Articles & Research from Venn Life Sciences

Considerations for Choosing a CDMO in the EU, US, or Asia

The evolving geopolitical landscape and other challenges Given the rapidly changing geopolitical landscape, (bio)pharmaceutical companies may be facing increasing challenges when conducting clinical trials in the US or EU with materials manufactured by Contract Development and Manufacturing Organisations (CDMOs) in Asia, and in particular China....

The importance of considering the target population – how patient-driven insights influence first-in-human dosing strategies.

Challenge As FIH clinical trials are studies during which a drug is administered to humans for the first time, and mostly performed with healthy participants, they serve the purpose of establishing a safe dose range for further clinical development. Our client needed to make sure...

CDMO Selection and Management: Venn’s Proven Strategies & Expert Advice

Biopharmaceutical companies often seek support in selecting a Contract Development & Manufacturing Organisation (CDMO) when they need to scale up drug product production – going from small sites to larger facilities – and do not have the capabilities in-house. Erik Gout, Director of Chemistry, Manufacturing,...

Chemistry Manufacturing and Controls (CMC)Late Phase Development

As pharmaceutical products progress through clinical trials, the Chemistry, Manufacturing, and Controls (CMC) division plays a crucial role in ensuring these products are effective, consistently safe, and of high quality.

Safety, Pharmacokinetics and Pharmacodynamics of Sofnobrutinib, a Novel Con-Covalent BTK Inhibitor, in Healthy Subjects: First-in-Human Phase I Study

An article by Clinical & Translational Science on the American Society for Clinical Pharmacology & Therapeutics.

A Solution for Asian Biotech Startups

An Asian client, a biotech startup, nominated a drug development candidate and contacted Venn for support and consultation on its early drug development with a vision for business expansion overseas.

The “SAS Macro”

The clinical team of pharmacokinetic (PK)/ pharmacodynamic (PD) data analysts and consultants at Venn Life Sciences performed the non-compartmental analysis (NCA) required for regulatory submission in an oncology trial involving a uniquely designed antibody as part of a combination therapy.

Seamless Solution - Technical Due Diligence Follow-up Consultation

Technical due diligence (or gap analysis) of a drug product is essential to identify direct risks and any bottlenecks that are not immediately obvious to investors. When you decide to invest in a product, management of the identified risks will be crucial for the success...

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