Fred Aslan

The pandemic was a challenging period for all. But it also offered us opportunities! The concept of Jupiter is a great example. Jupiter Bioventures, a product of virtual brainstorming with friends (Ned David, Ned Sharpless and Steve Tregay) to enable Mayo Clinic’s insatiable desire to create the next generation of Cures, is now a powerhouse of drug development that has attracted value-aligned investors and academic partners to join forces in the best interest of patients everywhere…. Congratulations Jupiter team! May the patients win….. Norman Sharpless Nathaniel David Steve Tregay Nirdesh K Gupta, PhD Steven VanNurden Peter Noseworthy, MD Vijay Shah Heidi Dieter Andy Danielsen Mayo Clinic Ventures James Rogers Clark Otley Olayemi (Yemi) Sokumbi, M.D. Pankaj Jay Pasricha Waleed Brinjikji Janani Reisenauer Justin Butler Geoff Johnson, MD, PhD Melissa Noel, MBA, MSE, Johannes Fruehauf, Owen Garrick, MD, Jeanette Caban Cheryl Willman, M.D. #venture, #biopharma, #capital, #venturecapital #accelerator, #drug #drugdevelopment, #development, #technology, #commercialization, #technologytransfer, #research, #clinicaltrial, #patient, #cure, #transform, #venturestudio, #disease, #cancer

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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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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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Nymbl Science is ENTERING THE CHAT- or the podcast- on Digital Health Heavyweights Podcast. This story hits home for a lot of us. An elderly person who falls, and then is incapacitated. A grandmother, great-grandmother, grandfather, great uncle, or neighbor. They have a serious fall, and then they are never the same.💔 Nymbl is a great solution to help people stay active and independent in their own homes. To work on their sight, and balance, in order to give the elderly population a chance to avoid those 'inevitable' falls. CHECK IT ALL OUT ON EPISODE 46. Today I sit down with Edward Likovich, PhD, CEO and founder of Nymbl Science, and Robert Mirsky, Chief Medical Officer. Nymbl is a scientifically proven fall prevention program for Medicare Advantage members. We chat how Ed founded Nymbl in sad inspiration from his grandfather's fall-related death and the impact it had on his family. Dr. Mirsky explains how Nymbl helps elderly patients stay independent and active by retraining their balance reflex. Walking is not enough, balance is also about your REFLEXES. How does Nymbl work? Nymbl has a personalized program combining exercise, cognitive challenges, and medical education to engage older adults and reduce falls. They walk us through the member experience, and surprisingly enough, post COVID elderly people have been much more tech-adoptive than you would assume. We discuss their world's largest fall prevention study, Nymbl's incredible actuarial model, challenges, successes, Medicare advantage, emotional wellbeing of the elderly, the next 5 years and more!! Some key takeaways: 🏃‍♂️ Nymbl helps elderly patients stay independent and active by retraining their balance reflex. 🛡️ Addressing balance and other age-related issues early on is crucial to prevent falls and improve overall well-being. 💪 Nymbl's personalized program combines exercise, cognitive challenges, and medical education to engage older adults and reduce falls. 📉 The vendor space in digital health is shifting towards at-risk payment models based on real ROI. Nymbl has a high adoption rate among older adults and engages them effectively by meeting them where they are and providing valuable information. 🌍 They have conducted the world's largest fall prevention study and can prevent about 20% of injurious falls.

