Five O'Clock with Theral Timpson

This Is Ukraine’s 1776: Rostyslav Semikov

0:00 Parents live close to the Zaporizhzhia nuclear power plant 5:50 This is Ukraine’s 1776 13:45 Some history 22:19 What are your thoughts on President Zelenskyy 28:31 This is not Zelenskyy’s war. This is the people’s war At a recent biotech conference, I met Ukrainian American Rostyslav Semikov. He agreed to come to…

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2 years ago · Theral Timpson

At a recent biotech conference, we met Ukrainian American Rostyslav Semikov, CEO of Audubon Bioscience. He agreed to come on our sister podcast, Five O’Clock, to talk about the war in his country, which he says is their “War of Independence, their 1776.” It’s a great conversation, so we’re sharing it today with the Mendelspod audience.

Last, Congress included $200 million in aid as part of the annual defense bill. But the larger aid package of $110 billion to Ukraine and Israel has been stalled by Republicans. Are Americans growing weary of support?

Rostyslav’s parents live in Ukraine near the Zaporizhzhia nuclear power plant. Not only are bombs dropping around them, but there could be a horrible nuclear accident.

“Every time we talk, they say we may not see you. And if something happens to us, we love you,” he says at the outset of today’s show.

What is the history of the cultures between Ukraine and Russia? Rostyslav says Russian President Vladimir Putin thought he would be welcome in Ukraine and overtake Kyiv within three days. Twenty-one months later, the war drags on.

Rostyslav reminds us that the support of France turned the tide in the American War of Independence.

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However, 2023 has been a tough year for the precision medicine industry. Some say the industry has been in crisis. Almost all the major genetic testing companies have endured sizable layoffs and/or restructuring. Invitae shed 30% of their workforce. Sema4/GeneDx became just GeneDx and cut their reproductive health testing. The same story of downsizing has been true across biotech and pharma. The lead sequencing tools company, Illumina--after a fifteen-year run that made investors giddy with wonder--has been suffering. One of our guests recently called 2023 an annus horribilis for the company, the term England's Queen Elizabeth used for 1992, the year Windsor Castle burned.

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Five O'Clock with Theral Timpson

Zack Abbott on GMOs and ZBiotics' Solution to Tough Mornings after Drinking

Listen now (41 mins) | Chapters: 0:00 Hangover biology 8:12 Concern over GMOs: what is “natural?” 26:36 The age of synthetic biology 33:20 Who’s making the decision: me or my microbes? Many of us enjoy a glass of wine over dinner. Sometimes two. Sometimes more. And we all have our own hangover cures. Lots of water. Some folks say salt helps if you have a headach…

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3 years ago · Theral Timpson

Scientist entrepreneur and CEO of ZBiotics, Zack Abbott, was recently featured on our sister podcast, Five O’Clock. ZBiotics is making a genetically engineered probiotic to improve “mornings after” drinking. Most of the toxic acetaldehyde that comes from alcohol is processed by the liver.  But some of it goes to the gut, and Zack says this is what gives us the morning-after symptoms. 

Zack says that concern over GMOs is rooted in a good place, and he goes on to address the fears around GMO products.  Addressing this question head-on is a great passion for Zack. Part of the reason for founding ZBiotics was to engage with consumers on the GMO discussion, giving them a product that is helpful and optional. (Zack says we have been forced to accept many GMO products.)

Zack and his company are part of a growing movement in synthetic biology focused on new consumer products that will enable better health and sustainable living.

Special Offer: Let’s face it, after a night with drinks, I don’t bounce back the next day like I used to. I have to make a choice: I can either have a great night OR a great next day. That is until I came across Zack and his genetically engineered probiotic. ZBiotics is offering the Mendelspod audience 15% off your first order. Click here and use discount code “THERAL.”

Those of us with some history in the field of diagnostics are saying, “Here we go again.”

The last round during the Obama administration (towards the end, I might add—why not at the beginning?) had all of the interested parties putting on their best arguments for and against or somewhere in between. As soon as we had all weighed in with our brilliance, Trump was elected.

Here’s one of our most recent interviews on the topic from 2016 just before the election with John Longshore, Director of Molecular Pathology at the Carolinas Healthcare System, now Head of Scientific Affairs for Global Oncology Diagnostics at AstraZeneca.

