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Draft agenda
Day 1
Tuesday, March 24th 2015
7.30
Registration & Buffet Breakfast in the Exhibition & 1-2-1 Partnering Area
Shared Morning Plenary (shared between Metabolic, Oncology and Autoimmune &
Inflammation Leaders Forums)
A scene-setting analysis of macro trends and drivers impacting novel drug
development at the highest level
9.00
Chair’s introduction
Invited speaker:
Dr Claude Bertrand, Executive Vice President & Chief Scientific Officer, Ipsen
Multiple stakeholder Keynote presentations & panel discussion
How much is too much? Diverse stakeholder perspectives on how drug developers can stay on
the right side of changing cost-value equations over the coming decade
How will reimbursement decision-making continuing to evolve? What will be justifiable in 2020,
2025?
9.10
Analyst’s perspective
Mark Trusheim, Visiting Scientist, MIT Sloan School of Management
9.30
Payer’s perspective
Invited speaker:
Dr Alan Muney, Chief Medical Officer, Cigna
9.50
Big pharma Keynote response
How are we driving innovation and product differentiation across the pipeline to meet
the challenges of tomorrow’s marketplace?
Invited speaker:
Dr John Leonard, Senior Vice President, Global Pharmaceutical Research & Development,
Abbott
10.10
Biopharm perspective
Dr Jerome B. Zeldis, Chief Executive Officer, Celgene Global Health and Chief Medical
Officer, Celgene Corporation
10.30
Presentation reserved
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
1
11.05
Questions for the speakers & roundtable discussion
Speakers of the session plus
Dr Tim Rolph, Vice President, Program Value Enhancement, Pfizer Inc
11.35
Close of session - Morning Coffee in the Exhibition & 1-2-1 Partnering Area
Metabolic Leaders Forum plenary session
Analyzing macro metabolic therapeutic area trends/external drivers and
their impact on novel drug development strategy
12.15
Chair’s introduction
Dr Ming Wang, Vice President, Diabetes Disease Area Leader, Johnson & Johnson
Presentations…
KOL & Pharma industry perspectives: Examining the drivers behind evolving metabolic TA
drug development pipelines
How are recent and imminent changes to T2DM and obesity markets in particular changing the
landscape for key industry players?
12.20
Industry perspective 1
Dr Marcus Schindler, Vice President, Head of CVMD, iMed, AstraZeneca
12.40
Questions & discussion
12.45 The novel class of SGLT2 inhibitors, current knowledge and expectations. Impact on
future developments for the treatment of T2DM
Preclinical and clinical results with SGLT2 inhibitors
CV outcome studies. What, if?
Dr Michael Mark, Vice President CardioMetabolic Diseases Research, Boehringer
Ingelheim Pharma GmbH & Co KG
1.05
Questions & discussion
1.10
Presentation reserved
1.30
Questions & discussion
1.35
Buffet Lunch in the Exhibition & 1-2-1 Partnering Area
2.40
Industry perspective 3
Dr Eckhard Leifke, Global Head of Development, Diabetes Division, Sanofi
3.00
Questions & discussion
3.05
Industry perspective 4
Invited speaker:
Dr Anne Philips, Senior Vice President, Clinical Medical & Regulatory Affairs, Novo Nordisk
3.25
Questions & discussion
3.30
Further questions for the speakers and roundtable discussion
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
2
How to validate new metabolic disease targets in business terms? Insights into how to
define your target product profile - and predict your future label – for products hitting the
market in 5-10 years’ time
4.00
Afternoon Tea in the Exhibition & 1-2-1 Partnering Area
4.40
Chair’s introduction
4.45
Presentations & panel discussion
Comparing and contrasting mechanisms of action of the commercially available
therapeutics interventions for T2DM currently on the market – which ones will come to
the fore?
Can we rank the attributes required for a T2DM drug to be successful, beyond lowering
HbA1c? (Weight loss? CV benefit? Beta cell preservation?)
What will be the impact of biosimilars? Of novel routes of administration? Of
combination therapies?
