karthik

.docx

School

Northeastern University *

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Course

5010

Subject

Medicine

Date

Apr 3, 2024

Type

docx

Pages

4

Uploaded by CommodoreMusicWren24 on coursehero.com

1. a. What is BKK? Where is its intended geographic market? What is its intended indication for use from a clinical perspective? BKK is a unique and proprietary formulation of nonopioid anaesthesia drugs created by Dr. Brad Worthington. It is used for pain management during and after surgical procedures. BKK is formulated by combining three FDA-approved drugs: bupivacaine, ketorolac, and ketamine. When administered locally at the surgical site, BKK provides long-lasting pain relief for up to 40 hours, preventing nausea and inflammation, and reducing the need for opioid pain relievers in surgical patients. BKK's intended indication for use from a clinical perspective is to provide effective pain relief for patients undergoing various surgical procedures, including orthopaedic, general, OB/GYN, and plastic surgery. The primary goal is to minimize opioid use and its associated risks, such as opioid dependency and side effects, by offering a multimodal analgesic alternative. The intended geographic market for BKK would likely be the United States, where the opioid epidemic and the need for nonopioid alternatives for pain management are significant concerns. However, the text does not explicitly mention the geographic market, so this assumption is based on the context provided. 1. b. What are the alternative paths to market from a regulatory perspective? (A description here is fine, as opposed to an analysis) New Drug Application (NDA): This path entails finding an institutional investor to fund BKK's NDA process. It involves substantial financial resources and an expensive FDA approval process. Compounding Pharmacy Partner: Another choice is to collaborate with an compounding pharmacy to create and promote BKK as a combined medication. This approach doesn't need FDA approval but does require costly analytical testing. Convenience Kit: The third option is to develop and market a convenience kit containing the three component drugs (bupivacaine, ketorolac, and ketamine) separately bottled in the correct amounts, along with instructions for mixing and administering BKK. Each of these paths has its own regulatory considerations and risks, and the choice will depend on factors such as financial resources, patent protection, regulatory compliance, and the company's willingness to navigate the FDA approval process.
1. c. Who are the stakeholders involved in the commercialization process for BKK? Regulatory Authorities (FDA): The FDA plays a crucial role in the commercialization process, particularly if Dr. Worthington and his team decide to pursue the New Drug Application (NDA) pathway. FDA approval is required for the product to reach the market. Angel Health: Angel Health is a potential marketing and distribution partner for BKK. They have expressed interest in promoting and selling the product to their network, including large hospital systems. Compounding Pharmacies: Compounding pharmacies are potential manufacturing partners for BKK. They would be responsible for producing and distributing the combination drug. Medical Leaders in Healthcare (MLH): MLH represents a major hospital system and is a potential customer for BKK. They have a vested interest in finding effective nonopioid alternatives for their surgical procedures. Convenience Kit Manufacturer: If the convenience kit option is chosen, the manufacturer responsible for producing the kit becomes a significant stakeholder. 2. What is Worthington struggling with? What are the challenges he faces in bringing BKK to market? The challenges faced by Worthington in bringing B.K.K to market are: 1. N.D.A The very first option they have considered is institutional investment/ Venture capitalists to fund the new drug. They both had meetings with several private equity investors and had listened to their terms and conditions. The investors wanted I. 10% equity in H.H. in exchange for $ 2.5 million to pass the first N.D.A hurdle. II. 50-60% of H.H. in exchange for $ 10-25 million to pass the second and third handle. This led to Worthington and Ballad leaving 35% ownership and approval takes 18-24 months.
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