Norwood, MA (PRWEB) October 08, 2013
BioPharm Insight™ is emphasizing orphan drug development this month with an exclusive subscriber report on the orphan drug market base and an educational webinar on the topic. BioPharm Insight – which is part of Infinata, a Financial Times Group company – is a leading provider of business intelligence solutions which also include BioPharm Clinical™, High Net Worth Insight™ and Wealthmonitor™.
Orphan drugs are designed to treat some of the rarest medical conditions known to humans. In the U.S., a rare disease is defined as affecting less than 200,000 individuals at any point in time. According to the NIH, there are about 7,000 rare diseases that fit this definition, including cystic fibrosis, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, and Gaucher’s disease.
BioPharm Insight Orphan Drug Report
BioPharm Insight reports typically uncover industry news up to two years before other news organizations. The report covers companies including Shire, Vertex, BioMarin, Alexion, Neopharm Group, and Isis/Biogen. Report highlights include:
- The top 10 most expensive FDA-approved therapies in the U.S.
- Global licensing agreements for orphan drugs from 2007-2013
- Global trends of licensing agreements for orphan drugs from 1Q07-2Q13
Educational Webinar: The Do's and Don’ts of Orphan Drug Development
On Tuesday, October 15, 10:00am EDT, BioPharm Insight will host an educational webinar on the orphan drug approval process. Topics include:
- Common misconceptions of orphan drug development, for example: shorter, more lenient approval pathways are prevalent, but it is not quite that simple
- Various classifications of rapid approval: "accelerated approval" is not the only pathway for post-Phase I or Phase II approval
- What happens when there is no validated biomarker for an orphan disease? What are the alternative pathways for rapid approval in this case? What are the hurdles to actually validating a biomarker?
Speakers are Dr. Tim Cote, Principal and CEO of Cote Orphan Consulting, and former Director of the FDA's Office of Orphan Drugs; and, Kurt R. Karst, Director, Hyman, Phelps, & McNamara. Moderators are Jennifer Smith-Parker, Assistant Editor and Anusha Kambhampaty, Senior Healthcare Reporter with BioPharm Insight.
Register at https://www4.gotomeeting.com/register/242000183.
Read Jennifer and Anusha’s recent article on orphan drugs on Applied Clinical Trials.
About BioPharm Insight
BioPharm Insight is the definitive guide to the global biopharma community. BioPharm Insight provides subscribers with an information edge by combining the most comprehensive real-time database of companies, drugs, contacts, M&A and licensing deals, forecasts and clinical trial data with proprietary forward-looking intelligence uncovered by an independent team of investigative journalists months or even years before it breaks in mainstream media. To learn more, visit http://www.biopharminsight.com.
About Infinata, Inc.
Infinata provides personalized technology solutions to turn information into insight. Services include a comprehensive BioPharm Solutions Suite, unique Wealth Prospecting tools and innovative Custom Data Services. Infinata is a part of Mergermarket, a Financial Times Group company and a division of Pearson plc. To learn more, visit http://www.infinata.com.
Business Inquiries: Holly Burke, hburke(at)infinata(dot)com, 781-619-0131
Media Inquiries: Brenda Nashawaty, Brenda(at)nashawaty(dot)com, 617-688-3253