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BKK: COMMERCIALIZING A NEW DRUG
A CASE STUDY
1) In 2-3 paragraphs please present a situational description of the case that addresses:
What is BKK? Where is its intended geographic market? What is its intended indication for
use from a clinical perspective?
What are the alternative paths to market from a regulatory perspective? (A description
here is fine, as opposed to an analysis)
Who are the stakeholders involved in the commercialization process for BKK?
BKK is a nonopioid anaesthetic medication formulation developed by Dr. Brad Worthington,
a medical specialist with vast experience in the field. This formulation combines three FDA-
approved medications: bupivacaine, ketorolac, and ketamine to generate a locally infiltrated
pain relief for use in surgical operations. The novel combination of these medications in BKK
provides a number of clinical benefits, including the prevention of nausea and inflammation,
both of which are typical causes of surgical patient pain. Importantly, BKK is extremely
successful at reducing, and in many cases eliminating the need for opiate pain medications
during and after surgery. From a clinical perspective, BKK is intended to be used in surgical
procedures to provide pain relief at the surgical site. Its unique formulation and properties
make it particularly well-suited for a range of surgical specialties, including orthopaedic,
hernia, plastic, breast, gall bladder, and other surgeries. The clinical goal of BKK is to enhance
postoperative pain management, minimize opioid use, reduce patient discomfort, and
accelerate post-surgery recovery. BKK's intended clinical use aligns with Dr. Worthington's
commitment to reducing opioid exposure and dependency in surgical patients.
From a regulatory perspective, there are three alternative paths to market for BKK:
New Drug Application (NDA):
This path involves seeking institutional investment to fund the
NDA process with the FDA. It offers additional patent protection and the support of
institutional partners for marketing, production, and distribution. However, it carries risks
such as potential litigation costs, loss of control, and competition from other pharmaceutical
companies. The NDA process requires significant time and financial resources.
Compounding Pharmacy Partnership:
BKK can be produced and marketed as a combination
drug in partnership with compounding pharmacies. This option involves less regulatory
approval but is subject to federal restrictions on marketing and promotion of compounded
drugs. It is associated with moderate growth potential and fewer up-front costs.
Convenience Kit:
Developing and marketing a convenience kit containing the separate
components of BKK offers longer shelf life and a more traditional pharmaceutical sales
model. It allows for easier distribution and sales promotion. This option involves higher per-
dose costs but no up-front costs.
The stakeholders involved in the commercialization process for BKK include Dr. Brad
Worthington, the inventor, and medical professional; Thurman Ballard, an independent
consultant in the healthcare industry; potential investors, such as private equity firms;
compounding pharmacies, as potential manufacturing partners; healthcare institutions and
systems, such as Medical Leaders in Healthcare (MLH) and AngelHealth; surgeons and
medical professionals who would administer BKK; and patients, who would benefit from
improved postoperative pain management and reduced opioid exposure. Each stakeholder
plays a crucial role in determining the path to market and the eventual success of BKK in
addressing the opioid crisis and improving patient care in surgical settings.
2) What is Worthington struggling with? What are the challenges he faces in bringing BKK
to market?
Dr. Brad Worthington is encountering a number of problems and difficulties in bringing BKK,
his patented formulation of nonopioid anaesthetic medicines, to market:
Financial constraints:
are one of the most significant issues Worthington faces. He put
$150,000 of his retirement assets into the creation and patenting of BKK. He also anticipates
recurring fees, such as the upkeep of his patent. These financial constraints limit his ability to
pursue certain routes to market, particularly the costly New Drug Application (NDA) process,
which could necessitate millions of dollars in upfront expenditure. [CITATION Gol \l 16393 ]
Competitive Landscape:
The pharmaceutical industry is highly competitive, and several
major pharmaceutical companies are developing their own long-acting nonopioid analgesics.
These potential competitors could pose significant challenges, including patent challenges
and potential litigation, which might inhibit BKK's commercialization and overall success.
Regulatory Obstacles:
Each prospective market entry strategy for BKK entails navigating
complex regulatory processes. An NDA requires FDA clearance and significant money.
