PHARMACEUTICAL EXECUTIVE NEWSLETTER

In this ISSUE

Novartis' Data Science Enablers

Drug Research and Review Issues on FDA Radar

Key Observations on the General Data Protection Regulation (GDPR)

Top Story

8 Tipping Points: Pharm Exec's 2019 Industry Forecast

Pharm Exec's annual look at what lies ahead for the biopharma industry in the coming months examines eight key trends that look to be at tipping points in their evolution and poised to shape the life sciences landscape in 2019
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Regulatory

FDA Sets Records in Approving More New Drugs

It's been a banner year in the new drug approval business: CDER approved 59 novel drugs and biologics in 2018, surpassing previous high marks and improving on recent gains, with additional new products approved by the CBER boosting the total. Jill Wechsler reports
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AI & Big Data

Novartis: Data Science as True Strategic Partner

Mimi Huizinga and Miriam Donaldson talk about how Novartis is laying the foundations for a new operating model as a "medicines and data science company"
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AI & Big Data

Digital Visionary: Andre Heeg, Sandoz

Andre Heeg, Sandoz's new Head of Digital, tells Pharm Exec about his digital vision for the company
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Digital

Finding the Right Digital Partner

Paul Upham outlines the key considerations that inform companies' evaluation and selection of digital health partners
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New Markets

5 Myths About Biosimilars

The introduction of biosimilars has been one of the biggest milestones in autoimmune treatment, but an air of uncertainty still lingers around the true impact of these new players. So what has happened in the market since their arrival?
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Industry update

// Onconova Therapeutics (Newtown, PA) announced the appointment of Dr. Steven Fruchtman as Chief Executive Officer and a member of the Board of Directors. // Allena Pharmaceuticals (Newton, MA) announced that Louis Brenner, M.D., President and Chief Operating Officer, will be promoted to Chief Executive Officer and appointed to the Board of Directors, effective February 1, 2019. // Retrophin (San Diego, CA) named Eric Dube, Ph.D. as President and CEO. // Unum Therapeutics (Cambridge, MA) reported that Christiana Stamoulis, President and Chief Financial Officer, will be stepping down from the company, effective January 31, 2019. // BioDelivery Sciences International (Raleigh, NC) appointed Terry Coelho as Chief Financial Officer. // Enochian Biosciences (Los Angeles, CA) announced that its new Executive Vice-Chair, Dr. Mark Dybul will be taking over the leadership of the company following the departure of Eric Leire as Chief Executive Officer. // Reata Pharmaceuticals (Irving, TX) appointed Geoffrey A. Block, M.D., as Vice President, Nephrology.

Calendar

/ January 22–23, 2019: 14^th Biosimilars Summit /

Alexandria, VA

/ January 23–24, 2019: Data Analytics and Decisions /

Philadelphia, PA

/ January 24–25, 2019: Specialty Therapies 2019 /

Las Vegas, NV

/ January 29–30, 2019: 6^th Annual Clinical Data Disclosure and Transparency /

Philadelphia, PA

/ March 4–6, 2019: 20th Annual Patient Assistance and Access Programs – PAP 2019 /

Baltimore, MD

/ March 12–13, 2019: Pharmaceutical Compliance Congress Asia /

Shanghai, China

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