Newsletter | September 26, 2024

09.26.24 -- FDA Finalizes Guidance On Dose Optimization For Oncology Therapies

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REGULATORY & COMPLIANCE

FDA Finalizes Guidance On Dose Optimization For Oncology Therapies

The FDA recently finalized its guidance on "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" — with a few notable updates since its draft.

How, Why, And When To Apply For An Orphan Drug Application

Gain access to strategic insights for clinical trial sponsors on targeting an orphan drug designation and the logistical considerations involved in pursuing this path from the outset.

The Impact Of sIRB Mandates On Study Teams

Explore the practical implications faced by investigators and their support staff, such as navigating new bureaucratic procedures and adhering to revised regulatory requirements.

Local Affiliate Product Services

Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies.

OUTSOURCING MODELS

Clinical Development Negotiation: How Can A Notebook, Chronodex, And Compendium Help Enhance Partnerships?

What can three tools — a notebook, a chronodex, and a compendium — teach clinical research professionals about successful negotiation and collaboration? RHIEOS-Ventures and Dealligence's Larry Ajuwon explains.

A Deeper Dive On Mitigating Financial Risk Before Selecting A Vendor

In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, which could jeopardize the success of a clinical trial.

Analytical Method Development In A High Potent Facility

Leveraging a CDMO to oversee all aspects of analytical method development is crucial for achieving speed in clinical trials, regulatory approval, and commercial launch.

Meeting 100% Recruitment 7 Months Ahead Of Schedule

Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.

Ensuring Effective Pharmacovigilance Regulatory Intelligence

Discover the key PV RI capabilities that pharma, biotech, and medical device companies are adopting to ensure comprehensive and cost-effective strategies.

Flow Cytometry And PBMC Isolation

Altasciences’ clinical facilities are integrated with state-of-the-art flow cytometry laboratories. We are equipped with advanced platforms and staffed by a dedicated team of in-house experts.

Functional Service Provider (FSP) Value Proposition

Partner with us to co-create strategies and achieve operational excellence with our FSP capabilities, providing value as an extension of your team to advance your development programs.

EVENTS

DIA/FDA Oligonucleotide-based Therapeutics Conference

Date: Oct. 28-30, 2024 | Location: Washington, D.C.
The DIA/FDA Oligonucleotide-Based Therapeutics Conference brings together leading experts to inform, educate, and share advancements in oligonucleotide-based therapeutic product development. Developed collaboratively by regulators, industry professionals, and academics, the program covers a wide range of topics from the nonclinical, CMC, and clinical areas. The conference offers a unique experience with multiple perspectives presented, and the opportunity to interface with regulators from around the globe. Learn more.

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