Strategy Emerging Markets for Risk Mitigation


An interview with Willem Kools, PhD, Head of Technology Management, Merck

Expansion into emerging markets is a key growth strategy in the life sciences sector, with numerous pharmaceutical companies interested in adding production and/or R&D capabilities there in the coming years. Conducting R&D and manufacturing work in emerging markets is not a straightforward endeavor, however, and numerous challenges must be addressed for projects to run smoothly.
BioPharm International recently spoke with Willem Kools, PhD, head of technology management at Merck, about the role of education in breaking down some of those barriers to entry in emerging markets such as Singapore, India, China, Brazil, South Korea, and elsewhere. He explains how experts from the M LabTM Collaboration Centers are leading the way in making emerging markets a less-risky proposition for biopharmaceutical companies wanting to expand there.

BioPharm International: What challenges stand in the way of a drug company entering an emerging market?

Kools: Seven out of nine M LabTM Collaboration Centers are located in emerging markets. Given our successful track record working in these areas, we get a lot of questions from clients about how to successfully work and bring technology for biopharmaceutical projects into emerging markets.
The first challenge that comes to mind is access to technical expertise. While some companies have come to emerging markets to develop and manufacture biopharmaceuticals like vaccines, not much more-complex biopharmaceutical work has been conducted in these areas. In many cases, the infrastructure for large-scale biopharmaceutical production is still growing and there is not a large pool of experienced and skilled workers in these areas to draw on.
Thus, it is critical from a risk-mitigation perspective to work with knowledgeable partners who understand how to train local talent with appropriate workforce skills (i.e., technical experience and regulatory understanding) while dealing with the speed-to-market challenges inherent in biopharmaceutical work.
At the M LabTM Collaboration Centers, we strongly feel that to make a business environment in emerging markets attractive enough for companies to invest, it’s critical to take the lead in training and sustaining a qualified, skilled, and knowledgeable workforce. This was the goal of an important collaboration between the M LabTM Collaboration Centers and the Singapore authorities. Drawing on our years of technical and regulatory expertise, we have trained employees of biopharmaceutical companies and regulatory inspectors based in Singapore for the past eight years. In fact, about 70% of the Singapore pharmaceutical workforce has been trained by our technical experts, with 80% working in manufacturing operations.
For biopharmaceutical R&D and manufacturing efforts to be successful in emerging markets, we cannot be the only ones who know how to work there. In other words, information cannot exist within a silo. M LabTM Collaboration Centers have seen time and time again that having a strong focus on client collaboration and helping to build a stable and skilled workforce through training programs benefits the entire community and helps avoid road bumps as projects grow.

BioPharm International: How difficult is it for biopharmaceutical companies to navigate an uncertain regulatory environment?

Kools: Our company has a long track record of strong relationships with regulatory bodies in numerous countries, and we support the development and implementation of critical regulations in countries just starting to see increased pharmaceutical development and production. As a trusted partner, we believe it’s vital to be on top of the regulations as they stand today as well as to have our finger on the pulse of how they are evolving.
In addition, we want to help local regulators in emerging markets understand the global regulatory dynamic and help them achieve the right level of standards, best practices, and oversight so they can ensure product safety for patients. At the end of the day, that’s what we all strive for in this industry.

BioPharm International: How are the M LabTM Collaboration Centers helping to overcome these regulatory barriers?

Kools: We ensure regulators know all the ins and outs of safe biopharmaceutical manufacturing, what to look for, what not to look for, what is already known, and more. Furthermore, we feel it’s important to guide approaches in process characterization and validation toward meeting both local and global standards. Last, a growing focus for us is initiating good discussions about how to evolve regulatory frameworks so that customers in those regions have certainty about the expectations.

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