(This article was published on Natural Product Insider magazine for November, 2009 Issue. http://www.naturalproductsinsider.com/articles/2009/11/is-my-product-ready-for-clinical-trials.aspx)
A clinical trial is considered low-hanging fruit in the dietary supplement industry, yielding immediate marketing value. Other types of data to support claims for a health ingredient or supplement are not as glamorous or accretive to the bottom line. Ideally, consumers want to know whether a product works on them and not just in animals. Regulators even specify controlled human studies are the gold standard for evidence of efficacy of health ingredients or drugs.
Before nutraceutical firms started to look at clinical trials in a big way, product marketers relied on testimonials from satisfied consumers and health care practitioners. Today, companies are increasingly dedicated to clinical trials; however, two types of preclinical research—“Formulation & Analytical Development” and “Animal Pharmacology & Toxicology”—are important, although the investment can seem costlier than the results.
Formulation & Analytical Development
As an example, suppose you have a novel compound from India that you want to market globally. Traditional knowledge and some in-house laboratory data substantiate certain health benefits. Ready to make that claim in most countries? Not without a passport.
The passport is a review of the finished product’s quality. Ingredient certificates of analysis (C of A) provide details on the ingredient itself; however, formulation and production steps ranging from granulation to tableting can impact the compound. Further, novel delivery systems and dosage forms also affect an ingredient’s bioavailability and stability.
On a global level, innovation in novel nutraceutical dosage forms has been slow, although some actives have been converted into forms suitable for food or beverage formulation.
There has been little innovation in new dosage form design such as sustained release or delayed release herbal products, patches, oral release sublingual tablets, etc. On a global level, Japanese firms have converted a large number of actives into functional food forms. But take our example from India. Curcumin, which has been studied for many health effects, has been shown to have poor bioavailability in humans, making innovative formulation or delivery technology a must.
The bottom line—if a finished product is not standardized as it leaves the production lines, stays stable on the shelf and is well available at the target sites of action in the human body, having a hot marketing claim won’t deliver results.
Animal Testing
Some firms may question the need for spending money on animal work if they are committed to investing in clinical trials. Perhaps it is less than ethical to test on animals when human research is equally possible for potentially harmless natural health products, right? Wrong. There is still plenty of research that is possible only in lab animals and not straight away or not at all in humans. Where there are specific safety concerns from traditional use or where the manufacturing process is likely to alter the ingredient dramatically, it is required by the regulators to perform some basic or extensive safety testing in animals before marketing or even human trials.
Even when animal studies are not required by regulations, in vitro and in vivo efficacy studies both offer advantages of screening several ingredients and doses of the same ingredient rapidly and more efficiently in the lab than it would be ever possible in a clinical setting. Moreover, some animal models are available that can elucidate mechanisms of actions which are difficult to reveal in simple human studies. Pharmacokinetic and bioavailability indicators can come out quicker and may be equally respectable as expensive human data.
Also, only having anecdotal data can hamstring the ability to design an appropriate clinical study protocol. Human studies can be expensive, even if off-shored. For clinical trials to be successful and cost-effective, the trial objectives need to be focused. Animal study results can provide this single-point focus to permit the development of a clinical study protocol that is likely to generate a positive outcome. This industry has a history of presumably good products failing in the clinic due to over-ambitious or poorly conceived trial objectives within the constraints of limited resources of time and money.
There are several possible approaches for nutraceutical product development, not one single path as is generally the case with pharmaceuticals. A balanced approach of doing some preclinicals before, during and after the clinical phase of research is prudent. But, each product is different. In some cases, it might be worth running a small pilot human study before doing any preclinical work; however, sample size being small in such a study, one must be prepared to forgo using this data for regulatory purposes. In certain cases, human studies may be more easily set up and in cases such as where “quality of life” is the research endpoint, only a human study will do. There can be many reasons for not doing extensive animal work before getting into clinical trials, but there are not many for avoiding formulation development totally. Typically clinical trials last for longer than a year. A non-uniform or an unstable product going out to human subjects in a study over several months has a potential to create chaos and not authentic and reliable data.
