THE CLIENT’S CHALLENGE
A biotech company was two months away from submitting their first-ever NDA. The CEO knew he needed to hire a new sales team, but handling everything internally with the staff they had seemed daunting. The functional heads in the company, who had 10-20 years of experience, felt they were prepared for what was needed to launch the company’s first product upon FDA approval. The first-time CEO and was not sure he agreed with his direct reports’ opinions. He contacted Ayd Group for advice.
First, we collected detailed information from the CEO about different aspects of the company. It was important to know how complex the company’s operations could be. Part of this information gathering included an understanding of how the company operated internally and the degree to which they relied on third-party service providers. In addition, we wanted to hear from the CEO what his own opinions were about what was and was not in good shape from his point of view. This background information was further supplemented by conducting one-on-one interviews with the CEO’s direct reports and a handful of others deemed key. These discussions were deemed critical as it was necessary to understand their perspectives because they would be the ones responsible for implementation. After analyzing the information gathered in total, a picture arose that revealed a substantial disconnect between the individuals interviewed and the CEO.
The reality of the situation was that there was a combination of differing opinions among the senior ranks of the company as to what “commercial readiness” meant. So, while some employees were very confident, others were not. In at least one case, there was evidence of a silo or withholding of information critical to the rest of the organization. Furthermore, the deeper we went into the organization’s ranks, the less we were able to find consensus among employees that the company was ready to launch its first commercial product about one year later.
Having encountered similar situations before, Ayd Group determined that it was best to present the findings to the CEO along with a benchmark example of what commercial readiness should more closely resemble. This way, the CEO could ask more meaningful questions such as, “What do we need do to do get where we need to be?”
A written summary with recommendations was delivered to the company CEO. After much further discussion, the project moved from “assessment phase” to the “gap remedy phase.” This next phase included seeking specific input from second- and third-line employees of the company to establish a benchmark from where a recommended implementation plan would begin. The information obtained resulted from a deep dive into each specific functional area as well as an evaluation of work streams that crossed multiple functions within the company. This analysis represented a snapshot of what systems were in place and how well they were working.
The conclusion in the written report included a high-level scorecard that was used to illustrate to the company CEO where the major gaps existed and what their criticality was, as well as a proposal to address each issue with a time and cost estimate. While the CEO was concerned about what was presented, it turned out that the summary report validated what he already believed was the situation. The priority areas which needed to be brought into compliance or created for the first time included:
- Updates Needed in The Quality Management System (QMS)
- Insufficient oversight of third-party operations (CMO)
- Incomplete Vendor Quality Management System
- Additional staff to be added to internal QA/QC function with training
- New staff to be added to supply chain and distribution
- Upgrades Needed to Regulatory Affairs Function
- Automated systems to manage all post-approval commitments
- Additional staff to manage PAS, CBEs, annual reports, etc.
- Experienced subject matter experts to monitor and oversee advertising/promotional materials
- Establishment of a Pharmacovigilance Function
- Function to be created anew and remain an internal function
- New staff to be hired and trained
- Experienced Sales and Marketing Team Needed
- New staff to be hired and trained
- Understanding of market channels
The CEO accepted most of the recommendations needed to fill gaps and bring the company into GMP compliance. The CEO also agreed with the recommendations needed to transition the company into a state of commercial readiness. A Master Plan was developed so that the work needed to address the gaps could proceed, using a staged approach such that the impact on day-to-day operations would be minimized.
The company’s Quality Management System (QMS) had not been updated since the company’s inception five years earlier. Hence, an overhaul was necessary, not only to address a larger scope of operations, but also to bring systems into compliance with current-day regulations. Ayd Group developed an updated QMS suitable for the company’s anticipated commercial operations. We also drafted a Quality Agreement to be put in place between the client and their CMO.
The client’s QA/QC employees were mainly experienced in managing investigational drug product. Hence, it was highly recommended that experienced individuals be hired where needed. Similarly, the regulatory function’s employees had less than ten years of experience. We recommended to upgrade the senior regulatory position to be a function head with appropriate experience. Additional regulatory staff should be hired to monitor promotional and advertising materials that were to be placed on the company’s website and elsewhere. Ayd Group drafted job descriptions for all new positions. We also assisted the client in the selection and installation of a commercially available regulatory information management system (RIMS) appropriate for the company.
A new pharmacovigilance function was needed, and it was concluded that it should be internal to the company. Even though this was the first product launch, the company was anticipating other launches to come in the following year. The company was new to this work stream and opted to hire a seasoned person for the role.
Lastly, the CEO knew that he needed to hire a sales and marketing team, but our findings helped him to make better preparations. The company’s first product launch was for a sterile injectable drug. However, the next new product launch, which was anticipated within 1-2 years, was for an oral tablet. These products are very different from each other, with each having a different target end customer. Since it would be necessary to have separate sales and marketing teams to focus on the specific needs of the different product types, Ayd Group’s recommendation was to focus in the short term on the first product launch only.
All of the work to correct deficiencies and fill gaps for the client was completed before their first product received FDA approval. The product launch was not without a few challenges, but the company is selling its first commercial product.