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BIO-Europe Spring® 2015 Program Overview

www.ebdgroup.com/bes/program
Sunday, March 8, 2015
19:30–22:00
Welcome Reception

All BIO-Europe Spring attendees are cordially invited to join us for a welcome reception.

You will be able to pick up your name badge at the welcome reception.

Monday, March 9, 2015
07:45
Registration opens
07:45
Exhibition opens and Continental Breakfast
09:00–10:30
Parallel Workshops
Translational medicine: From discovery to early stage drug development

Monday, 09:00–10:30

Panelists:
  • François Ballet – President, Council of Administration, Institut Hospitalo Universitaire (IHU) Cardiométabolisme Nutrition (ICAN)
  • Manuel Gea – CEO and VP R&D IS, Bio-Modeling Systems: Mechanisms-Based Medicine
  • Kurt Hertogs – Platform Innovation and Incubator Strategy Leader, Johnson & Johnson Innovation, London
  • Maya Said – VP, Head of Strategy, External Innovation and Science Policy, Sanofi Global R&D
BIO-Europe Spring® 2015
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Is nano becoming the next sweet spot for drug development?

Monday, 09:00–10:30

Nanomedicine is now ubiquitously present with an increasing number of companies using nanotechnology that may provide new tools for physicians and ultimately change disease treatments. Nanomedicine players are globally represented by two complementary organizations: the European Technology Platform for Nanomedicine (ETPN) in Europe and the Nanomedicines Alliance in the US. Both organizations have witnessed the maturation of nanomedicine as more and more clinical data becomes available, an increasing number of registered studies and authorized products translating into more nano-therapeutic deals. The panelists will discuss whether and how this maturation will progress and the impact on development in the global pharmaceutical industry.

Moderator:
Laurent Levy – CEO, Nanobiotix; Vice-Chairman, ETPN

BIO-Europe Spring® 2015
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Reimbursement in European markets

Monday, 09:00–10:30

Reimbursement regimes in the US and key European markets continue to evolve and "innovate." This includes new and greater use of health technology assessment and related measures ostensibly designed to focus on ensuring that new products are rewarded only insofar as they provide additional therapeutic value. This panel explores both whether changing systems are really working that way, and the growing sharing of experience between payers and value assessment agencies in key markets, including the United States. It will also explore the additional burdens these systems are putting on developers of new products to demonstrate "value."

Moderator:
Joe Damond – Senior VP, International Affairs, Biotechnology Industry Organization (BIO)

Panelists:
  • Robin Kenselaar – VP, Europe, Middle East, Africa, Genzyme
  • Alexander Natz – Secretary General, EUCOPE
BIO-Europe Spring® 2015
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Vaccines for infectious diseases

Monday, 09:00–10:30

Moderator:
Phyllis Arthur – Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy, Biotechnology Industry Organization (BIO)

Panelists:
  • Pierre D'Epenoux – Executive VP, Chief Strategy Officer and Head of Business Development, Theravectys
  • Nicholas Jackson – Associate VP, Head of R&D for the Dengue Program, Sanofi Pasteur
  • Russell P. "Rip" Wilson – Senior VP, Business Development, Novavax, Inc.
BIO-Europe Spring® 2015
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10:45–12:30
Welcome and Plenary Session
Welcome
Opening remarks
Opening Plenary Session
Moderator:
Antoine Papiernik Antoine Papiernik
Managing Partner
Sofinnova Partners

Speakers:
Pierre-Henri BenhamouPierre-Henri Benhamou
Co-Founder, Chairman and CEO
DBV Technologies
Paul J. HastingsPaul J. Hastings
Chairman and CEO
OncoMed Pharmaceuticals
Rachel K. KingRachel K. King
Co-Founder and CEO
GlycoMimetics Inc.

