Key Opinion Leaders (KOLs) are experts in their field and a respected voice in medical circles. They have an influential quality coveted by companies within the pharmaceutical industry.
In this blog, we look at the role of KOLs and the 5 steps to creating an effective partnership.
1. The role of a KOL
A KOL is typically a respected medical expert highly regarded in their field as a result of their innovative research at highly respected institutions, publications in high impact research journals, and presentations at renowned conferences. As a result, they have gained a reputation as a thought leader within their specific field, and in turn, their expert opinions and actions can have a significant effect on the adoption of a new product/brand or the ability to influence consumer purchasing decisions.
In many ways, they are ‘influencers’ and can impact the communication of new pharmaceutical research and the development of medicines. They contribute at various stages of the drug life cycle, from discovery and research to patient access and marketing. They can help with understanding the disease area and the potential therapeutic features of a product, guide the design of a clinical trial, and voice the unmet needs of the patient.
Companies who target, engage, and sustain meaningful relationships with highly regarded KOLs can secure benefits such as increased visibility, extended market reach, and increased revenue post-market authorisation.
2. Targeting KOLs
It is important to identify and engage with KOLs who can support your overall goals. The objectives of the partnership and the corresponding activities will depend on where the products or services are positioned in their life cycle. The diagram below shows the stages of a clinical trial and the role they could play:
Partnerships with KOLs should be part of a global strategy that includes market access, medico-marketing campaigns and sales initiatives.
Map out the profile of an ‘ideal’ candidate and establish what characteristics are essential for the KOL to achieve your desired goals. Identify the opportunities for engagement in supporting the activities that will bring your objectives to life, such as writing scientific articles, conferences presentations and lectures, peer-to-peer engagement, thought leadership, as well as involvement in guideline development and patient advocacy activities.
What are the expectations?
It is very important to define what is expected from the partnership such as direct or indirect benefits for the product under development. For each key opinion leader, you should clearly detail what is needed from them in supporting the project/product, and what they can expect from the pharma company to support them professionally in return.
Targeting the right KOL
The targeting phase should identify where a partnership would be beneficial. Creating a relevant selection criterion and gathering accurate and reliable information about the key opinion leader is very important to ensure the quality of the partnership. The potential selections should be filtered by field of expertise, level of reputation, and scope of influence.
When choosing the right KOL medical influencers, the following criteria should be considered:
It is important to pick people who have suitable credentials and hold positions of authority e.g., head of medical institutions or well-known professor.
Area of expertise or interest in a specific area or technique
This will depend on the product or drug been developed and its purpose, but they will need to have significant expertise in the field required.
Reputation and reach of influence
A well-respected key opinion leader will most likely be someone who has been seen to influence their peers and the health authorities. They may also have received honours/awards for their work. It will also be important to consider whether they have a local, national, or international reach depending on the requirements.
Level and practice of communication
If the KOL is expected to write articles and carry out lectures, then it is preferable that they have significant experience in these areas and are happy to engage in these activities.
Predisposition to partnering with pharma companies
One of the most encouraging criteria would be their previous activity with other pharmaceutical companies and whether they have carried out partnerships in the past with success.
Once the group of potential KOLs has been chosen then they will need to be approached to discuss a potential partnership.
How to find KOLs
They will often share their thought leadership through traditional advertising means such as publishing research or speaking at conferences; while more technologically savvy KOLs will utilise online social media channels to share information and collaborate with peers.
KOLs can be found by:
- Observation and referral – professionals already in a specific subject area can identify who is an influential member of that community.
- Literature searches – finding prominent thought leaders by researching publications in the specific area required and looking at editorial boards of medical magazines.
- Lectures – look at the list of speakers at renowned conferences in the special disease or research area. This is a good way to find people who have good communication skills in the speciality you are targeting.
- Social media influencers and research – KOLs in the medical/pharma world will be affiliated with their university or institution pages and most likely be active on social media platforms, particularly LinkedIn and Twitter. ResearchGate is also a professional network for scientists and researchers where over 15 million members from all over the world share, discover and discuss research. You can connect and collaborate with colleagues, peers, co-authors, and specialists.
3. KOL marketing regulations
There are strict guidelines that must be adhered to in the UK when it comes to the promotion of medicines and a specific licensing system for medicines, operated by the Medicines and Healthcare products Regulatory Agency (MHRA). If a Key Opinion Leader is to discuss a new drug, then they must adhere to these regulations.
These are documented in full in the MHRA’s Blue Guide.
MRHA have identified five key learning points during their review of advertising for new products:
- Indication – The authorised indication of the product should be stated clearly and prominently at the outset to ensure that claims are set in a clear context. Advertising should not serve to extend the use of the product beyond the licensed indication, particularly where use is restricted to a specific patient group or as a second-line treatment.
