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Articles by Windrose Partners
Registered Dietitians in the Natural Products Industry: Friend or Foe?
At that time, the number of dietitians attending the expo and other industry-related conferences was nothing like it is today. When other PhD-RD colleagues from our company’s R&D department accompanied me, they often “tsked” with distaste when pursuing trade show booths exhibiting bold product claims that weren’t heavily supported with citations from the scientific literature.
‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics
Our first memory of the axiom “You are what you eat” arises from our college days in the early 1970s. The saying meant that people need to eat good food to be fit and healthy. When the term was used, we usually referred to macrobiotic, organic whole foods. We also recall that later the phrase was applied in sports nutrition and used to admonish bodybuilders and other athletes to eat the right combination and amounts of nutrients to build muscle and achieve training goals.
Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal
Aging is less about a number and more about the myriad of internal and environmental factors causing physical and anatomic changes that cause decline in function. Advances in science have identified some factors behind the aging process. These factors include exposure to cellular stress, chronic inflammation, dysregulation of lipid metabolism, and programmed cell death.
The Value of Clinical Evidence Supporting Nutraceuticals
By Greg Stephens, Windrose Partners, and David Wilson, MA01.26.22 In prior Business Insights columns we have offered insight on claims made for nutritional products, scientific support for product claims, and regulatory considerations for both the U.S. and internationally.
Healthcare Practitioner Channel Dynamics: A Thriving Market For Dietary Supplements
By Gregory Stephens, Windrose Partners09.09.21 Growth in this channel reflects the public’s strong desire for non-pharmaceutical, nutrition-based medical options; increased acceptance of supplements by conventionally trained physicians; and more practitioners seeking new revenue streams to help offset declining insurance reimbursement and other financial pressures.
The Off-Label On Ramp
By Gregory Stephens, Windrose Partners, and Sheila Campbell, PhD, RD01.19.21 It is important to understand that FDA regulates drug approval, not drug prescribing, and doctors are free to prescribe to patients drugs they feel are medically appropriate. Actually, the practice is legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies. A physician can, however, get into trouble if he or she falls below appropriate standards of care.
Going Global With Clinical Nutrition Products
Global markets present additional regulatory hurdles, but focusing on countries with more clearly defined requirements can help simplify the process. By Gregory Stephens, Windrose Partners06.02.21 Increasingly, manufacturers and marketers of nutritional formulations are looking beyond U.S. borders when developing new products. This expands market potential but at the same time presents new challenges.
Medically Necessary Foods: Pricing & Reimbursement Considerations
By Gregory Stephens, Windrose Partners04.08.21 An article in Nutrition in Clinical Practice provided a glimpse into early use of clinical nutritionals or medical foods (2006 Aug;21(4):411-5). When U.S. President James Garfield was shot in 1881 by Charles Guiteau, Garfield survived for 79 days. He was given rectal feedings of mixed whiskey and partially hydrolyzed beef and beef broth every four hours for most of that time.
Spotlight On Clinical Research In The COVID-19 Era
By Greg Stephens, Windrose Partners, & Sheila Campbell, PhD, RD09.08.20 And some products were marketed based solely on their “story.” For example, the ingredient was found in a remote region of the world being used by the indigenous people who lived into their 100s with no evidence of disease. Little or no scientific substantiation was given, or asked for. A good story is still important.
A Business Perspective On Protecting Confidential Information: The NDA
By Gregory Stephens, Windrose Partners11.09.20 Why should we care about what may be perceived as subtle details of a document we sign if it helps to expedite the process and brings parties together to clinch a business deal? It is a common practice in our industry for a party seeking to initiate business discussion to send another party a Non-Disclosure Agreement (NDA) also known as a Confidential Disclosure Agreement (CDA).
Protecting Your Investment: A Business Perspective For Intellectual Property
By Gregory Stephens, Windrose Partners06.02.20 In this issue, we focus on another element of intellectual property: patents. This is not a legal opinion for your intellectual property (IP) options, but rather a business perspective to aid in developing your IP strategy. The investment for bringing new nutritional ingredients and products to market is increasingly expensive. At Natural Products Expos 20 years ago, larger dietary supplement companies would launch a wide array of new products.
