Experts in Pharmaceutical

Top 7 experts
Steve Jolley
Steve Jolley

Mendham, NJ | Drug Safety and Pharmacovigilance Consulting: Auditing, Signaling, Training

I provide expert safety consulting to the pharmaceutical industry, specializing in pharmacovigilance auditing and signal detection. I have 28 years’ experience in drug safety & pharmacovigilance and have worked with clients in the US, Europe, Japan, India and China. I have led over 100 drug safety and pharmacovigilance audits and risk assessments of companies, business partners, and contract research/safety organizations, typically followed by remediation efforts. I am member of DIA’s training faculty and instructor for DIA’s Clinical Safety and Pharmacovigilance Certificate Program. In... Read more

Osama Ibrahim
Osama Ibrahim

Gurnee, IL | Consultant Biotechnology

Dr. Osama Ibrahim is a highly-experienced Principal Research Scientist with particular expertise in the field of microbiology, molecular biology, food safety, and bioprocessing for both pharmaceutical and food ingredients. He is knowledgeable in microbial screening /culture improvement; molecular biology and fermentation research for antibiotics, enzymes, therapeutic proteins, organic acids and food flavors, biochemistry for metabolic pathways , enzymes kinetics, enzymes immobilization, bioconversion, and analytical biochemistry. Dr. Ibrahim was external research liaison for... Read more

Anastassios Retzios
Anastassios Retzios

San Ramon, CA | President, Bay Clinical R&D Services, LLC

- Broad experience in drug and biologics clinical development clinical development in a variety of therapeutic areas - Development of clinical and regulatory strategy - Management of clinical studies in all phases of development - Strategic Project Management and Portfolio Review - Authoring and compiling protocols and NDAs - Communications with regulatory agencies (FDA, EMEA, Ministry of Health- Japan, Health Canada, etc) - Management of large clinical R&D teams - Due diligence for product purchase or inlicensing Specialties Clinical Development Strategy Communications with... Read more

James McArdle
James McArdle

Carlsbad, CA | CMC consulting for the pharmaceutical industry

I offer consulting in pharmaceutical development in the area of chemistry, manufacturing, and control for both small molecules and synthetic oligonucleotides from pre-clinical stages through launch. I provide guidance on regulatory strategy, regulatory documentation, technology transfer, analytical development, stability, drug substance synthesis and scale-up, stability of drug substance and drug product, and sourcing key starting materials and GMP CMOs. I have extensive experience on ICH Expert Working Groups, including serving as Topic Leader for Q3C, Residual Solvents; Deputy Topic... Read more

John Greenbaum
John Greenbaum

Orlando, FL | Owner, GDCI Consulting, Inc.

18 years of successful Regulatory Consulting and operating a Clinical Research Organization. Hundreds of therapeutic and diagnostic products have been brought to market with our help. We have substantial experience with regulators in multiple disciplines and generally good relationships with them. We work with virtually all branches and divisions of the US FDA. In Clinical Research we have ongoing trials at 11 institutions and support numerous others with clients research and clinical teams. Specialties: Regulatory Strategy, Regulatory Submissions, Regulatory approvals, Clinical... Read more

Mary Corkins
Mary Corkins

Libertyville, IL | Senior Healthcare Reimbursement Executive

Medical Device / Biologics Product Reimbursement Over twenty years of experience managing reimbursement activities on a local, regional and national level with a focus on increasing sales and product adoption through effective product launch strategies, marketing and reimbursement program management. Track record of rapid goal attainment and results delivery with each client. Tactical, strategic, and analytical project methodologies with in-depth understanding of hospital finances and the revenue cycle. MBA degree, certification in medical coding and auditing. > Experienced from all... Read more

John Bloom
John Bloom

Indianapolis, IN | President, Bloom Consulting Services and Consultant, Office of the Center Director, FDA

John C. Bloom holds a B.S. degree in biology from the Univ of Pittsburgh and doctorates in veterinary medicine and hematology/oncology from the Univ of Pennsylvania. He completed his postdoc training at Jefferson Medical College in hematology/oncology and served on the Faculty of the Univ of Pennsylvania School of Veterinary Medicine as Chief, Clinical Laboratory Medicine, before joining Smith Kline & French Labs as Assoc Dir of Pathology. He later joined Lilly Research Laboratories as Head, Clinical Pathology, in the Toxicology Division, and subsequently moved to the Medical Division,... Read more