Clinical trial data can be a good tool for differentiating a new or existing product in the crowded market. But it may not be the right time to rush in and pluck this fruit yet. Discuss with your scientific team and outsourcing partners and time it right. An early start on a holistic approach to product development is more likely to yield results in the long run rather than ad hoc decisions on a clinical trial just because the competition has done one. A good dialogue between the preclinical and the clinical teams, set up at an early stage, can be a fair determinant of success. A regulatory expert to guide on research and business strategy can be an added benefit. In this light, contract research organizations (CROs) offering a single point management of the regulatory affairs and preclinical and clinical research programs offer a huge benefit.
Jayesh Chaudhary, is CEO of Vedic Lifesciences Pvt. Ltd., a contract research organization serving the pharmaceutical, phytopharma and nutraceutical industries; contact him at jayesh.chaudhary@vediclifesciences.com .
Monday, February 15, 2010
DESIGN THE STUDY RIGHT – MAKE YOUR SUPPLEMENTARY DREAMS COME TRUE
The story so far…….
Once upon a time, nutraceutical and functional food manufacturers lived and thrived in an unregulated world. Their products addressed a variety of health concerns and came with either implied or overt assurances of safety and efficacy. Sales were good and incidents of side effects or lack of efficacy went unquestioned. As these products did not fall into the ‘drugs’ category, they did not come under the purview of existing drug regulations which demanded proof of safety and efficacy of the drug before it reached the consumer. The creation of a ‘market’ for nutraceuticals was the next best thing that happened to manufacturers since sliced bread.
But now….
Unfortunately, like all fairy tales, this one too came to an end. Law makers stepped in and introduced systems for safeguarding the health and pockets of consumers. Writing a nutraceutical’s success story began to seem like a distant dream.
Dietary supplement (DS) and functional food (FF) manufacturers today are under scrutiny to ensure that they churn out products which really do what they say they do. Simultaneously, they have to race against time to reach the market as soon as possible. Given that the number of DS and FF products lining retail shelves is ballooning everyday, one can well understand their concerns.
As if getting adequate returns on investment on developing the product wasn’t difficult enough, DS and FF manufacturers today have to contend with grabbing a slice of the market. Add to it the fact that in premium markets like the US and the EU, because claim policing authorities are on a 24x7 vigil to trim or eliminate unsubstantiated claims, manufacturers can hardly afford to sit back and relax hoping their coffers would get replenished with no questions asked.
The problem - Regulatory Dragnets
In December 2006, EU decision makers adopted Regulation (EC) no. 1924/20061 to ensure that any nutrition and health claims made on a food label in the EU is clear and substantiated by scientific evidence which would be verified by EFSA (The European Food Safety Authority).
Under the Dietary Supplement Health and Education (DSHEA) Act of 1994, FDA has jurisdiction over the safety and labeling of dietary supplements while the FTC has jurisdiction over advertisements for dietary supplements2 Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading so as to help preserve consumer confidence in his product.3
FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons. The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.
The case is quite similar even in other markets around the world where regulators demand to see proof that such products work and are safe to use for the duration of the health condition they address.
If you thought getting regulatory go-aheads was easy, think again! Recently, the USFDA refused a claim for lutein (eye health) 4 EFSA too has a tough image regarding its role in assessing data for claim substantiation. In fact, industry experts feel it’s a notch tougher than even the USFDA. Apparently, only about 2% 5 of the scientific papers presented on clinical trials on nutraceuticals survive the regulatory check post. The reasons for rejection are many, some being poor study design, short treatment duration and too few compliant subjects to allow a sound statistical analysis. Lack of product standardization and other quality issues have also contributed to this failure of data acceptance. The amount of time and money lost due to lack of adequate foresight and planning is heart-wrenching since this could have been well avoided.
Thus DS and FF have to literally go on trial in the regulators’ courts and undergo cross-examination of their efficacy and safety. It is only the quantum and strength of scientific evidence derived from clinical trials that can help manufacturers either win or lose their case and put their products in the hands of consumers or face the penalty of holding back or withdrawing their products from the market.
The solution – CRO assistance
Facing such trials would become easier with the technical and operational support of a Contract Research Organization (CRO). CROs can design and undertake the necessary clinical trials to help DS and FF manufacturers successful in generating the necessary body of evidence to back their product’s label claims in the market they wish to enter.
Evaluating dietary supplements and functional foods requires a different approach as compared to pharmaceuticals in order to ensure that the data generated on the product’s safety and efficacy is scientific and adequate without being unduly excessive and untailored to cater to the need of backing the specific claims the manufacturer wishes to make.
