Alan Ryan

Clinical Research Consulting

West Palm Beach, FL

1

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About

Recognized scientist with over 150 articles and 40 years of experience in preclinical and clinical research, including protocol development, report writing, publications, and FDA submissions. As VP of Clinical Research , I developed the clinical research program for the omega-3 fatty acids DHA and EPA and for sodium fluoride. I managed bioavailability studies and Phase II studies. I developed and submitted a 505(b)(2) INDs. At Martek Biosciences, I was involved with developing and directing preclinical and clinical research to evaluate the effects of DHA on cognitive function and cardiovascular health. Before joining Martek, I was employed for 22 years at Abbott Laboratories. I was inducted into Abbott’s Volwiler Society in recognition for scientific excellence and leadership. I have published extensively on infant feeding practices, breastfeeding trends, childhood growth and development, body composition, cardiovascular disease, and omega-3 fatty acids. I managed the successful submission of two new drug applications (NDAs): one for Lovaza® (formerly Omacor®), an omega-3 fatty acid drug for the treatment of hypertriglyceridemia, and the second for NeoProfen®, an "orphan" IV drug for the treatment of patent ductus arteriosus in premature infants. I received my PhD from the University of Michigan, Ann Arbor. After serving 27 years in the U.S. Navy Reserves (Intelligence), I retired as a Commander. As a consultant, I have prepared protocols for Phase II and III trials, articles for publication, and regulatory materials for IRB approval including Type B meetings. I wrote protocols, articles and final reports for drugs and supplements for the treatment/management of cardiovascular disease, pain, CNS disorders, decline of cognitive function, kidney stones, and drug abuse. Specialties: Human nutrition, drug development, preclinical and clinical research, omega-3 fatty acids, pain management, GCPs, regulatory submissions.

Work experience
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Dec 2013 - Present

Clinical Research Consulting

President

Provide consulting services for all aspects of clinical and preclinical research including protocol development, CRO selection, IRB submissions, data interpretation, final study report writing, publications, orphan drug submissions, and FDA correspondence and submissions. Therapeutic areas: cardiovascular, pain, CNS, cognitive function, pediatrics, drug abuse, diabetes, kidney function, liver function (PSC, NASH) Areas of expertise: omega-3 fatty acids, nutrition, enteral and parenteral feeding, infant formulas, publication writing (sometimes ghost-writing), clinical site monitoring, regulatory submissions, drug development, Type B meetings with the FDA, preclinical studies Clients: Big pharmaceutical and start-up companies dealing with drug development, dietary supplements, OTC pain medications, drug abuse screening, 505(b)(2) applications, IRB approvals for clinical studies, protocol development, preclinical safety studies, and peer-reviewed publications. Clients include Abbott, Aurora, DSM, Vizuri Health, Thetis, BioProcess, Advanced Clinical Laboratory Solutions, Heliae Development, LLC, Evolva, Captozyme, MPM, Oxidien

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Sep 2012 - Dec 2013

Sancilio and Company, Inc.

VP, Clinical Research

* Head of preclinical and clinical research * Developed clinical research program for omega-3 fatty acids and sodium fluoride * Wrote protocols and managed two bioavailability studies and two Phase II studies * Wrote and submitted IND 505(b)(2) for a triglyceride-reducing omega-3 fatty acid drug

Jan 2006 - Aug 2012

Martek Biosciences Corporation, a Division of DSM

Executive Director, Clinical Research

* Head of all aspects of preclinical, clinical research, and drug development; supervise a team of 3 PhD, 2 CRAs, and lab personnel * Received Henry “Pete” Linsert, Jr. Innovation Award, DHA Improves Cognition, 2009 * Developed preclinical and clinical research program for MATK-90, a concentrated form of Docosahexaenoic acid (DHA) for triglyceride reduction and other indications * Developed advisory board meetings to identify appropriate strategies for drug development * Organized two Type B meeting with the FDA; prepared pre-IND briefing packages * Managed and implemented several clinical trials to evaluate nutritional benefits of DHA in healthy children, children with medical conditions, and adults with memory impairment * Designed and supervised preclinical program for new strains of DHA

