Author: Suzanne Broussard, PhD
One of the first steps toward obtaining approval to market drug products or biological compounds in the United States is the submission of an Investigational New Drug (IND) application. Your research team is hard at work developing a very promising new drug, and they are naturally anxious to get a product to market. An important part of this process is to have a spot-on IND submission that sails through the FDA’s evaluation program.
New drug products and biological therapies go through a rigorous review process to prove they are safe and effective. So, what role does the IND submission play in this process? Prior to marketing, a New Drug Application (NDA) or Biological License Application (BLA) must be submitted and approved by the FDA’s respective consumer watchdog organizations, the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). In order to submit an NDA or BLA application, products must first be tested for safety and efficacy in human clinical trials, which is where INDs come into play. Federal Law prohibits transportation of drugs across state lines without an approved marketing application. Approval of an IND allows the drug or biologic to be legally transported and distributed across state lines for use in the clinical trials that support the NDA and BLA applications.
(more…)Author: Suzanne Broussard, PhD
The unique characteristics and manufacturing processes of therapeutic biological products and drug compounds lays the framework for the differences in regulatory requirements for getting into the marketplace. While, biologics and drugs are both used for the same purposes — to treat, prevent, and cure diseases — biological products are much more complex in nature. By comparison, common drug compounds are relatively simple.
What exactly is a biological product?
Biological products are comprised of large and complex protein structures that are primarily derived from living material, including human, animal, and microorganisms. Proteins are often post-transcriptional modified, including glycosylation, oxidation, deamidation, and this has a profound effect on protein properties. As seen in the figure below, this contrast with conventional drug compounds, such as aspirin, that have a smaller molecular weight and are chemically synthesized. Peptides can fall into either regulatory category and are comprised of amino acids just like a protein, but peptides are smaller.
The vast differences in complexity and size are depicted in this figure.
Defining biological products and drug compounds is the first step to understanding the common and unique regulatory requirements for each. FDA’s definition is the only one that matters for the purpose of obtaining marketing approval in the United States, and the definition for biologics is in a transition period.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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