The cost of researching and developing a nutraceutical is lesser than that of a pharmaceutical whether in India or abroad 6 However, the Return on Investment (ROI) on nutraceuticals is also substantially less as compared to that of the latter. One major strategy in maximizing profits then is to cut costs. This can be best achieved by ensuring that the cost of the clinical trial and the time required to generate the necessary evidence for backing claims is tightly controlled. This is easier said than done. Any manufacturer without adequate experience in conducting clinical trials is bound to find the hurdles involved in the process daunting, if not defeating. The costs of conducting studies can be enormous for the uninitiated sponsor. Similarly, the time spent in completing the whole project would put him at a disadvantage as compared to his competitors in reaching the market, not to mention the costs of lost opportunity he would have to bear.
The advantage of using a CRO lies in faster recruitment, and the flexibility it affords by providing additional capacity or expertise in different therapeutic areas. A CRO with strong capabilities and a rich experience in conducting clinical trials (CTs) on nutraceuticals can make all the difference in ensuring that the sponsor has a zero headache deal on obtaining the necessary data for his product within stringent timelines and costs. Vetting the product’s identity, purity and capability and the sponsor’s need to make specific claims requires a thorough understanding of the science behind herbal and other traditional forms of health supplements.
Maintaining your wallet’s health - Offshoring
Having extolled the virtues of CROs then, here is a piece of advice for DS and FF manufacturers in the US / EU and other countries in the West – offshore your clinical trials – it will translate into further savings in time and cost. Countries like India and China today are a hub for clinical trials.
India especially with its diverse patient pool, GCP-trained investigators with specialized knowledge in their specific therapeutic areas, English speaking Clinical Trial personnel, cutting edge laboratory and data capture technology and low man-hour costs are the best bet for a sponsor wishing to minimize costs in product research.
The cost of conducting clinical trials on pharmaceutical products in India is roughly 50% of the cost of the trial when conducted in the US 7 or probably even in the EU. One can then extrapolate this finding to nutraceutical research and development and expect similar if not more reduction in costs in India as compared to the western world.
The strategy – A robust trial design that keeps the end in view
The importance of a well planned, well designed trial in determining the ultimate success of the product cannot be emphasized enough. Only a CRO with expertise in CTs on nutraceuticals can know just how to tweak the study design and manage it operationally to ensure positive outcomes that when collated into a report at the end of the study provide loud and clear evidence on the product’s claims. All this, without compromising on the safety and welfare of the trial subjects and the quality of data generated. Generation of data which would be acceptable to regulators reflects the expertise of a well experienced CRO, as this focus is necessary right from the outset while planning and designing the study.
The design of a nutraceutical trial has a very important role to play in ensuring study outcomes which could have a bearing on the advancement of health and wellness therapies and quality of life standards for patients with various afflictions. Double blind randomized placebo or active comparator controlled clinical trials are the gold standard for generating evidence about the safety and efficacy of a product. Choosing such and closely modified study designs can provide invaluable insights in improving the quality of healthcare. Randomization introduces measures of eliminating bias in treatment allocations. However, a poorly designed randomized trial will not generate credible and useful data on the product as would a well-designed study.
The success of a research trial depends on many factors and the overall strategy that carefully takes them all into consideration. However, the strategy to designing a good trial should be based on the question that one needs to ask regarding the dietary supplement to be evaluated. In his article on research in clinical practice, Dr. Arun Nanivadekar, Former Medical and Research Director, Pfizer India, writes, “The process of research has two aspects: getting an idea is one, and verifying it is the other.” 8 Getting the idea equates with generating the question that would need verification via a trial. Although at times one might find that the research question that ought to be answered is a tough nut to crack, it is imperative that one avoids the easy way out by asking an easier but a useless or a less useful question. Having asked the right question is the first step to designing the trial to get the right answers and to ensure study success.
To quote Jayesh Chaudhary, Founder and CEO of Vedic Lifesciences, a CRO specializing in nutraceutical claim substantiation trials, “Determining the primary question to be asked in a clinical trial of a dietary supplement is critical to its success. Ask a wrong question and you end up with the wrong answer, no answer or an answer that has no market or regulatory value.” 9 Thus in a nutshell, a well designed study can provide the answers to support nutraceutical label claims while maintaining an optimal cost/ benefit ratio thus maximizing profits while minimizing costs.
