Amelia Wall Warner
Entrepreneur and Pharmaceutical Executive
- Role
- Member Board of Directors at Catalyst Clinical Research
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Amelia Wall Warner
Amelia Warner is a dynamic entrepreneur known for innovative and highly productive team leadership. She has led diverse teams across her career, including leading/founding companies in the Life Sciences space successfully to transaction, leading Top 10 Pharmaceutical teams in Translational Science, and leading academic programs in Translational Science.Amelia is the CEO and founder of Clinical Trial Concepts, Inc, an novel informatics company focused on tools to revolutionize the clinical trial industry. She is the former Board Chair, Founder and CEO of Global Specimen Solutions, Inc.(GSS)- an innovative company that offers new-to-market informatics solutions and CRO services for translational medicine and human specimen research. In 2017, Amelia won leadership awards for Women in Business and CRO of the year for her role at GSS. In two and a half years, this company created a new CRO market space, successfully built Top Pharma clientele, and sold to a public company in December 2017.Before GSS, she joined Gentris Corporation as CEO and President and a Director on the Gentris Board of Directors in 2013 and built the financial and operational infrastructure for corporate turnaround leading to a successful sale of the company to a public company in 2014. Amelia has over 15 years experience building and incorporating personalized medicine strategies for clinical pharmacogenomic research. Amelia conceptualized and built biorepository programs from the ground up at Children\'s Hospital of Philadelphia, Schering-Plough, and Merck. Customizing programmatic needs from academic programs to pharmaceutical company needs, She leads international teams focused on optimizing genetic sample collection, data generation, and data transfer globally and continues to work on international policy for both genetic specimens and human specimen research. She was a PhRMA representative to ICH E16 for Genomic Biomarker Data Submissions and is Past Chair of the I-PWG.
Experience
Member Board of Directors
Mar 2019 — Present
Education
St Jude Childrens Research Hospital
Residency and Fellowship, Pediatric Oncology Pharmacotherapy and Pharmacogenomics Research
1998 — 2001
Wake Forest University
Bachelor of Science (BS), Biology, General
1991 — 1995
The University of North Carolina at Chapel Hill
PharmD, Pharmacy
1994 — 1998
Skills
- CRO
- Oncology
- Protocol
- Biobanking
- Medical Writing
- Human Specimen Research
- Translational Research
- Biomarkers
- Therapeutic Areas
- Pharmacology
- Bioinformatics
- Ctms
- Mergers & Acquisitions
- Personalized Medicine
- Life Sciences
- Pharmaceutical Industry
- Sop
- Pharmacogenomics
- Genomics
- In Vitro
- Clinical Research
- Clinical Pharmacology
- Vaccines
- Molecular Biology
- Regulatory Affairs
- Lifesciences
- Pharmacodynamics
- Genetics
- Regulatory Submissions
- Glp
- Clinical
- Informed Consent
- Strategic Planning
- Clinical Development
- Neuroscience
- Immunology
- Assay Development
- Medical Affairs
- Translational Medicine
- Drug Development
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