Because of federal limits on selling compounded pharmaceuticals, collaborating with
compounding pharmacies entails regulatory constraints. Creating a convenience kit also
necessitates regulatory considerations, such as clinical and packaging testing.
Risk Assessment:
Worthington and Thurman Ballard must carefully assess the risks
associated with each commercialization option. These risks include potential litigation, loss
of control, competition, and the likelihood of success. Each path has its own set of risks, and
the wrong decision could have significant consequences for BKK's future.
Limited Resources:
Because Worthington and Ballard have limited resources, they must
carefully spend their existing finances in order to make the best strategic judgments. They
must assess the ROI, the time required for commercialization, and the possible influence on
treating the opioid issue.
Stakeholder Management:
Various stakeholders are involved in the commercialization
process, including potential investors, compounding pharmacies, healthcare institutions,
surgeons, and patients. The hurdles of the commercialization path include managing these
connections, aligning interests, and gaining crucial collaborations.
Worthington's main challenges are financial constraints, regulatory difficulties,
competitiveness, risk assessment, resource allocation, and stakeholder management. To
effectively bring BKK to market and meet Worthington's vision of lowering opioid exposure
and improving postoperative pain management, these issues must be carefully considered,
and smart decisions must be made.
3) How does the opioid public health crisis relate to the aforementioned challenges,
regulatory or otherwise?
The opioid public health epidemic is inextricably linked to Dr. Brad Worthington's obstacles
and regulatory considerations in bringing BKK to market. Worthington's commitment to
tackle the opioid issue is a motivating motivation for the creation of BKK and has a
substantial impact on the decisions and challenges he faces.
In response to the opioid crisis, the regulatory landscape has evolved, with regulatory bodies
being more watchful and cautious about opioid-related products. This increased scrutiny
influences Worthington's regulatory path, since BKK must meet high standards and prove its
effectiveness in reducing opiate usage. For example, in a study published about minimizing
post operative opioid usage after a Hip Arthroscopy, it said – “In patients undergoing a hip
arthroscopy, performing a pre-operative PENG block and intra-operative BKK pericapsular
injection will result in decreased postoperative pain, PACU time, and inpatient and
outpatient opioids compared to general anaesthesia only and general anaesthesia with
intracapsular Marcaine.” [ CITATION Wid23 \l 16393 ]
The opioid crisis has highlighted the critical need for nonopioid pain management solutions,
especially in surgical settings. The opioid crisis has generated a clinical necessity for solutions
such as BKK that can reduce opioid use before and after surgery, coinciding with the broader
healthcare objective of addressing the opioid problem. The opioid problem has serious
financial consequences for the healthcare system, including the expenses of opioid-related
treatment and healthcare consumption. BKK's ability to reduce opioid use has the potential
to directly impact healthcare costs, making it an appealing alternative for healthcare
providers and hospitals. The opioid crisis has resulted in a greater understanding among
patients and healthcare providers about the hazards and repercussions of opioid usage.
Patients are becoming increasingly concerned about opioid-related adverse effects and
addiction, while doctors are actively looking for nonopioid alternatives.[ CITATION Sto19 \l
16393 ] This increased awareness strengthens BKK's value offer.
In this atmosphere, healthcare stakeholders are more ready to work on opioid-reduction
measures. Nonopioid alternatives are being investigated and supported by surgeons,
hospitals, and pharmaceutical corporations. Primary prevention of opioid addiction is
possible when non-opioid analgesic drugs are used. Employing alternative analgesic drugs in
the peri-operative period that have a lower addiction potential and less respiratory
depression has therefore become a matter of great national importance. [ CITATION Boh20 \l
16393 ] Worthington may use this collaborative environment to seek partnerships and
sponsorships for BKK. The opioid epidemic not only inspires the development of nonopioid
alternatives such as BKK, but it also shapes the regulatory landscape, clinical need, financial
concerns, stakeholder engagement, and market dynamics. While it brings hurdles, it also
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gives Worthington and BKK with a compelling potential to have a real impact on opioid
usage in surgical settings and solve a vital public health issue.
