Pharmaceutical Commerce - November/December 2009 - (Page Cover1)

Business Strategies for Pharma/Bio Success NovemBer/deCemBer 2009 Packaging & drug delivery Brand marketing | Communications Pharma Gets a ‘Just in Time’ Speedup With the Switch to digital Printing ‘Print on demand’ changes traditional design, production and inventory practices for labels, inserts and other printed packaging By F.J. Quinn The full weight of FdA’s regulatory might usually comes down to almost trivially simple elements: the label, insert and related packaging that surround the pharmaceutical product. From black-box warnings, to implementing the new Risk Evaluation and Mitigation Strategies (REMS—see related article), to anticounterfeiting and other brand-protection measures, the physical embodiment of all this attention is slips of paper or film—along with the critically important information printed on them. Thus, a change from the traditional printing technologies, such as offset or flexo printing, to digital printing Fig. 1. Catalent uses the KB KaratPress for short-run digital printing. Credit: KB can shake up many other industry processes. Digital printing, or print on-demand (POD), is simply the same technology used in printers on most office desks, (usually, ink-jet printing), but in industrial printing, the technology is transforming packaging design, invencontinued on page 22 > Industry Tackles the New remS Hurdle FdA’s requirements for risk evaluation and mitigation challenge both new and existing commercialization processes By Suzanne Shelley A key element of the 2007 FDA Amendments Act (FDAA)—the change from “requested” post-marketing compliance plans to mandated Risk Evaluation and Mitigation Strategies (REMS)—has now come to the forefront for both newly approved and commercial biopharmaceuticals. While some REMS are little more than a beefedup patient medication guide, others can involve complicated patient registries and certifications of physicians, pharmacists and even distributors. Moreover, the unexpected announcement of a “classwide” REMS requirement for long-acting opioid drugs last spring (Pharmaceutical Commerce, March p. 24) raises the possibility of programs that potentially will alter the fundamental process of delivering medications to patients. There are the preliminary signs of an industry backlash, as evidenced by the lawsuit filed by Allergan over how a version of its Botox muscle relaxant is marketed (see box). But for the most part, brand managers are marshaling their resources and developing and executing plans per FDA guidance. For service providers to the industry, a minor land rush is on to gain recognition as contractors that can handle the new requirements effectively. “In a healthcare environment where access is already an issue for many patients on multiple other levels, REMS is adding a layer of complexity whose impact will need to be evaluated,” observes Uwe Tigör, MD, SVP of medical strategy for the InVentiv REMS team, InVentiv Health (Saratoga Springs, NY). By design, REMS programs are meant to implement a variety of measures to control prescribing practices, drug handling and utilization in order to safeguard patients and others from adverse events or unintended exposure to the drug. However, industry is increasingly recognizing that these programs have the potential to erect logistical and administrative barriers. These barriers could lead prescribers to select alternative therapies for reasons that have nothing to do with clinical appropriateness and in doing so, restrict a product’s continued on page 14 > Supply Chain | Logistics Cargo Theft emerges as a New Biopharma Worry The signs are apparent that there is organized criminal activity focused on pharma logistics By Nicholas Basta There are two ways to think about in-transit pharmaceutical security to get real serious, real fast: one is to realize that if a single shipment of product gets lost or stolen, the entire lot to which that shipment belonged might be subject to recall—and ask yourself, how much is my product worth on a per-lot basis? The second, more conceptual perspective is to realize that all of the PhD scientists’ work in developing a new pharmaceutical, the expert manufacturing, marketing and sales management, and the high-cost advertising or promotion for that product comes down to a single truck driver, unsupervised, making a delivery to a warehouse or distribution continued on page 19 > What’s Inside Getting value From end-of-Life-Cycle Pharmaceuticals 12 design and Implementation of Physician Segmentation 13 disputing drug Patents 26

Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2009

Pharmaceutical Commerce - November/December 2009
Top News
Business & Finance
Brand Marketing | Communications
SupplyChain | Logistics
Information Technology
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Editorial Index | Meetings

Pharmaceutical Commerce - November/December 2009