John Hollway

Some VC investors believe that brick and mortar - referring to a physical presence of some kind - should be avoided at all costs. Yet, the track record of clinic and hybrid care businesses in health care indicates otherwise. ==> One Medical (sold for $3.9 billion to Amazon), Oak Street (bought by CVS for $10.6 billion), Lifestance (IPO at $7.5 billion market cap), and PE-backed Premise Health (acquired by OMERS Private Equity for $1.1 billion) If a clinic is indicated as the optimal way to deliver care for that patient population, there are creative ways to build and operate them. Full article below with advice and strategies on how to build and operate hybrid clinics from my teammate Anarghya Vardhana from Maveron, Amir Dan Rubin from OneMedical Group, Steven Eidelman from Modern Animal and more!

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The Supreme Court's overruling of "Chevron Doctrine" and it's potential implications for the future of biotech, healthcare and psychedelics: In a 6-3 decision, the Supreme Court ended the 40-year regime of “Chevron Deference”: a doctrine that required courts to defer to regulatory agencies’ interpretation of ambiguous laws or statutes. For example, under Chevron Deference, the courts would defer to the FDA on any ambiguities in the Federal Food, Drug, and Cosmetic Act (abbreviated as the FFDCA, one the primary pieces of legislation that grants the FDA its regulatory authority). In the new post-Chevron era, a drug company who feels that they are harmed by the FDA’s interpretation of ambiguous sections of the FFDCA can now sue the FDA rather than being stuck with their interpretation. This has massive potential consequences for companies seeking FDA approval – including many of our portfolio companies. Per the Washington Post: “New drugs approvals, for instance, are supposed to be based on “substantial” evidence grounded in “adequate and well-controlled investigations” — which the agency has interpreted to mean studies that include a control group, minimize age and gender biases and standardize doses . . . now, a single judge . . . could weigh in and say that the FDA has interpreted ‘adequate and well controlled investigations’ incorrectly.” On the psychedelic front, the end of Chevron may provide an angle for companies to fight the DEA if they try to schedule novel psychedelic compounds (to work with scheduled drugs, companies must apply for and receive burdensome controlled substance licenses). It will take years for the impact of the Chevron overruling to become clear. The Supreme Court decision didn’t immediately change any regulations, it simply opened the door for companies to fight regulatory agencies. Focalpoint Partners will be watching post-Chevron lawsuits related to the FDA & DEA carefully. For a more thorough treatment of this topic, I recommend Wilson Sonsini’s blog post: https://lnkd.in/gTcT4z4s

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As MassBio releases its 5-year strategic plan today, I'm thrilled to share key insights from my recent podcast conversation with Jason Cordeiro, Chief Operating and Innovation Officer. I had no idea about some of these programs, so I bet you'll learn something new even if you think you know all about MassBio! Here are some key takeaways from our conversation: 🌱 Nurturing Early-Stage Companies: MassBio is launching a Launchpad program to provide roadmaps and potential partners for startups, along with plans for a seed fund linked to their MassBio Drive accelerator. 🤖 Embracing AI and Tech: There's a strong focus on supporting AI-driven drug development and "tech for biotech" companies, recognizing the importance of digital innovation in the industry's future. 💰 Expanding Investor Base: MassBio is developing a program to demystify life sciences investing and attract new funders to the sector. 🧬 Fostering Diverse Talent: The successful Biodiversity initiative is expanding, with plans to develop targeted programs in different communities plus a new focus on executive-level talent development in partnership with The Termeer Foundation. 📣 Amplifying Industry Impact: MassBio aims to better communicate the biotech industry's story to lawmakers and the public, emphasizing its broader impact beyond financial metrics. These initiatives are part of MassBio's comprehensive strategy to maintain Massachusetts' leadership in the biotech sector. I'm excited to see how these plans unfold over the next five years! #Biotech #MassBio #Innovation #LifeSciences #AIinHealthcare Don't miss the full conversation! Link to podcast in comments.