- Key safety messages – Safety information required to support safe use of the product should be included, particularly for a new product where the detail aid has a clear educational function. It should include risk management messages and details of any monitoring required with other key contraindications, warnings, and side-effects from the product SPC.
- Images and straplines – These can convey powerful messages about the properties of the product but must portray realistic expectations for use of the product and be supported by relevant data. Pictures intended to depict a patient must be representative of the indicated patient population.
- Clinical studies – Findings from secondary endpoints of clinical studies should be set within the context of the primary endpoint and companies should not ‘cherry-pick’ favourable findings. Care should be taken to present non-inferiority clearly and not to exaggerate tolerability (e.g., ”placebo-like”) or the importance of individual differences, particularly where these are not statistically significant.
- Materials for the public – Promotion of prescription-only medicines to the public is prohibited. Exceptionally, companies may issue press releases to announce the launch of an innovative new product. These must be factual, balanced and non-promotional in content. Likewise, patient materials must be consistent with the patient information leaflet and not contain promotional claims. Non-promotional items should not refer to the product as 'approved' and avoid excessive use of the brand name.
They will need to be carefully briefed on what they can and cannot say about the product they are researching, developing and/or marketing.
Further guidance can be found from these sources:
- Guidance from gov.uk on advertising medicines is also comprehensive
- Synapse – law for life sciences:
- The Definitive Guide to Global Transparency Regulations for the Life Sciences discusses the Sunshine Act which is related to the payment to healthcare practitioners/KOL from pharma.
4. KOL partnership plan
Once you have engaged with your chosen KOLs and got them on board, their interactions with the pharma company and the activities they are expected to carry out should be defined and formalised in an implementation plan with objectives and result measuring. Pharma companies should balance what they expect from them in terms of activities, and what the Key Opinion Leader gives them in terms of services to ensure a win-win partnership.
Activities a KOL could conduct:
- Article writing: They could support the pharma company activities and mission by writing for scientific journals and magazines about new medical research and guidelines, or give advice about patient management.
- Content review: The KOL could advise the marketing team on the scientific rationale that supports the messages or claims of the product, and assess and edit the product information or patient leaflet in line with the MHRA guidelines.
- Lectures: They may agree to speak about topics of interest for the company and/or share their own experience as a prescriber of the company products.
- Press conferences: KOLs may speak at press conferences on behalf of the pharmaceutical company to share detailed information about the research or drug and answer questions.
- Education: They may communicate topics of interest for the pharma company during Continuous Medical Education (CME) sessions. See our blog 'What is the Future of CME?'
- Advisory boards: KOLs can help to give strategic advice as well as estimate key market trends and ensure effective planning of product development, marketing strategy, etc.
- Internal communications: They may play an effective role during internal meetings by sharing their expertise with the teams and informing them about scientific trends and the position of competitors.
- Scientific studies: KOLs maybe those involved with the medical research and participate in the design and implementation of the study. Their involvement will depend on their field of interest and credentials.
The partnership and communication plan should be carefully monitored using key performance indicators (KPIs) and regularly reviewed to determine its success. For more help with influencer marketing and public relations in the pharmecutical arena see our 'PR plan for pharma'.
5. Measuring success
Once the objectives and activities have been completed, it is important to measure the success of the partnership. The regularity of review can be decided by them and the coordinator(s), and they will discuss the level of mutual satisfaction achieved and whether any adjustments need to be carried out.
Some questions to evaluate at each meeting:
- Is the communication with the KOL and the point of contact working well? Are they communicating effectively and frequently enough with each other? What measures can be taken to improve this?
- Has the Key Opinion Leader been given enough information about the product, including any informational materials for that phase of the product development such as the clinal trial research, or the summary of product characteristics (SPC)? What extra information is needed?
- When and how have they been promoting the product and how many people have been reached? This is the most important measure of success and so records should be kept of the number of attendees at conferences, where articles have been published and cited (if applicable), and what one-to-one meetings they have had (if applicable). It will be also important to review if the KOL has been following the regulations as set out by the MHRA.
- Are the agreed benefits of the partnership being met for both the Key Opinion Leader and the pharma company? Particularly are the services provided by them fulfilling the goals of the pharma company. If yes, can these be expanded upon in any way, and if no, how can this be rectified?
This data should be recorded and their activities enhanced and modified to ensure the partnership is continuing to be mutually beneficial and in line with the KPIs. At the end of the partnership, conclusions can be drawn to shape future partnerships. Check out our blog 'How to successfully measure success'.
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