Insights

Rethinking Clinical Trials for Pregnant and Breastfeeding Patients

August 5, 2026

Pregnant and breastfeeding individuals have long been excluded from clinical drug development, leaving physicians and patients to make critical treatment decisions with limited human data. In this timely article, Nonclinical Considerations for Support of Pregnancy and Lactation in Clinical Trials, an international team of experts (including Aclairo’s Ron Wange) explores how drug development can move beyond routine exclusion and toward the safe, ethical inclusion of these underserved populations. The authors examine how current developmental and

Congratulations to Lauren Mihalcik on Election to the ACT Council

October 1, 2026

Please join us in congratulating Lauren Mihalcik, PhD, DABT on being elected to the Council of the American College of Toxicology (ACT). This distinguished achievement reflects the respect and confidence that colleagues across the toxicology community have in Lauren’s expertise, leadership, and commitment to advancing the science and practice of toxicology. Through this role, Lauren will help guide the strategic direction and continued success of ACT in promoting excellence in toxicological sciences. Aclairo is proud

Moving Beyond the NAMs vs. Animals Narrative in Pharmaceutical Development

September 14, 2026

As part of an effort to reframe the prevailing narrative of NAMs as a replacement for animals towards one of understanding the scientific utility (context of use) of both types of models, Dr. Wange joined an international team of regulators, former regulators, consultants, drug developers and NAMs developers in publishing a commentary in Regulatory Toxicology and Pharmacology entitled “Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in

ACT Signature Webinar (Delivered 9/2/2026)

September 14, 2026

Weight of Evidence Approaches for DART Assessments of Oligonucleotides: Current Reality and Future Considerations This presentation focuses on the regulatory expectations for the Developmental and Reproductive Toxicity (DART) assessment of oligonucleotide-based therapeutics (ONTs). The presentation provides a high-level introduction to ONTs, their structures and modes of action as well as the existing guidance related to the investigation of DART risk for these agents. While existing guidance primarily supports the use of WoE approaches when DART

ACT

September 14, 2026

Meet us in San Antonio – Nov 15-18, 2026 Learn more about ACT 2026: actox.org/am/am2026/

Safety considerations for cereblon-recruiting targeted protein degraders

August 24, 2026

Aclairo’s Ron Wange and the HESI Targeted Protein Degrader Safety Group recently published a review of key safety issues with cereblon-engaging TPDs. Off-target degradation poses a safety consideration for teratogenicity as well as for haematopoietic, gastrointestinal, central nervous, cardiovascular and reproductive system toxicity, so an early in vitro evaluation of likely off-target degradation is advisable. The free full-text link is here: https://rdcu.be/femcA

Advancing Treg Cell Therapy

May 25, 2026

Uyen Dinh, PhD and I were delighted to be asked to contribute to a special edition of Frontiers in Immunology on “Advancing Treg Cell Therapy”. We outline the key nonclinical considerations for opening an IND for Treg therapies. https://lnkd.in/eVyu-Nya

News & Events

Practical perspectives on scientific problem-solving.

Rethinking Clinical Trials for Pregnant and Breastfeeding Patients

Congratulations to Lauren Mihalcik on Election to the ACT Council

Moving Beyond the NAMs vs. Animals Narrative in Pharmaceutical Development

ACT Signature Webinar (Delivered 9/2/2026)

ACT

Safety considerations for cereblon-recruiting targeted protein degraders

Advancing Treg Cell Therapy

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