Making your product’s fairy tale have a happy ending is possible without incurring financial nightmares. Choosing the right CRO and thereby the best study design, is the best way to go about it.
Dr. Aliya Shakeel is Medical Writer at Vedic Lifesciences Pvt. Ltd. For more information on growing yournutraceutical business you can reach her at vedic@vediclifesciences.com or on +91 22 42025703
References
1) Food Science and Technology Ireland Publication of the Institute of Food Science and Technology, Ireland
Volume 2, September 2008
www.icmsf.iit.edu/pdf/FoodScienceTechnologyIrelandVol2-2008.PDF
2) Brackett R. : The Regulation of Dietary Supplements: A Review of Consumer Safeguards
March 9, 2006
http://www.fda.gov/NewsEvents/Testimony/ucm112576.htm
3) Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act December 2008
http://www.fda.gov/Food/.../ucm073200.htm
4) Qualified Health Claims: Letter of Denial - Xangold® Lutein Esters, Lutein, or Zeaxanthin and Reduced Risk of Age-related Macular Degeneration or Cataract Formation (Docket No. 2004Q-0180)
December 19, 2005
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073291.htm
5) Berry P: EU health claims and accompanying legislation - time lines
Nutraceuticals International June 01, 2006
http://www.accessmylibrary.com/coms2/summary_0286-15771927_ITM
6) A G Pise, D Sreedhar, M Janodia, V Ligade & N Udupa : Changing paradigms in drug discovery
November 27, 2008
http://www.pharmabiz.com/article/detnews.asp?articleid=47207§ionid=50
7) Clinical trials are now increasingly outsourced to developing countries like India
http://www.offshoringtimes.com/Pages/2006/BPO_news926.html
8) Dr. Nanivadekar A : On research in clinical practice Perspective in clinical research official publication of the Indian Society for clinical research
9) Chaudhari J: Selecting Health Claims for Nutraceutical Clinical Trials
Natural Products Insider 12/21/09
http://www.naturalproductsinsider.com/articles/2009/12/selecting-health-claims-for- nutraceutical-clinical- trials.aspx
Once upon a time, nutraceutical and functional food manufacturers lived and thrived in an unregulated world. Their products addressed a variety of health concerns and came with either implied or overt assurances of safety and efficacy. Sales were good and incidents of side effects or lack of efficacy went unquestioned. As these products did not fall into the ‘drugs’ category, they did not come under the purview of existing drug regulations which demanded proof of safety and efficacy of the drug before it reached the consumer. The creation of a ‘market’ for nutraceuticals was the next best thing that happened to manufacturers since sliced bread.
But now….
Unfortunately, like all fairy tales, this one too came to an end. Law makers stepped in and introduced systems for safeguarding the health and pockets of consumers. Writing a nutraceutical’s success story began to seem like a distant dream.
Dietary supplement (DS) and functional food (FF) manufacturers today are under scrutiny to ensure that they churn out products which really do what they say they do. Simultaneously, they have to race against time to reach the market as soon as possible. Given that the number of DS and FF products lining retail shelves is ballooning everyday, one can well understand their concerns.
As if getting adequate returns on investment on developing the product wasn’t difficult enough, DS and FF manufacturers today have to contend with grabbing a slice of the market. Add to it the fact that in premium markets like the US and the EU, because claim policing authorities are on a 24x7 vigil to trim or eliminate unsubstantiated claims, manufacturers can hardly afford to sit back and relax hoping their coffers would get replenished with no questions asked.
The problem - Regulatory Dragnets
In December 2006, EU decision makers adopted Regulation (EC) no. 1924/20061 to ensure that any nutrition and health claims made on a food label in the EU is clear and substantiated by scientific evidence which would be verified by EFSA (The European Food Safety Authority).
Under the Dietary Supplement Health and Education (DSHEA) Act of 1994, FDA has jurisdiction over the safety and labeling of dietary supplements while the FTC has jurisdiction over advertisements for dietary supplements2 Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading so as to help preserve consumer confidence in his product.3
FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons. The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.
The case is quite similar even in other markets around the world where regulators demand to see proof that such products work and are safe to use for the duration of the health condition they address.
