Commercializing BKK: Strategies for a Nonopioid Drug Success

BKK: Commercializing a New Drug 1. In 2-3 paragraphs please present a situational description of the case that addresses: a. What is BKK? Where is its intended geographic market? What is its intended indication for use from a clinical perspective? b. What are the alternative paths to market from a regulatory perspective? (A description here is fine, as opposed to an analysis) c. Who are the stakeholders involved in the commercialization process for BKK? a . BKK: Commercializing a new drug, is a case study on Dr. Brad Worthington’s lifelong effort to get a nonopioid drug to market. BKK (Bupivacaine, Ketorolac and Ketamine) is a formulation of nonopioid analgesics made from three separate FDA approved drugs bupivacaine, ketorolac, ketamine. Dr. Brad Worthington had made this combination of drugs to make a locally infiltrated pain reliever that showed 40 hours of duration of action. Bupivacaine, which is a local anesthetic, ketorolac is a non-steroidal anti-inflammatory drug and ketamine is a common anesthesia drug. (Goldberg G & Matherne PG, 2019) b. Three potential routes to market for BKK exist from a regulatory standpoint: 1. New Drug Application (NDA): For this route, you must engage with an institutional investor to raise the millions of dollars necessary to submit an NDA to the FDA. BKK can be sold as a new chemical entity and afforded greater protection than the current patent by receiving NDA approval. This course of action is risky, though. 2. Combination medicine: Selling BKK as a combination medicine is a different strategy. Although this route involves pricey analytical testing, it does not require further FDA approval. BKK can be sold without requiring a

new drug application by marketing it as a combination medicine. 3.Convenience Kit: The third strategy calls for creating and promoting a convenience kit. c. The following parties are involved in the commercialization of BKK 1. Dr. Brad Worthington: As the brains behind BKK's development and its founder, Dr. Worthington is essential to the venture's commercialization. He is in charge of making important choices and offering knowledge on the clinical and medical elements of BKK. 2. Thurman Ballard: Dr. Worthington is good friends with Thurman Ballard, a commercialization consultant. He collaborates closely with Dr. Worthington to create marketing plans for BKK, including finding suitable partners, holding product demonstrations, and negotiating the practical issues of commercialization. 3. Institutional Investors: These financial backers could help BKK become a commercial success. They give the money required to seek regulatory clearances, carry out clinical trials . 4. Surgeons and medical experts: Surgeons and experts in medicine who have used BKK or have showed interest in utilizing it are crucial stakeholders. The successful implementation and acceptance of BKK among the medical community depends on their input and support. 5. Patients: Patients who might gain from the special pain-relieving abilities of BKK are also stakeholders. Their

interactions with BKK and the results they get will affect how the company is perceived and used by consumers. 6. Regulatory Authorities: The U.S. Food and Drug Administration (FDA) and other regulatory bodies are important to the commercialization process. They check for regulatory compliance while approving the efficacy and safety of new medications. 2. What is Worthington struggling with? What are the challenges he faces in bringing BKK to market? Dr. Worthington faces several challenges in bringing BKK to market: Worthington and his team must decide which path to take for commercialization - pursuing an NDA, marketing BKK as a combination drug, or developing a convenience kit. Each path has its own advantages and considerations, such as regulatory requirements, patent protection, and time to market. Choosing the right path requires careful evaluation and consideration of various factors. A novel drug's commercialization requires substantial financial resources. To assist the regulatory approval procedure, clinical studies, manufacture, marketing, and distribution of BKK, Worthington must raise money from institutional investors. It can be difficult to find investors prepared to put up the necessary money and who believe in BKK's potential . Bringing BKK to market requires getting regulatory permission, such as FDA approval. To ensure compliance with safety and effectiveness standards and to resolve any potential hazards or regulatory bodies' concerns,

