{"id":46506,"date":"2023-10-17T10:58:18","date_gmt":"2023-10-17T10:58:18","guid":{"rendered":"https:\/\/entertainment.runfyers.com\/index.php\/2023\/10\/17\/give-biotech-a-chance-for-the-planets-sake-eu-lawmakers-urged-techcrunch\/"},"modified":"2023-10-17T10:58:18","modified_gmt":"2023-10-17T10:58:18","slug":"give-biotech-a-chance-for-the-planets-sake-eu-lawmakers-urged-techcrunch","status":"publish","type":"post","link":"https:\/\/entertainment.runfyers.com\/index.php\/2023\/10\/17\/give-biotech-a-chance-for-the-planets-sake-eu-lawmakers-urged-techcrunch\/","title":{"rendered":"Give biotech a chance for the planet&#8217;s sake, EU lawmakers urged | TechCrunch"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div>\n<p id=\"speakable-summary\"><span class=\"featured__span-first-words\">European Union lawmakers<\/span> are being urged to avoid too much risk aversion from holding back the potential of the homegrown biotech sector.<\/p>\n<p>Developments in biotech could be transformative in a range of critical sectors. Beyond huge promise in healthcare, innovative, low carbon applications in areas like agriculture and food systems and energy production could help address pressing environmental and sustainability challenges. But there\u2019s concern among some local operators that the bloc\u2019s current approach could cap potential biotech benefits \u2014 especially in the context of the urgency required to tackle the climate crisis.<\/p>\n<p class=\"m_-8931204457283301062xmsonormal\">\u201cThe main<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">regulatory<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>challenges<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">for the EU\u2019s <span class=\"il\">biotech<\/span> startups are long<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>timelines for approval of new products and<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">a<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>lack of openness towards modern <span class=\"il\">biotech<\/span> solutions that may lead to GMO solutions<span lang=\"EN-US\">,\u201d Jo\u0161ko Bobanovi\u0107, partner at Sofinnova Partners, a major investor in European biotech, tells TechCrunch. \u201c<\/span><u\/>Today, EU startups often do not bother trying to get approval in Europe because<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">of long approval timelines, opting instead to<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>go directly to the US or Asia. This is a huge loss for Europe given the plethora of leading-edge technologies developed<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">here.<\/span><\/p>\n<p class=\"m_-8931204457283301062xmsonormal\"><span lang=\"EN-US\">\u201cR<\/span>ecent Nobel prizes for technologies like CRISPR or for discoveries that led to RNA vaccines<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">highlight<\/span><span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span>European regulators<span lang=\"EN-US\">\u2019 hesitance<\/span><span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span>to<span lang=\"EN-US\">ward<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>genetic technologies<span lang=\"EN-US\">, similar to favoring<\/span><span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span>landlines<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">over<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>mobile phones. <span lang=\"FR\">(<\/span>Remember<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">what happened with<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>Nokia and smart phones.<span lang=\"FR\">)<\/span> The<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">potential benefits of these<\/span><span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span>innovations<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">far outweigh the risks even as they are<\/span><span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span>part of<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">a<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>duly rigorous regulatory cycle.\u201d<\/p>\n<p>\u201cIf you look at venture capital, there\u2019s significantly more money going into the synbio [synthetic biology] community in the United States, and so we\u2019re really at a disadvantage here in Europe,\u201d says Stef van Grieken, CEO and co-founder of EU-based startup <a href=\"https:\/\/techcrunch.com\/2022\/11\/16\/protein-programmers-get-a-helping-hand-from-cradles-generative-ai\/\" target=\"_blank\" rel=\"noopener\">Cradle<\/a>, which offers generative AI tools to help bioengineers design proteins. \u201cThere\u2019s also a lot of regulatory risk in Europe. So GMO, a lot of these types of techniques are considered genetic modification. And rules in Europe are very strict. And so if you look at a company like <a href=\"https:\/\/techcrunch.com\/2023\/08\/07\/meatable-35m-cultivated-meat-pork-foodtech\/\" target=\"_blank\" rel=\"noopener\">Meatable<\/a>, that\u2019s growing meat in in a dish instead of using a cow \u2014 they\u2019re a Dutch company but they\u2019re launching their products in Singapore, in the United States due to regulatory constraints.