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Metabolic Disease Drug Discovery Conference: Monday September 21, 2009

Workshop A Registration 8:30 9.00am - 11.30pm Pre-Clinical Model Comparison & Selection for Metabolic Study It is incredibly valuable to develop and use representative animal models to investigate pathophysiologies. It is also important for evaluating potential strategies for treatment and prevention of the disease and related complications. This workshop will delve into model selection, comparison and what models are new in the market. What will be covered: Evaluating the current common models used for studies & evaluations -- Comparing & contrasting models: - Diet-induced obesity (DIO) mice - db/db mice - ob/ob - *Zucker diabetic fat (ZDF) rat - GK rat - Sand rat - Non-human primates -- Identifying common drawbacks - mutation of single gene -- Deciding what model should be used to obtain best results Workshop B Registration 11:45 12:15 - 3.15pm Diabetic Nephropathy Targets and Therapies Advanced diabetic nephropathy is the leading cause of glomerulosclerosis and end-stage renal disease worldwide. Given our better understanding of the pathophysiology of diabetic nephropathy, newer therapies to treat this condition are slowly emerging. This workshop will uncover and review some of the novel approaches to these new drug development pipelines focused on Diabetes. It will also identify some of the most commercially viable pipelines currently in development. What will be covered: -- Demonstrating efficacy of the renin inhibitor, aliskiren, to decrease a marker of nephropathy progression, that is albuminuria -- Displaying how sulodexide, a glycosaminoglycan, works to reduce proteinuria presumably by restoring the already reduced glycoproteins present in the glomerular basement membrane -- Learning new and interesting agents tested in the context of different pathophysiological mechanisms of diabetic nephropathy -- Discussing current therapies proven to slow the progression of diabetic nephropathy include blockade of the renin-angiotensin system (RAS) with either angiotensin-converting enzyme inhibitors or angiotensin receptor blockers -- Summarizing new therapies for slowing the progression of diabetic nephropathy General Sessions Day 1: Tuesday September 22, 2009 7:45 Registration & Coffee 8:15 Chairman"s Welcome & Opening Remarks 8:30 Keynote Presentation: Anti-Obesity Peptides -- Discussing new scientific data in the obesity pipeline -- Showcasing new findings on various preclinical programs, including a new Y-family mimetic and the peptide hybrid (phybrid) platform -- Understanding how this therapeutic research shows promise for reducing the risk of cardiovascular disease associated with obesity and type 2 diabetes Dr. Michael Hanley, Chief Scientific Officer, Amylin Pharmaceuticals, Inc Session I: Large Molecule Anti-diabetic Drug Discovery Chair: Dr. Ming Wang, Scientific Director, Metabolic Disorders Research, Amgen 9:15 Use Of Biologics Targeting Metabolic Diseases -- Providing an overview on the development trends of biologics targeting metabolic diseases -- Improving drug efficacy by increased targeting accuracy -- Conducting toxicology studies to ensure product safety -- Examining the potential hazards and risks associated with biologics targeting metabolic diseases Dr. Ming Wang, Scientific Director, Metabolic Disorders Research, Amgen 10:00 Networking Break 10:30 FGF-21: Examining Current Study and Adapting For Diabetes Treatment -- Discovering novel therapeutic protein with biological properties similar to Fibroblast Growth Factor 21 (FGF-21) for the treatment -- Understanding how the molecules are capable of mimicking the biological properties of the natural protein -- Adapting this promising candidates for the treatment of metabolic disorders such as type 2 diabetes and obesity -- Demonstrating how the C-terminus of FGF21 is critical for binding to нІ-Klotho Bei Shan, Executive Scientific Director, Metabolic Disorders, Amgen 11:15 Discussion: Evolving Regulatory Environment for Metabolic Drug Development -- Updating on the new 5 year cardiovascular study requirement for diabetic drugs -- Sharing the government"s envision of the implementation process -- Increasing efficiency in target selection/development in preclinical stage - early suggestion & guidance on what the FDA is looking for in the clinical stage -- Providing a cross section update on changes for endocrine & metabolic diseases & how they effect drug development Invited: Mary Parks, Director, Division of Metabolism and Endocrinology Products, FDA Dr. Andrew Swick, Director, Cardiovascular & Metabolic Diseases, Pfizer Global R&D 12:00 LUCHEON Session II: Small Molecules Anti-Diabetic Drug Discovery Chari: Dr. Yin Liang, Head of Diabetes Section, Metabolic Disease Team, Drug Discovery, Johnson & Johnson 1:00 New Therapeutic Approaches --- De-Stressing Metabolic Disease -- Examining Cellular stress events and inflammation in metabolic