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Worthington must negotiate the complex regulatory landscape.. To be successful commercially, BKK must safeguard its intellectual property. When Worthington's patent counsel found an earlier occurrence of a comparable word in the public record, he may have faced a challenge. This might have an effect on BKK's originality and patentability. Worthington must take care of this matter and make sure that BKK is well protected by his patent. Worthington is aware of the same multimodal anesthetic treatments being developed by other pharmaceutical companies. In terms of differentiation, market positioning, and market share acquisition, the presence of competitors in the market presents a hurdle. To distinguish out in the crowded market, Worthington must clearly express the special advantages and benefits of BKK. 3. How does the opioid public health crisis relate to the a forementioned challenges, regulatory or otherwise? 1. There is a substantial demand for nonopioid painkiller alternatives as a result of the opioid crisis. To lower the danger of addiction and overdose, patients, healthcare professionals, and legislators are actively looking for alternatives to opioids. This offers BKK the chance to potentially fill the gap in the market for successful non- opioid pain management. To meet this need and win over the market, Worthington must, however, successfully position and distinguish BKK in the marketplace.

2. Healthcare organizations and professional organisations have updated their treatment recommendations to put nonopioid pain management choices first in response to the opioid crisis. These recommendations have an impact on how doctors prescribe medications and how novel painkillers like BKK are adopted. Worthington must demonstrate that BKK is successful in lowering opioid usage and enhancing patient outcomes in order to align BKK with these changing recommendations. 3. The opioid problem has also had an impact on insurance companies and reimbursement practices. They may give favorable coverage and reimbursement for medications like BKK that offer efficient pain management without the hazards associated with opioids because they are increasingly focused on supporting nonopioid options. Worthington may still have trouble negotiating the reimbursement environment and obtaining good coverage for BKK. 4. The public's understanding and worry about the dangers and effects of opioid use have increased due to the opioid crisis. The desire for nonopioid options may increase as a result of this increased understanding, which may also stigmatize opioid-based pain care. It also implies that Worthington must confront any resistance or skepticism from patients, medical professionals, and the general public who might be wary of using novel pain management techniques. 4. How would you evaluate the risks and benefits

associated with each alternative pathway for bringing BKK to market? Analyzing the advantages and disadvantages of each potential route for commercializing BKK necessitates taking into account a number of variables. Here is a comparison of the advantages and disadvantages of each pathway: An NDA is a new drug application. Risks: - Regulatory Approval: Obtaining an NDA necessitates a stringent regulatory approval procedure, which can be expensive, time-consuming, and uncertain. There's a chance that regulatory authorities will reject the application or add delays or new requirements. - Patent Protection: While an NDA may provide greater protection than the current patent, there is still a chance that competitors will dispute the patent or infringe upon it. - Financial Investment: To complete the NDA process, substantial financial resources are needed. clinical trials, the regulatory procedure, and marketing initiatives. Gaining NDA certification makes BKK a new chemical entity, giving it better patent protection and commercial exclusivity. Benefits: - Strong Intellectual Property. - Market distinction: BKK's market positioning and distinction from other pain management choices can be improved by being acknowledged as a new medicine. - Possibility of Greater Reimbursement: Drugs with NDA approval may have a higher likelihood of receiving favorable reimbursement and insurance coverage. 2. Combination Drug: Risks: - Analytic Testing: To ensure precise formulation and quality control when marketing BKK as a combination medicine, costly analytic testing is

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necessary. The overall expenses and time to market may increase as a result. - Competitive Environment: There is a chance that the market share will be affected by competition from other businesses creating multimodal anesthesia solutions that are similar to theirs. Benefits: - Faster Time to Market: Since marketing BKK as a combination medicine avoids the need for additional FDA approval, it may offer a shorter road to market than the NDA method. - Potential Savings in Costs: Utilizing already FDA-approved medications may result in reduced development expenses than coming up with an entirely new molecule. - Lessening of Regulatory Barriers: Avoiding the NDA procedure makes the regulatory requirements simpler, allowing for a greater emphasis on quality assurance 3. Convenience Kit: Risks: - Current Good Manufacturing Practice (cGMP) Compliance: Creating and distributing a convenience kit necessitates adherence to regulatory procedural standards, including cGMP compliance. The process of ensuring compliance can be difficult and expensive. - Market Acceptance: The adoption and acceptance of BKK by surgeons, medical professionals, and hospitals are essential to the convenience kit pathway's success. It may take a lot of work to persuade them to use the kit and adhere to the instructions. Benefits: - Simplified Distribution: By offering a ready-to- use remedy, the convenience kit makes it simpler for healthcare professionals to deliver BKK at the point of care. The convenience kit eliminates the need for separate sourcing and measuring, which may result in cost savings because it supplies the right amounts of each of the three component medications.

