The critical value of engaging KOLs early in the drug development process
Constrained healthcare budgets, pressure on pricing, generic brand competition and market access hurdles at home and abroad are increasing the pressures on pharma companies bringing new drugs to market.
However, congress and publication data from Medmeme shows that the volume of information disseminated ahead of a product launch can have a significant impact on its success, enabling pharma to achieve higher sales and make the most of the short competitive product life cycle.
Engaging the right key opinion leaders (KOLs) at an early stage in the life cycle, and utilising their expertise and influence, is key to securing timely and positive data dissemination, yet many companies underestimate the true value of this engagement.
Indeed, many pharma companies have been shown to wait until phase III has started before approaching KOLs. However, the latest analyses show that the best time to start engaging is around three years before launch, when preliminary data on dose and efficacy first becomes available.
In addition to giving advice on large scale clinical trial design and patient recruitment, KOLs can help pharma tackle critical barriers to success at this point - the need to balance efficacy against the risk of adverse events in phase III.
They can also help pharma better understand the challenges that their target group of patients face, such as co-morbidities and managing complicated combination therapies. This allows industry to take a more holistic approach to drug development and to see that its drug will fit into the specific treatment pathway or support the right economic outcomes research.
To pave the way for the acceptance and eventual adoption of a new product, pharma also needs to start educating healthcare professionals (HCPs) on the disease burden, treatments currently available and unmet needs at the end of phase II.
When KOLs have been involved in helping to shape the development of a drug from an early stage, they can become valuable advocates for it and can help to ensure that the education is clear, concise and appropriate
Knowing what’s possible
Successful product launches are not just about providing quality data; they are about knowing that quality data is being shared among the largest possible audience. Indeed, the share of scientific voices (SoSV) in the years leading up to the launch of a new product can be a significant factor in its success (SoSV is the collective number of times a manufacturer’s drug or molecule is noted in the scientific literature). This Medmeme database includes information scanned from over 11,000 scientific meetings and over 10,000 reputable publications and can be used to measure the impact and visibility of a given product in the scientific arena.
Figure 3, which was published in an article in the Journal of Pharmacology & Clinical Research in December, uses Medmeme data to show the volume of peer-reviewed data (publications and meeting abstracts) pertinent to the three most highly investigated emerging cancer immunotherapies over the last full year (2015).
To achieve such results, it is, of course, essential to identify the right KOLs for the right project at the right time. While many pharma companies are confident about engaging with the top five to 10 KOLs in a therapy area, they often fail to widen the net to other KOLs who could provide valuable insights, or fail to keep abreast of rising stars.
In the past, identifying KOLs was often difficult and time-consuming, but thanks to the power of data, pharma companies can now have this kind of information at their fingertips. Medmeme recommends that pharma identifies a broad range of KOLs with a variety of attributes and segments them accordingly. For example, some KOLs may be experts in clinical trial design while others might excel in public speaking.
Also, working with KOLs in each of your target markets is key because even if pharma does get its drug approved by NICE or its European equivalents, it does not necessarily mean that it will be used. Translating quality research for the benefit of local health economies is crucial in communicating the need for approval.
Early stage KOL identification and engagement is demonstrably critical for pharma. It can help the industry to confirm and expand its knowledge on key therapy areas and refine and rework new products to ensure that they really meet the needs of patients. It ensures that SoSV is being driven by people who really understand the relevant therapy area and whose opinions are valued and respected by HCPs and the wider healthcare