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From Clinical Development to Commercialization: Effective Strategies for New Treatment Launches

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There is an ever evolving and increasing need for new drugs in the market for meeting patient and caregivers needs. However, the drug commercialization process is highly expensive and extraordinarily lengthy. Before reaching the final stage of market launch, the drug needs to go through various stages, testing, regulations, obstacles, and irregularities.

Therefore, pharmaceutical companies must have a well-thought-out plan ready for each stage before they begin on the journey to the clinical development process. It is also imperative for pharma companies to recognize that they operate within a competitive landscape, where rivals are also leveraging real-world evidence (RWE) and analytics to drive their drug development initiatives.

The key steps to to clinical development process are:

  1. Discovery and target identification
  2. Preclinical research
  3. Investigational new drug (IND) application
  4. Clinical trials
  5. New drug application(NDA) or Biologics license application(BLA)

For successful drug commercialization, companies must have proficiency in each stage of clinical development. Therefore, partnering may help to expedite clinical development and drug launch. Proper planning and strategy for the entire drug development process are essential for successful launches.

Cognizance of Competitors and Market Place:

As mentioned above, numerous companies are actively engaged in developing similar drugs indicating a competitive landscape in this field. So, the best way to begin is to compile high-quality RWE data and understand it. In cases of uncertainty regarding similar molecules, leverage real-world evidence data to examine historical data of trials, drug launches, post-launch efficacy, sales volumes, and prices. Analytical data can be utilized to understand success and failure across various phases, payers, and reimbursements, ultimately determining the best course of action for drug success.

Finding the right data, compiling, consolidating, and analyzing it to derive maximum benefits is the key to success.

Calculating The Cost Utility, Budget Impact, and Effectiveness of Drug

Bringing a new molecule to the market requires huge investment and effort. In order to save both cost, time, and effort, RWE data should be utilized to find out answers to the following questions:

  1. What is the goal of the product?
  2. Is there a market for the drug, which can grow in the future?
  3. Are there enough funds allocated/capital to carry on till the commercialization?
  4. Are we satisfying the unmet needs of the patients through this drug?

It is essential to ensure that the molecule planned for development has market demand in which assessment of demand-supply ratio becomes very crucial. This involves analyzing the molecules to identify the right one among these. Choosing the right molecule is the first right step toward a cost-efficient and effective drug development process.

Using historical data, evidence, and insights to understand the number of years, approximate cost, efforts were spent on the same molecule and profit generated. Understanding such data can provide accurate insights and support decision-making.

Understanding Every Phase of Clinical Trials

Upon discovery and identification of the target molecule, gene, or protein, the subsequent step involves initiating research and development, laboratory, and animal testing for preclinical studies and Investigational New Drug (IND) application. After this has been achieved, the next step is launching clinical trials.

The next step is to establish the framework for clinical trial success across all its three phases. A robust clinical development strategy with strict protocol and that complies with regulatory requirements should be the first step.

To achieve success in clinical trials, it is necessary to follow these guidelines

  1. It is important to choose the right partners with the right set of clinical skills that are required.
  2. Narrow down to the specific clinical condition that aims to the target.
  3. Ensure the best quality controls along with the best clinical trial design process.
  4. Allow peer reviews by professional third-parties to test professional quality of data, deviations and discrepancies in the data.
  5. Estimate the effect on the patient’s condition needs to be seen so as to determine the clinical trial to be successful

There is much more to be done during clinical trial phases such as leveraging RWD data, insurance claims, EHR, and much more. CROs/CDMOs are best suited to smoothen clinical operations and pharmaceutical companies heavily rely on such organizations.

Ensure Optimal Drug Success

Although approval for the clinical trial has been obtained, the process is not yet complete.

  1. The drug should fulfill the unmet needs of the patient population.
  2. The drug needs to be safe and efficient.
  3. The drug needs to be cost-effective (at least not priced higher than the competitors).
  4. The payers should concur with the findings and should be ready to reimburse.

For the optimal success of the drug, a reliable professional partner is essential to navigate through potential barriers effectively. Search for partners who can provide comprehensive data analysis, advanced market research, can target the right physicians/KoLs and relevant patient population, can leverage online tools and platforms.

In conclusion, the success of new treatment launches depends on various factors:

  1. Designing a robust commercialization plan.
  2. Communicating with the right healthcare providers.
  3. Highly advanced marketing and distribution plan.
  4. Utilize payer data for good coverage.
  5. Support healthcare professionals and other stakeholders by clarifying drug related queries.
  6. Make the drug easily accessible to all stakeholders.