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K21 Cancer Drug Dev “The programme looks excellent” Prof Karol Sikora, Global Clinical Expert - Cancer, AstraZeneca Cancer Drug Development: New Directions and Challenges 10th & 11th March 2003, The Hatton, London Gain an insight from leaders in the field: • Prof Karol Sikora, Global Clinical Expert - Cancer, AstraZeneca • Dr Pearl Huang, Director, Oncology, GlaxoSmithKline • Dr George Blackledge, Vice President, Medical Director, Oncology, AstraZeneca • Dr Giorgio Massimini, Director, Clinical Oncology, Pharmacia • Dr Paolo Paoletti, Vice President, Medical – Oncology, ALIMTA Product Team Leader, Lilly • Dr Paul Quartey, Medical Director, Schering-Plough • Dr Juergen Hammer, Head, Bioinformatics, Genetics & Genomics, Roche • Dr Peter Traxler, Senior Scientist, Research Manager, Novartis • Dr Jonathan Allis, Vice President, Imaging Technology Group, Amersham Health • Dr Jeffrey Ulmer, Senior Director, Chiron • Dr Leonard Post, Senior Vice President, Research & Development, Onyx Pharmaceuticals • Prof Stephen Jackson, Deputy Director, Wellcome Trust / Cancer Research UK Institute • Prof Ian Judson, Professor, Cancer Pharmacology, Honourary Consultant Medical Oncologist, Institute of Cancer Research / Royal Marsden NHS Trust Programme Highlights • TRANSLATIONAL MEDICINE: keep up to date with the latest technology • REGULATIONS: assess new ways of satisfying requirements • IMMUNE RESPONSE EXPLOITATION: review the current approaches • TARGETED DRUGS: focus on the new directions • NETWORKING: exchange ideas with leaders in the field PLUS A HALF DAY EXECUTIVE BRIEFING Novel Immunotherapeutic Vaccine Platform 12th March 2003, The Hatton, London. In association with www.smi-online.co.uk/cancerdrugs.asp Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 50% DISCOUNT Academic Researchers receive 50% discount Supported by www.smi-online.co.uk/cancerdrugs.asp Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 8.30 Registration & Coffee 12.40 Lunch 9.00 Chairman's Opening Remarks TRANSLATIONAL MEDICINE Prof Karol Sikora, Global Clinical Expert - Cancer, AstraZeneca OPENING ADDRESS HIGH-THROUGHPUT TARGET IDENTIFICATION AND ASSESSMENT TRANSLATIONAL CANCER RESEARCH 2.00 Benefits of “Process Biology”, a modular target 10th March 2003 March 10th 9.10 The key to the future assessment approach • The paradigm shift in cancer drug development • The new order of corporate research organisation • Need for operational improvements of the target • Bridging the academic - industrial divide assessment process • Harnessing innovation in biomarkers, surrogates and imaging • Expression analysis technologies for drug discovery • Creating diagnostic capability to package with new Day One • Prioritising most likely drug candidates therapeutics • Knowledge discovery in an integrated environment • Creating centres of excellence in translational research Prof Karol Sikora, Global Clinical Expert - Cancer, AstraZeneca • Integrating traditional and in silico approaches Dr Juergen Hammer, Head, Bioinformatics, Genetics & REGULATORY MATTERS, CLINICAL TRIALS AND PUBLIC POLICY Genomics, Roche WHAT ARE THE CRITERIA? IMAGING RESEARCH PROGRAMMES 9.40 Iressa – the first of a new type of cancer medicine • Clinical benefits 2.40 Bringing diagnosis and therapy together • Results of clinical trials • Identifying new molecular diagnostic products • Tumour response rates required for regulatory approval • Acceleration of research decisions • Convincing controls • Imaging technology • Compassionate use programmes • Facilitating early approval of new therapeutics Dr George Blackledge, Vice President, Medical Director, Oncology, AstraZeneca • Application to treatment of cancer • Future potential for finding new and powerful diagnostic and MEETING THE CHALLENGE OF PUBLIC POLICY therapeutic products 10.20 Getting it right with NICE Dr Jonathan Allis, Vice President, Imaging Technology Group, • Mode of action of Caelyx® in fighting cancer Amersham Health • Patient selection for treatment • Importance of cost issues • Benefits of cost issues regarding numbers of patients eligible 3.20 Afternoon Tea for treatment • Efficacy and tolerability factors ANGIOGENESIS • Ease of administration Dr Paul Quartey, Medical Director, Schering-Plough MULTIPLE MYELOMA AND MYELOPROLIFERATIVE DISORDERS 11.00 Morning Coffee 3.40 The ImIDs • Thalidomide NEW APPROACHES TO CLINICAL DEVELOPMENT • Celgene’s STEPS programme 11.20 New drugs, new criteria • Maximum tolerated dose • Multiple myeloma and myeloproliferative disorders • Biological effective dose • Myelofibrosis with myeloid metaplasia • Accurate dose:response information • REVIMID • How significant is shrinkage / no shrinkage? • ACTIMID • Reliability of tumour markers • Future directions • Assessment of combination therapy of new drugs with traditional ones Dr Jerome Zeldis, Chief Medical Officer, Vice President, Medical Dr Giorgio Massimini, Director, Clinical Oncology, Pharmacia Affairs, Celgene NEW ANTICANCER DRUGS INNOVATIVE CANCER THERAPY 12.00 Impact of changing targets on trial design • Preclinical aspects of new drug development – developing pharmacodynamic assays as an integral part of the preclinical 4.20 ONCOLYTIC VIRUSES package • Advantages of adenovirus as platform • Recently identified new targets • Exploiting the abnormal p53 and RB pathways in malignant • Development of mechanism-based clinical trials cells • Defining the Optimum Biological Dose – is this a realistic goal? • Specificities of adenoviruses ONYX-015 and ONYX-411 • Impact of new targets on conventional concepts of Phase I / II trials • Clinical experience : safety and efficacy • Imatinib in gastrointestinal stromal tumour – lessons for future • Armed therapeutic viruses : oncolytic adenoviruses as vectors molecular targeted therapies for transgene delivery • Satisfying the regulatory authorities – are phase II trials ever Dr Leonard Post, Senior Vice President, Research & Development, enough? Onyx Pharmaceuticals Prof Ian Judson, Professor, Cancer Pharmacology, Honorary Consultant Medical Oncologist, Institute of Cancer Research / Royal Marsden NHS Trust 5.00 Chairman’s Closing Remarks and Close of Day One www.smi-online.co.uk/cancerdrugs.asp Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 8.30 Re-registration & Coffee 12.40 Lunch 9.00 Chairman’s Opening Remarks MULTIPLE ANTI-CANCER DRUGS WITH NOVEL MECHANISMS Prof Jim Cassidy, Professor, Oncology, Cancer Research UK, OF ACTION Medical Oncology 2.00 A clinically validated target, the mitotic spindle FUNCTIONAL GENOMIC APPROACH • Role of mitotic kinesins in cell division • Transcriptional profiling demonstrating the over expression of 11th March 2003 March 11th GENES-TO-DRUGS kinesin spindle proteins (KSP) in cancer 9.10 Exploiting the commercial potential of the 2001 Nobel Prize • Biochemical studies of KSP enzymatic inhibition in Medicine • Breadth of anti-tumour activity • Cell cycle biology pathways and checkpoint control • Mechanism-based anticancer drug design • Absence of treatment-associated neuropathy • Preclinical data Day Two Day Two • CDK Inhibitors: an emerging class of anticancer Rx • Alternative approaches targeting cyclin inhibition Dr Pearl Huang, Director, Oncology, GlaxoSmithKline • The Mitosis pathway and G2/M-specific drug design • Implications of the new paradigm for companies and investors EXPLOITING THE IMMUNE RESPONSE Spiro Rombotis, Chief Executive Officer, Cyclacel TARGETED MOLECULAR THERAPY CANCER CELL-SPECIFIC MONOCLONALS WITH TOXIC PAYLOADS TARGETED TREATMENTS 2.40 Toxic drugs 9.40 Is the era of cytotoxics over? • Mechanism of action • Targeting treatment with cytotoxics • Technological procedures • Have targeted treatments lived up to their expectations? • Toxicology issues • Development of new cytostatic targeted treatments Dr Paolo Paoletti, Vice President, Medical – Oncology, ALIMTA • Regulatory matters Product Team Leader, Lilly • Preclinical data • Advantages of the technique SIGNAL TRANSDUCTION INHIBITION • Pitfalls to be overcome 10.20 Protein kinase inhibitors with broad therapeutic potential Dr Steve Holmes, Vice President, Antibody Discovery, Oxford • Mechanism of action at the molecular level GlycoSciences • Rational design - a challenge for a medicinal chemist • Preclinical profile at the enzymatic, cellular and in vivo level • Clinical data 3.20 Afternoon Tea • Successes and failures • Future challenges CANCER VACCINE STRATEGIES Dr Peter Traxler, Senior Scientist, Research Manager, Novartis 3.40 An overview • Review of vector platforms for therapeutic vaccines 11.00 Morning Coffee • Autologous vaccines DNA REPAIR: NEW TARGETS FOR CANCER THERAPY • Recombinant vaccines 11.20 Drugs as inhibitors of DNA repair • Naked antibodies • Biochemical and genetic methods for validating drug targets • Radioactive conjugates • Detection, signalling and repair of DNA double strand breaks • Combination treatments (DSB) • Encouraging results in early phase cancer vaccine clinical trials • Targeting the homologous recombination system and the non- homologous end joining (NHEJ) systems Dr Jeffrey Ulmer, Senior Director, Chiron • Inhibiting key enzymes in DNA DSB repair pathways • Enhancing the efficacy of chemotherapeutic agents and of ANTIBODIES TO MODULATE TUMOUR IMMUNITY ionising
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