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Biotech Showcase™ 2015 Program Overview

www.ebdgroup.com/bts/program
Sunday, January 11, 2015
1:00–5:30 pm
Level 4, Balboa
Biotech Showcase™ pre-event
The tactics of closing funding deals

This workshop is focused on delivering results and securing funding at All Levels: Boards, Angels, VCs, Corporate Partners and Other Sources of Funds, with four hours of intensive and interactive discussion, on-your-feet sessions, war stories and insights aimed at folks looking for financing. It is designed to accelerate your funding activities and eliminate unnecessary noise.

Preregistration is required, more information can be found here.

4:00–7:00 pm
Level 4, Cyril Magnin Foyer

All Biotech Showcase attendees are invited to pick up name badges prior to the beginning of the conference on Monday.

Monday, January 12, 2015
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–9:00 am
Workshops
Reading the tea leaves: How to interpret FDA, CMS, and SEC actions

Monday, 8:00–9:00 am
Level 4, Mission I

What do actions and non-actions from the FDA, CMS, and SEC mean for biotech companies advancing products in development and investors in these companies? What events are par for the course, and what constitutes a red flag? How do you know whether a company has a good chance of succeeding? Or, will it fall prey to the ever-increasing bureaucracies? The session will include experts in working with the FDA and CMS.

Panelists:
  • David M. Fox – Partner, Hogan Lovells US LLP
  • Joseph V. Gulfo – Biopharma/Medtech Executive and Speaker; Author "Innovative Breakdown"
  • Beth L. Roberts – Partner, Hogan Lovells US LLP
Biotech Showcase™ 2015
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Going international: A value creation move for specialty biopharmaceuticals? Lessons from Onyx, Intermune and Cubist

Monday, 8:00–9:00 am
Level 4, Mission II

What role does "going international" play in creating value? How and when should Specialty Biopharmaceutical companies consider establishing presence abroad? What are roadmaps and best practices, and what are some of the pitfalls?

On August 25, 2013, Onyx sold for USD 10.4 billion to Amgen. On September 29, 2014, InterMune sold for USD 8.3 billion to Roche. And on December 8, 2014, Cubist announced it would be sold for USD 9.5 billion to Merck. All three players established international offices in recent years, Onyx and InterMune in late 2010, Cubist in late 2012. From going international to trade sale, Onyx's share price more than tripled to USD 125, InterMune's more than quintupled to USD 74, and Cubist's more than doubled to USD 102.

Join a panel discussion with the executives and investors who led the "going international" initiative at Onyx, InterMune and Cubist, and discover some of the lessons they learned about value creation along the way.

Moderator:
Stephen Bissig – Managing Partner, Leader Growth

Panelists:
  • Luigi Costa – CEO, Nordic Nanovector ASA
  • Giacomo Di Nepi – Executive VP and Managing Director, Europe, InterMune
  • Matt Fust – Board Member, Ultragenyx Pharmaceutical
  • James Healy – Managing General Partner, Sofinnova Ventures; Board Member, InterMune
  • Patrick Vink – Senior VP and General Manager International Business, Cubist Pharmaceuticals, Inc.
Biotech Showcase™ 2015
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Key trends in specialty drug management and their impact on product commercialization strategies

Monday, 8:00–9:00 am
Level 3, Powell

Spending on specialty drugs in the US is growing faster than ever. About 30% of the estimated drug spend in 2012 was on specialty drugs, a number that is expected to grow to 50% by 2018. To drive value in this environment, plans must look for ways to control costs and improve the quality of care today and into the future. As seen with Sovaldi and other specialty drugs, manufacturers must demonstrate the clinical and economic value of their product like never before to align with the evolving business model and needs of health plans. This panel will explore the key trends in specialty drug management and their implications for manufacturers launching a product in this space.