If you thought getting regulatory go-aheads was easy, think again! Recently, the USFDA refused a claim for lutein (eye health) 4 EFSA too has a tough image regarding its role in assessing data for claim substantiation. In fact, industry experts feel it’s a notch tougher than even the USFDA. Apparently, only about 2% 5 of the scientific papers presented on clinical trials on nutraceuticals survive the regulatory check post. The reasons for rejection are many, some being poor study design, short treatment duration and too few compliant subjects to allow a sound statistical analysis. Lack of product standardization and other quality issues have also contributed to this failure of data acceptance. The amount of time and money lost due to lack of adequate foresight and planning is heart-wrenching since this could have been well avoided.
Thus DS and FF have to literally go on trial in the regulators’ courts and undergo cross-examination of their efficacy and safety. It is only the quantum and strength of scientific evidence derived from clinical trials that can help manufacturers either win or lose their case and put their products in the hands of consumers or face the penalty of holding back or withdrawing their products from the market.
The solution – CRO assistance
Facing such trials would become easier with the technical and operational support of a Contract Research Organization (CRO). CROs can design and undertake the necessary clinical trials to help DS and FF manufacturers successful in generating the necessary body of evidence to back their product’s label claims in the market they wish to enter.
Evaluating dietary supplements and functional foods requires a different approach as compared to pharmaceuticals in order to ensure that the data generated on the product’s safety and efficacy is scientific and adequate without being unduly excessive and untailored to cater to the need of backing the specific claims the manufacturer wishes to make.
The cost of researching and developing a nutraceutical is lesser than that of a pharmaceutical whether in India or abroad 6 However, the Return on Investment (ROI) on nutraceuticals is also substantially less as compared to that of the latter. One major strategy in maximizing profits then is to cut costs. This can be best achieved by ensuring that the cost of the clinical trial and the time required to generate the necessary evidence for backing claims is tightly controlled. This is easier said than done. Any manufacturer without adequate experience in conducting clinical trials is bound to find the hurdles involved in the process daunting, if not defeating. The costs of conducting studies can be enormous for the uninitiated sponsor. Similarly, the time spent in completing the whole project would put him at a disadvantage as compared to his competitors in reaching the market, not to mention the costs of lost opportunity he would have to bear.
The advantage of using a CRO lies in faster recruitment, and the flexibility it affords by providing additional capacity or expertise in different therapeutic areas. A CRO with strong capabilities and a rich experience in conducting clinical trials (CTs) on nutraceuticals can make all the difference in ensuring that the sponsor has a zero headache deal on obtaining the necessary data for his product within stringent timelines and costs. Vetting the product’s identity, purity and capability and the sponsor’s need to make specific claims requires a thorough understanding of the science behind herbal and other traditional forms of health supplements.
Maintaining your wallet’s health - Offshoring
Having extolled the virtues of CROs then, here is a piece of advice for DS and FF manufacturers in the US / EU and other countries in the West – offshore your clinical trials – it will translate into further savings in time and cost. Countries like India and China today are a hub for clinical trials.
India especially with its diverse patient pool, GCP-trained investigators with specialized knowledge in their specific therapeutic areas, English speaking Clinical Trial personnel, cutting edge laboratory and data capture technology and low man-hour costs are the best bet for a sponsor wishing to minimize costs in product research.
The cost of conducting clinical trials on pharmaceutical products in India is roughly 50% of the cost of the trial when conducted in the US 7 or probably even in the EU. One can then extrapolate this finding to nutraceutical research and development and expect similar if not more reduction in costs in India as compared to the western world.
The strategy – A robust trial design that keeps the end in view
The importance of a well planned, well designed trial in determining the ultimate success of the product cannot be emphasized enough. Only a CRO with expertise in CTs on nutraceuticals can know just how to tweak the study design and manage it operationally to ensure positive outcomes that when collated into a report at the end of the study provide loud and clear evidence on the product’s claims. All this, without compromising on the safety and welfare of the trial subjects and the quality of data generated. Generation of data which would be acceptable to regulators reflects the expertise of a well experienced CRO, as this focus is necessary right from the outset while planning and designing the study.
The design of a nutraceutical trial has a very important role to play in ensuring study outcomes which could have a bearing on the advancement of health and wellness therapies and quality of life standards for patients with various afflictions. Double blind randomized placebo or active comparator controlled clinical trials are the gold standard for generating evidence about the safety and efficacy of a product. Choosing such and closely modified study designs can provide invaluable insights in improving the quality of healthcare. Randomization introduces measures of eliminating bias in treatment allocations. However, a poorly designed randomized trial will not generate credible and useful data on the product as would a well-designed study.