4) How would you evaluate the risks and benefits associated with each alternative
pathway for bringing BKK to market?
Evaluating the risks and benefits of each alternative pathway for bringing BKK to market
requires a nuanced assessment that takes into account various factors specific to the
situation:
NDA Pathway
(Option 1):
Benefits:
Pursuing a New Drug Application (NDA) offers enhanced patent protection and
institutional support for marketing, production, and distribution. It aligns with the rigorous
FDA regulatory standards, establishing BKK as a novel drug.
Risks:
The NDA process is costly, time-consuming, and carries a risk of failure, with
significant upfront and ongoing financial investments required. Litigation challenges from
larger pharmaceutical companies are also a concern. Moreover, the lengthy approval
timeline delays market entry.
Evaluation:
This pathway presents potential long-term benefits in terms of patent protection
and market positioning, but it involves substantial financial risks and uncertainties due to the
competitive landscape and lengthy approval process.
Compounding Pharmacy Partnership
(Option 2):
Benefits:
Partnering with a compounding pharmacy offers a faster route to market with
lower upfront costs. BKK can leverage existing relationships with medical professionals and
organizations, providing a moderate growth opportunity.
Risks:
Regulatory limitations on marketing compounded drugs may hinder widespread
adoption. Moreover, the level of control over the product may be reduced, and the revenue
growth potential might plateau over time.
Evaluation:
This option is less financially risky and offers a quicker entry to market but may
have limitations in terms of scalability and long-term growth.
Convenience Kit
(Option 3):
Benefits:
A convenience kit provides an attractive packaging solution, enabling traditional
pharmaceutical sales and leveraging sales representatives. It has potential for a larger
market due to a longer shelf life and ease of use.
Risks:
The per-dose cost is relatively high, impacting pricing and potential adoption. The
reliance on a manufacturing partner introduces dependency on their capabilities and quality
control. The initial market entry may be slower.
Evaluation:
This option offers greater market reach and flexibility in sales and marketing but
involves higher per-dose costs and dependency on a manufacturing partner.
Overall, the choice among these pathways involves a trade-off between patent protection,
time to market, upfront costs, control, and long-term growth potential. Dr. Worthington and
Thurman Ballard must carefully weigh these factors and consider the competitive landscape,
regulatory environment, and financial resources available to make an informed decision on
the best path forward for BKK.
5) Should Worthington be concerned with the competitive landscape for products that
may serve the same clinical market that BKK purports to serve?
Yes, Dr. Worthington should be concerned about the competitive landscape for drugs that
may compete with BKK in the same clinical market. Several aspects contribute to the
importance of competitive analysis in this context:
Market Saturation:
When numerous goods with comparable clinical applications enter the
market at the same time, market saturation can occur. This can lead to severe competition
for market share, pricing pressures, and potentially slower product uptake.
Regulatory Obstacles and Challenges:
Competing products may encounter comparable
regulatory obstacles and challenges. If additional medications are in the pipeline for
approval, they may impact the FDA's approach to examining and approving nonopioid
anaesthetic treatments, so influencing BKK's regulatory process.
Pricing and reimbursement:
The availability of numerous competing items might have an
effect on pricing tactics. If there are numerous options, healthcare providers may have more
bargaining power, thereby lowering rates and reducing BKK's profitability.
Market Differentiation:
Understanding rivals' strengths and shortcomings can assist
Worthington and his team in effectively differentiating BKK. In a competitive market,
identifying unique selling factors and correcting any flaws in BKK's value proposition
becomes critical.
Marketing and sales strategy:
can be informed by competitive analysis. It aids in the
identification of target categories, important influential individuals, and potential alliances
that can aid in market penetration.
Patent Protection:
Patent disputes and challenges may emerge if rival drugs with
comparable formulas or indications are developed. Worthington's intellectual property
strategy should take into account future competitors as well as the necessity to protect
BKK's patent rights.
