#businessofbiotech

In biotech, when "one of these things doesn't look like the other one," it can be a blessing or a curse. On one hand, scientific novelty is praised and rewarded. On the other, unfamiliarity breeds skepticism from the investment community. Brian Finrow, J.D. embraces that reality and the challenges that come with it. Despite an approach to developing antibodies and other biologics that looks decidedly different--they're developed from spirulina cell lines and, in some cases, designed for oral administration (gasp!)--Lumen Biosciences has won hard-fought funding from some nontraditional sources to continue its mission to democratize biologics. Finrow is Co-Founder & CEO at Lumen, and now a two-time guest of the Business of Biotech. He's a Harvard J.D., but don't hold that against him. He's one of the most approachable and transparent founders we've enjoyed the pleasure of hosting, and he didn't disappoint when we sat down for this talk in San Francisco. 

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The concept of programmable biology is fueling a new breed of biotech, one that requires the marriage of computational and traditional science (and both computational and traditional scientists) on the entire journey from discovery to commercial.  Bit.bio is exemplary of this new breed. Its CEO, Dr. Mark Kotter doesn’t pull any punches when addressing the complexity involved in building out the company’s capabilities. At the discovery stage alone, bit.bio has hired – and integrated – stem cell biologists, synthetic biologists, genetic engineering experts, cellular biologists, sequencing experts, data scientists, bioinformatics pros, and machine learning experts. 
On this episode of the Business of Biotech, recorded in San Francisco during JPM Week, we catch up with Dr. Kotter on the work bit.bio is doing, how it’s doing it, and how he and his leadership team are recruiting and retaining a new breed of biotech talent to sustain the effort. Let’s give it a listen. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Without doubt, the grand and collaborative experiment that was the mRNA COVID vaccine contributed mightily to the pandemic response and continues to save lives untold. It also demonstrated the collective power of public/private partnership in biopharma. Having acknowledged that, no first iteration of a new technology is ever the best iteration of that technology. On this week's episode of the Business of Biotech, we welcome Carsten Rudolph, Ph.D., co-founder and CEO of a company that recognizes this room for improvement. Ethris is developing mRNA-based candidates for the treatment of respiratory viral infections and rare pulmonary diseases, in addition to mucosal, multivalent, and mutation-agnostic prophylactic vaccines.   Dr. Rudolph explains the concept, the business case, and how he's navigating Ethris toward a better treatment and vaccine paradigm in the wake of the pandemic. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

A new year marks a fresh start for biotech partnerships, and to kick off 2024, we're highlighting a good one. Fina Biosolutions' Dr. Andrew Lees recently signed on with Scorpius BioManufacturing to support his company's growth plan. On today's episode of the Business of Biotech, Lees sits down with Scorpius VP of commercial operations Steve Lavezoli for a frank conversation on the ups, downs, and expectations of a biotech + CDMO relationship. In addition to contracts and master service agreements, the pair walk us through the day-to-day execution of the partnership and responsibilities of those involved in it. If you're considering signing on with an outsourced manufacturing partner, or thinking about making a switch, you won't want to miss this episode. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

During his leadership of the President's Emergency Plan for AIDS Relief during the George W. Bush administraion, Dr. Mark Dybul, M.D. shepherded programs credited with saving more than  25 million lives. For many years after that public service drew to a close, he continued the mission as executive director of The Global Fund to Fight AIDS, Tuberculosis and Malaria--working in lockstep with not only the world's leading scientists, but the likes of Bono and Sir Elton John along the way. 
But, it wasn't all glamor and heroics. Dybul had to influence some decidedly conservative global political machines of the importance of addressing the AIDS epidemic, particularly, at the time, in Africa. He had to fight through federal and global beuracracies for every dime of funding earned. His leadership required resolve in the face of complexity and adversity. 
Nothing could have better prepared him for biotech leadership, which has dealt Dr. Dybul an unfair share of unique adversity that's, quite frankly, the stuff of a Dateline NBC episode. On this epsiode of the Business of Biotech podcast, Dybul, CEO at Renovaro Biosciences, gets introspective on leadership forged in the fires of public service and battle-tested in the private sector.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Combined Therapeutics President & CEO Dr. Romain Micol is operating his company in a very noisy space, where hundreds of new biotechs have popped up on the coattails of a COVID-driven renewal of interest in mRNA vaccines. Micol recognizes that noise and the competition it brings for capital and mindshare. He's not only aware of it —  he  welcomes it. On this quick episode of the Business of Biotech podcast, Micol shares the unique approach Combined Tx is taking to distinguishing itself in the mRNA infectious disease and cancer vaccine space, from the delivery, safety, efficay, and business perspectives. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Earlier this year, Shawn Davis, Ph.D. left a pretty comfortable position at AstraZeneca (and Amgen before that, and Milliken, and others, before that) to lead Liberate Bio. He brought along another industry notable in Merck/Intellia alumnus Walter Strapps,  Ph.D., who serves as CSO at Liberate. Why'd they do it? Because RNA delivery is such a crucial step toward  revolutionary genetic medicine, but it's tough science. They think they can change that.  On this episode of the Business of Biotech, Drs. Davis and Strapps share how they're applying automation and machine learning technologies to minimize the challenges associated with targeted delivery of genetic medicine and  overcome the limitations of AAV.  During our conversation, they both leaned hard into how their previous experiences have shaped the work they're doing, and the wide-open business opportunities Liberate Bio is creating. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

