BIO-Europe Spring^® 2014 Program Overview

With the shortage of classical VC investing and the ongoing boom in early opportunities and strong entrepreneurs, traditional VC is beginning to share the spotlight with alternative models. For therapeutics companies that have already raised some capital or especially those that have products in the clinic, there are some new alternatives to choose from, including option deals, one-product financings from VCs, and pre-IPO royalty-based financing. Foundations, CROs and academic institutions are becoming bigger players as well. This workshop will highlight some of the new approaches and what is driving them.

Moderator:
Steve Dickman – CEO, CBT Advisors

• Sinclair Dunlop – Managing Partner, Rock Spring Ventures
• Joël Jean-Mairet – General Partner, Ysios Capital
• Kevin Johnson – Partner, Index Ventures
• Melissa Stevens – Deputy Executive Director, FasterCures

Share this:

Looking back on your last deal, what would you have done differently? During this interactive workshop, experienced business development executives will draw from their dealmaking experience and dive into some of the common and not so common pitfalls in partnering. The panelists will give examples of mistakes made in negotiations and around deal structures. They will discuss the correct use of arbitration clauses, how to prioritize deal points and how to recognize and acknowledge both parties' needs to create a mutually beneficial partnership.

Moderator:
Diane Romza-Kutz – Partner, Troutman Sanders

• Steven P. Damon – President and CEO, 4P Therapeutics
• Philippe Lopes-Fernandes – Senior VP, Head of Global Licensing, Business Development and Alliance Management, EMD Serono
• James O'Mara – VP, Corporate Development, Ironwood Pharmaceuticals
• Arthur J. Tipton – Global Head of Drug Delivery, Evonik Corp.

Share this:

In this session, we will explore the impact of new technologies and novel therapeutic approaches to advance cancer drug development and deliver on the promise of personalized medicine.

Experienced investors, pharma leaders and diagnostic development experts will explore:

• The role of next generation sequencing on the identification of new disease-modifying drug targets
• The role of next generation sequencing in oncology drug development, molecular diagnostics and the advent of personalized medicine
• Novel therapeutic approaches enabled by the latest technology advances

Finally, our panel of experts will discuss the multitude of opportunities for partnering by small and large companies alike in the brave new world of personalized oncology and next generation drug development.

Moderator:
John Freshley – CBO, Compendia Bioscience, now part of Life Technologies

• Joseph Monforte – Executive VP and CSO, AltheaDx, Inc.
• Linda Pullan – President, Pullan Consulting
• Cecilia Schott – Executive Director, Business Development, AstraZeneca

Share this:

Diabetes is one of the most significant health issues today and continues, despite major treatment advances, to warrant new, novel therapies to further help patients gain better control of their disease. As in the past, such innovations are likely to originate from academic research institutions. A recent survey sponsored by Novo Nordisk and conducted by Thomson Reuters indicates that in particular, biologic therapeutics innovation is showing a downward trend, this risk leading to lower rates of translational efforts. Thus, many of us are concerned about the status of research in this area.

• Brian Bloomquist – Senior Director, Diabetes and Endocrine, Global External R&D, Eli Lilly and Company
• Morten Faester – Director, Strategic Partnering and Business Development, AstraZeneca
• Alec Mian – CEO, Genmedica Therapeutics

Share this:

When a project tanks in a well-designed study, that's a risk we have to accept. For a good project to fail because of mistakes is disastrous. Common errors leading to a missed exit opportunity include:

• Wrong indication, causing development to be long and challenging to finance
• Under-powering, for budgetary reasons, resulting in equivocal results
• Choosing the wrong endpoints or wrong statistical analysis, increasing the cost considerably
• Designing the "perfect" study, without testing its feasibility, or choosing the wrong investigators, resulting in protocol amendments, delayed patient recruitment, and time and budget overruns

The good news is that the solution often involves nothing more than the consistent application of simple concepts.

The workshop covers how good study design, statistical approaches, protocol feasibility and site selection can substantially reduce the risk of cost overruns, delayed timelines and failed studies.

Moderator:
Grahaem Brown – Managing Partner, Competitive Drug Development International

• Axel Polack – General Partner, TVM Capital
• Stephen Senn – Member of CROS Scientific Board; Head, Competence Center for Methodology and Statistics (CCMS), CRP-Santé
• Michael Tansey – Managing Partner, Competitive Drug Development International

Share this:

• Carola Schropp – President, EBD Group
• Montserrat Basora – Entrepreneurship Manager of Barcelona Activa, Barcelona City Council
• Montserrat Vendrell – CEO, Biocat
• David Thomas – Director, Industry Research and Analysis, Biotechnology Industry Organization (BIO)

Share this:

We have heard it before: VCs don't fund real innovation anymore and pharma is unable to innovate successfully (and efficiently). If this is true, what does this trend portend and how can it be reversed? The panel will discuss collaborations among venture and pharma, how pharma is stepping more into the role of VCs and also how recent deal structures like structured M&As conflict with the VC model.

