SUMMARY: Deep background in phase 1 through 4 clinical, nonclinical, and regulatory medical writing and drug, biologic, combination, and medical device product development, with numerous publications in the medical literature—a rare combination of medical writing expertise, analytical skills, management experience, and medical knowledge.

WRITING EXPERIENCE: Write and edit ICH-compliant US and international regulatory submissions (12 eCTDs, including numerous NDAs, sNDAs, BLAs, sBLAs, INDs, 1 PMA, 4 combination drug/device submissions, and 1 CTA to China); clinical study protocols (all phases) and amendments;…

Contract medical writer with experience in 15 product launches and co-author of 26 peer reviewed articles. His therapeutic experience includes oncology, neurology and infectious diseases. He holds a PhD in Clinical Psychology and Neuroscience with a Masters in Communication.

Extensive medical, pharmaceutical writing, CME, sales training, promotional, regulatory, blended learning systems, and publications planning experience Direct participation in 15 major product launches Comprehensive regulatory/medical affairs background Development &  “guest” writing of 26 peer-reviewed journal articles Direct liaison with client product…

Zenaida is a professional with more than 35 years of regulatory and compliance experience.  She works with start-up and virtual firms that are in drug discovery and developing bio-molecular and new gene therapies and undergoing clinical trials. She also works with non-clinical academic institutions (current project as Head of QAU -San Diego) that need to ensure GLP (21 CFR part 58) and GCP (21 CFR part 312) systems are established, or developed and followed. She’s experienced at auditing multiple…

CURRICULM VITAE

 

GREGORY K. PENNOCK, M.D.

 

 

DATE OF BIRTH:               25 January 1968

 

BIRTHPLACE:                    Reading, Pennsylvania

 

HOME ADDRESS:              2110 San Oak Hammock Drive

                                                Ponte Vedra Beach, Florida 32082

 

HOME PHONE:                   (904) 395-3099

 

 

Project Manager with 30 years of experience in clinical research having started as a CRA. Experience includes time at Allergan, Baxter and Edwards. Therapeutic areas include oncology, ophthalmology, orphan and rare disease, CNS, cardiovascular, hemophilia, infectious diseases, neurological and gastrointestinal. She has completed PMI training and has planned, recruited, and budgeted global research projects.  She holds a BS in Business and an Associates in Respiratory Therapy.

Sandi is a results-oriented research professional with extensive experience in planning, negotiating, and managing…

Biostatistician in private practice statistical consultantcy based in Southern California. Elaine has over 20 years of experience in study design and data analysis for clinical studies, biotech research, and health care research for companies  ranging in size from governmental agencies and corporations, to CRO’s, start-up companies, and individual researchers.

Elaine works well with project teams. She has published work with researchers and colleagues in peer-reviewed journals. Elaine is also experience in addressing study methodology and data analysis questions/concerns with the FDA,…

Senior Clinical Research Professional with extensive experience in Clinical Trials Monitoring and Management.  Highly regarded for insightful and analytical approach to solving problems. Passionate about making a difference. Experience includes:

·       In-depth knowledge of clinical study process, FDA regulations and ICH GCP 

·       Electronic data capture systems such as InForm, Medidata RAVETM and DataFax

·        Interactive Randomization technology such…

Dr. Hamrell has over 35 years of experience including time with FDA, NIH and private sector.  He’s conducted numerous audits of specialty laboratories, nonclinical testing facilities, large clinical laboratories and study specific testing procedures. He set up multiple Regulatory Affairs departments, developed regulatory plans, performed GCP, GMP and GLP audits, and managed the preparation of marketing applications for both domestic and international regulatory agencies. He prepared submissions for drugs, biologics and medical device products. He is RAC certified and holds a…

Dr Kirakosian is a Contract CRA/Medical Monitor/Drug Safety/GCP Auditor with 25 years of experience in clinical research. Monitoring experience includes oncology, dermatology, neurology, infectious and metabolic diseases. She holds a foreign Medical Doctorate in internal medicine with additional training in GCP auditing, field monitoring and safety monitoring.

Independent Monitoring Specifics 1998 – Present: Dermatology – atopic dermatitis (assessment scales of mild eczema, VAS of pruritis, SCORAD, EASI, TE water loss measurements at selected sites), acne, rosacea, scalp psoriasis 4 years…

Business Developer with experience in IP, R&D strategy, FDA submissions and data analysis. Holds a BS in Economics and MS in Nutritional Science and is a military veteran.

PROFESSIONAL EXPERIENCE

Microbiome Therapeutic Regulatory Project Management

• Designed microbiome analysis plan for FDA regulatory submission & implemented clinical tracking reporting in collaboration with CRO to monitor critical patient information for FDA Phase 2b/3 clinical trial in 377 patients