Lauren Mihalcik
- Role
- Senior Consultant at Aclairo Pharmaceutical Development Group, Inc
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Lauren Mihalcik
Board-certified toxicologist with 20 years of experience in nonclinical pharmacology and…
Experience
Senior Consultant
Aclairo Pharmaceutical Development Group, Inc
Oct 2020 — Present
Senior Consultant with >19 years of experience in industry and FDA. Expertise includes: • Nonclinical Drug Development Strategies • Oligonucleotide and Gene Therapy Development Strategies • Product Development Strategies for Chronic Indications • Biosimilar Development Strategies • Target Liability Assessments • Nonclinical Model Development • Toxicology Study Design and Interpretation • Cardiometabolic Toxicology • Hepatotoxicology • SEND • Development of Scientific Justifications for Waivers • FDA Meeting Preparation
Skills
- Pharmacology
- Pharmaceutical Industry
- Molecular Biology
- Clinical Development
- Toxicology
- In Vitro
- Drug Discovery
- Drug Development
- Biochemistry
- Biotechnology
- Glp
- In Vivo
- Fda
- Life Sciences
- Good Laboratory Practice (Glp)
- Animal Models
- Drug Safety
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