MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Cell and Gene Therapies (CGT): 6 Detailed CMC Considerations for IND Submissions
BackgroundCell and gene therapies (CGT), often referred to as advanced therapeutic medicinal products (ATMPs), are rapidly emerging as favorable treatments, repeatedly targeting rare, ultra‑rare diseases and fall under regulators’ expedited programs [1]. To date, the...
Data Provenance in Real World Evidence Studies, Explained!
Data provenance in Real World Evidence (RWE) studies has quickly becoming an increasing focus in the industry, especially as 90% of pharmaceutical companies today have Real World Evidence teams according to Deloitte. If an audit is underway, for instance, consider an...
MMS Supported MAPS Public Benefit Corporation NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD
Canton, Mich. (December 13, 2023) – MMS, a data-focused Clinical Research Organization (CRO), announced Lykos Therapeutics, formerly known as MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine...
Patient Experience Data: An Important Consideration for FDA Benefit-Risk Assessments
From a drug development perspective, benefit-risk assessments can sometimes feel abstract. However, from a patient's perspective, they are a lived experience with a disease state and therapy. One benefit-risk assessment exists in paper and data, while the other lives...
Good Laboratory Practice (GLP): A Validation Approach
Good Laboratory Practice (GLP) is a quality control system for clinical research laboratories and organizations to ensure the integrity, consistency, and reproducibility of the data within non-clinical and clinical studies of products in development for human or...
FDA REMS Programs: Five Major Components for Compliance
The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...
Meet These Four Expectations When Shifting SOPs in the Pharmaceutical Industry into Electronic Format
Standard Operating Procedures (SOPs) in the pharmaceutical industry are documents used by an organization to provide step-by-step actions for a specific process. And, according to a published study in ResearchGate, a typical pharmaceutical company must manage an...
Quality in Clinical Trials Should be Owned by All Departments: Here’s Why
Quality in clinical trials is of utmost importance to the pharmaceutical industry, with the need for quality management systems estimated to grow to $4.5 billion by 2032 according to Global Market Insights. The best pharmaceutical pipelines are driven by good quality...
New Investigator Updates and the Need to Keep Your Clinical Study Protocol Up-to-Date
New Investigator Updates need to be made in the clinical study protocol and kept up to date to with the FDA. And, with more than 32,000 principal investigators globally, according to Applied Clinical Trials, these updates can occur more often than many clinical trial...