Development

Webinar Date/Time: Thu, Nov 16, 2023 11:00 AM EST

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

Spark Therapeutics and SpliceBio have formed a collaboration to develop a gene therapy that can treat an inherited retinal disease.

The California Institute for Regenerative Medicine has partnered with Forge Biologics, which will manufacture AAVs to help accelerate gene therapy programs in California.

Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price.

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

The Start-Up Market at CPHI Barcelona will bring together 27 start-ups, innovators, and small enterprises from across the pharma landscape.

Sherma Ellis Daal, brand director, Pharma at Informa Markets, gives a preview of CPHI Barcelona 2023.

CPHI’s Annual Report predicts huge impact of AI on drug development and manufacturing.

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

Salipro Biotech and Icosagen have entered into a multi-target collaboration to discover and characterize monoclonal antibodies.

Under this agreement, Acuitas Therapeutics’ LNP technology platform will be transferred to BIOVECTRA for use in manufacturing mRNA-based therapies.

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

The program will improve access to adeno-associated virus gene therapy vectors.

Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones.

Webinar Date/Time: Thu, Oct 26, 2023 11:00 AM EDT

Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Webinar Date/Time: Tuesday, October 17, 2023 at 11am EDT | 4pm BST | 5pm CEST

Webinar Date/Time: Mon, Oct 23, 2023 11:00 AM EDT