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WEDNESDAY, NOVEMBER 4
7:30 am Continental Breakfast Breakout Discussions
Attendees will join a table with their peers and a moderator to discuss some of the more important questions facing the industry. It is an informal yet informative way for attendees to learn from each other and make some new contacts. To get the most out of this interactive session, please come prepared to: share examples from your work, vet some ideas with your peers and most importantly, enjoy talking with your colleagues working in the diabetes field.
Table 1: Novel Intervention Points to Achieve Cardio-metabolic Benefit in T2D
Moderator:
Reid Huber, Ph.D., Executive Director, Metabolic Endocrine Drug Development, Incyte Corporation
Insulin sensitization: opportunities for novel agents
Inflammation: optimal approaches for intervention
Free fatty acids: strategies to achieve multi-organ benefit
Table 2: Success and Failures in Obesity Drug Discovery and Development
Moderator:
Rebecca A. Taub, M.D., Senior Vice President, Research & Development, VIA Pharmaceuticals
Obesity agents: achieving the 10% goal long term- what’s in the pipeline?
Weight loss drugs: primary benefit in diabetes and cardiovascular disease prevention
Safety issues: what level of risk is acceptable?
Table 3: Novel Approaches to Incretin Mimetic Delivery
Moderator:
Michael E. Trautmann, M.D., Medical Fellow, Global Exenatide Team, Eli Lilly and Company
Differences between oral agents (DPP IV inhibitors) and injectable GLP-1 receptor agonists
Optimizing the stimulation of GLP-1 receptors and potential limitations: Conclusions from FDA Advisory Hearing
New approaches using GI hormone and their receptors
Table 4: Comabting Diabetes with Strategies for Enhanced Pancreatic Beta Cell Survival and Regeneration
Moderator:
Fumihiko Urano, M.D., Ph.D., Associate Professor of Molecular Medicine, University of Massachussetts Medical School
8:35 Chairperson’s Remarks
Andrew Swick, Ph.D., Senior Consultant, Illuminate BioPharma Consulting LLC
8:40 Development of the First FDA-approved Dopamine Agonist for the Treatment of Type 2 Diabetes
Anthony H. Cincotta, Ph.D., President and Chief Scientific Officer, VeroScience
Cycloset is a unique, quick release formulation of bromocriptine, a sympatholytic dopamine D2 receptor agonist. Using this agent to treat type 2 diabetes evolved from basic science investigations of animals in the wild that exhibit marked annual cycles of metabolism, including insulin sensitivity. We found that cycloset can be added to a variety of non-dopamine agonists, peripheral acting anti-diabetes agents to provide added glycemic control benefit. Moreover, Cycloset was not associated with adverse cardiovascular event rates relative to placebo. This talk covers the R&D program of Cycloset from concept to FDA approval.
9:10 Is my Lead Diabetes Candidate “Developable” – Focusing on Biopharmaceutical and Formulation Issues from the Start
Akash Jain, Ph.D., Principal Scientist, Chemical & Pharmaceutical Profiling, Novartis Institutes for Biomedical Research
This presentation focuses on developability assessment of new drug candidates for diabetes and related CV and metabolic diseases. Time and material saving approaches for rapid selection of optimal physical form and formulation strategy for first-in-human studies will be highlighted. Application of a formulation risk assessment tool to early lead candidates for identifying solubility and exposure related development risks will be discussed. Early selection of suitable clinical and toxicology formulation principles for new diabetes candidates with sub-optimal physicochemical properties will be demonstrated using few case studies.
9:40 Update on Next Generation Incretin-Based Therapies
Michael Trautmann, M.D., Medical Fellow, Global Exenatide Team, Eli Lilly and Company
Studies with the incretin hormone GLP-1 have elucidated the therapeutic potential for augmenting GLP-1 receptor activity and improving glucose control in patients with Type 2 Diabetes. DDP-IV inhibitors increase GLP-1 levels roughly twofold by inhibiting the breakdown of endogenous GLP-1 while peptide therapeutics binding to the GLP-1 receptor directly mimic even higher levels of GLP-1. The different modes of action of GLP-1 including glucose-dependent insulin stimulation and suppression of glucagon result in significant HbA1c reductions without weight gain. In addition GLP-1 receptor agonists delay gastric emptying and decrease appetite resulting in significant weight loss.
10:10 Networking Coffee Break in the Exhibit Hall
10:55 KEYNOTE PRESENTATION
Cardiovascular Outcome Studies of Diabetes Drugs
Steven E. Nissen, M.D., M.A.C.C., Chairman, Department of Cardiovascular Medicine, Cleveland Clinic Foundation
Although oral anti-diabetic agents have been available for more than 50 years, no adequately-powered comparative effective cardiovascular outcome trials exist for this group of drugs. This deficit in information stems from a misguided focus on the biochemical effects of these drugs, particularly the extent of lowering of HbA1c, rather than important health outcomes. Recent regulatory changes seek to close this gap. The current state of knowledge and rationale for this regulatory change will be the focus of this presentation.
