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In this ISSUE

Enabling Cultural Change in Organizations

FDA Opens Door to Importing Scarce and Costly Drugs

Gaining Ground with Stem Cells: Gil Van Bokkelen, Athersys

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Reconstructing
Does the Pfizer Restructuring Make Sense?
The Pfizer restructuring will be a case study in whether corporate restructuring & innovation can co-exist or whether M&A is the more viable answer, writes Edward Pratesi.
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A Framework for Successful Biopharma Launches Understanding the launch archetype and identifying critical success factors
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Opinion
The Key to Better Navigating VUCA Industry Conditions
Alison Horstmeyer discusses how pharma executives can apply four attributes of curiosity to negotiate VUCA (volatile, uncertain, complex, and ambiguous) conditions and improve organizational outcomes.
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Calendar
 
/ 12th Annual Forum on Transparency and Aggregate Spend 8/13-8/15 /
 
/ 4th Bio/Pharmaceutical Product Launch Summit 9/25-9/26 /
 
/ American Pharma Outsourcing Summit 10/2-10/3 /
 
/ 28th Annual Sharing Conference: Compliance 10/15-10/17 /
 
/ Basket & Umbrella Trials for Oncology 10/17-10/18 /
 
/ Crossroads: An Artia Solutions Conference 11/7-11/9 /
 
Oyster Point Pharma
The Pharm Exec Podcast: Episode 13
Jeffrey Nau is CEO of Oyster Point Pharma, a clinical stage pharmaceutical company focused on developing commercial therapies dealing with parasympathetic pathways. In a climate where oncology and rare diseases get most of the attention, Nau talks about what it's like working on diseases that don't get the same press, like dry eye, which is the focus of their current Phase 2 clinical trial. How this impacts raising capital and other bumps in the road he has come across. Having extensive experience with raising startup money, Nau outlines some best practices when it comes to funding.
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R&D
Optimizing the Digital Opportunity in Biopharmaceutical R&D
If advanced technologies hold the key to at least some of the productivity issues R&D organizations need to overcome, Nicholas Lakin asks what are the best strategies and operating models for exploiting these aids to their fullest potential.
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The FDA
Gottlieb Reshapes FDA to Elevate Centers, Streamline Policymaking
Scott Gottlieb is proposing to flatten out FDA's structure by having Center directors report directly to him, giving more authority to the agency's six product regulatory Centers and to the Office of Regulatory Affairs.
... /Read more/
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