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In this ISSUE

FDA-Required Labeling: Compliance and Consistency

Small Biopharma Struggles to Meet Development Challenges

From the Editor: When You Need Experts, Use Them

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Top Story
Does Pharma Really Want to Overhaul FDA?
In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation an efficient, rigorous FDA regulatory system, writes Jill Wechsler
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Driving compounds forward: Capsugel’s unique combination of drug and process design capabilities – coupled with premier depth in bioavailability enhancement and targeted delivery technologies – enable us to deliver the right solution for challenging compounds. We bring design to the CDMO space. Learn more
Market Access
In Search of a Silver Lining: A Global Market Access Outlook
Neil Grubert discusses what are likely to be some of the key trends in market access this year and beyond, and the implications for the life sciences industry
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DCAT Week: Business Development—Networking—Education
DCAT Week is the premier global event for the business of pharmaceutical development and manufacturing (March 20-23 in New York City). Organized by the Drug, Chemical & Associated Technologies Association, its unique model brings together members for high-level strategic meetings with key decision makers, timely educational programs and important networking opportunities. Learn more
Global
CMED: The “Curupira” of Brazil’s Pharma Market
Rafael Alencar, Mariana Torgal, Catarina Costa Pinheiro outline Brazil’s unique price-setting model for novel drugs—and the resulting pre-launch strategies for manufacturers
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E-Book: A High-Touch Approach to Product Access
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Risk Management
Reducing the Risks of Non-Compliance
Maria Gordian and Jason Evers outline the key steps to easing rising complexity and cost factors
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Legal
The Need for Intelligent IP Management
Haydn Evans looks at the role of intellectual property (IP) management in protecting pharmaceutical company products
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Regenerative medicine: Overcoming obstacles to reimbursement and market access
Live Webinar: Wednesday, March 8 at 3:00pm EST
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Calendar
/ March 29–31, 2017: DIA EuroMeeting 2017 /
Glasgow, UK
/ March 14–16, 2017: eyeforpharma Barcelona 2017 /
Barcelona, Spain
/ April 26–28, 2017: CBI’s 14th Annual Pharmaceutical Compliance Congress /
WASHINGTON, DC
/ June 6–7, 2017: Pharmaceutical Compliance Congress Canada /
Toronto, Canada
/ 20–22 June 2017: EphMRA Annual Conference 2017 /
Amsterdam, The Netherlands
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Biologics Manufacturing – Is Your Company Ready?
Live Webinar: Thursday, February 16 at 11:00am EST
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Value-Based Engagement Models: Making Collaborations between Pharma and Health Systems Work
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Industry update
//Margaret K. Feltz was named Chief Ethics & Compliance Officer at Purdue Pharma (Stamford, CT).//Retrophin (San Diego, CA) announced William “Bill” Rote, Ph.D. has been appointed Senior Vice President, Research and Development, effective immediately. //The Biotechnology Innovation Organization (BIO) announced that Majority Staff Director of the House Energy and Commerce Committee Dr. Gary Andres, will be joining as Senior Executive Vice President of Public Affairs. //Michael Coleman, Ph.D. has stepped down as President and CEO of InGeneron (Houston, TX). He will join the company’s Scientific Advisory Board. Ron Stubbers, formerly the company’s Vice President of Operations, was appointed President. The company has started the search process for candidates to replace Dr. Coleman as CEO. The company also announced the appointment of Glenn Winnier, Ph.D. as Chief Scientific Officer.//
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From Big Data to Measurable Outcomes: Success with Value-Based Contracts
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