GREENVILLE, N.C.
-Metrics Inc. recently completed its 100th “first in man” Phase I study, a significant milestone within the contract pharmaceutical development industry.
“This achievement reflects two important facts about Metrics: One, we have demonstrated scientific expertise in Phase I work and, two, we’ve had such scientific expertise for quite a while,” said Dr. Thomas B. Gold, director of pharmaceutical development and new technology.
As defined by the U.S. Food and Drug Administration, a Phase I study introduces an investigational new drug into humans. Closely monitored and usually conducted in healthy volunteers, a Phase I study assesses issues such as safety, tolerability, pharmacokinetics and pharmacodynamics, and normally includes dose escalation. Armed with such information, pharmaceutical companies can design a well-controlled and scientifically valid Phase II study.
A Phase I study presents special challenges that Metrics’ seasoned scientists are experienced in handling, such as formulating the active and inactive components of an investigational drug and determining the correct dosage, Gold said. Metrics has particular expertise in oral dosing.
“There’s a good deal of science in a Phase I study in terms of chemical and physical compatibility of the active pharmaceutical ingredient with other functional components within the tablet or capsule,” Gold said. “The fact we’ve managed more than 100 first in man studies for leading companies proves we’ve got an excellent process for conducting Phase I work and our clients know it.”
Last year, Metrics completed an $18-million, 47,000-square-foot expansion that doubled its overall facility size and dramatically grew service offerings to clients. Because of its expansion, Metrics’ capacity for Phase I work increased and the company now can conduct more such studies concurrently. Metrics also can scale up studies as needed through Phase III and commercial, keeping
them under one roof.
Metrics’ facility addition included a new larger scale manufacturing facility with a production capability of 1 billion tablets per year; four new analytical laboratories; stability storage; a totally segregated cytotoxic and potent compound development facility; and a microbiology laboratory.
Headquartered in Greenville, N.C., Metrics Inc. provides quality pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry. The company is one of the fastest-growing contract pharmaceutical development laboratories in the United States today. Visit online at
www.metricsinc.com/fast-track.htm
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
POETYK PsA-2 Trial Shows Efficacy of Sotyktu as an Oral Therapy for Psoriatic Arthritis
March 11th 2025Sotyktu (deucravacitinib) demonstrated significant efficacy in improving psoriatic arthritis symptoms compared to placebo in the Phase III POETYK PsA-2 trial, with a well-tolerated safety profile.