disease -- Discussing the role of endoplasmic reticulum adaptive function and JNK activity in pathophysiology -- Identifying novel approaches to modulate these critical biological events -- Understanding the discovery of small molecule drug candidates Dr. Teo Uysal, President & CEO, Syndexa Pharmaceuticals 1:45 Understanding TGR5 as a Target for Potential Treatment of Metabolic Disorders -- Discussing energy homeostasis and glucose homeostasis -- Examining past roles and understanding of bile acids in paracrine and endocrine regulation -- Knowing the new properties in the bile acid receptor discovery unfolded in the form of TGR5 2:30 Networking Break 3:00 GPR119: Multifaceted Regulation of Glucose Homeostasis by Novel Agonists -- Providing an overview of GPR119 regulation of incretin and insulin release -- Exploring endogenous lipid regulators of GPR119 -- Discussing key aspects of GPR119 agonist development -- Discovering efficacy in chronic rodent models of Type 2 Diabetes Dr. James Leonard, Sr. Director, Metabolic Disorders, Arena Pharmaceuticals, Inc. 3:45 Discovery of PF-04620110: A Selective DGAT-1 Inhibitor for the Treatment of Type-2 Diabetes -- Examining drug design in the context of DGAT-1 chemical landscape/pharmacophore analyses -- Preclinical evaluation DGAT-1 inhibition on diabetic and obesity endpoints in a chronic setting -- Understanding integration of safety derisking strategies in the early lead generation and optimization stages -- Discussing Phase I pharmacokinetic/safety results in the context of preclinical predictions Dr. Robert Dow, Associate Research Fellow, CVMD Chemistry, Pfizer Global Research and Development 4:30 End of Day 1 General Sessions Day 2: Wednesday September 23, 2009 7:45 Registration & Coffee 8:15 Chairman"s Welcome & Opening Remarks Session III: New Strategies in Metabolic Diseases Drug Discovery 8:30 Defining the Inflammation Aspects in Varies Metabolic Processes -- Inflammation issues in Lipid Metabolism -- Discussing the role of inflammation in hypertension -- Identifying methods that results in the resolution of inflammation (mimic of cyclopentenone prostaglandins activities) -- Inflammation"s effect on hypertension, CKD and Diabetics -- Linking inflammation with the future metabolic drug development Dr. Raju Mohan, Director, Exelixis Inc. 9:15 Developing RNAi Therapeutics as a Product Pipeline of Innovative Drugs to Treat Metabolic Diseases -- Utilizing RNAi into a significant product pipeline of innovative drugs -- Understanding how genes are turned on and off in cells -- Discussing the potential and next step in converting the unique method in to specific drug development -- Evaluating the future therapeutic and commercial potential Dr. Sanjay Bhanot, Vice President of Metabolic Diseases Research & Development, Isis Pharmaceuticals 10:00 Networking Break 10:30 Utilizing Unique Discovery Platforms to Develop Drug Candidates for Treating Diabetes -- Discussing the discovery of novel small molecule drugs -- Summarizing different techniques that allows liver-specific delivery of new and existing drugs -- Pros and Cons of using varies discovery platforms Dr. Yin Liang, Head of Diabetes Section, Metabolic Disease Team, Drug Discovery, Johnson & Johnson Session IV: Drug Development in Metabolic Diseases 11:15 SGLT2 Inhibition: A Novel Approach to the Treatment of Type 2 Diabetes -- Discussing the role of glucose reabsorption by SGLT2 in renal physiology and in diabetes -- Presenting data on the pharmacodynamic effects of the SGLT2 inhibitor dapagliflozin -- Presenting data on the safety and efficacy of dapagliflozin in patients with type 2 diabetes -- Discussing SGLT2 inhibition as a potential treatment modality for type 2 diabetes Dr. James F. List, Group Director, Cardiovascular and Metabolics, Bristol-Myers Squibb 12:00 LUNCHEON FOR SPEAKERS & DELEGATES 1:00 Defining and Understanding Obesity - Overcoming the Challenges in its Drug Development -- European and US regulatory requirements for clinical development of obesity treatments -- Benefit/risk hurdles for new obesity agents seeking approval -- Obesity is a chronic disease - Association of comorbidities and obesity and goals for effective treatments -- Role of Obesity agents as treatment for Type 2 diabetes Dr. Wesley W. Day, Vice President, Clinical Development, VIVUS, Inc. 1:45 Drug Cycle Management: Debating on the Implementation of New Study Requirements -- Deciding when and where to start the program -- Discussing the proper steps to start the process - Do you consult the FDA first -- Managing the current drug development process, inserting in the new requirement -- Overcome financial challenges, convincing management, funding raising issues -- Sharing strategies in extending the life cycle of existing drugs (patent strategies) -- Predicting & measuring ROI Dr. Wick Johnson, Senior Director, Worldwide Business Development, Pfizer 2:30 Networking Break Session V: Reaching Out

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