Introduction

By Anil Kane, PhD, MBA, Global Head of Technical & Scientific Affairs, Thermo Fisher Scientific

The increasing complexity in drug development and the highly competitive industry landscape are creating a dramatic shift in how pharmaceutical and biotech companies plan for and execute drug development and production. Speed, quality, and cost continue to be critical levers, but the challenge of achieving the right balance under the growing pressure to expedite development has made selecting the “right” outsourcing partners a strategic priority for pharmaceutical and biotech companies seeking to get their product to market as quickly as possible.

With increased market expectations and new and more stringent regulatory hurdles, these companies are also seeking advanced supply chain opportunities to optimize the development of their molecules. For many, establishing a partnership with a CDMO is more cost effective than investing internally on infrastructure.

Outsourcing offers drug sponsors a variety of benefits, including access to a global network of cGMP facilities with high capacity and highly qualified experts across multiple disciplines. Having access to such vast industry expertise facilitates the seamless transition of projects through all phases of development. Strategic collaboration with a CDMO partner that has deep scientific expertise and industry experience can keep projects on track and accelerate market entry.

This is especially critical for small and mid-size companies that don’t have the in-house capabilities needed to support the capacity needs and time constraints, or the technical and regulatory knowledge or resources to successfully plan for and file an IND/IMPD for their regional and global launches.

As precision medicine becomes more pervasive, the benefits of CDMO outsourcing are expanding by an order of magnitude for both small biotech companies and large pharma. The active pharmaceutical ingredients (APIs) and formulations developed for precision drug products are often drastically more complex and require specialized handling. While large pharmaceutical companies often have the capacity and knowledge to keep this work in-house, the small batch size requirements of precision therapies make it impractical.

To address these needs, more companies are turning to outsourcing all or part of their drug development and manufacturing projects. In 2021 alone, 46% of newly developed drugs were outsourced to CDMOs¹.

A well-established CDMO can offer drug sponsors strategic advantages due to the collective years of deep industry knowledge and experience within these organizations. The speed and agility with which CDMOs are capable of working benefits sponsors by providing shortened development timelines and reduced errors that lead to costly delays and rework. Ultimately, a CDMO’s main objective is to get the sponsor’s drug developed and to market as soon as possible – allowing patients to receive critical medications faster.

Thermo Fisher Scientific is a global CDMO providing industry-leading, end-to-end pharma services solutions. We provide tailored drug development, manufacturing, and clinical services through our comprehensive Quick to Care^TM program and assist clients in balancing speed and risk during early development to successfully file an IND/IMPD with our Quick to Clinic^TM program. Everything we do is geared at ensuring that our client's drug achieves its full potential as a life-changing breakthrough for patients all around the world.

¹Source: GlobalData, Pharma Intelligence Center Drug Database