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BIO-Europe Spring® 2016 Program Overview

www.ebdgroup.com/bes/program
Sunday, April 3, 2016
19:00–21:30
Welcome Reception

All BIO-Europe Spring 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, April 4, 2016
07:45
Registration opens
07:45
Exhibition opens and Continental Breakfast
09:00–10:30
Parallel Workshops
New partnerships are a sign of the times: Opportunities for collaborations

Now more than ever before, we are seeing cross-sector collaborations that are changing traditional R&D models. Whether they're public-private partnerships, patient foundations and biotechs, incubators and pharmacos, or government entities and industry, novel agreements between stakeholders are leveraging the assets and expertise available to make greater progress and contributions to science. We'll review some prime examples of successful and impactful partnerships.

Moderator:
Mike Ward – Global Director of Content, Informa Pharma Insights

BIO-Europe Spring® 2016
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Finding the sweet spot: Defining and accessing your market

In the push to prove a successful end point, biotech companies can often lose sight of the more practical hurdles that also exist in getting their products on the market. Moving a therapy out of the lab and into the commercial arena raises questions of how to operate in a complex policy and legal landscape, including patents and IP, regulatory regimes and reimbursement and healthcare systems. Early market access activities and partnerships can mitigate or increase risk, but are complicated by the need to manage these hurdles in multiple jurisdictions. What effective strategies can assist in identifying these hurdles in order to position new drugs, not just as therapies but as products with a secure pathway to an end user? How must the partnering approach market access planning shift in order to take the full spectrum of drug development, clinical, legal and commercial, into account?

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

Panelists:
  • Niklas Mattsson – Partner and European Patent Attorney, Awapatent
  • Bernd Mühlenweg – Chief Business Officer, Nanobiotix
BIO-Europe Spring® 2016
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Let's get personal: Advances in precision medicine are changing the way we identify and treat disease
The future of vaccine development

Strategic alliances are necessary to insure a balance of commercial viability while providing access to diverse patient populations. How are companies, research organizations, government agencies, and others working together to overcome the challenges of innovation, development, manufacturing, and market access? Panelists will discuss the unique economic and societal considerations in addressing infectious diseases.

BIO-Europe Spring® 2016
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10:00–18:30
One-to-one Meetings ►
10:45–12:30
Welcome and Plenary Session
Welcome
Opening remarks

Speakers:
  • Anna Chrisman – Group Managing Director, EBD Group
  • Karin Wanngård – Mayor of Stockholm
  • Anders Lönnberg – National Coordinator for Life Science, Sweden
  • David Thomas – Director of Investment and Policy Research, Biotechnology Innovation Organization (BIO)
BIO-Europe Spring® 2016
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Opening Plenary Session
12:00–14:00
Luncheon
13:30–18:15
Parallel Panel Discussions
Business Development
Keeping your head: VCs and biotechs navigating uncertain markets

After a period of strong growth, healthcare has not proved immune to the volatility of the financial markets early this year. VCs, usually the first port of call for fundraising biotechs, have an important role to play in ensuring innovation continues, while still being vulnerable to the vagarities of market cycles. How do VCs differentiate themselves when capital is plenitful? How can they foster growth and innovation when slowdowns render risk unpalatable? Can VCs operate so as to drive sustainable healthcare market growth rather than a new bubble or a new trough?

BIO-Europe Spring® 2016
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The Alliance Manager: Bridging the culture gap

Drug development has never been more collaborative. Companies big and small, disease foundations, university research departments, government health services, and more are all potential partners for the development of new therapeutics. The sheer variety of organizations working together can result in the collision of differing organizational cultures and it is at this juncture that the role of alliance manager comes into its own. Join this panel to hear recent examples of how alliance managers translate the processes, languages, and structures between companies to ensure that, to achieve the end goal of every partnership, the entire team is following the same playbook.

Moderator:
Mark Archer – Global Head, Business Development, inVentiv Health

BIO-Europe Spring® 2016
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The new normal: Effective alternative financing

As demands on healthcare systems around the world shift in response to demographic changes and the burden of growing chronic conditions, there is a growing need for newer sources of capital to add to the traditional ones to fund the development of therapies. As a result, the financial aspect of healthcare is seeing a new breed of participants who are eager to establish themselves as long-term contributors. Disease foundations led by private donors, organizations created to support initiatives that answer the needs of specific patient populations, wealthy individuals keen to contribute to achievable if ambitious healthcare targets; these and others are all claiming their place on the spectrum of healthcare financing. Join this panel to hear from funders, companies and organizations who are actively engaged in the new matrix of alternative healthcare finance. Learn how you can engage with these new players and make the most of the expanding variety of options in your industry.

