Outsourcing the Product Launch Processes

Mark Wiesman

Abstracts: A product launch is often a milestone event for a biopharma manufacturer. Years of effort have gone into clinical trials and regulatory approvals, and manufacturing, marketing and patient-outreach efforts have been made. The product owner only awaits the final FDA approval, and then wants to get the product as broadly distributed as possible, in the shortest time possible. It is becoming a more common industry practice to work with an outsourced services provider to carry out this launch. There are responsibilities that the services provider can take on; there are those that are better kept in the hands of the product owner. Working with a services provider has the potential to take advantage of economies of scale—the services provider might have warehouses, vehicles and personnel that routinely handle high volumes of product distribution efficiently and accurately, and to maintain these capabilities at a cost that is less than the individual manufacturer’s would be.

This article will review the critical decisions to make when considering, and then working with, an outsourced services provider. A guiding principle to keep in mind: Every product launch is different. Each launch should be evaluated on the basis of its own requirements.

Types of product launches
Just as there are many types of biopharmaceutical products, there are many types of launches. An analysis of how to handle a product launch should begin with an evaluation of the requirements of that launch.

Here are the most common categories
1. Branded pharmaceutical (conventional oral solid)
2. Generic pharmaceutical – first to market
3. Generic pharmaceutical – second or later launch
4. Specialty (parenteral, temperature-controlled, drug/device combination, etc.)
5. Launch through selected distribution channel (full-line wholesaler; specialty distributor; limited distribution specialty pharmacy, clinic, etc.)

The model that most analysts of the biopharma industry look at is the introduction of a potential blockbuster branded product—the ones that might address a condition in an entirely new way with a first-of-its-kind pathway. These blockbusters have become progressively more rare in recent years. Meanwhile, hundreds of specialty products, generics, or products intended for specific channels (such as the hospital pharmacy) are being introduced. These products can require launch logistics to be planned as carefully as those for the blockbusters. In 2008, for example, FDA approved 20 new molecular entities (NMEs or branded pharmaceutical), but also 91 generics, frequently launched by 5-15 companies, of various formulations. The overall approval process by the FDA can take 7 years or more, starting from the identification of an NME. The planning for an NME product launch can begin as long as two years in advance of the expected approval date (shorter for most generics).


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