Moderator:
Jenny Gaffney – Director, Avalere Health

Biotech Showcase™ 2015
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8:00–9:50 am
Regenerative Medicine and Advanced Therapies State of the Industry Briefing
Introduction and industry update

Introduction and industry update
Monday, 8:00–8:20
Level 4, Cyril Magnin Ballroom

Speaker:
  • Edward Lanphier – President and CEO, Sangamo BioScience; Chair, Alliance for Regenerative Medicine
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Gene therapy and genome editing: Defining the clinical and commercial requirements for success

Gene therapy and genome editing: Defining the clinical and commercial requirements for success
Monday, 8:20–9:05
Level 4, Cyril Magnin Ballroom

This session features CEOs and senior executives from several of the leading gene therapy companies in a discussion looking forward to the expected clinical, regulatory and commercial inflection points for the sector in 2015 and beyond. Panelists will discuss what will be required to sustain momentum in the sector and some of the unique strategies and partnerships that will be required for clinical and commercial success.

Speakers:
  • Katrine Bosley – CEO, Editas Medicine
  • Thomas Chalberg – Founder and CEO, Avalanche Biotechnologies
  • Steven Paul – CEO, Voyager Therapeutics
  • Josh Schimmer – Managing Director and Senior Research Analyst, Piper Jaffray
  • Jeffrey Walsh – COO, bluebird bio
  • Sue Washer – President and CEO, AGTC
  • Kristina Zsebo – CEO, Celladon
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Dose, delivery, data: Understanding the three D's of Advanced Therapy drug development

Dose, delivery, data: Understanding the three D's of Advanced Therapy drug development
Monday, 9:05–9:50
Level 4, Cyril Magnin Ballroom

This panel of industry CEOs and senior executives will examine key issues related to advanced therapies as the field progresses over the next 12 months. Much of the discussion in the cell and gene therapy sectors revolves around dose, the method of delivery of the product and how the sector will manage expectations around a number of key data events anticipated over the next two years.

Speakers:
  • Tony Fiorino – CEO, BrainStorm Cell Therapeutics
  • Adam Gridley – President and CEO, Histogenics
  • Paul Laikind – President and CEO, ViaCyte, Inc
  • C. Randal Mills – President and CEO, California Institute for Regenerative Medicine (CIRM)
  • Robert Willenbucher – Head, Janssen Cell Therapy and Head, Janssen Incubator, Janssen R&D
  • Paul Wotton – President and CEO, Ocata Therapeutics
Biotech Showcase™ 2015
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8:00 am–12:00 pm Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm
Lunch Plenary
Value creation: Private and Public investment strategies and stage gates for success

Monday, 12:00–1:30 pm
Level 4, Cyril Magnin Ballroom

How do investors perceive value? Each stakeholder will place a different value on assets in each phase for different reasons; each type of investor will assess value with their own, unique focus. There is no longer one set of rules to evaluate pharma/biotech investments.

Evolving market dynamics dictate a shift in focus toward products where innovation still drives market value. In addition, development times differ by therapeutic area, as do product types, new indication and treatment paradigms—all of which change over time. The value defined today may not be the value realized in the future. Therefore, investment strategy must converge with existing company strategic strengths in established and existing areas of corporate investment. Whether a public or private investment, value will drive the deal.

Join this panel of senior industry executives from emerging biotechs, large pharmas, VC firms and investment banks as they discuss the key drivers that dictate "value" creation, and which pitfalls to avoid on the path to acquisition, partnership or joint commercialization models.

Moderator:
Mike Griffith – President, Commercial Division, inVentiv Health; Executive VP, inVentiv Health Inc.

Panelists:
  • Stephen Bloch – General Partner, Canaan Partners
  • Iain Dukes – Senior VP, Business Development and Licensing, Merck Research Laboratories
  • Ross Hammerman – Managing Director, UBS Investment Bank
  • Melinda Richter – Head of Johnson & Johnson Innovation, JLabs
Biotech Showcase™ 2015
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1:45–5:30 pm Company Presentations ►

Private Biotech
Public Biotech

1:30–6:00 pm
One-to-one Meetings ►
Tuesday, January 13, 2015
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–9:00 am
Workshops
Type 1 Diabetes: Novel therapies, devices and diagnostics on the horizon

Tuesday, 8:00–9:00 am
Level 4, Mission I

As a chronic and highly prevalent (>1 million patients in US) autoimmune disease, type 1 diabetes (T1D), especially if inadequately treated, has a major impact on the healthcare system and dramatically affects patient quality of life. This session will highlight some of the innovative therapies and devices in development to better treat (and cure and prevent), reduce complications and relieve the daily burden of T1D. Furthermore, the panelists will discuss the commercial opportunities for companies developing innovative and impactful disease-modifying agents for this chronic disease and why this makes T1D-focused companies an attractive investment option.