Moderator:
Steve Dickman – CEO, CBT Advisors

Panelists:
  • Charlotte Brogren – Director General, Vinnova
  • Christopher De Souza – Director, Broadview Ventures
BIO-Europe Spring® 2016
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The convergence of therapeutics and digital health.

Digital health is evolving rapidly with the development of products that have medical applications. Gain insight on big pharma's approach to these emerging digital medicine technologies including the unique partnership opportunities and strategies. Panelists will discuss how therapeutic applications, clinical trials, drug delivery, and adherence will be altered by digital medicine's influence.

BIO-Europe Spring® 2016
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Partnerships in Regenerative Medicine and Advanced Therapies
Stem cell therapies: The panacea for all that ails us

We have seen exciting advances in this field but what will it take to bring cures to the market? The emergence of new technologies to potentially treat neurological, immunological, and genetic diseases is promising but there are many pitfalls. This session will discuss the clinical, manufacturing, and regulatory pathways towards realizing the promise of these therapies.

BIO-Europe Spring® 2016
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Targeted cancer therapies: Breakthroughs in new treatments

With the advances in immunotherapies, we have seen more partnerships, IPOs, and clinical developments than ever before. Whether through checkpoint inhibitors, combination therapies, or CAR-T therapies, there is much to be excited about. We will highlight the newest breakthroughs and explore what's in the pipeline that has the industry buzzing.

Moderator:
Mike Ward – Global Director of Content, Informa Pharma Insights

BIO-Europe Spring® 2016
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Advanced therapies: The keys to treating rare diseases

In treating Duchenne Muscular Dystrophy, Huntington's disease, cystic fibrosis, and other rare diseases, we are seeing new technologies transforming the treatment landscape. Hear from the leading companies as they discuss the promising advances that may not only treat but possibly cure these rare disorders.

BIO-Europe Spring® 2016
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It's not a mirage: The promise of cell and gene therapy is real

How will the landscape change as more diseases have the potential to be treated or even cured with the advances in this field? What will it take to make these promises into a reality? Pharma execs will share insights on their strategies in developing, manufacturing, and commercializing these life-changing treatments.

BIO-Europe Spring® 2016
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Therapeutic Insight 2016


Therapeutic Insight by Defined Health
Connecting drug pricing to value: The industry's greatest challenge

Connecting drug pricing to value: The industry's greatest challenge

The drug pricing controversy now raging in the US has only one solution that will be palatable to the healthcare industry complex; there is nearly universal agreement that the price of drugs must be firmly based on their value. Indeed, unless this is done, we run the risk of killing the fruits of the enormous scientific progress made over the past 10 years. But espousing this objective is a lot simpler than accomplishing it, as value is very much in the eyes of the beholden stakeholder. In the EU, where value based pricing is the norm, the stakeholder vote is controlled almost entirely by the payer, and is based on long-established but nonetheless quite crude metrics (such as DALY). And in the US, where both the costs and benefits of drugs can impact a number of different key stakeholders over time, hurdles to demonstrating value are even more daunting.

This panel will discuss the numerous obstacles that exist to consistently and objectively valuing prescription medicines and explore innovative ways in which these can be addressed.

Moderator:
Ed Saltzman – President, Defined Health

BIO-Europe Spring® 2016
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Management of diabetes: Beyond the insulin and incretin pathways

Management of diabetes: Beyond the insulin and incretin pathways

Large Pharma Diabetes franchises (Novo Nordisk, Sanofi, Merck, and Eli Lilly), driven by innovative insulins and incretin pathway modulators (GLP-1 and DPPIV), have experienced rapid growth in recent years. The newest drug class in the treatment of type 2 diabetes, SGLT-2 inhibitors (gliflozins), was originally pursued after gene mutations in SGLT-2 were found in people with a benign familial renal glucosuria. Inhibition of SGLT-2 blocks reabsorption of glucose in the kidney and represents the first insulin-independent glucose lowering agent that not only lowers HbA1c, but has a favorable body weight reduction profile and has shown cardiovascular outcomes improvement when added to standard of care. However, when one looks at the antidiabetic drug development pipeline today, there is a concern that such innovation is lacking and that, despite the growing magnitude of the disease prevalence, with genericization of the category and the advent of biosimilars, the diabetes market growth trajectory may be coming to an end. In an attempt to stimulate innovation and address currently underserved patient populations, there is interest in studying micro-specialty, metabolic diseases and adding novel modes of therapy into development portfolios. In this context, the panel will discuss emerging science leading to treatments for such special populations (neonatal diabetes, hyperinsulinemia, and Maturity Onset Diabetes of the Young (MODY)), and evaluating the potential of RNA-based therapies (PTP-1B, PCSK9, ApoC-III, APO(a), etc.) and gene and cell based therapies (Gene Editing, Regulatory T-Cell and artificial pancreases).

