www.diabetes-conference.com Register online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Riccardo PerfettiVice President Global Medical Affairs,Diabetes DivisionSanofi-Aventis

James F. ListVice President, Full DevelopmentBristol-Myers Squibb

Martin SimánDirector, Design and InterpretationCentre of ExcellenceAstraZeneca

Stuart PocockProfessor of Medical Statistics, London School of Hygiene & Tropical Medicine

Arne RingHead of the Statistics and ModellingGroup, Diabetes Trials UnitUniversity of Oxford

Hans-Jürgen WörleVice President & Therapeutic Area HeadMetabolism, Clinical Development andMedical AffairsBoehringer-Ingelheim

Phil AmberyMedical Director, Cardiovascular and Metabolic R&DGlaxoSmithKline

Sandra SouzaTeam LeadMerck & Co.

Jamie DwyerCo-Director, Nephrology Clinical Trials CenterVanderbilt University Medical Center

Bruce L. RiserDirector, Pharmaceuticals andSolutions, Medical Products Division, Baxter Healthcare

John WildingHead , Department of Obesity and EndocrinologyUniversity of Liverpool

Frederick TamReader in Renal MedicineImperial College London

KEY SPEAKERS INCLUDE:

KEY REASONS TO ATTEND:• Receive updates on novel GLP1 receptor agonists, SGLT2 and DPP-4

inhibitors • Review clinical results from the DEMAND study • Utilise biomarkers and imaging for the development of novel

cardiovascular and renal therapies• Evaluate new targets to reduce hypertension and endothelial

inflammation• Ensure compliance with new FDA and EU guidelines when conducting

risk-benefit assessments

Cardio-renal risk in type 2 diabetes information from clinical trials:what we have, what do we need to know?

Workshop leader: Luigi Gnudi, Professor of Diabetes and Metabolic Medicine, Honorary Consultant in Diabetes and Endocrinology,Head, Unit for Metabolic Medicine, Cardiovascular Division, King’s College London

1.30pm-5.30pm

REGISTER BY 6TH JULY AND RECEIVE £300 DISCOUNTREGISTER BY 28TH SEPTEMBER AND RECEIVE £100 DISCOUNT

SMi present their...

Diabetes, Cardiovascular & Renal ComplicationsWednesday 28th & Thursday 29th November 2012Copthorne Tara Hotel, London

PLUS ONE INTERACTIVE PRE–CONFERENCE WORKSHOPTuesday 27th November 2012, The Copthorne Tara Hotel, London

Register online at www.diabetes-conference.com • Alternatively f

Diabetes, Cardiovascular & Renal Complications Day One | Wednesday 28th November 2012 www.diabetes-c

8.30 Registration and Coffee

9.00 Chairman’s Opening RemarksMorning Chairman: Martin Simán, Director, Design and InterpretationCentre of Excellence, AstraZeneca Afternoon Chairman: Luigi Gnudi, Head, Unit for Metabolic Medicine,Cardiovascular Division, King's College London

Cardiovascular Targets, Clinical Trials & Regulatory Guidelines

KEYNOTE ADDRESS9.10 Therapeutic targets to reduce cardiovascular disease in type 2

diabetes• Links between diabetes and CVD• Novel diabetes drugs and CVD• Future directionsPhil Ambery, Medical Director, Cardiovascular and Metabolic R&D,GlaxoSmithKline

9.50 Cardiovascular outcome trials in diabetes- where are we heading?• The Rosiglitazone story and the RECORD trial• The ACCORD and ADVANCE studies• FDA guidance for industry• The LEADER, TECOS and EXSCEL trials • Meta-analyses: good and badStuart Pocock, Professor of Medical Statistics, London School ofHygeine and Tropical Medicine

10.30 Morning Coffee

10.50 Cardiovascular risk: shifting regulatory perspectives• FDA's response to Vioxx• FDA's response to Glitazones• FDA's response to obesity drugs• Litigation and risk >2• EU regulatory position• Implications of cardiovascular safety threshold for efficacy

assessmentJohn Warren, Director, Medicines Assessment

11.30 Legal liability of inadequately defined risk• Risk/benefit assessments: clinical prognostic risk, socio-economic

and environmental risks, consumer protection, intellectual property,commercial risks and risk of criminal sanctions

• Risk/benefit profile: current international legislation and regulatoryobjectives for medicinal products

