Embracing the Virtual Development Model in Biopharma

By Joseph Lamendola Ph.D.

Joseph Lamendola, PhD discusses the challenges many biopharma companies face and how Virtual Development can help create solutions.

In my experience working with biopharma companies, virtual development is an option that continues to grow and increase in value. There are some key benefits biopharma companies experience when they virtualize their R&D teams, and they all help reach one goal: creating a better product efficiently.

To begin, we have to look at some of the challenges biopharma companies face. It is well-documented that the cost of developing new therapies is on the rise while the return on investment on R&D spend across the life science industry is at an all-time low. In addition to these challenges, smaller biopharma companies also face the additional roadblock of limited talent and resources. My experience working with different entrepreneurial biopharma companies has highlighted that these firms often lack the specific therapeutic and industry knowledge needed to effectively build and accelerate assets through the development lifecycle. Without the budget or talent needed to fully develop their assets, these organizations could face months of delay from the FDA for several reasons, including clinical and regulatory development.

Furthermore, many biopharma companies, from small to very large, have become reliant on contract research organizations (CROs) to execute many, if not most, of their clinical trials. However, this reliance on CROs has had a negative impact on data quality. If these data quality issues are not fixed before submission, the FDA ends up doing the final quality check, possibly postponing the approval for several months.

Key Benefits

There are a few key benefits of virtual development that biopharma firms encounter when they leverage a virtual pharma model. In terms of their team, there is lots of flexibility. Creating a full-time team can be a long process, but virtual development is built to perform as a short-term, efficient program. Without the need for a full-time team of subject matter experts, organizations can scale much more efficiently while experiencing the accompanying improvement in clinical outcomes and a competent drug development process.

One specific case I encountered recently proved to be a great advocate for the virtual pharma model. A small biopharmaceutical company had a 505(b)(2) filing that was falling behind schedule and at risk of failure. We deployed a cross-disciplinary development team ranging from high-level strategic leaders to regulatory and CMC subject-matter experts to help create high-quality deliverables for the FDA submission while ensuring data accuracy and quality. By utilizing the virtual pharma model, this firm accelerated the timeline for the 505(b)(2) submission by months while also improving the quality of the FDA submission materials resulting in increased revenues and company value.

Next Steps in the Process

If executives want to improve their chances of clinical and regulatory success while minimizing cost, they should consider leveraging a more virtual development approach. To get started, my recommendation is to work with a third-party and build a team that knows drug development inside and out. Subject matter experts in these organizations have developed hundreds of assets throughout their careers and can provide your development team the unbiased, objective perspective needed to improve your development strategies to help improve your chances of success.

Once your development strategies have been pressure-tested and refined, it is then critical to understand how to efficiently build a team that can effectively handle added work demands while accessing critical therapeutic or functional knowledge as necessary. My experience working with many different biopharma companies has highlighted that many firms require additional support in the following areas:

  • Regulatory Strategy
  • Submission and Project Management
  • Clinical Development (to access specific therapeutic expertise)
  • Quality Assurance
  • Toxicology
  • Clinical Pharmacology
  • Biostatistics

Firms will often augment their internal teams with these critical resources to effectively access critical capabilities while minimizing the burden for full-time headcount on the books. Whether it be organization before submission or getting the quickest approval from the FDA, engaging a broad team of development experts in this virtual development manner will help accelerate your development process, anticipate and minimize development risks, and maximize your overall R&D spend.

Ultimately, every organization developing a new product should have the same checklist and approval review, regardless of size. Focusing on your virtual pharma development and building out an efficient team is the first thing on that list, and it will save time and bring success to your product and organization as a whole.

Joseph Lamendola Ph.D.

About the Author: Joe Lamendola, Principal of YourEncore's Regulatory Center of Excellence, over a 30-year regulatory career, is responsible for 30+ approvals across 10+ therapeutic areas. With hundreds, if not thousands, of agency interactions under his belt, Joe provides clients with the insights, relationships, and credibility needed to bring drugs to patients quicker.

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