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 Oncology, Metabolic 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
Phacilitate Oncology 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
10.30
Presentation reserved
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
Oncology Leaders Forum plenary session
Analyzing macro oncology therapeutic trends/drivers and their impact on
development strategy
12.15
Chair’s introduction
12.20
Keynote: Is the era of incremental improvements in cancer therapy finally over?
If so, what will be the impact on current pharma oncology R&D pipelines?
Will the efficacy bar be raised for regulatory approval?
Where next for the TKI area?
Roy D. Baynes, MD, PhD, Senior Vice President, Global Clinical Development, Merck
Research Laboratories
12.40 Presentations & panel discussion
How will evolving regulations impact development of the next wave of targeted oncology
therapeutics?
How will PDUFA 6 impact oncology drug development stakeholders in general?
Quantifying the impact of the changing regulatory landscape for companion diagnostics
in the US on novel drug development
Panellists
Dr Richard Buller, Vice President & Head of Clinical Development, Pfizer Oncology
Dr Gary Kelloff, Special Advisor, DCTD, CIP, National Cancer Institute (NCI)
Dr Howard Fingert, Senior Medical Director, Business Development & Clinical
Intelligence, Takeda Oncology
Invited panellists:
Dr Tal Zaks, Senior Vice President & Head of Global Oncology Division, Sanofi
Dr Sandra Horning, Global Head of Clinical Development, Oncology Haematology, F
Hoffman-La Roche
1.35
Buffet Lunch in the Exhibition & 1-2-1 Partnering Area
Oncology Leaders Forum plenary session
Immunoncology: Defining next steps in translational and clinical
development
2.40
Chair’s introduction
Dr Jeff Humphrey, President, Chief Medical Officer, Kyowa Hakko Kirin Pharma Inc
2.45
Presentations & panel discussion
How will we go about addressing key outstanding questions for the field around
combinations with checkpoint inhibitors?
Phacilitate Oncology 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
Exploring through case studies the challenges in identifying combinations and designing
optimal dosing sequence/studies for combinations of various therapeutic modalities with
PD-1 and PD-L1 inhibitors
o How do we evaluate the data?
Panellists:
Michael Giordano, MD, Senior Vice President, Head of Development, Oncology BristolMyers Squibb
Dr Rachel Humphrey, Senior Vice President, Immuno-Oncology,
AstraZeneca/Medimmune
Dr Laura Aguilar, Vice President, Clinical Research, Advantagene
4.00
Afternoon Tea in the Exhibition & 1-2-1 Partnering Area
4.40
Presentations & panel discussion
Redesigning the biomarker toolbox for immunoncology agents
Which translational tools and techniques will unlock the ability to predict patient
responses to checkpoint inhibitors, for example? How will we progress trial enrichment
strategies?
Panellist:
Dr Nicholas Dracopoli, Vice President, Oncology Translational Research, Janssen
Research & Development, Johnson & Johnson
Dr Stefan J Scherer, Vice President & Global Head of Correlative Science, Novartis
Pharmaceuticals Corporation
Dr Ian McCaffery, Head Oncology Biomarker Development, Companion Diagnostics,
Genentech
Invited Panelists:
Dr Mark Fidock, Vice President, Head of Personalised Healthcare & Biomarker Labs,
AstraZeneca
Dr Sudhir Srivastava, Chief, Cancer Biomarkers, National Cancer Institute
Anne-Marie Martin, Director for Clinical Biomarkers & Clinical Development, Oncology,
R&D, GlaxoSmithKline
5.30
Roundtable discussion
Immunoncology: The future
What are the key emerging immune checkpoint targets?
How can checkpoint inhibitor biology be applied to other TAs and indications?
What will follow checkpoint inhibitors as the next disruptive immunotherapeutic
technology in the cancer space?
o Is there more to come from the oncolytic virus therapy space, for example?
o Are there other effectors beyond T-cells on which we should focus? What
about T-cell suppression? NK-cell based immunotherapy? Myeloid
suppressor activity? Drugs that inhibit epigenetic markers?
CAR T-cells: Can/will they fly commercially?
Panellists:
Dr Claudio Carini, Global Head Clinical Immunology & Biomarkers, WRD, Pfizer inc
Dr Llew Keltner, Chief Executive Officer, Epistat
J. Joseph Melenhorst, PhD, Director, Product Development & Correlative Sciences
Laboratories, Translational Research Program, Department of Pathology and Laboratory
Medicine, University of Pennsylvania
6.00
Close of day 1, followed by a Cocktail Reception in the Exhibition & 1-2-1 Partnering Area
Phacilitate Oncology 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
Day 2
Wednesday, March 25th 2015
7.30
Registration & Buffet Breakfast in the Exhibition & 1-2-1 Partnering Area
Oncology Leaders Forum plenary session
Harnessing next-gen predictive translational tools and approaches to
inform oncology clinical trial design
9.00
Chair’s introduction
Case studies examining the effective integration of translational oncology and targeted medicine
How will we discover the next wave of stratification biomarkers? Which tools to use? (Gene
profiling? CTCs? Metabolomics?)