What constitutes a healthy, productive, and successful relationship between an emerging biopharma company and its contract develpment and manufacturing outsourcer (CDMO)?  Jenny Holt, Chief Development Officer at the biopharma company Ray Therapeutics has some opinions. So does John Maslowski, Chief Commercial Officer at the CDMO Forge Biologics. Think they align?
On this episode of the Business of Biotech, we dig into the trust, technical expertise, and project timeline considerations that required of a successful partnership. We also broach the risks associated with emerging CDMOs, the right balance among cost, quality, and time, what you should ask when evaluating outsourcing partners, and a whole lot more.

***REGISTER for the first-ever, interactive Business of Biotech Live! Legal & IP Protection For New Biotechs here!

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

This week's guest on the Business of Biotech, EVQLV's Andrew Satz, says AI and ML in biopharma are like sex in high school. "Many of the people who say they're doing it really aren't, and the one who really are aren't talking about it," he says. So, when it comes to the computational biology buzz, what’s real? What’s hype? What’s yielding benefit and what’s merely vaporware? In our talks with the leaders of new and emerging biotechs over the past 12 to 18 months, we've seen a steep increase in the application of – or at the very least, interest in – machine learning, AI, and computational biology tools for drug discovery, development, and beyond. Even those who are using some "ultra-light" application of new computational technology are eager to talk about it, as it’s clearly become as en-vogue as tacking “bio” onto your moniker was a few years back – even among companies who aren’t actually developing biologics. On this episode, Satz offers his take on the reality of adoption and shares advice on the fundamentals of AI and ML in biotech.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing. He "carried the bag" for GSK in his early days, directed oncology marketing efforts at Amgen, and led marketing and U.S. commercial efforts at Juno, then Celgene after it acquired the former. Kirby joined Orca Bio in timely fashion back in 2020, as today the company ushers its first cell therapy into phase 3 clinical trials, with strategically-dispersed follow-up candidates spanning all phases back to R&D. On this week's episode of the Business of Biotech, we get a one-on-one commercialization preparation discussion with one of the best in the business, and the straight-talking veteran doesn't disappoint in the strategy and insight departments. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

It’s been said that clinical trials are where emerging biotechs go to die. If the science doesn't kill quickly, poor cash management will slowly. And, even when good data opens the cash floodgates, post-round cash management savvy isn't necessarily intuitive to academic and scientific founders. Cash runway preservation is, however, ingrained in the cerebral cortex of one of our favorite mavens of biotech finance markets and management, Mr. Allan Shaw. He joins us on this week’s episode of the Business of Biotech for a conversation on post-financing fundamentals for new and emerging biopharmas.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Will machine learning revolutionize biopharma drug discovery? Has it already? This week on the Business of Biotech, we explore the intersection of tech and bio with Dr. James Field, founder and CEO of LabGenius. We'll get an insider's look at the formation of a company bridging the divide between computational and biological sciences, we'll learn why this ML-intensive leader applies a scientist's skepticism to the tech he's building, and we'll address fundamental data considerations along the way.  We'll also learn about the challenges and opportunities that come with balancing a company that's building both a high-tech drug discovery platform and drugs themselves. If you're concerned with what ML will do to —  or for —  your biopharma business, don't miss this episode. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Dr. Adrienne Leussa is one of my favorite follows. If the booming biotech scene on an incredibly diverse continent of 1.2 billion people interests you, she should be one of your faves, too. Dr. Leussa's intellect, energy, and glowing spirit contribute to her ambassadorship of the African biotech scene. She's an entrepreneur, a visionary, a communicator, and a tireless advocate for African biotech opportunity. On today's epsiode of the Business of Biotech, we share a lot of laughs as we learn how Adrienne's entrepreneurial beginnings selling nuts and lollies on the streets of Yaounde, Cameroon set the foundation for an accelerated academic career and a passion for bio business development. We also dive into Africa's growing biotech scene, discussing the support infrastructure available for budding entrepreneurs and the importance of technology transfer and commercial research innovations from local universities. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

