FDA Gains Approval to Revamp New Drug Review Operations

In this ISSUE

Improving the Lives of Bladder Disease Patients

Pharma 4.0: Redefining Product Development and Regulatory Operations

Who Will Head FDA?

Top Story

FDA Gains Approval to Revamp New Drug Review Operations

The Center for Drug Evaluation and Research (CDER) has finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs
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Launching Medical Devices in the Japanese Market
- How to navigate regulatory and reimbursement approval
Thursday, October 31, 2019 at 11am EDT
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Marketing

Pharmaceutical Native Advertising

Rafael Cosentino looks at how native advertising works, what cost benefits it provides, and measuring its success
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Japan Oncology Market – Best in Class Practices for Advancing Patient Outcomes
Tuesday, October 29, 2019 at 11am JST
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Calendar

/ October 8–9: Life Sciences West Coast Compliance Congress /

San Francisco, CA,

/ October 21–22: Real-World Data and Evidence Summit /

Arlington, VA

/ October 21–22: Life Sciences Value-Based Contracting /

Arlington, VA

/ November 13–14: 6^th Annual Global Compliance Congress /

London, UK

/ December 11: eyeforpharma Awards 2019 /

Philadelphia, PA.

/ December 11–12: Pharmaceutical Drug Pricing Strategies Summit /

Washington, DC

/ December 11: Clinical Trial Financial Management /

Philadelphia, PA.

Interview

Bernhardt Zeiher, Astellas: Shifting Approaches from Traditional R&D to Platform

Bernhardt Zeiher, Chief Medical Officer of Astellas, discusses how the company transitioned from a traditional R&D approach to a platform approach, the need for innovation models to change in pharma, and the impact academia has on drug development
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Launch Strategies: Trends and Challenges for Biotech Companies
Wednesday, October 23, 2019 at 10am EDT
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Interview

The Michael J. Fox Foundation: Better Diagnostics and Treatments for Dementia

Rachel Dolhun of The Michael J. Fox Foundation for Parkinson’s Research tells Pharm Exec about how she helps the Foundation to mobilize greater research engagement
… /Read More/

Japan Oncology Market – Best in Class Practices for Advancing Patient Outcomes
Tuesday, October 15, 2019 at 5pm JST
Register Now

Feedback

Pharm Exec Podcast Survey

As the Pharm Exec podcast enters its 3rd year, we are asking that podcast listeners take a quick, five-minute survey where we can glean more information about how you consume our episodes, how long they should last, and what topics you’re interested in hearing about. Please provide feedback before November 8th
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Industry update

//Salarius Pharmaceuticals (Houston, TX) announced the appointment of Scott Jordan to the new role of Chief Business Officer and the appointment of Mark Rosenblum as Executive Vice President Finance and Interim Chief Financial Officer. // Adamas Pharmaceuticals (Emeryville, CA) named Neil McFarlane as Chief Executive Officer and member of the Board of Directors. McFarlane succeeds Gregory Went, Ph.D., who was Chairman and CEO of Adamas from the company’s inception. // Kintai Therapeutics (Cambridge, MA) appointed Mark E. Nuttall, Ph.D., as Chief Business Officer.

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