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BIO-Europe® 2014 Program Overview

www.ebdgroup.com/bioeurope/program
Sunday, November 2, 2014
19:00–21:30
BIO-Europe® Welcome Reception

All BIO-Europe 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, November 3, 2014
07:45
07:45
Exhibition opens and Continental Breakfast
09:00–10:30
Parallel Workshops
The perfect pitch: Do you have what it takes to win over investors?

Monday, 09:00–10:30

Win a one-to-one meeting with a leading life science private equity investor. Members of the audience will have 30 seconds to pitch their company, product, technology or service to a star-studded panel of judges representing at least six life science investment firms. The top picks will be selected for a second round that includes two minutes of presentation and/or Q&A time with the judges. First and second place winners will receive a full 30-minute private followup meeting with the panelist of their choice. Judges will receive a written summary of all participant pitches and their scores, should they wish to follow up on their own. Audience preparation notes:

Participants will be judged on the quality and effectiveness of the overall 30-second pitch. Remember, the primary goal of an elevator pitch is to spark interest for a followup meeting. Pre-workshop coaching is available from the moderator (contact: doug@macbiocom.com). Practice, practice, practice!

Moderator:
Douglas MacDougall – President, MacDougall Biomedical Communications

Panelists:
  • Roel Bulthuis – Managing Director, MS Ventures
  • Michael Keyoung – Managing Partner, Portola Capital Partners
  • Michèle Ollier – Partner, Index Ventures
BIO-Europe® 2014
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Transparency vs. confidentiality of clinical trial data: Challenges and opportunities of the new European Regulation and the new EMA policy

Monday, 09:00–10:30

Innovative R&D, patient safety, and an efficient and effective regulatory framework are among the key issues on every industry executive's mind. The clinical trial process can make or break a product and even determine the fate of a company. Will the new European Regulation and the new EMA policy requiring the publication of clinical data make the process even more challenging or will the data transparency mandate provide opportunities for greater industry collaboration?

This panel will explore the major changes of this Regulation and the EMA policy and the affects for the sponsors on clinical trials performed in Europe. Panelists will discuss the potential impacts on clinical data reporting, patient confidentiality, and other critical implementation factors, and identify possible solutions for the industry that may help accelerate the development of new treatments.

Moderator:
Peter Homberg – Partner, Dentons

BIO-Europe® 2014
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Translational Medicine: Transforming research achievements into innovative therapeutic and diagnostic products

Monday, 09:00–10:30

The translation of biomedical research into effective therapeutics and diagnostics is the driving factor for innovation in the pharmaceutical industry. Successful translation depends on the right strategy and organization.

This panel presents best practice examples of internationally renowned translational centers. Panelists will discuss their strategies and experiences.

Moderator:
Simone Fishburn – Executive Editor, SciBX, BioCentury Publications Inc.

Panelists:
  • Issi Rozen – Director, Strategic Alliances, Broad Institute
  • Dave Tapolczay – CEO, MRC Technology Ltd.
BIO-Europe® 2014
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What your patents say about you as an innovator: Leveraging your PR into business opportunities

Monday, 09:00–10:30

Biotech innovators must deliver results on many fronts to succeed commercially. The intricacies of patent law are not typically top of mind, yet patents play an essential role in business success. Your patents also tell your business story not only to patent officials and judges but also to investors, regulators, marketers, activists and the rest of the world.

Patents are drafted for global filing, but legislative (and occasionally judicial) reform has not always understood biotechnology. There is fear surrounding the effects of enforcing biotech patent claims, especially when the claims relate to or are derived from higher life forms. When enforcement occurs, innovators also need to account for regional practices. An effective patent strategy can help you establish a successful reputation that is attractive to business partners and investors even prior to any forays before the courts.

We will examine situations where innovators should explain a patent's subject matter to decision makers (and the public at large) to enforce their IP. We will also consider to what extent education or legislative reform is required in various sample jurisdictions. Please join our panel of intellectual property leaders as we discuss best practices for getting biotech patents understood, issued, and enforced around the world as we outline why patents should be a critical part of your PR strategy.

