Around the World in 120 Days: Europe 101 - Opportunities for Collaboration & New Markets

Thursday, April 10 2014
8:00 am – 10:00 am

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

Join us for Part II of our Forum series:
Around the World in 120 Days: Biotech on a Global Scale

Europe is the second largest pharmaceutical market after North America.  With a strong academic base, a highly skilled workforce, and a number of government incentives, Europe continues to be an important territory in any biopharmaceutical company strategy as a venue for collaboration at all stages of drug development and as a market for products.

Please join us for the second part of the “Biotech on a Global Scale” series  as we introduce key concepts of doing business in Europe.  Attendees will leave with a better understanding of opportunities and challenges in Europe, including:

  • Product approval
  • Reimbursement and pricing
  • IP protection
  • Entrepreneurship
  • Financing
  • Commercialization policies

Attendees will also have the opportunity to meet the members of a number of European delegations to begin to discuss partnering in Germany, the UK and France.

Speakers:

  • Claus Becker, Head of Value and Access Group, Merrimack Pharmaceuticals
  • Thor-Björn Conradson, MD, Consultant, Drug Development Counselling Group, KLIFO
  • Peter Damsbo, MD, Consultant, Drug Development Counselling Group, KLIFO
  • Dave Gilbert, Advisory Board, NDA Advisory Services, UK
  • Scott Maguire, CEO, Xenetic Biosciences


Moderator:    

  • Mark Leuchtenberger, President and Chief Executive Officer, Acusphere, Inc.

 

This Forum is presented by the Legal & Regulatory and Business Development & Finance Forum Working Groups. 

 

Speaker Bios

Claus Becker, Head of Value and Access Group, Merrimack Pharmaceuticals

As Head of Value and Access group at Merrimack Pharmaceuticals Claus Becker is responsible for maximizing profitable access and reimbursement globally. Before joining Merrimack Pharmaceuticals, Claus was four years at Vertex working on HEOR, Value and Access issues for two very successful launches (Incivek and Kalydeco). In total, Claus Becker has more than twenty years of life science experience covering much of the value-chain including, conception of ideas for novel medicines, demonstration of proof of concept, clinical trials, manufacturing (pilot and full scale), portfolio & business planning and since 2009 Access and Reimbursement.

 

Thor-Björn Conradson, MD, Consultant, Drug Development Counselling Group, Klifo

Thor-Björn Conradson, MD from Gothenburg Sweden (1972) and PhD from the University of Lund (1987) has a specialist degree in Cardiology and General Internal Medicine. After 12 years as clinician he joined industry working 17 years for Astra AB and AstraZeneca and 7 years for the Nycomed Group. His key positions in the pharmaceutical industry have been Vice President, Research Support and Regulatory Affairs Astra Draco, Lund, Vice President, Corporate Regulatory Affairs, Astra AB, Södertälje, Sweden and Senior Vice President, International Product Development, Nycomed, Denmark.

Apart from almost 12 years’ experience as a physician (mainly cardiology) Thor-Björn Conradson has a broad experience from different areas of Drug Development, e.g. Medical Affairs, Drug Safety, Clinical Operations, Regulatory Affairs, Project Management.  He has contributed to several European MAAs and US INDs/NDAs in different therapeutic areas such as cardiovascular, respiratory, osteoporosis and pain.

 

Peter Damsbo, MD, Consultant, Drug Development Counselling Group, Klifo

Peter Damsbo has more than 25 years of experience from life science industry and science, including 3 years in the United States heading up clinical development of diabetes products for Novo Nordisk. Key positions include Chief Development Officer at Zealand Pharma, Vice President Clinical Drug Development at Novo Nordisk HQ, Medical Director Diabetes at Novo Nordisk USA, and Research Fellow at the Steno Diabetes Center, author and co-author of more than 20 peer reviewed papers. Peter Damsbo has carried 3 projects from preclinical phase through to worldwide registration from a clinical perspective, including writing the expert reports and presented at meetings and hearings with FDA and EMA. He has experience in medical device development and conducted numerous drug concept evaluations and been involved in drug licensing deals and due diligence processes.  Therapeutic areas expertise: Diabetes, Obesity, Metabolic Diseases and Inflammatory Diseases

 

Dave Gilbert, NDA Advisory Board

Until 2011 David Gilbert was Managing Director of the NDA Advisory Board, a group of EU ex-regulators offering strategic advice to Pharma companies large and small.  Today he remains a member of that Board and is also a freelance consultant.  NDA is science based and advises clients on how to do good drug development and to avoid classic development pitfalls.  Prior to joining NDA David held a senior regulatory positions in Europe including Head of Regulatory Affairs (EU) for Pharmacia and Head of EMEA Liaison for Novartis.  Mr Gilbert was very active in EFPIA, the European Pharma trade association,  during the establishment of the EMA and is familiar with the development of the Agency and its role and practices.  His background is in pharmaceutical research and development in the field of ophthalmics with a degree in Pharmacology from London.  Today his expertise is in strategic regulatory input to development, scientific advice, orphan drugs and Health Authority interactions. 

 

Mark Leuchtenberger, President and Chief Executive Officer, Acusphere, Inc.

Mark Leuchtenberger joined Acusphere, Inc. as President and Chief Executive Officer in 2013,  bringing experience in commercial operations, business development and preparing biopharmaceutical companies for product approval and commercialization.  Mr. Leuchtenberger most recently served as President, Chief Executive Officer and a member of the board of directors at Rib-X Pharmaceuticals (now Melinta) until its acquisition.  Prior to Rib-X, Mr. Leuchtenberger served as President and Chief Executive Officer of Targanta Therapeutics Corporation, where he led the company’s initial public offering in 2007 and its acquisition in 2009.  From 2006 to 2009 Mr. Leuchtenberger served as the President and Chief Executive Officer of Therion Biologics Corporation, a privately held cancer vaccine company.  Prior to Therion, Mr. Leuchtenberger was a senior officer at Biogen Idec Inc., where he led the Avonex® development and launch in the United States and subsequently managed North American and international commercial operations. Mr. Leuchtenberger received his M.B.A. from the Yale School of Management and his B.A. from Wake Forest University.  He is a director and past chairman of the Massachusetts Biotechnology Council Board of Directors and currently serves as a trustee for Beth Israel Deaconess Medical Center and Chairman of the Advisory Committee for the MassDevelopment Emerging Technology Fund.  He is a co-founder of Albor Biologics, Inc. and Alvos Therapeutics, Inc.

 

Scott Maguire, MBA, CEO, Xenetic Biosciences

Mr. Maguire joined Xenetic Biosciences (XBIO) in April, 2004 as CEO. He led the company’s 2006 listing on London Stock Exchange and transacted license deals that have exceeded $100M in cash milestones.  He has also led the capital raises from places wide and far, including the US, India and Russia. Scott has over 20 years of global life sciences and healthcare investment banking experience. He has advised many U.S. and European companies on capital raises and commercial development. In 1996 he co-founded the Arthur Andersen global healthcare corporate finance practice based in London. He left Andersen in 2001 and founded Healthcare Capital Partners Limited, a healthcare and life science corporate finance and proprietary investment boutique. Scott has sat on public company boards for over 8 years and has board positions in a number of UK companies.

 

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