The success of a research trial depends on many factors and the overall strategy that carefully takes them all into consideration. However, the strategy to designing a good trial should be based on the question that one needs to ask regarding the dietary supplement to be evaluated. In his article on research in clinical practice, Dr. Arun Nanivadekar, Former Medical and Research Director, Pfizer India, writes, “The process of research has two aspects: getting an idea is one, and verifying it is the other.” 8 Getting the idea equates with generating the question that would need verification via a trial. Although at times one might find that the research question that ought to be answered is a tough nut to crack, it is imperative that one avoids the easy way out by asking an easier but a useless or a less useful question. Having asked the right question is the first step to designing the trial to get the right answers and to ensure study success.
To quote Jayesh Chaudhary, Founder and CEO of Vedic Lifesciences, a CRO specializing in nutraceutical claim substantiation trials, “Determining the primary question to be asked in a clinical trial of a dietary supplement is critical to its success. Ask a wrong question and you end up with the wrong answer, no answer or an answer that has no market or regulatory value.” 9 Thus in a nutshell, a well designed study can provide the answers to support nutraceutical label claims while maintaining an optimal cost/ benefit ratio thus maximizing profits while minimizing costs.
Making your product’s fairy tale have a happy ending is possible without incurring financial nightmares. Choosing the right CRO and thereby the best study design, is the best way to go about it.
Dr. Aliya Shakeel is Medical Writer at Vedic Lifesciences Pvt. Ltd. For more information on growing yournutraceutical business you can reach her at vedic@vediclifesciences.com or on +91 22 42025703
References
1) Food Science and Technology Ireland Publication of the Institute of Food Science and Technology, Ireland
Volume 2, September 2008
www.icmsf.iit.edu/pdf/FoodScienceTechnologyIrelandVol2-2008.PDF
2) Brackett R. : The Regulation of Dietary Supplements: A Review of Consumer Safeguards
March 9, 2006
http://www.fda.gov/NewsEvents/Testimony/ucm112576.htm
3) Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act December 2008
http://www.fda.gov/Food/.../ucm073200.htm
4) Qualified Health Claims: Letter of Denial - Xangold® Lutein Esters, Lutein, or Zeaxanthin and Reduced Risk of Age-related Macular Degeneration or Cataract Formation (Docket No. 2004Q-0180)
December 19, 2005
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073291.htm
5) Berry P: EU health claims and accompanying legislation - time lines
Nutraceuticals International June 01, 2006
http://www.accessmylibrary.com/coms2/summary_0286-15771927_ITM
6) A G Pise, D Sreedhar, M Janodia, V Ligade & N Udupa : Changing paradigms in drug discovery
November 27, 2008
http://www.pharmabiz.com/article/detnews.asp?articleid=47207§ionid=50
7) Clinical trials are now increasingly outsourced to developing countries like India
http://www.offshoringtimes.com/Pages/2006/BPO_news926.html
8) Dr. Nanivadekar A : On research in clinical practice Perspective in clinical research official publication of the Indian Society for clinical research
9) Chaudhari J: Selecting Health Claims for Nutraceutical Clinical Trials
Natural Products Insider 12/21/09
http://www.naturalproductsinsider.com/articles/2009/12/selecting-health-claims-for- nutraceutical-clinical- trials.aspx
Maximizing Profit for Nutraceutical Firms
The Nutraceutical market worldwide is expected to reach USD 177 billion by 2013, growing at a CAGR of 7%, driven by the fastest growing category of dietary supplements.1
Are the small/medium sized enterprises (SME) going to participate in this growth equally or will they be left out of the party? Having worked for the last decade with a number of such SMEs, Vedic Lifesciences has some insight to share. We shall discuss possible strategies to help Nutraceutical SMEs grow rapidly in the future.
Revenue growth by any firm could be achieved a) by going global, b) by growing sales within the domestic markets or c) by improving product life spans through constant investments in the value offered to the consumer. Bottom-lines can be improved by ensuring that at least some brands in the portfolio can command a premium pricing.
