Latam Offers Great Potential as Clinical Studies, R&D Destination

Q: What is PPD’s main objective?

A: PPD is a contract research organization (CRO) that conducts clinical research on behalf of pharmaceutical and biotechnology companies. Its primary objective is to facilitate the development and availability of drugs and medicines for public consumption. Additionally, PPD engages in various stages of clinical research, from initial human testing to phase IV trials.

A year ago, PPD successfully completed its merger with Thermo Fisher Scientific (TFS) and is now actively integrating into the latter organization, adapting to its policies, rules, and standard operating procedures.

Q: What factors have contributed to PPD’s strong market position?

A: First and foremost, PPD/TFS places significant emphasis on its strong commitment to both clients and staff members. With a workforce of over a 100,000 individuals, there is a palpable sense of closeness and camaraderie within the organization. This cohesion and collaboration extends throughout the entire organization, transcending hierarchical boundaries. At all levels, PPD/TFS boasts exceptional teams that consistently exhibit quality and maintain consistency in their work. This commitment to excellence is readily apparent across the organization.

Q: In 2020, PPD/TFS focused on COVID-19 vaccines and treatment research. How has PPD/TFS's research regarding COVID-19 evolved and what is its goal?

A: COVID-19 is far from over. The virus is showing signs of resurgence and it is likely that we will encounter more variants in the future. For example, influenza has been a recurring threat and annual influenza vaccinations target three or four specific strains. Even with the vaccine, many still contract influenza every year, highlighting the continuous nature of these diseases.

Therefore, we must acknowledge that the situation with COVID-19 will persist and eventually we may encounter more resilient variants or face a stronger strain.

Despite the initial waves subsiding, we must not assume that everything is resolved. Research and ongoing studies continue to shed light on the virus and vaccines. At PPD/TFS, we are actively involved in various therapeutic areas, including COVID-19.

Q: What other research priorities does PPD/TFS have on a global scale?

A: PPD/TFS's research priorities span a wide range of therapeutic areas. Oncology is a significant focus. While there are ongoing discussions and restructuring within the company due to the merger, oncology is still a priority and holds considerable importance within PPD. In addition to oncology, PPD is actively engaged in a variety of therapeutic areas, including respiratory diseases, pediatrics, infectious diseases, such as COVID-19, and many others.

Q: How is PPD/TFS leveraging digitalization in its clinical research practices to enhance performance and improve efficiency?

A: PPD/TFS is dedicated to the constant evolution and advancement of its digital infrastructure. The company consistently explores new technologies, such as artificial intelligence and other digital platforms, to enhance its operations. This commitment to digitalization has led to the implementation of various interconnected platforms within the organization, which serve as channels of communication and collaboration, not only within PPD/TFS but also with its clients, primarily pharmaceutical companies. Through these channels, clients gain access to relevant information and insights, although some data remains confidential for the protection of the company, sites and stakeholders.

The continuous growth and innovation in the digital realm allow PPD/TFS to improve its capabilities and provide enhanced services. By leveraging digital platforms and technologies, PPD/TFS ensures it remains at the forefront of industry advances and can adapt to evolving needs and trends.

Q: How relevant are Mexico and Latin America for PPD/TFS? What are the main challenges the company faces in the region?

A: Latin America, including Mexico, plays a vital role in PPD/TFS’s research priorities. Despite having offices throughout Latin America, the selection of study locations primarily depends on client preferences, which often prioritize the US and the EU. However, there is a growing focus on the Asia Pacific region (APAC), which encompasses Japan, China, Korea, Malaysia, Singapore, Vietnam and Australia, among other countries. Consequently, PPD/TFS aims to redirect attention back to Latin America, a region that offers unique advantages.

Regulatory timelines in Latin America are often perceived as longer but this is mainly due to administrative requirements rather than inherent inefficiency. The region's large population coupled with the high prevalence of various conditions, makes it a promising candidate for clinical trials. Latin America boasts state-of-the-art facilities, experienced researchers and a substantial patient pool, particularly in major cities where renowned institutions and hospitals are abundant.

Compliance with regulations is crucial and PPD/TFS undergoes internal and external audits from regulatory bodies like COFEPRIS and the US FDA and from pharmaceutical companies. The digitalization of processes has significantly enhanced transparency and accountability, leaving a paper/digital trail that supports comprehensive record-keeping. PPD/TFS has implemented strategies to optimize efficiency, such as submitting complete trial packages to COFEPRIS rather than in fragmented stages, which has expedited regulatory approvals. COFEPRIS has made notable progress in digitizing its processes and may even explore artificial intelligence in the future.

Q: What is needed from the private sector to support academia in the development of talent?

A: In Mexico, medical schools and other educational institutions are gradually introducing new programs, including master's degrees. However, these programs are still not at the same level as those in the US. There are several reasons for this discrepancy. One of the contributing factors is the bureaucracy and administrative processes involved in establishing new academic initiatives. Despite these challenges, there will be more opportunities for collaboration between prestigious international institutions and universities in Mexico. The potential for knowledge exchange and the development of high-quality educational programs is vast. With concerted efforts, we can overcome the barriers and foster meaningful partnerships with academia.

Q: How does PPD/TFS envision its role in shaping the future of drug development and clinical research?

A: PPD/TFS has been experiencing remarkable internal growth with a workforce exceeding 100,000 employees. This expansion has led to the formation of diverse teams, providing exciting opportunities to engage with individuals from all around the world. PPD's growth trajectory is likely to continue as it operates under the umbrella of Thermo Fisher Scientific. The latter’s acquisition-driven growth strategy positions PPD for substantial development and success in the future.

Given its trajectory, it is highly probable that PPD will experience even more significant growth in the coming years. The potential for expansion and the continuous pursuit of new opportunities suggests a bright and promising future for the company.

Q: What are PPD/TFS's key goals and objectives for the near term?

A: As we explore new therapeutic areas, it is evident that genetics has become increasingly significant, particularly in the field of oncology. Modern oncological clinical trials differ greatly from those that took place 20 years ago, as tumor markers have become an integral part of the process.

There will likely be substantial growth in the APAC region. PPD/TFS had previously established offices in Ukraine and Russia but due to ongoing conflicts, those teams have been redirected to Poland and other neighboring countries.

Furthermore, PPD/TFS’s collaborations and partnerships with pharmaceutical firms have intensified. Through these alliances, PPD/TFS has become a designated provider for several studies. This strategic positioning often results in pharmaceutical companies exclusively choosing PPD/TFS as their preferred CRO. Additionally, bundled package deals are offered for multiple trials, providing advantageous options for both PPD/TFS and pharmaceutical companies. As science and medicine continue to advance, PPD/TFS must evolve accordingly.

PPD, part of Thermo Fisher Scientific, is a leading global contract research organization that provides comprehensive and integrated services to support drug development. It also offers laboratory and life-cycle management services.