Category: Policy

It’s been a big week here at Ginkgo and for the future of the bioeconomy!

The White House issued an executive order to launch a national biotechnology and biomanufacturing initiative & tapped Ginkgo’s Renee Wegrzyn to lead the Advanced Research Projects Agency for Health.

The White House has made it clear: the future lies in biotechnology. On Monday, Sept. 12, President Biden signed an executive order – Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy – that launched a national biotechnology and biomanufacturing initiative. The executive order will accelerate the use of biotech in industries such as agriculture, medicine, and energy as an alternative to fossil fuel-based products.

Also on Monday: Dr. Renee Wegrzyn — Ginkgo’s very own Vice President of Business Development — was tapped by President Joe Biden to lead the Advanced Research Projects Agency for Health (ARPA-H) as its first director. ARPA-H is a new government agency, formed in March 2022, that will drive biomedical innovation to support the health of all Americans.

Then, on Wednesday, Sept. 14, Ginkgo’s CEO Jason Kelly joined a Summit on Biotechnology and Biomanufacturing, hosted at the White House. Government and industry leaders discussed how to grow the bioeconomy and better leverage it against our most pressing economic, ecological, and societal challenges like climate change and supply chain insecurity. Jason spoke about being at the forefront of “the DNA Age” and noted the importance that this industry be built with care and U.S. values. Read Jason’s full remarks below.

The new Executive Order on Biotechnology and Biomanufacturing stands to have a momentous impact on the industry.

The executive order contains a wide array of new efforts by the U.S. government to support the wider synthetic biology and biotechnology sector. Read the full White House fact sheet here for a quick overview. Here’s a snapshot of the initiative objectives:

• Grow domestic biomanufacturing capacity
• Expand market opportunities for bio-based products
• Drive research and development to solve our greatest challenges
• Improve access to quality federal data
• Train a diverse skilled workforce
• Streamline regulations for products of biotechnology
• Advance biosafety and biosecurity to reduce risk
• Protect the U.S. biotechnology ecosystem
• Build a thriving, secure global bioeconomy with partners and allies

 

Ginkgo’s Renee Wegrzyn asked to lead ARPA-H

Ginkgo is feeling OVER THE MOON that Dr. Renee Wegrzyn, our current Vice President of Business Development, has been asked to be the inaugural Director of ARPA-H. Renee will be charged with shaping the agency’s vision and approach from the ground up. We at Ginkgo know that Renee is the perfect person to meet this moment. Before Ginkgo, Renee accrued a diverse set of experiences leading R&D teams in industry and serving as a Program Manager at DARPA. She’s spent the past two years developing Ginkgo’s biosecurity innovation pipeline, implementing new tools to combat infectious disease, and shaping our emergency COVID-19 response.

We will miss Renee dearly, but view her upcoming appointment as a huge signal of progress for the future of biotech, pharmaceuticals, and medical innovation. We feel this is a major leap forward in creating an equitable, resilient, and innovative health system. Read the full White House announcement about Renee here.

Read through our CEO Jason Kelly’s full remarks from the White House Summit on Biotechnology and Biomanufacturing.

Jason visited the White House on Wednesday to discuss the future of biotechnology with government officials and industry leaders. Many topics were explored, like bringing bio-products to market, expanding domestic biomanufacturing, and using biotech to strengthen supply chains as well as fostering a diverse, skilled workforce and next generation of leaders.

Watch the recording of the full Summit or read a transcript of Jason’s live remarks below.

“Today, Ginkgo is the largest designer of synthetic DNA in the world. What does that mean? It means you go on a computer, you type ‘ATCGGG,’ you hit print, and a piece of DNA gets printed out of our labs in Boston or partner companies like Twist in California. We then take that DNA, and we put it into the genome of a cell – like installing an app on your phone. And it makes the cell do something new! That’s our business. We do that as a service for customers.

So what types of applications are we seeing our customers ask for? Well, we work with Bayer Crop Science on a project – a $100 million project – to engineer microbes to produce fertilizer for crops. We’re helping them develop microbes that take nitrogen right out of the air and feed it to the crop. If you are successful at this, that’s 1 to 2% of global greenhouse gas, and it’s a big supply chain problem as we know today –  that’s just one project.

We have a project with a company called Allonnia that’s asked us to engineer microbes to break down PFAS. This is something where the administration’s really led, thanks to the EPA, to get this chemical out of our water sources.

We’ve worked with companies that want rare disease treatments to ones that focus on rare earth element recovery.

The range on bioengineering is unbelievable. To me, this means that the DNA Age that’s coming is going to be more important than the Electronics Age that we saw over the last 75 years.

While biology is programmable like electronics and computers, it’s important to note that it’s not predictable like computers. We saw this with COVID-19 – biology can get out of control. And so it was great to hear the comments [earlier during this summit] about biosecurity and biosafety. I think this is going to be absolutely critical as we do that. So we’ve been lucky to work with the CDC — with their airports program — that caught the first cases of the BA.2 and BA.3 variants entering the US with our surveillance sequencing program. This is the beginning of a ‘hurricane warning system’ for infectious disease. We have to have this stuff as we enter the age of programmed biology.

