Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups01.05.21
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
Aji Bio-Pharma provides drug product aseptic fill finish services for CytoDyn's Leronlimab, currently being used in clinical trials for COVID-19 patients
The first oral treatment in three distinct types of advanced prostate cancer –non-metastatic and metastatic castration-resistant prostate cancer (CRPC).
U.S.-based, state-of-the-art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic.
JoyL Silva of Pfizer CentreOne discusses global market and regulatory changes driving drug development strategies and the evolution of CDMO services and ops.
PPS is a turn-key contract packager offering bottling, blister packaging, folding carton production, kitting, as well as vial/ampule and parenteral labeling.
Clinical leaders discuss bringing together disparate processes and systems for improved collaboration and more efficient trial execution at Veeva R&D Summit
Jim Reilly, vice president of clinical strategy at Veeva Systems10.18.19
A look at landmark changes in the management of data in the life sciences over the last 20 years and how the industry has addressed the challenges these develop
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challenge
Ryan Carpentier, Executive Director of Business Development, Cryoport09.23.19
FDA classified 3P facilities as acceptable for manufacture of target molecule, and appropriate for commercialization in the US once product is authorized
Cytegrity™ is a stable producer cell line developed by St. Jude Children’s Research Hospital for the treatment of X-linked severe combined immunodeficiency
New streams of real-world data from electronic health records and other data sources, with advances in ML, will be crucial for creating next-gen clinical trials
Jennifer Bradford, Ph.D., Head of Data Science at PHASTAR08.19.19
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standards
Underscores potential for momelotinib to address unmet needs of patients with Intermediate/High-Risk myelofibrosis who have previously received a JAK inhibitor
Venclexta combined with Gazyva is an approved chemotherapy-free option for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL)
Digital analytical services provider will design, generate and deliver integrated analytical data packages, & strategic support along the full development chain