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We are proud to once again lead FIZE Medical ‘s financing, this time its Series A-4 round. Rapha Capital Management, LLC has been leading FIZE’s financing since 2020. We are delighted to add Valitas Ventures and eHealthVentures as investors and board observers in this round. As a physican, urologist, FIZE Board Chairman and principal at Rapha Capital, whose mission is to identify potentially disruptive biopharmaceutical and medtech companies within a sea of less compelling opportunities, I am excited as FIZE enters 2025 with an expanded clinical research plan to harness the data generated by the growing installed base of FIZE kUO devices to provide meaningful guidance to physicians managing their critically ill patients as well as demonstrate the operational and safety efficiencies in managing the Foley catheters of entire health systems in a unified and improved manner. For more, see https://lnkd.in/eB2iujFR

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🚨 The #FDA's latest draft guidance on accelerated approvals takes aim at "dangling" approvals—products still marketed despite failed confirmatory trials. The agency is now mandating tighter timelines (2-4 years for oncology), more transparency in withdrawal processes, and public involvement. 🕵️‍♂️ This marks a shift from flexibility to rigor, signaling that the accelerated pathway is no longer a free pass. For #biopharma, it's both a challenge and an opportunity to align trial strategies earlier. Is this the FDA tightening the reins—or just evolution in regulatory science? FDA website: https://lnkd.in/gqc-z-5e #pharmanews #breakingnews

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Our new provider-exclusive product is called MYOS MD, an all-natural supplement that helps reduce muscle loss associated with aging, disuse, and/or medical treatment. MYOS MD is powered by our proprietary ingredient, Fortetropin®, a unique bioactive composition derived from raw, fertile chicken egg yolks – clinically shown to lower myostatin, down-regulate the Ubiquitin pathway, and increase rate of muscle protein synthesis in older adults. Watch video below for more insight into the product, and/or visit myosmd.com for more info. #longevity #wellness #muscle #health #obesity #sarcopenia

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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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Diakonos Oncology CFO Anthony Baldor is at #BIO24 this week to make a company presentation and meet with potential partners and investors. For those interested in learning more about Diakonos’ unique dendritic cell vaccines for cancer, we can be reached through the BIO ONE Partnering System. Mr. Baldor’s company presentation takes place on Tuesday, June 4th at 3:00 pm PT in Company Presentation Theater 2 at the San Diego Convention Center. Mr. Baldor’s presentation will include a review of Diakonos’ highly differentiated double-loaded autologous dendritic cell vaccines for cancer, and an operational update on the company’s plans for growth, including clinical development outlook and expansion of its leadership team. Diakonos recently completed a Phase 1 trial of DOC1021, its lead vaccine for glioblastoma multiforme (GBM), and is planning a Phase 2 study. The US Food and Drug Administration has granted Fast Track and Orphan Drug status for DOC1021. Two other clinical trials are under way with dendritic cell vaccines targeting pancreatic cancer and angiosarcoma. “We are very excited about the results of our Phase 1 trial for GBM,” Mr. Baldor said. “Data observed to date give us great confidence in our dendritic cell vaccines and their potential to treat a broad range of solid tumor cancers, including the most deadly. Twelve month survival is currently at 90% for evaluable patients, and the therapy is well tolerated.” Diakonos’ dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that better harness a patient's immune system to target and eliminate cancer cells by initiating a natural immune response. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs when compared to leading cell therapy approaches. Visit our we site: diakonosoncology.com to learn more. #cancerresearch #cancer #biopharma #clinicaltrials https://lnkd.in/dET5pqbD

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There's a deep personal history for me with this major acquisition today. Incyte (Rich Levy) had the vision at the time (2016) to let me design a very bold #phase2 #clinicaltrial with topical #ruxolitinib which ended up being the first FDA-approved JAK inhibitor in dermatology as OPZELURA® (ruxolitinib) HCP. Incyte acquires John E. Harris, MD, PhD's Villaris Therapeutics backed by Medicxi to go after #vitiligo. John E. Harris, MD, PhD and I are co-founders of Alys Pharmaceuticals which is going after #urticaria #itch #vitiligo and beyond again backed by Medicxi. In parallel in 2019, we publish an early and key paper in the journal Immunity (Meixiong et al. Immunity 2019) with Xinzhong Dong who discovered MRGPRX2 (actually, the entire family). I then start advising Escient Pharmaceuticals with the most bullish optimism about MRGPRX2 as target for #skin #diseases and witness a brilliant execution by Veena Viswanath et al. Incyte makes a bargain acquisition today for $750 million to transform skin disease in #dermatology and #allergy. The key point here is that MRGPRX2 antagonist will NOT be competing IMO with other more moderate-to-severe assets in #CSU like #barzolvolimab. They will mutually grow the market for #CSU across the mild to severe spectrum in a disease that is growing in incidence and poorly penetrated even by great drugs like #omalizumab. Keep in mind, #antihistamines are >$2 billion annual sales for #itch, which it does not even work for that well! This will accelerate new treatments for #urticaria and much beyond. Great for our patients.

