Luba Greenwood, J.D.

Proud to have fellow Biotechnology Innovation Organization board member and Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) CEO Frank Watanabe testify at the House Ways and Means Committee hearing on July 12th in Salt Lake City. Frank highlighted the contributions the biotech industry has made to human health and the economy: "In the last quarter century, American life expectancy has continued its steady increase upwards, with roughly one-third of that improvement directly attributable to biopharmaceutical innovations.” The big picture: The industry’s direct and indirect contribution to the U.S. GDP is anywhere from 2-7%, with an economic impact of $2.9 trillion in 2021. Biotech capabilities enhance national security by ensuring we can care for ourselves. Legislative proposals that would support innovation include: - The Ensuring Pathways to Innovative Cures (EPIC) Act, which would give small molecule drugs the same 13-year protection from price controls as biologics, and the ORPHAN Cures Act, which would exempt orphan drugs from price controls even if approved for more than one indication. - The Tax Relief for American Families and Workers Act (H.R. 7024), which was passed by the House earlier this year, to restore the R&D tax deduction. Allow for monetization of net operating losses (NOLs) and reform Section 382 on NOLs. - Improve the capital gains exemption under Section 1202 to encourage investment in small biotechs. - Ensure strong strong patent protections and reasonable regulation of M&A activity. Proud of the work BIO does to support the industry, and proud to be a part of community that works tirelessly to drive innovation and improve human and planetary health. #patientsfirst #biotechnology #innovation #humanhealth #sustainability

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By leveraging AI with vast genetic databases, we are not only quickening the pace of identifying potential drug targets but also enhancing the accuracy of clinical diagnostics and predictive modeling. Recently, I had the privilege of discussing the profound impact AI is having on pharmaceutical R&D with Kim Branson, GSK's SVP Global Head of Artificial Intelligence and Machine Learning. Listen on Raising Health: https://lnkd.in/g6QUm2-A

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Merck taps AI-focused biotech for new ADC pact worth $376M Biolojic Design, Ltd., a biotechnology company that uses computational biology and artificial intelligence (AI) to transform antibodies into programmable, intelligent medicines, today announced that it has entered into a multi-target drug discovery collaboration with Merck KGaA, Darmstadt, Germany. The partnership will leverage Biolojic Design’s AI-driven discovery platform to design therapeutic antibodies for the treatment of cancer and immunological disorders. Under the terms of the agreement, Biolojic Design will receive a low double-digit million euro upfront payment and research funding from Merck. It will also be eligible for drug discovery, development, regulatory and commercial milestone payments that may total up to €346 million. Biolojic Design will also be eligible to receive tiered royalties on net product sales. #biotech #antibodies #artificialintelligence #biopharmatrend Image credit: Biolojic Design

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I wrote on 23 August 2021 that the European Commission was wrong in pursuing the Illumina/Grail merger, for many more reasons than an obvious lack of jurisdiction over the case, as CJEU decided yesterday - https://lnkd.in/dtrP_84M. This case represents a blatant abuse of power and responsibility for those involved must be engaged. So, I expect a mea culpa, followed by a letter of resignation from Ms. Vestager. But this is not all, Illumina received a fine of almost half billion Euros for an alleged ”gun-jumping”, it has been forced to divest Grail (it still has a minority package thou), incurring a loss of more than 7 billion USD (!!) and had significant legal cost in pursuing a futile legal battle, only because the enforcement of the competition rules in the EU is so rotten that one person can determine the outcome of any action, without proper oversight or balancing of the powers in the form of a true collective decision in such important matters. What happened in Illumina shatters all the good things the European Commission did and puts a spotlight on the very weak enforcement of the EU competition rules on the European pharma companies, which cartelise and have secret deals with governments in the EU, while the European Commission turns a blind eye. #illumina https://lnkd.in/dxVSvANd

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Learn more about our SPEO Model and the impact of a KRO in your drug development journey!!

