|
Published by: SMI Publishing, Ltd
Published: Oct. 2, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- 9.50 REGULATORY ISSUES IN THE DEVELOPMENT OF DRUGS FOR DIABETES AND METABOLIC DISORDERS
- Completing trials and satisfying regulatory requirements
- Metabolic Syndrome
- Diabetes
- Obesity - Adults
- - Children/adolescents
- Atherosclerosis
- Conduct of trials/requirements for regulatory approval
- Dr Satish Singh, Expert Clinical Assessor, MHRA.
- 10.30 Morning Coffee
- 11.00 DEVELOPING NOVEL TREATMENTS FOR AN EMERGING EPIDEMIC: TYPE II DIABETES
- The gut - a sophisticated endocrine organ
- Incretins as endogenous turbochargers
- Augmenting the incretin effect by inhibiting DPP-IV
- DPP-IV inhibitors - a crowded field?
- Demonstrated clinical efficacy of DPP-IV inhibition
- The therapeutic potential of DPP-IV inhibition
- Dr Uwe Gudat, Global Brand Medical Director, Dyslipidemia & Diabetes, Novartis.
- 12.20 Networking Lunch
- 2.40 DPP-4 INHIBITION FOR THE TREATMENT OF TYPE 2 DIABETES
- Discovery of Sitagliptin
- Overview of DPP-4 Biology
- Discovery of Sitagliptin
- Preclinical profile of Sitagliptin, including effects on beta cells
- Clinical studies with Sitaglipin
- Profile/potential advantages of Januvia vs current therapy
- Dr Nancy Thornberry, Executive Director, Metabolic Disorders, Merck Research Laboratories.
- 2.40 CASE STUDY: CETILISTAT - AN INVESTIGATIONAL DRUG FOR OBESITY AND CO-MORBIDITIES
- Exploring current Phase II trial results
- Target profile for an obesity drug in today’s environment
- Cetilistat: evidence of efficacy and tolerability in obese adults?
- Efficacy in obese diabetics
- Superior tolerability profile and patient compliance
- Challenges for the future in a global problem
- Dr Richard Palmer, CEO, Alizyme P L C.
- 3.20 Afternoon Tea
- 3.40 MB06322 (CS-917)
- A potent and selective inhibitor of fructose 1,6-bisphosphatase for controlling gluconeogenesis in Type II diabetes
- Overview of gluconeogenesis in Type 2 diabetes mellitus
- Inhibition of fructose-1,6-bisphosphatase as a means to decrease hepatic glucose output
- Structure-guided drug design strategy in the discovery of CS-917
- Review of animal models and clinical data showing the utility of CS-917 in providing long term glycemic control in the full spectrum of T2DM patients in the absence of weight gain
- Dr Howard Foyt, Vice President, Clinical Development, Metabasis Therapeutics Inc.
- 3.40 SIBUTRAMINE - A 20:20 HINDSIGHT PERSPECTIVE ON ITS APPROVAL AND USE AS A DRUG TO TREAT OBESITY AND RELATED CO-MORBIDITIES
- Case study
- The marketing approval process
- Efficacy in long-term obesity management
- Beneficial effects of sibutramine in metabolic syndrome
- The Sibutramine Cardiovascular OUTcome (SCOUT) trial
- Professor David Heal, Director, Renasci Consultancy Ltd.
- 4.20 AMYLIN ANALOGUES: FOR THE TREATMENT OF DIABETES, OBESITY AND CARDIOVASCULAR DISEASE
- A fascinating success story, including a progress report on Byetta
- Amlyin analogues - mechanism of action
- Hear an update on the preclinical and clinical development of pramlintide for obesity
- Effect on patient weight loss/weight stabilisation
- Gaining FDA approval for Type I and Type II diabetes -best practice advice
- Case study: Symlin®
- Filing for European regulatory approval: Pramlintide and it’s submission preparation to the European authorities
- Byetta - why has this drug become so successful despite not being marketed directly to consumers?
- Are there any plans for the non-diabetic study of this drug?
- Seeking approval for the expanded use of BYETTA® - current status
- Best practice advice - launching your product
- Dr Matthew Wintle, Director, Medical Affairs Programmes, Amylin Pharmaceuticals Inc.
- 4.20 ASSESSING THE LATEST IN CLINICAL DEVELOPMENT FOR OBESITY RELATED METABOLIC DISORDERS
- Case study: Rimonabant - Phase IIIb
- A classic CB1 antagonist?
- Review of clinical data - results from phase III trials and beyond
- Comparing rimonabant at doses of 5mg and 20mg with placebo - what do we learn?
