The following content was created on behalf of an advertiser. It was not written by our editorial team and does not necessarily reflect our opinions. For more information, read more here.
Over the years, CROs have evolved from a transactional “pair of hands” to organizations that are true partners in their clients’ drug discovery journey, providing them with cutting-edge science and access to innovative technology platforms, insights and expertise in specific therapeutic areas. This increased focus on therapeutic development benefits pharma and biotech, particularly organizations looking to invest in science rather than infrastructure.
Today, the healthcare industry faces tremendous pressure to rapidly move therapies from R&D to clinical trials. This demand has contributed to the expanded role of CROs and requires their scientists to demonstrate their skills and innovation as a “drug hunter”. Such expertise can originate from experience in big pharma and be further enhanced through a wide variety of collaborations with academia, biotech, as well as large pharmaceutical companies.
“Historically, CROs have traditionally been approached by pharmaceutical companies for capacity building or transactional research work,” said Heidi Kingdon Jones, global vice president of sales and marketing at IRBM, a drug discovery and early development CRO.
“When the pharma company entered into full discovery programs, the CROs often handled the back-up program while the pharma company managed the lead program.”
But companies have begun to realize that partnering with a CRO can 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 multiple preclinical development programs to be executed more efficiently and effectively.
“Over time, CROs have shifted from a transactional arrangement with clients to working hand-in-hand in an integrated manner to manage client programs through a multidisciplinary research approach,” noted Michele Lucche, vice president and head of North American business development at IRBM. “CROs are now recognized by biotech as well as pharma as a trusted partner who can lead both the primary and back-up program.”
CRO as Think Tank: Evolving Partnerships
In 2009, as pharmaceutical companies began to consolidate research, development and manufacturing sites to be more streamlined, the increased reliance on the CRO as a trusted partner became apparent: The relationship went from 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 pharmaceutical company,” Luche explained.
“There has also been concern in the past about diversifying too much, particularly with concerns that intellectual property could be compromised. Today, sponsoring companies of all sizes, from nonprofits and virtual biotechs to large pharmaceutical companies, prefer to engage with trusted CROs that have the relevant expertise, platforms and expertise in preclinical programs.
Skilled collaborators working closely together can create a sort of “think tank” that can use the collective knowledge and experience of a particular goal or approach to create a “power team” that can accelerate client programs with a goal of more getting drugs to patients quickly and potentially in greater numbers,” Lucche said.
“Furthermore, this enhanced role of CROs and their innovative programs and cutting-edge technologies have made them increasingly attractive places to work for people across the industry. “The brain power and industry know-how that has gone into CROs makes them fully abreast of new modalities and new goals,” added Kingdon Jones. “It’s made a huge difference in how CROs operate.”
CROs as Drug Hunters: Diverse Portfolios and Flexibility
This change in the CRO space is reflected in IRBM’s history: starting as a research institute, it evolved into a drug discovery site for Merck Research Laboratories and then became an independent CRO. Using its strong foundation in research alongside its large pharmaceutical heritage, Kingdon Jones explained that IRBM “can apply a wealth of innovative methods that it has developed in-house over the decades.“
Since IRBM was already a drug hunter, it was able to continue to invest its efforts in deep science, allowing it to offer solutions to solve customers’ problems.
“This drug hunter mindset serves biotechs 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 someone who knows what critical experiments will get you to that point, rather than someone who is doing a box-ticking exercise,” Luche added.
These days, more and more CROs are hiring a Chief Scientific Officer (CSO). With a CSO on board, CROs are more adept at developing cutting-edge technologies to support drug discovery programs. The CSO helps the company stay abreast of industry and science trends, which directly benefits customers because early-stage discovery is research-based, requiring multifaceted, flexible approaches.
“You need people who can keep up with the latest research and are not limited to just one subset of the whole process, like small molecule chemistry, for example,” Kingdon-Jones said. “Our CSO, Carlo Toniati, keeps us focused on the science as we work on more challenging targets and different therapeutic modalities for our customers.”
Tips for choosing a CRO: let the science speak for itself
True flexibility is a major part of biotech and CRO partnerships in the space today. Scientific know-how to run a particular program through prior experience, along with knowledge of relevant therapeutic areas or modalities are important factors in evaluating a CRO.
“For further validation, it is imperative to speak with the scientists at the selected CRO,” Luche added. “Seeking CRO input on your preclinical program allows you to understand and appreciate how they can contribute.”
Working with CROs who recognize the opportunity but also the limits of their expertise is also critical.
“For a drug discovery program, you would want to get the best capabilities as and when needed,” Luche continued. “Similarly, a CRO should not claim to be able to do absolutely everything, instead it should signal when outsourcing to another provider may be more valuable to the customer.”
However, partners should also keep in mind that “science should always guide the contract. If a CRO is tied to a strict benchmark, they are almost forced not to think about the science,” she continued. “While boundaries are needed within the treaty, there must be recognition that science must always drive a preclinical research and development agenda.”
A future of strong academic connections and translational research
For virtual biotechs or non-profits, “partnering with a CRO with integrated capabilities and standby infrastructure is especially beneficial because they need to invest in their science instead of real,” Kingdon Jones said. “Such CROs with fully integrated capabilities can be spread across different buildings or cities. However, IRBM’s great pharmaceutical heritage and capabilities brought together under one roof are why we are particularly favored by this community.”
Having everything in one place benefits customers as it speeds up cycle times: samples do not need to be sent between sites for analysis.
Furthermore, to ensure cost-effective and constructive feedback between projects, the IRBM team makes an active effort to stay abreast of the latest scientific developments, new modalities and technology platforms. Such a perspective is appropriate given where the industry is headed.
Kingdon Jones predicts: “As the pharmaceutical and biotech industries look to academia for innovation, CROs are likely to find themselves working more closely and earlier in the journey with academia to develop new technologies.”
“Dedicating time and resources to building new platforms and technologies, along with developing relationships with academia, has become a top priority for CROs. Accordingly, the science within IRBM will continue to be driven by the goal of providing the best possible outcomes for patients.
This is how IRBM and its multidisciplinary team can ensure that your molecule is the best it can be.
Images courtesy of IRBM.