What innovative deal structures and business development trends can we expect to see
from the major players moving forward, and what will drive them? (Eg. M&A vs.
licensing)
Pre-competitive consortia: What are the next steps /areas of focus for key examples in
the metabolic area?
Panellists:
Dr Tim Rolph, Vice President, Program Value Enhancement, Pfizer Inc
John L. Brooks III, President & Chief Executive Officer, Joslin Diabetes Center
Dr Eckhard Leifke, Global Head of Development, Diabetes Division, Sanofi
Dr Michael Mark, Vice President CardioMetabolic Diseases Research, Boehringer
Ingelheim Pharma GmbH&Co KG
Dr Christoph Pittius, Vice President, Head of Transactions, CVMD iMed (Cardiovascular
& Metabolic), AstraZeneca AB
6.00
Close of day 1, followed by a Cocktail Reception in the Exhibition & 1-2-1 Partnering Area
Day 2
Wednesday, March 25th 2015
7.30
Registration & Buffet Breakfast in the Exhibition & 1-2-1 Partnering Area
Metabolic Leaders Forum plenary session
What is the future for obesity drug development?
9.00
Chair’s introduction
External perspectives
What do payers/physicians want to see from an obesity drug beyond weight loss?
What level of weight loss is acceptable for reimbursement?
How will the reimbursement landscape for obesity change in the near future with new drugs?
Currently approved obesity therapeutics - where do they fall short and what commercialization
hurdles do they face?
9.05
Healthtech Evaluator perspective
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
3
Dr Naomi Aronson, PhD, Executive Director of Clinical Evaluation Innovation & Policy in
the Office of Clinical Affairs, Blue Cross, Blue Shield Association
9.25
Questions & discussion
9.30
Physician’s perspective
Invited speaker:
Dr Susan Mandel, Associate Chief, Division of Endocrinology, Diabetes & Metabolism,
Perelmann School of Medicine, University of Pennsylvania
9.50
Questions & discussion
Industry responses
Current obesity therapeutics in development – what advantages do they offer compared to
approved therapeutics?
What factors hinder the successful development and commercialization of novel obesity
therapeutics - safety, patient acceptance of obesity as disease, reimbursement, patient education,
or others? And how to address them from the industry perspective?
How is patient stratification set to unfold in the obesity space?
9.55
Industry perspective 1
Invited speaker:
Dr Michelle A Baron, Vice President Clinical Research & Chief Medical Officer, Intarcia
Therapeutics
10.15
Questions & discussion
10.20
Industry perspective 2
Invited speaker:
Dr Robert Scott, Vice President, Head of Global Cardiovascular & Metabolic Development,
Amgen Inc
10.40
Questions & discussion
10.45
Short presentations & roundtable discussion
Obesity-related diabetes: How will novel therapeutics, devices and bariatric surgery
approaches alter the metabolic disease landscape as a whole?
Dr Elaine Chiquette, Vice President, Medical Affairs, GI Dynamics
Invited speaker:
Dr Keith Gersin, Chief of Bariatric Surgery, Carolinas Medical Center
11.25
Close of session - Morning Coffee in the Exhibition & 1-2-1 Partnering Area
Metabolic Leaders Forum plenary session
Optimizing T2DM/obesity clinical trial designs and development strategies
12.00
Chair’s introduction
Designing optimal CV outcomes studies (including real-world studies)
How to highlight risk as early as possible?
How is the regulatory landscape around CV and other safety-related outcomes expected to
evolve? Are there alternatives to current clinical/regulatory parameters to alleviate the patient
recruitment burden?
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
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12.05
Presentation 1
Dr Christophe Arbet-Engels, Vice President, Metabolic Clinical Development, BoehringerIngelheim
12.25
Presentation reserved
12.45
Presentation 2
Invited speaker:
Dr Maya Vincent, Global Medical Director, Diabetes, Sanofi
1.05
Questions for the speakers & panel discussion
How are the debates around interim results of CV safety and the adoption of novel
biomarkers set to play out?
