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Developing and Launching Drugs, Considerations, and Best Practices
Developing, launching, and marketing drugs can be complex and require multiple considerations by the company, the public, and regulatory agencies; however, following best practices can ensure a profitable and effective launch.
Like developing, launching, and marketing any product, drug development and launching is a complex, costly, and intricate process. However, unlike other markets, the pharmaceutical industry has an added layer of complexity associated with the safety and efficacy of the products they create. According to an article published by Deloitte Insights, it costs approximately $2 billion to bring a medication to market in the United States. Despite the enormous spending on developing and marketing a pharmaceutical product, nearly 36% of all launches will fail and may result in a revenue loss. A comprehensive understanding of the multifaceted steps required to successfully develop and launch a product and utilize best practices is critical to minimizing financial losses and ensuring that the company meets its clinical endpoints.
The Drug Development Process
According to the FDA, there are five critical steps to drug development, including the following:
- discovery and development
- preclinical research
- clinical research
- FDA review
- FDA post-market safety monitoring
Discovery and Development
The first step, drug discovery and development, can be complicated as discovery is usually not linear. Drug discovery can begin by accident when new insights into disease are revealed. Multiple other factors, such as an existing treatment gap, the development of new technologies, or the testing of existing molecular compounds, can fuel discovery. The discovery phase happens predominantly in laboratories but may also occur in hospitals and other care settings.
At this point, development can begin, allowing pharmaceutical companies and drug developers to explore the compound further. Development at this phase typically requires an in-depth analysis of the drug’s pharmacokinetics, and researchers may also choose to analyze dosages to find the ideal dose, drug delivery, and more. The development phase may also be beneficial for comparing the new drug with existing drugs.
This step is typically when a pharmaceutical company begins to analyze the benefits and profitability of the drug. Additionally, this is when most pharmaceutical companies will file for a patent if it is applicable.
Preclinical Trials
The preclinical trials may be in vitro or in vivo, but at this point, the study is done on nonhuman subjects or models. This may mean that the developer uses a chip-on-a-tip technology or an animal model to understand the compound and its biological interactions better. Historically, animal trials had been required before the FDA would sign off on human trials; however, the recent enactment of the FDA Modernization Act 2.0 will allow companies to apply to use alternatives to animal models.
In the US, the FDA expects the preclinical phase to follow good laboratory practices. In this phase, studies are usually small and used to develop dosing and analyze toxicity levels. Based on the results of these studies, investigators can decide whether they will proceed to the clinical research phase.
Clinical Research
The clinical research phase is when drugs are tested on human participants. Preclinical data, while beneficial, is incomparable to human trials. Clinical trial designs may vary depending on the drug being tested, the intended patient population, and whether there are already similar existing therapies. Additionally, this phase may be driven by market analysis done by a pharmaceutical company.
There are four phases of clinical trials. Proceeding to the next phase depends on the results of the previous stage. According to the FDA, 70% of drugs transition from phase 1 to phase 2, while progression dips to 33% between phase 2 and phase 3. Finally, only 25–30% of drugs proceed from phase 3 to phase 4.
Each phase varies in size and time, getting increasingly larger and longer. Reasons for discontinuing clinical trials can range from lack of funding to safety concerns and beyond.
FDA Review
In the US, the FDA review is the next critical step. Depending on the type of drug application, the review process may vary. Depending on the type of medication or the current conditions surrounding its need, the FDA may grant some drug makers expedited approval. This process is complex and requires reviewing data collected on the drug at hand and comparisons with an existing drug. The FDA advisory committee for that drug will recommend it to the organization, which will then decide whether to approve the product and stipulations.
FDA Post-Market Safety Monitoring
The final step is the FDA’s post-market safety monitoring, another multifaceted product development, and marketing aspect. This part of the development cycle may involve pharmaceutical companies filing supplemental applications or INDs for marketed drugs. This would allow them to conduct additional resources, expanding or altering the drug’s intended uses, doses, and more.
At this point, the FDA may also inspect manufacturing facilities and monitor the drug for any reported adverse actions. The FDA has MedWatch and the Medical Product Safety Network (MedSun), which function as monitoring tools and a way to report the safety and efficacy of products.
Finally, the FDA will regulate drug advertisements and labeling, which the organization must approve before a drug company implements them. The most crucial part of advertising is that it cannot be misleading. The drug cannot make claims that are not true and must accurately display side effects and prescribing information.
Beyond the FDA
The FDA is a significant regulator of the drug development and launch process. With consumer safety and product efficacy as primary goals, the FDA’s proposed steps for drug development fail to consider product revenue. Unlike the FDA, pharmaceutical companies that launch the product have a vested interest in ensuring that the product sells and reaches a broad range of people. With this adjunct goal, pharmaceutical companies take additional steps to ensure product success. How a pharmaceutical company launches a product can impact its relationship with consumers, payers, and providers.
Considering how many pharmaceutical products fail during launch, Deloitte suggests, “launch preparation should begin much earlier in the development process by incorporating market access perspectives, engaging a wider set of industry stakeholders, and involving deeper cross-functional collaboration.”
Deloitte advises pharmaceutical companies to consider the disease they are trying to treat, the patient population, unmet needs, the patient’s journey, other existing treatments, and the main stakeholders. An early understanding of these aspects is necessary to launch a product effectively. Even clinical trial designs should account for these aspects, so this analysis needs to be conducted shortly after drug discovery.
Audience Engagement
Many sources, including ExtendMD, explain that audience engagement is critical to a successful product launch. The pharmaceutical company should consider patients, healthcare providers, payers, and other consultants and members of the industry.
Early engagement is critical for ensuring the product’s success — marketing a pharmaceutical product too close to or just after the launch can put the company at a disadvantage, as providers are less likely to prescribe it until they have learned more about it. According to ExtendMD, even minor delays in prescribing can lead to significant losses in revenue.
Many believe that audience engagement should begin one year before FDA approval. Depending on the target audience, the company may consider virtual and more cost-effective advertising than traditional billboards or print advertising.
In simplified terms, the audience engagement process will begin by identifying the audience first, such as patients, payers, and healthcare professionals. Among these large groups of people, companies may consider looking at smaller groups, for example, patients affected by breast cancer or healthcare providers that work in oncology for a drug meant for breast cancer patients.
Advertising
Next, companies will develop a plan for reaching these audiences regularly, for example, marketing on websites their target audience frequents or attending conferences related to the disease they aim to treat.
Regular engagement allows pharmaceutical companies to recognize products and patterns that are more successful and analyze why.
The FDA’s website lists three different kinds of advertisements for prescription drugs: product claims, reminders, and help-seeking ads. Product claim ads describe the drug’s purpose, benefits, and potential risks. Reminder Ads will only include the drug’s name but not its purpose. Finally, help-seeking ads will only discuss a disease or condition but will not mention the medication.
Overall, the drug development and launch process is convoluted and comprises many moving parts. The varying stakeholders in this process have different priorities, which help inform their protocols and strategies. The financial and clinical endpoints can drive development, research design, and marketing strategies.