12:30–13:30
Luncheon
13:30–18:15
Parallel Panel Discussions
Business Development
Blurred lines: Product development and manufacturing of biologics

Monday, 13:30–14:30

By 2016, 45% of top 100 drugs sales will come from biologics. Production of biologics has specific and specialized requirements compared with small molecules. What are the strategies needed for the successful product development of biologics and what capabilities are required for long-term growth? This session will address these aspects of the development and production of biologics:

  • Importance of crossdivisional and crossfunctional collaboration for integrated and strategic development
  • Global infrastructure and partnering along the value chain of development and manufacturing
  • Challenges to manage increasing complexity of biologic formats while giving the patients global access to innovative treatments

BIO-Europe Spring® 2015
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Major deal transactions

Monday, 14:45–15:45

The panelists in this session examine some of the significant deals of the last 12 months, including transactions they have been involved in, and what these deals reveal about pharma's priorities, strategy and the options available to drug development companies in need of a corporate partner. Join dealmakers from these major companies for a strategic look inside the deal.

BIO-Europe Spring® 2015
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16:00–17:00
Innovative financing models
Due diligence: How to ensure a successful process

Monday, 17:15–18:15

Moderator:
Martina Molsbergen – CEO, C14 Consulting Group

Panelists:
  • Chris Brown – Director, Scientific Licensing, Worldwide Business Development, GSK
  • Jan Case – Senior Director, Corporate Due Diligence, Shire
  • Ann Connolly – Senior Director, New Ventures, Johnson & Johnson Innovation, London
  • Carl Jessop – Due Diligence Director, AstraZeneca
BIO-Europe Spring® 2015
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In the Spotlight
Land of the Rising Sun: Also the land of opportunity for new business development

Monday, 13:30–14:30

This session will highlight the new initiatives and policies implemented to foster the growth of Japan's biopharma industry. Japan is currently the world's second largest economy and home to the largest aging population, and there are more opportunities than ever before for cross-border collaborations and investments. Panelists will provide insights on the advantages and keys to partnering with Japanese companies.

BIO-Europe Spring® 2015
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Cell-based immunotherapies for cancer: What types of partnerships will support successful commercialization?

Monday, 14:45–15:45

While the success of PD-1 inhibitors and other immunomodulators and their potential as combination treatments have led to a stampede by large pharma into cancer immunotherapies, there has been equally compelling news coming from the smaller group of companies focused on adoptive T-cell therapies and cell-based approaches. These types of therapies, most of them autologous, require a very different way of thinking about treatment and the types of partnerships needed to support successful commercialization. This panel will feature pharmaceutical companies that have decided to embrace this challenge as well as the perspective of smaller companies seeking partnerships that go beyond traditional back-ended, milestone-driven structures given the need of both parties to embrace risk and clinical challenges upfront.

Panelists:
  • Robert Ang – Senior VP, Business Development, Bavarian Nordic
  • Nina Mojas – Head, Oncology Evaluation, AstraZeneca
  • Stephen Rubino – Global Head, Business Development and Licensing, Cell and Gene Therapy Unit, Novartis Pharmaceuticals Corporation
BIO-Europe Spring® 2015
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Gene therapy and genome editing: Addressing key considerations along the product development pathway

Monday, 16:00–17:00

The renewed enthusiasm for gene therapy—in vivo and ex vivo and versatile genome editing technologies such as CRISPR/Cas-9 and Talen—have put the spotlight back on gene therapy. Large pharma and large-cap biotech are also jumping into the space with investments and partnerships focused on both monogenic disorders and ultra-orhpan indications that could be closer to the market as well broader market opportunities with much longer development timelines. Given that many of these opportunities will involve delivery technologies, or next-generation approaches to delivery as well as other key enabling platforms, we can expect to see an expanding number of deals with key technology developers as the field continues to mature. This panel will include the perspective of executives from some of the leading gene therapy companies in addition to key executives within large pharma who are working to position these new opportunities within their R&D pipelines.

Moderator:
Frédéric Revah – CEO, Genethon

Panelists:
  • Katrine S. Bosley – CEO, Editas Medicine
  • Clark Pan – VP, Head of Discovery Therapeutics, Shire
BIO-Europe Spring® 2015
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Next generation treatments in ophthalmology: Can gene and cell-based therapies meet growing expectations for early clinical success?