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NY Illumina/GRAIL lawsuit Final Part: Summation "Illumina’s directors and officers, foreseeing their non-exculpated liability in connection with their decision to close the Acquisition in spite of the EC standstill order, determined to shift that liability to Illumina at a cost of up to $100 million, made that shifting of liability a requirement before they would approve the Acquisition, and at the same time abandoned $150 million in insurance for the Company that could have funded Illumina’s financial losses associated with the Acquisition. At no time was this approved by a disinterested vote of disinterested directors or stockholders, and it was not fair to Illumina. By stripping away the Company’s insurance down to $0, while at the same doubling their D&O insurance to $300 million, Illumina’s directors and officers abandoned their fiduciary duties to the Company and left Illumina unprotected while protecting themselves at Illumina’s expense." "Prior to acquiring GRAIL, Illumina’s financials were strong, and its share price reflected that as it traded at its closing peak of $524.24 on August 16,2021. However, after the Acquisition, GRAIL acted like a millstone around Illumina’s neck, costing billions of dollars to maintain while providing no benefit to Illumina." "The Acquisition ultimately dropped Illumina’s cash balance to zero. On March 8, 2021, Illumina entered into a credit agreement with Bank of America for $750 million to help pay for the Acquisition and to keep the lights on at Illumina. When that proved insufficient to carry Illumina’s rising costs, on March 16, 2021, Illumina issued another $1 billion in notes. Less than two years later, on January 5, 2023, Illumina deemed it necessary to sign another $750 million credit agreement to “finance the working capital needs, and for general corporate or other lawful purposes, of Illumina and its subsidiaries.” Illumina has been unable to seek any other potential acquisition opportunities as it spent the bulk of its cash balances on the Acquisition." "By reason of the Director Defendants’ positions with the Company as directors, they owed the Company and its stockholders a duty of loyalty. deSouza and Dadswell owed the same duty of loyalty as Illumina officers. By closing the Acquisition, Defendants breached that duty in three ways: causing a knowing violation of the law, consciously disregarding their fiduciary duties and engaging in self-dealing."

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🚀 Big News in Biopharma! 🚀 Profluent is making waves at the intersection of biotech and AI. Their innovative approach promises to revolutionize gene editing, and they're doing it with a bold move: open-sourcing their work! 🌐🔬 Introducing OpenCRISPR 🧬 Profluent's OpenCRISPR initiative is set to provide customizable gene-editing proteins designed entirely by AI. Imagine AI-generated CRISPR-like proteins that have never been seen before, capable of editing the human genome with unparalleled precision. 🔍 Highlights: AI-Powered: Trained on vast databases of protein sequences, Profluent's AI can generate hundreds of thousands of CRISPR-like proteins. OpenCRISPR-1: Their top-performing AI-created gene editor boasts 400+ mutations compared to CRISPR-Cas9, reducing off-target editing by 95% and keeping unwanted genetic changes below 1%. Why This Matters Attempting to edit human DNA with AI-designed systems is nothing short of a scientific moonshot. Profluent's success points to a future where AI can design bespoke cures for diseases, democratizing gene editing. 🔬 Real-World Impact: While AI-designed drugs have been in clinical testing for years, CRISPR tech just got its FDA green light last year with Casgevy for sickle cell disease and beta thalassemia. These treatments show the incredible potential of gene editing to transform lives. Open Collaboration Profluent invites researchers to test and provide feedback on OpenCRISPR-1. Their goal is to partner with top research institutions and drug developers to expedite the development of new genetic therapies, ensuring safe and ethical practices. Recent Milestones $35M Funding: Backed by Spark Capital, Insight Partners, Air Street Capital, and top angel investors from OpenAI, Salesforce, and Google. Join the Revolution This is a watershed moment in gene editing. Profluent is not just pushing the boundaries of what's possible; they’re opening the doors for global collaboration. Let's build the next generation of genetic medicines together! 👉 Read more and get involved: https://lnkd.in/gN9p-H6j #GeneEditing #CRISPR #AI #Biotech #OpenSource #Innovation #Profluent #HealthcareRevolution

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Check out the webcast next Wednesday (7/17) to learn about Adverum’s advances in the treatment of nAMD!

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Irrationally undermining patents does not solve the problem, though it raises unanswerable questions. What is the right number of patents for a biopharmaceutical product? Would they fit on the head of a pin? The Senate bill has that level of logic in the context of a patent system designed to incentivize, not limit, innovation. The system should encourage improvements to features like bioavailability, stability, safety, side effect profiles, and even convenience, not to mention repurposing drugs. Also, one good patent is enough to substantially extend exclusivity, so what happens then? Instead of playing games with patents, payers, including the biggest payer of all, the US Government, should condition adding a product to its formulary on the manufacturer's commitment to surrender exclusivity after a defined period (10 years?) by waiving injunctive relief for patent infringement after that time. That's a free-market, agreement-based solution with predictable effect. Competitors can license downstream development patents for royalties, rewarding unpredictable innovation that may occur during development. Or competitors can accept the risk and cost of designing around such patents. Either way, competitors can come to market. FRAND-like licensing programs would facilitate post-exclusivity licensing, and innovators would be assured of financial benefit for improving biopharmaceutical products after initial development.