11:40 PANEL SESSION: Clinical Landscape for New Diabetes Drug Candidates
Moderator: Steven Nissen, M.D., M.A.C.C., Chairman, Department of Cardiovascular Medicine, Cleveland Clinic Foundation
What will the standard diabetes regimen of the future look like? Which combinations are likely to have best safety profile, efficacy and ease of use?
Glucose lowering -- should that be the main goal of therapies? What are other possible end points?
CV toxicity -- where to draw the line?
Incretin based therapies and their CV profile -- are there better options?
Panelists:
Michael Trautmann, M.D., Medical Fellow, Global Exenatide Team, Eli Lilly and Company
Jorge Plutzky, M.D., Assistant Professor of Medicine, Harvard Medical School; Director, Vascular Disease Prevention Program, Brigham and Women’s Hospital
Rebecca A. Taub, M.D., Senior Vice President, Research & Development, VIA Pharmaceuticals
12:25 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:55 Chairperson’s Remarks
Rebecca A. Taub, M.D., Senior Vice President, Research and Development, VIA Pharmaceuticals
2:00 DB959: A Novel, Dual PPAR delta/gamma Agonist for the Treatment of Type 2 Diabetes
Mary Kay Delmedico, Ph.D., Project Leader, Dara Biosciences
An important class of drugs for the treatment of T2D includes drugs which target peroxisome proliferator-activated receptors, known as PPARs. DB959 is a non-TZD dual agonist of PPAR-delta and -gamma subtypes, and is the first compound in development with this subtype profile. In March 2009, the United States Food and Drug Administration cleared the Investigational New Drug Application to begin Phase 1 trials for DB959. We will present an overview of the favorable nonclinical pharmacology, toxicology, and safety studies and provide an update on clinical plans.
2:30 ARRY-403: A Glucokinase Activator with Excellent Efficacy in Multiple Models of Type 2 Diabetes
Thomas D. Aicher, Ph.D., Principal Research Investigator, Medicinal Chemistry, Array BioPharma, Inc.
ARRY-403 is a small molecule, glucokinase activator (GKA) that entered clinical trials in April, 2009. Supporting preclinical data, including its selectivity and excellent oral bioavailability in multiple animal species will be presented. In several, well-established in vivo models of Type 2 diabetes, ARRY-403 was highly efficacious in controlling both fasting and non-fasting blood glucose and demonstrated less potential for hypoglycemia than known competitor GKAs. In combination with standard-of-care drugs, ARRY-403 provided additional benefit of controlling glucose with no adverse consequence on serum lipid homeostasi
3:00 Networking Ice Cream Refreshment Break in Exhibit Hall (Last Chance for Viewing)
3:40 Targeting Sodium-Glucose Co-transporter 2: Knockout and Pharmacology program of LX4211
Melanie K. Shadoan, Ph.D., Senior Scientist, Metabolism and Cardiology, Lexicon Pharmaceuticals, Inc.
LX4211, an oral small molecule inhibitor of SGLT2 intended to treat type 2 diabetes, is currently in early-stage clinical trials. SGLT2 was identified from our analysis of nearly 5,000 druggable mammalian genes, using mouse gene knockout (KO) technologies. SGLT2 KO mice excreted large amounts of urinary glucose and were among the most glucose tolerant of our KO lines. In preclinical studies, LX4211-treated diabetic mice showed increased urinary glucose excretion, lower HbA1c levels and improved glucose tolerance. Normal rats and dogs receiving LX4211 also showed high urinary glucose and reduced body weight gain despite higher caloric intake.
4:10 A Diabetes Clinical Candidate Against a New Target: Soluble Epoxide Hydrolase
D. Euan MacIntyre, Ph.D., Senior Vice President, Drug Discovery, Arete Therapeutics
4:40 Clinical Results on a 2nd Generation FBPase Inhibitor (MB07803) for the Treatment of Type 2 Diabetes
Barry Gumbiner, M.D., Vice President, Clinical Development & Chief Medical Officer, Metabasis
MB07803 is a novel investigational drug that inhibits fructose 1,6 bisphosphatase, a key enzyme regulating hepatic glucose production. Recent clinical trial data will be presented demonstrating that in patients with well-established and poorly-controlled type 2 diabetes, treatment with MB07803 monotherapy results in rapid and pronounced fasting and postprandial glucose-lowering. Additional data describing the drug’s tolerability and safety profile will be presented, including data suggesting that MB07803 may exhibit reduced effects on lactate metabolism and acid-base balance compared to the first generation compound.
5:10 Close of Conference
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