I love to travel, and I’ve been fortunate enough to have travelled to many interesting places all over the world. But while reaching the destination is the goal, it’s the planning of the trip that is the real challenge, working out routes, logistics of connections, great places to stay and interesting sites to visit.

The drug development journey could be viewed in a similar way. Drug developers will certainly know they’ve journeyed by the time their drug eventually makes it to treating the patients for which it’s intended. I believe that smoothing out this journey is the job of a dynamic contract research organization (CRO), leveraging their capabilities, skills and experience to walk side-by-side with the developer to anticipate hurdles, avoid costly delays and get the drug to its destination as efficiently as possible.

Like using a travel agent to book flights, connections and accommodations, the use of one single supplier to provide an integrated range of services simplifies the drug development journey. By decreasing the number of vendors that drug developers need to manage, the often complicated, time consuming and resource intensive processes that would otherwise have to be invested in sourcing multiple solutions for different service elements can be avoided. Such responsibilities include the vetting of vendors, Request for Proposals (RFPs), and devoting the necessary project management resources to ensure projects run coherently.

Considerable work would be required to collect data from multiple vendors, clean it and analyze it, and then get those data ready for registration submissions—such work is time consuming and resource draining. Working in partnership with an experienced CRO with an established history of handling regulatory submissions, managing and conducting multiple studies, the foresight and agility to conduct additional studies as they become necessary during development, and then compiling data reduces effort, adds up to saving time and money, and, ultimately, speeds up the journey of drug development.

Progressing a compound from the lab to the clinic also requires the knowledge necessary to navigate the labyrinth of regulations and global regulatory bodies, a task especially challenging for the many, smaller developers who typically lack access to such expertise. Partnering with a CRO that has the depth of experience of what is, and is not, required by global regulators helps to anticipate and prevent delays in getting to the clinic, especially so for the considerably more complex biologic compounds.

Multi-service CROs are also well placed to offer expertise in combining pre-clinical toxicology with an in depth understanding of biology for effective translation in bioanalysis to support clinical studies. Expert advice is required not just on what is the best and most appropriate safety study to run, but also on what is the most appropriate bioanalytical approach and biomarker to use to test a particular molecule/compound. It is considered by many as best practice to employ one CRO to provide both bio-analytical pharmacokinetics in pre-clinical studies and also to carry out the regular bioanalysis required during clinical stage studies, transferring the pre-clinical understanding of a compound’s properties and method validations to the human modality.

Utilizing the same CRO for both the short-term acute studies and for chronic testing—particularly longer term Developmental and Reproductive Toxicology (DART) and carcinogenicity tests brings similar efficiency benefits. It also provides the advantage of seamless transfer of historical data, smoothly taking the drug into the relevant chronic study elements of later stage development.

Another example of such partnership benefits is in Chemistry, Manufacturing and Control (CMC). As CMC laboratory analytical testing spans the entire development cycle from initial R&D discovery studies through to QC batch release testing for Phase I, II and III clinical studies, and onwards into commercial scale release, having access to these services in one supplier improves the efficiency of data collection and validation, and leverages the experience of running the same assays over a long period of time.

Finally, few CROs are in a position to also assess the environmental impact of pharmaceuticals and biopharmaceuticals. At Envigo we have the ability to integrate this component into our service offering to drug developers, drawing on the dedicated in-house environmental research capabilities that we provide to the chemical and crop protection industries. The ability to write waivers, advise on triggered studies, conduct those studies and present data to regulatory authorities extends the support we are able to give, helping customers meet post-marketing compliance requirements in a timely manner.

A collaborative relationship
For CROs and drug developers to work successfully together, a relationship based on scientific and operational understanding is best started right at the outset. Early collaboration to understand the scientific and regulatory challenges that are likely to be faced in progressing a compound into the clinic, and beyond into marketing authorization, proves hugely beneficial in anticipating the likely scope of studies, data requirements and programming  of studies.

I believe successful collaboration needs to embrace both proactivity and a beginning-with-the-end-in-mind mentality. These two principles are critical to maximizing the effectiveness of a CRO progressing compounds and molecules through key development milestones, leveraging experience to anticipate hurdles and proactively work to overcome them, while avoiding costs and unforeseen delays.

Focusing on this mind-set means that the qualified CRO seeks to leverage its scientific and regulatory expertise early, even as early as the RFP stage, rather than merely quoting for a “perfect-world” study and then surprising customers with unexpected additional costs. We prefer to leverage our experience in anticipating issues and quoting “real-world” estimates of what a study will likely require. Sure, this means our estimates might at first appear higher, but this proactive honesty is appreciated by our customers as we seek to build trust into the relationship.

Key to our collaborative “end-in-mind” approach is to continuously consider the next development milestone, leveraging our experience to act as development partner to our customers and advise accordingly. For instance, if a drug candidate’s clinical indication is for patients with late-stage or advanced cancer, I believe that CROs should work proactively with drug developers to make sure that they can take full advantage of the regulatory opportunities to streamline their preclinical safety studies. Similarly, with orphan drugs CROs should be especially proactive, working closely with the developer and regulatory bodies to determine what toxicology testing will or will not be needed, and to optimize study design.

Drug developers should not have to journey alone. CROs should act as partners, leveraging their experience to anticipate the best route through key milestones with services tailored to meet the specific needs of that developer with that drug indication in specific markets, actively seeking to build trust by placing a strong emphasis on communication and collaboration. This need is best met by experienced CROs with flexible working models that respond fast to meet customer needs, and the breadth of capability to provide integrated insights across the many disciplines needed to successfully arrive with a drug to market.
Happy traveling! 

---

Lynn Lewis is chief commercial officer at Envigo. In this role she is responsible for the commercial strategy and implementation within Envigo. Functional activities include marketing, sales, new service planning, and customer service that drive business growth and increase market share.