\u201d<\/p>\n<p>He also points the level of <a href=\"https:\/\/www.whitehouse.gov\/ostp\/news-updates\/2023\/03\/22\/fact-sheet-biden-harris-administration-announces-new-bold-goals-and-priorities-to-advance-american-biotechnology-and-biomanufacturing\/\" target=\"_blank\" rel=\"noopener\">recent biotech support announced by the Biden administration<\/a>, including a pledge to invest <a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/white-house-unveils-2-billion-biotech-spending-plan-ahead-industry-summit-2022-09-14\/\" target=\"_blank\" rel=\"noopener\">$2 billion in biotechnology and biotech manufacturing<\/a> \u2014 suggesting the bloc is lagging behind on financial support for the field too. \u201cAccording to McKinsey, about 60% of our current economic inputs you could make with biology,\u201d he says. \u201cAnd so that\u2019s substantial, right? Like everything that we consume is a lot larger than the things on the internet.\u201d<\/p>\n<p>\u201cOne of the things that\u2019s starting to become obvious is there\u2019s lots of application domains for these types of techniques,\u201d he adds, discussing generative AI\u2019s role in accelerating biotech R&amp;D. \u201cI mean, I\u2019m excited about ChatGPT and [popular generative AI] applications but let\u2019s say\u2026 [helping] science and R&amp;D teams to get their bio-based products to market faster to help us solve climate change may be a bit more important than producing better marketing copy.\u201d<\/p>\n<p>Earlier this month the European Union adopted a list of <a href=\"https:\/\/defence-industry-space.ec.europa.eu\/system\/files\/2023-10\/C_2023_6689_1_EN_annexe_acte_autonome_part1_v9.pdf\" target=\"_blank\" rel=\"noopener\">ten technologies<\/a> it considers critical to the bloc\u2019s future economic security \u2014 ranging from AI, quantum and advanced semiconductors, to space tech, robotics and biotech \u2014 making a clear statement of recognition of transformative and strategic potential. At the same time, four of the listed techs were flagged for further risk assessment, including biotech (the other three pegged for extra scrutiny are: AI, advanced semiconductors and quantum).<\/p>\n<p>The Commission\u2019s recommendation suggested Member States conduct collective risk assessments of these four critical areas by the end of the year \u2014 with lawmakers highlighting the possibility that transformative potential could also lead to highly sensitive risks, such as threats to fundamental rights or civil-military fusion.<\/p>\n<p>Reports have suggested the move <a href=\"https:\/\/www.euractiv.com\/section\/economy-jobs\/news\/stricter-eu-controls-on-critical-technologies-possible-from-spring-2024\/\" target=\"_blank\" rel=\"noopener\">could prefigure the introduction of additional EU regulations<\/a>.<\/p>\n<p>Of the four technologies flagged for risk assessments, biotech may be the least familiar, in terms of public understanding \u2014 with the term spanning practices like genetic modification; new genomic techniques (such as <a href=\"https:\/\/techcrunch.com\/2018\/01\/31\/watch-what-it-actually-looks-like-when-crispr-snips-a-strand-of-dna\/\" target=\"_blank\" rel=\"noopener\">CRISPR-Cas9 gene editing<\/a>); gene-drive; and synthetic biology (aka synbio; a multidisciplinary field); all of which were explicitly name-checked in the Commission\u2019s PR as examples of biotech that should be risk assessed by Member States.<\/p>\n<p>The listed techs all deal with manipulating genetic material but can involve different approaches and applications. Developments in one field may also dial up potential elsewhere \u2014 such as gene editing techniques increasing potential applications for synthetic biology, for example \u2014 further advancing the complexity of developments since there may be overlap in how these biotechnologies are applied.<\/p>\n<p>Despite relatively low public awareness of biotech advances, Cradle\u2019s van Grieken points out some techniques have actually been widely used in industrial processes for years \u2014 helping to produce things like detergents which can work at lower temperatures (via industrially produced enzymes); or synthetic insulin for diabetics (i.e. instead of extracting biological insulin from the pancreatic glands of slaughtered cows and pigs).<\/p>\n<p>While, as noted above, a newer wave of alternative protein startups \u2014 including companies being built in Europe \u2014 are leveraging developments in the field to do things like scale lab-grown meat or produce non-animal derived dairy proteins, on a mission to transform food systems without the huge carbon footprints attached to traditional (animal-derived) meat and dairy.<\/p>\n<p>But it\u2019s interesting how under the radar some of these regional applications of biotech remain. Certain terminology may be preferred (or avoided) in marketing copy \u2014 likely with an eye on regulatory risk and\/or consumer trust.<\/p>\n<p>\u201cPrecision fermentation is not synthetic biology per se,\u201d a spokesperson for one alt protein startup \u2014 France\u2019s <a href=\"https:\/\/techcrunch.com\/2023\/10\/11\/bon-vivant-seed\/\" target=\"_blank\" rel=\"noopener\">Bon Vivant<\/a> \u2014 told us, when we asked what it meant by \u201cprecision fermentation\u201d, the term it prefers for explaining its dairy-targeting biotech, querying the bio techniques it\u2019s applying to repurpose yeast microorganisms to brew up cow\u2019s milk proteins.<\/p>\n<p>\u201cAs a board member of Food Fermentation Europe, Bon Vivant is still working on a science based and still easily understandable definition,\u201d the spokesman also responded to our ask. Its marketing copy, meanwhile, studiously avoids saying it\u2019s genetically modifying yeast to produce milk proteins \u2014 which is essentially what it\u2019s doing \u2014 the closest it comes is writing that it \u201cprograms\u201d yeasts.