The Future of Protein Production Summit Speaker Profile: Hannah Lester, CEO & Principal, Amgen Regulatory Consulting

A regulatory affairs expert with more than 15 years’ experience, Hannah Lester has worked extensively on cell-cultured products, plant protein isolates, fermentation and precision fermentation products, algae, seaweed, and traditional foods. Here, we find out a little bit more about her hopes and dreams for the alternative proteins sector

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What makes Amgen Regulatory Consulting stand out from the crowd, according to Hannah Lester, the company’s CEO & Principal, is that it was one of the first regulatory consultancies in the world to specialize only in alternative proteins and food-tech.

In a relatively nascent yet fast-paced sector, where regulators are often playing catchup with the scientists, this is a key differential. “People also really feel our passion for the industry and know that we are not your typical regulatory consulting company,” Lester notes, with a smile.

In a nutshell, Amgen assists clients in the space to determine if their products are feasible from a regulatory perspective and provides regulatory strategic advice to find the optimal route to market. “We also help to build the evidence and studies they need to present to the regulatory authorities to demonstrate that their product is safe to enter the market,” Lester explains. “We provide regulatory support in the European Union, the UK, the USA, Australia/New Zealand and Singapore.”

In addition to her role with Amgen, Lester is also currently Head of Regulatory at the French cultivated meat company, Gourmey, which is busy trying to bring foie gras to the table. She hasn’t always worked in food though. Before entering the industry, she worked on veterinary medicines, specifically anti-parasitic drugs for pets and food producing animals. On that previous career, she says she felt increasingly uncomfortable about how they were used prophylactically and were causing issues with resistance, much as we have seen with bacteria and antibiotic resistance.

When I heard about cultivated meat about six years ago, I thought, ‘Wow – this is the future!’ I then started researching and learning everything I could about the technology and the regulatory environment and hurdles

“I then got into regulatory affairs and worked on feed additive registrations, as I believed that feed additives provided an alternative to antibiotics and could help to support more sustainable farming practices, but I began to feel more and more uneasy supporting animal agriculture and trying to find short-cuts to improve the efficiency of animal farming. So, when I heard about cultivated meat about six years ago, I thought, ‘Wow – this is the future!’ I then started researching and learning everything I could about the technology and the regulatory environment and hurdles.”

That kick-started Lester’s passion for alternative proteins and food-tech in general, so she began reaching out to companies in the space to see how she could assist them. “I remember attending the 2019 KindEarth.Tech event in Amsterdam and met the inimitable Ira van Eelen and was just so inspired by all the incredible people and companies that wanted to make a difference that I decided that I wanted to play a part in this amazing ecosystem and realized that I could contribute by supporting these companies in getting regulatory approval. “

In supporting the food-tech industry’s innovators, Lester sees first-hand the myriad of challenges. “I think the biggest ones for food-tech companies are making that shift from biotech companies to companies that produce safe food at scale,” she says. “There are not enough people with the right skillsets to go around. Fermentation scientists and bioengineers, for example, are in hot demand, and of course regulatory hurdles pose a very big challenge for all food-tech companies.”

Scaling, as ever, is also a hurdle and here Lester believes that funding is one of the major roadblocks. “Currently, food-tech companies are heavily reliant on investments from venture capital. If they get cold feet, then this will seriously slow things down and impede scale-up. We need government investment support, perhaps in the form of a shift in agricultural subsidies and tax-relief.”

I think a lot of the investments made during the boom-time were not so aware of the regulatory challenges and expected products such as cultivated meat to obtain approval much more quickly than we have seen

On the topic of finance, after riding the crest of a spectacular wave for a few years now, investments into alternative proteins have tailed off a little, albeit this is more likely a realistic adjustment to a period of over-exuberance. “I speak to a lot of VC companies looking to invest in alternative proteins,” Lester reveals. “I think a lot of the investments made during the boom-time were not so aware of the regulatory challenges and expected products such as cultivated meat to obtain approval much more quickly than we have seen. I think they are now much more focused on the regulatory challenges faced by companies and want to know the regulatory feasibility of getting a product to market. I am now seeing that regulatory is a massive part of the due diligence assessments.”

Lester is not concerned though. “I believe companies in the sector will weather the current economic storm. We need food-tech and alternative proteins to increase food security and reduce the negative impact of intensive animal agriculture.”

These economic blips aside, Lester cites recent developments such as the US Food and Drug Administration’s apparent thumbs-up for UPSIDE Foods’ cultivated chicken products as a reason to be optimistic about the medium- and long-term prospects for the sector overall.

The UPSIDE pre-market consultation was not the first to be submitted as they are Cell Culture Consultation (CCC) number ‘002’, hence it will be interesting to see who was ‘001’ and when their FDA feedback will be published

“The FDA ‘No Questions’ letter on the UPSIDE Foods dossier is indeed a positive signal to the industry, investors, etc,” Lester notes. That said, she believes the job is only half done. “The FDA evaluates the safety of cultivated meat up to the point of cell harvest and then the USDA/FSIS are responsible for post-harvest safety including labeling. UPSIDE still needs the green light from the USDA before being able to place its cell cultivated chicken on the US market. Interestingly, the UPSIDE pre-market consultation was not the first to be submitted as they are Cell Culture Consultation (CCC) number ‘002’, hence it will be interesting to see who was ‘001’ and when their FDA feedback will be published.”