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NY Illumina/GRAIL lawsuit Part 1: Conflicted Deal Process (continued from https://lnkd.in/gCFnVprG) The complaint goes into detail on the negotiation that took place during August 2020 as GRAIL pushed Illumina up for an initial $6B offer (🤯) to $8B (🤯🤯) to $10B including performance bonuses (🤯🤯🤯). And then this - there was NO DUE DILIGENCE: "On September 6, 2020, management apprised the Board of additional information concerning a potential transaction with GRAIL. The presentation noted that despite multiple offers and counters, “formal diligence” had not yet been conducted, but would focus on multiple issues. SIX DAYS LATER, on September 14, 2020, the acquisition was unanimously approved by the Illumina Board. Aravanis also attended this meeting." This confirms by worst fears - Illumina spent over $8B on a deal that never underwent due diligence 🤯 My theory is that Illumina had hired Aravanis from GRAIL and so figured they had the inside scoop on what was going on in GRAIL. They somehow ignored the fact that the person they were relying on to advise them on the deal stood to make $10M or more if Illumina purchased GRAIL. Sheer idiocy by the board: Aravanis clearly should have played no part in the process but was present at the board meetings. This is so obvious a f*ck up that a coverup was later attempted: also from this complaint: "Chairman Thompson and the Board published two letters to shareholders that falsely claimed that (due to his large GRAIL holdings) Aravanis had been “recused from any decisions to sign and close the GRAIL acquisition.” The Aravanis hiring was only most obvious conflict of interest - the entire negotiation was full of problems resulting from the intertwined relationships between the two companies (half the GRAIL board were ex-Illumina execs and board members). From the complaint: "Illumina’s one-month Acquisition process appears to have suffered from other process failures. Board members learned from an anonymous survey of Illumina’s directors and officers that during [the] GRAIL acquisition, there were multiple streams of unauthorized communications between an Illumina Board Member and GRAIL Board Members and the bankers.” Speaking of banker, famously Goldman Sachs represented both Illumina and GRAIL in the deal; note though that the higher the price of the deal, the higher their compensation 🤯

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Debuting today: BioPharma Dive's new Drug Patent Tracker! Jonathan Gardner and Ned Pagliarulo put together this extremely helpful, detailed and dare I say beautiful tracker that charts the IP protecting billions of dollars in pharmaceutical profits. Specifically, it focuses on the 30 top-selling drugs in the industry, including Merck's Keytruda, Novo Nordisk's semaglutide, AbbVie's Humira and Bristol Myers Squibb's Eliquis. The tracker's launch is timely, given the biopharma industry is facing a patent cliff "of tectonic magnitude" (as Jon previously reported) that will put more than $200 billion in annual revenue at risk through 2030. Would love for everyone to take a look and let us know your thoughts! #biotechnology #pharmaceutical #patents https://lnkd.in/g4fHPYAU

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Very happy to see this interesting discussion on The Future of Life Sciences: Recording from Foley & Lardner LLP. And it was quiet a surprise to see our good friend Andreas Goutopoulos (at 1:05:00) mentioning BIOEMTECH as an example of a Greek preclinical CRO. His words were really touching and we look forward to working with Actithera and be part of their promising compounds. https://lnkd.in/dN3xemZf #HIN #HellenicInnovationNetwork #targetedtherapy #drugdiscovery #radiopharmaceuticals, #preclinicalresearch, #molecularimaging #nuclearmedicine

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Join us in San Diego for #RNALeaders Sept 4, 5.  We are updating partners on our latest IV-formulated RNA program data. BIORCHESTRA Co., Ltd.'s #RNAi update covers: ✨ In-vivo progress on our neurodegenerative diseases franchise and proprietary IV-formulated RNAi research in #Alzheimer's and #Parkinson's ✨ Status of our #ALS program FDA IND pathway  ✨ Licensing negotiations for #MAPT, #SNCA, #INHBE/ #MAFLD, and #Glaucoma ✨ Our bridge round syndicate and #NYSE pathway To those requesting one-on-ones though LinkedIn, please reach us at [email protected] Novo Nordisk, SV Health Investors, PJT Partners, Perella Weinberg, William Blair Investment Banking, Jefferies, Leerink Partners, Nomura Securities International, Inc., Cain Brothers, UBS, Oppenheimer & Co. Inc., Wells Fargo Corporate & Investment Banking, Guggenheim Partners, Outcome Capital, Eric J. Dimise, PhD, Michael Bardi, Michael Zhang, Veet Misra, Cantor Fitzgerald, Noël Brown, Samuel Siu, CPA, RBC Capital Markets, John C. Reed, Novo Holdings, Lilly Asia Ventures 礼来亚洲基金, Sumitomo Mitsui Banking Corporation – SMBC Group, #pfizercolleague, Centerview Partners, Morgan Stanley Investment Management, Bank of America, Mallinckrodt Pharmaceuticals, Grünenthal Group, Evercore, New York Stock Exchange https://lnkd.in/gaWRkNDU The Janssen Pharmaceutical Companies of Johnson & Johnson, Otsuka Pharmaceutical Co., Ltd., ONO PHARMA USA, ONO PHARMACEUTICAL CO., LTD., Sanofi, Novartis Gene Therapies

