Pharmaceutical Business review

2nd Annual Diabetes and Diabetic Retinopathy

Key Speakers
– Dr. Peter Adamson, Vice President and Head of Research Ophthiris, GlaxoSmithKline
– Dr. Richard Carr, Senior Director, Merck Sharp & Dohme
– Dr. Hans-Jürgen Wörle, Vice President, Therapeutic Area Head Metabolism, Boehringer Ingelheim Pharma GmbH & Co. KG
– Dr. Michael Mark, Vice president, Therapeutic Area CardioMetabolic Diseases Research, Boehringer Ingelheim Pharma GmbH & Co. KG
– Dr. David H Solomon, President, Chief Executive Officer, Zealand pharma A/S
– Dr. Steven Engle, Chairman and CEO, XOMA (US) LLC
– Dr. Rob Jones, Senior Director, Medicinal Chemistry, Arena Pharmaceuticals
– David M. Kendall, Chief Scientific and Medical Officer, American Diabetes Association
– Dr. Araneo Barbara, Director of Complications Research, Juvenile Diabetes Research Foundation
– Dr. Francesco Impagnatiello, Research Manager, Nicox Research Institute
– Dr. Selwyn Ho, Sr.Director, Marketing, Retina, Allergen EAME
– Professor. P.M. Dodson, M.D, FRCP, FRCOphth Consultant, Diabetes & Medical Ophthalmology, Birmingham Heartlands Hospital, Birmingham, UK
– Professor Sue Lightman, Professor of Clinical Ophthalmology and Consultant Ophthalmologist, Institute of Ophthalmology, University College London / Institute of Ophthalmology and Moorfields Eye Hospital
– Alireza Falahati-Nini, M.D, FACE President, Utah Endocrinology Associates Medical Director, St. Mark’s Hospital Diabetes Center
– Simon Taylor MA PhD FRCOphth, NIHR Clinical Lecturer in Ophthalmology, UCL Institute of Ophthalmology

Diabetes is becoming an epidemic and is expected to reach $86.9 billion by 20251; world health organisation predicts that 4.4% of the world population will have diabetes by 2030. Of the 246 million people with diabetes about third have signs of diabetic retinopathy3 and about third of these might have vision-threatening retinopathy defined as severe retinopathy or macular oedema4.

Research is constantly going on to develop a better understanding of physiologic characteristics of type 1 and type 2. Recognition of the contribution of fasting and postprandial blood glucose levels to overall glycemia, new treatment approaches that focus on achieving tight glycemic control and other therapeutic options that allow the practitioner to develop treatments tailored to meet the individual patient needs are being addressed.

Visiongain’s 2nd Annual Diabetes and Diabetic Retinopathy conference is designed to bring together the industry experts to discuss every aspect of drug development for diabetes, from latest clinical development through to dealing with regulatory issues.

By attending this conference, you will:
– Assess new developments in currently used treatments -Human insulins and analogues,DPP-IV inhibitors, Sulphonylurea and Biguanide, Alpha-Glucosidase Inhibitor, GLP-1 agonist, SGLT inhibitor etc
– Gain insight about the future market trends in insulin, oral anti-diabetic and non insulin injections
– Find new treatments for diabetes
– Overcome challenges in developing novel anti-diabetic therapies
– Evaluate the latest clinical development for diabetic retinopathy
– Effectively target glycaemia and blood pressure levels for prevention of retinopathy development and progression
– Advance role of lipid lowering therapy
– Understand the new medical treatments in diabetic retinopathy -ocular therapy (laser photocoagulation)
– Explore emerging ophthalmic treatments -Anti-VEGF therapy
– Examine the challenges in regulating development & approval of drugs in Diabetes