• Examples of regulatory failure: Vioxx, Seroxat, the glitazones andTGN1412

Peter Feldschreiber, Barrister, Four New Square

12.10 Networking Lunch

Diabetic Nephropathy & SGLT2 Inhibitors

1.30 The kidney as a target for diabetes treatment: from concept toclinical reality• Normal renal glucose transport• Does altered renal glucose transport contribute to hyperglycaemia

in diabetes?• Blocking renal glucose transport – theoretical considerations• SGLT2 inhibitors as treatment for diabetes: benefits and risksJohn Wilding, Professor of Medicine & Honorary ConsultantPhysician, Head of Department of Obesity and Endocrinology,University of Liverpool

2.10 Long-term efficacy of Dapagliflozin in patients with type 2 diabetesmellitus receiving high doses of insulin• The mechanism: inhibition of renal glucose re-uptake• The concept: glycaemic control through urinary glucose excretion• The therapeutic potential in the treatment of diabetes: benefits

and risksJames F. List, Vice President, Full Development, Bristol-Myers Squibb

GLP-1 Agonists

2.50 From the biology of GLP-1 receptor agonists to their use in thetreatment of type 2 diabetes: the development of lixisenatide• Basal insulin and GLP-1 mimetics: complimentary therapies for

type two diabetes• Scientific rationale for near-physiological use of GLP-1• Clinical Evidence on safety and efficacy of combing basal insulin

with GLP-1Riccardo Perfetti, Vice President Global Medical Affairs, DiabetesDivision, Sanofi-Aventis

3.30 Afternoon Tea

3.50 Efficacy and safety of Linagliptin in phase IIIa and IIIb programs andin various sub-populations• Glycemic efficacy and safety assessment across various

sub-populations• Assessment of macrovascular safety• Assessment of microvascular outcomesHans-Jürgen Wörle, Vice President & Therapeutic Area HeadMetabolism, Clinical Development and Medical Affairs, BoehringerIngelheim

Panel Discussion

4.30 Assessing endpoints for diabetic cardiovascular and renalcomplications- where are we and what are the prospects for thefuture?Topics will include assessing therapeutic interventions for vascularcomplications and attenuating the progression of hyperglycaemia,dyslipidaemia and angiopathy. How will new EMA and FDA guidelines impactclinical research and trial design? Improving study end-points in trial designand incorporating longitudinal data will also be discussed.The panel will comprise a selection of the day’s speakers.Chair: Arne Ring, Head of the Statistics and Modelling Group,Diabetes Trials Unit, University of OxfordPanellists: Riccardo Perfetti, Vice President Global Medical Affairs,Diabetes Division, Sanofi-AventisJames F. List, Vice President, Full Development, Bristol-Myers SquibbPhil Ambery, Medical Director, Cardiovascular and Metabolic R&D,GlaxoSmithKlineJohn Warren, Director, Medicines Assessment

5.10 Chairman's closing remarks and end of day one

Want to know how youcan get involved?

Interested in promoting yourpharmaceutical services to

this market?Contact Kellee Halliburton,

SMi Marketing on +44 20 7827 6194 or email

khalliburton@smi-online.co.uk

• Diabetes & Obesity, Clinical R&D• Endocrinology and Metabolic Diseases• Cardiology and Cardiovascular Diseases• Nephrology and Kidney Diseases• Anti-Diabetic Agents & Advanced Diabetes Systems• Biomarkers and Imaging• Imaging and Translational Medicine

Who should attend:Chief Executive Officers, Chief Scientific Officers, Presidents, Vice Presidents, Professors, Heads, Directors,Clinicians, Principal Scientists, Principal Investigators, Managers, Project/Team Leaders in:

• Drug Development• Insulin Analogues• Molecular Medicine • Medical Statistics, Biostatistics and Statistical Methodology• Clinical Trials and Regulatory Affairs• Business Development, Licensing & Partnership• New Products Global Marketing

fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Day Two | Thursday 29th November 2012conference.com

8.30 Re-registration and Coffee

9.00 Chairman's Opening RemarksJohn Wilding, Professor of Medicine & Honorary ConsultantPhysician, Head of Department of Obesity and Endocrinology, University of Liverpool

Targets for Inflammation, Hyperkaleamia and Atherosclerosis

OPENING ADDRESS9.10 Inflammatory cytokines, profibrotic growth factor biomarkers and

therapeutic targets in diabetic nephropathy & obesity-relatedglomerulopathy • Diabetic nephropathy is the most common cause of renal failure • Obesity is an import cause of chronic kidney disease• Recent lession form patients treated with bariatric surgery• Urinary cytokines and pro-fibrotic growth factors are non-invasivebiomarkers for progression of renal diseasesFrederick Tam, Reader in Renal Medicine, Imperial College Kidney and Transplant Institute, Imperial College London

