Research and Development Strategies
FDA-approval process and the drug-commercialisation process. In order to fully benefit from this investment, the marketing of these products should focus on the natural derivative of the drug. Physicians are looking for such treatments, both for their patients and for themselves, and are genuinely interested in finding and prescribing products in which they are confident of the purity, content and efficacy. The omega-3-acid ethyl esters fish oil product, Lovaza®, provides an example of the rapid change in prescribing habits that can occur when an NHP that was previously only available as a dietary supplement becomes available as a prescription drug.
Those pharmaceutical companies that now begin the process of identifying and developing NHPs into BDs will be at the forefront of the convergence of the consumer and physician demographic and psychographic shifts that are driving the demand for these high-quality naturally derived products. n
1.
Chen ST, et al., New therapies from old medicines. Nature Biotechnology, 2008;26(10):1077–83.
2. Guidance for Industry. Botanical Drug Products. FDA
Jay Udani is the Founder and chief executive officer of Medicus Research, the premier clinical research organisation for the natural health product industries, including botanical drugs, dietary supplements and functional foods. He is a board-certified internist who served as Chief Resident at Cedars-Sinai Medical Center in Beverly Hills, before completing two fellowships in Health Services Research and Integrative Medicine at Cedars-Sinai/UCLA. Dr Udani is the Medical Director of the
Northridge Hospital Integrative Medicine Program, where he successfully incorporated evidence-based alternative medicine treatments into his private practice and into hospital service lines including oncology, cardiology and gastroenterology. He is also on the clinical faculty of the UCLA School of Medicine and was one of the first physicians to become a Certified Principal Investigator (CPI) through the Academy of Pharmaceutical Physicians and Investigators/Association of Clinical Research Professionals (APPI/ACRP). He is the recipient of many prestigious awards, including the 2008 Natural Products Association Clinician of the Year, the AMA National Achievement Award and the Harvard Medical School Pinkney Fellowship in Orthopaedic Research. He was also voted Best Physician Specialist and Best Medical Speaker in Los Angeles by the Daily News.
http://www.fda.gov/cder/guidance/index.htm
3. Peine IC, Upgrading the dietary supplement manufacturing process to meet drug GMPs. Presented at
DIA Annual Meeting, June 15, 2010.
4. Christensen CM, The Innovators Dilemma, New York: Harpers Collins Publishers, 2000.
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