About Us
"We are clinical pharmacologists and drug developers with innate ability to aid in solving drug development challenges and developing straight forward strategies for successful therapies."

Dr. Sanela Bilic is a pharmaceutical executive and clinical pharmacology leader with over 20 years of global experience in strategic drug development. She has an exceptional track record of leading multidisciplinary teams and advancing innovative therapies across the full drug development continuum, from target identification and translational research through IND-enabling activities, first-in-human studies, dose optimization, and late-stage clinical development. Her expertise spans small molecules, biologics, antibody-drug conjugates (ADCs), cell therapies, and immuno-oncology.
Dr. Bilic is recognized for integrating scientific excellence with strategic leadership to accelerate development programs and optimize clinical development pathways. She has extensive experience designing clinical pharmacology strategies, implementing model-informed drug development approaches, and advancing dose optimization initiatives aligned with the FDA’s Project Optimus. She has successfully led the clinical pharmacology strategy for more than 120 development programs and has extensive experience interacting with major global regulatory authorities, including the FDA, EMA, PMDA, MHRA, Health Canada, and NMPA.
After earning her Doctor of Pharmacy and MBA from Drake University, Dr. Bilic completed a prestigious two-year Drug Development Fellowship through the University at Buffalo (SUNY) and Novartis Oncology. She began her career in Oncology Clinical Pharmacology at Novartis, where she spent 13 years leading clinical pharmacology strategy across multiple development programs and serving as the clinical pharmacology lead for numerous global regulatory interactions. She subsequently joined D3 Medicine (now Certara) as Senior Director of Clinical Pharmacology, where she partnered with biotechnology and pharmaceutical companies worldwide to develop integrated clinical pharmacology and translational strategies, support regulatory submissions, and lead clinical pharmacology due diligence for business development opportunities.
Throughout her career, Dr. Bilic has served as a strategic leader bridging research, early development, and late-stage clinical development. Her combination of scientific expertise, regulatory insight, and business acumen has made her a trusted advisor to executive leadership teams advancing transformative therapies for patients worldwide.
Our Drug Development Experience

Preclinical Development
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Clinical Development
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Immuno-oncology Development & Strategy
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Clinical Pharmacology Strategy & Development
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FDA & Global Regulatory
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Strategic Due Diligence
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Pharmacometrics
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Pharmacokinetics
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Project Optimus Services
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Model Informed Drug Development
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