Moderator:
Michael C. Rice – Senior Consultant, Defined Health

Panelists:
  • Olle Korsgren – Professor, Cell Therapeutics, Department of Immunology, Genetics and Pathology, Rudbeck Laboratory, Uppsala University Hospital
  • Tomas Landh – Innovation Sourcing VP, Senior Principal Scientist, Novo Nordisk
BIO-Europe Spring® 2016
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After inflammation, fibrosis: Will biopharma follow nature's lead?

After inflammation, fibrosis: Will biopharma follow nature's lead?

The autoimmune inflammatory disease (AIID) category is one of the largest in the pharmaceutical industry responsible for >USD 50 billion in sales/year. Success in this category was driven by development of therapeutics targeting conserved mediators (e.g. TNFα) that contribute to a large variety of AIIDs. Although pharma continues to profit from AIID, a number of observations suggest that innovators may soon need to look elsewhere: (1) key indications driving sales are well-served by available products; (2) existing franchises now cover many of the remaining indications; (3) payers are pushing back on products that don't provide superior outcomes; (4) biosimilars are coming! Like AIID, fibrosis represents a common process driven by conserved mediators, but fibrosis remains an area of great unmet need and untapped commercial potential (e.g., sales for NASH may reach USD 35-40 billion by 2025). As fibrosis is often the end-result of inflammation, companies developing AIID drugs may be well positioned to capitalize on the enormous potential of this space. However, fibrosis poses its own unique set of challenges (e.g., prevention vs. treatment paradigm, lack of non-invasive biomarkers, unclear regulatory path, potential for payer pushback). This panel will discuss the potential and pitfalls of looking beyond AIID to the uncharted territory of fibrosis.

Moderator:
David J. Lomb – Senior Consultant, Defined Health

Panelists:
  • Karl-Henrik Grinnemo – Chief Medical Officer, IsletOne Therapeutics
  • Hans T. Schambye – CEO, Galecto Biotech AB
BIO-Europe Spring® 2016
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Neurodegenerative disorders: Are we finally scaling the wall?

Neurodegenerative disorders:  Are we finally scaling the wall?

There have been several notable company formation/financing announcements in the field of neurodegenerative disease of late (Denali, Voyager, Yumanity), coming off of years of little investment in the field. The increased willingness on the part of investors and pharma to jump in now is due to a convergence of factors, including advances in the science, better understanding of disease due in part to the development of better imaging and other tools, and improved animal and disease models. In parallel, we have seen vastly improved access to funding, reflecting the increase in investor enthusiasm due to perceived risk reduction more in line with investor risk tolerance, and reinforced by the sustained availability of an open IPO window.

The tremendous unmet need in neurodegenerative conditions remains unchanged. What remains to be done to move the needle sufficiently in terms of our understanding of disease biology, validated targets, disease models, and biomarkers in order to move the field markedly forward?

Moderator:
Ginger S. Johnson – VP, Defined Health

BIO-Europe Spring® 2016
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Pharma Presentations
18:00–18:45
Exhibit Hall Hospitality Reception
19:00–21:00
Evening Networking Reception
Stockholm City Hall

Stockholm City Hall
Hantverkargatan 1
Entrance: through Inner Courtyard
11152 Stockholm | (map)

The Stockholm City Hall is one of Sweden's most famous buildings, and one of the capital's most visited tourist attractions. It houses offices for 200 people including the Municipal Council, and is also famous for its grand ceremonial halls and unique art pieces, like the Golden Hall with its more than 18 million pieces of gold mosaic. The Stockholm City Hall is the venue of the Nobel Prize banquet held on December 10 each year.

Sponsored by:

Stockholm, capital of Scandinavia Stockholm, capital of Scandinavia

18:30–19:00 Shuttle buses depart from the conference center to the evening event.
21:00–21:30 Shuttle buses depart from the evening event to all conference hotels.

