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BioPharm America™ 2014 Program Overview

www.ebdgroup.com/bpa/program
Sunday, September 21, 2014
6:00–8:00 pm
BioPharm America Welcome Reception

All BioPharm America attendees are cordially invited to join us for a welcome reception.

Boston Marriott Copley Place
110 Huntington Avenue
Boston, MA 02116 (map)

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

Monday, September 22, 2014
7:30 am
7:30 am
Exhibition opens and Continental Breakfast
9:00–10:30 am
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

Judges:
  • Peter Barrett – Partner, Atlas Venture
  • Bernard Davitian – VP and Managing Director, Sanofi-Genzyme BioVentures, Sanofi
  • Brian Gallagher – Partner, SR One
  • Frederick Jones – Director, Broadview Ventures, Inc.
  • Nilesh Kumar – Director, MS Ventures
BioPharm America™ 2014
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1+1=3: How unconventional pharma & VC collaborations are expanding R&D budgets

In recent years, pharma company R&D budgets have been under pressure. Pharma companies are struggling to find ways to continue to advance the development of attractive drug candidates from their own pipelines while simultaneously looking outside for attractive programs they can acquire. One way pharma companies can do more within a constrained R&D budget is to partner with outside investors in innovative ways in order to develop attractive drug candidates with "other people's money." This panel of industry experts will explore some of the ways that pharma companies and VC firms are partnering to develop drugs and generate investment returns.

Moderator:
David Collier – CEO, Velocity Pharmaceutical Development

BioPharm America™ 2014
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10:45 am–12:30 pm
Welcome, Keynotes, and Opening Plenary Discussion
Special Presentation
Announcement of the Fierce 15

Announcement of the Fierce 15

The Fierce 15 is a hunt that involves the biggest ideas in biotech, the most daring characters in biopharma, and entrepreneurs doing things that haven't been done before. The result is fifteen privately held drug developers or platform biotechs with the potential to have a huge impact on the treatment of human diseases. John Carroll, Editor-in-Chief of FierceBiotech, will announce the winners live onsite.

Speaker:
  • John Carroll – Editor-in-Chief, FierceBiotech
BioPharm America™ 2014
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Keynote Addresses
Speakers:
Flemming OrnskovFlemming Ornskov
CEO
Shire
Gary NabelGary Nabel
CSO
Sanofi

Opening Plenary Discussion
Orphan diseases: Looking for guardians

Monday, 11:15 am–12:30 pm

Orphan Spotlight: Leading biopharma executives will discuss how changes in the overall healthcare market are affecting their corporate strategies in addressing rare diseases. The session will cover topics such as the reimbursement landscape, patient access, and partnering deals, to understand the most significant factors impacting innovative product development and the business of fulfilling unmet medical needs.

Moderator:
Karen Bernstein – Co-Founder, Chairman, and Editor-in-Chief, BioCentury

Panelists:
  • Gary Nabel – CSO, Sanofi
  • Flemming Ornskov – CEO, Shire
BioPharm America™ 2014
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12:30–1:30 pm
Luncheon
1:30–5:00 pm
Parallel Panel Discussions
Dealmaking and Strategy
Mayflower II: The migration of European biotechs to the US

Amid the breaking wave of US IPOs, more and more of the candidates are European. In addition to the early entrants such as UniQure from the Netherlands (IPO in February 2014), a crop of new companies is appearing from abroad on these shores.

Meanwhile, European markets seem to be (finally) opening up for biotech IPOs. Pixium Vision raised USD 46.7 million on EuroNext Paris in June 2014 and ArGEN-X has announced that it will list there soon. These IPOs are typically smaller and company valuations are lower.

What factors determine where a European company will file? Will they continue to flock to US markets? How long can this trend last? And with some of its best companies coming overseas, is Europe being relegated to a kind of "minor league" status in biotech and life sciences?

