Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed and reach the market successfully.

Drug development is the process of bringing a new pharmaceutical drug or a medical device or a treatment procedure to the market. Many developers often lack a clear and optimized development strategy which may lead to failure in reaching pre-determined targets and timelines or even may lead to product failures.

Every drug development process in Unique

Strategically developing a plan for a drug to reach the market is equally important as developing a drug. Every newly discovered drug or medical device has its unique pathway to reach the market. Many factors vary from product to product such as type of product, the category it belongs, disease prevalence, study design, regulatory pathway, phases of trials need to conduct, etc.

Proper strategic planning reduces financial burdens, saves time, and finds the best short way to reach the market.

Drug development

The general drug development involves the following steps

  1. Pre-clinical development
    1. Pharmacodynamics
    2. Pharmacokinetics
    3. Toxicology
    4. Safety human dose identification
  2. Clinical development
    1. Phase 0
    2. Phase I
    3. Phase II
    4. Phase III
    5. Phase IV studies (pivotal studies)
    6. Proof of concept trials
  3. Market approval
    1. Country selection for marketing
    2. Regulatory process
    3. marketing

One or more steps may be added or skipped based the product under development

But from the strategic view, the entire process is taken in a different perspective and the steps are broadly classified as

  1. Pre-clinical development strategy
  2. Clinical development strategy
  3. Marketing strategy

So before going into the details, let’s know exactly what is drug development strategy?

A comprehensive drug development strategy

A comprehensive drug development strategy is a detailed roadmap for advancing a new compound from the lab through each stage of development, ultimately arriving at the envisioned marketed drug product. 

This requires a multi-disciplinary project team of experienced experts in strategic planning, which outlines the chemistry, manufacturing, and controls (CMC) and formulation activities, key nonclinical studies, and Phase I-III clinical trials, regulatory submissions, and health authority interactions, market launch activities, and life-cycle management. 

What is a drug development strategy?

Drug development strategy is an optimized and dynamic process that moves forward in defined stages. A carefully planned set of steps or action plans, and visionary interpretations progressing from pre-clinical to the first-in-human Phase I to Phase II “proof of concept” and pivotal Phase III trials for registration.

The drug development process is not as simple as it looks and involves various strategic steps that can skip some procedures, reduce timelines and costs, and present the most precise pathway.

A proper clinical development strategy should answer the following questions

  1. What is the end goal of a pharmaceutical product or medical device?
  2. What are the desired product attributes: indication or usage & dosage, administration & pharmacology, adverse reactions & toxicology, clinical data, clinical safety, and efficacy. 
  3. Identifying the most feasible country for clinical trials. global data acceptance, developmental infrastructure, clinical developmental costs.
  4. Identifying the most efficient and effective ways for clinical developments
  5. Potential markets and marketing strategies.

“When you are not sure about the path, then how sure you are that you reach the destination?”

Clinical development strategy

Most start-ups, small- or mid-sized pharmaceutical, biotech, or medical device companies lack the resources and the time to build a detailed research strategy and an extensive and precise roadmap to complete the clinical development process. 

In designing a successful clinical development strategy, pharmaceutical and medical device sponsors shall not only consider the needs of regulators but also identify the optimized pathways, anticipate regulatory hurdles, understand the market scope, product uniqueness, and value.

Failure in creating such roadmaps leads to unnecessary processes, project delays, management failures, unexpected costs, and budget burden, market failures, etc.

The Clinical development Strategy (CDS) is a comprehensive plan that maps out the overarching strategy and vision for the drug or therapy. The development strategy includes 

  1. Product risk assessment and market evaluation
  2. Precise pathway recommendation and country/s selection
  3. Plan key studies required, establish efficient and effective study designs
  4. Identification of clinical investigators, research sites, etc.
  5. Strategic plans for regulatory submissions and regulatory agency interactions
  6. Special considerations such as faster regulatory approvals, incentives, etc.

Let’s discuss one by one how does the clinical development strategy benefit 

Product risk assessment and market evaluation

  • Before starting any process of clinical development and after pre-clinical studies, the results and outcomes are to be keenly evaluated for likeliness that the product is good to move forward, and check whether the pre-clinical data complies with the regulatory requirements. This is important to avoid unnecessary processes, costs, and time. This can only be achieved by a thorough risk-benefit assessment and regulatory understanding. For some high-risk products, Risk Evaluation and Mitigation Strategies (REMS) strategy can be thought out.
  • Market evaluation is an important step before planning any next process. It is important to answer the basic questions that, does your drug/medical device have competitors? if yes, does your research overweigh the existing drug market? and what is the market forecast (by the time the product reaches the market)?