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Explore our latest overview of March 2024's U.S. Biotech Funding. The top eleven private funding rounds we followed amassed $1.85 billion, contributing to a total cumulative funding of $3.76 billion. Key Highlights: >> Mirador Therapeutics led with a Series A funding of $400 million. >> Alumis secured $259 million in Series C funding. >> Sionna Therapeutics and Capstan Therapeutics followed closely with Series C and Series B funding of $182 million and $175 million respectively. >> Engrail Therapeutics concluded the top five deals with $157 million in Series B funding. >> Also included Aeovian Pharmaceuticals, Avenzo Therapeutics, Clasp Therapeutics, Rakuten Medical, Nocion Therapeutics, Inc., FogPharma Other Noteworthy Points: >> San Diego stood out as a prominent cluster, hosting headquarters for 5 of the top 11 companies that collectively secured over $1 billion in funding. >> Series A funding dominated with $750 million spread across 5 deals. >> Among the 109 investors we tracked, key players such as Alexandria Real Estate Equities, Inc., OrbiMed RA Capital Management, ARCH Venture Partners, Catalio Capital Management, Cormorant Asset Management, LP, F-Prime Capital, Farallon Capital Management, Fidelity Investments, Forbion, The Invus Group, Perceptive Advisors, Sofinnova Partners, T. Rowe Price venBio, Nextech Invest

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$100 million to develop covalent biologics for oncology ! Enlaza Therapeutics just secured $100 million in Series A funding, led by J.P. Morgan Asset Management’s Private Capital division, to advance its covalent biologic platform for novel protein drugs, particularly in oncology. ⚗️Safer and more tolerable tumor penetration : Enlaza's War-LockTM technology creates biologic drugs that bind irreversibly to disease targets, enhancing efficacy and safety. By promoting covalency, it improves therapeutic performance, reduces systemic exposure, and allows sustained biologic effects with minimal dosing. Using proprietary amino acids, Enlaza engineers precise biological medicines with enhanced properties, offering a versatile solution across different protein-drug formats. 💊Investors : J.P. Morgan led the funding round, joined by existing investors like Frazier Life Sciences and new ones including Amgen and Regeneron's investment arms.

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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. ☀️🍁 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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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

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Nice short article on medtech ups and downs. Don’t need a subscription on this one! Reduced biopharma funding could slow medical device growth—50% of revenue in life sciences comes from biopharma. Physician visits suggest fewer surgeries—impacting demand for surgical devices. FDA LDT rules could raise costs & limit competition in diagnostics. R&D spending & clinical trials remain strong, a high number of device approvals & active clinical trials — 756 as of May 2024 — point to a promising future. Automation & supply chain optimization can improve margins during lower sales periods. Data can optimize inventory management, logistics, and geographic footprint. How can MedTech companies adapt further? #FutureOfWork #MedTech #RandD

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This is perhaps where the "U" turn for DTx starts? I'm not suggesting we will enter the highly bullish times of 2018-2021 but I think like a lot of technology cycles, this may serve as an inflection point as we look back on this 2-4 years from now. In addition to some of the additional coverage guidance around breakthrough treatments, we may see folks filing back into this space over the next 12-18 months. #dtx #digitaltherapeutics #FDA #reimbursement

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