From patient-centricity to venture capital networks
The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases. Since biotechnology companies often focus on a small portfolio of compounds within a specific therapeutic area, many lack the resources, drug development experience or therapeutic expertise required to bring novel therapies to market. Moreover, biotechnology companies often prefer a light internal infrastructure, creating the need for externalised clinical development with partners that can devise a clinical development plan that is tailored to a company's specific needs.
Seeking a partner in drug development can help small biotechnology companies streamline trial designs across the entire spectrum of drug development. The services offered by a partner such as a CRO can span from the preclinical phase through to commercial positioning. For example, partnership between a biotechnology company and a CRO can provide benefit when it comes to adopting patient-centricity into trial designs and establishing networks with venture capital (VC) firms to attain clinical research funding. Here we discuss these examples to illustrate the value of partnering with a CRO, as well as outline key characteristics to look for in a strong drug development partner.
Adopting patient centric models
According to the FDA, 70 percent of Americans have reported being inclined or even very willing to participate in clinical research.1 Despite this, only about 5 percent of adult cancer patients were enrolled in clinical trials at the time of the report, highlighting an opportunity for more patients to become involved.1 Integrating the patient voice into clinical trials has potential to address this by impacting patient recruitment, enrollment and retention. Although patient-centric approaches to trial design holds great potential, there is a perception amongst small companies that it is too costly and time-consuming to put into practice, preventing them from pursuing these approaches. With experience and expertise, however, there are several opportunities for companies to integrate the patient perspective effectively.
Working with an experienced CRO partner can help incorporate patient-centric approaches into clinical plans in a thoughtful way. These tactics can ensure that patient experiences, needs and priorities are recorded and incorporated in future trials for the sponsor, and can be tailored to the needs of each study. Working with a CRO to develop a step-wise approach to patient-centricity can make it feasible for small biotechnology companies that may not otherwise have the resources or expertise to integrate these tactics on their own. Accessing this expertise can help biotechnology companies to develop clinical trials that better serve patients without sacrificing efficiency.
Establishing networks with VC firms
The ability to work effectively with VC firms and clinical research experts is critical to biotechnology companies when it comes to demonstrating the value of their scientific discoveries. As such, the opportunity to establish networks with VC firms is a strong example of how a CRO partnership can be particularly beneficial to biotechnology companies.
Partnering with a CRO can help facilitate these relationships and accelerate development of novel therapies. For example, ICON’s rich VC network, includes a partnership with ALSA Ventures’ Eclipse model. This programme focuses specifically on assisting biopharmaceutical companies generate first-in-human data as quickly and efficiently as possible.
Characteristics of a strong partnership
Working with a drug development partner that has experience bringing novel therapies to market can benefit small biotechnology companies, as exemplified by the opportunity to elevate patient-centric approaches and network with VC firms. Moreover, when selecting a drug development partner, biotechnology companies should consider a nimble approach. This strategy allows different functions to be moved as needed based on the project requirements, and enables knowledge-sharing and distribution of resources between the CRO and the sponsor. In addition, this type of partnership allows for the development of complementary workflows and governance.
The ICON team has experience establishing key processes and infrastructure internally for biotechnology companies, including due diligence and asset valuation, good manufacturing practices, flexible costing models and regulatory expertise. To learn more about ICON’s services in this sector, visit https://iconplc.com/sectors/biotech/
Sources
- https://www.fda.gov/news-events/speeches-fda-officials/16th-annual-accelerating-anticancer-agent-development-and-validation-workshop-05092019