Over the years, CROs have evolved from a transactional ‘pair of hands’ to organizations that are true partners in their client’s drug discovery journey, providing them with cutting edge science and access to innovative technology platforms, insights and expertise in specific therapy areas. This enhanced focus on therapeutic development benefits pharma and biotech, in particular organizations that want to invest in the science instead of in infrastructure.
Today, the healthcare industry faces immense pressure to quickly progress therapies from R&D stage to clinical trials. This demand has contributed to the broader role of CROs and requires their scientists to demonstrate their “drug hunter” skills and innovation. Such expertise may originate through a background in big pharma and further honed through many, varied collaborations with academia, biotechs as well as big pharma.
“CROs were traditionally approached in the past for surge capacity work or for transactional research by pharma companies,” said Heidi Kingdon Jones, Global Vice President of Sales & Marketing at IRBM, a drug discovery and early development CRO.
“When pharma did contract out complete discovery programs, CROs would often be handling the backup program while the pharma managed the lead program.”
But companies began to recognize that partnering with CROs could mean leveraging the latter’s comprehensive technology platforms, as well as a significant knowledge base across multiple drug classes and therapeutic areas. This can enable running multiple preclinical development programs more efficiently and effectively.
“Over time, CROs shifted from a transactional arrangement with clients to working hand in hand in an integrated fashion to drive client programs through a multidisciplinary research approach,” noted Michele Luche, Vice President and Head of North America Business Development at IRBM. “Now CROs are recognized, by biotech as well as by pharma, as a trusted partner that can lead both the main and the backup program.”
CROs as a brain trust: evolving partnerships
In 2009, when pharma companies began consolidating research, development and manufacturing sites to be more streamlined, the increased dependance of CROs as a trusted partner became visible: The relationships switched from being functional to more strategic in nature.
“Although the industry still somewhat relies on CROs to conduct transactional research, CROs are now tasked with making contributions to the science to further complement the biotech or pharma company,” clarified Luche.
“In the past, there was also concern of diversifying too much, especially with the worry that intellectual property may be compromised. Today, sponsoring companies of all sizes, from not-for-profits and virtual biotechs to large pharma, prefer to engage with trusted CROs who have the relevant expertise, platforms and track records on preclinical programs.
Skilled collaborators working closely together can create a sort of ‘brain trust’ which can leverage the collective knowledge and expertise of a certain target or approach to create a “powerhouse team” that can expedite client programs with the goal of delivering medicines to patients more quickly and, potentially, in higher number,” said Luche.
“Additionally, this enhanced role for CROs, and their innovative programs and state-of-the-art technology has made them increasingly attractive places to work for people from across the industry. The “brain trust” and the industry knowhow that has come into CROs makes them fully up to date on the new modalities and new targets,” added Kingdon Jones. “This has made a huge difference in the way CROs operate.”
CROs as drug hunters: diverse portfolios and flexibility
This shift in the CRO space is reflected in IRBM’s history: starting off as a research institute, it evolved into a drug discovery site for Merck Research Laboratories and then became an independent CRO. By leveraging its strong foundations in science research alongside its big pharma heritage, Kingdon Jones explained that IRBM “can apply a wealth of innovative methods that it has developed in-house over the decades.”
Because IRBM was already a drug hunter, it has been able to continue investing its efforts in deep science, allowing it to offer problem solving solutions to clients.
“This drug hunter mindset serves biotechs that are trying to get to the next inflection point; they can benefit from people who will give them sound advice when they need it. You want to work with somebody who knows which critical experiments will get you to that point, instead of someone doing a box ticking exercise,” added Luche.
These days, more and more CROs are hiring a Chief Scientific Officer (CSO). With a CSO in the company, CROs are more adept at developing cutting edge technology to support drug discovery programs. A CSO helps keep the company up to date on the industry trends and the science, which directly benefits clients because early discovery stages are research based, requiring multi-faceted, flexible approaches.
“You need people who can keep up with the latest research and aren’t just limited to a single sub-set of the entire process such as small molecule chemistry, for example,” said Kingdon Jones. “Our CSO, Carlo Toniatti, keeps us focused on the science as we work on tougher targets and different therapeutic modalities for our clients.”
Tips on choosing a CRO: letting the science speak for itself
Real flexibility is a core part of biotech-CRO partnerships in the space today. The scientific knowhow of running a particular program through prior experience, along with the knowledge of relevant therapeutic areas or modalities are important factors when appraising CROs.
“For further validation, speaking to the scientists at the shortlisted CRO is a must,” added Luche. “Seeking the CRO’s opinion on your preclinical program allows you to understand and evaluate how they can contribute.”
Working with CROs that recognize the possibility, but also the limits of their expertise, is also critical.
“For a drug discovery program, you would look to obtain the best capabilities as and when needed,” Luche continued. “Likewise, a CRO should not claim they can do absolutely everything, instead they should flag when outsourcing to another provider might be more value for the client.”
However, partners should also keep in mind that “science should always drive the contract. If the CRO is tied to a stringent benchmark, they are almost forced to not think about the science,” she continued. “While boundaries within the contract are needed, there has to be a recognition that science should always be driving a preclinical research and development program.”
A future of strong academic ties and translational research
For virtual biotechs or not-for-profits, “partnering with CROs with integrated capabilities and infrastructure on stand-by is especially beneficial, as they should be investing in their science instead of in brick-and-mortar,” said Kingdon Jones. “Such CROs with fully integrated capabilities can be spread out in different buildings or cities. However, IRBM’s big pharma heritage and capabilities being housed under one roof are why we are particularly favored by this community.”
Having everything in one location benefits clients as it speeds up the cycle time: samples do not need to be shipped between sites for analysis.
Moreover, to provide cost-effective and constructive feedback across projects, the team at IRBM makes an active effort to stay updated with the latest scientific developments, new modalities and technology platforms. Such an outlook is apt considering where the industry is heading.
Kingdon Jones predicted: “As the pharma and biotech industry is looking to academia for innovation, CROs are likely to find themselves working more closely, and earlier on in the journey, with academia for developing new technologies.”
“Allocating time and resources to building new platforms and technologies, alongside developing relationships with academia has become paramount for CROs. Aligned with this, the science within IRBM will continue to be driven by the goal to provide the best possible outcomes for patients.”
Here’s how IRBM and its multidisciplinary team can ensure your molecule is the best it can be.
Images courtesy of IRBM.