Lifecycle management (LCM) of a drug is one of the most critical strategic initiatives (bio)pharmaceutical companies can undertake. LCM, done right, gives pharma companies a competitive edge, helps to maximize sales and retain market share, improves profitability and mitigates drug patent cliffs.
While many functional departments of a pharmaceutical company are involved in LCM in this blog we will take a look specifically at the different roles external experts play throughout the lifecycle of a drug from research to post-launch activities.
Choosing experts for every stage of the lifecycle
There is great value in knowing external experts well, building long-term relationships and keeping them engaged throughout the lifecycle of a drug. In addition, different phases of a drug’s lifecycle require different types of insights, advice and support and therefore call for different – additional – experts to be engaged over time.
In this blog we take a look at different types of external experts and how they can provide critical insights during the various stages of a drug’s lifecycle of a drug.
Long-term: the trusted external advisor
From the earliest stages of research to post-launch activities: trusted strategic advisors provide critical insights throughout the entire process based on their extensive experience. Here is an example: during the earliest phases of drug development a company must critically assess the target, mechanism of action and overall unmet need of a compound that – some 10 years down the road when it is approved – will translate into a profitable market opportunity. A risky decision that needs to be made against the backdrop of an ever-changing industry, evolving care models and an uncertain competitive environment. While even experts with many years of experience in the therapeutic field don’t have crystal balls that provide them with the correct answers, their experience is invaluable when making these early, critical decisions.
A drug that makes it through clinical trials has a long history of generating data and information. Experts, who have been involved early on, have seen the data as they were generated, have poured over them, discussed and analyzed them and will be able to provide deep insights with regards to positioning and for educating healthcare providers.
Experts are often in high demand for various reasons and accurately aligning need to expertise can make the difference between an expert advising you - or your competition. While established experts are well-known and easy to identify it is critical to consider emerging experts as well. These experts are establishing a scientific point of view and are in a great position to remain actively engaged throughout the commercialization processes.
Expert input during critical lifecycle stages
Expert advice guides all phases of drug development, where critical decisions are addressed by aligned domain expertise. When considering preclinical research, experts might engage in preliminary efficacy, toxicity, pharmacokinetic and safety considerations. Further, they may help to inform in vitro and in vivo experiments.
Clinical trial failures can result from an insufficient understanding of how the investigational product interacts with the body. These interactions can vary (sometimes widely) between animals and humans, between healthy subjects and patients, and between one demographic group and another. Experts engagement with Phase II trials is critical as it relates to establishing therapeutic dosing and drug efficacy for large-scale Phase III studies.
During Phase III, an expanded set of expert engagements becomes critical, including advisors who can help navigate regulatory hurdles the drug might face. As a compound moves closer to the patient, it is also time to start engaging experts who are recognized by institution or within a region of the country. These experts will begin to broadly convey the underlying science, unmet medical needs, and ultimately describe an accurate patient persona who will see improvements in outcomes.
Once approval has been secured, local or community experts who have earned the trust of their colleagues and can support educating the healthcare community about the new product. Examples are HCPs who present at regional conferences or are active as committee membership of regional medical societies.
Based on this discussion we grouped external experts into four different categories. The lines are not always clear-cut and well-defined but this segmentation model can help map specific experts to phases of the lifecycle.
- Strategic advisor - recognized experts and/or rising stars who are leading/focused on a particular area of science. These experts can be involved throughout the entire lifecycle of a drug, they provide thought leadership, sit on advisory boards and are well networked and therefore able to make introductions to other experts.
- Technical and clinical experts – domain experts or experienced clinicians that play critical roles during distinct phases of drug discovery or development, e.g. pre-clinical research or clinical studies and publish their work in peer-reviewed journals.
- Trusted experts – are critical in late clinical development and the pre- and post-launch phases. These experts clearly understand and believe in the benefits of using the drug for treating the appropriate patients and as a result become advocates for the product. Authenticity and credibility are key as well as true buy-in based on data and science.
- Educators – community experts with extensive experience in treating patients. They get involved in the pre- and post-launch phases to educate their peers.
Expert mapping and engagements are dynamic ongoing processes that start during the early phases of pre-clinical development and extend all the way into the post-launch phase. The critical questions companies have to answer are:
- What external insights do we need and when?
- Which decisions need external input?
- Whom do we need to educate?
Identifying external experts
Experts within these categories can have very specific profiles that can make them difficult to identify based on existing networks and standard online searches only. To avoid subjective and time-consuming processes, life science professionals should consider leveraging SaaS-based global expert solutions designed to drive impactful outreach and strategic engagement. Starting with the whole universe of experts and then using a rationally designed process to narrow down the list to identify a short-list of experts allows users to quickly identify and prioritize the right experts for every stage of a product’s lifecycle.