Precise pathway recommendation and country/s selection

  • No drug follows the same path of clinical development and varies with many factors. Hence determining the pathway is critical and there is no established gold standard set of steps.
  • For example, the FDA suggests seamless trial designs, which compress the phases of a trial into one continuous trial, as well as basket, umbrella, and platform trials for orphan drugs. Some categories of drugs have exceptions to submitting the clinical trial data after market approvals. Hence for developing a precise pathway one should be thorough of both the regulatory and the drug under evaluation.
  • Some categories of drugs have access to accelerated and Fastrack approvals with minimal or no regulatory fee, priority review, application & evaluation fee exemptions, etc. Such options should be evaluated for applicability.
  • Country/’s selection for conducting clinical trials is critical in the clinical development process. Region selection depends on product-related factors, regional factors, past trial conducting experiences, etc, and conducting country-level feasibility helps in identifying the best country/s for clinical development.
  • This process evaluates the regulatory aspects, ICH and GCP compliance, ethics approval scenario, disease prevalence of target treatment, available patient population, patient recruitment and retention potential, qualified professionals, and facilitated site availability, logistics & site reach convenience, global acceptance of data generated and many more,

Plan key studies required, establish efficient and effective study designs

  • Depending on the risk and the product category, a strategy has to be developed to establish the required studies and proper study design to comply with the regulatory requirements. Studies shall be designed in such a way that they utilize minimum resources and yet produce efficient data.
  • Strategic planning includes determining an efficient study design, assessment criteria, number of subjects required, number of study sites required, analyzing the inclusion and exclusion criteria, etc.
  • Considering adaptive trials, combining phases of trials, planning proof-of-concept trials, implementing new modern study designs such as umbrella, basket, and platform trials are part of the strategic planning.

Identification of clinical investigators, research sites, etc.

  • 90% of clinical trials fail in reaching timelines and proposed budgets. this is due to many of the reasons such as recruitment failures, inefficient professionals, trial initiation delays, site incapabilities, etc. hence, finding the right qualified investigators and facilitated sites are crucial for any successful clinical trial. Conducting clinical trial feasibility in the clinical development strategy helps in finding many of these answers.

Strategic plans for regulatory submissions and regulatory agency interactions

  • The regulatory submission has to be made after each successful phase of clinical trial and after which the process moves to the next phase. Proper clinical trial monitoring strategies and assessing the outcomes is important to avoid regulatory submission delays and avoid complete process failures.
  • Drug regulations can be complicated and often vary among countries/regions regulators such as FDA, TGA, EMA, PMDA, KFDA, CFDA, etc. This requires a clear idea of regulatory requirements, identifying pros and cons, study outcome assumptions and this can be achieved by combining the scientific drug development expertise with thorough regulatory knowledge.

Special considerations such as faster regulatory approvals, incentives, etc.

  • Strategic development planning involves the evaluation of various regulatory pathways that Fastrack the approval process or provide incentives or provide developmental benefits.
  • For example, regulators like the US, EU, Australia, Japan, and many more offer tax benefits and developmental convenience for orphan drugs (a drug for rare disease)
  • FDA offers special recommendations for innovative products and benefits for SME (Small and Medium Enterprises). EMA also provides special considerations for SME. Countries like Japan, China accept foreign clinical trial data in some circumstances. These regulatory understandings help in skipping some of the regulatory steps and ease the market approval process.
  • Hence, in conclusion, Establishing a clinical development strategy before you start clinical trials always helps to know and determine the clear path and be sure that every step is going in the right and precise way.

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References

  1. https://journal.emwa.org/preclinical-studies/preclinical-research-in-drug-development/
  2. https://www.covance.com/content/dam/covance/assetLibrary/whitepapers/Regulatory-White-Paper-WPCDS029.pdf
  3. https://www.labsexplorer.com/c/4-tips-for-your-preclinical-development-plan_12#:~:text=The%20preclinical%20development%20is%20a,pharmacology%2C%20pharmacokinetic%20and%20toxicology%20testing.