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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?

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
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

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
What your patents say about you as an innovator: Leveraging your PR into business opportunities

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

BIO-Europe® 2014
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10:45–11:15
Welcome and Opening Remarks
11:45–12:30
Opening Plenary Session
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?
Make hay while the sun shines: Strategies for companies looking to make funding last once times are lean again
New structure in pricing and reimbursement
Mind the gap? Meeting an emerging demand for access to medicines in late-stage clinical trials, prior to commercial launch

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.

BIO-Europe® 2014
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Spotlight Track
Late stage complications in diabetes
What is the role of large pharma in developing advanced therapy medicinal products—are they essential or not?
Personalized medicine with an emphasis in immunotherapy
Orphan drugs

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

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

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.

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

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

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
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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