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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Researchers must characterize the anti-drug-antibody (ADA) response in preclinical and clinical studies and report any ADA-positive samples as a risk-based approach. Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S.

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Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Conversations in Drug Development Trends

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?

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PPD Early Development Services: Accelerating the Clinical Process

PPD

Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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The future of mental health treatment: Zelquistinel’s role

Drug Target Review

The drug’s pharmacokinetics (PK) and pharmacodynamics (PD) are closely linked. Donello was most recently Vice President of External Science & Innovation at Allergan/AbbVie, where he led R&D innovation efforts to develop strategic collaborations, in-license clinical-stage assets and evaluate M&A opportunities.

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Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

The Pharma Data

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021). Our Commitment to HIV.

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Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Research has shown that these immune system proteins have the ability to trigger anti-cancer immune pathways. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

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Women in STEM with Cristina de Min

Drug Target Review

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.