9.10
Case study 1
Dr Robert Schlegel, Vice President, Oncology Translational Medicine, Novartis Institute
for Biomedical Research
9.35
Questions & discussion
9.40
Case study 2
Dr Gary Kelloff, Special Advisor, DCTD, CIP, National Cancer Institute (NCI)
10.00
Questions & discussion
10.05
Presentation reserved
10.25
Questions & discussion
10.30
Use of a predictive biomarker based on characteristics of the host
Case study of ruxolitinib, a Janus kinase inhibitor for treatment of solid tumors based on
the CRP driven Glasgow Prognostic Scale
Importance of the tumor microenvironment and host factors in guiding cancer therapy
Onco-inflammation as a hallmark of cancer
Dr Richard Levy, Executive Vice President, Chief Drug Development & Medical Officer,
Incyte
10.55
Questions & discussion
11.00
Case Study 4
Dr Humphrey Gardner, Vice President Translational Medicine, AstraZeneca
11.20
Close of session - Morning Coffee in the Exhibition & 1-2-1 Partnering Area
Oncology Leaders Forum plenary session
How is cutting edge data analysis enabling the interrogation of increasingly
complex and diverse datasets to identify novel predictive markers?
12.00
Chair’s introductory overview: How will next gen data integration/analysis drive
improvements and efficiencies in oncology drug development decision making?
Phacilitate Oncology 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]
4
Genomics, proteomics, IHC, etc. – how will various data sources/types fit into the
picture?
Invited speaker:
Justin Guinney, Director, Computational Biology, Sage Bionetworks
12.15
Case study 1
Invited speaker:
Werner Boeing, Chief Information Officer, Hoffman-La Roche
12.35
Presentation reserved
12.55
Roundtable discussion
Next-gen sequencing - how do you interpret a patient’s individual genome information
in the clinical development context?
What applications do sequencing and data interpretation trailblazers see within the
oncology drug development sphere?
o Can it/will it be of benefit in clinical trial design?
How do they see their business models developing?
What’s the view from regulatory and pharmacoeconomic perspectives?
Invited panellists:
Dr Walter Offen, Global Head of Statistical Innovation & Data & Statistical Sciences, Abbvie
Dr Warren Kibbe, Head, Centre for Biomedical Informatics & Information Technology,
National Cancer Institute
Dr Deborah Moroshini, Vice President Clinical Development, Foundation For Medicine
Dr Jennifer Levin-Carter, Chief Medical Officer & Founder, N for One
Benjamin Szilagyi, Global Head Clinical Data Information Sciences, Hoffman-La Roche
Dr Levi Garraway, Associate Professor of Medicine, Department of Medical Oncology,
Dana-Faber Institute
1.20
Buffet Lunch in the Exhibition & 1-2-1 Partnering Area
Oncology Leaders Forum plenary session
Oncology clinical trial designs of the future
2.30
Chair’s introduction
Dr Jeremy Barton, VP, Head of Oncology, Biotechnology Clinical Development,WRD,
Pfizer Inc
Case studies
How to integrate novel predictive markers with Bayesian statistical approaches to design
clinical studies?
2.35
Case study 1
Invited speaker:
Dr Barry H Schwab, Vice President, Clinical Biostatistics, Johnson & Johnson
2.55
Case study 2 – Presentation reserved
3.15
Questions for the speakers & panel discussion
Exploring the statistical arguments for and against the adoption of surrogate endpoints in
oncology
Phacilitate Oncology 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
3.35
Afternoon Tea in the Exhibition & 1-2-1 Partnering Area
Focus on rare cancers: Case studies highlighting effective and efficient trial designs and
innovative approaches to challenges such as patient recruitment, endpoint selection, and lack of
disease natural history data
4.10
Case study 1
Invited speaker:
Dr Henry Fuchs, Chief Medical Officer, Biomarin
4.30
Case study 2
Invited speaker:
Dr Robert Arbeit, Vice President, Clinical Development, Idera Pharmaceuticals
4.50
Case study 3
Invited speaker:
Dr Robert Bray, Senior Vice President & Chief Scientific Officer, Soligenix
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
Oncology Leaders Forum plenary session
Combination therapy: Optimizing partnering models, clinical trial designs
9.00
Chair’s introduction
9.10
Case studies followed by roundtable discussion
Dissecting partnering models utilized for recent individual Phase I and Phase II
combination studies
What are the keys to ensuring rapid and efficient partnering in a non-competitive setting?
How have negotiations around ‘next steps’ been handled?
Combination Alliance: Building a framework to encourage academic-industry
collaborations for early phase combination trials within ECMC network
Panellist:
Dr Hazel Jones, Head of Combination Therapies, Centre for Drug Development, Cancer
Research UK
Case studies: Risk mitigation and decision making in oncology phase I trials
10.10
Case study 1
Dr Christopher Slapak, Vice President, Early Phase Development & Distinguished Lilly
Scholar, Eli Lilly & Co
10.30
Questions & discussion
Phacilitate Oncology 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]
6
10.35
Case study 2
Dr Bruno Osterwalder, Senior Vice President, Senior Strategic Advisor, Global Drug
Development and Medical, Merck KGaA
10.55
Questions & discussion
11.00
Morning coffee in the Exhibition & 1-2-1 Partnering Area
Case studies
Designing and delivering combinations to combat tumour resistance - what dosing and sequence
to choose?
11.40
Case study 1
Invited speaker:
Dr Jorge Otero, Executive Medical Director, Clinical Development, Amgen
12.00
Case study 2
Novel-Novel combinations: Examining pros and cons of trial designs utilized to date
12.20
Case study 1
Dr Archie N Tse, Senior Director, Clinical Development, Oncology, Daichii Sankyo Inc
12.40
Case study 2
1.00
Close of the Phacilitate Oncology Leaders Forum 2015 – Buffet Lunch in the Exhibition
& 1-2-1 Partnering Area
Phacilitate Oncology 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