In this age of COVID-19, many companies and individuals have awakened to the idea of the virtual office and working from home. But for many of us in small start-up pharma companies, this has been the reality for many years. Due to the explosive growth of the contract research, development, manufacturing, clinical, marketing, and sales companies and consultants, it has been possible to completely commercialize a pharmaceutical product as a virtual company.
With only a staff of 1-5 employees, and without offices, laboratories, or warehouses, a new virtually operated company can be very nimble and initiate product development extremely efficiently saving time and money.
This virtual model has been favored by companies like Sollievo Pharmaceuticals when the product of interest is repurposing or enhancing an already approved drug. In these specific cases, the regulatory process that can be applied, known as a 505(b)(2) NDA, permits the company to reference and include in their submissions existing preclinical safety data and other information that is known for the approved product.
Thus, these products can navigate the development and regulatory processes, leading to approval, in 3 to 5 years, and at a substantially lower cost compared to a new molecule program that can take up to 15 years and cost more than $2 billion.
Although the prospects and probability of success are increased for these repurposed drugs and delivery enhanced products, there are unique leadership challenges that come with the virtual development model. In the virtual company, the significant resources that were just down the hall, are no longer available. The delegation, particularly in the early days of a startup, is usually not an option. Therefore, the tasks of strategy development, project planning, fundraising, selecting and contracting outside organizations and consultants, and project management falls squarely on the company leadership team.
The leadership challenges in a virtual company are different than what is encountered in a typical development organization. The leader must now rely on their experience and have both a broad yet focused understanding of all the disciplines and requirements needed to develop a realistic fundable plan that can be executed by outside contractors. For example, the table highlights the many different disciplines that are required to develop the Sollievo injectable product.
To manage the complexity associated with drug development a creative leader must be able to leverage not only their experience but also their intuition, gained over many years, to be confident in making timely decisions in a fast-paced program, even when all the data is not available.
As we know, a focused leader with a clearly articulated product vision is critical in fundraising. Equally important is how that vision is communicated to outside contractors in a way that in a clear plan that is accurately quoted and executable. Whereas it is routine for the company leadership to modify and evolve the product profile, as more information becomes available, failure to quickly re-calibrate the outside contractor is a recipe for timeline delays and cost overruns. To avoid these preventable delays necessitates routine communication with the outside contractors and requires an effective project manager within their organization to be the single point of contact.
A resilient virtual company leader must be a very good negotiator. Since small nimble virtual companies lack the bureaucracy of larger established companies, many of the very capable contract organizations, unfortunately, are larger companies. Bureaucratic snags, scheduling conflicts, and detrimental resource allocation decisions are inevitable and can dramatically impact anticipated timelines. Negotiation and innovative contingency planning are skills used often to maintain timelines and resolve conflicts.
Finally, the ability to take risks is a key success factor in the fast-moving world of a virtual company. The key is to take calculated risks early in the program that have the most upside benefit and little downside. For example, early product development with two or more pathways is more expensive but ensures product success.
Timid and conservative leadership at the onset of program initiation are key factors in constraining momentum. In spite of what one might think, the greatest influence on shortening time to approval comes from decisions that occur in the early stages of development. This is due to the fact that preclinical, clinical, and regulatory approval timelines are mostly fixed, and there are few levers to significantly change the timeline on the back end.
In summary, leadership in a virtual company can be challenging for the unprepared, but an experienced, focused, resilient, intuitive and visionary leader who can see beyond the horizon can be very successful in the world of the virtual start-up company.
Written by Dr. Robert K. Schultz, Ph.D. Have you read?
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