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Read More - PLM Institute
STRATEGIC INFORMATION FOR THE NUTRITION INDUSTRY Volume XX | No. 4 | APRIL 2015 | Ingredient Innovation | newhope360.com/nbj | $199 The Personalized-Nutrition Boom Microbiome research, wearable fitness trackers, and at-home DNA tests usher in a new era by Lisa Marshall W hat does the future of person- puts it, “it’s not so simple.” Our resident might consider supplements. Meanwhile, alized medicine look like? Ask bacteria, bodily fluids, and easily trackable people with certain versions of the ACTN STRATEGIC INFORMATION FOR THE NUTRITION INDUSTRY Jeffrey Bland. He’s already living it. biometrics also provide key pieces of the gene respond better to endurance sports, Over the past year, the nutritional bio- picture needed to accurately customize our while those with others are better suited chemist and founder of the Personalized path to wellness. And thanks to an infusion for strength training. And where genome Lifestyle Medicine Institute has had his of investment and an explosion of research, mapping cost $300,000 just five years ago, consumers can now map their genomes entire genome sequenced once, his gut those fields are booming, too. bacteria assessed four times, and his The ultimate key, says Bland, will be to for $3,000 and get readings of smaller blood, spit, and urine scrutinized quar- bring all that information together swiftly chunks for just $100. What’s new: Unlike DTC-predecessors terly to measure everything from insulin and affordably in a form the average lay(which have mostly ceased to exist in the sensitivity and inflammation to food al- person can understand. That day may not wake of the Food and Drug Administration’s lergies and nutrient absorption. He tracks be so far off. 2013 request that 23andMe discontinue its his sleep habits, heart rate, and physical “We are already starting to see the interPersonal Genome Service) most companies activity via monitors around his wrist and section of genomics, phenotypic markers, today route their services through practichest. He analyzes and uploads the result- and wearable devices with the power of intioners. In 2014, New Orleans-based startup ing data points to his personal account on formatics and big data,” says Bland. “We are the cloud, which he frequently accesses to moving from the age of the average to the GenoVive began offering a gene-based weight-management system through phyanalyze changes to his diet, supplement age of the individual.” choices, and exercise habits. Here’s a look at what’s here, and what’s sicians. Patients have their saliva analyzed for 17 SNPs related to diet and exercise, and “I’ve learned a tremendous number of coming: an algorithm assigns them a daily calorie things about myself that I’ve already been count and one of four diets. They can even able to put into action,” says Bland, one of Gene sequencing 100 participants in the Hundred Person What it tells us: In recent years, the have their customized meals and suppleWellness Project, a pilot research study field of nutritional genomics has discov- ments delivered to their door daily. “Those who stick to the closed-loop system by the Seattle-based Institute for Systems ered hundreds of genes that influence the Biology (ISB). “It has been extraordinarily way we metabolize nutrients, perceive diet tend to lose more than those who do it empowering.” taste, regulate hunger, and respond to ex- on their own,” says founder Vic Castellon, Bland’s ultra-quantified year has no- ercise. “We have figured out that your diet who lost 85 pounds on the plan. Six-yeardoubt been an expensive one. (ISB report- and genes absolutely interact, helping to old Pathway Genomics offers 12 categories edly budgeted $10,000 per subject.) And he determine the best nutrients for you,” of genetic tests, via 20,000 practitioners. Its is quick to acknowledge that he, as a sci- says Michael Nova, M.D., PhD, chief inno- most popular tests, the Healthy Weight DNA entist, can interpret his data more readily vation officer for San Diego-based genetic Insight test and Pathway Fit test—a favorite than the average Joe could. But his experi- testing company Pathway Genomics. For among athletes—explore about 80 genes. ence says a lot about how far the person- instance, the APOA, PPARG and FABP With $14.4 million in revenue in 2013, $80 alized nutrition/wellness movement has genes all influence fat burning and stor- million from investors, and a three-yearcome—and where it’s headed. Twelve years age. Depending on which variants—or growth rate of 2,416 percent, Pathway was after the completion of the Human Genome single nucleotide polymorphism (SNPs)— recently named No. 173 on Inc. 500’s list of Project prompted a flurry of direct-to-con- you have, you may be better suited for a fastest-growing private companies. What’s coming: In September, with sumer DNA tests and “you have this gene higher-fat or low-fat diet. Some variants funding from the IBM Watson Group (a so you should do this” advice, pioneers in interfere with absorption of vitamins D business unit dedicated to developing the field have come to realize that, as Bland and C or Omega 3s. People with those CONTINUED ON PAGE 3 nbj 2015 Personalized Nutrition Strategic Information for the Nutrition Industry HEAR IT AS IT HAPPENS: @nutritionbizjrl 01 Cheaper tests, wearable tech, 08 13 and advances in nutrition science have converged to take personalized nutrition from industry ideal to consumer expectation. Direct marketing puts thousands of MLM distributors face to face with millions of customers, but that personal contact won’t necessarily mean success in personalized medicine. As research continues to show how much our wellbeing is tied to the gut, probiotics and microbiome products become a consumer gateway to concepts of personalized nutrition. 