MODULE 1: GENOME AND TARGET EVALUATION WEDNESDAY 4 JANUARY Chairman: Jan Fleckner, Novo Nordisk

Transcription

1 MODULE 1: GENOME AND TARGET EVALUATION WEDNESDAY 4 JANUARY 2006 Chairman: Jan Fleckner, Novo Nordisk Welcome and Introduction. Overview of the Drug Development Process Ole J. Bjerrum, DFU Break Identification and Validation of Pharmaceutical Targets the Role of Functional Genomics Jan Fleckner, Novo Nordisk Biological modeling in Drug Discovery Søren Berg Padkjær, Novo Nordisk Lunch How to correct when inflammation runs loose Birgitte Ursø, Novo Nordisk The discovery Process of Glucagon Receptor Antagonists Jesper Lau, Novo Nordisk Break Science in Silico do it yourself Jan Fleckner, Novo Nordisk Questions and evaluation Module 1 aims at introducing discovery functions such as how to identify and validate targets. Targets are identified in one of several ways including use of genomic information as well as biological and disease knowledge. During module 1 we will look at how genomic technologies may be used to assist the identification of novel targets. Targets may be identified based on aberrant expression in e.g. animal model systems or in disease settings. Whereas bio-informatics may also in itself be used to identify targets, another highly relevant use is to make rational design of protein targets and their interaction partners. This is the subject of the second talk. The biological reasoning behind identification of targets based on disease knowledge will be exemplified through description of candidate drug discovery of inflammatory disease. Discovery functions are most commonly run as projects and the fourth talk will be a project case story. Finally, the last session of the day is getting hands on, searching the internet for biological and drug relevant information.

2 MODULE 2: IDENTIFICATION OF LEAD STRUCTURES THURSDAY 5 JANUARY 2006 Chairman: Fritz Poulsen, Novo Nordisk Hit Finding I: HTS Fritz Poulsen, Novo Nordisk Break Hit Finding II: Therapeutic Target Based Assays in HTS Lone Pridal, Novo Nordisk Break Hit-to-Lead Tine Stensbøl, Lundbeck Lunch Introduction to Cases Fritz Poulsen, Novo Nordisk Case 1: Lead Identification in a Project with a Defined Molecular Target Case 2: Lead Identification in a Project where the Overall Effect but not the Specific Target is Known Lars Iversen, Novo Nordisk Bo Falck Hansen, Novo Nordisk

3 MODULE 3: MEDICINAL CHEMISTRY; LEAD OPTIMIZATION AND SYNTHESIS FRIDAY 6 JANUARY 2006 Chairman: Frederik Björkling, Topotarget A/S Medicinal Chemistry - Key Parameters for a Successful Lead Optimisation Frederik Björkling, TopoTarget Break Scale-Up to Clinic and Production Elisabeth Carstensen, TopoTarget Patents in Pharmaceutical Industry Birgit Thalsø-Madsen, LEO Pharma Lunch Case 1: Development of NovoSeven Recombinant Coagulation Factor VII Case 2: Optimisation and Development of a CNS Product Inger Mollerup, Novo Nordisk Benny Bang-Andersen, Lundbeck Break Case 3: The Discovery and Optimisation of Novel Inflammatory Compounds Frederik Björkling, TopoTarget

4 MODULE 4: NON-CLINICAL SAFETY MONDAY 9 JANUARY 2006 Chairman: Flemming Højelse, H. Lundbeck incl. break Non-clinical Safety assessment for the Drug Development Process Requirements for MAA/NDA (Safety Pharmacology & toxicology), Part I Non-Clinical Safety Assessment for the Drug Development Process Requirements for MAA/NDA (Safety Pharmacology & Toxicology), Part II Flemming Højelse, H. Lundbeck Flemming Højelse, H. Lundbeck Lunch ADME: Absorption, Distribution, Metabolism, Excretion Lars Dalgaard, H. Lundbeck Break Pharmacokinetics and Toxicokinetics in Drug Development Frank Larsen, H. Lundbeck Case

5 MODULE 5: ANIMAL BIOLOGY AND PHARMACOLOGY TUESDAY 10 JANUARY 2006 Chairmen: Jørn Arnt, H. Lundbeck, Sandra Hogg, H. Lundbeck Use of animal models for selection of drug candidates Sandra Hogg, H. Lundbeck Break In vivo technologies for target identification and validation Michael Didriksen, H. Lundbeck Break Running a discovery project interactive game. Room U1, U4 Sandra Hogg, H. Lundbeck, Michael Didriksen, H. Lundbeck Lunch MODULE 6

6 MODULE 6: PREFORMULATION TUESDAY 10 JANUARY 2006 Chairmen: Anders Buur, H. Lundbeck A/S Introduction to Preformulation Anders Buur, H. Lundbeck A/S The Drug Discovery - Drug Development Interface Final Form Selection and Solid State Characterization Anders Buur, H. Lundbeck A/S Anette Frost Jensen, Novo Nordisk A/S Break Formulation Aspects in preclinical and phase 1 clinical testing Drug Delivery Bringing Value to Development Karsten Petersson, Novo Nordisk A/S Anders Buur, H. Lundbeck A/S Q&A All

7 MODULE 7: PHARMACEUTICAL FORMULATION TUESDAY 24 JANUARY 2006 Chairmen: Sven Frøkjær, The Danish University of Pharmaceutical Sciences Introduction Course Leaders The European Pharmacopeia and its Role Henning G. Kristensen, DFU Tablet Technology Per Holm, LifeCycle Pharma A/S Break Formulation Design of Biopharmaceuticals Lone L. Kimer, Novo Nordisk Topical Formulation Design Jens Hansen, LEO Pharma Lunch Reaction Kinetics A Prerequisite for Stability Studies Anders Buur, H. Lundbeck A/S Stability Issues Mogens Lauritzen, Novo Nordisk Break Formulation Aspects of Clinical Trial Products Michiel Elema, H. Lundbeck A/S Up-Scaling Poul Berthelsen, Nycomed Pharma O & A All

