Combination Therapies: Benefits and Challenges in Drug, Device, and Biologicals Development examines the numerous advantages of combination products for both the marketing company and the patient, evaluates combination therapies on the market from both a therapeutic and business perspective, identifies opportunities, hurdles, and regulatory issues for novel products, and profiles companies participating in this area.

Today, combination products range from drug-drug combinations to drug-device combinations, such as drug-eluting stents for coronary blockages, to drug-biological products, such as monoclonal antibodies combined with a chemotherapy agent for the treatment of cancer. Each product type offers significant solutions to many of the problems plaguing healthcare.

Pharmaceutical companies are turning toward fixed-dose combination products to diffuse the impact of generic competition, revitalize established brands, fill gaps in product pipelines, and enhance patient compliance. As the cost of drug research continues to climb, the number of new molecular entities submitted for approval to the FDA is decreasing. Drug developers are seeking ways to offset this imbalance. Generally, combinations of established therapies carry low risk but high financial reward because the resulting product comes with new patents that protect it from generic competition.

For the patient, fixed-dose combination products usually result in fewer prescriptions and are less expensive than buying the medications separately. Also, patients need to take fewer pills which leads to an increase in compliance, resulting in better health outcomes.

Combination Therapies: Benefits and Challenges in Drug, Device, and Biologicals Development looks at the history of combination therapies (drug-drug, drug-device, and drug-biological), explains FDA guidelines on combination products, discusses how patents play a role in decision-making, and examines different approaches the pharmaceutical industry has taken with regard to combination products and patent extensions. Marketplace issues such as labeling, pricing, and managed care involvement are also examined. Examples of each type of combination product are discussed at length.

About the Authors

Richard Fisler is a consultant with Beachhead consulting (www.beachhead.com), a consulting firm specializing in technology evaluation, strategic planning, and market assessment in the life science industry. Prior to his work at Beachhead, he brought a wide variety of high technology platforms to market through positions in the microarray and live cell microscopy industries. Additionally, he has spent 11 years in management and engineering in the medical imaging field.

Olivia Scaros graduated from the University of Illinois in 1988 with a Doctor of Pharmacy degree. She has been employed by various pharmaceutical firms, including Sandoz Pharmaceuticals, Bayer Corporation, and Pfizer Inc., both as an employee and a consultant. For the past 13 years, Dr. Scaros’ main focus has been medical writing, including study reports, clinical protocols, articles, and other projects for the pharmaceutical industry.