Pharmaceutical Commerce - November/December 2010 - (Page 1)

Business Strategies for Pharma/Bio Success www.PharmaceuticalCommerce.com NOVEMBER/DECEMBER 2010 Business & Finance Packaging & Drug Delivery How to Transform REMS Into an Opportunity to Develop a More Successful Drug Launch By Craig Kephart, Centric Health Resources Oral Liquids Hold Steady as a Drug Delivery Method Although overshadowed by oral solids, oral liquids provide important benefits for pediatric, geriatric and specialized therapies By F.J. Quinn Among all pharmaceuticals, oral dosages are preferred, when pharmacokinetics permit them. And among oral dosages, oral solids— pills—are the most common form. But there have been, and will continue to be, a significant number of drugs that are administered as oral liquids; additional forms of liquid products include topical ointments, droplets, or sprayed or inhaled aerosols. Oral liquids have some disadvantages in commercial distribution, according to industry sources. They generally need airtight packaging and have a shorter shelf life. Manufacturing is more challenging, and care must be taken to keep the formulation components in suspension. (It is for some of these same reasons that certain injectable drugs are freeze-dried [lyophilized] into powders and then reconstituted as a liquid prior to injection.) continued on page 22 > Risk Evaluation and Mitigation Strategies (REMS), established by the FDA Amendments Act of 2007, are now a common component of new product launches. While they are looked on as an added burden to commercialization, we believe that they offer an opportunity to create an enhanced program to better serve the needs of the marketplace. For any drug market, be it for orphan diseases or for a broader population, manufacturers should view stricter requirements as an opportunity to fully integrate REMS into a streamlined distribution channel that builds a more programmatic solution and creates value that goes beyond the therapeutic outcome of the drug. In the process of getting a drug to market, pharmaceutical manufacturers should begin viewing FDA’s REMS as a two-fold opportunity. First, the REMS development process should begin early in the drug development cycle as a means for avoiding potential delays. In the current atmosphere of health care reform and tougher standards, manufacturers are finding that more of their drugs require REMS to ensure Fig. 1. The steps to a health management system that its benefits outweigh its risks. In a recent survey of manufacturers whose products had received a REMS mandate, 77% noted that the REMS discussion contributed to a review extension.[1] Approaching the process as an opportunity to enhance the approval timeline early on—and putting together a thorough, “real world” proposal with the approval application—serves to minimize delays related to REMS. The second opportunity that REMS provides occurs once the drug has become commercialized. Upon drug launch, manufacturers can leverage REMS by using it as a platform to offer more robust health management services by regularly connecting with patients, educating, collecting data, and going beyond simply discussing a drug’s side effects. Health management addresses the needs of the patients beyond managing the therapy (see box). It deals with the emotional impact of their disorder, co-morbidities, concomitant interactions, impact on daily living activities, avoidance of unnecessary health care utilization, and so on. Health management utilizes regular patient contact to help patients address issues continued on page 10 > Brand Marketing | Communications The Struggle to Get Anti-Infectives on a Faster Track to Commercialization A looming crisis in drug-resistant anti-infectives is not being met with a commensurate industry effort. Governments and industry are trying to code By Suzanne Shelley Credit: Centric Medical leaders have been sounding the clarion call for over a decade: Something has to be done about the rising resistance of infectious agents to existing drugs, combined with the dearth of new anti-infectives to combat them. So far, however, there has been little movement. The death toll from drug-resistant pathogens keeps ticking upward worldwide. And the number of new antiinfectives passing through clinical trials remains a trickle. Unlike oncologics or cardiovascular drugs, where substantial R&D efforts show intermittent advances, anti-infectives suffer from both little funding and few promising research directions. At the root of this are two confounding problems in commercializing anti-infectives: a new, more powerful agent would be held in reserve for only the most recalcitrant infections, limiting its commercial potential; and nearly all anti-infeccontinued on page 15 > PRSRT STD US POSTAGE MENDOTA, IL PERMIT 200 PAID http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2010

Pharmaceutical Commerce - November/December 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 - November/December 2010

Pharmaceutical Commerce - November/December 2010 - Pharmaceutical Commerce - November/December 2010 (Page 1)
Pharmaceutical Commerce - November/December 2010 - Pharmaceutical Commerce - November/December 2010 (Page 2)
Pharmaceutical Commerce - November/December 2010 - Pharmaceutical Commerce - November/December 2010 (Page 3)
Pharmaceutical Commerce - November/December 2010 - Contents (Page 4)
Pharmaceutical Commerce - November/December 2010 - Contents (Page 5)
Pharmaceutical Commerce - November/December 2010 - Editorial (Page 6)
Pharmaceutical Commerce - November/December 2010 - Op-Ed (Page 7)
Pharmaceutical Commerce - November/December 2010 - Top News (Page 8)
Pharmaceutical Commerce - November/December 2010 - Top News (Page 9)
Pharmaceutical Commerce - November/December 2010 - Business | Finance (Page 10)
Pharmaceutical Commerce - November/December 2010 - Business | Finance (Page 11)
Pharmaceutical Commerce - November/December 2010 - Business | Finance (Page 12)
Pharmaceutical Commerce - November/December 2010 - Business | Finance (Page 13)
Pharmaceutical Commerce - November/December 2010 - Brand Marketing | Communications (Page 14)
Pharmaceutical Commerce - November/December 2010 - Brand Marketing | Communications (Page 15)
Pharmaceutical Commerce - November/December 2010 - Brand Marketing | Communications (Page 16)
Pharmaceutical Commerce - November/December 2010 - Brand Marketing | Communications (Page 17)
Pharmaceutical Commerce - November/December 2010 - Supply Chain | Logistics (Page 18)
Pharmaceutical Commerce - November/December 2010 - Supply Chain | Logistics (Page 19)
Pharmaceutical Commerce - November/December 2010 - Information Technology (Page 20)
Pharmaceutical Commerce - November/December 2010 - Packaging & Drug Delivery (Page 21)
Pharmaceutical Commerce - November/December 2010 - Packaging & Drug Delivery (Page 22)
Pharmaceutical Commerce - November/December 2010 - Packaging & Drug Delivery (Page 23)
Pharmaceutical Commerce - November/December 2010 - Legal | Regulatory (Page 24)
Pharmaceutical Commerce - November/December 2010 - Legal | Regulatory (Page 25)
Pharmaceutical Commerce - November/December 2010 - Executive Training & Development (Page 26)
Pharmaceutical Commerce - November/December 2010 - Executive Training & Development (Page 27)
Pharmaceutical Commerce - November/December 2010 - Executive Training & Development (Page 28)
Pharmaceutical Commerce - November/December 2010 - Executive Training & Development (Page 29)
Pharmaceutical Commerce - November/December 2010 - Executive Training & Development (Page 30)
Pharmaceutical Commerce - November/December 2010 - Meetings & Editorial Index (Page 31)
Pharmaceutical Commerce - November/December 2010 - Meetings & Editorial Index (Page 32)
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