9.50 CCN3: a novel anti-fibrotic agent with particular application to theprevention and treatment of diabetic renal disease• CCN2 as pro-fibrotic matricellular cytokine and validated target in

diabetic nephropathy• Discovery of CCN3 as an endogenous anti-fibrotic protein in

mesangial cells in vitro• Validation of CCN3 in animal models as a potential therapy Bruce L. Riser, Director, Pharmaceuticals and Solutions, MedicalProducts Division, Baxter Healthcare and Professor of Physiology andBiophysics / Medicine, Rosalind Franklin University of Science andMedicine

10.30 Morning Coffee

10.50 Leukocyte recruitment in vascular inflammation• Principles of leukocyte capture and migration from the endothelial

perspective• Potential role for leukostasis in diabetic retinopathy• Vascular dropout and angiogenesis in diabetic retinopathy• Identification of therapeutic targetsJohn Greenwood, Hugh Davson Professor of Biomedical Research andHead of the Department of Cell Biology, University College London

11.30 Control of hyperkalemia to extend the benefits of aldosteroneblockade in diabetic nephropathy and heart failure• The renin-angiotensin-aldosterone system (RAAS) is implicated in the

progression of heart failure, renal disease, and diabetic nephropathy• RAAS inhibition represents the cornerstone of therapy that serves to

preserve renal function and delay disease progression• Despite demonstrated cardio- and renoprotective outcomes in RAAS

blockade studies, hyperkalemia associated with RAAS therapy oftenprevents optimum use of the drugs

• The novel, high-capacity potassium binding polymer, RLY5016, hasbeen developed to prevent and treat hyperkalemia in heart failure anddiabetic nephropathy patients, particularly in patients receiving longterm RAAS therapy

Jerry Buysse, Chief Scientific Officer and SVP, Research, Relypsa

12.10 Networking Lunch

1.30 Treatment of diabetic dyslipidemia

• Dyslipidemia as a leading factor in the formation of atherosclerosis

• Diabetics in particular have additional risks and therapeutic needs for

lipid modifiers

• Impact of lowering of LDL cholesterol, triglycerides and Lp(a)

• 3196: a liver-directed thyroid hormone receptor-beta agonist for the

treatment of hypercholesterolemia

Rebecca Taub, Chief Executive Officer, Madrigal Pharmaceuticals

Trial Design and Translational Medicine

2.10 The changing spectrum of diabetic nephropathy: minimal

albuminuria, background therapies, and implications for trial design

• Understand the classical and "new" paradigm of diabetic nephropathy

• Describe the patients who do not have significant albuminuria with

advanced CKD in diabetes

• Recognize the implications of background therapy on trial design in

diabetic nephropathy

Jamie P. Dwyer, Co-Director, Nephrology Clinical Trials Center,

Nephrology and Hypertension, Vanderbilt University Medical Center

2. 50 An integrated “omics” approach to discover and validate FGF21 target

engagement biomarkers

• Phosphoproteomic profiling of cultured adipocytes

• Transcriptomic profiling of mouse adipose tissue; identification of

RNA transcripts and secreted proteins

• In vivo validation of proposed target engagement biomarkers

Sandra Souza, Team Lead, Merck & Co.

3.30 Afternoon Tea

3.50 Lipotoxicity in type 2 diabetes

• Why does fat accumulate in cardiac muscle?

• The association between cardiac steatosis and cardiomypoathy in type

two diabetes

• Mechanistic effects of lipoapoptosis

Vera Schrauwen-Hinderling, Postdoctoral Researcher, University of

Maastricht

4.30 Chairman’s Closing Remarks and Close of Day Two

Supported by SPONSORSHIP AND EXHIBITIONOPPORTUNITIES

SMi offer sponsorship, exhibition, advertising andbranding packages, uniquely tailored tocomplement your company’s marketing strategy.Prime networking opportunities exist to entertain,enhance and expand your client base within thecontext of an independent discussion specific toyour industry. Should you wish to join theincreasing number of companies benefiting fromsponsoring our conferences please call:Alia Malick on +44 (0) 20 7827 6168 or email:amalick@smi-online.co.uk