Moderator:
Steve Dickman – CEO, CBT Advisors

BioPharm America™ 2014
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Behind the headlines: Large series A financings deconstructed

Obtaining a large round of Series A financing can garner a promising young biotech a lot of attention and validation from the life science community with news of the deal ricocheting around inboxes, twitterfeeds and industry rags within hours. But what are the actual terms behind the headlines? How much of this capital is actually contingent? What types of milestones do entrepreneurs need to achieve? What are the risks and benefits of tranched deals? For those companies that close these deals, what is it about them that made them so appealing to investors? The product/technology? The leadership team? Please join us as we deconstruct these deals and explore how to obtain and optimize them.

Moderator:
Jeffrey L. Quillen – Partner, Foley Hoag LLP

Panelists:
  • Jim Geraghty – Entrepreneur-in-Residence, Third Rock Ventures
  • Ed Mathers – Partner, Washington DC, NEA
BioPharm America™ 2014
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Pharma's big bets on risky therapeutic areas
In the Spotlight
Challenges in orphan CNS indications

Moderator:
Richard Brudnick – VP and Co-Head, Business Development, Biogen Idec

Panelists:
  • Kees Been – President and CEO, Lysosomal Therapeutics, Inc.
  • Mustafa Sahin – Director, Translational Neuroscience Center, Boston Children's Hospital
  • Robert Weisskoff – Partner, Fidelity Biosciences
BioPharm America™ 2014
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The power of the patients: How patients are getting things done in the drug development process

From funding research to recruiting for clinical trials to working with the FDA and CMS on regulatory and reimbursement issues, patients have an increasingly vital role in R&D. The impatient patient is not sitting idly by waiting for much needed cures and treatments—they are active partners in the search for remedies and initiating projects like The Race to Yes social media campaign, providing millions in undiluted research capital, and collaborating with industry partners on patient-trial matching. Learn how patients are making an impact and how biopharmacos are partnering with these groups to leverage the "power of the patients" and make new treatments available as quickly as possible.

BioPharm America™ 2014
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Under the spotlight: The pressures of being an early stage public company

Now more than ever before, investors expect big payoffs and look for significant clinical outcomes and commercial success from their biotech investments. How do new public companies meet the demands and operate under the close scrutiny of savvy investors? Is it a race to go take advantage of the open IPO window and raise capital while it's available? What impact has going public had on the company's R&D strategy? In addition to managing their pipelines, public companies need to have sophisticated IR & PR teams to address issues around financial reporting, governance, compliance, and infrastructure. We'll examine the tradeoffs companies make when they decide to go public and hear from executives of newly minted companies to gain insights on managing the pressures of the markets, learn what it takes to keep stakeholders happy in a high risk environment, and seek guidance for private companies that are considering filing.

BioPharm America™ 2014
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Advanced Therapies
Clinical outlook for new immuno-oncology treatments

The clinical pipeline for new cancer immunotherapies is growing with new technologies targeting almost the entire spectrum of cancer indications. This panel will consider the clinical outlook for various cancer immunotherapies: PD1 and checkpoint inhibitors, cell-based immunotherapies and adoptive T-cell therapies, and other novel approaches to treating the disease. It will also consider the extent to which the clincial advances and breakthrough therapy opportunities are driving partnering activity.

BioPharm America™ 2014
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What type of partnerships will lead to successful advanced therapy and regenerative medicine programs?

Next generation therapies involving gene therapy, gene modification technologies and cell-based therapies may not reach commercialization along traditional routes with a large pharma stepping in to acquire or license rights to clinically-advanced products. Many of the key technologies involve platforms and autologous or individualized approaches that require differest skill sets than those present in more traditional product development groups. This panel will look at the types of partnerships—early and later stage—that could become more commonplace as this sector continues to evolve. It will also consider the role of stakeholders such as hospitals, patient groups, and even the large infrastrucutre players that will play a crucial role in the success of advanced therapies.

Moderator:
Brock Reeve – Executive Director, Harvard Stem Cell Institute

Panelists:
  • Eric Halioua – Co-Founder and CEO, Promethera Biosciences
  • Frederick Jones – Director, Broadview Ventures, Inc.
BioPharm America™ 2014
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Developing a sustainable commercial model: Can we devise a pricing system for next gen therapies with multiple winners?

Despite the interest and enthusiasm around the therapeutic potential for these products in a variety of indications, the pricing question remains unanswered. This session will include stakeholders currently thinking through these issues and working to develop successful commercialization models.