Monday, 17:15–18:15

Many experts predict that some of the early clinical successes in cell and gene therapy will be for ophthalmological indications such as retinitis pigmentosa, AMD, glaucoma, or some of the large number of orphan diseases of the eye where delivery and well-defined clinical outcomes are less of an issue. This panel will examine some of the latest developments related to the commercialization of new treatments for the eye and how these treatments are being positioned for clinical and commercial success.

BIO-Europe Spring® 2015
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Therapeutic Insight 2014


Therapeutic Insight by Defined Health
Beyond HbA1c: Reducing cardiovascular complications in diabetes patients

Beyond HbA1c: Reducing cardiovascular complications in diabetes patients
Monday, 13:30–14:30

The diabetes segment of the pharmaceutical market is continuing strong growth, fueled by demographics and innovation. However, higher regulatory hurdles, the need for CV outcomes studies, and threats from genericization and biosimilars place doubt on how long this trajectory can continue. There is no argument that the magnitude of morbidity, mortality and healthcare costs associated with Type 2 diabetes (T2DM) is one of the largest burdens on healthcare systems. Glycemic control remains an important objective, with metformin as a foundational therapy upon which novel drug classes (DPP-IV inhibitors, long-acting GLP-1s, insulin analogues, SGLT-2 inhibitors) are added. These new therapies have been approved in recent years based on reductions in HbA1c (regulatory surrogate marker) and non-inferior cardiovascular toxicity demonstrated in the shortest possible time. Although the availability of these new therapies allows better glucose-lowering strategies, few trials have yet to show unequivocal cardiovascular risk reduction with glucose lowering, even though most diabetic patients eventually die from cardiovascular causes, and cardiovascular events prompt the largest healthcare expenses. Accordingly, recent updates to guidelines for the management of T2DM include optimized glucose lowering to reduce the risk of microvascular disease, but further cardiovascular event reduction is recommended by vigilant blood pressure control via antihypertensives, and lipid reduction with potent statins for all diabetics above the age of 40 regardless of LDLc level. However, it is unclear how antidiabetic drug classes will prove additional cardiovascular event reduction on top of optimal cardioprevention, and there is concern that the diabetes pipeline is lacking sufficient investment to provide adequate innovative mechanisms to adequately feed pharma diabetes franchises in the future.

This panel will discuss the opportunities and challenges in reducing cardiovascular complications in diabetes patients and the development and commercialization of novel cardioprevention therapies.

Moderator:
Michael C. Rice – Senior Consultant, Defined Health

Panelists:
  • Jonas Hallén – Clinical Program Leader, R&D, Pronova BioPharma (now part of BASF)
  • Tomas Landh – VP, Senior Principal Scientist Innovation Sourcing, Novo Nordisk
BIO-Europe Spring® 2015
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Neuroregenerative approaches for neurodegenerative diseases

Neuroregenerative approaches for neurodegenerative diseases
Monday, 14:45–15:45

Currently available therapies for neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, multiple sclerosis and amyotrophic lateral sclerosis range from moderately disease modifying to mildly symptomatic to nonexistent—all leaving significant unmet need. Neuroregenerative medicine, which aims to regenerate and restore a damaged nervous system, has to date been considered a potentially disruptive technology, but not yet sufficiently developed. Of late, however, important advances are being made, with several programs in clinical development. Paradigms being explored take several forms, including re-engineering a patient's stem cells to promote neural growth and methods aimed at counteracting inhibition of neural factors. Neuroregenerative methods are also being used to create disease models for these still largely ill-understood diseases by reprogramming adult stem cells from patients into pluripotent stem cells that can be differentiated into specific nerve cells affected by the disease.

Key questions/issues to be addressed on this panel discussion include:

  • What are the key near-term milestones/value inflection points that will support neuroregenerative medicine as a viable therapeutic approach?
  • Which organizations/companies are making real progress, with which types of approaches (e.g., neurotrophins and growth factors, stem cell therapy, gene therapy)?