Lab directors, CEOs, and physicians must be all asking the same thing today. Is this a decision that will shortly be reversed?

Arguments against regulation include:

a) This is a dynamic, new, and quickly changing field. Early regulation will hamper an area of medicine that is still figuring itself out. There is a danger in defining the rules before we know what the game is.

b) Many LDTs are created for narrow situations. For labs to go through the regulatory process might make the tests redundant. Think of the early days of the pandemic.

c) Regulation is expensive. Many labs would have to give up serving patients with a test because they can’t afford the resources necessary to see it through the regulatory process.

d) Many of these tests are direct-to-consumer and consumers deserve the right to their genomic information without a paternalistic government interfering.

Arguments for:

a). Testing, such as genetic testing, is part of the field of medicine and should therefore be regulated. Harm can be done to patients. From Friday's press release: "The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death.”

b) Yes, point taken about a developing field, such as whole genome sequencing tests. But how do we know what the game is unless we define the rules? As the FDA says in the press release, regulation could benefit innovation. If you look at the history of drug development, the FDA has a reputation for being the gold standard worldwide. FDA approval can mean good business because there is buy-in from physicians, patients, scientists, and the government.

c) Regulation can be done in stages and based on the risk level of the test in a way that is good for patients and businesses.

d) Direct-to-consumer tests can impact the patient just as a test administered in a hospital.

Regulation and oversight should not be politically partisan. Famously, the EPA was created during the Nixon administration. There is bipartisan legislation before Congress called the VALID Act introduced in the House of Representatives by Congressman Larry Bucshon (R-Ind.) and Congresswoman Diana DeGette (D-Colo.). The VALID Act proposes to modernize regulatory oversight of in-vitro clinical tests (IVCTs) – including in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs). Perhaps the process is too slow for those in the Biden administration, but the legislation has been created and modified with input from stakeholders on all sides.

We’ve invited Dr. Jeff Shuren from the FDA to the program to talk about this recent change in policy and what it can mean for the industry and for patients. And we will find someone to represent the laboratories that for years have pushed back on the topic. This decision might mean more if it came out just after the upcoming election. In any case, the FDA must listen to all stakeholders and proceed in a measured way that will not discourage an area of medicine with such terrific promise.

Friend of the program and diagnostics consultant, Bruce Quinn, weighed in on his blog, Discoveries in Health Policy, here.

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We’re out recently with an interview of a company that may end up in the history books. Called SonALAsense, the company is treating cancer with sound.

Chief Medical Officer Ely Benaim explains how the new therapy works. First of all, treatment with sound is accompanied by an intravenous formulation of aminolevulinic acid (ALA) which stimulates the body to make heme. (The most common heme is hemoglobin.) Cancer cells need much more ALA than normal cells to function and grow, says Ely. Cells also need iron to convert ALA into heme. When cancer cells are given more ALA but without iron, they become a potential “smart bomb” which is then activated by ultrasound.

Similarly, therapy using blue light has been approved for years for skin cancers. But light cannot pass through the body like sound and this therapy is therefore not efficacious for internal cancers. In addition, ultrasound as a technology has been widely developed—there is nothing to invent here.

Trials are ongoing.

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With the announcement of the Nobel Prize this week for Medicine and Physiology going to biochemist Katalin Karikó and immunologist Drew Weissman for discoveries that enabled the development of mRNA COVID vaccines, we’ve been re-reading a terrific article by Gina Kolata that came out in the New York Times during the pandemic.

She grew up in Hungary, daughter of a butcher. She decided she wanted to be a scientist, although she had never met one. She moved to the United States in her 20s, but for decades never found a permanent position, instead clinging to the fringes of academia.

Now Katalin Kariko, 66, known to colleagues as Kati, has emerged as one of the heroes of Covid-19 vaccine development. Her work, with her close collaborator, Dr. Drew Weissman of the University of Pennsylvania, laid the foundation for the stunningly successful vaccines made by Pfizer-BioNTech and Moderna.

On Monday, they were jointly awarded the Nobel Prize for Physiology or Medicine for their research.

For her entire career, Dr. Kariko has focused on messenger RNA, or mRNA — the genetic script that carries DNA instructions to each cell’s protein-making machinery. She was convinced mRNA could be used to instruct cells to make their own medicines, including vaccines.