05 Regulatory pushback from 09 As the science of personalized 16 The science is better, but it’s still FDA has changed the 23andMe business model—in a way that could give the company an even bigger impact. 07 Not all personalized nutrition tests involve labs and pin pricks. A new wave of hydration guages could let beverage companies build tests directly into their packaging. nutrition evolves, business plans will need to evolve with it. Insiders and entrepreneurs predict who might succeed in the personalized nutrition space, and how they’ll get there 11 Q&A with NBJ co-founder Tom Aarts, who discusses the pioneers of the personal-nutrition movement and where they’re leading the industry. Editor in Chief John Bradley Senior Editor Rick Polito Research Analyst James Johnson Design Cindy Zelenak Subscription Services Kim Merseli Exec. Director of Content, New Hope Natural Media Carlotta Mast nbj Editorial Advisory Board Tom Aarts complicated: Any move toward personalized nutrition will have to lean on the practitioner channel. NBJ Co-founder & EAB Chairman 18 As it has with nutrition, the CEO, Vitargo Global Sciences, LLC personalized healthcare space is finding that anti-aging products are not a once-size-fits-all play. 21 As science outruns policy, and policy outruns legislation, how can the FDA keep up? Steve Allen Retired Nestlé Executive Anthony Almada Mark Blumenthal Founder, American Botanical Council Bob Burke Founder, Natural Products Consulting Greg Horn CEO, Specialty Nutrition Group Adam Ismail Executive Director, GOED Loren Israelsen President, UNPA Larry Kolb President, TSI Health Sciences Bernie Landes President, Nutritional Products Consulting Janica Lane Managing Director, Piper Jaffray Michael McGuffin President, AHPA Randi Neiner Director of Market Research, Shaklee Ian Newton NBJ’s monthly publication focusing exclusively on the nutrition industry can now be delivered straight to your mobile device! To subscribe, please call Subscriber Relations at 303-998-9536. april 2015 Managing Director, Ceres Consulting Patrick Rea Founder, Health Business Partners Kantha Shelke Founder, Corvus Blue Scott Steinford CEO, QX-Partners Peter Wennström President, Healthy Marketing Team Nutrition Business Journal® (ISSN 1548-6168) is published 12 times a year in 10 editions by New Hope Natural Media, a division of Penton Inc., 1401 Pearl Street, Suite 200, Boulder, Colorado, USA 80302. © 2015 Penton Inc. All rights reserved. This publication may not be duplicated or reproduced without written permission. Please visit www.nutritionbusiness.com or call 303.998.9536 to order a subscription. Annual digital subscription rate is $1,395. Corporate rates and licenses are also available. newhope360.com/nbj | 2 nbj 2015 Personalized Nutrition Strategic Information for the Nutrition Industry COVER STORY CONTINUED LETTER FROM NBJ: IT’S ALL PERSONAL Almost 10 years ago, while looking for cutting-edge dietary advice for a story I was working on, I happened upon a man named Laurent Bannock, a British nutritionist and personal trainer who had just set up a practice in Santa Fe, New Mexico, where I was living. Though I thought I was just reporting a story and relying on a local source, I was in fact about to change my entire approach to food. Without having ever really thought about the term, I was about to dive into the world of personalized nutrition. Bannock had been a staff trainer at a gym in London, where he became Princess Diana’s personal trainer. Through that connection, he started advising several other British celebrities and became a star trainer in his own right, appearing on TV and in magazines to dispense all sorts of health advice—right up until the point when he decided that his fame had outrun his knowledge. So he promptly gave it all up and moved to the US to obtain a master’s degree and certifications in nutrition and sport science. He was just re-establishing himself as a practitioner when I happened into his office. Bannock’s approach at the time was to zero in on ethnic backgrounds as a starting point for dietary advice and to supplement that with blood, urine, and saliva tests to measure lipids, hormones, free radicals, and the like. He then put me on a customized and very specific diet—game meats and ancient grains were in, chicken and nightshades were out, and each day started with a handful of dietary supplements—and offered this bit of explanation: “Food