We work with the US Department of Health and Human Services(HHS) through Operation Expanded Testing. This is in my opinion one of the most important biosecurity programs in the country: it kept schools open through the Omicron wave and it’s rolled out nationwide testing available for free in schools. Enormously important. 

The last thing I want to say is as we’re building this technology, it’s extremely important that we do it with care. It was excellent to hear the comments about wanting to share the benefits of this technology with the wider public. I think it’s also important to note, we want the wider public to participate in this technology. We spend a lot of time on literacy. We teach people to read and write. We need bio literacy. We need to teach people to read and write DNA so that they’re not just receiving the benefits of this, they’re the actual creators of this in the future. I want to say the DNA Age is coming, and I want to thank you all for your leadership in making sure that it’s built on US values.” — Jason Kelly, CEO of Ginkgo Bioworks

Find the full press release detailing the ARPA-H announcement here along with all of the latest news from the Ginkgo team.

Exciting times ahead! What will you grow with Ginkgo?

Earlier today, the US Senate passed the final version of the FY 2022 National Defense Authorization Act (NDAA), which establishes a National Security Commission on Emerging Biotechnology. From here, the Act heads to the White House for President Biden’s signature. Its passage signifies the increasing importance of biotechnology and synthetic biology to competitiveness and national security.

The Commission comes at a critical time for national and international biosecurity. As communities around the globe continue the fight against COVID-19, we are relying on synthetic biology to give us the tools to test, vaccinate, and protect global populations. Further, synthetic biology and biotechnology are vital tools in our efforts to address climate change and meet emissions reductions targets. It’s essential that governments do all they can to support the growth of these critical technologies.

Once established, the new Commission will consider the methods and means necessary to advance the development of synthetic biology, bioengineering, and associated technologies to comprehensively address the national security and defense needs of the United States while enabling a thriving bioeconomy. Specifically, the Commission will present a strategy to establish the United States as the leader in the global bioeconomy. This will include clearly outlined steps the country must take to responsibly use synthetic biology for national security and defense – including the defense against biological threats – and promote synthetic biology innovation.

The time is ripe for such an effort, and we applaud it.

According to McKinsey & Co., in the next 10-20 years, industrial applications of biology are expected to generate direct economic impacts of up to $4 trillion per year, much of which is expected to result from applications of biotechnology such as those created by cell developers on our platform.

At Ginkgo, we’ve long believed that synthetic biology is the next frontier of biotechnology and biosecurity. Countries around the world are heavily investing in this technology, and the National Security Commission on Emerging Biotechnology will help the United States better understand the needs of the domestic and global bioeconomy and the biosecurity landscape presented by the first decades of this biological century.

We applaud Armed Services Chairman Sen. Jack Reed (D-RI) and Rep. Adam Smith (D-WA-9), and Ranking Members Sen. James Inhofe (R-OK) and Rep. Mike Rogers (R-AL-3), as well as Reps. Mike Gallagher (R-WI-8) and Seth Moulton (D-MA-6) for their bipartisan leadership in establishing this important Commission.

Our products were built with genetic privacy as a core ethical and design principle. We’d like to explain a bit more about our company, how we do our testing, and why we don’t collect human genetic information.

There are many reasons why people should care about their genetic privacy and who might have access to the sequences of their DNA. We take all privacy concerns very seriously, and we developed our pooled test with privacy as an essential design principle.

Our test is a public health tool designed for communities. This means the only data we’re interested in collecting or analyzing is data that will enable communities to formulate the best public health response to COVID-19. Specifically, we’re only interested in the viral RNA in the pooled samples.

At its core, our pooled test is designed to be an easy way for groups of people to swab their nostrils and receive a result. Each nasal swab is also bound to capture some biological material from each person, including small bits of their DNA. However, we have no interest—financial, scientific, or otherwise—in the human DNA that’s also present in these samples. Still, we feel it is necessary to safeguard people’s privacy through several layers of protection.

Layers of Privacy Protection

Our first layer of privacy protection begins at the school and on our website. The names of the individuals in a pooled sample cannot be entered into our website by schools. This means we never see information about which person’s swab is in which tube; we do not know this information. The participants in each tube are anonymous to us. Our HIPAA-compliant website also provides a layer of protection at the school by minimizing access to results to only people authorized by each school.

We also protect privacy in our labs. When pooled samples are sent to our network of labs, we use one of two methods to identify whether or not the virus is present in the sample. Some labs use a technique called PCR, which gives us a simple “yes” or “no” answer to whether the genes of the virus—and thus, the virus—are present in a sample. Our lab and others use PCR combined with a technique known as sequencing, which also gives us a “yes” or “no” answer. However, the sequencing process can also read and record the sequence of viral genes. This gives us more detail about the virus if it’s present in a sample, which can be useful for detecting new variants. You can read our “ELI5” explainer post on how our test works for more information.

