Ravi dhorajiya Cash Study 1
docx
keyboard_arrow_up
School
Long Island University, Brooklyn *
*We aren’t endorsed by this school
Course
PHA660
Subject
Medicine
Date
Feb 20, 2024
Type
docx
Pages
4
Uploaded by CorporalMagpie4068
1(A)
BKK is a special and exclusive combination of bupivacaine, ketorolac, and ketamine used
for nonopioid anesthesia. This combination is meant to give surgery patients long-
lasting pain relief and lessen their dependency on opiate painkillers.
BKK's special blend of bupivacaine, ketorolac, and ketamine has demonstrated a number of advantages, including the avoidance of nausea and inflammation—two major
factors that contribute to postoperative pain.
From a clinical perspective, BKK is meant to be used in a variety of surgical procedures, such as general, orthopedic, OB/GYN, and plastic surgery treatments. With an estimated value of $4.9 billion for the 15 million surgeries performed each year, the postoperative pain market for these procedures is theoretically projected to be large in the United States. BKK is in a position to help surgical patients who require better postoperative analgesia and to lessen their reliance on opioids.
1(B)
From a regulatory perspective, BKK has several options for entering the market, such as:
New Drug Application (NDA) with Institutional Investment Partner: The NDA process is looking for an institutional investment partner to fund it in order to provide extra patent protection and institutional support for marketing, manufacture, and distribution.
Collaboration with Compounding Pharmacy: Producing and distributing BKK in conjunction with a compounding pharmacy may provide a quicker path to market.
Manufacturing a Convenience Kit: Creating a BKK convenience kit would require figuring out how to manufacture the medication and how to supply it.
1(C)
The following stakeholders are participating in the BKK commercialization process:
Dr. Brad Worthington
Thurman Ballard
Potential Investors
Compounding Pharmacies
Regulatory Authorities
Healthcare Providers
Industry Experts
These stakeholders play crucial roles in the decision-making, development, regulatory approval, production, distribution, and use of BKK as it moves through the commercialization process.
2.
Regulatory Obstacles: Managing the intricate regulatory environment, which includes getting FDA permission for BKK's commercialization, making sure FDA regulations are followed for selling compounded pharmaceutical products, and taking into account any issues pertaining to patents.
Manufacturing Partnerships: Locating and forming alliances with 503B manufacturers or compounding pharmacies that are able to consistently and safely produce BKK in accordance with legal requirements.
Financial Restrictions: Handling the substantial outlay of funds necessary for the commercialization phase, such as those related to patenting, setting up a manufacturing facility, paying attorneys, and continuing research and development.
Market Exclusivity, Risk Assessment, Commercialization Options, Competitive Landscape, and Patent Considerations Together, these difficulties show how complex and difficult it is to commercialize a new pharmaceutical product like BKK because it involves financial, legal, operational, strategic, and scientific issues.
3.
The opioid crisis is linked to the above described issues, whether they are regulated or not, because BKK was created as an inexpensive way to help lower opioid exposure and dependency.
Other factors that have an impact on the market include market demand, public health, and competitive landscape. The opioid crisis has resulted in a complex regulatory and market environment for nonopioid analgesics like BKK, with more scrutiny, higher demand, and a quickly changing competitive landscape.
4.
The risks and benefits of each potential route for commercializing BKK can be assessed in the manner described below:
New Drug Application (NDA) with the FDA: Risks: The protracted FDA clearance procedure, which can take up to 24 months, the competitive pressure from rival pharmaceutical companies creating comparable treatments, and the possibility of failure.
Benefits: Searching for an institutional investment partner to finance the NDA process would lead to increased patent protection and institutional support for marketing, production, and distribution.
Partnership with a compounding pharmacy:
Risks: Modifications to the legislation pertaining to compounding medications, prohibitions on the advertising and promotion of compounded medications, and restrictions on the sales of conventional pharmaceuticals.
Benefits: Forming a joint venture with a compounding pharmacy may offer a comparatively quicker path to market, along with income growth rates and development prospects that are moderate.
Creating and promoting a convenience kit:
Risks include the requirement for packaging tests, related setup expenses for the production line, and the unpredictability of success.
Benefits: With a moderate probability of success, creating and promoting a convenience kit could offer a distinctive market offering and possibly a quicker path to market.
5.
There is an increasing need for nonopioid analgesics like BKK, as evidenced by the fact that many hospitals that previously compounded their own drugs internally are now
Your preview ends here
Eager to read complete document? Join bartleby learn and gain access to the full version
- Access to all documents
- Unlimited textbook solutions
- 24/7 expert homework help
looking into outsourcing agreements with FDA-accredited and -inspected compounding manufacturing facilities.
BKK has a lot of potential to be a good solution to the need for nonopioid analgesics, and
it is probably going to be eligible for accelerated status, which might shorten the time it takes to launch a new medication.
6.
In my opinion, bringing BKK to market offers promise as a nonopioid analgesic option for surgical procedures, With a potential market value of $4.9 billion annually. There is a clear clinical need because BKK is thought to be well suited for the 15 million surgical procedures performed annually in the US.
Healthcare facilities are looking into outsourcing agreements with FDA-accredited compounding manufacturing facilities, which is driving up demand for nonopioid analgesics like BKK.
The optimal course would rely on a number of variables, including available funds, risk appetite, and the intended rate of market entrance. To choose the best course of action for BKK, a detailed evaluation of these aspects would be required.
Reference:
BKK: Commercializing a New Drug ^ UV7977
Oberholzer-Gee et al.
https://store.hbr.org/product/bkk-commercializing-a-new-drug/UV7977