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Over the weekend I was thinking (as one does 🤪) about Illumina moats. A clear sign that they're less effective than they've been historically is the traction that Element Biosciences has in the benchtop space, and MGI's success in overcoming Illumina's long held IP moat. I've heard that concern aboutthis problem drove Illumina's focus on vertically integrating via the GRAIL acquisition; I think it's fair to say that didn't work both because of regulators and it wasn't a real thing. So what's a monopoly to do? Obviously try and catch next the week wave - in my opinion that's proteomics sequencing - but that's going to take a lot of time and investment and technology risk. What can be done right now to shore up the moat as it's at immediate risk? One idea would be to license its core SBS technology to other life science companies. Some of the pros and cons: PROS: - Lets OtherCo's do the vertical integration. A great example of this is what Thermo Fisher Scientific has done with Genexus - built a clinical grade sample to answer system around Ion Torrent technology. Illumina has nothing like this because it doesn't have the extraordinary breadth of IVD experience and technologies that Thermo brought to the table. Why not license SBS to companies with these capabilities such as Danaher Corporation, QIAGEN and Roche? - Flexible high margin business model. Sure at one end of the licensing spectrum is royalties with 100% margin but low revenue, but there also the option of selling consumables. The seed for that model can be seen in the new MiSeq: all the complexity/IP is in the consumable (CMOS, fluidics, etc), very little in the instrument. Perfect for partnerships - you guys build the razors and we'll build the razorblades. - Licensing creates amazing moats as it turns potential large-company competitors into customers. It's a win-win for those customers: they get access to a constantly improving low risk NGS technology while being able to focus on their true value added, which is in non-NGS things. - I'm guessing this wouldn't be a problem for regulators - they would see it as a good thing as Illumina is sharing it's IP with others which feels anti-monopolist. CONS: - Potential for cannibalizing Illumina sales with licensee sales. This requires careful choice of licensees and limiting their field of use e.g. licensing SBS to Qiagen to only build a clinical sample to answer. And maybe picking winners here would be an anti-trust issue? Dunno. - Leakage of IP to licensees - Other? Struggling a little for a business analogy there. Kind of like Arm: a true platform with a great moat and scalable business model; customers for sure build vertically integrated solutions around their IP. Any other pro/con suggestions or business analogies?

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Reflecting on recent challenges in biopharma M&A underscores the complexities and risks involved in strategic deals. Many of these deals involve assets that are still in development, carrying clinical and regulatory risks. Another possible confounding variable is deal size, as deals in the $1 billion range had the most success. While these acquisitions were intended to bolster innovation and market position, setbacks -- like failed clinical trials and regulatory hurdles -- have reshaped priorities and impacted financial outcomes in the present. It's clear that such experiences emphasize the critical need for meticulous due diligence (prior research on regulations) to secure deals more consistently in the future. #Biotech #Biopharma #Acquisitions

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University of Pennsylvania spinout Interius BioTherapeutics raises $67M in a private equity round. The Philadelphia company is seeking to raise a total of $82.5 million from its Series B round. July 9, 2024 Interius was granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a first-in-human Phase 1 clinical trial of INT2104, its lead in vivo CAR candidate for treatment of B-cell malignancies. #funding #financing #genetherapy #invivo #CARtherapy #therapeutics #Bcellmalignancies #celltherapy #genetherapy #advancedtherapies #regenerativemedicine #lifescience #lifesciences #biotech #biotechnology #clinicaltrials #seriesfinancing #equityfinancing

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Bristol Myers Squibb partners with Prime Medicine, Inc. Medicine to advance #celltherapy in #immunology and #oncology. The #collaboration includes a $110 million upfront payment to develop optimized Prime Editor reagents for specific targets, utilizing PASSIGE technology. With potential milestones totaling $3.5 billion, Prime aims to extend its cash runway through the first half of 2026. This innovative approach combines Prime Editing with enzyme technology, ensuring precise genome modifications without double-stranded DNA breaks or off-target edits. Keith Gottesdiener, CEO of Prime Medicine, highlighted the benefits of PASSIGE at a recent industry event. #CellTherapy #Innovation #BiotechCollaboration #collaboration #advancedtherapies #tcell #biotech #biotechnology #lifescience #lifesciences #milestones #110mupfront #primeediting #enzymetechnology

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Interested in the latest developments at the FDA's Office of Therapeutic Products (#OTP)? Join a free, public webinar on June 14th featuring Dr. Nicole Verdun, OTP's Super Office Director, and Rachael Anatol, Ph.D., Deputy Super Office Director. What you'll learn: The new "Super Office" structure of the OTP Progress on hiring new staff An overview of the OTP's organization Brought to you by Alliance for Regenerative Medicine. Please use the link in the post below. #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #lifescience #lifesciences #regulatory #structure #biotech #biotechnology #webinar #productupdate #regulatorystructure

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