Delivering life-changing drugs to patients is a complex process filled with scientific and logistical challenges. One critical phase in this journey is the early stages of drug development, where decisions about drug formulation and dosage ranges are instrumental in informing the subsequent clinical development program. Having the capability to modify these elements in real time, based upon observed clinical and pharmacokinetic data, is crucial and can be effectively managed with an on-site pharmacy. This capability not only streamlines the process but also significantly reduces time and costs.
Learning and confirming
During early phase clinical trials, the ability to modify drug formulations in real time and dosage strengths is crucial, while adhering to all regulatory standards and maintaining Current Good Manufacturing Practices (cGMP) standards. This approach eliminates the necessity to establish final specifications for the formulation, or an optimal dose concentration and a dosage range for evaluation based exclusively upon the available nonclinical data at the time of transition from preclinical to clinical research, although these data provide a framework for evaluation. It enables more accurate and timely adjustments in response to clinical observations, enhancing trial efficiency, reducing costs and minimizing the need for external vendors, which simplifies administrative processes.
Worldwide Clinical Trials (Worldwide) has a Clinical Pharmacology Unit (CPU) located in San Antonio, Texas, that features a state-of-the-art on-site pharmacy that plays a fundamental role in both drug development and the approval of life-saving therapies. The onsite pharmacy, coupled with Investigation Drug Services in Early Phase represents a highly differentiated capability within Worldwide.
This facility offers tailored drug formulation solutions that respond immediately to trial needs as well as comprehensive inventory control and temperature-sensitive storage, ensuring test-articles are kept in optimal conditions.
Our integrated approach guarantees that every step—from formulation to dose administration—meets the highest standards of quality and efficiency.
Addressing uncertainty with cGMP expertise
Worldwide’s integrated pharmacy adheres to cGMP standards, guaranteeing stringent guidelines for the highest quality and consistency in drug formulation and manufacturing processes.
The CPU ensures the safe and seamless progress of clinical trials by adhering to the FDA’s cGMP regulations. These processes are designed to safeguard the safety of patients and trial personnel, maintain the integrity of the Investigational Drug Product (IDP), and ensure that the data collected is based on IDP manufactured using validated and reputable compounding and manufacturing techniques.
“Our pharmacists meticulously review the study protocol and investigator’s brochure, focusing on sections related to safe dose selection, maintaining IDP storage stability, conducting mock batch preparations, handling complex dose preparations, following blinding procedures, ensuring proper dose administration, and maintaining drug accountability in compliance with cGMP, GCP, FDA, CFR and DEA regulations. The primary objective of early phase clinical trials is to transition an investigational drug product from scientific research to medicinal use while prioritizing the safety of volunteers at the highest level,” explained Nishi Soni, Associate Director of Pharmacy Operations at Worldwide.
Accelerating data-driven decisions
A full-service CRO with an on-site pharmacy facilitates direct pharmacist access to the study-assigned primary investigator. This close collaboration is particularly relevant to translational research, as close cooperation between the sponsor and the investigative staff is essential to defining key pharmaceutical and pharmacological attributes.
The interaction ensures prompt resolution of issues, modification in dosage level or regimen if required, with minimal obstacles, and helps mitigate the risk of protocol violations related to the investigational drug product, thereby safeguarding study timelines and goals.
“When pharmacy processes align with clinical trial operations, our clients can implement strategies to streamline study processes and optimize dosage formulations and adjustment costs. Through on-site centralized pharmacy services, study timelines can be expedited, dose flexibility can be provided, and formulation consistency can be more effectively controlled,” Soni explained.
Time and informed decision processes are essential aspects in successful drug development. Highly codified procedures, supervised by well-trained professional staff, ensure the trial generates valuable insights and supports the drug’s successful advancement into late phase studies. For example, the on-site pharmacy team plays a pivotal role in reviewing and contributing to research trials, from the initial discussions regarding formulation development in late phase drug discovery into the initial stages of protocol development and eventually study implementation, offering vital feedback to the medical director and primary investigator.
Providing a template for early phase research
At Worldwide’s on-site centralized pharmacy, all study cohort doses are prepared just in time, enabling dose flexibility based on safety, exposure, and observed clinical and pharmacokinetic data. These adaptations also occur within a highly regulated clinical trial environment where the management of IDPs is crucial. Meticulous accounting for all test articles is mandated from Phase 1 to Phase 4 and beyond completion.
At Worldwide, success hinges on the collective commitment of its team, from translational scientists who specialize in interpreting nonclinical data informing a clinical program, through operational specialists who assure study implementation at the highest level of patient safety. “The driving force behind our pharmacy team is engagement—we work passionately with certified expertise to deliver excellence. We are dedicated to providing white-glove services to all our external and internal clients,” Soni added.
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- Source: https://www.biopharmadive.com/spons/maximizing-efficiency-in-translational-medicine-with-an-on-site-pharmacy/714960/