BioPharm America™ 2014
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5:15–6:15 pm
Keynote Panel
State of the Industry: A focus on the financial landscape in the life sciences

Moderator:
Bruce Booth – Partner, Atlas Venture

Speakers:
  • Kevin Starr – Partner, Third Rock Ventures
  • Liam Ratcliffe – Managing Director, New York, New Leaf Venture Partners
BioPharm America™ 2014
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7:00–9:30 pm
Evening Networking Reception with Buffet-style Dinner
Tuesday, September 23, 2014
7:30 am
7:30 am
Exhibition opens and Continental Breakfast
8:30–12:30 pm
Pharma and Large Biotech Presentations
8:00 am–6:00 pm
One-to-one Meetings ►
11:15 am–12:30 pm
Company Presentations ►
10:00–11:00 am
Workshop
Challenges in developing differentiated treatments for autoimmune diseases

Humira is currently the top selling pharmaceutical in the world and represents just one of eight approved targeted therapies for RA, a market with an estimated prevalence of less than USD 5 million in the seven major pharmaceutical markets. Rheumatoid arthritis, as well as many of the other indications in which anti-TNFs are entrenched, has all the hallmarks of a mature market (including biosimilars on the horizon), and many view the market as overcrowded. However, significant unmet medical needs remain in RA, where approximately one-third of patients are not achieving a 20% improvement in symptoms on biologics, and needs are even greater in other indications such as IBD. Within this setting, developers of early stage programs are struggling to differentiate their programs and to choose the appropriate indication and path forward for clinical development. Our panel will discuss the challenges associated with differentiating products at early stages of development in autoimmune disease, and potential strategies for choosing lead indications and demonstrating proof-of-relevance to potential partners and/or investors, as well as patients and payers.

BioPharm America™ 2014
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12:30–1:30 pm
Luncheon
1:30–4:30 pm
Company Presentations ►
4:45–5:45 pm
Keynote Panel
The nearest exit may be behind you: The story of CoStim Pharmaceuticals

On February 17, 2014, CoStim Pharmaceuticals, a little startup just about a year removed from its first big funding round and focused on the hot field of immune checkpoint biology, was acquired by Novartis. In this session, the key players—co-founders, investors and Novartis—will share the company's story, from vision and formation through exit and beyond.

Moderator:
Michal Preminger – Executive Director, Office of Technology Development, Harvard University

Panelists:
  • Seth Ettenberg – Head Oncology Biologics, Novartis Institutes for Biomedical Research
  • Roger Kitterman – Managing Partner, Partners Healthcare Innovation Fund
  • Robert Millman – Managing Director, MPM; Co-Founder and President, CoStim Pharmaceuticals
  • Arlene Sharpe – Co-founder, CoStim Pharmaceuticals; Professor of Immunobiology at Harvard Medical School
BioPharm America™ 2014
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5:45–7:00 pm
Harvard Innovation Exhibit and Reception

Hosted by:

Harvard University Harvard University
Wednesday, September 24, 2014
7:30 am
7:30 am
Exhibition opens and Continental Breakfast
8:30 am–12:30 pm
Company Presentations ►
8:00 am–3:00 pm
One-to-one Meetings ►
9:00–10:00 am
Panel Discussion
All innovation roads lead to Massachusetts: Pharma's approach to the Boston biotech cluster

Undoubtedly, Boston is one of the most fertile biotech breeding grounds in the world. Top research institutes, early stage VC money, the who-is-who in serial entrepreneurs and a solid representation of mature biotechs, all within a few square miles, create an unmatched environment for innovation to thrive. No wonder most pharma companies are building a strong presence to be close to the action. During this session the leaders of several Boston R&D centers will discuss their approach to accessing innovation.

BioPharm America™ 2014
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10:00–11:45 am
Academic Innovators™ Showcase

Join us for our Academic Innovators™ presentation track as we work with industry leaders to shine a spotlight on the many scientific advances with strong translational potential being made in the academic world.

BioPharm America™ 2014
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12:30–1:30 pm
Luncheon
3:00–4:00 pm
Closing Reception
Arrow Up


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