Who will be there?
Presidents, Chief Executives, Chief Scientific Officers, Chief Operating Officers, Senior Vice Presidents, Vice Presidents, Heads, Senior Directors, Directors, Clinicians, Principal Scientists, Principal Investigators, Managers, Project/Team Leaders in:
– Diabetes & Obesity, Pre-Clinical and Clinical R&D
– Retinal Diseases
– Ophthalmology, Visual Science and Vision Research
– Endocrinology and Metabolic Diseases
– Cardiovascular and Gastrointestinal Diseases
– Anti-Diabetic Agents & Advanced Diabetes Systems
– Drug Development
– Monoclonal Antibodies
– Molecular Neuroscience
– New Products Global Marketing
– Business Development, Licensing & Partnership
– Venture Capital
– Regulatory Affairs

Day 1

Day 1, Monday 7th February 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Perspective on emerging treatments for diabetic retinal disease and the challenges for prevention and treatment
– Overview on diabetes
– JDRF view of clinical unmet need
– Reach out to adolescents and adults
– Screening and prevention
– Sight-sparing treatment
– JDRF view of gaps in research
– Collaboration
– Diagnostics
– Therapies
– Policy and reimbursement
– Education

Dr. Barbara A. Araneo
Scientific Program Director – Complications Therapies
Juvenile Diabetes Research Foundation

10:20 Finding new treatments for diabetes
– DPP4- inhibitors
– SGLT-2 inhibitors

Dr. Michael Mark
Vice president, Therapeutic Area Cardio Metabolic Disease
Boehringer Ingelheim Pharma GmbH & Co. KG

11:00 Morning refreshments

11:20 Examine the challenges in regulating development & approval of drugs in diabetes
– Implication of the new FDA CV guidance, can one still develop gluco-centric compounds?
– What is feasible size of a phase III program in the light of the new requirements?
– What patients should be included and at what stage of the CDP?

Dr. Hans-Jürgen Wörle
Vice President, Therapeutic Area Head Metabolism
C MED Clinical Development & Medical Affairs
Boehringer Ingelheim Pharma GmbH & Co. KG

12:00 GLP-1 – new treatment paradigms in diabetes – The Zealand Pharma Story
– Overview of GLP-1s
– The discovery at Zealand of Lixisenatide and its commercialisation by sanofi-aventis
– New directions of GLP-1s in the treatment of diabetes and related obesity

Dr. David H Solomon
President, Chief Executive Officer
ZEALAND Pharma A/S

12:40 Networking lunch

13:40 GPR119 Agonists for the treatment of Type 2 Diabetes
– Overview of GPR119
– Mechanism of glycemic control
– Clinical status

Dr Rob Jones
Senior Director, Medicinal Chemistry
Arena Pharmaceuticals

14:20 DPP-4 Inhibitors updates

Dr. Richard Carr
Senior Director
Merck Sharp & Dohme

15:00 Afternoon Refreshments

15:20 Treatment targets in diabetes: where do we stand following ACCORD?
– Review the history of studies in intensive glycemic control (from UGDP to ACCORD) and discuss the impact of these interventions on microvascular complications in diabetes
– Discuss the relative impact of early vs late intervention and its impact on microvascular complications risk
– Outline the findings of more recently published studies of more intensive glycemic control (ACCORD, ADVANCE and VADT) as relates to retinal complications of diabetes
– Review the risk-benefit of more intensive treatment strategies as relates to diabetes intervention
– Discuss current treatment targets for glucose, lipids and blood pressure following completion of the ACCORD trial

David M. Kendall, MD
Chief Scientific and Medical Officer
American Diabetes Association

16:00 Review of current and emerging – DPP-4 Inhibitors and GLP-1 Analogs
– Review of the Physiology of Incretins (GLP-1 and GIP) as well as DPP-4 Inhibitors
– Review of current and emerging drugs from the GLP-1 and DPP-4 Inhibitor classes
– Review of current evidence for "Beta-Cell Preservation" in animals (and Humans?)
– Review of current evidence of positive effect of these two classes on cardiovascular health
– Review of long-term data (5-year +) on sustainability of diabetes management with these two new classes
– Potential Adverse effects and why?