1.20
Buffet Lunch in the Exhibition & 1-2-1 Partnering Area
Defining the most significant opportunities for drug developers seeking to
differentiate their metabolic TA pipelines
Focus on complications and comorbidities of T2DM and the metabolic
syndrome
2.30
Chair’s introduction
Clinician’s perspectives combined with industry clinical development case studies:
Analyzing the medical need, R&D pipelines, and evolving marketplaces for a range of
indications
Examining the most recent translational/clinical development strategies, trial designs/endpoint
selection, and data for leading candidates
What progress is being made in identifying biomarkers of early stage disease or for patient
stratification?
2.35
3.35
4.10
NAFLD/NASH
Short presentations & panel discussion
Dr Manu Chakravarthy, Executive Director, Early Development & Discovery Sciences,
Discovery Medicine Leader, Diabetes & Endocrine, Merck & Co, Inc
Invited speakers:
Dr Anthony Muslin, Vice President, Head of Cardiovascular & Fibrosis, Sanofi
Dr Luciano Adorini, Chief Scientific Officer, Intercept Pharmaceuticals
Dr Patrice Rioux, Chief Medical Officer, Raptor Pharma
David Hagerty, Executive Vice President, Clinical Development, Conatus Pharma
Afternoon Tea in the Exhibition & 1-2-1 Partnering Area
Diabetic nephropathy
Dr Cristina Rondinone, Vice President, R&D, Head, Cardiovascular/Metabolic Diseases,
Medimmune
Invited speaker:
Dr Reshma Kewalramani, Nepthrology & Metabolic Therapeutic Area Head, Amgen
Dr Michael Allen, Therapeutic Area Head, Urology & Nephrology, Astellas Pharma
Dr Joseph Bonventre, Professor of Medicines and Health Sciences & Technology, HarvardMIT Health Sciences & Technology
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
5
5.10
Questions for the speakers & panel discussion
5.30
Close of day 2
Day 3
Thursday, March 26th 2015
7.30
Registration & Buffet Breakfast in the Exhibition & 1-2-1 Partnering Area
Metabolic Leaders Forum plenary session
Novel targets, pathways, modalities – what’s coming next in the pipeline?
9.00
Chair’s introduction
Keynote presentations
Where are the novel targets coming from for cardiometabolic diseases, particularly those with
the potential to enable earlier therapeutic intervention?
9.10
Keynote 1
Karin Conde-Knape, PhD, Vice President Cardiovascular & Metabolism, Johnson &
Johnson Medical
9.30
Questions & discussion
9.35
Keynote 2
Invited speaker:
Dr Philip Larsen, Vice President, Global Head of Diabetes Research & Translational
Science, Sanofi
9.55
Questions & discussion
10.00
Short presentations & panel discussion
Assessing progress to date in identifying and understanding different disease
populations and the mechanisms behind variations (eg. of Beta cell dysfunction in prediabetes)
Invited panellists:
Dr Pol Boudes, Chief Medical Officer, CymaBay
11.00
Morning coffee in the Exhibition & 1-2-1 Partnering Area
Case studies: What’s the latest data for novel product candidates in development with varying
modalities/mechanisms of action?
Defining the progress and potential of each one
What specific challenges are they facing and how are translational/clinical development
strategies being adapted as a result?
11.35
Case study 1 – Metabolic surgery (bariatric surgery and devices)
Dr Elaine Chiquette, Vice President, Medical Affairs, GI Dynamics
11.55
Case study 2 - cell therapy
12.15
Case study 3
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
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Invited speaker:
Dr Griffin Rodgers, Director, National Institute of Diabetes & Digestive & Kidney Disease
12.35
Questions for the speakers & closing panel discussion
1.00
Close of the Phacilitate Metabolic Leaders Forum 2015 – Buffet Lunch in the Exhibition
& 1-2-1 Partnering Area
Phacilitate Metabolic Leaders’ Forum 2015, 24th – 26th March, Boston, MA.
Draft Agenda – Strictly Private & Confidential
© Phacilitate Limited, 2014
For more information, please contact David McCall on +44 (0)20 7384 8050; [email protected]
7