• [[ Whitepaper ]] Connecting With Rare Disease Patient Communities: Patient Advocates

    laureng Whitepapers April 19, 2018
  • [[Whitepaper ]] Disruptive Innovation in Rare Disease Markets

    laureng Whitepapers April 19, 2018
  • Choosing the Right Channel Strategy for Specialty Product Success

    Karina Kusova Clinical Development, Market Access, Orphan Drug Congress, Supply Chain & Manufacturing, Uncategorized, Whitepapers May 3, 2017
  • [Whitepaper] Challenging Conventional Patient Recruitment and Care Strategies for Rare Disease Studies

    Karina Kusova Clinical Development, Orphan Drug Congress, Uncategorized, Whitepapers April 10, 2017
  • [[whitepaper]] The New Reality: Maximizing Value in Rare Disease Launches

    Karina Kusova Clinical Development, Featured on App, Orphan Drug Congress, Uncategorized, Whitepapers April 6, 2017
  • What’s New in Rare Cancer Research? (Spoiler Alert: A Lot!)

    Karina Kusova Advocacy, Clinical Development, Market Access, Orphan Drug Congress, Orphan Drugs Live October 10, 2016

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Orphan Drug Congress

Orphan Drug Congress

How Advocacy and Policy Intertwine

In Orphan Drug Congress by Tim PeplowAugust 15, 2013Leave a Comment

“In the past and, perhaps to some extent, today, the specialized care and medications required for the appropriate management of patients with rare diseases, such …

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Spoiler Alert: World Orphan Drug Congress, Geneva 2013

In Advocacy, Clinical Development, Market Access, Orphan Drug Congress, Partnering & Investment, Regulation & Government by Matt TurnerJuly 31, 2013Leave a Comment

The secret is out. The unrivaled networking event for orphan drug developers is once again taking place in Geneva on the 14th-15th November 2013. Whether …

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Dr Janet Woodcock on the FDA’s new Breakthrough designation

In Orphan Drug Congress by Tim PeplowJuly 29, 2013Leave a Comment

Janet Woodcock, MD, Director of the FDA’s CDER drug division discusses the FDA’s new Breakthrough Designation for new drug approvals. Source: CurrentMedicine.TV  

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Dr. Richard Pazdur on the Breakthrough Designation Requirements

In Orphan Drug Congress by Tim PeplowJuly 29, 2013Leave a Comment

“Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, emphasizes the importance of adequate …

The Canadian orphan drug market – Eric Gervais of Medunik Canada

In Orphan Drug Congress by Tim PeplowJuly 29, 2013Leave a Comment

Eric Gervais, Executive Vice President of Medunik Canada, presented at World Orphan Drug Congress USA 2013 on the topic, ‘Myth and reality on the Canadian …

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Martine Zimmerman of Alexion on Europe’s regulatory process

In Orphan Drug Congress by Tim PeplowJuly 29, 2013Leave a Comment

Martine Zimmermann, Executive Director Global Regulatory Affairs at Alexion Pharmaceuticals, presented at World Orphan Drug Congress USA 2013 on the topic, ‘Where industry stumbles in …

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Identifying biomarkers to articulate the value of an orphan drug: a look into Vertex’s Kalydeco case – Charles Johnson, Vertex

In Orphan Drug Congress by Tim PeplowJuly 29, 2013Leave a Comment

Charles Johnson, VP of Global Medical Affairs at Vertex Pharmaceuticals, presented at World Orphan Drug Congress USA 2013 on the topic, ‘Identifying biomarkers to articulate …

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Three Reasons Orphan Drugs Are Hot

In Orphan Drug Congress by Tim PeplowJune 19, 2013Leave a Comment

“Dr. Coté is the leading national regulatory expert in orphan drug development. With 22 years of Federal service at the FDA, NIH, and CDC, Dr. …

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