Richard Chin

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

4

1 Comment

Takeda's CEO's annual letter hits on some key themes that many biopharma CEO's are converging on: value-based care, price transparency, breaking up the middlemen, and driving healthcare access and equity. "For several years I have been outlining Takeda’s thinking on health equity—including advocating for a transition to value-based health care that pays for outcomes and care quality, emphasizing the need to prepare for the next pandemic by ensuring global vaccine equity and explaining how the protection of intellectual property rights is essential to incentivize investment in R&D. One area where we would like to see greater progress this year is pharmacy benefit managers reform. We support efforts in Congress to delink rebates from list prices or wholesale acquisition cost. It is a complex system, but the bottom line is that the current system creates misaligned incentives that ultimately result in higher costs for the system and higher out-of-pocket costs for patients. One potential way to address these challenges is through greater transparency. Transparency at the point of purchase for patients would empower them to make decisions knowing exactly what their costs will be. This could lower costs for the entire system by building in greater pricing accountability along the chain so that no stakeholder can benefit from the inefficiencies that result in the prices that patients pay today." At COEUS, we are working with the world's leading biopharma companies to help transition them from a broken FFS model towards value-based care. We have built the world's leading platform that hosts the biggest CGT commercial launches, and rapidly moving into Oncology, Obesity/ Diabetes, and beyond. 1. Enabling Value-Based Healthcare: Our solution facilitates the transition to value-based healthcare by providing a powerful tool for creating and managing contracts that pay for outcomes and care quality. 2. Enhancing Transparency: By aggregating disparate healthcare data from various sources, our platform provides unprecedented transparency into the entire healthcare ecosystem. This empowers payers, providers, and patients to make informed decisions and helps stakeholders across the value-chain to tie price and value to therapeutic outcomes. 3. Driving Innovation: Our platform's ability to evaluate complex rules for value-based contracts, real-world evidence studies, and health equity measurements fosters innovation in the pharmaceutical industry. By providing a tool to measure the impact of new solutions, we help companies drive medical advancements while ensuring equitable access. 4. Improving Access and Affordability: Our solution helps identify areas where access and affordability can be improved without compromising innovation. By providing data-driven insights into the effectiveness of various interventions, we enable stakeholders to make informed decisions that benefit patients and the healthcare system as a whole. Visit https://coebra.ai/.

10

Is Dyne Done? While Dyne's corporate website announces a positive spin on DMD clinical trial results, investors were not convinced by safety nor efficacy measures leading to stock drop. CBO, COO, and CMO now announced resignation, leaving the CEO to manage the executive team catastrophe. Regardless, the company will push forward towards registration, perhaps in hopes of receiving special benevolence from Peter Marks along the way... As I am not a specialist in DMD clinical measures, can anyone comment how does the Dyne outcome compares with Sarepta Exondys-51? https://lnkd.in/ey9RwXZF

29

5 Comments

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

86

4 Comments

An insightful (and inevitable) panel at HLTH USA, 'Straight to the Source: A Middleman Saga,' tackled the pressing issue of price transparency in the pharmaceutical supply chain. Josh Flum from LRVHealth kicked off the conversation with a question about the complex pricing dynamics between PBMs and pharmaceutical manufacturers. He highlighted the growing tension between list prices, post-rebate pricing, and how patients ultimately bear the brunt of the costs, with increasing finger-pointing between stakeholders. He raised the crucial question: How do we find a balance between price, payment for innovation, and patient access? Lori Reilly, COO of PhRMA, emphasized the vital role that competition plays in reducing drug prices. She referenced the case of hepatitis C treatments, where competition between branded products successfully drove prices down. However, Lori pointed out a significant challenge: while insurers and PBMs benefit from these price negotiations, patients often don’t see the savings. Instead, many patients with high deductibles are left paying the full list price at the pharmacy counter, despite the deep discounts negotiated behind the scenes. Lori shared a startling example from a study of Medicare Part D, where 79 of the top 100 most rebated drugs resulted in patients paying four times more than insurers. To address this, she proposed three key changes: 1. Breaking the link between PBM payments and list prices, which incentivize higher costs. 2. Passing discounts directly to patients at the pharmacy counter to reflect the real savings negotiated. 3. Increasing transparency in the system to ensure that patients aren't left paying unfairly inflated prices. Rick Gates, SVP of Walgreens, focused on improving patient engagement and pharmacy infrastructure. He stressed the importance of digital enhancements like check-in tools and scheduling systems to simplify the pharmacy experience for consumers. Laura Jensen from Amazon Pharmacy echoed the call for greater transparency and simplicity in healthcare access. She emphasized that healthcare remains far too complicated and that Amazon is focused on making healthcare as seamless, accessible, and transparent as any other service they provide. With increasing pressure from policymakers on drug pricing and innovation, this discussion was inevitable. The healthcare industry is reaching a critical point where we need to find a balance between affordability and fostering continued innovation. #HLTH2024 #HealthcareInnovation #PriceTransparency #PatientAccess #DigitalHealth #PharmaPricing #FutureOfHealthcare

