The Role Of Leadership In Pharmaceutical Research And Healthcare Advancements – Key Opinion Leaders (KOLs) are experts in their field and respected voices in medical circles. They have the impressive quality recognized by companies in the pharmaceutical industry.
In this blog, we look at the role of KOLs and 5 steps to creating an effective partnership.
The Role Of Leadership In Pharmaceutical Research And Healthcare Advancements
A KOL is typically a respected medical expert in their field at highly respected institutions as a result of their innovative research, publications in high-impact research journals, and presentations at renowned conferences. As a result, they have gained a reputation as innovative leaders in their specific field, and in turn, their expert opinions and actions can have a significant impact on the ability to influence new product/brand or consumer purchasing decisions.
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In many ways, they are “influential” and can affect the communication of new drug research and drug development. They contribute to various phases of the medicine life cycle, from discovery and research to patient access and commercialization. They can help understand disease areas and potential therapeutic capabilities of a product, guide clinical trial design, and express patients’ unmet needs.
Companies that target, engage and maintain meaningful relationships with highly respected KOLs can secure benefits such as increased visibility, increased market reach and increased after-sales revenue.
It’s important to identify and engage with KOLs who can support your overall goals. The objectives of the partnership and related activities will depend on the stage of the life cycle of the products or services. The diagram below shows the steps of a clinical trial and the role they can play:
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Partnerships with KOLs should be part of an overall strategy that includes market access, medical marketing campaigns, and sales initiatives.
Map the profile of an “ideal” candidate and establish the attributes necessary for a KOL to achieve the desired objectives. Identify engagement opportunities to support activities that bring your goals to life, such as scientific articles, conference and keynote presentations, peer engagement, thought leadership, as well as involvement in guideline development and patient advocacy activities.
It is very important to define what is expected from the partnership as direct or indirect benefits for the product under development. For each KOL, you must clearly describe what is required of them to support the project/product and what they can expect from the company to support them professionally.
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The focusing phase should identify where the partnership will be beneficial. Creating relevant selection criteria and collecting accurate and reliable information about the key opinion leader are very important to ensure the quality of the partnership. Potential selections should be filtered by area of expertise, reputation level, and scope of influence.
It is important to choose people who have appropriate credentials and hold positions of authority, for example, heads of medical institutes or renowned professors.
It depends on the product or medicine being developed and its purpose, but they will need to have significant knowledge in the required area.
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A respected KOL is likely to be someone who has demonstrated influence among their peers and health authorities. They may also have received honors/awards for their work. It will also be important to consider whether they have a local, national or international reach, depending on needs.
If the KOL is expected to write articles and conduct lectures, he had better have significant experience in these areas and be involved in these activities.
One of the most encouraging criteria will be your previous activity with other pharmaceutical companies and whether you have successfully established partnerships in the past.
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Once a group of potential KOLs has been selected, they will need to be contacted to discuss a potential partnership.
They will often share their thought leadership through traditional advertising channels such as research publications or conference talks; While more tech-savvy KOLs will use online social media channels to share information and collaborate with colleagues.
There are strict guidelines to be followed in the UK regarding the promotion of medicines and a unique licensing system for medicines administered by the Medicines and Healthcare products Regulatory Agency (MHRA). If a KOL wants to discuss a new medicine, they must follow these rules.
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They need to be carefully informed about what they can and cannot say about the product they are researching, developing and/or marketing.
After engaging and including the chosen KOLs, their interactions with the pharmaceutical company and the activities they are expected to perform must be defined and formalized in an implementation plan with objectives and outcome measures. Pharmaceutical companies have to balance what they expect from them in terms of activities and what KOP offers them in terms of services.
The partnership and communications plan should be carefully monitored through key performance indicators (KPI) and reviewed regularly to determine its success. Check out our ‘Pharma PR Blueprint’ for more help with effective marketing and public relations in the pharmaceutical industry.
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Once the objectives and activities have been achieved, it is important to measure the success of the partnership. The regularity of the 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 made.
This data should be recorded and your activities reviewed and modified to ensure the partnership continues to be mutually beneficial and in line with KPIs. At the end of a partnership, conclusions can be drawn to shape future partnerships. Check out our blog ‘How to measure success effectively’.
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The legacy of male bias in drug research, regulation and marketing needs to be corrected, argue Sundari Ravindran and colleagues.
Women are excluded from drug research for a number of reasons. 1 The thalidomide tragedy of the 1960s led to protective restrictions on the participation of pregnant women and women of childbearing age in clinical trials. Other barriers are the perceived complexity and high costs of the study if women are included, the reluctance of women to participate, and the pervasive behavior of the male body in general. To combat male bias in health research, 2 in 1993, the landmark National Institutes of Health (NIH) Revitalization Act changed the model to recommend the inclusion of women in phase III clinical trials. It condemned medical interventions for women based primarily on research conducted on men.
Major regulatory agencies in the US, Europe, and Canada, whose approvals often influence other countries, have made some positive but piecemeal efforts to include sex and gender in drug regulations (in Supplementary Box 1). There is growing evidence of the effects of sex and gender on a wide range of health interventions, including drug safety and efficacy profiles 4 (Supplementary Box 2). New policies promoted by U.S. and Canadian health research funding agencies require that drug development experiments include an equal balance of male and female cells, tissues, and animals, and that diverse groups of women be recruited into clinical trials. .5 New Premarket US Food and Medicines Administration, European Medicines Authority, and Health Canada processes for drug approval have specifically promoted the inclusion of gender-diverse women, older women, and pregnant and lactating women in clinical trials and reports data (Supplementary Box 1).
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However, approaches and practices in medicines research and regulation are still largely insensitive to the influence of sex and gender on health outcomes. 56 For example, the International Council has not recognized a specific requirement for the synthesis of technical requirements for medicinal products for human use. , independent guidelines on the inclusion of women, continuing to refer to women as specific subgroups to be considered when appropriate. 7 Drug efficacy, safety, and toxicity journals and industry rarely report sex or gender differences in production. label.
There are gaps in gender and gender considerations at each stage of the research and regulatory pathway to commercialization of a new medicine (Figure 1). Testing new molecules for product development must include experiments on genetically male and female cells, essential for the early detection of sexual differences.
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