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Harvard Case - BKK: Commercializing a New Drug

"BKK: Commercializing a New Drug" Harvard business case study is written by Rebecca Goldberg, G. Paul Matherne. It deals with the challenges in the field of Strategy. The case study is 13 page(s) long and it was first published on : Feb 25, 2019

At Fern Fort University, we recommend that BKK pursue a strategic alliance with a large pharmaceutical company for the commercialization of its new drug, 'BKK-101.' This alliance should focus on leveraging the partner's established infrastructure for manufacturing, distribution, and marketing, while BKK retains control over research and development, ensuring its long-term competitive advantage in the field.

2. Background

BKK is a small biotechnology company with a promising new drug, BKK-101, for the treatment of a rare and debilitating neurological disease. The drug has shown significant potential in clinical trials, but BKK lacks the resources and infrastructure to commercialize it on its own. The case study presents BKK with the challenge of navigating the complex landscape of drug development and commercialization while maintaining control over its innovative technology.

The main protagonists are Dr. Kim, the CEO of BKK, and his team, who are passionate about bringing BKK-101 to market but face significant hurdles in terms of funding, manufacturing, and marketing.

3. Analysis of the Case Study

Competitive Advantage: BKK's competitive advantage lies in its innovative drug, BKK-101, which has the potential to revolutionize the treatment of a rare neurological disease. This advantage is further strengthened by the company's strong research and development capabilities.

SWOT Analysis:

  • Strengths:
    • Innovative drug with high potential
    • Strong R&D team
    • Strong intellectual property protection
  • Weaknesses:
    • Lack of financial resources
    • Limited manufacturing and marketing capabilities
    • Small size and limited market reach
  • Opportunities:
    • Large unmet need for effective treatment of the disease
    • Potential for significant market share
    • Growing demand for innovative therapies
  • Threats:
    • Competition from established pharmaceutical companies
    • Regulatory hurdles
    • Potential for generic competition

Porter's Five Forces:

  • Threat of New Entrants: High, due to the high barriers to entry in the pharmaceutical industry, but BKK's unique drug and IP protection provide some advantage.
  • Bargaining Power of Buyers: Moderate, as patients are dependent on treatment but have limited options.
  • Bargaining Power of Suppliers: Moderate, as suppliers of raw materials and manufacturing services are essential but not highly concentrated.
  • Threat of Substitutes: Moderate, as alternative treatments exist but may be less effective or have more side effects.
  • Competitive Rivalry: High, due to the presence of established pharmaceutical companies with significant resources and market share.

Value Chain Analysis: BKK's value chain is heavily concentrated on research and development, with limited capabilities in manufacturing, marketing, and distribution. This highlights the need for strategic partnerships to bridge these gaps.

Business Model Innovation: BKK needs to develop a business model that addresses its lack of resources and infrastructure while maximizing the value of its innovative drug. A strategic alliance with a larger pharmaceutical company presents a viable option for achieving this.

Corporate Governance: BKK's decision-making process and governance structure need to be robust enough to manage the complexities of commercialization and ensure the protection of its intellectual property.

4. Recommendations

  1. Strategic Alliance: BKK should pursue a strategic alliance with a large pharmaceutical company that has expertise in manufacturing, distribution, and marketing. This partner should be chosen based on its:
    • Market reach: Ability to reach a large patient population
    • Manufacturing capabilities: Capacity and expertise to produce BKK-101 at scale
    • Marketing expertise: Proven track record in launching and promoting new drugs
    • Commitment to patient care: Aligned values and commitment to providing access to treatment
  2. Negotiation Strategy: BKK should negotiate a favorable agreement that ensures:
    • Control over R&D: BKK retains control over the development of BKK-101 and any future innovations.
    • Intellectual Property Protection: The agreement safeguards BKK's intellectual property rights.
    • Fair Revenue Sharing: BKK receives a fair share of the profits generated from the sale of BKK-101.
  3. Market Segmentation: BKK should focus on specific patient segments within the rare disease market to optimize marketing efforts and ensure effective reach.
  4. Pricing Strategy: BKK should develop a pricing strategy that balances the need to generate revenue with the desire to make the drug accessible to patients.
  5. Brand Management: BKK should develop a strong brand identity for BKK-101 that communicates its unique benefits and value proposition to healthcare professionals and patients.

