Pharmaceutical business methodology for high volume, low risk sales through accelerated manufacturing

Abstract

It is a business method to add and introduce trading partners in pharmaceutical sales so that mass production and approval can be carried out simultaneously. It is a method to promote the early spread and use of pharmaceuticals, reduce risk by guaranteeing purchases in advance, and increase sales volume. This will speed up mass production, which was not possible before.

Description

[Technical field]

[0001] The present invention relates to the field of pharmaceutical sales software and analytics. More specifically, the present invention relates to a pharmaceutical business method for high volume, low risk sales with accelerated manufacturing that uses specialized software analysis tools to facilitate simultaneous mass production of pharmaceutical products while seeking regulatory approval of the drug. [Background technology]

[0002] For decades, the pharmaceutical industry has relied on a sequential approach to research and development and manufacturing at scale. The initial R&D and regulatory compliance costs are staggering for the pharmaceutical industry and therefore must be recouped in a fairly short time frame with the initial rollout of a new drug. This sequential approach has resulted in low initial sales and huge costs, resulting in high costs of newly launched drugs for consumers and delayed time to market. While the R&D and regulatory compliance costs are recouped as the drug matures, on the drug manufacturing side, the need to meet the necessary regulatory requirements puts pressure on time to market. The result is a cost-time curve where consumers cannot benefit from the drug unless both regulatory and mass production requirements are met. This results in pharmaceutical companies missing out on a potentially large market of consumers in a crisis situation where a large amount of the drug is needed in a very short period of time.

[0003] The dilemma of missing out on a potentially large market for a medicine is highly problematic when the invention of a vaccine or therapeutic drug causes an entire country, and perhaps the entire international community, to desperately need an immediate vaccine as well as a treatment to prevent or slow the spread of the disease and even prevent death until manufacturing capacity reaches mass production levels. The inability of pharmaceutical companies to bridge the gap between meeting regulatory requirements early while ramping up manufacturing capacity to meet such urgent conditions is problematic. Summary of the Invention

[0004] According to the present invention, a pharmaceutical business method for high volume, low risk sales with accelerated manufacturing is provided that overcomes known problems regarding the gap between meeting regulatory requirements and supplying large quantities of pharmaceuticals manufactured on demand.

[0005] In particular, specialized computer software analytical methods are provided for high volume, low risk sales with accelerated manufacturing that allows pharmaceutical products to be manufactured in large quantities while simultaneously meeting regulatory requirements.

[0006] In accordance with an exemplary embodiment of the present invention, a pharmaceutical business method for high volume, low risk sales with accelerated manufacturing of pharmaceutical products is provided, which includes a computer-assisted, proprietary software analytical decision-making process for determining market strategies and negotiating advance purchase agreements and delivery of pharmaceutical products to end consumers.

[0007] The present invention provides many important advantages. One important advantage is the timely sale and delivery of medicines to previously unrealized potential markets in the pharmaceutical market. Thus, the present invention enables near real-time access to most important vaccines and therapeutic medicines to large populations that would otherwise not be able to obtain such vaccines or therapeutic medicines, resulting in a sustainable business model that reduces the spread of disease and even premature deaths.

[0008] Those skilled in the art will further appreciate the advantages and superior features of the present invention, together with its important aspects, by reading the following detailed description in conjunction with the drawings. [Brief description of the drawings]

[0009] The drawing diagram is a flow chart of a dedicated software analysis with computer hardware for a pharmaceutical business method for high volume low risk sales with accelerated manufacturing, according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] In the following description, like parts are designated throughout the specification and drawings with the same respective reference numerals. The drawing figures may not be to scale and certain components may be shown in a generalized or schematic manner and identified with trade designations for clarity and conciseness.

[0011] The drawing figure is a flow chart of a pharmaceutical business method for high volume low risk sales with accelerated manufacturing, according to an exemplary embodiment of the present invention. At the drug planning stage 100 or any time thereafter, computer-assisted specialized software analysis decision tools are utilized to determine whether the drug is a candidate for parallel regulatory compliance and bulk manufacturing 101. For parallel regulatory compliance and bulk manufacturing 101, one or more additional entities or parties must be involved. These entities or parties negotiate advance purchase agreements 102 with the pharmaceutical company. A successful agreement 103 will include elements that allow the additional entities or parties to ensure a reasonable price and ensure parallel regulatory compliance and bulk manufacturing that allows the pharmaceutical company to recover necessary costs and expected profit margins if such profits are desired. Once an agreement is reached 104 and the drug is accepted by the appropriate regulatory agency 105, delivery of the drug to the end consumer 107 begins. If the drug does not meet the regulatory conditions, the quantity of the drug already manufactured is appropriately disposed of. If the drug is not a good candidate for parallelization seeking regulatory compliance and bulk manufacturing 101, or if an advance bulk purchasing agreement has not been fully negotiated 102 or accomplished 103; standard marketing strategies and regulatory frameworks 106 may be pursued; and standard marketing strategies and regulatory frameworks 106 may be utilized for delivery of the drug to the end consumer 107. If it is determined that the drug has potential for an advance purchasing agreement 103 and utilizes standard marketing strategies 106, the drug may follow both routes 102.

[0012] The expected result is a pharmaceutical business method for high volume, low risk sales with accelerated manufacturing. Pharmaceutical companies can benefit from the pre-bulk sales volume in a low risk format due to the nature of the pre-bulk purchase agreement 102. Additionally, the pre-bulk purchase agreement 102 can also include clauses attractive to pharmaceutical companies to further reduce risk, such as reduced liability or guaranteed liability limits in case the drug does not meet regulatory requirements 105, and guaranteed payment for discarded drug 108.

[0013] The expected outcome for the end consumer, the beneficiary of an advance bundle purchase agreement102, is the rapid delivery of newly developed medicines107 and reduced risk. Like a vaccine during a pandemic, an advance bundle purchase agreement104, if successful and enacted, can provide health benefits to prevent the spread of disease and premature deaths that would otherwise go unrealized.

[0014] Pharmaceutical company is defined herein as a party or entity that intends to manufacture, produce, sell, and market pharmaceutical products. The term entity or party is defined herein as a government, company, individual, association, institute, organization, non-profit organization, or other organized group of people. Advance bulk purchase agreement means a treaty, agreement, pact, contract, bond, pledge, promise, arrangement, negotiation, or similar, whether oral or written, for the purchase, distribution, or sale of a pharmaceutical product prior to full regulatory approval, with the purpose of meeting regulatory requirements while mass-producing the drug in parallel. The term seeking regulatory approval is defined herein as the process by which a pharmaceutical product is deemed safe and effective through clinical trials and the resulting data, or other means imposed on the pharmaceutical company by a regulatory agency, and the drug is allowed for consumption by end users. The term mass production is defined herein as the ability of a pharmaceutical company to produce a drug product at a scale and in sufficient quantities to meet the required demand, such as in the case of vaccine production during a global pandemic.

[0015] Although preferred exemplary embodiments of a pharmaceutical business method for high volume, low risk sales through accelerated manufacturing have been described in detail herein, those skilled in the art will also recognize that various substitutions and modifications can be made to the method without departing from the scope and spirit of the appended claims.

Claims

1. A computerized software analysis method for mass production of low-risk pharmaceutical products with accelerated manufacturing, where mass production and regulatory approval are conducted in parallel.

2. The method of claim 1 , wherein an additional party or entity negotiates a pre-emptive blanket purchase agreement.

3. 3. The method of claim 2, wherein a pre-purchase agreement is successfully negotiated with the one or more additional parties or entities.

4. The method of claim 3 , wherein the blanket purchase agreement is established.

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