Newsletter | June 5, 2019

06.05.19 -- Manufacturing Facility Will Meet Needs Of Cell & Gene Trials

Featured Editorial
Manufacturing Facility Will Meet Needs Of Cell And Gene Trials
By Ed Miseta, chief editor, Clinical Leader

Abeona Therapeutics is developing investigational gene and cell therapies for people living with serious and rare diseases. Last year, Abeona held a ribbon-cutting ceremony to celebrate the groundbreaking of a manufacturing facility that is one year later producing gene therapy material for their clinical and preclinical programs. As is the norm with gene therapy, Abeona uses a virus as vehicles to deliver functional copies of defective genes.

4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development
By Jamie Cartland and Philip Winkworth, PA Consulting

The data landscape is evolving rapidly, and some pharmaceutical companies are taking strong positions to gain privileged and preferential access to data. Oncology is at the forefront of this movement and is heralding a wave of activity across other therapy areas.

Industry Insights
How A Problematic Database Project Inspired Me To Revamp eClinical Software
Article | By Mike Novotny, Medrio

Mike Novotny, founder and CEO of Medrio, shares an experience from early in his career of building databases that showed him that, by having the right data at the right time, doctors can make decisions allowing patients to live their best lives possible.

First Thoughts After ISOQOL 2018
Article | By Mark P. Wade, TransPerfect

IRT USA 2018 presented some resonating themes: the need for better project management and never losing sight that the patient is at the center of everything we do.

Building Faster, Patient-Centric Studies In A Changing Regulatory Environment
Article | By Cindie Kazmer, Cenduit LLC

IRT USA 2018 resonating themes - the need for better project management and never losing sight that the patient is at the center of everything we do.

505 (b)(2) vs. ANDA: How Complex Drugs Fit In
White Paper | By Samantha Hoopes, Ph.D., RAC, and Sheila Bello-Irizarry, Ph.D., RAC, Rho

Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

Syncing Transparency Processes To Improve Clinical Trial Compliance
Case Study | TrialScope

The sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.

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