Regulations Impacting the Pharma Industry
1990, April – ICH was first formed during a meeting, held by the EFPIA in Brussels, in 1990. Representatives of the regulatory agencies and industry associations of Europe, Japan, and the United States met, primarily, to plan an International Conference.
1991– The adoption of final version of " common rule" governing protection of human subjects for research sponsored by all federal agencies
1992 – PDUFA, the first FDA user fee program.
1993 – Second ICH Conference in Orlando.
1996 – Third ICH Conference in Yokohama.
1996 – Congress enacts HIPAA (Health Insurance Portabiality & Accountability Act) with provisions regarding privacy of human medical records.
1996-ICH GCP Guideline finalized
1997– FDAMA-pediatric studies & incentives (expanded under 2003 Pediatric Research Equity Act); clinicaltrials.gov, fast track approvals
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.