Market Share and Growth:
Understanding the competitive landscape enables for more
realistic forecasts of market share and growth. It aids in the establishment of attainable goals
and timetables for BKK's market penetration.
Preferences of Patients and Physicians:
Different items may appeal to patients and
physicians in different ways. Understanding these inclinations can aid in the direction of
marketing efforts and communications.
Dr. Worthington must do a thorough examination of the competitive landscape in order to
make educated conclusions concerning BKK's commercialization plan. It assists in
anticipating obstacles, identifying chances for difference, and developing a strategy that
successfully places BKK in a potentially crowded market.
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?
In my opinion, bringing BKK to market is not just a wonderful concept, but also a critical step
in addressing the opioid issue and enhancing patient outcomes in surgical procedures. BKK
has the potential to change pain management in healthcare by minimizing opioid reliance
and accompanying consequences with its unique combination of nonopioid medicines.
Furthermore, the opioid epidemic in the United States has reached frightening proportions,
making it critical to investigate and promote nonopioid alternatives such as BKK.
The best pathway to the US market for BKK, in my opinion, would be the convenience kit
option. This choice aligns with several key advantages:
Market Accessibility:
The convenience kit pathway offers a more streamlined and accessible
route to market entry compared to the NDA option, which involves lengthy regulatory
processes. Given the urgency of the opioid crisis, a quicker market entry is highly desirable.
Patient and Physician-Friendly:
Convenience kits simplify the administration process for
healthcare providers and ensure accurate dosing. This can lead to increased adoption and
improved patient outcomes, as it reduces the risk of errors in drug mixing and
administration.
Sales and Marketing Potential:
Unlike compounding pharmacies, which face restrictions on
marketing compounded drugs, convenience kits can be promoted using traditional
pharmaceutical sales and marketing strategies. This allows for proactive engagement with
healthcare professionals.
Longer Shelf Life:
The convenience kit's longer shelf life due to separate drug packaging
offers practical benefits. It reduces the risk of waste and expiration, making it more efficient
for healthcare facilities.
Control Over Pricing:
With the convenience kit pathway, Dr. Worthington can exercise
greater control over the sale price, potentially mitigating the higher per-dose production
costs. This control is valuable in achieving a balance between affordability and profitability.
Considerations:
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Cost:
The per-dose cost for the convenience kit is relatively higher than the compounding
pharmacy option. However, the ability to control the sale price may help offset this cost,
making it a viable choice.
Manufacturing Partner:
Selecting a reliable and accredited manufacturing partner is critical
to ensure quality control and consistency in the production of the convenience kits.
Market Adoption:
Initial market entry may be slower compared to partnering with
compounding pharmacies that have established relationships with medical professionals.
However, the convenience kit's advantages, such as longer shelf life and ease of use, can
help overcome this challenge.
Competitive Landscape:
Continuous monitoring of the competitive landscape is essential, as
other products with similar indications may enter the market. Effective differentiation and
marketing will be crucial.
While the convenience kit option has its considerations, such as selecting a reliable
manufacturing partner and addressing potential market competition, its overall benefits
align with the urgency of the opioid crisis and the need for a practical, patient-centered
solution. Therefore, I believe the convenience kit pathway is the most suitable choice for
bringing BKK to the US market, as it offers a balanced approach between speed to market
and effective market penetration.
To summarize, below is a complete overview of the internal and external issues that Dr.
Worthington should examine when deciding how to commercialize BKK in the US market.
This involves the following critical considerations:
Internal Factors:
Financial Resources:
Dr. Worthington's personal finances and available investment capital
are critical. The cost of each pathway and ongoing expenses must align with available
resources.
Ownership and Control:
Dr. Worthington's desire to maintain control over BKK is important.
Assess the extent of control he is willing to relinquish to investors or partners in each
pathway.
Expertise and Capabilities:
Dr. Worthington's expertise in anaesthesia and Thurman
Ballard's experience in the healthcare industry provide internal strengths. Evaluate how
these strengths align with pathway requirements.