Moderator:
Vaughn Kailian – Managing Director, MPM Capital

• Frances Heller – Senior VP, Business Development, Bristol-Myers Squibb
• Bernhard Kirschbaum – Executive VP, Head of Global Research and Early Development, Merck Serono
• Ed Mathers – Partner, NEA
• Denise Pollard-Knight – Managing Partner, Phase4 Ventures

Share this:

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.

Moderator:
Wendy Johnson – President and CEO, Aires Pharmaceuticals

• Jette Asboe Lassen – Director, Business Development, Symphogen
• Nikhil Puri – VP, Worldwide Business Development, Lead for the Emerging Markets/Established Products Business, Pfizer
• Helga Rübsamen-Schaeff – CEO, AiCuris
• Christian Zahnd – CEO, Molecular Partners

Share this:

After taking somewhat of a beating in previous years, biotech has been a hot sector on Wall Street this past year. The Nasdaq Biotech Index shot up significantly, also compared to the broader market. And the fact that the 2012 total number of biotech IPOs exceeded that of 2011 indicates that there could be a growing appetite for these types of investments for 2013 and the years to come. But there's no indication that we're on the verge of returning to the exuberant years of the 1990s when biotechs more easily went public at very attractive valuations. The current market is very selective and mostly open to later stage, diversified and de-risked companies as only a small number of preclinical stage and/or single asset companies were able to go public. There is also an ever widening gap between US and EU capital markets for biotech, in terms of total market capitalization, performance and availability of specialized pockets of capital to be deployed in public markets. In this panel discussion, we will review examples, identify trends and try to predict the future.

Moderator:
Sander Slootweg – Managing Partner, Forbion Capital Partners

• Barbara Duncan – CFO, Intercept Pharmaceuticals
• Dan Lepanto – Managing Director, Head of M&A, Leerink Swann
• C.A. (Oscar) Izeboud – Managing Director, Kempen & Co Corporate Finance B.V.
• Daniel Paterson – VP and Head, Corporate Development and Diagnostics, Verastem

Share this:

Increasing pressure to heighten productivity and lower cost has led many pharma companies to completely rethink their R&D and commercialization strategies. The blueprint is changing—be it by innovative internal structures or through external resources such as M&A or collaborations with VCs, academic institutions, or biotechs. External resources promise new sources of innovation, but also create new challenges for the R&D and commercial teams tasked with delivering approvable, reimbursable and differentiated products at the end of the development process. Join this session as we review both early successes and lessons learned from the implementation of novel R&D and commercialization blueprints, and discuss what they could mean for the industry as a whole.

Moderator:
Jeff Stewart – Senior Engagement Manager, Campbell Alliance

• Peter G. Nell – Director, Early Licensing, Bayer HealthCare
• Sudhir Kumar Singh – Senior VP, GVK Biosciences Pvt. Ltd.
• Richard Soll – Senior VP, Integrated Services; Head, Corporate Alliances, WuXi AppTec
• Greg Wiederrecht – VP and Head, External Scientific Affairs, MSD

Share this:

In an environment constrained by traditional investment approaches, stakeholders in the drug development value chain have started to come together to explore collaborative models to drive innovation. What role does pharma play in such models? Can non-dilutive funding such as government grants jump-start innovation at the intersection between discovery and development? This panel will discuss collaborative and business approaches and new paths to funding drug discovery and development.

Moderator:
Manuel Lopez-Figueroa – VP, Bay City Capital; Scientific Liaison, Pritzker Neuropsychiatric Disorders Research Consortium

• Gwen A. Melincoff – Senior VP, Shire Strategic Investment Group, Shire Pharmaceuticals
• David T. Phillips – Partner, SR One
• Richard N. Seabrook – Head, Business Development, Technology Transfer, The Wellcome Trust
• Christian Suojanen – Partner, Valor Management; Co-Chairman, TTS Global Initiative

Share this:

Recent failures and setbacks around late stage Alzheimer's candidates have shown again that this field is one of the most problematic indications for drug development. A limited understanding of the disease, large scale clinical trials and insecurity around reimbursement make Alzheimer's a challenging indication for biotechs and send VCs running. During this session, a panel of experts will examine research, development, financing, and reimbursement of Alzheimer's drugs.

