Today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. Companies pour money into a development program with the hope that their product will reach the market faster. But what if it didn’t have to be that way? There is a proven approach to optimize your resources, design and time activities smarter, and get a drug to market with the most impact, all while reducing wasted efforts.
A Clinical Pharmacology Gap Analysis is the most efficient route for designing and completing a clinical pharmacology program.
A Gap Analysis will identify any missing elements in your data package, prepare a plan to prioritize your program’s needs, to provide specific questions to FDA regarding the required Clinical Pharmacology studies for approval, providing action items to accomplish those needs before you submit your NDA to the FDA. This service is designed to look backwards at your data in order to guide your program forward by answering these three broad questions:
- What will the FDA require of your program?
- Can your existing data satisfy those requirements?
- What’s the most efficient way to satisfy any remaining requirements?
In the sections below, we’ll explain how our team of consultants can answer each of these questions to efficiently guide your development program.
What Will the FDA Require of Your Program?
Every program is different and although there is no “one size fits all plan,” FDA reviewers in the Office of Clinical Pharmacology and Biopharmaceutics use the same guidelines to assess the suitability of clinical pharmacology and PK/PD information to support label claims for all new drugs. The FDA has provided a policy document (the Clinical Pharmacology and Biopharmaceutics MAPP) that explicitly defines what reviewers are to look for in new drug applications (NDAs) and biologics license applications (BLAs).
This policy document is the starting point for a Gap Analysis, but it is not the end. Using our extensive network of regulatory specialists and clinical pharmacology experts, we have an exhaustive list of questions that FDA reviewers will ask of every applicant. Several example questions are provided below:
- Has the ability of the drug to prolong the QT or QTc interval been adequately assessed?
- For oral dosage forms, what is the effect of food on the bioavailability of the drug from the to-be marketed dosage form?
- Does the PK in healthy volunteers allow extrapolation of results to patient populations?
- What dosage regimen adjustments are recommended for patients with renal impairment?
- Are there any in vivo drug-drug interaction studies that indicate the exposure and/or exposure-response relationships are different when drugs are co-administered?
Spanning all issues related to clinical pharmacology and biopharmaceutics, a Gap Analysis ensures that you will have a strategy to provide an informed answer for every question, regardless of whether you plan to file an NDA, partner with another pharma company, or to inform important data-driven strategy decisions. By addressing all required PK/PD components before submission, you will save your program unnecessary resource, time and money.
Can Your Existing Data Satisfy Those Requirements?
A comprehensive analysis of your existing data is necessary to evaluate which questions can be answered and which ones still require additional information, as well as recommend the optimal timing for planned activities. Our scientific consultants meticulously comb through your existing studies to uncover hidden PK/PD gaps. Decades of experience give them an unparalleled ability to assess the scope and implications of clinical pharmacology studies. The Gap Analysis will govern planned and future studies to ensure you get the most value out of your data moving forward.
Given the complexity of many early phase clinical studies, it can be difficult to deconvolute the myriad of overlapping objectives and endpoints. For example, many First Time in Human studies are combined with Multiple Ascending Dose cohorts and Food Effect arms. Due to the multiple goals in such a study, the results can often be under-powered, rendering the data inconclusive and requiring the recruitment of additional subjects or additional studies. Careful planning with the help of a clinical pharmacologist or pharmacokineticist is crucial to avoid missteps in your clinical studies.
What’s the Most Efficient way to Satisfy the Remaining Requirements?
At the same time that your data is being analyzed for gaps, our clinical pharmacology experts formulate a plan for how to address any unanswered questions. By incorporating modeling and simulation strategies into your development program, we can often help you avoid expensive clinical trials without compromising scientific standards. For example, in many cases we can use an approach called a Concentration-QT Analysis to establish the risk of QT prolongation and potentially avoid the expense of conducting a full thorough QT/QTc study. In recent years, the FDA has expressed its strong support for modeling and simulation in drug development and to inform decision making.
At Nuventra, we understand that both time and money are always constrained in drug development. Start optimizing your resources today and contact Nuventra to begin your program’s Gap Analysis.