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1982 - 2010

US Navy

Commander

Naval Intelligence

Jan 2000 - Dec 2005

Abbott Laboratories

Volwiler Associate Research Fellow, Pharmaceutical R&D

* Managed NDA submission for drug to treat patent ductus arteriosus in premature infants. NDA submitted September 2005; NeoProfen® approved April 2006 * Managed NDA submission for hypertriglyceride-reducing medication to prevent atherosclerosis. Submitted to FDA January 2004; Omacor® (Lovaza®) approved November 2004 * Wrote ISE, ISS, and package inserts for Omacor® and NeoProfen® * Developed budgetary and manpower requirements for FDA submission * Negotiated contract with CROs and held CROs accountable for achieving milestones * Managed Market Research to conduct focus groups and surveys for product launch

Jan 1999 - Jan 2000

Ross Products Division, Abbott Laboratories

Manager, Pediatric Sales Support

* Explained clinical data and market share information to sales force * Analyzed AC Nielsen and national survey data of infant formula products * Served as marketing research liaison to clinical R&D and sales force * Developed sales aids for sales force

Jan 1997 - Jan 1999

Ross Products Division, Abbott Laboratories

Senior Group Leader

* Served as QA liaison for multicenter infant formula clinical feeding trials * Organized SOP Committee, wrote SOPs, and served as SOP Chairperson * Supervised and managed a team of 15 Clinical Research Associates * Provided training to research unit on SOP/GCP/ICH procedures * Published papers on breastfeeding trends, iron nutrition, and infant and childhood nutrition

Aug 1983 - Jan 1997

Ross Products Division, Abbott Laboratories

Group Leader

* Managed clinical monitoring teams for multicenter infant formula clinical feeding trials; over 65 trials conducted annually * Developed and conducted GCP and SOP training for Pediatric and Medical Departments * Responsible for site selection, monitor assignments, and contract negotiation * Managed activities of CROs during Phase III through Phase IV clinical trials

Jan 1991 - Jan 1994

Ross Products Division, Abbott Laboratories

Senior Clinical Research Associate

* Developed several infant formula study protocols for various products * Responsible for all day-to-day study activities for protocol and GCP compliance * Developed informed consent forms, CRFs, training materials, and other monitoring tools * Monitoring experience both domestic and international; monitored up to 15 sites concurrently

Jan 1986 - Jan 1991

Ross Products Division, Abbott Laboratories

Manager, Marketing Research Nutrition Services

* Designed and implemented annual national surveys of infant feeding practices to determine market share and identify potential marketing opportunities * Developed SAS programs to analyze infant feeding and growth data from large databases * Published results of surveys in peer-reviewed medical journals * Worked with academic investigators to evaluate infant and childhood growth data

Jan 1983 - Jan 1986

Ross Products Division, Abbott Laboratories

Marketing Research Associate

* Evaluated biochemical data from National Health and Nutrition Examination Surveys (NHANES I, II and III); resulting data were used in sales aids and for publications * Evaluated obesity data for the development of dietary programs (New Direction) * Trained team of nurses to collect anthropometric measurements of obese patients * Developed sales aids for several important pediatric products

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1976 - 1982

University of Michigan

Research Assistant

Studied the dental remains of Australopithecus afarensis (Lucy). Published findings with Dr. Donald Johanson (discoverer of Lucy). Taught: Introduction to Biological Anthropology, Introduction to Human Evolution, and Growth, Nutrition, and Health in the United States. Field work: Archeological Excavation, Flagstaff, AZ, 1974; Collecting Eocene Mammals, Badlands, WY, 1976; Museum Collections (Neanderthals, Homo erectus, Australopithecus, modern humans) in U.S., Hungary, Italy, France, Belgium, Croatia, Germany, UK, 1979-1980. Clinical studies in U.S., Europe, and South America, 1984 to present.

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