Moderator:
Kees Been – Former CEO, EnVivo

• Amir Kalali – VP, Therapeutic Strategy Head, Neuroscience, Quintiles Inc.
• Gerhard Koenig – Senior VP, Research and CSO, EnVivo Pharmaceuticals
• José Luis Molinuevo Guix – Alzheimer's Disease and Cognitive Disorders Unit, Neurology Service, Clinical Institute of Neurosciences (ICN), Hospital Clinic of Barcelona
• Walter Schmidt – CEO, AFFiRiS

Share this:

How is Europe's healthcare "cost containment" affecting dealmaking in biotech? It's complicated. An ever-changing policy environment that varies from country to country is directly influencing the "value" that the buy-side places on pipeline assets. At the negotiating table, innovator companies may pitch pipeline value based on current marketplace pricing, whereas large, multinational pharma companies are looking five to ten years down the road when new government-driven reimbursement plans become law. This panel explores both the current status and the outlook for cost-containment measures in Europe, and their implications for innovators and developers of new medicines, with an emphasis on the effect on biotech deals.

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

• Tara Delaney – Head of European Markets, Senior Director, International Public Affairs, Pfizer, Inc.
• Alexander Natz – Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
• Esteban Plata – General Manager, Spain, AbbVie
• Mercedes Prior – Senior Global Market Access Manager, Almirall

Share this:

While the pharmaceutical companies may be waiting for the first cell therapy products to achieve favorable Phase III results before they make a major financial commitment, their interest in stem cells is by no means tepid. They are showing a robust interest in stem cell biology and the use of stem cells for a variety of drug discovery applications. This session will explore how this interest is manifest in a new wave of drug discovery collaborations with industry and academia and how some of the newest technologies, such as iPSCs, could transform the industry's approach to preclinical research.

Moderator:
Eduardo Bravo – Managing Director and CEO, TiGenix

• Elona Baum – General Counsel and VP, Business Development, CIRM
• Gary Rabin – Chairman and CEO, Advanced Cell Technology
• Matthias Steger – Global Head, Research and Technology Partnering, Roche
• Alain Vertes – Park BioVentures

Share this:

There is palpable excitement within the cancer research community and among clinical oncologists with many of the new advancements in cancer immunology. Yet despite the excitement industry is still trying to understand how these products will be commercialized successfully and overcome key regulatory and reimbursement challenges. These risk factors need to be addressed in the context of every partnership or collaboration necessary to move these products forward and provide the capital necessary to fund late-stage development. This panel will address how cancer immunotherapy companies and all companies developing advanced therapies must approach partnering in dealing with products that do not lend themselves to traditional partnering models.

Moderator:
Bob Preti – CEO, Progenitor Cell Therapy

• Anne Altmeyer – VP, Business Development and Licensing, Oncology, Novartis
• Peter Ho – Director, Business Development, ImmunoCellular Therapeutics
• Christine Mikail – Executive VP, Corporate Development, General Counsel and Secretary, Dendreon Corporation
• Manfred Ruediger – CEO, Kiadis Pharma

Share this:

There is little doubt that advances in genetic medicine that will render drugs more "precise" will translate into clear and compelling benefits for patients and better value for payers. Tempering the excitement, however, is that (a) the development of genetically targeted drugs in other fields lags years behind those now being seen in oncology, and (b) targeted approaches may not address widespread chronic diseases, including cardiovascular disease, neurodegeneration, infectious diseases and inflammatory disorders, which represent the lion's share of global disease burden both today and for the foreseeable future.

The staggering costs of these widespread chronic diseases suggest there is still a place for meaningfully differentiated new drugs for large patient populations. Importantly, the biology of at least some of these diseases is comparatively well understood and clear development paths exist, mitigating, to at least some extent, scientific risk. However, the bar for differentiation for new branded medicines is higher than ever and involves multiple stakeholders.

Ed's presentation will discuss the imperative for pharma and biotech to balance steady and exciting progress in the discovery and development of genetically targeted medicines with a pragmatic approach to developing differentiated drugs for the most widespread diseases.

• Ed Saltzman – President and Founder, Defined Health

Share this:

The cancer field has been undergoing some significant changes and challenges, especially as targeted therapies are developed, from molecular stratification of patients to the increasing pushback from payers and cancer centers themselves around the cost benefits of new therapies. To some degree the use of molecularly targeted agents directed to specific patient populations can help overcome market access barriers by providing a stronger efficacy signal and hence meaningful clinical value. The potential downside to the "niche-ification" of cancer is that supporting a sustainable oncology franchise expansion could become more difficult. 

This panel will explore how novel targets and trial designs are enabling the advances and possibly providing unique ways for oncology companies to grow their franchises and to create the data for novel products with differentiated value propositions that garner the interest of all the key constituencies—patients, physicians, regulators and payers.