<\/p>\n<p>Yet it\u2019s widely accepted that precision fermentation is an example of synthetic biology. (See, for e.g., <a href=\"https:\/\/en.wikipedia.org\/wiki\/Industrial_fermentation#Precision_fermentation\" target=\"_blank\" rel=\"noopener\">Wikipedia\u2019s definition<\/a>: \u201c<em>Precision fermentation is an approach to manufacturing specific functional products which intends to minimise the production of unwanted\u00a0by-products\u00a0through the application of\u00a0<a title=\"Synthetic biology\" href=\"https:\/\/en.wikipedia.org\/wiki\/Synthetic_biology\" target=\"_blank\" rel=\"noopener\">synthetic biology<\/a>, particularly by generating synthetic \u2018cell factories\u2019 with engineered genomes and metabolic pathways optimised to produce the desired compounds as efficiently as possible with the available resources<\/em>.\u201d) So it\u2019s curious to observe a European startup that\u2019s doing interesting things with synthetic biology being so reluctant to say so.<\/p>\n<p>The example speaks to the uncertainty steeping biotech developments in Europe \u2014 suggesting disruptors remain worried that causing a splash here could amp up their regulatory risk and bring fresh limits on their fledgling businesses, or at least trigger a new wave of consumer concern, rather than inviting admiration and unlocking homegrown support (or even \u2014 dare we say it \u2014 congratulatory cheerleading).<\/p>\n<h2>Cautionary tale<\/h2>\n<p>Cradle\u2019s van Grieken is concerned the EU taking an overly risk averse approach to biotech is out-of-date with where the bloc needs to get to; that precautionary treatment of biotech is riskily self-defeating when it comes to the challenges now facing the bloc, including its headline green ambition to get to \u2018Net Zero\u2019 by 2050.<\/p>\n<p>Europe is already \u201clate to the party\u201d when it comes to recognizing the economic and strategic importance of biotech compared to the US and parts of Asia, he argues. <span style=\"font-size: 1rem; letter-spacing: -0.1px;\">But his worry about the EU\u2019s <em>modus operandi<\/em> is an active frustration that the bloc may be creating a blindspot by not being more encouraging of a sector with transformative potential when it comes to tackling the existential crisis of climate change.\u00a0<\/span><\/p>\n<p>\u201c[Synbio\u2019s potential] is not actually being recognised in the environmental policies of the EU,\u201d he suggests. \u201cIf you look at the European Green Deal, a lot of it is focused on energy \u2014 like energy production, insulating more homes; it\u2019s focused on recycling; on reducing pollution \u2014 like mobility; those types of things. Synbio isn\u2019t really a theme. But it could be an incredibly powerful resource for the EU.<\/p>\n<p>\u201cThis specific [Commission] call to the Member States to figure out what the risks are [for biotech] \u2014 my worry is that we\u2019ll see increased regulation in this space without actually trying to promote the space and become\u2026 a leader in this space. Which we currently, unfortunately, are not. So that\u2019s my biggest worry. But I do think at least recognising that it is something that could be strategic, it\u2019s a good first step.\u201d<\/p>\n<p>\u201cBiotech is a serious business and we need serious regulation here,\u201d he adds when pressed to confirm his position. \u201cBut inversely, we don\u2019t want to hamper innovation based on outdated notions of what this technology can and cannot do.\u201d<\/p>\n<p><span lang=\"EN-US\">\u201cThe<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>EU needs to accelerate its regulatory processes and<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">be more receptive<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>to new technolog<span lang=\"EN-US\">ies,\u201d agrees Sofinnova\u2019s Bobanovi\u0107.<\/span> \u201cThis is<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">a<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>critical success factor in the global race to address climate change but<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">also to<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>ensure food<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">independence,<\/span><span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span>a topic becoming more prominent post<span lang=\"EN-US\">\u2013<\/span>COVID-19.\u201d<\/p>\n<p><span lang=\"EN-US\">\u201cFailing to adapt may see our innovations benefiting<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>other markets and<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">the EU<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>los<span lang=\"EN-US\">ing its <\/span>competitive edge<span lang=\"EN-US\">, much like the<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>electronics industry. Once<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><span lang=\"EN-US\">we lose<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>talent and knowledge centers<span lang=\"EN-US\">,<span class=\"m_-8931204457283301062apple-converted-space\">\u00a0<\/span><\/span>it is impossible to recover<span class=\"m_-8931204457283301062apple-converted-space\"><span lang=\"EN-US\">\u00a0<\/span><\/span><span lang=\"EN-US\">them,\u201d the investor\u00a0also warns.\u00a0<\/span><\/p>\n<p>Consumer concern about genetically modified organisms (GMOs) does have a long history in the EU \u2014 <a href=\"https:\/\/en.wikipedia.org\/wiki\/Genetically_modified_food_in_the_European_Union\" target=\"_blank\" rel=\"noopener\">especially in relation to food safety<\/a> \u2014 which likely informs the precautionary approach the bloc has adopted towards the use of biotech in food production since at least the early 2000s. Out of that has come <a href=\"https:\/\/food.ec.europa.eu\/plants\/genetically-modified-organisms\/gmo-legislation_en\" target=\"_blank\" rel=\"noopener\">a legal framework<\/a> that\u2019s focused on health and safety; harmonized risk assessments; labelling; and traceability.