“A very interesting programme”
Dr Martin Trang, Vice President & Head, Business Unit Hormone Therapy & Urology, Orion Pharma

Discover the latest research and developments at SMi’s Conference…
Osteoporosis and Menopausal Disorders
19th & 20th May 2003, The Hatton, London

A unique opportunity to learn from leading industry experts including:

 Dr Sanjay Kumar, Director, GlaxoSmithKline
 Dr Robert Spirtas, Chief, Contraception & Reproductive Health Branch, CPR, NICHD, National Institutes of Health
 Dr Donato Agnusdei, Osteoporosis Consultant, Europe & Latin America Eli Lilly
 Dr Ji Li, Research Scientist, Amgen
 Dr John Fox, Senior Scientist, NPS Pharmaceuticals
 Prof Andrea Genazzani, Professor & Chairman, International Society of Gynaecological Endocrinology & University of Pisa
 Dr Eugene McCloskey, Clinical Senior Lecturer, Honorary Consultant, Metabolic Bone Diseases, World’s Health Organisation, Collaborating Centre, Metabolic Bone Diseases & University of Sheffield


Key benefits of attending:

DIAGNOSTICS: focus on early detection of osteoporosis
HRT THERAPIES: learn about potential benefits and dangers related to HRT
ALTERNATIVE STRATEGIES: review novel approaches to the treatment of osteoporosis
BONE FORMING AGENTS: understand the use of parathyroid hormone peptides for the treatment of osteoporosis
EXPERIMENTAL AREAS: gain an insight into combination therapies





















Day One – 19th May 2003

8.30 Registration & Coffee

9.00 Chairperson’s Opening Remarks
Dr Juliet Compston, Reader, Metabolic Bone Disease & Honorary Consultant Physician, University of Cambridge

KEYNOTE ADDRESS
9.10 Introduction to the endocrinology of the menopause and ageing women
 Why is menopause an important issue?
 What is the role of endocrinology?
 Ways of effectively preventing or managing some of the problems that can be associated with the menopause
 How to improve quality of life by preventing the harmful consequences of estrogen hormone deprivation
 Overview of future strategies
Prof Andrea Genazzani, Chairman & Professor, International Society of Gynaecological Endocrinology & University of Pisa


THE MENOPAUSE, BONE TURNOVER AND METASTATIC RISK OF PRIMARY BREAST CANCER
9.40 The role of anti-metastatic potential of bisphosphonates
 The effects of systematic treatment of breast cancer on bone turnover differ in pre-menopausal women and post-menopausal women
 Changes in biochemical markers but not bone mineral density appear to be associates with metastatic risk
 The suppression of bone resorption reduces the risk of bone metastases
 The incidence of visceral metastases of mortality also appear to be reduced
Dr Eugene McCloskey, Clinical Senior Lecturer & Honorary Consultant, Metabolic Bone Diseases, World’s Health Organisation, Collaborating Centre for Metabolic Bone Diseases & University of Sheffield

DIAGNOSTICS
10.20 Diagnostic test for monitoring osteoporosis
 Improving the efficiency of monitoring osteoporosis
 The importance of early detection of osteoporosis
 Improving screening methods and rates of diagnosis
 The difficulties involved in producing diagnostic test, in terms of finance etc
 Lessons learned so far
 Future strategies
Dr Andy Anderson, Managing Director, Crawford Medical


11.00 Morning Coffee

HRT THERAPIES

ESTABLISHMENT OF RESEARCH AGENDA FOR HRT
11.20 Why is HRT still suggested/requested?
 Health risks of E vs E + P
 Outcome of NIH meeting
 New directions in HRT
Dr Robert Spirtas, Chief, Contraceptive & Reproductive Health Branch, CPR, NICHD, National Institutes of Health




HORMONE REPLACEMENT THERAPIES (HRT)
12.00 Established and potential benefits
 Estrogen replacement therapy (ERT)
 Where does progestogen fit into therapy?
 What is the role of estrogen in the prevention/treatment of osteoporosis?
 Androgen therapy
 Additional potential benefits of HRT
Dr John Stevenson, Reader & Honorary Consultant Physician, Imperial College London

12.40 Networking Lunch

PHYTO ESTROGENS: THE OTHER HRT?
2.00 Review of studies with natural estrogens in peri and post menopausal women
 Menopausal symptom relief
 Osteoporosis
 Cardivascular system
 Endometrium and breast tissue
Dr Terttu Haring, Director, Women’s Health, Kendle


COMBINATION THERAPIES
2.40 Pros and cons
 Current combination therapies
 Optimisation and improvements in bone mass and bone strength while minimising side effects
 Clinical trials of combination of therapeutic agents for osteoporosis
 Safety assessment
 Effectiveness of combining therapies for osteoporosis
 Future strategies for combination therapies
Dr Juliet Compston, Reader, Metabolic Bone Disease & Honorary Consultant Physician, University of Cambridge


3.20 DISCUSSION SESSION
Pros and cons of HRT therapies
Led by:
Dr Juliet Compston, Reader, Metabolic Disease & Honorary Consultant Physician, University of Cambridge & Dr Eugene McCloskey, Consultant, Metabolic Bone Diseases, Women’s Health Organisation & University of Sheffield

