“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.” — Roslyn Carter Each November, National Family Caregivers Month...
Premier Research
In recent years, the number of approvals for combination products and 505(b)(2) applications has been rising. Combination products consist of at least two constituent parts, each subject to its own statutory and regulatory requirements. Unlike fixed-dose combination therapies, which consist...
As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Combination products can be either two or more active pharmaceutical molecules, combined to address different aspects of a...
When a submission is sent through the FDA’s Electronic Submissions Gateway, it goes through an automated check of many validation rules as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. This validation check determines if the submission...
Development and reproductive toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings. Their goal is to detect any effects of a drug within a complete reproductive cycle as relevant to humans — from initial...
Barry Mangum, Senior Vice President, Pediatrics at Premier Research, talks about the importance of pediatric research, its evolution over the years, and the obstacles and opportunities the industry faces. Q: How long have you been in pediatric clinical research, and...
Consulting
Gene Therapy and Pharmacokinetics
How and When to Incorporate PK Design into Your Gene Therapy Development Plan Gene therapy, which was in its infancy around 30 years ago, is fast gaining prominence in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19....
Oncology & Hematology
New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials
Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life, and these insights can be particularly valuable in oncology research. However, there has been a lack...
Clinical Development
ANDA or 505(b)(2): Choosing the Right Abbreviated Approval Pathway for Your Drug
For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of...
While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advances were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation. Traditional trials, especially...