Product Quality and Efficacy:
The clinical effectiveness and safety of BKK are paramount.
Internal assessments of product quality and competitive advantages are essential.
Marketing and Sales Strategy:
Assess the team's internal readiness to market and sell BKK.
Consider the ability to manage sales representatives and marketing efforts.
External Factors:
Regulatory Landscape:
Consider the FDA's regulatory requirements and approval processes
for each pathway. Evaluate the level of scrutiny, time frames, and associated costs.
Competitive Landscape:
Analyze the external competitive environment, including existing
drugs like Exparel [ CITATION Dis20 \l 16393 ]and emerging alternatives. Understand the
dynamics and timing of competition.
Opioid Crisis Impact:
Assess the external impact of the opioid crisis, including public
awareness, government policies, and healthcare providers' willingness to adopt nonopioid
alternatives.
Market Demand:
Analyze external factors related to market demand, such as healthcare
facilities' willingness to adopt BKK, reimbursement policies, and patient preferences.
Legal and Litigation Risk:
Evaluate the external legal environment and the potential for
patent disputes or litigation from competitors. Weigh the risk and costs of legal battles.
Partnering Opportunities:
Assess external partnerships with investors, compounding
pharmacies, or manufacturers. Examine alignment with pathway options and partnership
terms.
Economic and Healthcare Trends:
Consider broader external economic and healthcare
trends, including shifts toward value-based care and cost containment, which can affect
market dynamics.
Critical Considerations and Factors:
Financial Viability:
Ensure that the chosen pathway aligns with available financial resources
and offers a sustainable business model.
Clinical Efficacy:
Prioritize pathways that maintain or enhance BKK's clinical effectiveness
and safety.
Regulatory Approval:
Evaluate the regulatory pathway's feasibility, including the FDA
approval process and potential challenges.
Competition:
Understand the competitive landscape and assess BKK's differentiators.
Market Acceptance:
Consider the readiness of healthcare providers to embrace BKK and
patients' preferences.
Legal Risk:
Assess the potential legal challenges and the cost of defending BKK's intellectual
property.
Control and Ownership:
Balance the desire to retain control over BKK with the need for
external partnerships.
Time to Market:
Weigh the speed of market entry against the associated risks and benefits.
Impact on Opioid Crisis:
Consider how each pathway contributes to addressing the opioid
crisis and reducing opioid dependency.
Patient Outcomes:
Prioritize pathways that lead to improved patient outcomes and reduced
healthcare costs.
Partnership Opportunities:
Explore the potential for strategic partnerships that enhance
BKK's market penetration.
Long-Term Sustainability:
Assess the long-term sustainability of the chosen pathway and its
alignment with BKK's mission.
Dr. Worthington should carefully weigh these internal and external factors and consider how
each pathway aligns with BKK's core objectives and values. The decision should aim to
maximize the benefits, minimize risks, and optimize the potential for BKK's success in the US
market while addressing the opioid crisis effectively.
References
Bohringer, C. A. (2020). The Benefits of Opioid Free Anesthesia and the Precautions
Necessary When Employing It.
Translational perioperative and pain medicine, 7(1),
152–157
. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6844148/
Discepola, P. B. (2020). EXPAREL® (Long-Acting Liposomal Bupivacaine) Use for Popliteal
Nerve Block in Postoperative Pain Control after Ankle Fracture Fixation.
Pain research
& management, 5982567.
https://doi.org/10.1155/2020/5982567
Goldberg, R. a. (2021). BKK: Commercializing a New Drug.
Darden Case No. UVA-QA-0909
.
http://dx.doi.org/10.2139/ssrn.3345361
Stoicea, N. C. (2019). Current perspectives on the opioid crisis in the US healthcare system: A
comprehensive literature review.
Medicine, 98(20), e15425
.
https://doi.org/10.1097/MD.000000000001
Widmeyer, J. R. (2023). A Novel Approach to Improving Post-Operative Pain and Minimizing
Opioid Consumption After a Hip Arthroscopy.
Orthopedic reviews, 15, 7425
.
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