Member of Adelphi University’s Profiles in Success program.
Founder, President and CEO, Research Dynamics Consulting
Adelphi memory: “Working on my master’s thesis on the brain chemistry of mice with professor Harold Grob.”
Best Professional Moment: Receiving the Realizing Business Potential Award from Ernst & Young’s Entrepreneur of the Year Program in 2004.
Advice to students: ”It’s amazing how you just live your life and when you think back on it, you think…wow, I did that. Following my passion always provided a way to achieve my goals and got me through the difficult times.”
Lorraine Ellis, M.S. ’80 has a habit of seizing opportunities in her own unique way.
After college graduation, Ms. Ellis moved to Germany and spent two years teaching at an American school in Regensburg. She also instructed soldiers who were preparing for their GED diplomas.
A few years later, when she found herself commuting to Adelphi from Westchester County, New York, she convinced her professors that she could perform research and experiments in the labs at Revlon Health Care, where she worked.
Later, when she saw how many small pharmaceutical companies struggle to navigate the FDA’s clinical trials procedures, she founded her own company to bring more new drugs to the market.
“Only 1 in 10,000 new drugs make it from the research lab to the pharmacy,” says Ms. Ellis. “That’s where the excitement lies for me, bringing new drugs from concept to reality.”
Ms. Ellis’ firm, Research Dynamics Consulting, specializes in helping research teams and small pharmaceutical and biotech companies navigate the complexities of clinical testing and business procedures.
“New drugs are often discovered by scientists and researchers who struggle to meet the FDA’s strict operating guidelines for clinical testing. That’s where we come in,” she says.
With years of experience in critical care, and specialty fields including cancer, AIDS, and hepatitis medications, her firm oversees everything from protocol preparation to data collection and analysis. Her employees serve as trainers, consultants and field monitors, who can be a resource for the pharmaceutical or biotech company, university research scientists, and the doctors participating in the clinical study (clinical investigators).
One of her greatest triumphs has been contributing to the implementation of electronic data management (EDC).
“The pharmaceutical industry has been slow to change,” she says. “I knew we needed to develop partnerships with companies specializing in internet data collection and other cutting-edge technologies.”
“Capturing the study data through the internet in real time helps our field monitors to be knowledgeable of the data being generated as it happens. Real time data allow for better and more informed project decisions for faster development and FDA approval”
EDC technology allows Ms. Ellis to review data from around the country from her headquarters in Rochester, New York. For field visits, she complements her 15 permanent employees with a network of experienced clinical research professionals to monitor clinical investigator clinics throughout the country. Their projects can last from four months to four years; and they typically work with five to ten new drug products each year.
Prior to founding her own company, Ms. Ellis was a clinical research associate with Fisons Pharmaceuticals, and was the Director of Clinical Operations for the company when it purchased Pennwalt Corporation in 1988.
In 1993, she received her M.B.A. from the Rochester Institute of Technology, and founded Research Dynamics. “After years in and around the labs, I found that I was increasingly drawn to the business side of science,” she says.
Her company has been listed as a Rochester Top 100 company for three consecutive years. Ms. Ellis has also been honored by Ernst & Young’s New York Entrepreneur of the Year program.
Ms. Ellis lives in Pittsford, New York with her husband Marty and their daughters Mandy and Kristi. When she’s not taking care of her company or her family, she escapes to a sailboat on Lake Ontario. She is a volunteer with the Association of Clinical Research Professionals and is a member of the Women President’s Association.