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Bioenterprise B.C. hosts Vancouvers First Agri-Tech Pitch Night

Posted on October 25 2017 | Author: Jessica Taylor

Agri-tech and agri-food companies from across the Lower Mainland came together on October 18th for Vancouver’s first Agri-tech Pitch Night! The event was co-hosted by Bioenterprise B.C. and Volition Events to provide companies with the opportunity to receive feedback and coaching on their 3-minute pitch.

“This was a great opportunity to showcase British Columbia’s growing agri-tech and food sector,” said Jessica Taylor, A/Regional Manager of Bioenterprise B.C. “ The sector is growing rapidly and B.C. has such a unique ecosystem of support for these types of ventures. Companies need more opportunities like this for both feedback and exposure.”

It’s not often that entrepreneurs have the chance to practice their pitch in front of an expert panel and receive constructive criticism and recommendations.  Each panellist provided a unique perspective, and while feedback varied they provided some great tips that entrepreneurs should remember:

1. Bait the Hook: whether you have 5 minutes or 30 seconds, your pitch is meant to pique the interest of investors and other potential partners. Don’t worry about telling them all of the details, that’s what the follow-up conversation is for.

2. Ask!: Whether or not you are doing a raise be sure to let the audience know what you are looking for. Do you need a mentor? Connections to strategic partners?

3. Be Clear: Make sure that your innovation, competitive advantage, and ask are all very apparent to the audience. Practice and receive feedback as often as possible.

 

The pitch night brought together several companies within the ag-tech sector, including:  500 Foods, Burnaby Organic Greenhouse, Coast Protein, Compy, Hagensborg Chosolates (Truffle Pig), MyFoods Market, NuWave Research Inc., and Wise Bites.

Winners from Pitch Night were selected by an audience vote following the company pitches. The top three placing’s included:

 

Sustainable cricket protein powders and bars

 

 

Sustainable and ethically sourced chocolates

 

                    

On-site solutions in vacuum microwave dehydration for food






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Dietary Supplement Claim Substantiation What Evidence is Stipulated by Law?

Posted on October 20 2017 | Author: Admin

The Food and Drug Administration (FDA) requires that a notification from the manufacturer, packager or distributor of a dietary supplement for the claim statements made on product labels is submitted to the FDA no later than 30 days after the first marketing of the product [1]. With this said, dietary supplement claim substantiations in the U.S. are not scientifically reviewed and approved for acceptability prior to entering the market. This is different from some other markets where claim statements are subject to substantiation requirements and pre-market approval. Companies in the dietary supplement industry are responsible for keeping on file the substantiation for all claims made on their labels. However, they may struggle with what type of evidence is suitable for substantiation. This leads us to the Regulations – what does the law require for the substantiation of dietary supplement claims?

Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6))[2], a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim is required to have substantiation that the claim is truthful and not misleading. In the Act itself, there is no mention of the type of evidence required for substantiation. However, the FDA provides some guidance as to their current thinking regarding suitable substantiation claims for dietary supplements in a guidance document titled “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403 (r)(6) of the Federal Food, Drug and Cosmetic Act[3]. This guidance document demonstrates the FDA’s position for evidence requirements: “Although there is no pre-established formula as to how many or what type of studies are needed to substantiate a claim, we, like the FTC, will consider what the accepted norms are in the relevant research fields and consult experts from various disciplines.”

In this guidance document, the FDA specifies evidence which may substantiate a claim: (a) Human studies: Intervention studies (note: “randomized, double-blind, parallel group, placebo-controlled trials offer the greatest assessment of a relationship between a dietary supplement and outcome”), and/or (b) Human studies: Observational studies (includes Case reports, Case-series studies, Case-control studies, Cohort studies, Cross-sectional studies, Time-series studies, and Epidemiological studies.

Importantly, the FDA also discusses what types of additional information may be useful as background information to support a claim, but alone may not be adequate to substantiate a claim: Animal studies; In vitro studies; Testimonials and other anecdotal evidence; Meta-analysis; Review articles; Comments and Letters to the Editor or Product monographs.

The FDA’s guidance document provides the administration’s current thinking on evidence for dietary supplement claims but it is not legally binding because the Act does not list evidence requirements for substantiation. Therefore, appropriate/acceptable evidence for claims is not definitive and what is considered ‘scientifically sound and reliable’ evidence may be different depending on the nature of the claim and the message it conveys to consumers.   Therefore, companies marketing dietary supplements need to be confident in their claim substantiation in order to prevent any disputes with the FDA and FTC.