- Can Rimonabant be well tolerated for long-term use?
- The phase IIIb trial programme for Rimonabant - what indications are available for studies in patients with diabetes, dyslipidaemia and cardiovascular disease?
- Achieving regulatory approval
- Going to market - key strategies for success
- Dr Douglas Greene, Senior Vice President, Chief Medical Office , Sanofi-Aventis.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Elena Sebokova, Disease Area Head, Metabolic Diseases, F. Hoffmann-La Roche.
- 9.10 ADDRESSING UNMET NEEDS
- Where do we go from here?
- Assessing the need for effective anti-obesity/anti-diabetic drugs
- What is the profile of an ideal therapy?
- Novel approaches to drug discovery
- Target-based therapies - what exciting treatments are on the horizon?
- Combination therapies - will they be required?
- Dr Simon Westbrook, Associate Research Fellow, Cardiovascular & Metabolic Diseases, Pfizer.
- 9.50 HOW TO STUDY NEW ANTI-DIABETIC AGENTS?
- Best practice advice from the industry
- How to overcome the challenges in developing novel anti-diabetic therapies?
- Clinical evaluations and comparative studies
- Novel concepts - anti-diabetic agents with cardioprotective mechanisms
- New methods of improving clinical development for your organisation
- Future prospects
- Dr Richard Carr, Senior Director, Novo Nordisk.
- 10.30 Morning Coffee
- 11.00 ADVANCES IN CNS ANTI-OBESITY THERAPEUTICS
- The identification of CNS targets for obesity therapeutics
- CNS pathways regulating feeding and energy expenditure
- Opposing regulation by melanocortin and NPY in the hypothalamus
- Is grehlin a player?
- Combinatorial effects on energy homeostasis
- Dr Alison Strack, Senior Research Fellow, Merck & Co Inc.
- 11.40 NEXT GENERATION DRUGS
- Developing novel targets for drug discovery
- Current and upcoming targets for treating diabetes and obesity
- Novel approaches that target multiple risk factors simultaneously
- Options for treating the cardiovascular risk of patients with metabolic syndrome
- Case examples
- Challenges, benefits and limitations of these targets
- The future outlook
- Dr H. James Harwood, Principle Research Investigator, Pfizer.
- 12.20 Networking Lunch
- 1.50 MCH1R AS AN IDEAL TARGET FOR ANTI-OBESITY THERAPY
- Understanding MCH biology in animals
- MCH signalling influences food intake
- Key differences in MCH receptors between animals and humans
- Opportunities to address obesity in humans through manipulation of MCHR1
- Alex Depaoli, Director Global Development, Amgen.
- Dr Riccardo Perfetti, Associate Director, Medical Sciences, Amgen.
- 2.30 NEUROENDOCRINE AND METABOLIC FACTORS CONTROLLING APPETITE, OBESITY AND INSULIN RESISTANCE
- Regulation of appetite and obesity by NPY and POMC pathway
- Balance between NPY and POMC regulates insulin sensitivity
- NPY and hepatic insulin resistance via sympathetic nervous system
- Role of peripheral hormones in central regulation of appetite and insulin sensitivity
- PYY redirects substrate utilization towards fat oxidation
- Dr Anita Hoek, Research Scientist, Vascular and Metabolic Disease Research Department, TNO Prevention and Health.
- 3.10 Afternoon Tea
- 3.40 ALTERING THE EXPRESSION OF HEPATIC GENES INVOLVED IN LIPID METABOLISM IN ZDF RATS
- Topiramate - a case example
- In obese-associated Type II diabetic rodent models, topiramate (TPM) reduced the body weight gain, improved insulin sensitivity and enhanced insulin release
- The molecular mechanisms of TPM anti-obesity and anti-diabetic effects remain unknown
- DNA microarray data revealed that TPM treatment altered hepatic gene expression of metabolic enzymes and signaling regulatory proteins involved in energy metabolism
- These gene expressions were independent of food intake as demonstrated by pair-feeding
- TPM regulates hepatic expression of genes involved in lipid metabolism, which could be part of the mechanism by which TPM reduces plasma triglyceride levels and improves insulin sensitivity in obese-diabetic rodents
- Dr Yin Liang, Principal Scientist, Metabolic Research Team, Johnson & Johnson.