Moderator:
Jay Zakaïb – Partner, Gowlings, Canada

Panelists:
  • Gustavo de Freitas Morais – Partner, Dannemann Siemsen
  • Shahnaz Irani – Principal, Spruson & Ferguson
  • Hubert Witte – Head Patent Department Basel, F. Hoffmann-La Roche Ltd
BIO-Europe® 2014
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10:45–12:30
Welcome, Keynotes, and Opening Plenary Discussion
Keynote Addresses
Speakers:
Andreas BuschAndreas Busch
Member, Executive Committee;
Head, Global Drug Discovery
Bayer HealthCare
Belén GarijoBelén Garijo
President and CEO
Merck Serono
David LoewDavid Loew
Senior VP
Commercial Operations, Europe
Sanofi

Opening Plenary Discussion
Opening Plenary Discussion

Monday, 11:45–12:30

Moderator:
Jean-François Formela – Partner, Atlas Venture

Panelists:
  • Andreas Busch – Member, Executive Committee; Head, Global Drug Discovery, Bayer HealthCare
  • Belén Garijo – President and CEO, Merck Serono
  • David Loew – Senior VP, Commercial Operations, Europe, Sanofi
BIO-Europe® 2014
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12:30–13:30
Luncheon
13:30–18:15
Parallel Panel Discussions
Business Development Track
The right deal at the right time: How are sell-side dealmakers getting it right, or wrong, in today's environment?
Access to funding for European companies

Monday, 14:45–15:45

A dynamic biotech sector depends on a vital stock market, not only as a source of fresh money, but also as an exit route for investors. But whereas the US biotech sector relies on a central platform, the European stock market is highly diverse. As more and more EU companies set up shop in the US or go for their IPO, what does this mean for EU companies looking for access to capital? Out-licensing products and a reliance on government grants are two ways they are bridging the gap, but it's not enough for many of these companies. Alternative sources of capital are of increasing interest. We sit down with a variety of investors from both sides of the pond to explore funding options for these companies.

Moderator:
Boris Mannhardt – CEO, BIOCOM AG

Panelists:
  • Siegfried Bialojan – Head, Ernst & Young Life Science Center, Ernst & Young
  • Todd Davis – Founder and Managing Director, HealthCare Royalty Partners
BIO-Europe® 2014
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Early market access

Monday, 16:00–17:00

Adapted licensing seeks to maximize the positive impact of new active substances to public health, and will therefore become a major strategy for pharmaceutical companies. This session covers the regulatory environment of AL, as well as the regulatory and reimbursement regime of existing pre-market access (named patient, compassionate use, ATU) in pharmaceutical key markets in the EU.

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

Panelists:
  • Benjamin Gannon – Senior Director, Government Affairs and Public Policy, Vertex Pharmaceuticals
  • Alexander Natz – Secretary General, EUCOPE
  • Cord Willhöft – Partner, Life Sciences Regulatory, Fieldfisher
BIO-Europe® 2014
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Mind the gap? Meeting an emerging demand for access to medicines in late-stage clinical trials, prior to commercial launch

Monday, 17:15–18:15

Countless patients around the world are in urgent need of new therapeutic alternatives to address a huge degree of unmet medical need. Patient demand, which has been increasingly reported in the news and via social media, can put intense pressure on the physicians treating those patients, and biopharma companies to provide pre-launch access to drugs that are in late-stage clinical trials.

In an area where global regulations are complex and constantly evolving, this panel explores the industry environment, regulatory landscape and the options available around early access, using the new UK Early Access to Medicines Scheme (EAMS) as a case study. It will further discuss the roles that pharma, biotech, regulators, access program providers, and physicians play in bridging the gap between clinical trial results and full commercial availability for a drug, along with the opportunities and challenges that exist in this complex space.

Moderator:
Steve Bates – CEO, BIA

Panelists:
  • Mark Corbett – Senior VP, Clinigen GAP
  • Luc Dochez – Chief Business Officer, Prosensa
  • Markus Kosch – Lead Oncology, Europe, Africa and Middle East, Pfizer
BIO-Europe® 2014
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Spotlight Track
Late stage complications in diabetes
Next-generation cancer therapies: What types of partnerships will guide development of targeted and individualized immunotherapies, CSC drugs and other new cancer treatments?

Monday, 14:45–15:45

The drug development community is flush with new approaches to treating hematological cancers, solid tumors, and other cancer-associated illnesses. New companies are being formed every day and virtually every large pharma and large cap biotech company has a focused effort in cancer immunotherapies. The traditional path for developing these new treatments may not be relevant given the unique requirements of some of these new treatments. This may necessitate different types of deal structures and development milestones and the involvement of new stakeholders such as medical centers and other groups. This session will examine the new world of cancer drug development and the implications for partnerships and product development strategies.

BIO-Europe® 2014
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Corporate views on personalized immune intervention

Monday, 16:00–17:00

Personalized medicine has the potential to transform medical treatment as the mechanisms of disease and treatment become better understood. Antibodies, the dominant class of stratified immunotherapies, already amount to more than EUR 35 billion in sales worldwide.

The presentations and panel discussion will focus on current and future developments in personalized immune intervention markets, potential risks, and business strategies to realize the full market potential.