Moderator:
Jeffrey M. Bockman – VP, Defined Health

• Anne Altmeyer – VP, Business Development and Licensing, Oncology, Novartis
• Stefan Frings – Global Head, Oncology Immunology Therapeutic Area, Roche Partnering
• Michael Meyers – VP, Scientific Innovation Leader, Oncology, Janssen Pharmaceutical Companies of Johnson & Johnson
• Peter Sandor – VP, Global Marketing, TA Head Oncology, Amgen

Share this:

The recent approval of the "Generating Antibiotic Incentives Now" or "GAIN" Act in the US, and clearer EMEA guidelines for development, have opened the door for the resurgence of antimicrobial R&D. "Closer to reality" guidelines for development and approval of agents, incentives for accelerated review, and extension of marketing exclusivity are enticements for companies of all sizes to enter or re-enter the space. The panel will discuss the importance of these new measures to companies and their potential impetus to antimicrobial discovery and approval of novel agents. In addition, they will provide perspectives on key questions, such as: Do the changes mean biotechs can "go it alone" focused on pathogens, as opposed to indications, without the need for a specialty or big pharma partner?   If so, how does the funding model need to change? What are the implications for future development of larger indications?

Moderator:
Timothy Joslin – Managing Director, Europe, Defined Health

• Jacques Dumas – VP and Head, Strategy Infection Innovative Medicines (iMed), AstraZeneca
• Jarrod Longcor – VP, Corporate Development, Rib-X Pharmaceuticals
• Rodger Novak – Global Head Infectious Diseases R&D, Sanofi
• Carol Ann Olson – Executive Medical Director, Therapeutic Area Head for Infectious Diseases, PPD

Share this:

In the context of an increasingly generic standard of care, the commercial risk now associated with many of the major CNS diseases (e.g., depression, epilepsy, migraine, schizophrenia, ADHD) has become too large for several of the big and specialty pharma companies. We have seen a mass exodus from CNS, with the exception of high risk/high reward programs, such as Alzheimer's disease modifying therapies, though these continue to disappoint. Companies that are not ready to give up on CNS may see an opportunity to level risk by targeting orphan diseases and high unmet need market subsets. Lured by the successes in other therapeutic areas (e.g., orphan oncology indications and enzyme replacement therapies) and the promise of relatively low cost/short timeline development programs, friendly regulatory authorities, pricing flexibility, and minimal commercialization costs, the pipeline for CNS orphan indications and disease subsets is growing. This "road less traveled" does not necessarily leave behind the challenges inherent to CNS drug development—a relatively limited understanding of the underlying disease biology, subjective clinical endpoints and a high placebo response rate. Join us while we explore the pros and cons of the CNS orphan space.

Moderator:
Ginger S. Johnson – VP, Defined Health

• Tom Blackburn – Principal and CEO, TPBioVentures LLC
• Paul Gallagher – President, Compass Strategic Consulting
• Marc Martinell – Founder and CEO, Minoryx Therapeutics
• John McDonald – VP, Co-Head Business Development, Mergers & Acquisitions, Biogen Idec, Inc.
• Jeremy Springhorn – VP, Corporate Strategy and Business Development, Alexion

Share this:

• Patrick Tricoli – Global R&D Strategy, External Innovation and Science Policy, Sanofi
• John Orsato – Corporate Licenses, Sanofi

• Markus Kalousek – Global Business Development & Licensing, Search & Evaluation Head WWF, Novartis

• David Chapman – Senior Director, Scientific Licensing, Shire Pharmaceuticals

• Günter Huhle – VP Business Development and Mature Brands, EMEA Janssen-Cilag

• Christoph Hüls – VP, Head of BioPartnering, Global Business Development and Strategy, Merck Serono, a division of Merck KGaA, Darmstadt

• John Poulos – VP, Head of Licensing and Acquisitions, AbbVie

• Anand Gautam – Director, Biopharmaceutical Innovation Sourcing, Novo Nordisk

• Ian K. Moules – Senior Director, Search and Evaluation, Global Licensing and Business Development, Takeda Pharmaceutical Company Ltd.

• Cecilia Schott – Executive Director, Business Development, Personalized Healthcare, AstraZeneca

• Stefan Frings – Global Head, Oncology Immunology Therapeutic Area, Roche Partnering

• Kinney Horn – Associate Director, Genentech Partnering

• Lubor Gaal – Strategic Transactions Group, Bristol-Myers Squibb

• Christoph Geserick – Director Early Licensing, Business Development and Licensing, Bayer HealthCare

• Rob Pinnock – Regional Licensing and Acquisitions Lead UK, IRL, Portugal and Spain, MSD

• Stewart Kay – Director, Transactions, GlaxoSmithKline