Pharmaceutical Commerce - July/August 2011 - (Page Cover1)

PDMA Sharing Conference, p. 18 IQPC Cold Chain Forum, p. 22 Business Strategies for Pharma/Bio Success WWW.PHARMACEUTICALCOMMERCE.COM JULY/AUGUST 2011 Business Finance Legal Regulatory Achieving Launch Excellence A Question of Penetrating the Dynamic Market Recognizing the realities of how new product launches enter the market By Rob Harold & Filip Odqvist, IMS Health Aggregate Spend Laws: Here Comes the Sun The industry is far from ready when it comes to collecting, aggregating, cleansing and disclosing data about regulated financial transactions with doctors and hospitals By Suzanne Shelley IMS’ research has shown the window of opportunity to set your launch trajectory remains incredibly short. That means that years of preparations will be judged in the manner of months with victors experiencing steep trajectories leaving the conquered with trajectories hugging the x-axis. So what determines a product’s trajectory? And how do you ensure that the trajectory exhibits steep uptake? While literature on the topic often focuses on how a company ensures launch success internally, this article will delve deeper into the fundamentals of how a new product enters the market at launch. It will focus on the component most critical to a product’s launch success, the dynamic market, and illustrate how the dynamic market affects a product’s trajectory. Figure 1: Product markets are a combination of existing and new patient bases The Dynamic Market: A Trajectory’s Source A pharmaceutical market can be divided into two components: (a) The static market which includes patients who continue on their current therapy, and (b) the dynamic market, which consists of patients who (i) switch from one therapy to another (ii) add therapy to their existing treatment paradigm and (iii) are new therapy starts. For a new product, the dynamic market is crucial as it represents the main source from which the product establishes its trajectory. First of all, by definition new products can only launch into the dynamic market since there is no previous patient base (Fig. 1). That is, on the first day, 100% of prescriptions written for a product come from the dynamic market. Secondly, in the first six months approximately 60% of the total prescriptions written for a product come from the dynamic market (Fig. 2). A product that fails to penetrate, or has trouble penetrating, one or several of the patient segments within the dynamic market, will therefore not achieve the maximum steepness of its trajectory. continued on page 12 > There appears to be a slow-moving train collision looming for the US pharma industry over aggregate spending rules, for which data collection is supposed to begin on January 1. Having been called “the most disruptive force affecting pharma sales and marketing today,” according to Eric Newmark, research director for IDC Health Insights’ Commercial Life Sciences Practice (Framingham, MA), the Physician Payments Sunshine Act, enacted in March 2010 as part of the federal Patient Protection and Affordable Care Act, or PPACA—goes into effect in less than six months. The “agg spend” rules of PPACA require drug and med-device manufacturers to report expenditures or other “transfers of value” paid to healthcare professionals and hospitals—and sets some limits on how much can be spent on specific individuals. Data capture is set to begin in January 2012 and annual reporting to the government begins in March 2013. continued on page 28 > Manufacturing & Packaging New Labeling Laws Encouraging Innovative Ways to Update Rx Drug Info By F.J. Quinn The implementation of new labeling laws is challenging pharmaceutical companies to put in systems and processes to ensure compliance. But the task is easier said than done, industry members say, as product labeling content is often duplicated in multiple documents for various product strengths, dosage forms and presentations, resulting in a large set of data difficult to manage and synchronize. “The more regulated label practices get, the more important it is that vendor and client work closely together on finding the ideal customized solution,” says Gene Dul, president of Schreiner MediPharm U.S. (Blauvelt, NY), a specialist pharmaceutical label company. “Though the label has to carry a lot of information and combine user friendliness with patient safety—which demands a high level of sophistication—it still has to be easily integrated into the production processes at the pharmaceutical manufacturer and run smoothly on the dispensing machines.” The labeling laws, implemented the past four years by FDA, aimed at forcing pharma companies to capture a physician’s attention to the most important pieces of drug information before a product continued on page 25 > MENDOTA, IL PERMIT 200 PRSRT STD US POSTAGE PAID http://WWW.PHARMACEUTICALCOMMERCE.COM

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011
Contents
Op-Ed
Top News
Business/Finance
Brand Communications
Supply Chain/Logistics
Manufacturing & Packaging
Legal/Regulatory
Information Technology
PDMA Exhibitors
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover1)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover2)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page 3)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 4)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 5)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 6)
Pharmaceutical Commerce - July/August 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 8)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 9)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 10)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 11)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 12)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 13)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 14)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 15)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 16)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 17)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 18)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 19)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 20)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 21)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 22)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 23)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 24)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 25)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 26)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 27)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 28)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 29)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 30)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 31)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 32)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 33)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 34)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page 35)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page Cover4)
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