<\/p>\n<p>Consumer awareness of cutting edge biotech may be low but a <em>perception<\/em> of public concern over GMOs in food, which took root after an earlier era of developments during a time of more lax regulation, has been harder to shift. Yet actual consumer concerns are concentrated elsewhere, research suggests.<\/p>\n<p>A\u00a0<a href=\"https:\/\/www.efsa.europa.eu\/sites\/default\/files\/corporate_publications\/files\/Eurobarometer2019_Food-safety-in-the-EU_Full-report.pdf\" target=\"_blank\" rel=\"noopener\">2019 Eurobarometer survey on food safety<\/a> indicates EU citizens\u2019 concern over GMO has declined while worries about food risks associated with traditional farming methods are riding high. So while 44% of respondents (the largest proportion) said they were concerned about the presence of antibiotics and hormone residues in meat; and 39% were worried about pesticide residues in foods; a lower proportion \u2014 27% \u2014 said they were concerned about GMO being used in foods and only 4% were concerned about genome editing in this context (albeit, for the latter bio technique, the survey also found relatively low knowledge of the use of genome editing in food production \u2014 21% vs 60% for GMO in food \u2014 so very low concern there may be a reflection of low awareness).<\/p>\n<p>The survey results suggest EU policymaking in this area \u2014 certainly on the food front \u2014 risks being out of step with public safety concerns. (To wit: Environmental pollutants in fish, meat and dairy was another big worry for 37% of respondents.)<\/p>\n<p>Taken together the Eurobarometer paints a picture of regional consumers with substantial anxieties about the health risks (and environmental toll) attached to current farming and agricultural practices \u2014 and lower concern about biotech being applied to engineer food output. (Also relevant: A <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/api\/files\/document\/print\/en\/ip_21_3156\/IP_21_3156_EN.pdf\" target=\"_blank\" rel=\"noopener\">Eurobarometer survey from 2021<\/a> which found an overwhelming percentage of EU citizens consider climate change to be the most serious problem facing the world.)<\/p>\n<p>Yet the bloc remains saddled with a regulatory regime that<a href=\"https:\/\/www.reuters.com\/world\/europe\/late-night-breakthrough-brings-eu-closer-deal-farm-subsidies-2021-06-25\/\" target=\"_blank\" rel=\"noopener\">\u00a0ploughs massive subsidies into traditional agriculture<\/a> while demanding high levels of caution \u2014 and even throwing up regulatory hurdles \u2014 when it comes to applying biotech to critical sustainability challenges. Critics argue this combo looks increasingly misaligned with where the bloc says it wants to get to with its flagship green transition.<\/p>\n<p>Of course it\u2019s worth noting that policymaking across the 27-Member State bloc is complex, with many entities necessarily involved in change-making. The Commission\u2019s role, while important as a proposer of new pan-EU laws (and\/or legislative reforms), is just part of the picture. EU Member States themselves can also have their own biotech and bio-ethics rules and reforms \u2014 so a Commission intervention listing biotech as a critical tech, and pushing for Member States to conduct risk assessments, may be aimed at driving for harmonization between this patchwork of national laws \u2014 which could, ultimately, streamline and simplify life for biotech entrepreneurs down the line.<\/p>\n<p>Other factors also play a role. Another notable development for regulation of novel biotechs in the EU occurred, in 2018, when the Court of Justice (CJEU) <a href=\"https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&amp;docid=204387&amp;pageIndex=0&amp;doclang=EN&amp;mode=req&amp;dir=&amp;occ=first&amp;part=1&amp;cid=353866\" target=\"_blank\" rel=\"noopener\">ruled<\/a> that organisms produced using relatively new techniques, such as gene editing, should fall under the bloc\u2019s existing rules on GMO. So the legal system is also involved in interpreting how existing rules apply to biotech developments. But, again, it\u2019s up to policymakers to keep up with such developments and make sure legislative frameworks are providing the right incentives.<\/p>\n<p>\u201cEurope is complex in terms of regulation, market access,\u201d says Sofinnova partner Cedric Moreau, who is focused on the pharmaceuticals side of biotech investing. \u201c<span style=\"font-size: 1rem; letter-spacing: -0.1px;\">We are not as the US [where] when you have the go from the FDA you have a more than a 300 million people market opening and very homogeneous.\u201d<\/span><\/p>\n<p>\u201cWe see where the European Commission wants to go \u2014 making sure that [it\u2019s] not overlapping with State Members\u2019 policy and making sure that the definition, and the category and the activity are very well defined; to not prevent any innovation or [developments] in the space that could be impacted by [divergence in Member State laws],\u201d he suggests.