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
Conference Coverage for Scientific and Social Media:
Aviva Lev-Ari, PhD, RN
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
2012pharmaceutical
Aashir Awan, Phd
Alan F. Kaul, PharmD., MS, MBA, FCCP
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amnondanzig1724
anamikasarkar
apreconasia
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David Orchard-Webb, PhD
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Demet Sag, Ph.D., CRA, GCP
Dror Nir
evelinacohn
Gail S Thornton
Irina Robu
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kellyperlman
Ed Kislauskis
larryhbern
lmulligan13gmailcom
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Rosalind Codrington, PhD
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Rick Mandahl
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Dr. Sudipta Saha
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When Dr. Hamburg mentioned FDA is envying the NIH did she meanFDA is desiring more research funds and lab space to enhance their primary mission or are they trying to compete with NIH as an innovation center?
Dr. Williams,
Thank you for your comment.
My sense was that she is fully aware of the vast difference in size, and budgets. The envy was referred to the in-depth scope of the research pursuit at the NIH and the upmost quality of the scholars in residence.