Mira Chaurushiya

Coming out of the Biocom California CEO Summit, I share biotech investor predictions and CEO insights in the latest edition of Vital Signs: https://lnkd.in/ghXYRsaq

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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Excellent way to spend 1 minute, 30 seconds. DSO shares via an embedded video in the article below how Modality.AI is making an impact with patients. It is wonderful to have NIH SEED as a partner on this journey. Relentless Venture Fund David "DSO" Suendermann-Oeft #Neurotech #AI #BIO2024 #precisionmedicine #clinicaltrials #healthtech #healthcare #digitalhealth

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In a notable prelude to #JPM2025, Tune Therapeutics has announced a $175M Series B funding round to advance its epigenetic editing platform. Epigenetic editing represents a compelling alternative to traditional gene-editing technologies, focusing on controlling gene expression without altering the underlying DNA. This approach offers the potential for safer, reversible therapies and could play a major role in tackling diseases like cancer, rare genetic disorders, and neurological conditions. The last few years haven’t been easy for genetic medicine. Challenges like delivery limitations, scalability, and concerns over off-target effects have underscored how complex translating genomic innovation into real-world treatments can be. Tune’s focus on fine-tuning gene activity rather than permanently rewriting the genome offers an alternative to overcoming some of these barriers. Let's hope that after such a significant investment, the interest in editing as a transformative technology will grow . As JPM 2025 kicks off, many of us will watch out for where exciting conversations about genetic medicines will go. Read the full article in the Endpoints News: https://lnkd.in/e8CFVEHW #JPM2025 #Epigenetics #Biotech #GenomicMedicine #HealthcareInnovation

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I've been spending a lot of time thinking about the productivity problem in life sciences R&D - which, in my opinion, seems to be the single biggest problem to solve in all of life sciences.   Inefficiency takes on an entirely new meaning in biopharma vs. other industries where it simply amounts to sunk cost. In biopharma - particularly for the long tail of smaller biopharmas - it can be the difference between missing and meeting milestones, securing and not securing funding, life and death. Being efficient is increasingly a requirement for survival. Tech certainly isn't a golden bullet, but we see a lot of opportunity for it to help move the needle, especially if it's in combination with behavioral/cultural change.   Over the last month or so I've been sharing our high-level thoughts on this topic through a series of blog posts, the last of which was published today (see comments for links to the prior two posts). This really only begins to scratch the surface on our thinking here and we're eager to chat with folks in greater detail. If you’re working in this space or have insights to share, I'd love to hear from you! https://lnkd.in/g9EsD5b3

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Fast-forward 10 years when every bio company has access to highly performant models for in silico molecular design... Assuming this translates into many more high quality candidate molecules, there will be insatiable demand for already-scarce clinical development talent. Clinical development skillsets will become multiples more valuable. An optimist might argue we need to start preparing our clinical development regulatory and operational infrastructure for materially higher throughput.

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Interested in seeing what Rocky Balboa, Jeff Spicoli, AI and machine learning have in common, check out this Timmerman Report article on east Coast vs West Coast AI culture clash. We are fortunate to have a network of experienced AI & machine learning professionals available for consulting assignment. Let us know if we can be of help.

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💥Rewind on 2024 Therapeutic Cancer Vaccine 2024 highlights A revolution is happening - in the intricate dance of our own immune cells. At Uneedle, we don't just observe this transformation; we help engineer it. 🔮 Key Milestones: → Presented groundbreaking microneedle platform at OIS XIV in San Diego → Showcased suprachoroidal injection advances at AAO in Chicago → Expanded microneedle applications beyond traditional boundaries → Reflected on 30 years of biotech innovation at TechMed Event 🧬 Why This Matters: For over a century, we've battled cancer with chemical weapons. Now, we're teaching our own immune system to become the strategist and soldier. Three Posts That Capture Our Journey: 1. Keytruda: A Forgotten Dutch Invention "Did you know KEYTRUDA®, currently the world's best-selling cancer drug, was invented in the Netherlands?" https://lnkd.in/eWHVGjmJ 2. (R)evolution in Cancer Treatment "A silent revolution is transforming cancer treatment. We're increasingly turning to cellular therapies, replacing chemical drugs with our body's own immune response." https://lnkd.in/enw6Cg-d 3. Understanding Checkpoint Inhibitors "Checkpoint inhibitors prevent T cells from being blocked when trying to kill tumor cells - essentially removing the brakes from our immune system's most powerful weapon." https://lnkd.in/eBcHwYi6 🔮 2025 Horizon: Therapeutic cancer vaccines are no longer a distant dream. They're becoming our most powerful tool in the fight against cancer. And yes, I'll still be watching those deer in Overdinkel, finding inspiration in nature's own complex systems. One thing remains certain: Ideas are cheap, execution is everything. #CancerVaccines #Microneedles #DrugDelivery #Suprachoroidal #Biotech #LinkedInRewind #2024Wrapped -- Get your 2024 LinkedIn Rewind! Go to coauthor.studio