The Business of Biotech took a road trip to Pittsburgh to visit with Peptilogics CEO and founder Dr. Jonathan Steckbeck, whose Ph.D. work was inspired by the loss of his father-in-law to a hospital-borne infection. That work subsequently led to the formation of a company committed to leveraging peptide therapeutics to address PJI (prosthetic joint infection), cystic fibrosis infection, as well as rare genetic disease and oncological indications. Dr. Steckbeck walks us through the transition of his academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, and the virtues of doing biotech business in Pittsburgh. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Since Dan O'Connor stepped in as CEO at Ambrx late last year, the company's stock has rallied on the revival of a previously-shelved anti-HER2 ADC. It also raised $78 million and completed its ATM (at-the-market) offering. O'Connor is no stranger to overcoming adversity. A former marine captain, he was among the first deployed to the Persian Gulf to fight in Operation Desert Shield. While his leadership at Ambrx is anything but militaristic, he ascribes much of his style, and certainly his approach to adverse conditions,  to his military time. On this episode of the Business of Biotech, we welcome back Dan O'Connor to discuss the resuregence of Ambrx and leadership resilience in an industry that demands it. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? John Balchunas is on the front lines in his position as Workforce Director at NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, and he says advanced degrees and pedigrees aren't the answer. The breadth and depth of NIIMBL's efforts to influence the next generation of the biopharma workforce — from  high school vocational programs to community colleges and on-the-job development—might surprise you. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda that plants seeds early and often. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

We often talk about biotechs taking "big swings." This week's guest is swinging for the fences with a lineup of gene therapies designed to address multiple forms of hearing loss, which affect multiple millions (if not, billions) of people worldwide. Adding to the challenge she's accepted, Sensorion CEO Nawal Ouzren is architecting an approach that seeks to restore hearing that's been lost due to genetic factors, treat sudden hearing disorders, and proactively prevent hearing loss due to common causes such as cisplatin induced ototoxicity or cochlear implantation. Listen in as Ouzren shares her holistic and aggressive plans with the Business of Biotech. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Today's episode of the Business of Biotech covers a lot of ground with Enzyvant CEO Bill Symonds, Pharm.D. Among other things, we discuss the career moves Dr. Symonds has made within the "vant" environment since his involvement in the launch of the original Roivant,  the approval of Rethymic, the merger of Altavant and Enzyvant, and the company's intentions for a brand new regenerative medicine manufacturing facility in Research Triangle Park. From drug approvals to mergers, from internal manufacturing capacity to founders-turned-presidential candidates, this one's got it all. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Among a growing cluster of Pittsburgh biotechs, you'll find BlueSphere Bio, an early-stage company discovering T-cell receptors to leverage against tumor-specific antigens in individual cancer patients. Its leader, CEO Keir Loiacono, Esq., works with a sense of urgency inspired by his own cancer journey. Business of Biotech host Matt Pillar and guest co-host Jon O'Connell, executive editor at Bioprocess Online, toured Bluesphere's state-of-the-art facility perched on the bank of the Monongahela River. Then, we sat down with Loiacono to learn his story and discuss the company's vision for the future of personalized, adoptive cell therapy.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

SPECIAL EDITION: BoB@JPM
Elixirgen Therapeutics CEO Akihiro Ko joins the Business of Biotech for the final  episode in our special series recorded at JPM Week in San Francico. Life Science Leader Chief Editor Ben Comer joined us for the conversation. We dive deep into Elixirgen's unique, temperature-controlled in-vivo gene expression technology designed to address common cell therapy administration challenges and unwanted, off-target immunogenicity effects. Ko also shares progress on the company's ex-vivo candidate EXG-34217,  an autologous cell therapy for telomere biology disorders, offers his take on the ever-crowded RNA therapeutics space and how the company is separating itself from the crowd, and much more!

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!