4 Questions to Ask When Establishing a Pharmacovigilance Organization

Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with the priorities of bringing a new drug to market. However, asking the right questions before starting the journey can mitigate the risks of PV findings and ensure a successful PV function build for the organization. This blog outlines four common but critical questions to ask when supporting emerging biotech organizations as they establish a successful PV organization.

Q: When is the appropriate time to establish a PV organization?

A: Emerging biopharma organizations are like snowflakes: no two fit a standard mold. There are many interdependencies, differences in risk tolerances, talent, experiences, drug safety profiles, and chosen vendors, to name a few. There are many aspects to understanding the right time to build a PV organization. It can take tremendous business acumen from the Chief Medical Officer (CMO) and clinical leaders to understand the triggers for engaging help.

It is both a common and a best practice to begin initial conversations with a PV expert during Phase II but before Phase III clinical trials. Important triggers to start this discussion include:

• Realization of being late to the game. There is no organized PV function within the Phase II to Phase III timeline or when the new drug application (NDA)/marketing application approval is 18 to 24 months out.
• The numbers game: Safety reporting relative to the number of patients, trials, products, partners, contract research organizations (CROs), serious adverse event (SAE), and countries becomes too difficult to manage under the current model
• The stage and complexity of developmental programs help define the appropriate time to investigate a PV resourcing model.
• Clinical trial SAE/suspected unexpected serious adverse reaction (SUSAR) volume reaches an inflection point whereby the CRO’s ability to manage processing in a timely and accurate manner is compromised.
• The organization determines that an unacceptable risk of not having PV expertise exists.

I have seen too many organizations delay, thinking they do not yet need a PV presence, and then they place the emergency call for help.

Q: What are the essential roles during the early stages of a PV organization, and why?

A: This answer to this question is multifaceted. The triggers for hiring PV and supporting staff, part-time contractors, or other staff augmentation are often convoluted business decisions. This is challenging for emerging biopharma organizations because PV resources are highly specialized, rare, and expensive.

We typically see a need to hire a safety scientist with generalist and operational skills early on. This role can work to onboard a safety services provider and assist with PV case processing and reporting activities.

At the functional build stage, an incalculably small number of organizations need a full-time Head of Pharmacovigilance. During a standard work week, there would not be enough hours to keep this role busy. The best practice for growing biopharma organizations would be to fulfill this role with an experienced, part-time Acting Head of Pharmacovigilance who is integral to the safety governance model and has availability a few hours each week to oversee the medical and business aspects of the growing PV function. The situation becomes murkier since vital, quantified PV resources are rare in the marketplace. Contracting with part-time expertise is an intelligent and efficient way to share top talent.

Dr. John Price authored a paper on this topic a few years ago for anyone considering a PV functional build: Pharmacovigilance in Crisis: Drug Safety at a Crossroads, Clinical Therapeutics, Vol 40, # 5, 2018, 790-797.

Roles within quality assurance, regulatory affairs, and project management also provide valuable partnerships as processes are codified into standard operating procedures (SOPs), regulatory pathways are formed, and a safety governance model is established.

Q: What role does a drug safety program play in a PV organization?

A: A PV organization needs a robust drug safety program, focusing on establishing the following supportive components for many of the reasons stated above:

1. Quality controlled documents
2. Signal detection and management
3. Safety governance model
4. Safety review team and safety surveillance plan
5. Inspection readiness
6. Safety services provider and safety database

Q: What would be the top strategic insights you would offer to an emerging biopharma to consider when establishing a PV organization?

A: I see these insights as three distinct pieces.

First, lacking a clear vision is problematic because teams need to understand what the organization is striving for. Many clinical and business leaders understand the need for PV but have difficulty visualizing the tactical components and the future state. It is so complex that they often do not know where or how to start.

Second, leaders don’t always know the differences between strategies and tactics. Understanding the differences makes life easier when planning complex projects. Strategies are road maps. They get you from where you are today, the “R state,” to where you need to be, the “2B state” or future state. Tactics are the vehicles to help you get there. An effortless way to remember the differences is that tactics cost money; strategies don’t.

Also, critically important to establishing a sound architecture for a PV organization is maintaining a strategy-based plan and not an issues-based plan. This would result in an optimized way of moving toward the 2B state. Even good leaders spend an inordinate amount of time planning for issues that may never come up. Since the vast majority of issues identified are relatively inconsequential, they would not be the focus of a strategy-based plan. If a problem is insurmountable, it will become a critical success factor in a strategy-based plan that would need to be addressed, or it would add a high probability of failure.

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