<\/p>\n<p>\u201cIt\u2019s important to make some clear rules, clear definitions because [as investors] we need clarity,\u201d he also tells us. \u201cWhen we are investing in companies for five, eight, 10 years we cannot bet on regulation that will decide if our drug is a high unmet medical need or just an unmet medical need [for example]\u2026 And if our market exclusivity will be 10 years, or six years or nine years or five years. So we need to have clarity \u2014 and if it\u2019s not clear enough what we will have to do to build our business case is always to retain the more conservative scenario.\u201d<\/p>\n<p>\u201cAt Sofinnova, we are a strong believer of Europe,\u201d Moreau adds. \u201cBecause we are deploying \u2014 roughly 80% \u2014 of our capital in Europe. So we think that Europe is a fantastic playground for healthcare, for innovation. Because we have great science, great scientists, great people. And we have also an ecosystem that could really develop great success stor[ies]\u2026 Great products, impactful products for the patient. Then having said that\u2026 obviously, we think that there were several things that could be improved.\u201d<\/p>\n<h2>Climate urgency vs legal uncertainty<\/h2>\n<p>\u201cThere is some urgency to consider these types of techniques seriously,\u201d argues van Grieken, talking up the potential of synbio to help in the fight against climate change. \u201cI\u2019m not trying to advocate for \u2018no regulation\u2019 type of space. I think we need very strong controls. But on the actual end product, not on how they get researched and developed. And in certain cases, like for example with lab-grown meat or if you look at companies that are making alternatives to cheese or milk, those should be products that we should at least consider having on the market in the EU.\u201d<\/p>\n<p>\u201cTake a company like <a href=\"https:\/\/techcrunch.com\/2020\/10\/21\/bob-iger-goes-from-managing-mickey-to-directing-a-milk-replacement-startup-as-new-perfect-day-boardmember\/\" target=\"_blank\" rel=\"noopener\">Perfect Day<\/a> foods in the United States,\u201d he continues. \u201cThey\u2019re making milk without cows. They can do that at, like around \u2014 I think \u2014 it\u2019s 3% to 5% of the emissions compared to using a cow. That\u2019s a pretty significant improvement. And we use a lot of dairy products, right? And we have a planet on fire.\u201d<\/p>\n<p>As we <a href=\"https:\/\/techcrunch.com\/2022\/11\/16\/protein-programmers-get-a-helping-hand-from-cradles-generative-ai\/\" target=\"_blank\" rel=\"noopener\">reported last year<\/a>, Cradle is using generative AI to predict protein sequences to speed up R&amp;D for protein engineers building bio-based products. So its business is applying AI to accelerate biotech developments \u2014 which, of course, means it has an interest in speeding up biotech progress by encouraging a more R&amp;D-friendly regulatory environment, too.<\/p>\n<p>The acceleration its customers are seeing is considerable, as van Grieken tells it \u2014 turning what would \u201ctypically\u201d be a 1%-5% success rate for stabilizing a protein into a 50% success rate on average, thanks to the predictive power of its generative AI models. But stringent regulation is one brake the startup\u2019s tech can\u2019t uplift. Hence his call for EU lawmakers to zoom out and consider a bigger risk picture.<\/p>\n<p>One idea he welcomes is if the EU were to establish more regulatory sandboxes where biotech R&amp;D could be undertaken without so much legal uncertainty fogging the ambition \u2014 which amounts to a call for rules that focus more on outputs, than on the R&amp;D itself.<\/p>\n<p>When it comes to AI, a network of regulatory sandboxes is something the bloc is <a href=\"https:\/\/digital-strategy.ec.europa.eu\/en\/news\/first-regulatory-sandbox-artificial-intelligence-presented\" target=\"_blank\" rel=\"noopener\">in the process of setting up<\/a> \u2014 at the same time as EU <a href=\"https:\/\/techcrunch.com\/2023\/06\/14\/europe-takes-another-big-step-towards-agreeing-an-ai-rulebook\/\" target=\"_blank\" rel=\"noopener\">co-legislators are hammering out a comprehensive, risk-based framework for applying artificial intelligence<\/a>. So support for, and controls on, cutting edge techs are both possible under the regional lawmakers\u2019 playbook.<\/p>\n<p>Add to that, earlier this year (in April) the Commission put out out a <a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/pharmaceutical-strategy-europe\/reform-eu-pharmaceutical-legislation_en\" target=\"_blank\" rel=\"noopener\">proposal for reforming the bloc\u2019s pharmaceutical regulation<\/a> \u2014 which floats launching a regulatory sandbox as one of the suggested measures to boost regional innovation in drug research and design.<\/p>\n<p>But, in that case, the sandbox would be limited to products regulated as medicines. So even if the bloc\u2019s co-legislators adopt the proposal there are many other biotech innovations that won\u2019t be granted a safe space to experiment \u2014 since the end product they\u2019re aiming to disrupt isn\u2019t a pharmaceutical. (And of course climate change won\u2019t be fixed by popping a pill, personalized or otherwise.)<\/p>\n<p>Supporting the production of edible proteins without the climate-heating emissions of traditional agriculture is just one example of biotech\u2019s transformative potential for the environment. Bioplastics offer an alternative to petrochemical-based plastics, as another. While bioremediation is a field that offers promise for cleaning up pollutants \u2014 including by engineering microorganisms (such as algae) to accelerate uptake of CO2, the major climate heating gas.<\/p>\n<p>Also on a climate tip, production of biofuels could be more sustainably scaled up using biotech techniques \u2014 such as, again, by designing microorganisms that can more efficiently turn biomass into low carbon biofuels.