Of course, for others to follow UPSIDE’s lead and take their products from the lab to the frying pans of the general public requires a great deal of collaboration between all stakeholders, not least the regulatory agencies, governmental bodies, and industry and consumer associations.

We need a united voice to solve complex issues such as the labeling and nomenclature of alternative proteins, and also lobby governments and decision-makers to pave the way to market for these products

“There is a lot of cooperation between companies that are members of industry stakeholder groups such as Cellular Agriculture Europe and also cooperation between different cellular agriculture groups globally, which is very exciting and encouraging to see,” Lester enthuses. When asked if she believes there could be more collaboration between the industry’s innovators, she does concede it is difficult to balance collaboration with intellectual property in such a highly competitive environment. “I think collaboration among food-tech companies on pushing the regulatory agenda is an area where IP would not get in the way, and we need a united voice to solve complex issues such as the labeling and nomenclature of alternative proteins, and also lobby governments and decision-makers to pave the way to market for these products.”

Lester thinks the pathway for everyone in the sector could be made a lot easier to negotiate if we saw regulatory harmonization between major global markets and provision of clear guidance for applicants, although she is not holding her breath for that. “Mutual recognition of regulatory approvals between regions would be extremely beneficial to the industry, but probably highly unlikely,” she admits. “The best we can hope for is cooperation and knowledge exchange between regulators (which we are seeing between the USA and Singapore, for example), and for Codex Alimentarius to provide guidance that regulators in different countries/regions can adopt/adapt to their particular framework.”

Where there are challenges, there are opportunities. And let us not forget that we’re talking about disrupting an industrialized global food production system that is decades and decades old, and we humans have been eating meat for 3.3 million of our six million years on Earth. It’s not going to be a quick fix – alternative proteins are still in their very, very early days, hence the innovations making the headlines today will be superseded by more tomorrow. There is still so much more room for innovation.

And on that note, which of the products Lester has tasted is she most impressed with? “I recently tried Redefine Meat’s beef flank, which was incredible – the taste and texture were unbelievable,” she reports. “I also tried Remilk’s ice-cream containing their non-animal whey protein which was mind-blowingly good! In general, I am most excited about cultivated products and proteins derived from precision fermentation as they offer direct alternatives to conventional meat/dairy.”

Lester also feels that the nutritional qualities of alternative proteins need a great deal of focus as any novel source of protein that is intended to replace an existing source of protein should not be in any way “nutritionally disadvantageous”. Also, she adds, if we start making claims on alternative proteins then that can “get complicated from a regulatory point of view” as you need to be able to substantiate your claims and, in the European Union, “nutrition and health claims are strictly regulated”.

Of course, there is a much bigger picture when it comes to the introduction of alternative proteins. Livestock farming accounts not only for 59% of food-related GHG emissions, but also for 82% of agricultural land use. If animal-related products were replaced with more efficient, sustainable, alternative proteins, a dual climate benefit could be realized. Furthermore, according to a Boston Consulting Group/Blue Horizon report released in 2022, with 25% of global greenhouse gas emissions coming from the food value chain, a shift to alternative proteins may also represent the most capital-efficient and high-impact solution to addressing the climate crisis. It even went as far as to suggest that alternative proteins could save three times the emissions for each dollar invested compared with decarbonizing cement!

My eight-year-old niece lives in a small village in the English countryside, which is very conservative and many of the local families are connected to animal farming in one way or another – even she was recently debating cultivated meat with her friends

It will take time – years, perhaps even decades – but we will get there. We may be pinning our hopes on the generations to come. “My eight-year-old niece lives in a small village in the English countryside, which is very conservative and many of the local families are connected to animal farming in one way or another – even she was recently debating cultivated meat with her friends,” Lester tells us. “She boldly stood up in front of her classmates and said that it was the future! At first, they didn’t believe it was real, but she managed to explain that cultivated meat is ‘grown in big tanks like yoghurt and doesn’t hurt animals’. If we can get young people talking about alternative proteins, then this gives me great hope!”

Ultimately, though, Lester hopes that by 2030 we see cultivated meat and seafood on the shelves in supermarkets globally and that dairy and cheese made using precision fermentation are commonplace. “I also hope that these products are affordable and are being subsidized by governments that are serious about meeting climate and sustainability targets. As for us at Amgen Regulatory Consulting, well, I hope that we are able to play a part in helping many of these companies get regulatory approval.”

‍The Future of Protein Production Summit takes place virtually on 21/22/23 February 2023. Tickets are on sale now so to register to hear Hannah and more than 80 other speakers, 50 presentations, eight panel discussions, and three start up pitch symposiums, click here