Pursuing Market Viability Assessments for Clinical Nutrition Products
By Gregory Stephens, Windrose Partners01.07.20 In the September 2019 Business Insights column (“Clinical Nutrition: A New Market Opportunity”) we discussed the category of “clinical nutrition” products, which are most often used in hospitals and skilled nursing facilities, collectively referred to as the healthcare institution market. Clinical nutrition products address specific patient medical needs or requirements, typically disease management or prevention.
Preparing for FDA’s New Era of Food Safety
By Gregory Stephens, Windrose Partners, & Sanford W. Bigelow, Vanguard Global Associates LLC06.03.19 In this month’s column Windrose Partners and Vanguard Global Associates take a practical look at the U.S. safety requirements for nutraceutical products, whether they are dietary supplements, conventional foods, foods for special dietary use (FSDU), or medical foods.
Developing Scientific Support for Product Claims
By Greg Stephens, Windrose Partners & Sanford W. Bigelow, PhD, DABT, Vanguard Global Associates LLC11.05.19 In recent Business Insights columns Windrose Partners and Vanguard Global Associates have provided an overview of the U.S. regulatory requirements for food (conventional food, foods for special dietary use (FSDU), and medical foods) and dietary supplement products, whether under development or already commercialized.
Clinical Nutrition: A New Market Opportunity
By Greg Stephens, Windrose Partners, & Sheila Campbell, PhD, RD09.09.19 Another categorization is based on product distribution. Distribution channels may include conventional food stores, natural product stores, healthcare practitioners, multi-level marketing, catalogue, and e-commerce. Other product segmentations include benefit/indication (e.g., glycemic control, sports nutrition), consumer demographics (e.g., millennials, boomers) and at times, product forms.
Emerging Regulatory Pathways for Nutraceuticals
By Gregory Stephens, Windrose Partners & Sanford Bigelow, PhD, DABT, Vanguard Global Associates LLC04.01.19 In this column, Windrose Partners LLC and Vanguard Global Associates LLC provide an overview of regulatory considerations for taking new products to market. More specifically, our goal herein is to provide product formulators and marketing personnel with a brief roadmap toward development of commercially viable products while achieving regulatory acceptance in the marketplace.
Safeguarding Your Intellectual Property for Nutraceuticals
When considering intellectual property (IP), patents often come to mind first. Certainly, they are important components of IP; however, there’s more. IP also includes trademarks, copyrights, and trade secrets. People often confuse patents and trademarks. Even though they are both intellectual property rights and have some similarities, they are very different.
Taking the Mystery Out of Medical Foods
The medical foods market has grown to a multi-billion-dollar business and continues to expand in the U.S. and around the world. Globally, the market was valued at $12.3 billion in 2015 and is expected to grow at compound annual rate (CAGR) of 6.9% to 24.4 billion by 2025.Conditions associated with aging, Alzheimer’s disease, and diabetes, to name a few, are fueling growth.
Expect Changes For The Nutraceutical Industry In The Year Ahead
It’s that time when we are finalizing our business plan for the year. As a “boutique” consulting firm, our assessment includes a review of project activity over the past few years. How has it changed? What is constant, and what are the new opportunities we hope to pursue?
Unfolding The Interrelationship Between GI Health & Immunity
It has been estimated that the human body is 90% bacteria. So, for every cell in your body, you have nine cells of bacteria living in and on your body. Most of these bacteria are in the GI tract. Not surprisingly, the health of the GI tract is paramount to health of the body overall. Thus, the health of the gastrointestinal system and the health of the immune system are vitally linked. When gut bacteria are balanced, the immune system is also balanced.
Grow Your Nutritional Business Through Effective Market Research
Most of us likely have vivid memories of market research studies that may not have turned out as planned. A number of memorable experiences come from focus groups.In one study, surgeons told us in no uncertain terms that they (fixers of life) did not cause the problem (post-op reperfusion injury) for which we designed a nutritional prevention. Thus, why were we talking to them?
Challenges For Nutritional Products In Healthcare Facilities
Demand for nutritional products in healthcare facilities continues to grow rapidly. A key driver has been the increasing quality of clinical and cost-benefit research on nutritional interventions. More companies are also acquiring the know-how to penetrate this unique segment.Marketing to healthcare institutions differs quite significantly from non-institutional markets (e.g., natural products, FDMC, direct-to-consumer, etc.).
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