Growth by Going Global :
There may be challenges to domestic sales growth as competition from similar brands becomes fiercer and/or the distribution network becomes a bottleneck. On the other hand, going global requires an understanding of the foreign regulations and market conditions and the ability to identify and grow partnerships. Its imperative to partner with foreign companies who have the required regulatory expertise and marketing muscle to smartly overcome the deficiencies of the brand-owner company. A big opportunity to maximize profits is by moving up the “regulatory value chain”, meaning getting the same brand approved in a tougher regulatory atmosphere using supporting R&D data. Example, a manufacturer of a dietary supplement that is able to make only health claims in US can get the same product approved as a Natural Health Product in Canada and make medicine like claims. Importers will always prefer a brand that is already established in markets elsewhere provided the product can meet higher regulatory requirements in the importing country. Having an R&D dossier that was planned and compiled well will go a long way in establishing newer and rewarding markets in economies that may be doing better than the home market.
Domestic Growth:
Relaunching old brands in the domestic markets is a tougher challenge without a new marketing partner or infusion of new value into the product through R&D. Several global economies are still recovering, yet consumer choices for supplements and health foods are huge. In such a scenario, brands that don’t offer value will be wiped out. The cost of a well-conceived preclinical or even clinical program is still lower than an advertising campaign that companies spend on. But an ad can be only as good as the product it sells. A good ad will sell a bad product too, but only for a while. Whereas a good product doesn’t require much ad spend at all in today’s highly democratic and networked consumer world of social media and Web 2.0. Hence companies that do their own domestic marketing of wellness products may consider setting aside at least 50% of their previous year’s marketing and promotional budgets for R&D for the next 3 consecutive years.
Growth by Lifespan Extension:
History of health and wellness brands in most of the regulated world has shown that brands that are well-entrenched in the minds of the consumer psyche had a strong value proposition for the consumer in the first years of their launch. Value can be created through multiple ways and a universal technique remains evidence of health benefit or clinical efficacy. Stronger brands always last a lifetime and sometimes span several generations of consumers. Age-old Nutra brands can be ever-greened through continual R&D.
Profit Growth through Premium Pricing:
Only with innovation and value addition can a dietary supplement or health food rise above the clutter of other me-too brands. Consumers clearly will pay a dollar more for any specific and proven value over the other brands available. Intelligent R&D and smart marketing: neither can do without the other. Investment in only one of them without concurrent focus on the other can lead to disappointments in the short or long run.
The Road to Success via Product Innovation:
When all roads to business success seem to be going via product innovation, it is imperative to have a highly efficient R&D process in-house or outsource it to the most experienced and effective partner. A big reason why SMEs have shied away from own R&D so far in the nutraceutical industry worldwide is the wrong perception that R&D is risky and costly. R&D success must be ensured and costs contained for SMEs to be able to participate fully in the market growth that we are likely to witness in the Health and Wellness markets worldwide in the present decade. Research methods used by pharma do not offer the promise of risk-reduction and cost efficiency that nutraceutical companies look for. Nutraceutical companies need special research methods 2 , 3They must engage (early in the research program) a CRO that has the special skills and experience to handle such challenges specific to the natural product industry in order to participate in the competitive marketplace of wellness products today. Care must be taken that all research is compliant to the global regulations for such natural products. It must be further noted that the toughest global regulations for preclinical and clinical evidence for natural products are not difficult to comply with and are certainly not akin to drug regulations.
Cost-effective, speedy and compliant science is the starting point for building a great health and wellness brand for the world markets and maximizing ROIs in this sector.
Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences Pvt. Ltd. For more information on growing your nutraceutical business you can reach him at vedic@vediclifesciences.com
or on +91 9821086665
References:
1. Ernst & Young, FICCI: NUTRACEUTICALS - Critical supplement for building a healthy India.
www.ficci-nutraceuticals.com
2. Chaudhary J: Is My Product Ready for Clinical Trials
Natural Products Insider Nov 23, 2009
www.naturalproductsinsider.com
3. Chaudhary J: Selecting Health Claims for Nutraceutical Clinical Trials
Natural Products Insider Dec 21, 2009.
www.naturalproductsinsider.com
Are the small/medium sized enterprises (SME) going to participate in this growth equally or will they be left out of the party? Having worked for the last decade with a number of such SMEs, Vedic Lifesciences has some insight to share. We shall discuss possible strategies to help Nutraceutical SMEs grow rapidly in the future.
