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1) What is the value of a Medical Liaison team and how might they impact an organization during clinical trials and before/after product launch? Answer: An organization's ability to succeed depends on its medical science liaisons. They support a product's lifecycle, ensure its effective usage, serve as resources and scientific peers for the medical community, and counsel corporate colleagues internally on scientific issues. However, the primary objective is to maintain relationship with well-known physicians at important academic institutions and clinics, who are referred to as Key Opinion Leaders (KOLs). Clinical Examine: MSLs can be expensive, and sponsors want to stay within their resources, yet they provide a lot of benefits to the clinical trial process. Improved public impact and strategic agility in medical resources are two advantages. They give the company's core portfolio first priority and are receptive to new ideas. MSLs can also be essential for product marketing in order to guarantee efficient utilization of resources. They enhance the operations of medical affairs by adapting to the shifting needs of the market. MSLs have a significant impact on how a business operates and how the medication is subsequently sold. Lastly, MSLs can enforce compliance with relevant legislation due to their extensive knowledge base. It is imperative that each worker understands their duties(Yuvraj,2021). The role of MSL in the whole lifecycle of a product MSLs play a role at every stage of the product lifecycle as part of a strong medical strategy that is in line with larger commercial objectives: • In the early stages of development: Creating interest among outside experts in the science underlying novel molecules and how they work, as well as raising awareness through the strategic application of medical tactics. Through interactions with clinical trial sites, MSLs may also play a part in the clinical development programme. • Prior to launch: laying the foundation for market access and launch; proving to opinion leaders that they fully comprehend science and medicine; increasing awareness (by using medical strategy

strategically); and presenting data at scientific conferences. Data gaps in the development plan might now be apparent, and MSL might be involved in the start of the investigator-initiated study program. • Launch: Offering instruction on the application of the medication in clinical practice as well as the clinical evidence. In order to promote goal alignment and the product's potential for future commercial success, the launch medical plan will be an essential part of the overall commercial plan. • After launch: Providing answers to prescriber inquiries, continuing medical education, and carrying out publication- and investigator-initiated study plans will all play a bigger part in the MSL's job description. The MSL position is reactive in many nations, attending to KOLs' demands for their educational needs. Determining the approach and carrying out plan for data gathering might be another crucial MSL task. Assistance in setting up registries or conducting more official observational studies may be required for this(Yuvraj,2021). 2) How might KOLs impact a product's reputation? Answer: A KOL stands for “Key Opinion Leader” they may assist you in promptly identifying and connecting with your ideal audience, regardless of your goals for increasing awareness or generating leads. A KOL has essentially done all the legwork for you by taking the time to interact with a particular specialised audience and cultivating a community around that interest. A KOL is an especially effective way to connect with your target market. KOLs can help you build brand awareness or draw attention to a new product, both of which can increase sales. Given that 82% of consumers said they would heed an influencer's advice, it makes sense that a KOL may significantly affect your business's revenue. As an alternative, your business may think about working with a KOL to develop a limited-edition item. You'll get the most out of your investment if you use your KOL as a collaborator as well (Forsey,2019).

In addition to helping you reach a far higher percentage of potential customers than you may have otherwise, a KOL can guarantee that you're targeting the right target market for your business. It could be challenging for your brand to reach one million people by traditional advertising means without a sizable marketing expenditure, and traditional ads do not let you target a certain demographic , to reach a million people who are particularly interested in your sector, you may team up with a KOL who has a million followers on YouTube, Instagram, or another social media site. Compared to most traditional advertising tactics, a KOL relationship is faster, less expensive, and possibly more effective(Forsey,2019). 3) Imagine that you are an MSL, and part of your role is to recruit KOLs to engage with your company and gain confidence in your drug. (A)What is your main objective(s) in establishing a relationship with a KOL? Answer: First and foremost, KOLs are medical practitioners. In order to learn how to treat patients, they may have undergone fellowships or additional training in addition to attending medical or nursing school. Their main objective is to give their patients the best acute and preventative care possible. This needs to be the cornerstone of every interaction with KOLs, whether it be for business or medical purposes (Streamline Approach,2018). Medical Aspect The KOL's needs and interests may differ greatly if they are assisting a medical team. It's critical to foresee and comprehend their wants, whether it's to comprehend recent research on a particular receptor or the reasons for notable variations in response rates in a company's clinical trials. Business Aspect KOLs may have different requirements and interests when they interact with commercial sales and

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marketing teams. These demands could be anything from the creation of new patient support tools to speaking engagements and illness state education. Their aim is to influence PCPs' comprehension of a disease condition or help efforts to raise awareness about patient and carer support. KOLs do have professional objectives to further their careers in addition to providing treatment for their patients. Understanding requires acknowledging the personal benefits. Personal advantages include things like writing or speaking, as well as enhancing one's profile through publications and speaking engagements(Streamline Approach,2018). A few KOLs might be considering: Prospects for Research - investigations started by investigators or clinical trials supported by the firm Teaching - instructing residents or doctors White papers or screening tools as content creation tools Speaking engagements and publications that enhance one's personal reputation (B) Choose any new pharmaceutical or biopharmaceutical drug that interests you. It can even be the drug you picked in Module 2. What types of information should you gather about your drug, your disease, etc, in order to be well-prepared for meeting a KOL? Make short list of the type of information you would provide to the KOL and what source you could use to gather each type of information. Answer: Obtaining thorough information on Ajovy (fremanezumab), the ailment it treats, and relevant clinical and scientific data is crucial before engaging with a Key Opinion Leader (KOL) about the therapy. The following is a summary of the several kinds of information I would give the KOL are: 1. Drug Information:  Mechanism of action

