Richard Soltero, Ph.D.

Richard A. Soltero, Ph.D., is a pharmaceutical scientist, inventor, author, software entrepreneur, and recognized industry leader with over 50 years of experience in pharmaceutical research and development, biotechnology, analytical chemistry, GMP compliance, quality management systems, and pharmaceutical manufacturing. He has held senior leadership positions at Ciba-Geigy, now Novartis; Berlex Laboratories; Johnson & Johnson; SmithKline Beecham, now GSK; AAI; Magellan Laboratories; and Nobex Corporation.

Dr. Soltero led development programs that contributed to the commercialization of Regranex®, the first FDA-approved growth factor therapy for diabetic ulcers, and directed the oral insulin program at Nobex Corporation that resulted in a $283 million licensing agreement with GlaxoSmithKline. He is the founder of PharmaDirections and InstantGMP, where he pioneered cloud-based electronic batch record and quality management software for FDA-regulated manufacturers.

In addition to his scientific and entrepreneurial accomplishments, Dr. Soltero has been active in several leading professional and scientific organizations. He participated in the Eastern Analytical Association, where he organized and moderated multiple scientific symposia. He was also an official delegate to the United States Pharmacopeia, and held leadership roles within the American Association of Pharmaceutical Scientists, serving as Chair of both the Eastern Regional Division and the Southeast Regional Division.

Dr. Soltero is co-editor of the Wiley textbook Drug Delivery: Principles and Applications, inventor on more than 21 patents and patent applications related to drug delivery and pharmaceutical technologies, and has been cited more than 200 times in scientific and technical literature. His areas of expertise include pharmaceutical development, drug delivery systems, GMP compliance, quality management systems, electronic batch records, laboratory information management systems, analytical chemistry, and pharmaceutical manufacturing.

Selected Publications and Intellectual Property

Books

• Drug Delivery: Principles and Applications, John Wiley & Sons, 2005

Patent Families

• Pharmaceutical Compositions of Insulin Drug-Oligomer Conjugates and Methods of Treating Diseases Therewith
• Pharmaceutical Compositions of Calcitonin Drug-Oligomer Conjugates and Methods of Treating Diseases Therewith
• Methods of Synthesizing Insulin Polypeptide-Oligomer Conjugates

 

Professional Leadership and Scientific Organizations

• Eastern Analytical Association symposium organizer and moderator
• United States Pharmacopeia official delegate
• American Association of Pharmaceutical Scientists Eastern Regional Division Chair
• American Association of Pharmaceutical Scientists Southeast Regional Division Chair

Areas of Expertise

• Pharmaceutical Development
• Drug Delivery
• Oral Insulin
• Analytical Chemistry
• Pharmaceutical Manufacturing
• GMP Compliance
• FDA Compliance
• Quality Management Systems
• Electronic Batch Records
• Laboratory Information Management Systems
• Biotechnology Development
• Computer System Validation
• Pharmaceutical Quality Systems