Tag: consulting 104 results

Sponsors developing biologics must manage numerous scientific considerations specific to large-molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance. Clinical trials of biologics are designed to determine pharmacokinetics (PK),...

The development of biologics represents a major advancement, enabling the treatment of patients with many illnesses for which no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large-molecule products, including biochemical characterization...

“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...

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...

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....

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...

Background An international company developing an orphan drug product needed a partner experienced in FDA interactions to help it navigate the U.S. regulatory process from beginning formulation to NDA approval. The sponsor’s product used a novel delivery platform designed to...