Johnson & Johnson

With an illustrious past of 135 years, US-based Johnson & Johnson is the world’s largest and one of the most diversified consumer healthcare product manufacturers. At Digital Aptech, we assisted Johnson & Johnson in submitting FDA-compliant trial data for its B-cell lymphoma drug Teclistamab.

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Project Overview

Our data scientists and visualization experts collaborated with the biostatisticians at Johnson & Johnson to chalk out a detailed plan for clinical data trial submission
We aimed to help the pharma giant in structuring a well-documented Clinical Study Report to be submitted to the FDA for the aforementioned drug

Clinical trial data submission is the first step to getting any drug or medicine approved for worldwide manufacturing and sale. These are usually highly complicated, time-consuming procedures and organizations need to be very careful to ensure that their submissions are not rejected. Rejection would lead to unnecessary delay in drug roll-out and fund loss. Biostatistical and data science services are crucial to ensure smooth drug approval.

Client Background

The organization boasts a wide portfolio of consumer healthcare items, prescription and pharmaceutical products, and medical devices/diagnostics products.

Johnson & Johnson has been consistently striving to provide accessible and affordable healthcare solutions worldwide for a vibrant and healthier global community

Challenges

After submission of trial data, the FDA conducts stringent scrutiny in which the organization seeking trial data approval is obligated to answer certain queries and questions.
Clinical Study Reports are an essential part of the application for new drug approval.
Clinical trial data submission and approval is a tedious and complicated process. Pharmaceutical organizations need to be careful, as any error or discrepancy could lead to outright rejection by the FDA.

Technologies & Methodologies Used

Biostatistics
PK/PD Modeling and Simulation
Regulatory Data Standards (CDISC) and Compliance
Clinical Trial: SDTM and ADaM
Statistical Consulting and Planning

The Solutions Provided

Solution #1

Our team of data science experts, data visualization engineers, and other big data professionals helped Johnson & Johnson to form articulate and accurate responses needed during the clinical trial

Solution #2

We worked in collaboration with the experts at the client’s end to develop an FDA-compliant CSR or Clinical Study Report

Solution #3

Our biostatisticians used statistical planning, Statistical Report Writing, BA/BE analysis, PK and PK/PD analysis, PK/PD report writing, Toxicokinetics, etc to ensure faster drug approval

Key Features & Benefit

Submission of FDA-compliant CSR
Accurate responses to the FDA questionnaire, ensuring a lower rate of rejection
Better analysis of data trial results
Efficient post-hoc analysis

The Results

Our services accelerated the drug data trial process
The expertise that we provided helped to ensure zero rejection and assured approval
We helped the pharma giant streamline its business decisions and operations by letting it harness the power of big data.

Conslusion

Johnson & Johnson benefitted largely from the hassle-free approval of the drug in question. It saved substantial funds, resources, and time with direct approval
The direct approval also ensured faster large-scale production of the drug which enhanced the profit outlook of the company
The credibility of the drug and the pharma company improved
Johnson & Johnson decided to utilize AUI/ML and biostatistics to transform its other businesses

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