4.0 Chairperson’s Closing Remarks followed by Afternoon
Tea

Close of Conference
















Day Two - 20th May

8.30 Re-registration & Coffee

9.00 Chairman's Opening Remarks
Prof Andrea Genazzani, Professor & Chairman, International Society of Gynaecological Endocrinology & University of Pisa

MANAGEMENT OF OSTEOPOROSIS AT THE PRIMARY CARE
9.10 Is there a better way of managing osteoporosis?
 Osteoporosis – prevalent but neglected
 Osteoporosis and other chronic diseases
 Physician role in managing osteoporosis
 The primary care dignostic tools
 Conflicts and proposed resolution
 Summary – looking to the future
Dr Irit Yaniv, Vice President, Research & Development, Sunlight Medical


ALTERNATIVE STRATEGIES

NEWER THERAPEUTIC APPROACHES FOR THE TREATMENT OF OSTEOPOROSIS
9.40 New anti-resorptive and anabolic agents
 Existing therapies
 Need for new therapies
 Review of novel anti-resorptives
 Review of novel anabolic agents
 Future possiblities
Dr Sanjay Kumar, Director, GlaxoSmithKline

NOVEL ANTI-RESORPTIVE THERAPY FOR OSTEOPOROSIS AND OTHER OSTEOLYTIC DISEASES
10.20 Targeting the OPG-RANKL-RANK pathway
 Discovery of the signaling pathway
 Functional genomics and target validation
 Therapeutic targeting strategy
 Efficacy in pre-clinical animal models
 Early proof-of-concept human clinical data
Dr Ji Li, Research Scientist, Amgen




11.00 Morning Coffee

INTACT PARATHYROID HORMONE 1-84 AS AN ANABOLIC AGENT IN OSTEOPOROSIS
11.20 Does the whole molecule offer advantages over amino-terminal PTH fragments and analogs?
 Effects of intact PTH in patients with osteoporosis
 Effects of intact PTH on cancellous and cortical bone architecture and strength
 Role of carboxyl-terminal PTH fragments in bone
 Relevance of osteosarcoma
 The potential benefits or adverse consequences of combination (together or sequential) anabolic and antiresorptive therapies
Dr John Fox, Senior Scientist, NPS Pharmaceuticals

BONE FORMING AGENTS: PARATHYROID HORMONE PEPTIDES
12.00 Teriparatide: a new hope for patients with severe osteoporosis
 Teriparatide, from bone cracker to bone builder
 De novo bone formation after Teriparatide treatment
 Effects of Teriparatide on bone architecture
 Anti-fracture efficacy of Teriparatide
 Combining bone forming and anti-resorptive agents
 Future treatment strategies for patients with fractures using Teriparatide
Dr Donato Agnusdei, Osteoporosis Consultant Europe & Latin America, Eli Lilly

12.40 Networking Lunch

OSTEOPOROSIS – STAKEHOLDER INSIGHTS
2.00 Osteoporosis in the US, Japan, Germany, Italy, Spain and the UK
 How do diagnosis and treatment rates vary by gender and disease severity across the major pharmaceutical markets?
 How do treatment trends vary by disease severity and what really are the leading drugs in practice? Will this still be the case in five years’ time? What are the most important factors influencing physicians treatment practices?
 Dominance of the bisphosphonates: how long will Merck’s Fosamax (alendronate) be able to hold onto the market lead? Will P&G/Aventis’ Actonel (risedronate) be its biggest threat, or are there greater dangers in the pipeline?
 Can Lilly’s Evista (raloxifene) oust hormone therapy in the postmenopausal population?
 What impact will Lilly’s Forteo (Teriparatide) have on treatment patterns? What factors are affecting uptake and are physicians willing to prescribe the drug?
 What are the unmet needs in osteoporosis from a physician and patient perspective? What are pharmaceutical companies key strategies for success in this market?
Victoria Williams, Analyst, Datamonitor

VITAMIN D ANALOGS
2.40 2-methylene-19-nor-(20S)-1,25 (OH) 2vitaminD3
 How does vitamin D work?
 Past successes and failures in osteoporosis treatment
 A new class of vitamin D analogs
 Unique effect of 2MD in bone
 Future plans of 2MD in bone
Dr Lori Plum, Director, Research & Development, Deltanoid Pharmaceuticals

3.20 Afternoon Tea

COMMERCIAL ISSUES

IMPACT OF THE WHI-STUDY ON THE HRT MARKET
3.40 An overview
 General recommendations
 Concerns
 Market trends
 Drivers
 Outlook
Martin Trang, Vice President & Head, Business Unit Hormone Therapy & Urology, Orion Pharma


IMPACT OF PRODUCT PRESENTATION ON OSTEOPOROSIS MARKET
4.20 Winning in the osteoporosis market by improving presentation of non-oral therapies
 Product presentation influencing sales
 Development of strategies to maximise user acceptance
 Enchancing presentation of inhalation devices
 Enchancing the presentation of patches
 Enhancing injection devices
Kevin Maynard, Business Development Manager, Imprint Pharmaceuticals

5.00 Chairman's Closing Remarks and Close of Conference