Moderator:
Richard Insel – Chief Scientific Officer, JDRF

Panelists:
  • Richard Berenson – CEO, Thermalin Diabetes, LLC
  • Werner Cautreels – President and CEO, Selecta Biosciences
  • Joseph Hedrick – Venture Leader, Type 1 Diabetes, Disease Interception Accelerator, Janssen
  • Paul Laikind – President and CEO, ViaCyte, Inc
  • Howard Look – President and CEO, Tidepool
Biotech Showcase™ 2015
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The Life Sciences Report 2015 Small-Cap Watchlist

Tuesday, 8:00–9:00 am
Level 3, Powell

Join Senior Healthcare analyst Mara Goldstein of Cantor Fitzgerald and this panel of experts as they discuss their top small-cap biotech picks for 2015. This panel of biotech analysts will articulate why their favorite small-cap ideas are good investment opportunities. Follow the progress of the "Watchlist" throughout the year on The Life Sciences Report. This is a must-attend for investors looking for new ideas in the life sciences industry.

Moderator:
Mara Goldstein – Managing Director, Senior Healthcare Analyst, Cantor Fitzgerald

Panelists:
  • Reni Benjamin – Managing Director, Equity Research, Analyst, H.C. Wainwright & Co.
  • Bert Hazlett – Managing Director, Equity Research, Biopharmaceuticals, Ladenburg Thalmann & Co.
  • Joe Pantginis – Head of Biotechnology Research and Senior Research Analyst, Roth Capital Partners
  • George B. Zavoico – Managing Director, Equity Research, MLV & Co.
Biotech Showcase™ 2015
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Financing biotech more—or less—by the book

Tuesday, 8:00–9:00 am
Level 4, Mission II

New forms of financing such as crowdfunding are trying to establish a toehold in life sciences. How can the different approaches coexist? What sort of biotechs will arise in a universe populated with these investors? How will existing players adapt?

Moderator:
Steve Dickman – CEO, CBT Advisors

Panelists:
  • R. Doug Armstrong – Chief Business Officer, Dawson James Securities
  • Ethan O. Perlstein – Founder and CEO, Perlstein Lab PBC
  • Gregory C. Simon – CEO, Poliwogg Holdings, Inc.
  • Ajit Singh – Partner, Artiman Ventures
  • Asish K. Xavier – VP, Venture Investments, J&J Development Corporation
Biotech Showcase™ 2015
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8:00 am–12:00 pm
One-to-one Meetings ►
8:00 am–12:00 pm Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm
Lunch Plenary
How robust is the biotech rally and what could derail it?

Tuesday, 12:00–1:30 pm
Level 4, Cyril Magnin Ballroom

The biotech rally has fueled a steady stream of IPOs over the last two years, and there is optimism that this time the market is driven to results rather than hype. Commercialization may have brought some stability and sustainability to the market for biopharmaceutical companies, but there are still significant issues that could derail investment even in profitable firms. Backlash over drug pricing and compassionate use could cause generalist investors to balk. Public policy set-backs could undo many of the gains the industry has made under the JOBS Act. A less cooperative FDA slows key approvals and thus slows the momentum of the industry. Our panel will explore these issues and others that are key to the sector's financial sustainability.