<\/p>\n<p>European bioengineers are even working on genetically modifying plants to amp up their ability to fight indoor pollution (see: French startup <a href=\"https:\/\/techcrunch.com\/2022\/10\/27\/neoplants-bioengineers-houseplants-to-use-them-as-air-purifiers\/\" target=\"_blank\" rel=\"noopener\">Neoplants<\/a>). So when you start to really think about engineering biology for human and environmental utility the canvas looks broad indeed.<\/p>\n<p>Or, well, it should \u2014 but European biotech startups have to do their bluesky thinking from under a more legally clouded horizon.<\/p>\n<p>For biotech startups operating in the EU, van Grieken argues it\u2019s \u201csignificantly harder\u201d to do the R&amp;D and test potential innovations with so much regulatory risk hanging over the field. \u201cThere\u2019s a lot of uncertainty,\u201d he emphasizes. \u201cFor example, the Netherlands just introduced the ability to sample these types of [biotech-derived food] products and have investors taste them. But a very reasonable question from these investors is can you do that and sell this stuff? And if the answer is silence, then, you know, that is not a great answer. And I think this industry needs some clarity around that.\u201d<\/p>\n<p>Current EU rules also create some \u201cweird\u201d scenarios, as he tells it. For example, making an \u201cinformed edit\u201d to a genome (i.e. where a bioengineer thinks about what mutation to make) would \u201ctypically\u201d be considered a GMO in Europe (meaning the regulatory framework starts to apply) \u2014 whereas practices which produce random mutations, as happens a lot in the plant seed space, would not. So an operator that\u2019s, for instance, shining UV light on a plant seed and introducing random mutations falls under less regulatory risk than someone doing bioengineering to select for a specific mutation \u2014 perhaps seeking higher crop yield to boost productivity or resistance to drought \u2014 regardless of the motivations behind the intent.<\/p>\n<p>\u201cIf you think about how you might actually engineer one of these systems, it\u2019s considered problematic; but if you just do it randomly, it\u2019s fine. And so that\u2019s not very smart,\u201d he argues. \u201cBecause a lot of the techniques that we have today to make informed decisions about where to make changes in order to get to a certain outcome, that\u2019s also a safe outcome \u2014 so it\u2019s actually a lot better than doing it random.\u201d<\/p>\n<p><span style=\"font-size: 1rem; letter-spacing: -0.1px;\">\u201cIf you look at, for example, the United States or places in Asia where a lot of these synthetic biology techniques are allowed it\u2019s not like we\u2019re seeing any major problems,\u201d van Grieken also points out. \u201cSo we might be being a bit too constrained right now.<\/span><\/p>\n<p>\u201cYou should be able to show that your product is good; actually is improving its environmental footprint; is safe to use; is delicious, in the case to food, right \u2014 and all these types of things \u2014 and get approval for it in some reasonable amount of time so you can still get to market.\u201d<\/p>\n<h2>Towards a balanced approach?<\/h2>\n<p>Despite criticism that it\u2019s too cautious, EU lawmakers have been talking about evolving the bloc\u2019s approach to biotech. They have also been taking some action too.<\/p>\n<p>This summer, for example, the Commission adopted a <a href=\"https:\/\/food.ec.europa.eu\/system\/files\/2023-09\/gmo_biotech_ngt_proposal_2023-411_en.pdf\" target=\"_blank\" rel=\"noopener\">proposal<\/a> for a new regulation on plants produced by certain new genomic techniques (NGTs) which would allow plants produced in this way which could also occur naturally (or via conventional breeding) to be placed on the market \u2014 exempting them from requirements in the current GMO legislation.<\/p>\n<p>The NGTs the Commission has proposed loosening the rules for are targeted mutagenesis (aka plants that contain genetic material from the same plant); and cisgenesis, including intragenesis (i.e. plants that contain genetic material from crossable plants) \u2014 which would only need to undergo a verification process, under the proposal. Whereas transgenic plants (containing genetic material from non-crossable species) would remain subject to comprehensive, case-by-case risk assessment, approval and authorization prior to any sale under the EU\u2019s existing GMO Directive.<\/p>\n<p>The bloc\u2019s <a href=\"https:\/\/food.ec.europa.eu\/system\/files\/2020-05\/f2f_action-plan_2020_strategy-info_en.pdf\" target=\"_blank\" rel=\"noopener\">Farm to Fork Strategy<\/a>, meanwhile \u2014 part of the aforementioned European Green Deal which is focused on driving sustainability of agriculture and food production \u2014 recognizes biotech as having potential to contribute to the fight against climate change. \u201cNew innovative techniques, including biotechnology and the development of bio-based products, may play a role in increasing sustainability, provided they are safe for consumers and the environment while bringing benefits for society as a whole. They can also accelerate the process of reducing dependency on pesticides,\u201d the Commission wrote in the May 2020 strategy document.