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Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD

Alta Sciences

Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. I have spent the better part of my career working to make drugs safer. About the Author Beatrice Setnik, PhD, Chief Scientific Officer.

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Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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How nucleolar stress accelerates aging in mice

Drug Target Review

In 2005, he joined CNIO to lead the Genomic Instability Group where he has been ever since. Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects.

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes

The Pharma Data

The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools. The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design.

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PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

FDA Law Blog: Drug Discovery

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”).

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Altasciences’ Chief Scientific Officer Named a PharmaVoice 100 Honoree

Alta Sciences

Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinical drug development, with a focus on abuse potential studies. Since 2005, the PharmaVoice 100 has become one of the publication’s most anticipated features.

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Algae: a source for prebiotics and drugs to treat IBD

Drug Target Review

9 Academic scientists researching natural products often struggle with the pitfalls of drug development. Her lab applies bio-active metabolites as immune system regulators to prevent and treat diseases, and develops novel platforms to treat unmet diseases such as IBD. 7 (Suppl 2), S4 (2005). References: Linschoten et al.

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