Tuesday, April 5, 2016
07:45
Registration opens
07:45
Exhibition opens and Continental Breakfast
09:00–10:00
Workshop
Innovation in early stage funding

Research institutes active in life sciences face the "gap funding issue" of highly risky opportunities and look for seed funding solutions for their development into patient solutions. Therefore, academic institutes as well as pharma and venture capital companies in Europe are experimenting new ways to fuel and progress academic projects into the market arena, as this will create the critical mass of deal flows on which the European biotech industry can build. In this session, we link the different perspectives from all players involved.

Moderator:
Jan Staelens – Business Development Manager, VIB

BIO-Europe Spring® 2016
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08:00–18:30
One-to-one Meetings ►
09:00–13:00
Company Presentations ►
12:00–14:00
Luncheon
14:00–15:30
Workshop
Phase I: An inflection point in drug development and value generation

Phase I: An inflection point in drug development and value generationPhase I: An inflection point in drug development and value generation

An increasing number of "open innovation" initiatives aim to bring novel therapeutics to patients faster by facilitating public private partnerships, to solve common challenges encountered during the discovery and the drug development process.

Disruptive anticancer therapies increasingly come from small startups and biotechs. Phase I units in academic institutions have an active role to advance these innovations into the clinic. Biotech companies benefit from collaborating with Phase I experts well before Phase I trials will be initiated. Accessing this clinical expertise early on can significantly accelerate the development of disruptive innovations and increase the chance of success. Global pharmaceutical companies and investors play a major role in advancing novel therapies to patients. They partner both with biotechs as well as with academic centers, contributing their expertise in drug development and financial support.

In the first part of the session flagship academic institutions in Europe will show how they play the game, and how they can support small biotech companies in their drug development efforts. In the second part executives from biotech, pharma and the investment side will discuss the relevance and added value generated via Phase I clinical development and illustrate with case studies and examples for win-win partnerships.

Speakers:
  • Jean-Pierre Armand – Senior Oncologist, Expert in Phase I/II, Gustave Roussy Institute
  • Jeffrey Yachnin – Clinical Trials Unit, Department of Oncology, Karolinska University Hospital
Panelists:
  • Martin Bonde – CEO, Vaccibody
  • Johan Christenson – Partner, HealthCap
  • Dominique Costantini – CEO, OSE Pharma
  • Loïc Vincent – Head, Oncology External Innovation, Sanofi
BIO-Europe Spring® 2016
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14:00–18:00
Company Presentations ►
17:00–18:00
Workshop
How could life science industry capitalize on a life science cluster?

How can your organization benefit from being present in a life science cluster? We still are in an era of consolidation in the life science industry with a large number of mergers and acquisitions, and a redistribution of R&D resources towards external activities and collaborations. In addition, there is increasing competition from the emerging markets globally combined with the challenge of rising healthcare costs. As a result the small and medium sized enterprises (SMEs) as well as universities are important as additional drivers for continued innovation and growth. How can you take advantage of external research capabilities and strong regional networks? In this session our panelists will share their views and different perspectives on how to derive the most benefit from life science clusters.

BIO-Europe Spring® 2016
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17:45–18:45
Exhibit Hall Hospitality Receptions
19:00
Evening Networking Reception
Karolinska Institutet

Karolinska Institutet
Aula Medica
Nobels väg 6
171 65 Solna, Sweden | (map)

Karolinska Institutet is one of the world's leading medical universities and accounts for over 40 per cent of the medical academic research conducted in Sweden. Founded over 200 years ago, it has since 1901 selected the Nobel laureates in Physiology or Medicine. Karolinska Institutet's beautiful center, Aula Medica, boasts an auditorium with 1,000 seats, offices for about 100 people, 100 conference places, two restaurants and a cafe. Nobel lectures are arranged here, as well as scientific symposia, academic ceremonies and conferences.

Sponsored by:

J&J Innovation Karolinska Institutet

18:30–19:00 Shuttle buses depart from the conference center to the evening event.
21:15–22:30 Shuttle buses depart from the evening event to all conference hotels.

© Photographer: Ulf Sirborn

Wednesday, April 6, 2016
07:45
Registration opens
07:45
Exhibition opens and Continental Breakfast
09:00–13:00
Company Presentations ►
08:00–17:00
One-to-one Meetings ►
12:00–14:00
Luncheon
16:30
Closing Reception
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