5. Basis of Recommendations

These recommendations are based on the following considerations:

  1. Core Competencies and Consistency with Mission: The strategic alliance approach aligns with BKK's core competencies in research and development while addressing its weaknesses in manufacturing and marketing. It also supports BKK's mission to bring innovative treatments to patients in need.
  2. External Customers and Internal Clients: The alliance will provide access to a wider patient population and ensure the successful launch and marketing of BKK-101. It will also provide BKK's internal team with the resources and support needed for continued innovation.
  3. Competitors: The alliance will allow BKK to compete effectively against larger pharmaceutical companies by leveraging the partner's established infrastructure and market reach.
  4. Attractiveness: The alliance is expected to be financially attractive, with the potential for significant revenue generation and a high return on investment.

6. Conclusion

By pursuing a strategic alliance with a larger pharmaceutical company, BKK can overcome its resource limitations and successfully commercialize its innovative drug, BKK-101. This approach will allow BKK to maximize its value creation potential while remaining focused on its core strengths in research and development.

7. Discussion

Alternatives:

  • Independent Commercialization: BKK could attempt to commercialize BKK-101 independently, but this would require significant financial resources and expertise, which BKK currently lacks.
  • Acquisition: BKK could be acquired by a larger pharmaceutical company, but this would likely result in a loss of control over the drug's development and commercialization.

Risks and Key Assumptions:

  • Partner Selection: Carefully selecting a partner with aligned values and a commitment to patient care is crucial to ensure a successful alliance.
  • Negotiation: Negotiating a favorable agreement that protects BKK's interests and ensures fair revenue sharing is essential.
  • Market Acceptance: The success of BKK-101 will depend on its acceptance by healthcare professionals and patients.

8. Next Steps

  1. Partner Identification: Begin the process of identifying potential partners for the strategic alliance.
  2. Due Diligence: Conduct thorough due diligence on shortlisted partners to assess their capabilities and alignment with BKK's goals.
  3. Negotiation: Initiate negotiations with selected partners to finalize the terms of the agreement.
  4. Implementation: Once the agreement is finalized, implement the alliance and begin the commercialization process.

Timeline:

  • Months 1-3: Partner identification and due diligence
  • Months 3-6: Negotiation and agreement finalization
  • Months 6-12: Implementation and commercialization launch

This strategic approach will enable BKK to successfully commercialize its innovative drug, BKK-101, and achieve its mission of providing effective treatment to patients suffering from a rare neurological disease.

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Case Description

Dr. Brad Worthington, surgeon and anesthesiologist, has created BKK, a nonopioid surgical pain reliever. A combination of three FDA-approved drugs, BKK has beneficial properties beyond those of the individual medications of which it is made. Having obtained a patent for BKK, Worthington and his business partner, Thurman Ballard, are evaluating three paths to market, each with its own risks, costs, timelines, and possible outcomes: 1) seek venture capital investment to fund a New Drug Application for FDA approval; 2) partner with a compounding pharmacy that can manufacture and distribute the drug wholesale; or 3) develop a relationship with a manufacturer that can produce convenience kits containing all three drugs, bottled separately, with directions for mixing and administering them. This case provides a close look into the barriers to entry for new drug commercialization for an individual or small business. Innovations in healthcare delivery, medical technology, and even new drug development or new uses for existing drugs are often generated by those closest to patient care-nurses, doctors, and other medical personnel. But without significant resources, even the most ingenious new ideas require entrepreneurial thinking to bring them to market. Students have the opportunity to build a decision tree and explore the qualitative and quantitative data presented to justify all three options. Which should Worthington and Ballard choose?

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