 Pharmacokinetics and pharmacodynamics  Dosing regimens and administration  Safety and tolerability profile  Clinical trial data 2. Disease Information:  Pathophysiology of the disease  Epidemiology and disease burden  Current treatment landscape and unmet medical needs  Patient population characteristics and demographics  Disease progression and prognosis 3. Clinical Evidence and Efficacy:  Results from pivotal clinical trials (efficacy endpoints, study design, patient population)  Comparative efficacy and safety data against standard treatments or competitors  Long-term efficacy and safety data  Real-world evidence and post-marketing studies 4. Adverse Events and Safety Profile:  Common and serious adverse events observed in clinical trials  Safety signals, warnings, and precautions

 Monitoring and management of adverse events  Risk-benefit assessment 5. Market Access and Reimbursement:  Market access landscape (pricing, reimbursement, formulary inclusion)  Health economic evaluations and cost-effectiveness analyses  Access restrictions and payer policies  Patient access programs and support services 1. Mechanism of Action: Fremanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand, thereby preventing its interaction with the CGRP receptor. By blocking CGRP signaling, fremanezumab is believed to inhibit the transmission of pain signals and reduce the frequency and severity of migraine attacks(Ajovy,2018). 2. Pharmacokinetics and Pharmacodynamics: Fremanezumab has a half-life of approximately 31 days, allowing for once-monthly or once-quarterly dosing options. Following subcutaneous administration, fremanezumab reaches peak plasma concentrations within several days, with steady-state levels achieved after multiple doses. Pharmacodynamic effects include reduced CGRP activity and modulation of pain pathways involved in migraine pathophysiology.

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3. Dosing Regimens and Administration: The recommended dosage of fremanezumab for migraine prevention is 225 mg administered subcutaneously once monthly or 675 mg administered subcutaneously once quarterly. The medication is supplied as a single-dose prefilled syringe or autoinjector for subcutaneous administration. Injection sites include the abdomen, thigh, or upper arm, and patients can self-administer after proper training. 4. Safety and Tolerability Profile: Overall, fremanezumab has demonstrated a favorable safety and tolerability profile in clinical trials. Common adverse reactions may include injection site reactions, such as pain, erythema, or pruritus. Serious adverse events are rare but may include hypersensitivity reactions, anaphylaxis, or antibody formation(Healthline Media,2024). 5. Clinical Trial Data: Clinical trials evaluating the efficacy and safety of fremanezumab for migraine prevention have demonstrated significant reductions in migraine frequency, severity, and use of acute migraine medications compared to placebo. These trials have included both episodic and chronic migraine populations and have shown consistent efficacy across various patient subgroups. Long-term extension studies have also supported the sustained efficacy and safety of fremanezumab over extended treatment durations. 6. Long-term Safety and Efficacy Data:

Open-label extension studies and long-term extension studies of pivotal clinical trials offer important new information about the long-term safety and efficacy of fremanezumab. These studies evaluate the frequency of side effects with long-term usage, the need for dose modifications or additional therapies, and the durability of treatment response. Our comprehension of the advantages and disadvantages of ongoing fremanezumab medication for migraine prevention is aided by long-term evidence(Healthline Media,2024). 7. Real-World Evidence and Post-Marketing Research: These sources of information shed light on the efficacy, safety, and treatment regimens of fremanezumab in actual clinical practice settings. Real-world evidence (RWE) includes observational studies, patient registries, and post-marketing surveillance programmes. These studies assess outcomes in larger patient populations, which complements the findings from controlled clinical trials. References: Forsey, C. (2019, June 26). KOLS: What they are & why they’re key to your marketing strategy. HubSpot Blog. https://blog.hubspotcom/marketing/key-opinion-leaders Healthline Media. Ajovy: Side effects, use, cost, dosage, and more . Healthline. https://www.healthline.com/health/drugs/ajovy#what-it-is

Preventive treatment of Migraine–AJOVY® (fremanezumab-vfrm) injection . Preventive Treatment of Migraine–AJOVY® (fremanezumab-vfrm) injection. https://www.ajovy.com/ Streamline Approach(2018),What’s in it for the Kol? 3 keys to understanding their... What’s In It for the KOL? 3 Keys to Understanding their Goals and How to Move Forward. https://www.sharonibillik.com/blog/what-s-in-it-for-the-kol-3-keys-to-understanding-their-goals- and-how-to- Yuvraj. (2021, October 30). Yuvraj . HHM Global B2B Online Platform Magazine. https://www.hhmglobal.com/knowledge-bank/news/understanding-the-importance-of-msls-in-clinical-

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