- 4.20 THE GHRELIN PATHWAY IN THE CONTROL OF GLUCOSE HOMEOSTASIS
- Ghrelin antagonists
- Ghrelin is a gut-derived peptide that controls feeding and growth hormone release
- Recent studies have shown that ghrelin/ghrelin receptor knockout mice are resistant to diet-induced obesity
- These mice also have favourable metabolic parameters when faced with a metabolic stressor diet
- Small molecule ghrelin antagonists have been generated that are potent (nM), selective and safe for in vivo use
- Treatment with ghrelin antagonists improves glucose homeostasis in diet-stressed mice
- Dr Peter DiStefano, Chief Scientific Officer, Elixir Pharmaceuticals, Inc..
- 5.00 Chairman’s Closing Remarks and Close of Conference
AbstractMetabolic diseases affect millions of sufferers worldwide and are having an increasingly negative impact upon the health of our society as a whole. According to recent figures, type II diabetes affects more than 135 million people whilst those meeting the criteria set for obesity reaches 300 million respectively. Needless to say pharmaceutical companies are hot on the pursuit of lucrative solutions to aid in the prevention and/or management of major metabolic syndromes.
Following a series of well received events for the industry, SMi would like to announce it’s inaugural ‘Metabolic Diseases Forum’ designed specifically to uncover the latest market trends, challenges and emerging therapies. Understand the aetiology and epidemiology of key metabolic disorders whilst discovering new targets for drug discovery and hear reports from current and future clinical trials, including real clinical data, while we assess the clinical outlook for metabolic disease 2006 an beyond!
Enjoy our streamed sessions as we take a closer look at key disease specific drugs on track towards regulatory approval and market release. Learn how to complete your clinical trials whilst satisfying regulatory requirements and discover what is really expected in a new product application and how to achieve it. Join us and a host of leading experts including representatives from Sanofi-Aventis, Eli Lilly, Novo Nordisk, Pfizer, Amylin and many others at SMi’s Metabolic Diseases Forum 2006!
Our exceptional speaker line-up includes:
- Dr Michael Mark, Vice President, Metabolic Diseases Research, Boehringer-Ingelheim
- Dr Douglas Greene, Vice President, Regulatory Development, Sanofi-Aventis
- Dr David Maggs, Vice President, Medical Affairs, Amylin Pharmaceuticals
- Dr Howard Foyt, Vice President, Clinical Development, Metabasis Therapeutics
- Dr Satish Singh, Expert Clinical Assessor, Medicine & Healthcare products Regulatory Agency (MHRA)
- Dr Richard Palmer, Chief Executive Officer & Research & Development Director, Alizyme
- Dr Nancy Thornberry, Executive Director, Metabolic Disorders, Merck Research Laboratories
- Dr Richard Carr, Senior Director, Novo Nordisk
- Dr Uwe Gudat, Global Brand Medical Director, Dyslipidemia & Diabetes, Novartis
- Dr Alex De Paoli, Director, Global Development, Amgen
- Dr Cristina Rondinone, Director, Research, Metabolic Diseases, Hoffmann-La Roche
- Dr Andrew Swick, Director, Cardiovascular & Metabolic Diseases, Pfizer
Attend this industry specific forum to guarantee you hear international and expert perspectives on:
- THE METABOLIC DISEASES MARKET: Hear discussion on the latest trends, challenges and emerging therapeutics together with a view to addressing current unmet clinical needs
- REGULATORY GUIDELINES AND IMPLICATIONS FOR INDUSTRY: Can new regulatory standards reduce the time and cost of product development? Hear from the UK’s MHRA as they explain what can be expected in a new product application and how to achieve approval
- NEXT GENERATION DRUGS: Explore the current and future targets for treating diabetes and obesity with novel approaches such as RNAi, MCH1R and pathogenic pathways with relevant molecular targets for drug discovery
- TRANSLATIONAL MEDICINE: Understand how best to predict human efficacy based on preclinical data
- ASSESSING CLINICAL DRUG DEVELOPMENT: Listen to the experts as they review key drug developments over the past year with a focus on challenges, limitations and how they can be overcome
- CASE STUDIES: Hear from major industry players as they discuss real clinical data and what it means. Plus choose from two streams focussing on current and future therapies to alleviate diabetes and obesity
- GOING TO MARKET: Follow the progress of Lilly/Amylin’s Byetta - why has this drug become so successful despite not being directly marketed to consumers? Hear from the experts as they discuss how best to launch a drug for major metabolic disease
- THE METABOLIC SYNDROME: Attend our half-day Executive Briefing to understand why the metabolic syndrome is regarded as an unmet therapeutic need and a major commercial opportunity for many pharmaceutical companies
Get Full Details About This Report >>
|
|
US: 800.298.5699
Int'l: +1.240.747.3093
|
|
|
