“FOUNDED WITH A COMMITMENT TO EXCELLENCE AND A DEEP UNDERSTANDING OF THE PHARMACEUTICAL, BIOTECH, AND MEDICAL DEVICE INDUSTRIES, CUREEON IS YOUR TRUSTED PARTNER FOR MEDICAL AND CLINICAL SUPPORT IN THE AREAS OF PHARMACOVIGILANCE / RISK MANAGEMENT AND CLINICAL RESEARCH.”
OUR MISSION:
At CureEon, our mission is to deliver exceptional services that help our clients thrive in the highly regulated and dynamic landscape of the pharmaceutical industry. We are dedicated to providing the highest level of medical expertise in the areas of clinical research, pharmacovigilance and risk management, ensuring that our clients achieve their goals efficiently and effectively.
OUR VISION:
CureEon's vision is to be the preferred partner for pharmaceutical, biotech, and medical device companies seeking expert support in clinical research, pharmacovigilance and risk management. We aim to set the industry standard for excellence and innovation in these critical areas.
/WHO WE ARE
FOUNDER: DERRICK MCKINLEY, MD, MBA, PE
Pharmacovigilance and Clinical Research Physician
Dr. McKinley is educated as an engineer (Chemical and Biomedical / Carnegie Mellon and Harvard Universities) and physician (Washington University School of Medicine). He is an industry thought leader in the areas of clinical research, pharmacovigilance and risk management and has been providing leadership in these areas for more than 25 years for both investigational and marketed drugs and medical devices.
Dr. McKinley has overseen the medical and safety aspects of clinical trials, Phases I through IV. Dr. McKinley has monitored clinical trials and/or provided pharmacovigilance and risk management services for Pfizer, Theravance, Genentech, Biocryst Pharmaceuticals, J&J (Therakos), Biogen, AstraZeneca, NIH, BMS, Miragen, Boston Scientific, Berlex, Amgen, Bayer, UCB, Arcturus, Ionis, Akcea, Cobe, Shire, Celgene, Baxter, Terumo, ONO Pharmaceuticals, Astellas, Biovail, Celltech, Hospira, Novartis, InterMune, and Abbott Labs.
Therapeutic areas include autoimmune disorders (amyloidosis, UC, Crohn's disease, IBD, angioedema, RA, GvHD, psoriasis, etc.), oncology/immuno oncology (both solid tumor and hematologic malignancies), CNS (Parkinson's disease, epilepsy, multiple sclerosis, anxiety, depression, ADHD, dementia, nerve agent antidotes, etc.), hematology (anemia, thrombocytopenia, etc.), gene therapy (multiple rare diseases), 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 drugs), metabolic disorders, musculoskeletal (including osteoporosis, wound healing, tissue transplantation), renal medicine and endocrinology.
During his career, Dr. McKinley has authored or reviewed and approved 1,000s of individual case reports, over 250 aggregate reports (PSRs, PSURs, DSURs, PBRERs, ASRs, IND annual reports, etc.) and numerous Health Authority responses, signal detection assessments, benefit risk assessments, RMPs and REMS. He has successfully led several US, EU, and ROW regulatory inspections. Dr. McKinley has been directly or indirectly involved in several drug and medical device approvals in addition to the over 25 successful IND, NDA, IDE, PMA, 510K and BLA submissions and registrations supported in the US (including presentations at FDA Advisory Committees). Dr. McKinley has also worked on several international submissions involving the EMA, HMRA, Japanese Ministry of Health and Welfare (PMDA), Health Canada, TGA, etc. Dr. McKinley is a registered Responsible Person with the EMA.
