Each year, on September 17, healthcare communities worldwide observe World Patient Safety Day, an important occasion dedicated to raising awareness about patient safety and promoting efforts to reduce preventable harm in healthcare settings. Established by the World Health Organization (WHO) in 2019, this day calls upon governments, healthcare professionals, patients, and families to work together…
Premier Research
In rare diseases, patient opinion and insight often go unheard. However, for sponsors of rare disease clinical trials, study success often rests on incorporating the patient perspective as early as possible in development. Many patients with rare diseases have undertaken a long journey to diagnosis, so participating in a study may feel like a huge…
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become mandatory for studies involving drugs, devices, and other medical products. In this article, we highlight the key provisions…
Cell & Gene Therapy
FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000…
As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. High-quality IND-enabling studies demonstrate that a drug is reasonably safe for use in humans and that it exhibits sufficient pharmacological activity to justify further development, ensuring the highest probability of transitioning…
When pitching to investors, a sponsor is not just selling them on the product; it is also promoting its ability to develop that product. Investors want to know the risks involved with the program, but they are also evaluating the sponsor as a risk factor of its own. Investing in emerging biopharma companies is a…
Asking the appropriate questions during a pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (pre-IND) meeting can be a valuable component in planning a development program. For companies that have not previously interacted with the FDA in the early stages of a product’s development,…
Designing an adequate nonclinical program to support the safety of cell or gene therapy products is not always straightforward. In this blog, we will address common questions we receive from our clients and aspects to consider when designing those nonclinical studies. In which species should the toxicity study be conducted? Does it have to be…
Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI.
We spoke with Clinical Research Associates (CRA) to hear what they especially enjoy about working at Premier Research. Here’s what we discovered. If you’re interested in becoming a CRA at Premier Research, search current openings.