Moderator:
Ginger S. Johnson – VP, Defined Health

BIO-Europe Spring® 2015
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Revisiting underserved chronic conditions

Revisiting underserved chronic conditions
Monday, 16:00–17:00

2014 marked the second highest year on record for the approval of new chemical entities; the 41 new drugs approved were topped only by the 53 recorded in 1996. Importantly for patients, a sizable majority of these new drugs such as Merck's Keytruda represent genuine breakthroughs. Others, such as Vimizim from BioMarin (for the ultra rare enzyme deficiency, Morquio A), represent hope for patients with previously neglected diseases. But of the new drugs approved last year, only slightly above one-third are for chronic diseases afflicting large populations (and most of these are "me-too" offerings for Type 2 diabetes). Conspicuous by their absence are any novel approaches to treat osteoarthritis, depression, urinary incontinence, osteoporosis and other widespread chronic conditions. Moreover, a dramatic misalignment exists within the industry's development pipeline between the number of candidates for comparatively small population diseases and those for more common and costly conditions. Striking example: Depression afflicts nearly as many people in the US as does cancer (and its economic costs are greater) but the pipeline shows <50 programs in the clinic in the US vs. nearly 1,500 in cancer (and a similar pipeline disconnect exists between cancer and arthritis, heart disease and stroke). Ironically, today's "neglected diseases" are precisely the ones that drove pharma's great success in the past.

Moderator:
Ed Saltzman – President, Defined Health

BIO-Europe Spring® 2015
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Undermining metastases and preventing recurrence: Therapeutics targeting cancer stem cells

Undermining metastases and preventing recurrence: Therapeutics targeting cancer stem cells
Monday, 17:15–18:15

The inability to treat metastasis, the major source of mortality with most cancers continuing to be diagnosed late, is a key challenge in oncology. Various cells types have been proposed to account for the resilience that stymies therapy—both innate and acquired resistance, as well as genetic and epigenetic plasticity and hence heterogeneity. The idea common to most perspectives on metastases is that a hardy and stealthy subpopulation of cells exist—whether termed cancer stem cells (CSCs), dormant disseminated tumor cells (DTCs), or circulating tumor cells (CTCs), that may overlap completely or in part—that provide for the metastases. Numerous efforts have been underway to identify and define these cell types, and to develop specific therapeutics against them. For many in oncology, targeting such cells represents one of the Holy Grails of cancer, even in this age of immuno-oncology.

This panel will discuss the ideas underlying these unique cell populations, the various strategies being pursued to develop therapies against them, and the clinical development paths that may be different for these types of targets.

Moderator:
Jeffrey M. Bockman – VP, Defined Health

BIO-Europe Spring® 2015
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Pharma Presentations
13:30–18:30
One-to-one Meetings ►
18:00–18:30
Exhibit Hall Hospitality Reception
19:00
Evening Networking Reception
Tuesday, March 10, 2015
07:45
Registration opens
07:45
Exhibition opens and Continental Breakfast
09:00–13:00
Company Presentations ►
08:00–18:30
One-to-one Meetings ►
10:45–11:15
Workshop
First-in-human: A critical step for biotechs in cancer drug development

Tuesday, 10:45–11:15

Speaker:
  • Jean-Pierre Armand – Senior Oncologist, Expert in Phase I/II, Gustave Roussy Institute
BIO-Europe Spring® 2015
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11:15–12:15
Workshop
Collaborative models for early clinical studies between innovative biotechs and academics

Tuesday, 11:15–12:15

Moderator:
Jean-Pierre Armand – Senior Oncologist, Expert in Phase I/II, Gustave Roussy Institute

Panelists:
  • Øyvind K. Arnesen – CEO, Ultimovacs
  • Esteban Cvitkovic – CEO, OncoEthix
  • Filippo de Braud – Head, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale, Tumori, Milano
  • Vicenç Tur – CEO, Lipopharma
BIO-Europe Spring® 2015
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13:00–14:00
Luncheon
14:00–18:00
Company Presentations ►
17:45–18:45
Exhibit Hall Hospitality Receptions
19:00
Evening Networking Reception
Wednesday, March 11, 2015
07:45
Registration opens
07:45
Exhibition opens and Continental Breakfast
09:00–13:00
Company Presentations ►
08:00–17:00
One-to-one Meetings ►
13:00–14:00
Luncheon
16:30
Closing Reception
Arrow Up


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