14

1 Comment

At Windhaul Partners, we specialize in offering tailored strategic consulting and fractional staffing solutions to early-stage and pre-commercial biopharma companies. Our customized services are designed to help companies navigate shifting challenges, capitalize on new opportunities, and adapt to change effectively. Drawing from our rigorously vetted network of 500 biotech executives and experts, we offer unparalleled expertise across fractional, interim-to-permanent, or full-time roles. Here is a snapshot of our recent successes: • Strategic Pivot Fuels High-Value Partnership: We helped a clinical-stage biotech firm refine its drug development program and investor-facing narrative, resulting in a collaboration agreement with potential milestones totaling $300 million USD. • Interim Leadership Catalyzing Growth: Leveraging an interim Chief Medical Officer and key opinion leader, we provided invaluable guidance to steer the clinical development strategy, secure an IND approval, and oversee study execution for a biotech startup's flagship asset. • Navigating Regulatory Challenges with Precision: Guiding a pre-commercial biotech through the intricate terrain of an FDA Complete Response Letter, leading meticulous response preparation activities and ongoing agency engagement. Ready to navigate your business challenges together? Let's connect and drive your company towards success! #WindhaulPartners #BiopharmaConsulting #ExecutiveStaffing #SuccessStories #TransformativeResults

67

Editas Medicine Medicine Announces $50+ Million Monetization Financing with DRI Healthcare Trust Strengthens balance sheet with non-dilutive capital to enable further pipeline development and related strategic priorities CAMBRIDGE, Mass., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage gene editing company, today announced the sale of certain future license fees and other payments owed to Editas Medicine under its Cas9 license agreement with Vertex Pharmaceuticals to a wholly-owned subsidiary of DRI Healthcare Trust (DRI) for an upfront cash payment of $57 million. The upfront cash payment brings non-dilutive capital to Editas Medicine, helping enable further pipeline development and related strategic priorities. “We are pleased to partner with DRI to monetize a portion of the licensing payments from the Vertex Cas9 license deal we announced last December, providing us with considerable non-dilutive capital that we can put to work immediately as we develop our pipeline of future medicines,” said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. “We look forward to an ongoing relationship with DRI as we continue to execute our strategy.” Under the terms of the agreement, Editas Medicine will receive an upfront cash payment of $57 million in exchange for up to 100% of certain future annual license fees payable to Editas Medicine, ranging from $5 million to $40 million per year (inclusive of certain sales-based annual license fees that may become due) and a mid-double-digit percentage of Editas Medicine’s portion of a $50 million contingent upfront payment for which Editas Medicine is eligible under the Vertex license agreement. In addition to a portion of any such contingent upfront payment, Editas Medicine retains rights to fixed annual license fees for 2024 and a mid-single-digit million-dollar payment due to Editas Medicine in the event of Vertex’s achievement of certain annual sales milestones. https://lnkd.in/ecQYjKEH