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The GLP1 story illustrates the "academic-industrial valley of death”. What is interesting is how/why the eventual winners (Novo/Lilly) succeed. Ie not through novel target biology but meaningful iterations on delivery, safety, efficacy etc. 2x-daily exenatide to weekly semaglutide to oral semaglutide = masterclass in persistence of development. PCSK9 inhibitors - target ID was some amazing work, but the real change came from solving manufacturing challenges, optimizing dosing schedules, finding right patient populations etc. PD1/PDL1 - Merck wasn't first, but Keytruda dominates through trial design and execution informed by others' stumbles. When the market is so massive coming in 2nd/3rd no longer matters. ☠️ For smaller markets these dynamics reverse = Economics of coming in 2nd look very different, recruitment is a complicated mess, so are the costs, market is 30-60% smaller after the first one; and you just do not recover from suboptimal trial design.

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Massive (255 page😱) SEC filing describing the acquisition of Singular Genomics by Deerfield Management (thanks Broomer@Aseq). Adds new meaning to the term "kicking the tires", over 70 companies were contacted; those that dug in for a closer look included 12 public companies (assume included Thermo Fisher Scientific, not Illumina 🤣), 5 private companies (daring, probably wanted the cash), and 13 investment firms. The M&A board committee met 44 times (😱). In the end bidding came down to Deerfield and Tang - which we knew about - and one late player we didn't know about: Medical Excellence Capital, LLC (partner Kim Kamdar sits on Singular's board). Deals often blow up because of executives dissatisfied with the financial outcome. In this case the $24 was withdrawn, the board was forced to then consider liquidating the company (as bad as it sounds: laying everyone off, selling for parts) before a final hail mary save came in at $20 (a $10M oopsie). Must have been a sleepless December for all involved 😳😳😳: 10/30: "Deerfield had improved its offer to $24.00 per share and had again requested exclusivity. [The board informed Deerfield that it] was prepared to enter into an exclusivity arrangement" (Pretty amazing offer given that Singular had been trading at $6 prior to the bidding, seems like the board was doing a great job). 10/31: "[Singular advised Tang that they] would not be moving forward with Tang’s “best and final” offer of $22.50 per share in cash." 12/4: "The CSO reviewed his concerns with the rollover terms proposed by Deerfield and stated that he would not rollover his Singular Common Stock on the terms proposed by Deerfield." 12/8 Tang was re-approached given there was now risk in the Deerfield deal: "Tang indicated that if Tang were to submit a bid, it might be as low as $16.00 per share." 12/14: "Deerfield indicated that [due to] lack of support from the Company’s CSO...and to the Company’s cash position...Deerfield would be willing to proceed...at a reduced price of $18.00 per share" 12/14: "[Bankers advised the board that it] in response to the price reduction, they consider shifting focus to the Company’s other alternatives, including a potential liquidation..." 12/17: "[The Board informed Deerfield of their] willingness to proceed with a transaction at $21.00 per share" 12/20: "Deerfield informed [Singular] that Deerfield would be willing to acquire the Company for $20.00 per share" On December 22nd, the Singular board accepted Deerfield's $20 offer. Talk about negotiating against yourself 🙄🙄🙄 Good news is that it certainly reads as if Deerfield wants to keep the company as a running concern, I thought this might be just a way for them to get some cash back out 👏👏👏 https://lnkd.in/gGKHfuH9

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At Windhaul, we are committed to propelling growth and success for small to mid-sized clinical stage biotech companies. Our mission is straightforward: to elevate the value of biotech firms and their programs with patients, healthcare providers, and investors. Windhaul distinguishes itself as a premium boutique consulting firm and provider of innovative flexible staffing solutions leveraging highly experienced professionals. We specialize in navigating dynamic global regulatory landscapes and integrating forward thinking commercial and market access insights into the strategic decision-making process. Our team consists of seasoned industry leaders, including former c-suite executives and functional heads, who bring invaluable hands-on leadership and management expertise throughout the journey of developing and approving new therapies. Clients choose Windhaul for our immediate effectiveness and capability to seamlessly integrate expert consultants into their teams on an interim or fractional basis. Whether guiding the clinical, regulatory, or commercial development of complex biologics or cutting-edge therapies such as cell and gene editing products, Windhaul excels across the entire product lifecycle. Let's collaborate to drive innovation and create enduring value together. #Biotech hashtag #RegulatoryAffairs hashtag #CommercialStrategy hashtag #MarketAccess hashtag #DrugDevelopment hashtag #BiotechConsulting hashtag #BiotechStaffing hashtag #BiotechInvesting https://www.windhaul.com/

