Daniel Eisenman

Jan 21, 2025 | themedicinemaker.com | Daniel Eisenman

In part I, Daniel Eisenmann examined the evolution of cell and gene therapies from their early, controversial days in the 1970s to their current status as groundbreaking medical advancements. Here, he discusses the clinical trial process and how modern, decentralized approaches can further accelerate the field of cell and gene therapies.

Jan 14, 2025 | themedicinemaker.com | Daniel Eisenman

For decades, cell and gene therapies (CGT) seemed elusive, relegated to the world of science fiction. In the 1970s, in fact, TIME magazine featured a cover story titled, “The DNA Furor: Tinkering With Life,” which heightened public fears over the nascent field of genetic engineering, human gene transfer, and the creation of virulent microorganisms. In 1975, these concerns culminated in the Asilomar Conference on Recombinant DNA, discussing the potential biohazards and regulation of biotechnology.

Nov 16, 2023 | clinicalleader.com | Darshan Kulkarni |Daniel Eisenman |Scott Swindle

Impact Of Research Misconduct Updates On Clinical Trial SponsorsThe Office of Research Integrity (ORI) has proposed updates to the Public Health Service Policies on research misconduct. Darshan Kulkarni outlines how the proposal should influence sponsors to reevaluate existing trial practices. Reporting Unexpected Incidents To The IBCUtilize this comprehensive guide to better understand reportable incidents and the appropriate channels for communication when unforeseen events arise.

Oct 19, 2023 | clinicalleader.com | Peter H. Calcott |Daniel Eisenman |Charles Chrisawn |Michael Edwards

Medidata has a seat at the table where regulatory change happens. Our input helps accelerate your innovations into the marketplace. FDA Introduces Quality Management Maturity ProgramThe FDA program, described in a recent CDER document, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.

Sep 20, 2023 | clinicalleader.com | Daniel Eisenman

Article | September 20, 2023 By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services The burgeoning field of gene therapy is poised to receive a significant boost, courtesy of the forthcoming launch of "Operation Warp Speed for Rare Diseases" by the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).