7

1 Comment

Wow! Recursion Pharmaceuticals has agreed to buy Exscientia for $688 million in an all-stock deal, merging two leading AI-driven drug discovery platforms. This acquisition enhances Recursion's pipeline and partnerships, gaining assets from Exscientia, known for collaborations with Sanofi and Merck. The combined entity will have nearly $850 million in cash to advance treatments for rare diseases and cancer. Recursion aims to "make medicines better and faster" by leveraging Exscientia's AI drug discovery capabilities. This deal underscores AI's transformative role in revolutionizing the traditionally slow drug development process. I believe this powerful merger will yield exciting innovations in the coming years. https://lnkd.in/eUwRtnPn #Biotech #AI #DrugDiscovery #Innovation #Healthcare #Recursion #Exscientia

19

Practical insights and learnings from 18 months of implementing generative AI solutions, with a focus on Medical Affairs. Particular relevance for the budgeting season. More at https://ffi-ventures.com/

3

When investors think your gene therapy isn't good enough... That's what Lexeo is feeling right now on LX2006 for cardiomyopathy associated with Friedreich's Ataxia. Their Ph1/2 trial saw 50% of patients (8 total in the trial) experience a reduction of 10% in left ventricular mass index. There are only a handful of companies developing therapies for Friedreich's Ataxia, let alone the heart-related components of this rare disease. While Lexeo was optimistic about the data and taking it to discuss a future pivotal study with regulators, the market was not, knocking the stock down at present ~25%. The public markets are brutal with earlier stage companies. Depending on capital needs, it can be a bit easier to not be public when you're early in development. Regardless, another piece of positive news for AAV as it slowly comes out of its winter. Lines up with our beginning of the year predictions below! https://lnkd.in/drRreSCd

56

2 Comments

AbbVie has lost >$45B in market capitalization since the negative Phase II readouts on emraclidine, the schizophrenia drug they acquired via their $8.7B buyout of Cerevel Therapeutics. Competing neuropsychiatric drug developers Neumora and Neurocrine Biosciences have faced similar setbacks on their schizophrenia drugs leaving only Bristol Myers Squibb's Cobenfy (acquired via their buyout of Karuna Therapeutics for $14B in cash) and Terran Biosciences' TerXT the only real assets of significant value and with near-term hopes for commercialization. Given TerXT's superior release profile (once-daily oral pill vs. Cobenfy's twice daily regimen) along with a long-acting injectable form that could last up to six months, as well as TerXT's reduced side effects, analysts are speculating that TerXT could take substantial market share from Cobenfy which is projected to reach as much as $10B in annual sales. This all adds up to TerXT being exceptionally well positioned in a white hot neuropsychiatric biopharma M&A market.

24

3 Comments

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

80

3 Comments

With GLP medications like Ozempic, Wegovy, Mounjaro, and Zepbound making headlines, we’re launching a new 3-part series starting today on Raising Health to explore their impact. First up, we have Carolyn Bradner Jasik, MD, CMO at Omada Health, who joined me to discuss the impressive weight loss results and broader health benefits of GLP-1s, such as improvements in heart, kidney, liver conditions, and even addiction. We also touched upon the critical issues of accessibility, affordability, and the need for comprehensive support programs to manage side effects and ensure proper use. Listen to our full conversation here: https://lnkd.in/gDTYHw-6

95

3 Comments

Interesting read on gene therapy.

5

1 Comment

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

80

8 Comments

Coming soon to Podcast Channel near you. Check out the YouTube Channel and save your spot by being one of the first to subscribe. First episode to air soon!!!! https://lnkd.in/gNyu_aip #decodinghealth #science #knowledge