Alireza Falahati-Nini, M.D., FACE
President, Utah Endocrinology Associates
Medical Director, St. Mark’s Hospital Diabetes Center

16:40 Closing remarks from the chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day 2, Tuesday 8th February 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

Professor Sue Lightman
Professor of Clinical Ophthalmology
UCL/Institute of Ophthalmology and Moorfields Eye Hospital

09:40 Role of lipid lowering therapy in diabetes retinopathy
– How do lipids influence eye disease?
– Relationship of lipids and diabetic retinopathy
– Potential mechanisms of retinal damage by lipids
– Treatment of retinopathy with lipid lowering drugs: statins and fibrates
– CARDS,FIELD,ACCORD-EYE Studies
– Conclusion

PROFESSOR. P.M. DODSON, MD, FRCP, FRCOphth
Consultant, Diabetes & Medical Ophthalmology, Departments of Diabetes, Ophthalmology, & Heart of England Diabetic Retinopathy Screening Centre
Birmingham Heartlands Hospital, Birmingham, UK

10:20 Nitric oxide-donating glucocorticoids for effective and safe treatment of diabetic macular edema
– Targeting nitric oxide (NO) for the treatment of eye diseases
– Nitric oxide and IOP lowering
– Nitric oxide and oxygen saturation of the retina and ONH
– Potential of NO-donating glucocorticoids

Dr. Francesco Impagnatiello
Research Manager
Nicox Research Institute

11:00 Morning refreshments

11:20 Pazopanib eye drops in mouse models of diabetic eye disease
– Pazopanib is a multi-spectral tryrosine kinase inhibitor
– Pazopanib eye drops are in PhIIb development for neovascular AMD
– Will discuss efficacy of pazopanib in models of vascular leak and retinal neovascularisation

Dr. Peter Adamson
Vice President and Head of Research Ophthiris
GlaxoSmithKline

12:00 Emerging ophthalmic therapies: Glucocorticoids and the role of drug delivery systems in the management of diabetic macular edema.
– The pathophysiology of diabetic macular edema (DME) has a clear inflammatory component
– Glucocorticoids have been a key part of the armamentarium for the management of DME, both in monotherapy and in combination with other modalities
– Differences in the glucocorticoid molecular structure, routes of administration and pharmacokinetic profiles may result in clinically relevant differences
– In a long-term, chronic disease such as DME, Glucocorticoids in long duration drug delivery systems may play a role in reducing the burden of drug administration to patients, physicians and health care systems

Dr. Selwyn Ho
Sr. Director, Marketing, Retina
Allergen EAME

12:40 Networking lunch

13:40 Emerging ophthalmic treatments – Anti-VEGF therapy
– Rationale for anti-VEGF agents in diabetic macular edema
– Types of anti-VEGF agents in use
– Results of the main clinical studies./ trials
– Comparison with other treatment modalities
– Their use in clinical practise

Professor Sue Lightman
Professor of Clinical Ophthalmology
UCL/Institute of Ophthalmology and Moorfields Eye Hospital

14:20 Emerging medical treatments – Ocular therapy
– Advances in laser for proliferative disease
– Advances in laser for diabetic macular oedema
– Where are we now? – results of the clinical trials
– Role of vitreoretinal surgery

Simon Taylor MA PhD FRCOphth
NIHR Clinical Lecturer in Ophthalmology
UCL Institute of Ophthalmology

15:00 Afternoon refreshments

15:20 Diabetes drug delivery and diagnostics – towards the non-invasive revolution
– Alternative routes of insulin delivery
– Recent approaches in insulin delivery
– Targeting type 2 diabetes with non-invasive insulin

16:00 New approaches in GLP-1 delivery systems
– A new delivery system as a feasible approach to achieve sustained GLP-1 release
– Intravenous or subcutaneous injection, a non-injectable alternative for activating GLP-1 receptor signaling

16:40 Chair’s closing remarks

16:50 End of conference