In today’s drug development efforts, Research and Development has increasingly expanded to include multi-country strategies. Over time, pharmaceutical and biotech companies have made substantial impact on economies where development work is conducted, and some countries have developed strategies (i.e. Australia) to attract this lucrative market via financial incentives and offering available talent and access to populations to accelerate development. However, it was once more common to seek approval in one country and then expand the product into other markets once approved in the primary market. But now, competition and opportunity have pushed innovators to constantly improve to succeed in developing and making their product available to their addressable markets.
As technology has improved and markets grow, businesses like CROs supporting these innovators are sure to recognize the opportunity to serve innovators that are exercising multi-country operations. Innovators naturally seek outsourcing solutions to support their unique development needs to enable them to reach their goals with the least risk and yet fastest route to successful introduction of their products to available markets.
Today, CROs come in all “shapes and sizes” and have become a substantial part of innovators’ playbook to reach the pinnacle of successful drug development. As development has expanded globally, so have some CROs – expanding into logical geographic regions to support their clients in advancing R&D efforts and expanding their business opportunities. Most multinational integrated CRO service providers have expanded organically and acquisitively.
For those CROs that have advanced to multiple regions in the world, the ability and commitment to keep all the plates spinning – quality, technical operations, people operations, sales and marketing, business development, finance, IT, and more, require a commitment to building the infrastructure needed to truly be successful and continue to grow with their clients. These plates are moving at a rapid pace and in this line of work, there is little tolerance for letting any plate fall. The Facebook adage coined by Mark Zuckerburg: “move fast, break things” does not necessarily work well in this line of business. The requirements are such that we (CROs) must move fast, but with certainty and confidence that we are doing it correctly the first time. CROs should adopt the “measure twice and cut once” approach when contemplating international expansion.
Any CRO, whether expanding organically or acquisitively to keep up with pharmaceutical and biotech R&D development in the future, has considerable planning and evaluation that must be thoroughly and efficiently completed to ensure that infrastructure and support are foundational requirements for successfully meeting clients’ global R&D requirements. Fundamental Quality Management Systems (eQMS), regulatory requirements, Laboratory Information Systems (LIMS), Global Standard Operating Procedures (SOPs), IT infrastructure and cybersecurity measures, legal, sales and marketing client relationship management (CRM), financial systems, people operations and legal are all baseline requirements to build the foundation of an integrated CRO capable of meeting the needs of global R&D development. The realization is that to truly have an integrated brand and service, investments and commitment from company leadership, investors, and staff ‘s buy-in must be aligned. The CRO’s ability to bring this together and develop a culture of quality and service is the crown jewel in a successful journey in the evolution of a CRO that can evolve to meet the needs of its clients.
The world will continue to get smaller as opportunity creates needs of companies growing their business and moving into international markets. KCAS Bio has also embarked on this journey with a commitment to become an integrated CRO offering complete bioanalytical and biomarker development services to the pharmaceutical and biotech industries. Supported by a world-class investor, seasoned leadership team, and a culture of passion to support innovators’ development of quality of life and lifesaving products, KCAS Bio continues to expand and evolve. With modern facilities located in Kansas City, Philadelphia, and Lyon, France, and a partnership with Crux Biolabs, located in Melbourne, Australia, KCAS Bio’s advancing capabilities and global reach are underpinned by the countless hours of planning, evaluating, and investing to assure that KCAS Bio will continue to evolve and grow to meet drug development needs of today and tomorrow. What an evolution from our modest beginnings that started over 45 years ago.