Finding a Good Match
Rikki Hansen Bouchard, president and CEO of RH Bouchard & Associates (rhbassociates.com), advises biotechs to select a CRO for its expertise, adding that depending on the therapeutic area or the nature of the compound being developed it may be difficult to select a CRO partner for preclinical work that will also be a good choice when it comes time to take a drug into the clinic.
Bouchard also suggests that a biotech carefully weigh experience against globalization when selecting a CRO to guide it through clinical studies and the regulatory approval process.
Whereas a small niche CRO might offer the scientific expertise needed for a special type of drug compound or therapeutic application, if a successful business plan depends on obtaining regulatory approval in multiple countries, or the target therapeutic area requires a global approach to patient recruiting to attract a sufficient number of clinical subjects, then it may be wiser to seek out a partner with a more global reach.
The earlier in the drug development or preclinical process a company is looking for an outsourcing partner, the more critical the fit of the science, says David Harris, business development director at Southern Research Institute (www.sri.org), which offers discovery and development services on a contract basis, including safety assessment, bioanalysis, and formulation services.
Further down the pipeline, the contract services provided become more routine, and other metrics may be more useful for evaluating a potential partner.
A large part of a successful relationship is having the right chemistry with the CROs project team, says Dr. Sietsema. Get to know the project team and determine whether they are compatible with your companys philosophies, personalities, and work styles.
Also, determine if the CRO provides a single point of contact, or if your company will be required to interact with an ever-changing mix of people as your drug proceeds through the project.
Since the last funding boom came to an end, the biotech industry has seen the tremendous growth of virtual companies, which look to CROs for essentially all aspects of drug discovery, in-licensing interesting compounds, and seeking the in vitro and early animal study data that will determine whether or not they take a compound through to the next level of development.
This trend has blurred the lines between CROs and biotechs, according to Harris. He describes a survival model in which young biotechs move back and forth between operating as a biotech company and as a CRO, offering services that exploit a proprietary technology platform, scientific expertise, set of targets, or compound library collection to fund their internal research efforts and remain financially solvent.
Similarly, CROs have figured out that the financial sweet-spot is to participate in an IP stream, says Harris, and they are looking to get involved earlier in the discovery process, working alongside the biotech in a collaborative partnering capacity.
CROs are moving upstream, he notes, offering more preclinical and discovery services and linking up with clients earlier in the hopes of establishing a long-term partnership and sharing in the royalty stream, and for contract providers such as Southern Research Institute, pursuing their own in-house drug discovery efforts.
From the perspective of a specialty testing firm, such as IBT Reference Laboratory (www. ibtreflab.com), which partners with CROs, giving them the capability to offer a range of immunotoxicology testing, including measures of immunogenicity, hypersensitivity, immunosuppression, adverse immunostimulation, and autoimmunity, a key driver of the growing demand for contract testing services is the FDA.
John F. Halsey, Ph.D., president, CEO, and CSO at IBT points to the FDAs guidance document that calls for immunotoxicology as part of the preclinical studies and Phase I clinical testing of a drug candidate. These are not off-the-shelf types of tests; they require specialized resources and expertise, and a CRO would either have to develop this capacity internally or contract out the work.
Depending on the type of drug in development, Dr. Halsey recommends that when selecting a CRO partner, a biotech firm should ensure that the CRO either has the staff and specialized laboratories to perform these tests or access to that expertise.
He advises companies to probe beyond the knowledge base of the typical academic investigator when devising a drug development plan and to seek scientific input from a CRO or reference testing lab before taking a drug into clinical trials.
Recognizing the need to test for immunogenicity and immunotoxicity and understanding how to tailor those tests, as well as understanding their limitations, can save a biopharma company that is developing a protein or peptide therapeutic significant time, expense, and potential problems down the road, according to Dr. Halsey.
Dr. Halsey highlights two key advantages of working with a reference laboratory such as IBT, both early in the development of a biopharmaceutical, when the contract lab can formulate the appropriate biomarkers and begin measuring their levels to monitor for immunotoxicity, and later, when a product begins human testing, and the reference lab can help design the clinical trial and guide patient selection to increase the probability of demonstrating efficacy.