6

David H. Crean and John Foley are thrilled to announce the creation of a new CEO Life Science peer-to-peer advisory group for San Diego CEOs with the leadership team at REF(Renaissance Executive Forum) San Diego. The focus of the REF group will be on more mature companies post-Series A funded companies including those nearing IPO’s and publicly traded companies. The new cohort is expected to begin in early 2025.   REF is a global organization that brings together business leaders in peer advisory groups to enhance their leadership skills and business strategies. Founded in the USA over 30 years ago, REF operates by assembling groups of 12 to 15 business leaders. These groups meet monthly, guided by a Forum Leader, to discuss strategic decisions and personal goals in a confidential environment. REF emphasizes the concept of "Collective Intelligence," where the diverse experiences and backgrounds of members are leveraged to foster better decision-making and personal growth. The organization serves as a hub for over 2,500 entrepreneurs, members, forum leaders, partners, ambassadors, and global speakers, providing a platform for sharing best practices and accessing new opportunities. This peer advisory model is considered more effective than traditional one-on-one coaching, as it builds lasting relationships and provides diverse perspectives that are crucial for both personal and professional development.   The partnership with REF is a recognition of the great work achieved by CEO360 with early-stage life sciences companies over the last 2.5 years plus a desire to take this platform to another level with a larger platform that REF offers for later stage companies. REF currently has a growing international footprint with an unmet need in Life Sciences well beyond the San Diego ecosystem. REF is well positioned to address those needs in 2025 and beyond.   CEO360 will stick to its core and not move away from its early-stage focus. The new REF cohort will be held in addition to the three CEO360 cohorts currently underway in San Diego, the Bay area, and via a new virtual group that will likely involve international leadership. The vision is to create a feeder program where qualified, seed-stage Life Sciences companies can benefit from the power of peer-to-peer advisory as they progress through the stages of funding - Seed, Series A, Series B, and all the way through IPO.   From a timing perspective, the new REF Life Sciences group has just started recruiting CEOs and Ambassadors in the sectors of therapeutics, pharmaceuticals, diagnostics, nutraceuticals, medical devices, and health tech.    Please stay tuned for updates as we embark on this new exciting journey and extend our mentoring support to later-stage Life Sciences CEOs. Below is a link to the REF website.    https://lnkd.in/gcgcgsBy   #Leadership #LifeSciences #CEOs #REF

16

HUGE Congrats to the Corner Tx Team for Successfully Raising $54 Million to Fuel A New Era for Cancer Therapy! From the very beginning, our vision of Corner Tx, inspired by the motto "infection-like immunity = life-long immunity," was to revolutionize cancer treatment—enhancing survival rates and offering long-lasting protection to those afflicted. Typically, while the immune system efficiently targets infections without impacting healthy cells, it does not naturally combat tumor cells. Under the pioneering research from Jonathan Kagan's lab at Boston Children's Hospital, Corner's novel approach has been to replicate the body’s infection response to develop a robust immune defense against tumors. This strategy aims to attack existing cancers and prevent their future occurrences, promising a beacon of hope to countless patients eagerly awaiting breakthrough therapies. The excitement within the cancer community is palpable, bolstered by compelling evidence published in Science Magazine and Cell Reports. The studies illustrate that it is possible to deliberately provoke the immune system to reach an unprecedented level of activation - specifically to achieve hyperactive Dendritic Cells that have an enhanced ability to migrate to draining lymph nodes and stimulate potent cytotoxic T lymphocyte responses. For cancer patients in dire need of novel treatments, this milestone marks a significant step forward in developing potentially life-saving therapies and will propel Corner's antigen-agnostic approach into clinical trials. The funding, led by Ziff Capital Partners and including Cockrell Interests, Tanis Ventures, and Sandia Holdings, will boost Corner’s mission to enable the immune system to engineer long-living, disease-fighting T cells. The company has received funding from leading organizations like the Bill & Melinda Gates Foundation and partners with prominent biopharma companies to fully realize the protective promise of both therapeutic and preventative vaccines. Thank you Allison DeAngelis 🙏🏻 for providing an overview of the story and platform! Steven Altschuler M.D. Andrew Bellinger Nicholas Seaver Laura Brandano Andrew Cornforth, Ph.D. Sivan Elloul

89

2 Comments

Eli Lilly and Company's shares were up 7% this morning on guidance that they are seriously ramping up their production capacity for their obesity and diabetes drugs, Mounjaro and Trulicity. They also increase their revenue forecast by $2B this year! We already know that diabetes drugs like Ozempic have become very mainstream and the drug companies are all making huge profits, but the question is, can the average consumer or aspiring founder benefit from this craze? The answer is yes. I've shared my POV time and time again that I think that drugs like Ozempic are going to have a massive impact on the global economy for the foreseeable future. I break down how I would approach capitalizing on the whitespace Ozempic is generating because this is truly a once in a life time opportunity. #startup #entrepreneur #ozempic #diabetes #weightloss

104

16 Comments