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OMG you would think I would LOVE an announcement that Illumina and NVIDIA were working together but honestly this sounds like this morning's second case of Illumina having to give up a lot to get a little. Deal has two parts: (1) Illumina's "get" is to host a bunch of Nvidia tools for LLMs and data analytics in on the Illumina Connected Analytics platform. Also MONAI for spatial cell imaging workflows though not sure what they have to do with NGS. Anyway, this seems like a nice-to-have, maybe a convenience to customers - but I don't think it opens up any new functionality. Doesn't cost Nvidia anything, and they get to add another logo on their partners slide 🤷‍♂️ (2) Illumina (this is the "give" part) will be "enabling DRAGEN algorithms on NVIDIA GPUs". Not sure why this is good for Illumina, and the PR doesn't explain this benefit at all 🤯 DRAGEN is built on a hardware architecture - FPGA - that has nothing to do with GPU at all, in fact it's kind of the opposite. So Illumina is going to have to make a major investment in porting DRAGEN to Nividia GPU for no stated benefit to Illumina. But the benefit to Nvidia is clear: they get to claim yet another customer for their already vast GPU customer base, and they get to big to displace FPGAs in Illumina instruments. Must be missing something here 🤔🤔🤔 (Don't forget to check out our JMP podcast! https://lnkd.in/gU_qpY3S)

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Wow, I think we're really witnessing the Apple-ification of Illumina 👏👏👏 Jacob has really been focusing his messaging on offering customers a full NGS vertical and this new MiSeq seems to embody that vision very well. There's virtually no mention of $/Gb in the announcement (folks are scrambling to try and decode that) - tag line is "Fastest, simplest. For every lab." Steve Jobs famously envisioned the Macintosh as an "appliance" - a computer for everyone vs its predecessor Apple 2 which was a computer for hobbyists (we're now called geeks). This MiSeq evolution follows that Apple evolution pretty well. Obviously not a consumer product, but MiSeq has been radically improved in terms of ease of use that may create some elasticity in this stale market: - Room temperature simple-to-load cartridge: 3 steps/20 minutes. - Much faster run times (4X faster than old MiSeq) - Seamless integration of DRAGEN (local) and BaseSpace (cloud) Technically there's a radical technology change underling the new instrument: its hardware is based not on the old MiSeq design, but on the flowcell-on-CMOS design of the iSeq. That means that (I think, not an engineer 🤣 oh wait am an engineer 🤣) ALL the optics and ALL the fluidics are in the consumable. This flips the economics of the old MiSeq on it's head as the instrument becomes super cheap - it's just a box with a computer and a display - and the consumable gets more complex as it contains the CMOS imager chip that gets thrown out each run. BUT the utilization of MiSeq has never been that high - sits in the corner a lot - so maybe this is fine 🤔 Two misses in my opinion: - No sign yet of any simplification of the product line. Do we need MiniSeq and the iSeq 100? Can't the new instrument replace both of these plus the old Miseq?! Maybe one low cost/high margin instrument platform with a range of consumables of varying capacity? - WTF with the nightmare new name that I've avoided saying up until this point 🤯🤯🤯 MiSeq i100 🤯🤯🤯 You took too old names MiSeq and iSeq 100 and jammed them together and kept the iSeq 100 in the product line?! Why not call this something new and simple like, I dunno, Macintosh 🤣, and position it as replacing the old MiSeq, MiniSeq, and iSeq 100. This would distinguish the new instrument from the MiSeq which will have to be around forever for the DX version. Grrrr. Anyway, if a dumb name is the worst thing here, that's a big win for Illumina, congrats to all involved. Nice first major product launch under Jacob that delivers on differentiating beyond price. Could have made a bigger splash compltely reimagining the product line - but maybe he's more Tim Cook than Steve Jobs - ain't nothing wrong with that! 👏👏👏

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What worked yesterday isn't guaranteed to work tomorrow. As biotech startups transition from early- to late-stage development, their needs change. Lean teams, for example, may no longer be enough to support your operations as they continue to scale. Startups that recognise this and make sure they're prepared to adapt will experience a smoother transition. #Startups #Biotech #BusinessManagement #Scaling