Revenue growth by any firm could be achieved a) by going global, b) by growing sales within the domestic markets or c) by improving product life spans through constant investments in the value offered to the consumer. Bottom-lines can be improved by ensuring that at least some brands in the portfolio can command a premium pricing.
Growth by Going Global :
There may be challenges to domestic sales growth as competition from similar brands becomes fiercer and/or the distribution network becomes a bottleneck. On the other hand, going global requires an understanding of the foreign regulations and market conditions and the ability to identify and grow partnerships. Its imperative to partner with foreign companies who have the required regulatory expertise and marketing muscle to smartly overcome the deficiencies of the brand-owner company. A big opportunity to maximize profits is by moving up the “regulatory value chain”, meaning getting the same brand approved in a tougher regulatory atmosphere using supporting R&D data. Example, a manufacturer of a dietary supplement that is able to make only health claims in US can get the same product approved as a Natural Health Product in Canada and make medicine like claims. Importers will always prefer a brand that is already established in markets elsewhere provided the product can meet higher regulatory requirements in the importing country. Having an R&D dossier that was planned and compiled well will go a long way in establishing newer and rewarding markets in economies that may be doing better than the home market.
Domestic Growth:
Relaunching old brands in the domestic markets is a tougher challenge without a new marketing partner or infusion of new value into the product through R&D. Several global economies are still recovering, yet consumer choices for supplements and health foods are huge. In such a scenario, brands that don’t offer value will be wiped out. The cost of a well-conceived preclinical or even clinical program is still lower than an advertising campaign that companies spend on. But an ad can be only as good as the product it sells. A good ad will sell a bad product too, but only for a while. Whereas a good product doesn’t require much ad spend at all in today’s highly democratic and networked consumer world of social media and Web 2.0. Hence companies that do their own domestic marketing of wellness products may consider setting aside at least 50% of their previous year’s marketing and promotional budgets for R&D for the next 3 consecutive years.
Growth by Lifespan Extension:
History of health and wellness brands in most of the regulated world has shown that brands that are well-entrenched in the minds of the consumer psyche had a strong value proposition for the consumer in the first years of their launch. Value can be created through multiple ways and a universal technique remains evidence of health benefit or clinical efficacy. Stronger brands always last a lifetime and sometimes span several generations of consumers. Age-old Nutra brands can be ever-greened through continual R&D.
Profit Growth through Premium Pricing:
Only with innovation and value addition can a dietary supplement or health food rise above the clutter of other me-too brands. Consumers clearly will pay a dollar more for any specific and proven value over the other brands available. Intelligent R&D and smart marketing: neither can do without the other. Investment in only one of them without concurrent focus on the other can lead to disappointments in the short or long run.
The Road to Success via Product Innovation:
When all roads to business success seem to be going via product innovation, it is imperative to have a highly efficient R&D process in-house or outsource it to the most experienced and effective partner. A big reason why SMEs have shied away from own R&D so far in the nutraceutical industry worldwide is the wrong perception that R&D is risky and costly. R&D success must be ensured and costs contained for SMEs to be able to participate fully in the market growth that we are likely to witness in the Health and Wellness markets worldwide in the present decade. Research methods used by pharma do not offer the promise of risk-reduction and cost efficiency that nutraceutical companies look for. Nutraceutical companies need special research methods 2 , 3They must engage (early in the research program) a CRO that has the special skills and experience to handle such challenges specific to the natural product industry in order to participate in the competitive marketplace of wellness products today. Care must be taken that all research is compliant to the global regulations for such natural products. It must be further noted that the toughest global regulations for preclinical and clinical evidence for natural products are not difficult to comply with and are certainly not akin to drug regulations.
Cost-effective, speedy and compliant science is the starting point for building a great health and wellness brand for the world markets and maximizing ROIs in this sector.
Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences Pvt. Ltd. For more information on growing your nutraceutical business you can reach him at vedic@vediclifesciences.com
or on +91 9821086665
References:
1. Ernst & Young, FICCI: NUTRACEUTICALS - Critical supplement for building a healthy India.
www.ficci-nutraceuticals.com
2. Chaudhary J: Is My Product Ready for Clinical Trials
Natural Products Insider Nov 23, 2009
www.naturalproductsinsider.com
3. Chaudhary J: Selecting Health Claims for Nutraceutical Clinical Trials
Natural Products Insider Dec 21, 2009.
www.naturalproductsinsider.com
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