is a pharmaceutical cocktail. You can find benefits in almost anything, but you have to look at the whole picture. Different [ethnic] groups evolved with certain foods and without others. There’s just no diet that works for everyone.” This one very much worked for me. In one month, my cholesterol dropped 60 points (I had it checked independently), I was sleeping better and my body fat percentage dropped while my weight stayed the same. I was objectively healthier—because I was eating only for myself. Bannock was a bit ahead of his time, but not by much. Terms like “nutrigenomics,” “personalized medicine,” and “personalized nutrition” are everywhere now. Fast and cheap genetic sequencing, better understandings of the microbiome, and at-home diagnostics are making it possible for regular consumers to eat and supplement for their specific needs—and creating new product and service models for manufacturers, retailers, and practitioners. Inside this issue, NBJ founder Tom Aarts discusses leaders in the field of personalized medicine and opportunities for practitioners and supplement brands; Larissa Zimberoff looks at 23andMe’s move into targeted drug therapies, and Todd Runestad explores the booming business in probiotics and microbiome testing. Will the move to personalization mean a move toward high-margin, low-volume supplements? Will it strain the practitioner channel? Or will it just mean better and more efficient use of the tools we already have? Those are questions we’re just starting to explore. But one thing is certain: This is where everything is headed. John Bradley Editor-in-chief, NBJ @johnwbradley april 2015 apps using the Watson supercomputer), Pathway Genomics will roll out the Pathway Panorama mobile app. The app will tap into genetic information, published research, medical records, GPS coordinates, info from wearable devices, and Watson to give users instant answers to questions like “What should I eat today, given what I ate yesterday? or “I’m on a business trip: How far should I run and at what pace, given the change in altitude? “It is basically a supercomputer in your hand that will grab any information you allow it to in order to give you a very personalized answer,” says Nova. Microbiome Testing What it tells us: While all humans have roughly 99.9 percent of their genes in common, they vary greatly when it comes to their microbiomes—in what species they host and in what proportion, says researcher Rob Knight, PhD. Some organisms, like lactobacillus and bifidobacterium, protect against pathogens, while others help extract carbohydrates and amino acids from food, or promote immunity. A diverse microbiome is ideal, but poor diet, antibiotic use, and even lack of sleep and exercise can wipe out diversity. Knight says that for some conditions, like obesity, the microbiome is better than DNA for predicting a person’s risk. The good news: Unlike the genome, the microbiome can be easily changed. What’s new: These are early days for testing and even earlier days for acting on results. Knight’s American Gut Project, which he recently moved from the University of Colorado-Boulder to the University of California San Diego, expressly states that it is a “pure science project, not a fee-for service business.” For $99, participants get a kit for collecting and sending back samples and, once the samples are analyzed, a glimpse at what bacteria they host and how it compares to others. And every kit means more data for Knight and his colleagues, who hope to get a better picture of what a healthy microbiome looks like, so people can someday try to emulate or restore it. San Francisco-based Ubiome.com is taking a more traditional business approach. Founded in 2012 by Stanford grad Jessica Richman, the company raised $350,000 in newhope360.com/nbj | 3 nbj 2015 Personalized Nutrition 10 weeks via Indiegogo.com and another $6.5 million via traditional tech-startup investments. Richman concedes that Ubiome’s microbiome tests—which cost from $89 to $399—have been more of a “curiosity” so far. But that will change this year, as the company moves to offering actionable science-based advice and collaborates with companies on new microbiome-based products. What’s coming: In September, Massachusetts-based Seres Health announced initial results of clinical trials on SER-109, the first prescription “oral microbiome therapeutic” for the treatment of chronic Clostridium Difficile, a form of infectious diarrhea. A single dose was capable of restoring diversity to the microbiome. After eight weeks, 29 of 30 patients were infection-free. The company has a whole line of Health Ecobiotics in the pipeline to address infectious, metabolic, and inflammatory diseases. In 2014 it received $110 million in investments, including $65 million from Nestle Health Sciences. Meanwhile, Ubiome has launched a crowdfunded dental-health research project, in hopes of developing toothpaste and mouthwash to restore a healthy oral microbiome. And Richman says that major CPG companies are interested in developing microbiome-based shampoos and acne medications. She says she would also love to work with probiotic