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In 2022 when Illumina and GRAIL leadership where touting how many lives would be saved if only the antitrust authorities got out of the way, here's what was really happening. Please read carefully, shows how this "life saving" test doesn't work: "[With the] San Francisco firefighters, the test did not identify the statistically expected number of cancers, provided false positives for half the cancers it did identify, and missed at least three cases of confirmed cancer. In other words, the exercise showed Galleri to be a disaster." "In this example prominently featured on GRAIL’s website and in marketing materials as an example of how “multi-cancer early detection screening can be critical for those at elevated cancer risk”—GRAIL provided 1,786 screenings to a group of San Francisco firefighters and their family members, a “high risk” group for certain kinds of cancer. During that testing round, which was conducted on December 6, 2022—Galleri generated six false positives and identified only five instances of cancer." "...such a result is alarming in light of the fact that, based on statistical experience, cancer should have been detected in about 29 (not five) of the 1,786 tests. Moreover, of the five instances of where cancer signals were identified, two individuals already knew they had cancer to begin with. Further, all of the instances of detected cancer were at a “late stage,” and where the cancer was too advanced to make a difference for the patients. One firefighter was diagnosed with stage 3 pancreatic cancer and is now in hospice, while another firefighter was diagnosed with lung cancer, which has now metastasized to the brain." "Galleri also missed at least six instances in which the San Francisco firefighters actually had cancer—failing to identify instances of melanoma, prostate cancer, and lymphoma that were identified by private doctors just months after the Galleri test indicated “no cancer signal.” "Further, in one instance in the San Francisco firefighters screening where Galleri generated a false positive, the patient underwent a painful bone marrow biopsy procedure to determine whether the patient did have cancer. In that case, the patient’s bone marrow biopsy procedure, clinically shown to involve “unbearable pain” to the “worst possible pain” a patient can experience, revealed that there was, in fact, no cancer." "The screenings provided to the San Francisco firefighters were an expensive “disappointment.” According to Tony Stefani, the organization’s founder, the screenings demonstrated that the probability of catching an early-stage cancer through the Galleri test was “negligible,” and the screenings only caught “some serious cancers at a later stage,” which likely would have been detected within one or two months without the test. Given the test’s high costs and useless real-world performance, Stefani stated that Galleri was a total “disappointment” and that the foundation had been sold a “bill of goods.” 🤯🤯🤯

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Thank you, James Zanewicz, JD, LLM, RTTP, for the generous T2B shoutout in your latest BIO from the BAYOU episode! Commenting on T2Bmeet @ BIO: "It was really fascinating to have the communicators who were out there [at #BIO2024] trying to explain what companies are doing -- both to potential customers, to investors. The comms and brand is so present in everything." Definitely add this one to your weekend podcast list, and hear what else James had to say about T2B starting at the 13:07 mark!

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Congratulations to Alex, Lindsay, Michelle, and the rest of the Talus Bio team on the latest financing! This will be transformative for the team as they work to develop new drugs to target transcription factors. 👩‍🔬 What does the company do? Talus uses their platform to test for the effect of novel TF-targeted drugs in a live cell opening up the possibility of drugging many previously 'undruggable' targets. 💊 What do they have so far? The company is working on four targets including #brachyury for treating a rare cancer called #chordoma. 💸 Who is investing? The round is led by a stellar team at Two Bear Capital (J. Seth Strattan PhD and Avery Sonnenberg), with participation from Washington Research Foundation, BoxOne Ventures, and NFX 🌎 Why does this matter? Talus has an impressive technology that hopefully can create new treatment options for some serious conditions. The team worked doggedly to build the company off of grants in a harsh market cycle and this investment validates how far they've come. I'm excited to have this team in Seattle helping build the next generation of great biotech companies here! #biotech #financing #company #seattle

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Artiva Biotherapeutics, a clinical-stage NK cell therapy biotech, is trying again for the public markets, it revealed Friday afternoon in an #SEC filing. The San Diego biotech is going for a Nasdaq debut but in a very different biotech financing environment than when it originally sought an #IPO in the spring of 2021, at a time when large public floats were easier to achieve thanks to low interest rates and generalist investors’ intrigue in drug development. And this time around, it’s without partner Merck, which axed their CAR-NK solid tumor collaboration last October, according to Friday’s S-1 filing. #NKcelltherapy #celltherapy #cellandgenetherapy #advancedtherapies #publicmarkets #biotech #biotechnology #financing #funding #lifescience #lifesciences #IPOs #solidtumors #bloodcancers #autoimmunedisease GC Cell 5AM Ventures venBio RA Capital Management

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