Newsletter | July 31, 2024

07.31.24 -- In Defense Of The Full-Time Equivalent (FTE)

SPONSOR

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

FEATURED EDITORIAL

In Defense Of The Full-Time Equivalent (FTE)

"Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs. Hooking up to specific professionals at your CDMO still makes good sense."

5 Recommendations To Maximize CSV/CSA Outcomes

The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

INDUSTRY INSIGHTS

Customized Release Through Dispersed Dosage Formats

Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

Outsourced Drug Development: Short-Term Solution Or Long-Term Strategy?

As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

Increase Spray Drying Throughput For Brick Dust Compounds

We discuss three enabling technologies designed to improve drug solubility in organic solvents for spray drying and define the advantages and risks of each technology.

Liquids, Soft Foods As Vehicles For Enteric Coated Bead Drug Product

Take a deeper look at the challenges and solutions involved in creating a child-friendly medication delivery system, and learn about the importance of collaboration and meticulous scientific processes.

SPONSOR

PDA/FDA Joint Regulatory Conference 2024

The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP).

SOLUTIONS

Nasal Spray Development And Manufacturing Services

A partner with experts who are adept at working with complex, sensitive, and potent APIs; screening for the optimal formulation; and scaling up efficiently is vital for successful trials and commercialization.

Pharmaceutical Clinical Trial Distribution Services

Contracting an in-country pharmaceutical clinical depot brings efficiency to your clinical trial distribution. We handle most paperwork, permissions, components, warehousing, packaging, distribution, collection, and destruction as a single project.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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