Overall, it is advisable to ensure your substantiation is reviewed for appropriateness by a scientific & regulatory expert who is capable of assessing the scientific evidence in the relevant research field for the type of the claim statement being made on your label. If you do not have someone in-house capable of doing so, then you may want to consult with a third-party for assistance to ensure you have appropriate dietary supplement claim substantiation.

dicentra can assist in reviewing evidence for dietary supplement claims to ensure that customers have the right type of evidence and substantiation documentation on-hand for dietary supplements for the U.S. market.

Sources:
[1] FDA Structure/Function Claim Notification for Dietary Supplements
[2] The Federal Food, Drug, and Cosmetic Act (the Act). (21 U.S.C. 343(r) (6)).
[3] Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403 (r)(6) of the Federal Food, Drug and Cosmetic Act, Dec 2008.

View original blog here.






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Should I Patent This Blog?

Posted on October 03 2017 | Author: Michael Coulson

So, you think your new widget is the greatest thing since sliced bread. Like many others, you might think a patent is the logical next step to commercializing your invention, and you may be right. However, determining whether it makes business sense to patent is a complex issue, as are most legal matters. Here are a few of the many considerations to keep in mind when determining if a patent is right for you.

A patent is not a legal right to commercialize an innovation.

A patent is a direct exchange with the government. They offer you the legal right to exclude other people from using, selling, or making what you have claimed within your patent for a fixed period of time, in exchange for a detailed description of your innovation. Essentially, you are offering your cutting-edge knowledge to the public, in trade for the ability to take legal action against anyone, for a limited time, who chooses to infringe on the knowledge you have claimed.

Alternatively, you may have a patent on a certain innovation, but you might not have the freedom to operate within the space without infringing on someone else’s patent. For example, if a widget has three parts, the top, bottom, and middle, and you’ve created a better way to make the middle piece of the widget, you still need to put it together with the top and bottom, which may end up infringing on someone else’s patent.

There is a time limit for the artificial monopoly.

For the majority of countries, a patent is only valid for twenty years, after which, the innovation becomes public domain. Even then, during the time of the patent, the information of your product will be public domain, and likely if its innovative enough, someone may be able to better mimic your product with this knowledge. This is one of the reasons why food and beverage manufacturers tend not to patent their formulations. If Dr. John Pemberton of Coke-Cola decided to patent their formulation back in 1886, the patent would be long expired, by 1906 their secret sauce would be in the public domain, and likely all the coke knock-offs would taste a lot better.

It’s important to decide whether this invention is better suited for a patent or as a trade secret. Trade secrets can last forever, as long as they are kept secret by those who hold the knowledge. For example, it is rumored that KFC’s eleven herbs and spices original recipe, is stored in a vault in the Louisville headquarters, and processes six of the herbs and spices are mixed in one location with a set of staff, and the other five are mixed in a separate location, all to preserve the secret.

Patents are expensive, so they should have a return on investment.

The cost over the lifetime of a patent varies quite a bit depending on the complexity of the innovation, how long and involved the prosecution process is, and the jurisdictions for filing. The cost for filing just in Canada can range anywhere from $4,000 to $6,000 for preparation and filing for a relatively simple invention, but this figure can double, or even triple depending the complexity, and this is just in Canada. If, for example, you wanted to file an international PCT application and then file in multiple jurisdictions during national phase entry, you can easily run a six-figure bill.

With this in mind, it is extremely important to understand how the patent will be put to work. There are many ways to utilize a patent, whether it is for direct licencing, used as a signal of innovation for investors or consumers, or as a defensive move to block others from entering a market. Whatever the reason for patenting, it is important to ensure that it will be able to provide you with tangible benefit.

Now, the question at hand: Should I patent this blog?
The answer doesn’t matter, but even if I think I know, I should probably ask a lawyer.


Sources:
Invents. 2017. Do you have a great invention idea. Retrieved from http://www.invents.com/how-much-does-a-patent-cost/ 
The Times. 2012. The A to Z of friend chicken. Retrieved from https://www.thetimes.co.uk/article/the-a-to-z-of-fried-chicken-nrmm3qn0gg7 
Wilson, T. 2012. When to Patent something and how to do it. Globe and Mail. Retrieved from https://www.theglobeandmail.com/report-on-business/small-business/sb-growth/when-to-patent-something-and-how-to-do-it/article626823/?arc404=true 
CNBC. 2008. Colonel’s Secret Recipe Gets Bodygaurds. Retrieved from https://web.archive.org/web/20130923032226/ 
 

Michael Coulson
Analyst, Bioenterprise BC






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