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Please join this webinar on October 31 if you have interest in how to do metabolomics analysis accurately, quickly, and inexpensively using the data from your mass spec.

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Biotech Investors Refuel in 2024! "Flagship Pioneering, the sprawling life sciences investor and startup incubator, appears to be seeking more capital than originally planned for its eighth fund. The Boston-area firm is raising up to $3.5 billion, versus a $3 billion target outlined last November, according to documents from a pension fund that has invested in Flagship’s funds. The pension fund, Massachusetts Pension Reserves Investment Management , or Massachusetts’ PRIM, is committing up to $60 million to the fund, and other repeat investors have also ponied up: The Texas Municipal Retirement System (TMRS) committed $75 million and the State of Michigan Retirement System committed $200 million...." ARCH Venture Partners Foresite Capital TCGX Decheng Capital #venturecapital #capital #funding #financing #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #regenerativemedicine #lifescience #lifesciences #biotech #biotechnology #lifescience #lifesciences #investors #investment #funds

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July 27 2024 – 5 Notable Articles To Read Article: Artiva Biotherapeutics Announces Pricing of Upsized $167.0M Initial Public Offering Takeaway: A biotechnology company at the clinical stage, dedicated to developing effective, safe, and accessible cell therapies for patients suffering from severe autoimmune diseases and cancers. Source: GlobeNewswire Link: https://lnkd.in/driqTcHj Article: Funding surge for blank cheque companies points to Spac bounceback Takeaway: An investment class once written off due to early excesses and poor performance is now showing signs of revival. Source: Financial Times Link: https://lnkd.in/dZa_XGx7 Article: Informa agrees to buy Cannes Lions owner Ascential for almost £1.2B Takeaway: The acquisition of Ascential marks the completion of Informa's three-year investment program, which has strengthened its position as the world's largest events business. Source: Financial Times Link: https://lnkd.in/dsHnARte Article: VCs are still pouring billions into generative AI startups Takeaway: According to Crunchbase data, if the current trend continues, generative AI companies are set to match or surpass the approximately $21.8B raised in 2023. The breakdown of the H1 2024 total by stage is as follows: 198 angel/seed deals amounting to $500Mn, 39 early-stage deals totaling $8.7B, and 18 late-stage deals reaching $3.1B. Source: TechCrunch Link: https://lnkd.in/dPADfDt7 Article: National Basketball Association (NBA) Announces $77B TV and Streaming Deals with Amazon, The Walt Disney Company and NBCUniversal Takeaway: The new 11-year agreements, set to last through the 2035-2036 season, will have Disney paying the NBA an average of $2.6B per year, a significant increase from the $1.5B per year under the current deal. Source: The Information Link: https://lnkd.in/dRPU8cSq #news #research #ai #business

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This edition of Orrick’s life sciences series reviews key venture investment trends in Q2 2024 and features a roundtable on ARPA-H, which funds high-impact biomedical research. https://lnkd.in/gEEXNwpf

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Truly comprehensive, differentiated AI foundation models for human cellular and tissue biology are a material breakthrough for advancing anti-cancer and related therapies Great to see this progress from DCVC-backed NOETIK

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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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Fabulous to be on the investor panel for Mintz’s Life Sciences Pitch Event today, on yet another glorious fall day in Boston. ☀️🍁 (Although perhaps all meetings that start at 8am should come with good weather?) Key feedback shared by our panel: 🔹 Ensure your target market is clear - especially when the population for your relevant indication is highly heterogenous 🔹 Share your current assumptions about how your product may be used (e.g., chronically vs. episodically) and open questions 🔹 If you're exploring a range of commercial use cases, share how you anticipate prioritizing across them over time 🔹 If your GTM strategy requires you to displace heavily entrenched solutions and/or processes, share how you will enable these transitions 🔹 Note the specific set of milestones to be achieved with investment 🔹 Always include target timelines and potential paths to exit Thank you to the incredible lineup of entrepreneurs who pitched today, and please stay in touch! Thank you to Dean Farmer and Charlie C. for facilitating today's event. Thank you to panelists David Fogel, CPA, Ben Littauer (he/him), Molly Hoult, and Richard Wagner for your contributions. Great to meet you, and thank you for all of your help, Emily (Krasowski) Yanachkov and Diana Malkin. #lifesciences #pitchevent #investor #panel #boston