<\/p>\n<p>Although, subsequent to that, a 2021<a href=\"https:\/\/food.ec.europa.eu\/system\/files\/2021-04\/gmo_mod-bio_ngt_eu-study.pdf\" target=\"_blank\" rel=\"noopener\">\u00a0study<\/a> the EU undertook of new genomic techniques noted the \u201crapid\u201d development of NGTs and their products over the past two decades \u2014 finding \u201cc<span style=\"font-size: 1rem; letter-spacing: -0.1px;\">onsiderable interest\u201d in conducting research on NGTs in the EU. But it also identified that \u201cmost\u201d development is taking place outside the EU. Which does support the contention the bloc is lagging when it comes to biotech research, despite \u201cconsiderable\u201d homegrown appetite to do this cutting-edge work. <\/span><\/p>\n<p><span style=\"font-size: 1rem; letter-spacing: -0.1px;\">\u201cFollowing the [2018 GMO] ruling of the [CJEU], there have been reports of negative impacts on public and private research on new genomic techniques in the EU due to the current regulatory framework,\u201d the EU\u2019s executive also noted in the study. <\/span>\u201cRegulatory barriers would particularly affect small and medium-sized enterprises (SMEs) and smallscale operators seeking to gain market access with new genomic techniques, even though many Member States and stakeholders see opportunities for them in this sector.\u201d<\/p>\n<p>\u201cThe use of NGTs raises ethical concerns but so does missing opportunities as a result of not using them,\u201d it went on, essentially echoing van Grieken\u2019s point. \u201cBased on the findings of the study, most of the ethical concerns raised relate to how these techniques are used, rather than the techniques themselves.\u201d<\/p>\n<p>At that time, the Commission concluded that any further policy action in the area should be \u201caimed at reaping benefits from innovation while addressing concerns\u201d, further stipulating that a \u201cpurely safety-based risk assessment may not be enough to promote sustainability and contribute to the objectives of the European Green Deal and in particular the \u2018Farm to Fork\u2019 and biodiversity strategies\u201d. The document also explicitly recognized that risk assessment alone could lead to a flawed evaluation process \u2014 in which \u201cbenefits contributing to sustainability\u201d are not properly considered.<\/p>\n<p>Asked about the critique it\u2019s over-indexing on risk, when it comes to biotech, and not properly weighting potential sustainability (or, indeed, other) benefits, a Commission spokesperson declined to provide comment. But they pointed us to an <a href=\"https:\/\/research-and-innovation.ec.europa.eu\/research-area\/environment\/bioeconomy_en\" target=\"_blank\" rel=\"noopener\">EU webpage on R&amp;D and the \u201cbioeconomy\u201d<\/a> \u2014 where the EU\u2019s executive also talks up the transformative potential of homegrown biotech developments, writing for example that: \u201cStronger development of the bioeconomy will help the EU accelerate progress towards a circular and low-carbon economy. It will help modernise and strengthen the EU industrial base, creating new value chains and greener, more cost-effective industrial processes, while protecting biodiversity and the environment.\u201d<\/p>\n<p>The page also links to the bloc\u2019s long-standing <a href=\"https:\/\/research-and-innovation.ec.europa.eu\/research-area\/environment\/bioeconomy\/bioeconomy-strategy_en\" target=\"_blank\" rel=\"noopener\">bioeconomy strategy<\/a> \u2014 which features an action plan that lists carrying out an analysis of \u201cenablers and bottlenecks for the deployment of biobased innovations\u201d as one of 14 \u201cconcrete actions\u201d regional lawmakers are committed to (on paper at least).<\/p>\n<p>The EU bioeconomy strategy was originally set out back in 2012, and reviewed in 2018, with the aim of supporting 2030 Sustainable Development Goals; the Paris Agreement climate objectives; and new EU policy priorities \u2014 with the Commission writing then that reaping the \u201ceconomic, social and environmental benefits of the bioeconomy, dedicated bioeconomy strategies, investments and innovation are required at all levels in the EU\u201d. Hence the updated strategy emphasizing the need for the development of national and regional bioeconomy strategies.<\/p>\n<p>Five years on from that, the Commission lists just nine Member States that have set out a national bioeconomy strategy (Austria, Finland, France, Germany, Ireland, Italy, Latvia, the Netherlands and Spain) \u2014 meaning a substantial majority of EU members still lack this piece of the biotech ecosystem support puzzle. So, clearly, there\u2019s more work for regional lawmakers to do to match the bloc\u2019s ambition to build up Europe\u2019s biotech base with actions that deliver results.<\/p>\n<p>Looking ahead, Cradle\u2019s van Grieken sees two big ares of promise for biotech: Human health being the first one; and what he refers to as \u201cplanetary health\u201d as the second. \u201cThe reason why I left Google is because those are two of the major problems that my generation faces in the world,\u201d he tells TechCrunch. \u201cIn human health, increasingly I think we\u2019ll be a lot better at targeting disease with these types of [bioengineered] molecules and curing people.<\/p>\n<p>\u201cOn the planetary health side, I think what will increasingly see is that bio-based products will come out that are cheaper than the petrochemical or animal alternatives. Because, ultimately, biology can do a lot of these things in a much lower energy way and also environmental footprint. I think we\u2019re going to see\u00a0a breadth of products that is going to be super exciting.\u201d<\/p>\n<p>He\u2019s also bullish on cost \u2014 suggesting developments in generative AI can be the flywheel that speeds up biotech R&amp;D \u2014 and that acceleration of developments in the lab will draw down the costs entailed in unlocking the big, transformative biotech benefits.