Background on GSK and its Global Operations
GSK, a global biopharmaceutical company, plans to increase its clinical research investment in Mexico by up to tenfold over the next five years, provided regulatory conditions improve. This announcement was made by Sigfrido Rangel, the medical director of GSK México.
Current Investment and Plans for Expansion
Currently, GSK invests approximately 120 million pesos annually in developing clinical research protocols in Mexico. Mr. Rangel stated, “We have planned to quintuple or even multiply this investment by ten in the next five years,” should regulatory conditions improve.
Importance of Regulatory Improvements
Mr. Rangel emphasized that the key to increasing investments is the improvement of regulatory conditions in Mexico. He highlighted that expedited approval of research studies, quicker reviews by regulatory bodies, and faster ethics committee approvals would facilitate GSK’s participation in the country.
GSK’s Current Presence and Projects in Mexico
GSK currently has 90 clinical research projects underway in Mexico, spanning various stages of development and therapeutic areas such as oncology, HIV, respiratory diseases, and infectious diseases.
Government Commitment and Progress
Mr. Rangel acknowledged the Mexican government’s and regulatory authorities’ commitment to improving conditions for attracting investment and fostering the pharmaceutical industry’s growth. He noted that approval times for clinical studies have decreased from six months to three months, and he expects further reductions.
The digitalization of the Mexican Federal Commission for Protection against Health Risks (Cofepris) systems has contributed to improved turnaround times, though Mr. Rangel mentioned that there is still room for enhancement.
GSK’s Commitment to Clinical Research in Mexico
GSK is actively engaged in clinical research in Mexico, with over 900 patients participating in various protocols across the country. Their projects encompass vaccines, new medications for HIV, oncology treatments (including endometrial and multiple myeloma cancers), respiratory diseases (such as asthma and chronic obstructive pulmonary disease), and immunological conditions like lupus.
Benefits of Clinical Research
Mr. Rangel explained that clinical research not only enhances patient care but also provides access to innovative medications. This has piqued the interest of Mexican authorities in increasing investment in this area.
Alignment with Mexico’s Health Goals
Mr. Rangel stated that GSK is “totally aligned” with the Plan México, a national health strategy, and intends to continue investing in the country, where they have been present for over 60 years.
Global Investment Perspective
GSK invests around 20-21% of its profits in clinical research globally, which nearly equals the total sales of vaccines worldwide for the company. This demonstrates their commitment to research development.
Key Questions and Answers
- What is GSK’s current investment in clinical research in Mexico? GSK invests approximately 120 million pesos annually in developing clinical research protocols in Mexico.
- How much will GSK’s investment increase if regulatory conditions improve? GSK plans to quintuple or even multiply this investment by ten in the next five years.
- What therapeutic areas are GSK’s clinical research projects focused on in Mexico? These projects span oncology, HIV, respiratory diseases, infectious diseases, and immunological conditions.
- What is the current status of regulatory improvements in Mexico? Approval times for clinical studies have decreased from six months to three months, and further reductions are expected.
- How does clinical research benefit patients in Mexico? Clinical research enhances patient care and provides access to innovative medications.
- Is GSK aligned with Mexico’s health goals? Yes, GSK is “totally aligned” with the Plan México, a national health strategy.
