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 June 25, 2015 | ISSUE NUMBER 406 VOL 4

Top Story
FDA Safety and Innovation Act: Too Many Breakthroughs?
When the breakthrough program was established as part of the FDA Safety and Innovation Act, advocates envisioned about 2-3 designations a year. As of the end of May, the agency had received 308 requests for breakthrough status and had granted the designation for 90. FDA now wants to better educate industry on what really qualifies for breakthrough status, writes Jill Wechsler
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Worldwide Clinical Trials
Scientifically Minded, Medically Driven
You work tirelessly to bring better products to market and improve patients' lives. At WCT, we support you by consistently delivering quality results, on-time, on-budget and always bolstered by unrivaled science and medicine. Flexible. Reliable. Committed.
We aren’t satisfied until you are.

See our poster presentation at ASCP in Miami!

Pharma 50
Pharm Exec’s Top 50 Pharma Companies
Our annual Pharma 50 listing is clear proof that once-small and midsize biopharma companies are moving up to join the top ranks of big Pharma. Specialty drug sales, record-breaking M&A paired with tax synergies, and global expansion helped to bring a new face into this year’s Pharma 50 top 10, and substantially boosted the rankings of several others.
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On the road to integration
Moving your multichannel program into the fast lane

Live webcast: Wednesday, 1 July 2015 at 11 am EDT | 16:00 BST | 17:00 CEST
Join Peter Lammers and Liz Murray from Quintiles as they present insightful research findings regarding the state of the pharmaceutical industry and the use of multi-channel marketing strategies. Learn what other industries apply successfully and get different options for you to actually “make it happen” for your product.
Register for free

Patients
Toward Real-World Patient Centricity
Despite industry-wide ambitions of patient centricity, new innovation in pharma is still almost exclusively evaluated on safety and medical efficacy in the clinical trial setting. Mikkel Brok-Kristensen suggests pharma takes a look at the invisible costs and the needs beyond efficacy
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Breaking through the complexity
Improving oncology treatment and access in the UK

Live webcast: 30 June 2015 at 9 am EDT | 14:00 BST | 15:00 CEST
Join Dean Summerfield, Senior Vice President, Commercial and Consulting from Quintiles and Dr Jason Lester, Consultant Clinical Oncologist at the Velindre Cancer Centre as they discuss improving innovative oncology treatment and access in the UK.
Register for free

Europe
Joint Procurement of Medicines Climbs the EU Agenda
Ireland's signing of a vaccine procurement agreement this month gives it membership of a growing club of EU member states who are interested in working together to purchase medicines, writes Reflector
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Data
Big Data Innovation and Risk: Striking the Balance
Recent innovations in the collection, sharing, and analysis of vast amounts of data have the potential to greatly lower the cost of drug development and increase productivity, writes Adam Towvim
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//Intercept Pharmaceuticals announced the appointment of Juan Carlos Lopez–Talavera, M.D., Ph.D. as Senior Vice President of Medical Affairs. //Ipsos has appointed Gary Bennewies, currently the company’s Country Manager for Canada, to the newly created position of Chief Talent Officer. He will be based at the company's headquarters in Paris, France. //Cleave Biosciences (Burlingame, CA) announced Kanya Rajangam, M.D., Ph.D. has joined the company as Vice President, Clinical Development. The company also announced that Chief Medical Officer Alessandra Cesano, M.D., Ph.D. is leaving the company to pursue other opportunities. //

July 22–23: Expanded Access Programs
Washington, DC


August 11–12: Speed to Therapy Strategy Summit
Philadelphia, PA.


September 17–18: Immunotherapy Commercialization
Boston, MA.

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