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Regulatory affairs

Hey all, I know that I just posted yesterday but I wanted to get your feedback on going into regulatory affairs for biotech companies. I was offered an internship with a decent biotech in their regulatory affairs department.

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What is the Non-GMO Project’s Claim? Driving Sales.

In a recent piece on RealAgriculture.com, Andrew Campbell reports that the Canadian Food Inspection Agency (CFIA) does not consider the Non-GMO Project Verified seal, also known as the “butterfly” label, to be a non-GMO claim.

But, why is this important?

Because, Canada already has laws defining what is and isn’t a genetically modified organism (GMO), and according to the CFIA, the stipulations that companies must meet to receive the “butterfly” label don’t meet Canada’s definition of a non-GMO. As a result, consumers sent a barrage of complaints to the agency because they realized that many products that featured the “butterfly” label are not considered non-GMO by Canada’s definition.

But when CFIA reviewed the “butterfly” label they determined:

“… that because the Non-GMO Project Verified label is a third-party audit, and includes a website address for consumers to go to for more information, that it doesn’t mean consumers will see it as a non-GMO claim.”

Therefore, based on this ruling, food producers are free to continue marketing their product(s) with the “butterfly” label because, in the eyes of Canada’s main food enforcement agency, the label doesn’t conflict with Canada’s laws regulating non-GMO labels because it is not a non-GMO claim.

And the CFIA has a point. Even the Non-GMO Project’s website (albeit buried at the bottom of an FAQ page) affirms the notion that the label doesn’t actually mean GMO-free (emphasis mine).

While the Non-GMO Project Verified seal is not a “GMO free” claim, it is trustworthy, defensible, transparent, and North America’s only independent verification for products made according to best practices for GMO avoidance.

So, if the label doesn’t truly mean non-GMO, how is the Project able to get so many companies to apply, and pay a fee, for the “butterfly” label? It becomes clear when you scroll up to the first question on that same FAQ page.

Why should I get my product Non-GMO Project Verified?

Non-GMO Project Verified is the fastest growing label in the natural products industry, representing $22.3 billion in annual sales and more than 50,000 verified products for over 3,000 brands. Non-GMO products are in demand and the Non-GMO Project Verified seal is the most trusted non-GMO label among consumers.

Sales. It all comes down to sales. And according to the Non-GMO Project, products with their label are selling fast and well. Jump over to the Project’s “Product Verification” page and again, you’re met with value propositions about the label’s ability to make money:

Driving sales. Our retail partners report that Non-GMO Project Verified products are the fastest dollar growth trend in their stores this year. Annual sales of Non-GMO Project Verified products now exceed $19.2 billion.

What’s most important in this discussion, is the impact on consumer trust and the confusion created in the marketplace. As Campbell sums it up:

“If food companies can openly state that they will simply take off the words non-GMO and replace it with ‘Non-GMO Project Verified’ because the CFIA says they can, we are entering a new wild west in food marketing.

“How the CFIA translates a label that contains the term Non-GMO into not meaning a non-GMO claim is beyond me, especially when it’s being used to imply a superior product and potentially trying to guilt consumers into spending more money than they need to on food.

“If the CFIA isn’t going to keep companies using the Non-GMO Project Verified label honest, it’s time people realize they’ve been duped and turn their backs on the companies ripping them off.”

Read the full piece here.

 

What Is It with Food Acronyms?

I think it’s fair to say, that some, if not most, opponents of genetically modified organisms (GMOs) are aware of the science illustrating the safety behind the technology. Still, non-GMO activists are relentless in linking GMOs to negative health effects.

However, as Morgan Manghera writes for Food Insight, the official blog for the International Food Information Council Foundation, GMOs aren’t the only food acronyms receiving unfounded criticism. Since the 1960s, MSG (monosodium glutamate) has been facing a similar battle with negative public perceptions:

The MSG frenzy began in 1968 when biomedical researcher Robert Ho Man Kwok penned a letter saying he came down with an illness from Chinese restaurants – specifically restaurants that use MSG in their food preparation. At the time, MSG was popular, but Kwok’s letter turned the tables. MSG became the enemy substance: Consumers rebuffed it, and scientists began studying it with a more critical eye.

Despite numerous repeated studies which found that MSG does not cause numbness, weakness and heart palpitations – conditions reported by Dr. Kwok in 1968 – many Americans still say they avoid MSG some 50 years after the Kwok experience.  But why?  Why do consumers continue to avoid this ingredient that is approved as safe?

In trying to answer the why, Manghera spoke with Megan Meyer, PhD, Director of Science Communications at IFIC, and unsurprisingly, her explanations as to why consumers refuse to accept the science around MSG are all too familiar for those working to promote the safety of GMOs:

Consumers trust friends, family and health-centered blogs and websites as their primary influencers. This practice demonstrates a clear lack of trust in science and institutions.

Trusting friends and family is understandable. However, issues arise when friends and family members are influenced by false information provided by “health-centered blogs,” and other unscientific outlets, that only look to perpetuate fear. And frankly, fear works.