As part of our lab testing process, we do look for a particular human gene sequence. But we only do this as a quality control measure to ensure that samples were collected correctly and that our test worked as intended. This is a common method used in viral tests to ensure quality, and we selected our quality control sequence with privacy in mind. The sequence is nearly identical in every person and can’t be used to identify individuals. The gene sequence isn’t used or recorded for any purpose other than to provide a test result.

We also do not store the sequence of this gene. Simply put: we have no interest in it nor do we have your permission to store or use this information. Other than the quality control gene sequence, we never sequence, analyze, or use the human DNA that is present in the pooled sample.

Additionally, we do not store samples for longer than what is typical for quality standards. In our lab at Ginkgo, most of the time the sample is completely used up during the testing process. If there are leftover samples, we only retain those samples for 7-14 days and only do so for the purpose of quality checks or re-running tests if necessary. Thus, we do not (and cannot) perform tests on samples for research or any other purpose.

Our test also allows us to understand how the virus is changing and gives us the ability to track new variants. We can do this by sequencing the viral RNA when it is found in a pooled sample. Comparing viral RNA sequences is how public health organizations like the CDC understand what public health measures are needed to end this pandemic. To assist this effort, we may sequence the viral RNA that is found in a pooled sample. This genetic information cannot be connected to an individual.

Everybody’s Health is Connected

Many companies have benefited from collecting personal information from individuals and exploiting that data. We started Concentric with the goal of empowering communities and enabling public health because everybody’s health is connected. We are focused on making sure that our platform is used responsibly and with care for everyone it impacts. When it comes to Concentric, we’re not interested—even remotely—in the use of human DNA, human RNA, or other human biomaterials gathered through testing.

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Glossary

DNA: The molecule that’s used by living things for long-term storage of genetic information. (back)

Gene: “Gene” is actually a very tricky word to define! Nowadays, it usually means the sequence that instructs a cell to make a certain product. (back)

Genetic privacy: The idea that personal genetic information must be protected from unauthorized access or use. (back)

PCR (polymerase chain reaction): A technique that makes very many copies of a piece of DNA. (back)

RNA: Like DNA, RNA can provide instructions for making certain products. But it can also do more, like help cells carry out chemical reactions. (back)

Sequence: A series of specific molecules of DNA or RNA that make up a longer strand. (back)

Sequencing: Recording the specific molecules that make up a strand of DNA or RNA. (back)

 

Now more than ever, we see the importance of biology: from responding to public health crises to building more resilient supply chains, biology defines what is possible. That’s why we’re so excited to see the Senate take the time to consider biology in the bipartisan Bioeconomy Research and Development Act of 2020, which is set to be marked up by the Senate Commerce Committee on Wednesday, May 20th, 2020. Ginkgo enthusiastically supports this legislation, led by Senator Kirsten Gillibrand (D-NY), Senator Ed Markey (D-MA), Senator Cory Gardner (R-CO) and Senator Marco Rubio (R-FL).

The legislation elevates the importance of a cohesive and coordinated national strategy to guide and expand the field of synthetic biology through the implementation of a National Engineering Biology Research and Development Initiative. This Initiative will facilitate coordination between many U.S. agencies, including DOE, DoD, NIH, NSF, NASA, FDA, USDA, and EPA, to expand synthetic biology research, increase bioeconomy workforce training, and encourage commercialization of biological innovations.

This Initiative will help meet a critical need for federal government action that I recently described in testimony to the Senate Commerce Subcommittee on Science. To ensure America continues to be a leader in synthetic biology, the U.S. government must strategically reinvest in its bioeconomy. The U.S. has done this before with semiconductors, space technology, and ARPANET.

Video from the Securing U.S. Leadership in the Bioeconomy Senate hearing. My testimony begins at 41:27
Synthetic biology will be the world’s next industrial revolution. As proven by the COVID-19 pandemic, our ability to quickly develop new medicines and vaccines using synthetic biology, as well as to manufacture a wide range of essential materials and products in a sustainable and resilient way will define the technology of the 21st century the way that digital technologies defined the 20th. It is essential that the federal government has a cohesive, thoughtful strategy and makes robust investments in research and development programs that underpin the advancement of synthetic biology. The field was born out of U.S. Federal government research investments, and by advancing this legislation, Congress can help ensure American innovators continue to lead in this space.

Since microbes are currently our favorite organisms to engineer here at Ginkgo, it was great to see Wisconsin recognize the first official state microbe! Of course they chose Lactococcus lactis, the bacterium used to make many popular cheeses.   Maybe we can convince Massachusetts to choose E.coli as a state microbe for all the biotech drugs it has produced — need to help Coli beat its bad rap!