<\/p>\n<p>\u201cIt\u2019s also why we started Cradle \u2014 to really accelerate R&amp;D and make R&amp;D a lot cheaper,\u201d he says, arguing: \u201cThere is no fundamental reason why this cannot be done\u2026 Biology is ultimately capable of doing very complicated things at very low energy \u2014 like, look around you right now. There\u2019s probably a plant somewhere there and try to realise that it\u2019s just like water and ambient carbon that created that, right? It\u2019s just wild, if you think about it.\u201d<\/p>\n<p>French startup Bon Vivant, meanwhile, is working to build a European business that can help tackle the planetary health challenge head on. As noted above, it\u2019s reprogramming yeast microorganisms to produce milk proteins to offer the food industry an alternative so they can sell non-animal-based dairy products \u2014 which could have a massive impact on shrinking CO2 emissions if taken up at scale.<\/p>\n<p>Foods derived from animals, including dairy, are generally associated with the highest greenhouse gas emissions (see, for e.g., this <a href=\"https:\/\/www.un.org\/en\/climatechange\/science\/climate-issues\/food\" target=\"_blank\" rel=\"noopener\">UN data on kilograms of emissions per kg of food<\/a>) \u2014 owing to factors including land use, methane emissions from livestock and nitrous oxide emissions from the waste produced by animals. So biotechnologies applied to food production which can replace the need for us to get so much protein from animal sources have the potential for radical reductions in emissions if we integrate these new processes into our food systems.<\/p>\n<p>Asked about the regulatory challenge of building an alternative protein business in Europe, Bon Vivant\u2019s co-founder, St\u00e9phane MacMillan, offers two thoughts. On the one hand he sounds sanguine \u2014 suggesting high food safety standards in the EU could create a competitive advantage for local startups over time, as a sort of \u2018gold standard\u2019 mark (i.e. once regulatory clearance to sell locally is obtained, which he estimates in their case may take two to three years vs a quicker anticipated time-to-market over in the US).<\/p>\n<p>\u201cEveryone is saying, well, it takes too long in Europe to get approval. Okay, it\u2019s taking longer than any other countries but at the same time we have to be proud of standards that we have in Europe,\u201d he tells TechCrunch. \u201cThese standards are also the reason why European food is really seen as the best class in most parts of the world. So we have to comply with it. It takes a bit more time. But, at the same time, I think\u2026 that guarantee for the consumer that our products are absolutely non-GMO \u2014 that\u2019s really important and [builds trust] with customers.\u201d<\/p>\n<p>But he also suggests the bloc\u2019s policymakers need to find \u201cthe right balance\u201d \u2014 between having such high homegrown standards and risking a future where European consumers are forced to buy foreign bio products \u201cbecause we were not able to build the champions\u201d.<\/p>\n<p>\u201cIt\u2019s not black or white,\u201d he suggests. \u201cIt\u2019s a balance that we need all to find collectively. Both are right. But we just to find the right balance.\u201d<\/p>\n<p>Offering an investor perspective on the same point, Sofinnova\u2019s Bobanovi\u0107 sees even less upside for EU biotech startups trying to turn increasingly strict regional food safety standards into a competitive advantage. So \u2014 at the least \u2014 the suggestion is the bloc shouldn\u2019t be looking to pile more rules on the sector if it\u2019s serious about growing the bioeconomy.<\/p>\n<p>\u201cWhile Europe\u2019s stringent rules might enhance consumer trust in certain sectors, it\u2019s unlikely the case for biotech,\u201d he argues. \u201cUnlike the luxury industry where \u2018made in Europe\u2019 is an advantage most food products are destined for local consumption and consumers already trust regulations. Increased regulation is not likely to influence product adoption.\u201d<\/p>\n<\/p><\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/techcrunch.com\/2023\/10\/17\/biotech-eu\/\" target=\"_blank\" rel=\"noopener\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>European Union lawmakers are being urged to avoid too much risk aversion from holding back the potential of the homegrown biotech sector. Developments in biotech could be transformative in a range of critical sectors. Beyond huge promise in healthcare, innovative, low carbon applications in areas like agriculture and food systems and energy production could help [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":46507,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"class_list":{"0":"post-46506","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-tech"},"_links":{"self":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/posts\/46506","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/comments?post=46506"}],"version-history":[{"count":0,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/posts\/46506\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/media\/46507"}],"wp:attachment":[{"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/media?parent=46506"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/categories?post=46506"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/entertainment.runfyers.com\/index.php\/wp-json\/wp\/v2\/tags?post=46506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}