Gabriel Marcelín
Director General
Pharmometrica
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View from the Top

Clinical Trials: Where Science Meets Regulations

Wed, 09/05/2018 - 10:25

Q: What are Pharmometrica’s main priorities?

A: Pharmometrica is a private research center and an authorized third party, which allows it to provide research services to the pharmaceutical industry in accordance with regulatory requirements. We hold a license as a clinical and analytical unit that allows us to perform bioequivalence studies and dissolution assays. We study the efficacy of generic forms of innovative medicines that have already demonstrated to be safe and effective. Bioequivalence research in Mexico has been useful in several areas. Knowing how our population reacts to medicines helps us to modify prescription information to ensure safer and more effective therapeutic schemes.

Q: Are foreign pharmaceutical companies interested in conducting their bioequivalence tests in Mexico?

A: The law states that all generic medicines must be subjected to interchangeability or bioequivalence studies on the Mexican population before being sold in Mexico. While Mexicans are a highly mestizo population, the pharmacological behavior is sometimes surprising. For instance, Pharmometrica’s research team discovered that there are five subpopulations in Mexico, each with its own phenotype for Omeprazol. While some of these phenotypes could intoxicate with a 20mg dose, others will never heal with the same dosage.

Q: What are the main challenges that Pharmometrica has faced in conducting bioequivalence tests?

A: When a patent for an innovative medicine expires, the laboratory that launches the first generic will have the greatest commercial advantage. However, prices fall as more generics enter the market and the pharmaceutical industry then loses interest in that product. One way to help improve the generics market is to create a faster COFEPRIS protocol for authorizations. Research protocols must be verified and approved by independent research and ethics committees before trials can be conducted. If these committees are already doing this job, there is no point in COFEPRIS doing it again.

Q: What are the main obstacles to expediting the execution of research protocols?

A: Pharmaceutical companies are manufacturers and the responsibility for the design and execution of research protocols rests with the scientific team of authorized third parties. Bioequivalence studies are neither cheap nor fast. Just one study can cost about MX$1 million and take between six and nine months.

Q: What added value does Pharmometrica offer to entice companies to work at the institution?

A: We have a multidisciplinary approach and we provide coaching services. Pharmometrica is composed of researchers specialized in analytical chemistry, pharmacology, toxicology, statistics and regulatory affairs. We do not merely sell the project; we create synergies with our clients to perform an efficient and enhanced procedure.

Q: What are the main challenges that Pharmometrica has faced while recruiting volunteers?

A: The usual stay of a healthy volunteer is 15 days in a bioequivalence trial, while a clinical protocol entails monitoring a patient for months or even years. Researchers often carry out five to 10 protocols at a time because the pharmaceutical industry pays them for each patient they recruit. A good clinical researcher cannot be handling more than three or four protocols at a time. Pharmometrica can perform up to five bioequivalence studies at the same time.

Q: What does Mexico need to do to attract more opportunities in clinical research?

A: The main constraint is the time it takes the sanitary authority to authorize projects. I think the work should be redistributed and include more extensive training for the ethics and research committees. If a research committee issues an opinion on a protocol, COFEPRIS does not need to review it further.

Pharmometrica is a 100 percent Mexican research center specifically created to operate as an authorized third party. It develops clinical trials in generics interchangeability and bioequivalence