BIO-Europe® 2014
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Advancements in orphan drugs

Monday, 17:15–18:15

Moderator:
Hubert Birner – Managing Partner, TVM Life Science Management Inc.

BIO-Europe® 2014
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Pharma Presentations
AbbVie
Alexion Pharmaceuticals
Amgen
AstraZeneca
Bayer HealthCare Pharmaceuticals
Boehringer Ingelheim Licensing
Bristol-Myers Squibb
Eli Lilly and Company
Genentech
GlaxoSmithKline
Janssen Pharmaceutical Companies of Johnson & Johnson
Merck Serono, a division of Merck KGaA
MSD
Novartis Pharma
Novo Nordisk
Pfizer
Roche
Sanofi
Shire Pharmaceuticals
Takeda Pharmaceutical Company Ltd.
13:30–18:30
One-to-one Meetings ►
18:00–18:45
Exhibit Hall Hospitality Reception
19:00–22:30
Evening Networking Reception with Buffet-style Dinner
Jahrhunderthalle Frankfurt

Jahrhunderthalle Frankfurt
Pfaffenwiese 301
65929 Frankfurt | (map)

Jahrhunderthalle Frankfurt is an established international venue, a landmark symbolizing economic and cultural attainment in the 20th century. Designed by Friedrich Wilhelm Krämer and completed in 1963, Jahrhunderthalle Frankfurt is a commanding presence and a manifesto of modern style which owes its enduring contemporary appeal to the elegance of its flowing lines. This cultural and conference center hosts fine ballets, rock stars, and musicals as well as business events.

Hosted by:

Sanofi Sanofi
Tuesday, November 4, 2014
07:45
07:45
Exhibition opens and Continental Breakfast
09:00–10:30
Workshop
Innovative funding for SMEs in Europe

Tuesday, 09:00–10:30

With the shortage of early-stage life sciences funding, the role of government in funding the next generation of cures is becoming increasingly important. In January 2014, the European Union launched a multibillion euro funding program dedicated to all innovative small and medium sized enterprises (SMEs) in Europe. The session will provide an overview of this EU program and an introduction to its US counterpart, the US Small Business Innovation Research (SBIR) program.

The session will have three presentations. Two presentations will be made by high-level representatives from the EU (European Commission – DG Research and Innovation – Health Directorate) and the US (National Institutes of Health, National Cancer Institute) about the SME instrument and the SBIR programs respectively. Additionally, one presentation will be made by a European small business which will share its experiences in leveraging government funding to move their technology towards clinical adoption and commercialization.

Speakers:
  • Philippe Cupers – Deputy Head of Strategy Unit, Health Research Directorate, DG Research and Innovation, European Commission, Brussels, Belgium
  • Michael Weingarten – Director, NCI Small Business Innovation Research (SBIR) Development Center
BIO-Europe® 2014
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08:30–18:00
Company Presentations ►
08:00–18:30
One-to-one Meetings ►
12:00–13:00
Keynote Plenary Discussion
A day in the life of experienced dealmakers: Transformational deals that shaped the industry in 2014

Tuesday, 12:00–13:00

Moderators:
Evonne Sepsis – Founder and Managing Director, ESC Advisors
David Stubbs – Founding Partner and Managing Director, Inverness Advisors

Panelist:
  • Iain Dukes – Senior VP, Business Development and Licensing, Merck
BIO-Europe® 2014
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13:00–14:00
Luncheon
17:45–18:45
Exhibit Hall Hospitality Receptions
19:00–22:30
Evening Networking Reception with Buffet-style Dinner
Gesellschaftshaus Palmengarten

Gesellschaftshaus Palmengarten
Palmengartenstraße 11
60325 Frankfurt am Main | (map)

The Gesellschafthaus—Society House—at the edge of the Palmengarten, the green heart of the city, dates from 1870 with the Festsaal (Ballroom) as its centerpiece. With two classical chandeliers and the beautiful historical parquet floor, this room is a pleasure to behold. The rooms combine distinctive original designs and modern features, and each has a spectacular view of the artistically-designed flower garden as well as the idyllic Palmengarten in all its verdant splendor.

Sponsored by:

Bayer HealthCare

18:45–19:15 Shuttle buses depart from Portalhaus Messe Frankfurt to the evening event.
21:30–22:30 Shuttle buses depart from the evening event to all conference hotels.

Wednesday, November 5, 2014
07:45
07:45
Exhibition opens and Continental Breakfast
9:00–13:00 Company Presentations ► 8:00–17:00
One-to-one Meetings ►
13:00–14:00
Luncheon
16:30
Closing Reception
Arrow Up


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