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Great insights shared by Dr. Christopher Haley at Startup Genome on the vital connection between a region's assets and the appropriate accelerator stage. This article underscores how aligning these elements leads to remarkable outcomes in ecosystem development. A great read for all of my friends in ecosystem development. From my personal experience I'll add that misalignment, however, can have long-lasting effects. When startup programs or organizations backed by private or public funds falter, the recovery period for regions can extend from 3 to 8 years. This delay significantly impacts founders seeking mentorship, knowledge, and funding opportunities. #EcosystemDevelopment #StartupGenome #AcceleratorPrograms #FounderSupport

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Absolutely thrilled to announce our investment in Cleerly and support James Min, MD in the journey to transform the way we detect, understand, and treat heart disease. This investment perfectly represents why I focus on HCIT: the opportunity to drive meaningful, measurable improvements in the quality of care for millions of people. Cleerly's groundbreaking technology enables a more proactive, personalized approach to heart health—shifting the paradigm from reactive treatment to prevention. By leveraging advanced imaging and data, Cleerly empowers clinicians with the tools they need to better assess risk, identify disease earlier, and provide targeted interventions that save lives. Onwards and upwards! https://lnkd.in/eQwpfta4

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Boston's startup infrastructure "is primarily geared toward people starting companies in information technology, biotech, or climate tech. Good luck trying to launch a new retail concept, food brand, salon chain, or apparel line — industries where diverse founders are already working on promising ideas, often with scant support." Wrote this piece for Boston Globe Media's Ideas section... and the announcement of the new Boston XChange accelerator + incubator from Jaylen Brown plugs into this approach perfectly. "More diversity in the types of companies we nurture around here would help retain talent — and help our economy better weather the ups and downs of our dominant industries." With input from Derrick Duplessy Sidney Baptista Poorvi Patodia Anuradha Yadav Jen Faigel + more. Link in first comment.

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Proud to partner with Brian Weiss and his team at Carebox, who are enabling pharma sponsors, sites and advocacy groups to advance trial research and provide access to the latest treatment options for patients and caregivers in times of critical need. H.I.G. Capital’s investment represents Carebox’s first growth capital raise, and we are excited to provide the team with additional resources to continue their category-defining innovation path. Carebox addresses a significant market pain-point and provides a unique solution offering: ✅ Large and growing market opportunity - The pharma industry spent $230B on R&D in 2023 (growing to $270B by 2027), with $2B specifically on patient recruitment. Drug sponsors are increasingly disintermediating CROs and clinical sites to guarantee higher rates of enrollment, retention, and clinical efficacy. Additionally, clinical trials pipelines have shifted toward rare diseases, oncology therapies, and more complex therapeutic areas which require sick patients (vs. healthy participants). Participants for these trials are difficult to source and retain due to their low absolute occurrence rates and poor health. Many sponsors today leverage outsourced services businesses and in-house teams to manage the patient recruitment process, providing ample greenfield opportunity for Carebox’s self-service software offering and capture eligible patients at a cheaper cost-per-lead. ✅ Significant ROI - Patient recruitment and time to market are critical pain points in clinical trials for drug therapies, with failure rates of 48% to meet enrollment targets, 80% to meet enrollment timelines and 11% to enroll a single patient. These failure rates have led to increased trial costs and timelines, with US registered trial costs at $108B in 2023 (5-year CAGR of 5% and average cost per trial $14M) and the average duration to trial primary completion date increasing from 1.7 years in 2014 to 2.3 years in 2021. Not only do lengthier timelines increase costs, but it is estimated that there is ~$800k per day lost in revenue due to delayed trials. Carebox’s software offering provides more efficient, direct-to-patient intake and AI-driven matching to trials to get revenue producing therapies quicker to market. ✅ Differentiated product, with growing data moats - Carebox’s algorithm identifies patients for clinical trials, powers patient advocacy group referrals, and drives organic, high-intent traffic to patient-facing trial portals. This collection of products generates a data flywheel that reinforces the matching engine to drive better leads and higher rates of patient conversion into trials. CC: Albert Koh, Justin Marpole-Bird, Angela Chon, Emily Yu PR: https://lnkd.in/gfaTSz_f