8 MODULE 8: CLINICAL TRIALS WEDNESDAY 25 JANUARY 2006 Chairman: Bo Maach-Møller, Eli Lilly Danmark incl. 15 min break - The Clinical Research Process Nina Bjarnason, Rigshospitalet, Klinisk Farmakologi Regulatory Environment Nya Feldthus, Eli Lilly Clinical Plan Development & Protocol Development Ebbe Englev, Abbott Lunch GCP Kurt Pfeiffer Petersen, AstraZeneca Break incl. 15 min break - Case, Protocol Development Bo Maach-Møller, Eli Lilly The Clinical Research Process: Why do we conduct clinical research/trials? ICH E8 Definition of Clinical Research phases (exploratory/confirmatory) vs. definition of phase I, II, III & IV clinical trials. Who conducts clinical research? Randomization, blinding, trial design etc. Use of placebo. Bias. Statistitical considerations Regulatory Environment: Declaration of Helsinki. Danish Medicines Agency. Etichs Committeets. Data Protection Agency. EU Clinical Trial Directive. Role of sponsors and investigators. Clinical Development Plan & Protocol Development: What is a clinical development plan how does it link to it link to the Product Development Plan. Strategic considerations. Cost/value analysis. Timing. Protocol development in cooperation with other internal and external functions. Examples of protocols. Criteria for investigator selection. GCP: Principles & definations. Background. Roles and responsibilities. Quallity assurance. Misconduct and fraud. Case, Protocol Development: Based on a Clinical Situation and a short description of a new compound, this case will allow the students to discuss and identify key elements of the clinical trial protocol.

9 MODULE 9: REGISTRATION THURSDAY 26 JANUARY 2006 Chairman: Karen Hørlyk, RegAdviZe Introduction to Regulatory Affairs and the Development Process Karen Hørlyk, RegAdviZe The Legislative Framework Gitte Dyhr, H. Lundbeck Break Regulatory Strategy Karen Hørlyk, RegAdviZe Product Information Vibeke Bjerregaard, Novo Nordisk Break Life Cycle Management Ulla Brønnum, Novo Nordisk Lunch Case 1: SPC Vibeke Bjerregaard, Karen Højlyk, GitteDyhr Case2: Communication with authorities Karen Hørlyk, Vibeke Bjerregaard, Gitte Dyhr Break Case 3: Regulatory Strategy Gitte Dyhr, Karen Hørlyk, Vibeke Bjerregaard Summary Karen Hørlyk, RegAdviZe Synopsis to MIND Intro Module 9 Registration: All aspects within the pharmaceutical development process, production and sales of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy. Health Authorities attitudes and requirements etc. have a great influence on the drug development process and the success of it. These aspects are dealt with by Regulatory Affairs Professionals (RAPs). Knowing this discipline, how to focus the development process and co-operate with the RAPs can be vital for the success of a medicinal product development and even the survival of a pharmaceutical company.

10 The objective of Module 9 is to give the participants a brief introduction to the development process from a RAPs perspective, describe the role of a RAP and further illustrate the current trends and challengers for the future of the pharmaceutical industry. For this module we have further selected a few, but important issues where the RAPs have a great impact on the product development process. You will be guided through the legislative law frame in USA, EU and Japan and get a description of the differences between the three regions. The importance of the ICH initiative and its global impact on the legislation will be described. Regulatory affairs from a strategic viewpoint will be discussed. Product information as to a description for what a SmPC and the labeling of a product are. The SmPC is a document which consists of pages, costs 5-6 billion Dkr to develop over a timeframe of 8-12 years and so is the most important document for the industry at all. Finally, the activities within product maintenance or Product Life Science Activities will be described. The whole afternoon session will be devoted to case stories within SmPC, regulatory strategy and communication with the Health Authorities.

11 MODULE 10: QUALITY ASSURANCE FRIDAY 27 JANUARY 2006 Chairman: Jonna Hindkær, Novo Nordisk Introduction to Quality Jonna Hindkær, Novo Nordisk Break GXP in Discovery & Development Tony Jørgensen, Genmab Case: Development Issue Tony Jørgensen, Genmab Lunch Trends in and experiences from inspections Lise Lundbeck, Novo Nordisk Case: Responses to FDA Lise Lundbeck, Novo Nordisk Break The use of ISO 9000 in the pharmaceutical Industry Thomas Munk Plum, Novo Nordisk Cases on the basic ISO philosophy The concepts of Total Quality Management, incl. cases Thomas Munk Plum, Novo Nordisk

12 MODULE 11: PRODUCTION, STRATEGY AND MODULE 12: MARKETING (AND EXAMINATION) MONDAY 30 JANUARY 2006 MODULE 11: Chairman: Troels V. Christensen, H. Lundbeck MODULE 12: Chairman: Ole J. Bjerrum, The Danish University of Pharmaceutical Science Production aspects i Troels V. Christensen, H. Lundbeck Break Production aspects II Troels V. Christensen, H. Lundbeck MODULE Strategic portefolio Toke Ward Petersen, Novo Nordisk Lunch Marketing for Industrial Drug Development Karsten Lollike, Novo Nordisk Break Examination Room U1/U4, DFU Module 11. An overview of basic production concepts and how and when productions get into the drug development process are covered. Module 12. The complete drug development process concerns more than processing the drug substance. It also needs prioritization and management of the many simultaneous projects running. The introduction to the market is another success parameter to which you need to know how marketing works.