Senior Consultant

Debie Hoivik, PhD, DABT

A seasoned toxicologist and drug development leader with more than 25 years of experience in the pharmaceutical industry, she brings extensive expertise across nonclinical safety, early development, regulatory strategy, and global drug development. Her career includes senior leadership and scientific roles with Akebia Therapeutics, Boehringer Ingelheim, and GlaxoSmithKline.

Her experience spans the full drug development lifecycle, from discovery and candidate selection through clinical development, regulatory approval, and lifecycle management. She has supported programs across metabolic and renal diseases, antivirals, immunology, and inflammation, working with diverse modalities including small molecules, monoclonal antibodies, biosimilars, and oligonucleotides.

She has extensive experience developing toxicology and nonclinical safety strategies, interpreting complex study findings, conducting risk/benefit evaluations, and supporting due diligence and business development activities. Her regulatory experience includes INDs, CTAs, NDAs, MAAs, and BLAs, along with interactions with health authorities across major global regions.

In addition to her scientific expertise, she brings a strong strategic and operational perspective, having led multidisciplinary teams, global initiatives, external partnerships, and organizational change throughout her career