugs

Under the direction of Jürgen Bulitta et al.

Software and efficiency tools for Pharmacokinetic (PK) and Pharmacodynamic (PD) data analysis, simulations, dose individualization, and optimal design has made tremendous strides during the last decades. This refers both to teaching tools as well as to cutting-edge research tools that rely on high performance parallelized computing that would not have been possible even five years ago.

This fascinating development of PK/PD software will be presented with a real life operation of a large variety of the pharmacokinetic and pharmacodynamic modeling and simulation software. The laboratory will include hands-on demos of estimation, simulation, dose optimization / individualization, and optimal design software.

Offering hands-on experience at all levels
- from learning / teaching tools for undergraduate and graduate students,
- to cutting edge research / industry tools parallelized on a web-based computer cluster,
- to real life clinical applications.

Free communications on this topic are invited and may be presented. The top three submissions – based on the content of this the submitted abstract – will be directly included in the symposium and will qualify for the Magic Bullet Award. The other presentations will be presented in additional sessions.

Historians will review several important drugs where sufficient material is available for presentation. Paul Ehrlich found the Mast Cell during the research on his MD-thesis.

Also the Paul-Ehrlich-Exhibition and the theater play will give great insights into Ehrlich’s life and achievements.