companies to help personalize supplements: “Our goal is to move very quickly to commercialize this research.” Blood Testing What it tells us: To determine whether someone needs a supplement, or whether it’s working, there’s no better test than blood, says Paul Jacobson, of Thorne Research. Unlike gene tests, which map propensity for disease, blood shows what’s happening now. “Your blood regenerates every three to four months,” he says. “Let’s say you are diagnosed with high cholesterol and you want to get it down. You can take our products, change the way you eat, and have your blood tested later to see if it’s working.” Blood testing can also assess proteins associated with liver, lung, brain, and heart health; immune-cell activity; adrenal april 2015 Strategic Information for the Nutrition Industry health; and insulin sensitivity. And the advent of drop-in clinics, home test kits, and on-line practitioner consultation services has made it so a costly doctor’s appointment isn’t necessarily required. What’s new: Since 2014, Thorne has acquired a majority share of online health technology company Wellness FX and waded heavily into the diagnostics business with a new motto “solutions beyond supplements.” Wellness FX clients drop by a stand-alone Quest Diagnostics lab to give blood, and pay $78 to $1,000 for a blood panel. Options include thyroid, women’s health (which tests for hormones related to sleep and mood disturbance), sports performance, and heart health. Their results appear in an online dashboard, and they consult with an online practitioner who, if appropriate, steers them toward supplements. Other supplement companies are also partnering with diagnostic companies. Nordic Naturals steers customers to Lipid Technologies’ Holman Omega-3 Blood Spot Test, an at-home kit which tests for Omega 3 levels, and Pure Encapsulations has collaborated with the Cleveland HeartLab to align supplements with heart health biomarker tests. What’s next: After what Jacobson describes as a “building year” for Wellness FX, the company is now focusing on partnerships with health clubs, corporate wellness programs, and academic health research centers. Thorne recently rolled out a new line of supplements, LipoCardia, to support lipid metabolism and heart health, and the EXOS line of sports nutrition products. Bland believes that at a time when supplements have gotten a bad rap (sometimes deservedly), diagnostic testing may be key for getting individuals the supplements they truly need and, via follow-up, separating the ones that work from those that don’t. “Give a supplement to a big group of people and, on average, it doesn’t do that much,” Bland says. “But supplements given to the right person at the right dose at the right time can have a huge effect.” Scanners, wearable trackers, and other gadgets What they tells us: For the past several years, MLM company NuSkin has had its representatives use a “biophotonic scanner”a laser light shined on the palm of the hand—to measure antioxidant levels in prospective customers’ skin to assess the need for certain supplements. The company has scanned 17 million people and offers a money-back guarantee if no measurable difference is shown in eight weeks. “It is a cornerstone of our supplement category and a differentiating feature for our company,” says Joe Chang, the company’s chief science officer. In 2014 Thorne partnered with Itamar Medical Inc. to market EndoPAT, a non-invasive fingertip test that measures blood vessel function. Results can be uploaded to a person’s Wellness FX dashboard and incorporated with blood tests to help people make health decisions. Then there are wearable trackers, like those from FitBit, Jawbone, and Apple, which track activity, heart rate, sleep, etc. in real time and can nudge users toward better behaviors. What’s new: The smart fitness tracker market is expected to grow from $2 billion in 2014 to $5.4 billion in 2019, according to a March report by market-research firm Parks Associates. Nearly 30 percent of US households already have one. And new wearables go far beyond counting steps. Spire is a new clip-on device that measures breathing to map and analyze the user’s stress patterns and offers suggestions for chilling out if it detects things getting too tense. What’s next: Through his role in the Hundred Person Wellness Project—the first phase in the Institute of Systems Biology’s sweeping participatory wellness study—Bland was able to learn, via DNA testing, that he doesn’t synthesize Vitamin D well and he’s better suited for strength training than endurance sports. His blood tests showed he had relatively high levels of mercury (likely from his love of seafood) and has sensitivity to certain food additives. His FitBit tracker nudged him to move slightly more than he was. Within a few years, everyone can have this experience. “As we get more information measured non-invasively, get it to the cloud where it can be stored, develop algorithms for crunching it, and get it back to the user on their smartphone to personalize their unique questions we will have a transfor mative technology,” he says. newhope360.com/nbj | 4