Moderator:
Ellen B. Corenswet – Partner, Covington & Burling LLP

Panelists:
  • Ben Bonifant – Partner, Triangle Insights Group
  • Julia Gregory – CEO, Contrafect Corporation
  • Dan Mendelson – CEO, Avalere Health
  • Luke Miels – Executive VP, Global Portfolio and Product Strategy (GPPS), AstraZeneca
  • Dennis Purcell – Founder and Senior Advisor, Aisling Capital LLC
Biotech Showcase™ 2015
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1:45–5:30 pm Company Presentations ►

Private Biotech
Public Biotech

1:30–6:00 pm
One-to-one Meetings ►
Wednesday, January 14, 2015
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–9:00 am
Workshop
Apps as drugs

Wednesday, 8:00–9:00 am
Level 4, Mission I

Startups are pushing forward in several disease areas to augment or supplant pharmaceutical approaches with online apps or computer programs. In focus are areas like migraine, sleep and diabetes because those are both closely linked to regulated areas (insomnia drugs, insulin). The focus will be less on those apps that cover areas already addressed by pharmaceuticals, not "lifestyle" apps.

Moderator:
Steve Dickman – CEO, CBT Advisors

Panelists:
  • David Benshoof Klein – Executive Chairman, Interim CEO, Click Therapeutics, Inc.
  • Eric Elenko – CEO, Akili Interactive Labs
  • Alex Mian – CEO, Curelator, Inc.
  • Julie Papanek – Principal, Canaan Partners
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Investing in the immuno-oncology revolution

Wednesday, 8:00–9:00 am
Level 4, Mission II

The intersection of oncology and immunology is expected to produce even more headlines during 2015 as the next generation immunotherapies steadily progress with extremely promising results. In 2014 we already witnessed anti-PD-1 drugs such as Merck's Keytruda® (pembrolizumab) receiving FDA accelerated approval in the U. and Bristol-Myers'/Ono Pharmaceuticals' Opdivo® (nivolumab) receiving approval in Japan, both for treating melanoma. Join us for a discussion about the revolutionary new generation of immunotherapies such as PD-1, PD-L1, CAR T-cell, CTLA4 and others with such a large potential impact, both clinically and financially, that they can move the needle for large pharma investors and also provide exciting opportunities for biotech investors.

Moderator:
Stephen M. Dunn – President and Senior Managing Director of Research, LifeTech Capital

Panelists:
  • William Cao – CEO, Cellular Biomedicine Group Inc.
  • Bahija Jallal – Executive VP, AstraZeneca, Head of Medimmune
  • Catherine-Anne Pickering – Head, Oncology Licensing and Global Business Development, Merck Serono
Biotech Showcase™ 2015
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8:00 am–12:00 pm
One-to-one Meetings ►
8:00 am–12:00 pm Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm
Lunch Plenary
Are old funding models enough in a new era?

Wednesday, 12:00–1:30 pm
Level 4, Cyril Magnin Ballroom

A healthy market for exits, both IPOs and M&A, has replenished the pool of private capital targeting the biotechnology sector. It has also drawn new capital to the sector. New life sciences-oriented funds abound and corporate venture investment in the industry is at a five-year high.

How will all of this fresh capital be deployed? Game-changing biopharmaceutical innovation is expensive, risky and elusive. In the era of personalized medicine, it may not be realistic to rely primarily on early stage venture investment, public sector grants or internal R&D efforts to unlock innovative new technology. Will unconventional investments such as direct partnerships between biopharmaceutical companies and academic researchers, disease-focused foundations, crowdfunding or accelerators and incubators play an increasingly important role in the private investment ecosystem?

Our panel of industry veterans will discuss what the next five years holds for the biopharma sector.

Moderator:
Luke Timmerman – Biotechnology Journalist and Author, formerly of Xconomy

Panelists:
  • Vicki Anastasi – VP and Global Head, Medical Device and Diagnostics Research, ICON
  • Bruce Booth – Partner, Atlas Venture
  • Holger Reithinger – General Partner, Forbion Capital Partners
  • Susan Schaeffer – Editor, BioCentury, The Bernstein Report on BioBusiness
Biotech Showcase™ 2015
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1:45–5:00 pm Company Presentations ►

Private Biotech
Public Biotech

1:30–5:00 pm
One-to-one Meetings ►
5:00–6:00 pm
Level 4, Cyril Magnin Foyer
Closing Reception
Arrow Up


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Biotech Showcase 2015 EBD Group Demy-Colton Image Map