A one-size-fits-all approach to drug therapy can be rather ineffective when treating today’s diseases. Pharmaceutical companies understand treating complex diseases such as cancer or HIV will require an effective combination of drug therapies. Combination drug product development offers significant therapeutic impact. Modern pharmacology recognizes that diseases are often multifactorial, consisting of a spectrum of medical conditions, and that the one drug paradigm is not as effective or beneficial to the patient. In combination drug product development, designing effective drugs specific to molecular targets has been increasingly challenging.Due to the rise of drug resistance and the need for more effective and less destructive therapies, combination drug product development has become more increasingly popular. Although combination drugs may be more effective than a monotherapy approach, the methods of approval are similar. Efficacy and safety must be proven in clinical trials for combination of drug therapies development. Furthermore, sponsors must show how the drugs interact with one another assuringthe combination of the drugs does not cause a hazardous effect. FDA’s Office of Combination Products (OCP) was created in 2002, in FDA’s effort to streamline the approval process for combination products. OCP is responsible for reviewing and regulating all combination products pre and post market and they work in conjunction with other FDA agencies during the entire process.Pharmaceutical companies are innovating new combination drugs to treat aggressive diseases, such as HIV, taking combination of drug therapies development to the next level. Since HIV attacks the immune system, combination of drug therapies development must target the virus in its replication process via different methods. One drug may prevent the virus from binding to healthy cells while another drug may block the virus from transferring genetic information.Some HIV combination drugs have up to six different drugs. Sponsors must be prepared for the developmental challenges they will face with combination drug product development, even if the drugs comprised in the product are FDA approved. Developing new processes in combination of drug therapies development will be necessary, such as:
- evaluating preclinical safety in targeted areas of the body
- manufacturing of combination drug products
- designing clinical trials to establish safety and efficacy
Identifying new strategies to prevent redundancy in the clinical studies is key to expediting the combination drug product development process. FDA recommends that combination product developers give needed attention to the anticipated interactions their product will have in preclinical and non-clinical testing. The pharmaceutical industry is in the forefront with combination drug product development to treat comorbid conditions and drug resistance. Sponsors realize that disease is a result of the deterioration of physiological systems due to multiple factors including genetic and environmental, therefore developing treatment with the ability to target multiple issues is critical. The combination of drug therapies development has many challenges from the conception of the drug to marketing the product, however the benefits to patients far outweigh the challenges. Although combination drugs may encounter an array of scientific and technical development issues, these cutting-edge innovations are a big step towards the advancement of patient care.
Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
Pharmaceutical Development Group (PDG) is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and FDA regulatory affairs. PDG is a pharmaceutical consulting group focusing on NDA regulatory services, combination drug product development, and IND consulting services. PDG is a subsidiary of Biotech Research Group Corporation.