Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Friday, April 4, 12:45 pm – 1:30 pm Closing Keynote: Flemming Ornskov, CEO of Shire – MassBio Annual Meeting 2014, Royal Sonesta Hotel, Cambridge, MA

Reporter: Aviva Lev-Ari, PhD, RN

Conference Coverage for Scientific and Social Media

12:00pm to 12:30pm Margaret A. Hamburg, MD Commissioner, US FDA

FDA is envying NIH but will not be just the NIH. Positive in driving innovations in the process of approving drugs, new regulatory processes are ot be implemented in BioMedical innovation, the Agency id working on IP, Economic incentives, investment in Science, tax credits, only innovations will bring Patients the benefits of collaboration of Academia, Industry and Agencies – National goals delivery of innovation with cost mindfulness, important agenda for FDA, State of MA and the National goals.

Q&A

Control to Assess on Clinical Trial Data – US vs Europe – Transparency initiative at FDA. Europe took big step on giving access to Clinical Trial Data.- patient protection, companies moved forward to give access to Clinical Trial data. companies need to give FDA permission to access data the clinical trial data.

If drug is not approved – give access to data

At present time, access is sought if a drug is approved.

12:45 pm – 1:30 pm Closing Keynote: Flemming Ornskov, CEO of Shire – MassBio Annual Meeting 2014, Royal Sonesta Hotel, Cambridge, MA

Dr. Ornskov – ex- Bayer, ex-Novartis, started as Hematologist

Technology and Medicine: Commitment to innovations

Patients and their needs very important.

MA Leader in Health Care and innovation Epicenter

• 120 universities
• 30 hospitals
• IPO in MA – last two year – the majority in MA.
• MABio – an association with strong leadership.
• 80% of Older one chronic condition 60% has two

SHIRE Perspective – Rare diseases, challenges and INNOVATION there. In US 7 years to get right diagnosis, in UK it takes 5 years, 2-3 are wrong diagnosis

Rare disease: connective tissue: Lupus, Sclaordema

10,000 rare diseases

Rely on Collaborations: Academia @ CHildren’s Hospitals

10-13 years to get one drug, $20 million to develop one drug