Tag Archives: drug development

BIO Patient and Health Advocacy Summit: Patient-Focused Drug Development

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Panelists in this morning’s opening session outlined strategies for the FDA to better engage the patient community to guide the drug development process. “Patients should be providing input and guidance throughout the entire drug review process,” said Marc Boutin, Executive VP and COO of the National Health Council. Boutin highlighted the improvements made through PDUFA V to open up and enhance the Agency’s interaction and engagement with patients. “Integrating our perspective into how drugs are Read More >

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Who Cares About ALS?

ALS

1,100 days. That’s the average amount of time a person survives following a diagnosis of ALS. That is because ALS is a progressive neurodegenerative disorder defined by the loss of both upper and motor neurons which in the clinic is characterized by the atrophy of nearly all a person’s muscles.  These 1,100 days aren’t pretty. Each person will progressively lose their ability to speak, move or eat on their own. Most people will die from Read More >

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A Bright Future for Orphan Disease Indications

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In celebration of National Rare Disease Day BIO’s Industry Analysis team took a look at recently-approved drugs in the BioMedTracker database with an orphan indication designation. Our research found that 2012 saw the greatest number of approvals of therapies for orphan indications going back all the way to 2000 (This count includes previously approved drugs with new, orphan indication approvals).   Overall, 24 therapies were approved in orphan indications last year, including drugs for Anthrax, Gaucher’s Read More >

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Putting a Ring on It: Advice on Successful Drug Development Collaborations

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Drug development partnerships can look lucrative to small biotechs eager to monetize their discoveries, but, like any relationship, these tie-ups take work and both parties run the risk of ending up in tears. At BIO’s recent CEO & Investor Conference, a panel of industry veterans gathered to discuss best practices in drug development partnering. Moderated by Jeff Stewart, Senior Engagement Manager with Campbell Alliance, the panel “Putting a Ring on it: When Drug Development Partnerships Read More >

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Harder, Better, Faster, Stronger: Takeaways from Partnering For Cures 2012

Drug Manufacturing

The chorus to Kanye West’s 2007 chart-topper Stronger can teach us volumes about speeding drug development. Harder:  Drug development is challenging.  It takes over 10 years and more than $1 billon to bring a therapy through the product pipeline, from the research lab to clinical trials to FDA approval to prescription to patients suffering from the disease. The FDA approved over 30 innovative drugs last year, including more than 10 new treatments for cancer—a good Read More >

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