What's Next in: Strategy and Regulation

Strategy

There are at least two major factors that will shape the manufacturing industry as a whole. Daniel Ruppar, Industry Manager (North America) for the Pharmaceuticals and Biotechnology Division of Frost & Sullivan predicts that, due to continued globalization, we can expect to see "growth centers for the industry move to emerging market sectors." The industry will also experience "increased biopharmaceutical and specialty pharmaceutical interest from Big Pharma as they continue, and everyone continues, to evolve business strategies." In addition, as companies explore outsourcing in other regions, including Latin America, Ruppar predicts that intellectual property regulations will gain increased importance.

(IMAGE: PHOTOS.COM/MELISSA MCEVOY)

"Companies will continue to try to evolve their business models, and evaluate new forms of lifecycle, product, and pipeline strategies in order to achieve the growth they are looking for," says Ruppar. "I would expect that as Big Pharma tries to stay relevant, they will continue to explore merger and acquisition opportunities in order to bring in innovation."

For future product launches, Big Pharma can learn a great deal from the rash of recent product recalls and project terminations such as Eli Lilly's antiplatelet product and Pfizer's "Exubera." Inhaled insulin. "For the other pulmonary insulin developers, they will probably move now to do more back end work on strategy development, marketing, and assessing MD and patient education setups for their programs if they get to the market launch point," says Ruppar. "We will have to see if somebody else picks up Exubera. There are also points about the pipeline products in that area that could also still differentiate them from Exubera, especially with the positive difference in devices from developers such as Mannkind Corporation.

As for Eli Lilly's antiplatelet drug, Ruppar suggests that "It at least puts BMS/Sanofi-Aventis at ease for the time being as that would compete with Plavix. It looked like from the Oct 24 PR from Lilly that they were trying to adjust some things in the protocols. If it comes out there was an increase in bleed risk though then that probably would kill it for good. We will have to see what this "dose adjustment in certain subpopulations" really means."

Maribel Rios, senior editor,

Pharmaceutical Technology

Regulation

The globalization of the pharmaceutical industry will shape the oversight and regulation of drug manufacturing in the coming decades. Pharmaceutical companies are offshoring and outsourcing research and development and manufacturing operations to Asia and other regions at an increasing rate, mainly to reduce production costs. A large proportion of pharmaceutical ingredients now originate in India, China, and other newly industrialized countries. Finished drug products, especially generic drugs, increasingly will come from abroad. In addition, more clinical trials are being conducted overseas, and this development requires new methods for ensuring the integrity of data from foreign studies.

US Food and Drug Administration Deputy Commissioner Janet Woodcock predicted several months ago that these trends will continue and be accompanied by a parallel decrease in the US manufacture of pharmaceutical ingredients and drug products. These developments will require significant changes at FDA, including the development of a new regulatory model. Woodcock noted that the agency was established to regulate a domestic industry, not to deal with the increasingly complex issues raised by globalization.

The rising volume of food and drug imports is already requiring new programs and policies to ensure that products coming into the US meet regulatory standards. Because border controls and inspections will never be able to keep up with a steady rise in import volume, more cooperative programs for inspecting products at the manufacturing site will be needed. That will involve increased reliance on foreign regulators to inspect local manufacturing facilities and to ensure that drug ingredients and finished products meet quality standards.

The development of harmonized international standards for drugs and biologics has been an important undertaking for the last decade. These initiatives will continue to play a central role in ensuring drug product quality on a global basis. FDA also is working with other regulatory authorities to explore new models for accepting inspection findings from local agencies that can, in some cases, reduce the need for US inspectors to travel overseas. Although some policymakers will object to reduced direct oversight of medical products manufactured overseas for US consumers, FDA's limited resources will necessitate the increased reliance on capable foreign regulators to support US oversight of global pharmaceutical production.

Jill Wechsler, Washington editor,

Pharmaceutical Technology

Industry experts give their predictions for the next 30 years.