It’s one of the reasons that even through there has been no peer-reviewed scientific study connecting GMO consumption with negative health effects, the technology is still not widely accepted.

It’s easy for amateur health bloggers to write 600 words on why they think GMOs are bad. It takes a lot more time and scrutiny for scientists to rigorously study the technology and determine their conclusion.

So, why do many insist on trusting bloggers over scientists? Maybe it’s because the science isn’t as scary as you think. Plus, fear sells.

#BIO2018 Buzz of BIO Contest Winners Announced

The competition was strong for #BIO2018’s contest but only one winner from each category, “Technologies of Tomorrow” and “Pipelines of Promise,” could come out on top of the voting. Avery Therapeutics took the crown for “Technologies of Tomorrow” and biomarck Pharmaceuticals achieved the top spot in the “Pipelines of Promise” category. Buzz of BIO winners receive one complimentary Convention Access & Partnering registration pass and the opportunity to give a Company Presentation in front of industry colleagues at BIO’s convention.

Both companies, along with many others, will be presenting at the in Boston this June 4-7, an opportunity conducive to increasing visibility and attracting more partners at the event. Presenting biotechs pitch their companies’ stories, pipelines, and objectives to a global audience representing more than 70 countries. Company Presentations are open to all BIO International Convention registrants.

“Technologies of Tomorrow” winner, Avery Therapeutics, is a startup company dedicated to advancing tissue-engineered therapeutics to treat diseases and injuries to human muscle. Avery’s novel engineered tissue platform enhances cell therapy delivery by targeting the root cause of degenerative disease. Avery’s MyCardia™ treatment for heart failure demonstrated pre-clinical functional improvements anticipated to translate to a significant improvement in quality of life.

Winner of the “Pipelines of Promise” category, biomarck Pharmaceuticals, is developing its lead compound, BIO-11006 for non-small cell lung cancer (NSCLC) and acute respiratory distress syndrome (ARDS). They have active INDs for both indications and are conducting Phase 2 clinical studies in patients with NCSLC and ARDS in 2017/2018.

BIO is still accepting applications to deliver a company presentation. Gain access to business development executives, investors, research analysts, policy makers, and media, and get more activity in BIO One-on-One Partnering™ by presenting. to learn more about Company Presentations and for application instructions.

Biotechnology Reagents Market Growth Analysis, Share; Demand by Regions, Types and …

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Motif Bio to submit NDA for iclaprim

Motif Bio said the antibiotic may be suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes. Unlike many standard of care antibiotics, iclaprim is only minimally cleared via the kidneys. No nephrotoxicity was observed with iclaprim in the …

Puma Biotechnology (PBYI) PT Set at $95.00 by Stifel Nicolaus

Puma Biotechnology logo Puma Biotechnology (NASDAQ:PBYI) received a $95.00 price target from equities research analysts at Stifel Nicolaus in a research note issued on Friday, March 9th. The firm currently has a “buy” rating on the biopharmaceutical company’s stock. Stifel Nicolaus’ target price …

Biotechnology Reagent Market Overview – Key Futuristic Trends and Competitive Landscape 2023

Latest research study from HTF MI with title Asia-Pacific Biotechnology Reagent by Manufacturers, Regions, Type and Application, Forecast to 2023. The Research report presents a complete assessment of the market and contains Future trend, Current Growth Factors, attentive opinions, facts, historical …

Springing into the next crop season – what one farmer has planned

We’re a country that is generations from being on the farm, for the most part. And most people just don’t know that much about where their food comes from. Because of this, there are a lot of myths, misconceptions, and flat out rumors about how farmers manage their farms. There are claims that farmers are forced to buy certain seeds, or buy from a certain company. The reality is that farmers decide for themselves what to grow each year.  They choose what to do.  And those decisions are made based upon a variety of factors, including economics, weather, land, and global market demand.

GMO Answers has asked farmer and GMO Answers volunteer expert Brandon Hunnicutt to explain how he makes these decisions. Brandon lives on a piece of land that his family has farmed for over 100 years. He is passionate about agriculture, whether he’s trying to raise the next big crop, utilizing the next big technological advance, researching a product to make his crops healthier or more productive, or trying to protect agriculture from those who want to farm it.

In a new post on the GMO Answers Medium page, he talks about his options. And yes, those options include growing genetically modified seeds. Ultimately, the decision is his. He and his family have many questions to ask, and answer:

Our plan is developed in many the same ways a home gardener would develop their plan. We consider:

·         What crops do I like?

·         What grows well in my area?

·         Were there problems (disease, weeds, insects) last year that may be a problem this year?

·         Do I need to rotate crops to help with soil health?

·         Is there something new I would like to try?

·         Where am I going to purchase my seeds?

·         Do I have a preferred place to buy seeds or do I want to try something new?

Ultimately, their goal with all of these decisions is to produce the highest quality crop they can, free from pest damage and disease – just like any home gardener would do. Learn more about Brandon, and his decision making process, at the GMO Answers Medium page.