But for many years her career at the University of Pennsylvania was fragile. She migrated from lab to lab, relying on one senior scientist after another to take her in. She never made more than $60,000 a year.

By all accounts intense and single-minded, Dr. Kariko lives for “the bench” — the spot in the lab where she works. She cares little for fame. “The bench is there, the science is good,” she shrugged in a recent interview. “Who cares?”

Read the whole thing.

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Illumina will have a new face at the helm. Jacob Thaysen, former senior Vice President at Agilent Technologies and President of its Life Sciences and Applied Markets Group will be the new CEO of Illumina. At 48, he leads a company now celebrating 25 years of stunning success but showing signs of its age.

After the former CEO, Francis de Souza, resigned in June, Illumina has faced uncertain times. Still dominating the sequencing space, have they melted some of their wings flying too close to the sun with the reacquisition of early cancer detection firm, Grail? De Souza pushed through the purchase at a high price and against the demands of both U.S. and European regulatory bodies.

Illumina’s stock has tumbled in the past year along with that of many other life science companies due to the difficult post-pandemic economy. Grail is now seen to be worth half what Illumina paid for it.

This has put the company in the crosshairs of activist investor, Carl Icahn, who singlehandedly shook up the board and forced De Souza’s ouster.

Thaysen has an impressive resume in genomics and life science tools. From the press release:

Since 2018, he has overseen the unit responsible for Agilent's market-leading analytical instrument portfolio, informatics, and cell analysis franchise. During that time, he drove the division's revenue and significantly improved its operating profit. In 2022, that division, Agilent's largest, had revenue of approximately $4 billion, more than 50,000 customers, and an operating margin of approximately 30%. Mr. Thaysen has driven the transformation of the analytical lab with a focus on implementing a complete digital laboratory ecosystem combined with innovative and smart instruments. Prior to leading Life Science and Applied Markets, Mr. Thaysen was president of Agilent's Diagnostics and Genomics Group from 2014 to 2018, during which time he nearly doubled that division's operating profit.

Thaysen assumes leadership for one of the field’s great success stories precisely at the time of some decline. Recently Illumina downgraded their yearly forecast, partly as a result of the downturn in China, and there is no doubt the company faces stiff and ever-better competition from companies like Oxford Nanopore, PacBio, Element, and Ultima.

Thaysen “checks all the boxes,” said Evercore analyst Vijay Kumar to Reuters. The new Illumina leader understands the genomics and tools market and knows well the Illumina customer base. Another analyst, Patrick Donnelly from Citi, was not as positive. He told Reuters "It remains a show-me story given that investors were hoping for a hire with CEO experience.”

Can Jacob Thaysen pull it off, keep the holy Grail, and spur innovation ahead of the stiffest competition yet? Can he restore Illumina to its former glory?

He begins September 25th.

Speaking of former glory, Craig Venter is out with a new book telling of his voyage around the world collecting and characterizing tens of millions of marine microbes.  The book is co-authored with science writer, David Ewing Duncan.  Just in pre-release, the book promises to:

“Tell the remarkable story of these expeditions and of the momentous discoveries that ensued--of plant-like bacteria that get their energy from the sun, proteins that metabolize vast amounts of hydrogen, and microbes whose genes shield them from ultraviolet light. The result was a massive library of millions of unknown genes, thousands of unseen protein families, and new lineages of bacteria that revealed the unimaginable complexity of life on earth. Yet despite this exquisite diversity, Venter encountered sobering reminders of how human activity is disturbing the delicate microbial ecosystem that nurtures life on earth. In the face of unprecedented climate change, Venter and Duncan show how we can harness the microbial genome to develop alternative sources of energy, food, and medicine that might ultimately avert our destruction. A captivating story of exploration and discovery, The Voyage of Sorcerer II restores microbes to their rightful place as crucial partners in our evolutionary past and guides to our future.”

Venter is an exciting and seasoned writer with two bestsellers to his name.  He has been at the vanguard of the genomics revolution, piloting many of the field’s big projects from sequencing the genome to synthesizing a whole genome.  Ewing Duncan has written many books, mostly boosterism for the future of technology.  

