By Raphael G. Ognar
Raphael G. Ognar discusses the overlying challenges biopharma organizations have and how Virtual Development can save the day.
The minute a biopharmaceutical company receives their funding, they are in a race against time. While many biotech and biopharma organizations attempt to maximize their initial budget and utilize their own employees, many companies are seeking novel approaches to accelerate time to market and optimize their budgets through the utilization of partners and variable resourcing models. One of the latest approaches companies are utilizing is a virtual development model to building a team, leading to a versatile team with broad expertise.
One of the biggest problems companies and venture capitalists face while seeking to scale their new biopharma companies is the limited backgrounds and expertise on their team. Most of the people who are initiating and building platforms that eventually could convert into biotech are either scientists or involved in finance. Usually, these team members don’t know every part of the product development or commercialization lifecycle. While they can be very accurate in their field, they may not know how to build out a full strategy or business case, which requires multiple levels of cross-disciplinary expertise.
I have found that companies that move the fastest and can navigate the inevitable quality, regulatory, clinical, and commercial challenges have collaborated with highly accomplished industry experts early in the strategic planning process. Doing so often helps bring the necessary insights and knowledge to build numerous options which the company could pursue. The more upfront time you spend building out your team’s strategy, including planning for potential scenarios and having more than one hypothetical solution, the more time, money, and stress you will save yourself, your company, and your shareholders.
In addition to engaging strategic executives early in the process, the more innovative biopharma companies we see also leverage flexible, nimble talent delivery approaches. They will also seek to engage outside talent early and often instead of building a team from scratch with full-time employees which often takes too much time, wastes critical resources, and ultimately does not help drive assets to the market. Seeking external expertise through a virtual development model provides a flexible option that ultimately leads to project efficiency and success.
While building a highly nimble, virtual team can be complex I believe firms should work hard to partner with highly experienced, cross-disciplinary talent in an agile and cost-effective manner. Leveraging these subject matter experts can bring many benefits to the project, including:
When determining what kind of expertise needs to be included on virtual development teams, it is critical to understand where your team lacks critical competencies and engage highly experienced talent to complement your internal resources.
Through my years of experience, I have found that the most under-represented skillset on the management team at growing biopharmaceutical companies is a team of highly accomplished regulatory strategists. These individuals, especially if they came from larger pharmaceutical companies, were often the leader of their respective development teams, working across the other disciplinary areas, including clinical development, CMC, quality, and pharmacovigilance, to help design a strategy that would ultimately be agreeable to the FDA and receive regulatory success. Coming together, this team of subject matter experts, formed by the virtual development model, is able to react quickly to any issues that arise, providing a responsive, adaptive effort that can work within different areas.
For growing biopharma companies, having a regulatory strategist engaged early in the development process ultimately helps your firm understand how best to streamline the other critical talent necessary to move an asset along the development approach in a very agile, flexible, and cost-effective manner.
Growing biopharmaceutical companies should embrace and leverage a virtual development model and ensure corporate and development strategies are peer-reviewed by industry experts. This emulates the most innovative and productive firms I have seen, which seek a more virtual team approach to not only save money and time for your organization, but also reduce your personal stress and concerns.
Be sure to check out our webinar to learn more about how smart biotechs scale quickly and maximize value.