Newsletter | January 16, 2025

01.16.25 -- What Does The Data Science Industry Have To Say About The ICH M11 Guideline?

SPONSOR

Webinar: Balancing Innovation, Ethics, and Operational Excellence in Adaptive Oncology Trials

Clinical trials are evolving to incorporate adaptive designs, offering flexibility to refine protocols based on emerging data. Join us as leading experts in cancer research come together to discuss how to navigate the complexities of adaptive trials designs and how ethics reviews uphold patient safety, ensure informed consent, and provide robust oversight for evolving trial designs. Click here to learn more.

OUTSOURCING MODELS

Should You Choose An FSP Model? It Depends…

Small biotechs are often drawn to an FSP model because they believe it’s a less expensive option as compared to an FSO. But that’s not always the case, says Réne Stephens of Danforth Advisors, who gives some examples of what to consider before making your choice of outsourcing solution.

Essential Laboratory Services For Vaccine Trials

Testing vaccines is a rigorous but essential multi-stage process. From initial lab research to human trials and regulatory approval, discover how vaccines undergo scrutiny to protect public health.

Working With An In-Country Clinical Trial Depot

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Demystifying CGT Studies In Australia And The Broader APAC Region

Australia is home to qualified CRO partners that will guide your cell and gene (CGT) trial to regulatory success.

Integrated Programs To Bridge Molecules From Discovery Into Clinical Development

A new collaboration helps to remove obstacles from the critical path, reduce development risks, eliminate the white space in pre-clinical drug development, and shorten the pathway to clinical development.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Pursuing Breakthrough Therapies For Rare Metabolic Diseases

Explore how a comprehensive clinical trial team expertly coordinated the dosing administration and data review for gene therapy, ensuring meticulous management and streamlined processes.

SPONSOR

A Full-Service Solution Partner Disrupting the Outsourcing Paradigm

inSeption Group offers a full-service solution designed to disrupt the current outsourcing paradigm, resurrecting a common-sense approach to rebuild business trust and confidence in a client’s selected vendor. Primarily focused on oncology, hematology, neurodegenerative disorders, and rare/orphan disease indications, with a specialization in cell and gene therapy, inSeption has been a solution for its’ clients who have experienced the progressive degradation of today’s outsourcing options. Contact them.

REGULATORY

What Does The Data Science Industry Have To Say About The ICH M11 Guideline?

As the ICH M11 guideline nears approval, Hassan Khalid of AstraZenca and Jessica Jolly, a senior data and science executive, talk about how they feel about it and what they’ve been hearing from their peers in the data science industry.

2025 Safety And Regulatory Compliance Trends And Predictions

Explore the rapidly evolving regulatory landscape that pharmaceutical and biotech industries face as they integrate AI and advanced technologies into safety, compliance, and lifecycle management.

Why Regulatory CMC Strategy Is Crucial To Drug Development Projects

Our goal is to provide comprehensive Reg CMC strategic advising that not only aligns with regulatory expectations but also enhances the efficiency and success of your drug development efforts.

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