HALF-DAY PRE-CONFERENCE PM WORKSHOP

1.30pm – 5.30pmTuesday 27th November 2012Copthorne Tara Hotel, London

A: Cardio-renal risk in type 2 diabetesinformation from clinical trials:

what we have, what do we need to know? Workshop Leader:

Luigi Gnudi,Professor of Diabetes and Metabolic Medicine, HonoraryConsultant in Diabetes and Endocrinology, Head, Unit for

Metabolic Medicine, Cardiovascular Division, King’s College London

In association with

Overview of workshopThe workshop will cover aspects of the pathophysiology ofcardiorenal risk in patients with type 2 diabetes, which willsubsequently put treatment choices into context. Further lessonfrom recent clinical trials will be discussed in relation to patients’treatment and adjustment to “personalised therapy”. Simplebiomarkers and surrogate markers of disease will also becovered in relation to cardiorenal disease in diabetes.

What attendees can expect to gain from the workshop:• Insights into the pathophysiology of cardiorenal disease in

diabetes and targets for treatment, with a focus onpersonalised therapy

• An analysis of whether current clinical trials address theright questions in cardiorenal disease and what more can berealistically achieved.

• An evaluation of surrogate markers and biomarkers inclinical trials for cardiorenal risk in diabetes.

Programme1.30 Registration and Coffee

2.00 An introduction to cardiorenal disease in diabetes• The relationship between cardiovascular disease

and nephropathy in diabetes• Glomerular injury initiated by metabolic and

haemodynamic insults• Pathways involved in the pathogenesis of

diabetic glomerulopathy• Clinical insights from translational medicine

3.00 Afternoon tea

3.20 Joint group discussion (disease treatmenttargets - personalised treatment)

4.20 Coffee break

4.40 Joint group discussion (answers from clinicaltrials – surrogate markers)

5.30 End of workshop and private consultations withattendees

About the workshop hostLuigi Gnudi obtained his MD with Honours fromthe University of Parma (Italy) in 1988. Hesubsequently worked at the University of Padua-Italy (1989-1993) and Harvard Medical School(1993-1995). In 1998 he obtained a PhD inEndocrinological Sciences from the University ofMilan. He became a Fellow of both the RoyalCollege of Physicians and the American Society

of Nephrology in 2005. Dr Gnudi joined the Unit for MetabolicMedicine (within the Department of Diabetes, Endocrinologyand Internal Medicine) at King’s College London in 1997 asSenior Lecturer and was promoted to Professor of Diabetes andMetabolic Medicine in 2011. He became Head of the Unit forMetabolic Medicine in 2010. Prof Gnudi is subject editor forNephrology Dialysis and Transplantation, Metabolism, and theJournal of the American Society of Hypertension.

About King’s College London: King’s College London's School of Medicine is one of the UK'smost established and successful centres for medical researchand teaching. Located at three central London hospitalcampuses - Guy’s Hospital in London Bridge, St Thomas’Hospital near Waterloo and King’s College Hospital in SouthLondon - our research portfolio is closely aligned to our NHSpartners. The School delivers a comprehensive education andtraining portfolio, from undergraduate programmes in medicineand for allied health professions, to professional graduatetraining and research. As part of a multi-faculty institution, ourstudents benefit from some unique study options encompassingthe humanities, social and natural sciences.

SMi's PharmaceuticalForward Planner 2012

Diabetes, Cardiovascular& Renal Complications

JUNE

11-12 RNAi & Nanotechnology

JULY

2-3 KOL Management and MSL Best Practice inEurope (Switzerland)

9-10 ADMET 9-10 Social Media in the Pharmaceutical Industry 11-12 BioBanking

SEPTEMBER

17-18 Next Generation Sequencing19-20 Cancer Vaccines24-25 Biosimilars and Biobetters26-27 KOL Management

OCTOBER

3-4 Partnerships with CROs8-9 Pharmaceutical Orphan Drugs22-23 COPD: Novel Therapeuticsand

Management Strategies24-25 Point of Care Diagnostics - Market

Opportunities and Technology Trends29-30 European Pharmaceutical Pricing &

Reimbursement

NOVEMBER

5-6 Cell Based Assays5-6 Clinical Trials in CNS28-29 Diabetes

DECEMBER

3-4 Cold Chain Distribution

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DIABETES, CARDIOVASCULAR & RENAL COMPLICATIONS Conference: Wednesday 28th & Thursday 29th Novemberber 2012, Copthorne Tara Hotel, London, UK Workshop: Tuesday 27th November 2012, London, UK

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