Pharmaceutical Commerce - September/October 2010 - (Page 1)

Business Strategies for Pharma/Bio Success 2010 PRODUCT SECURI SUPPLEMTY ENT page 28 www.PharmaceuticalCommerce.com SEPTEMBER/OCTOBER 2010 Business & Finance Brand Marketing | Communications Rare Diseases and Orphan Drugs Lift Pharma Innovation As hundreds of candidate drugs receive official “orphan” status, the Orphan Drug Act gets re-examined. Meanwhile, these drugs are driving the growth of specialty pharmacy By Suzanne Shelley There are now 357 commercialized orphan drugs approved by the pathway outlined in the Orphan Drug Act of 1983 (ODA), with hundreds more receiving that status in clinical research phases. On the one hand, that number can be looked on as an unqualified success—many of these drugs are offered for rare diseases affecting (by regulatory definition) 200,000 patients or fewer in the US, or fewer than 5 per 10,000 patients in Europe. On the other hand, advocates for nearly 5,800 other rare diseases for which cures or treatments have not been commercialized are petitioning Congress to compel FDA to loosen the review and approval process, and provide even more incentives for manufacturers to develop new treatments. Equally significant, ODA status can help a struggling young biotech company to get a novel treatment method into commercial use; in some cases, the orphan drug status becomes the springboard for opening up a molecule, biologic or treatment to larger, non-orphan conditions. And now, Big Pharma is becoming enthusiastic about pursuing rare diseases, with companies such as Pfizer and GSK setting up orphan drug programs. A high proportion of orphan drugs are also specialty pharmaceuticals (60% are biologicals), requiring close coordination with providers (such as for infusion Pharmacos and Payers: Achieving Common Ground in a Changing Market By Terri Bernacchi and Mark Wiseman, Managed Markets Services, IMS Health Most would certainly agree that the main focus of discussion between manufacturers and payers is and has been, “What is the price of this drug, and what discount can I get from that price?” But this discussion has been going on since the first health plan set the first contract with a manufacturer, and now it has become much more nuanced. The complexities go both ways and may involve hard-to-measure elements such as patient demand, health plan quality metrics and outcomes, and the still-unfolding impact of government pricing. New drugs and technologies impact both the medical and pharmaceutical side of the payer universe, and the fact that manufacturers are more involved in proving ongoing safety and efficacy has created more of a sense of “shared responsibility.” continued on page 14 > Supply Chain | Logistics Booming Biopharma Cold-Chain Market Attracts High Industry Turnout therapies), and extensive patient support. This, in turn, is spurring the development of specialty pharmacies and specialty distributors to provide the hands-on service necessary. In some cases, specialty pharmacies, together with researchers and healthcare providers, help organize registries of rare-disease patients (who are often poorly diagnosed precisely because the condition is so rare), which in turn helps assemble the clinical-trial group to move the research process forward. Today, the bulk the 6,000 rare diseases that have been identified — 83% — are believed to affect fewer than 6,000 patients (each) in the US. “From a businesscontinued on page 12 > Record numbers of attendees and exhibitors came together at Philadelphia meeting By Nicholas Basta It’s an unusual industry meeting where agencies announce new regulations or guidelines and the audience applauds. But that is one perspective on the recent IQPC Cold Chain Distribution for Pharmaceuticals Global Forum (Philadelphia, Sept. 20-23), where an impressive list of groups, including USP Pharmacopeia (USP), International Air Transport Assn. (IATA), International Soc. For Pharmaceutical Engineering (ISPE), International Safe Transit Assn. (ISTA), Transportation Security Administration (TSA) and the UK’s Medicines and Healthcare Products Agency (MHRA) announced new, revised, or draft rules and guidelines to a generally receptive audience. And that audience was a new record high, according to the conference managers, IQPC (New York). About 550 were in attendance—a more-than 50% increase over the previous year. They, in turn, attracted 57 exhibitors, a near doubling from the previous year. What’s the buzz? The obvious answer is that the business of storing and delivering temperature-controlled biopharmaceuticals is growing; Pharmaceutical Commerce’s own Biopharma Cold Chain Sourcebook projects a double-digit growth rate over the 2008-2011 period (Pharmaceutical Commerce, April, p. 1). “Business has never been better,” says Mark Mohr, product development manager at Continental Air Cargo (Houston). Logistics service providers are eager to jump on the bandwagon, as the global logistics industry is still recovering from a disastrous drop-off in activity during 2009. While shipping volumes are on the increase, capacity has remained low, creating looming bottlenecks in continued on page 22 > © Dmitry Oshchepkov/iStockPhoto.com PRSRT STD US POSTAGE MENDOTA, IL PERMIT 200 PAID http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2010

Pharmaceutical Commerce - September/October 2010
Contents
Editorial
Op-Ed
Top News
Business & Finance
Brand Marketing | Communications
Supply Chain | Logistics
Information Technology
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Meetings & Editorial Index

Pharmaceutical Commerce - September/October 2010

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