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In Episode 2 of the "Brain Cancer Science Talk" series on #MissionGBM, we chat with Graeme Woodworth, MD (Chair of Neurosurgery, Director of the Brain Tumor Program, University of Maryland) about innovation in neurosurgical techniques and MR-guided Focused Ultrasound methods to transiently open the BBB for the purposes of diagnosing and treating brain cancers. Check it out, and stay tuned for more one-on-one Series discussions with the world's top brain cancer physician/scientists. Two scientists walk into a (Zoom) bar...and put their brains together. #braincancer #GBM #FUS #LITT #Connectomics

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Another great article in the Life Sci VC blog. Thank you Aimee Raleigh for the article on diligence! It also points out some limitations of current approaches (ERT, virus, RNA, agonists) to impart “gain of function” pharmacology and hence why I am excited about Entact and the ability to enhance protein function! Enjoy the article! https://lnkd.in/ewhqKx_p

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It was wonderful to be in conversation with Madison Mills of Yahoo Finance at their annual Invest conference earlier this week. We covered everything from the venture outlook for 2025, impact of elections on women's health investing and innovation, and more. Full clip and summary below 👇 https://lnkd.in/gS67sc2Y

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BIG NEWS FOR HORMONE HEALTH! Almost 2 years in the making, so proud of the Elix team for the completion of our second independent clinical trial focused on #PCOS (Polycystic Ovary Syndrome). Big shoutout to our medical advisors, our passionate team and most of all - our community members for your strength, resilience and belief in more sustainable approaches to our health and longevity. The clinical study assessed two of Elix's flagship products—Cycle Balance and Daily Harmony. These herbal supplements, rooted in 5,000 years of TCM research, target inflammation and hormone imbalances associated with PCOS. Results revealed that in a group of non-birth control users: * 89.3% of participants agreed that Elix Cycle Balance and Daily Harmony have helped to regulate their cycle.
 * 85.7% of participants agreed that they had fewer premenstrual and menstrual cramps after taking Elix Cycle Balance and Daily Harmony.
 * 71.4% of participants agreed that taking Elix Cycle Balance and Daily Harmony had improved their hormonal acne/breakouts and that they experienced fewer mood swings.
 The trial, conducted over six months, involved 70 participants with Polycystic Ovary Syndrome aged 18-36, divided into two groups: those using hormonal birth control (BC) and those not using it (No BC). Each participant was also diagnosed with PCOS and experienced symptoms such as irregular menstrual periods or the absence of menstrual periods and/ or excessive facial or body hair, thinning hair, hair loss on the scalp, oily skin, and or acne. Additionally, the majority of participants in the Clinical Study experienced improvements in the following symptoms: * Cycle regulation
 * Bloating
 * Fatigue
 * Mood swings
 * Anxiety
 * Sleep quality
 * Premenstrual and menstrual cramps
 * Hormonal acne/breakouts
 * Brain fog
 * Mental clarity
 * Focus
 * Weight gain
 * Unwanted facial / body hair
 * Fluid retention
 * Overall PMS symptoms
 * Overall PCOS symptoms
 * Overall health and wellbeing https://lnkd.in/eUjV7DkZ

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Interesting read on gene therapy.

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