Derrick McKinley

About Derrick McKinley

At the helm of CureEon\'s pharmacovigilance and clinical research divisions, my leadership…

Experience

1. Pharmacovigilance and Clinical Research Physician

   Cureeon

   Sep 2003 — Present · Raleigh-Durham, NC, US

   CureEon is a clinical contracting company providing the pharmaceutical, biotechnology, and medical device industries with service offerings primarily in clinical research, drug safety (pharmacovigilance), risk management. Clients include Pfizer, Theravance, Intellia Therapeutics, Genentech, Biocryst Pharmaceuticals, J&J (Therakos), Biogen, AstraZeneca, NIH, BMS, Miragen, Berlex, Amgen, Bayer, UCB, Arcturus, Ionis, Akcea, Berlex, Cobe, Shire, Celgene, Baxter, Terumo, ONO Pharmaceuticals, Astellas, Biovail, Celltech, Hospira, Novartis, InterMune, and Abbot Labs. Therapeutic areas include oncology/immuno-oncology (both solid tumor and hematologic malignancies), CNS (Parkinson’s disease, epilepsy, multiple sclerosis, depression, ADHD, dementia, nerve agent antidotes, etc.), hematology (anemia, thrombocytopenia, etc.), gene therapy (multiple rare diseases), autoimmune disorders (amyloidosis, UC, Crohn’s disease, IBD, angioedema, RA, GvHD, psoriasis, etc.), cardiovascular (hypertension, MI, stroke, etc.), pulmonary medicine (high frequency ventilation, IPP, etc.), ID (COVID-19, hepatitis, fungal, HIV, etc.), vaccines (including COVID-19, pneumococcal conjugate and oncology vaccines), pain management (including Schedule I through Schedule V), metabolic disorders, musculoskeletal (including osteoporosis, wound healing, tissue transplantation), renal medicine and endocrinology. The organization has authored or reviewed and approved of individual case reports, over 250 aggregate reports, numerous Health Authority responses, signal detection assessments, benefit risk assessments, RMPs and REMS. We have successfully led several US, EU, and ROW regulatory submissions and corresponding inspections including over 25 successful IND, NDA, IDE, PMA, 510K and BLA submissions and registrations in the US. We have also worked on several international submissions involving the EMA, Japanese Ministry of Health and Welfare, Health Canada, TGA, etc.

Skills

• Pharmacovigilance
• Product Lifecycle Management
• Clinical Trials
• Clinical Development
• Biotechnology
• Risk Management
• Pharmaceutical Industry
• Clinical Research
• CRO