Will the Voyage of Sorcerer II offer new insight into microbial science, or will it be another nature documentation about the fragile planet warning of global warming and doom?  Perhaps both.  It comes out next week.

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In the latest edition of The New Yorker, Dana Goodyear writes an updated story of the now infamous Chinese scientist who attempted live embryo editing, He Jiankui (JK).   Titled The Transformative, Alarming Power of Gene Editing (paywall), the article is instead exclusively about human germline genome editing.  

This story has been well told in recent books, including by Hank Greely and Kevin Davies.  It has been some time since JK first shocked the world by going rogue and releasing his work through YouTube. Dana now catches us up on the saga.  

In interviews with JK after his release from prison, she learns that the Chinese scientist is attempting a comeback, proposing new gene editing studies, and tweeting out (Xing?) advice. He is now the Director of Genetic Medicine at Wuchang University of Technology in Wuhan.

JK was released from prison in the spring of 2022, and quickly resumed his efforts at gene editing. When I spoke to him by Zoom this past January, he was in Shenzhen, with his wife and two young daughters, celebrating a spring festival. The family, he said, was moving to Beijing, where he was opening a new laboratory. He was posting regularly on Twitter, interspersing job listings for lab positions with blue-sky images of him teeing off on the golf course.

JK is thirty-nine, and wore a blue oxford shirt and a tweed blazer. He said that his new lab would be a nonprofit providing affordable gene therapy for rare conditions, and that he would focus first on Duchenne muscular dystrophy, a fatal disease that causes irreversible muscle damage, primarily in boys. This time, his patients would be not embryos but young children desperate for a cure. I asked if it was an attempt to redeem himself in the scientific community. “I don’t know if I’d use the word ‘redeem,’ ” he said. “I want to do it to help people today.”

He refused to discuss his embryo-editing experiment in any detail. Rocking back and forth as he spoke, he periodically broke out in uncomfortable laughter. “Hmm! I don’t know,” he said, smiling, when he was dodging a question. I asked if Lulu, Nana, and the third baby, Amy, knew that they had been edited. He looked at the ceiling and smiled. “I’m not going to answer this,” he finally replied. But he did want to dispel a rumor that had been circulating online. “The twins were not killed or sterilized,” he said. “They are living happily with their parents.”

As for the debacle that his experiment had caused, JK would admit to no greater error than bad timing. “I do acknowledge that I have done it too quickly,” he said. In one of his YouTube videos, he predicted that in twenty or thirty years gene-edited babies will no longer be controversial, or even remarkable. He likened himself to the pioneering founder of the field of I.V.F., Robert Edwards, whose career had followed a heroic arc. In 1978, when the first I.V.F. baby was born, Edwards was a figure of scandal and opprobrium. In 2010, he was awarded the Nobel Prize.

Dana also tracks down one of JK’s collaborators, Ryan Ferrell, a young American science PR executive, who gave up his job and moved to China to advise on the project.  It was Farrell’s idea to bypass the journals and publish on YouTube.  I personally know Ryan and have heard his story of the mis-episode, and he has some interesting additions, particularly of the time when it all went down.

Dana takes a trip to Oregon to the lab of Mitalipov to learn about editing non-viable embryos as well.

The New Yorker goes out to a large mainstream audience, unlike some of the expert books written on this story.  This will be perhaps the first time many read it in this detail.  That’s a good thing.  Though it is a long comprehensive article, I feel it misses telling the successes in the field.

The title promises to talk about gene editing in general.  Towards the end of the article we hear about two sibling kids, one with a rare disease, the other a carrier.  What Dana leaves out is the incredible blossoming of the field of gene therapy or the editing of somatic cells vs. germline cells. Somatic edits happen for just one person and are not passed on to future generations.  The FDA approved the first two gene therapies this year, one for Duchenne Muscular Dystrophy, and the other for sickle cell disease.  This is an exciting time of success in the gene editing field, even if we are years away from germline editing.  The other area skipped over here is the field of reproductive genetics where there is no need for gene editing, but rather sequencing-assisted IVF.  Selecting healthy embryos for implantation completely avoids the need to edit the germline.

The author of a single article must have priorities and stay focused. However, not talking about the successes in the field of gene editing—not to mention synthetic biology—this author missed the chance for a more balanced education of the lay audience.   The priority here is clearly doom and gloom about the future of genetics.

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