5. Should Worthington be concerned with the competitive landscape for products that may serve the same clinical market that BKK purports to serve? It is true that Worthington should be concerned about the market competition for goods that might target the same therapeutic market as BKK. It's critical to comprehend the competitive landscape for a number of reasons. 1.By analyzing the competition, Worthington can pinpoint BKK's special selling characteristics and factors that set it apart from competing goods. This information aids in properly placing BKK in the market and emphasizing its advantages over rivals. 2. Competing products might already be on the market and connected to medical professionals. To understand the amount of acceptability and potential obstacles to BKK's market traction, Worthington must assess the market share and adoption rates of these goods. 3. Competing products could have predetermined pricing policies and reimbursement arrangements. When setting competitive prices for BKK and negotiating favorable reimbursement terms, Worthington benefits from an understanding of the mechanics of pricing and the reimbursement landscape. 4. By examining the competition, Worthington can find flaws or potential improvements in its current offerings. With the use of this expertise, he can improve the characteristics of BKK and position it as a more cutting-

edge and alluring choice for patients and healthcare professionals. 5. Keeping an eye on the industry's competitors gives us information about new trends, technological breakthroughs, and prospective future changes in the clinical market. This knowledge enables Worthington to remain innovative and modify BKK's strategy as necessary to meet changing customer demands. Through awareness of the competitive environment, Worthington can create efficient plans to set BKK apart, deal with anticipated issues, and seize opportunities. By positioning BKK as an appealing option that stands out from the competition and offers special advantages, he can increase its likelihood of success. 6. In your opinion is it a good idea to bring BKK to market? What do you think is the best pathway to the US market for BKK? A . In order to make the optimal choice for BKK's route to the US market, Dr. Worthington must carefully consider her unique circumstances and objectives. As was already mentioned, each approach—NDA, combo drug, and convenience kit—has pros and downsides of its own. The ideal course of action would rely on elements such the desired amount of patent protection, finance resources, time to market, legal requirements, and the state of the

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market. To decide on the best course of action for introducing BKK to the US market, it is advised that Dr. Worthington and his team undertake a thorough analysis taking into account all pertinent elements, speak with subject-matter authorities, and perhaps even seek professional counsel. 1. Goldberg, Rebecca and Matherne, G. Paul, BKK: Commercializing a New Drug. Darden Case No. UVA-QA-0909, Available at SSRN: https://ssrn.com/abstract=3345361 or http://dx.doi.org/10.2139/ssrn.3 345361 2. 1. Understanding U.S. Regulatory Pathways for Drug Products. (2021, 3. December 24). IPD Analytics. Retrieved October 9, 2022, from 4. https://www.ipdanalyt ics.com/post/paths-to- approval-

understanding-u-s- regula 5. tory-pathways-for- drug-products 6. 1. Understanding U.S. Regulatory Pathways for Drug Products. (2021, 7. December 24). IPD Analytics. Retrieved October 9, 2022, from 8. https://www.ipdanalyt ics.com/post/paths-to- approval-

understanding-u-s- regula 9. tory-pathways-for- drug-products 10. 1. Understanding U.S. Regulatory Pathways for Drug Products. (2021, 11. December 24). IPD Analytics. Retrieved October 9, 2022, from 12. https://www.ipdanal ytics.com/post/paths- to-approval-

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understanding-u-s- regula 13. tory-pathways-for- drug-products 2. References -for-dr References 1. Understanding U.S. Regulatory Pathways for Drug Products. (2021, December 24). IPD Analytics. Retrieved October 9, 2022, from

https://www.ipdanalytics. com/post/paths-to- approval-understanding- u-s-regula t 2. References 1 . Understanding U.S. Regulatory Pathways for Drug Products. (2021,December 24). IPD Analytics. Retrieved October 9, 2022, from https ://www. ipd analytics . compost /paths-to-approval-understanding-u-s- regulatory-pathways-for-drug-products

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