Monicca Shanthanelson, PhD

Excited to share the latest feature in our "Partnering Spotlight" series, where we share some of the connections we are building to foster scientific innovation in healthcare. In this edition, our very own Neha Kaushal sits down with Daniel Anderson, Professor of Chemical Engineering at MIT, to discuss the potential of innovative #mRNA applications in vaccines and novel treatments for genetic diseases. Check out the video to learn more about our collaboration! https://lnkd.in/eHwpyjeY #vaccines #immunoscience

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Thoughts on this? >> Weekly review: Profound genetic deafness gene therapy, measles increases, and more - Contemporary Pediatrics >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #competitivemarketing #healthcare #biotech #pharma

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Today’s positive announcement about Gilead’s investigational PrEP medication among cisgender men, transgender men, transgender women, and gender non-binary individuals in our PURPOSE 2 trial is a remarkable achievement. I’m so proud that our commitment to inclusion was central to the success of the trial. Read the full press release here: http://bit.ly/3XlBEn7 Cisgender men, particularly those who identify as gay and are white, have been at the forefront of PrEP advocacy, inclusion in research, and PrEP uptake and persistence globally. But due to socio-structural factors like stigma, discrimination, health equity and access, PrEP uptake and clinical trial participation have lagged among cisgender men of color, transgender men, transgender women and gender non-binary individuals. Those most disproportionately affected by HIV are also the most underrepresented in clinical trials. We worked to address these kinds of disparities in multiple ways in PURPOSE 2, including:    ·      Establishing a trial-specific global community advisory group ·      Setting nuanced site-specific diversity goals based on local epidemiology ·      Selecting sites with expertise in delivering gender-affirming care and those with experience and trust in engaging with communities of color, underserved and vulnerable populations ·      Continually engaging with community advocates These and other efforts resulted in more diverse trial participation, including first-time PrEP users from historically underrepresented communities and, for the first time in a Phase 3 PrEP trial, intentional inclusion of transgender men and gender non-binary individuals . By the time we completed enrollment, PURPOSE 2 included more than 3,200 people across 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.   To help reach every person who needs or wants PrEP, across all populations, we know that we need new kinds of PrEP choices that could help increase uptake and persistence among people who have not benefited as much from existing PrEP options, helping to potentially reduce disparities in HIV transmissions globally.   Milestones like this remind me of Gilead’s commitment to helping to end the HIV epidemic for everyone, everywhere. Today, we celebrate PURPOSE 2 and how – through its exceptional level of inclusion and geographical representation, coupled with the innovation in the science, both in the investigational medicine and in the novel clinical trial design – we’re making that ambition a reality.   A huge thank you to our clinical team for designing and recruiting for such an innovative, intentional and inclusive trial, and to the community members and other key partners around the world who worked alongside us at all stages. We look forward to sharing more about the data at an upcoming scientific meeting. Charles Peterson Martez D. R. Smith Wakefield Jenna Rapues #PutPeopleFirst #GileadEmployee #PreventionWithPurpose For U.S. Audiences Only

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There was no better time for our annual Youth & Community Summit held last week in Denver, Colorado. An opportunity for us to connect with community partners across the US to re-ignite a sense of urgency in our collective effort to end the #HIV epidemic. I sat down with Princess Jauan D. to talk about the importance of involving community in everything we do. Within research and development at ViiV Healthcare, it’s so important that we understand evolving needs and continue to develop innovative options that will meet community where they are. By listening to community voices, we’ve been able to develop breakthrough options that have transformed the landscape of HIV care. From the world's first two-drug HIV treatment regimens to the introduction of long-acting medicines, we’ve been at the forefront of innovation for decades, providing people with options to meet their diverse needs. We firmly believe that with more treatment and prevention options, combined with our commitment to ending health disparities in partnership with communities across the US—we can #EndTheEpidemic. From drug development to advocacy, the communities we serve are the engine of our innovation. We must continue to listen, meet evolving needs, and support the community as they develop and implement the solutions that work best for them. Together we will continue to innovate and imagine what is possible. #EndingHIV #ImagineTheImpossible #WeWontStop

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My friends in biopharma are increasingly worried about the headwinds to the industry’s traditional business model. The impact is real - constant organizational transformation and layoffs. We predicted the challenge in our book - Redefining Innovation, and suggested pathways to new business models. However, we also understand the inertia and the inability to change. Overall, we foresee the industry becoming more like the utilities- regulated and price capped. As individuals passionate about the industry, it is time to rethink how we will disrupt and innovate ourselves, for our own viability. That in turn might be the impetus for large scale organizational transformation the industry needs now.

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The most interesting thing this week: You should not feel guilty anymore if your guilty pleasure is dark chocolate! 🎉 Increased consumption of dark chocolate was associated with a lower risk of T2D, according to three large prospective cohorts studies. Finally! 🎉 The power of Data-Driven but Human-Centred Evidence in action 😉 https://lnkd.in/gJdeqcpf #realworlddata #realworldevidence #rwe #rwd #data #healthcare #biopharma #medicalaffairs #patientcentricity #patientcenteredcare #medicalcommunication #themostinterestingthingthisweek

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In #NeurodegenerativeDisease news, specifically on an experimental treatment for #ALS, with this new #strategic partnership is penned between Dewpoint Therapeutics and Mitsubishi Tanabe Pharma America. ⚛️ The asset is the former's drug, designed "to address the accumulation of a protein into toxic structures that lead to neuronal dysfunction in people with ALS." 🤝 The alliance would grant MTP exclusive rights to license, upon achieving certain developmental milestones. ⚕️ This would add to MTP's existing US-marketed ALS treatment, #Radicava https://lnkd.in/evayrVv4' #Dewpoint #Mitsubishi #Pharma #Biopharma #Healthcare

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⚔ Battle of the anti-#FcRNs in myasthenia gravis... 📑 Johnson & Johnson touts its recent nipocalimab PIII data showcased at the #EAN: European Academy of Neurology Conference, possibly competitively positioned well vs. argenx's #Vyvgart. ⏩ Forward looking: 👥 To leverage efficacy as a differentiator; across a range of antibody-positive gMG patients (i.e., MuSK+, anti-LRP4+, and anti-AChR+) 🗓 Regulatory filing est. by EOY #gMG #GeneralizedMyasteniaGravis #Clinical #MedicalAffairs #Nipocalimab #ActivitiesOfDailyLiving #Autoimmune #Neurodegenerative #Pharma #Healthcare

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From an accelerated approval, Bristol Myers Squibb's KRAS-inh #KRAZATI obtains the nod for colorectal cancer (with Eli Lilly and Company's Erbitux (cetuximab)) https://lnkd.in/eRFiV9Fw "GlobalData recently predicted that the market for KRAS-targeting drugs in oncology could reach $4 billion by 2029, with Lumakras and Krazati accounting for around $1.4 billion of that total. Morningstar analyst Damien Conover said after the CRC approval that Krazati could become a $1 billion product, justifying BMS’ takeover of Mirati" 📈 As a #strategic milestone and growth potential standpoint, the treatment is only one of two on the market, representing a significant advancement in the treatment of this disease, particularly for patients with a specific genetic mutation. #BMS #Krazati #KRASinhibitors #CRC #Oncology #ColorectalCancer #RegulatoryAffairs #Pharma #Healthcare

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As humans are living longer - what does that look like? The article below asks an important question: "Surging numbers of seniors are already causing tectonic shifts in American society. In the coming years, those changes—from the economy and the workplace to health care and beyond—will become more consequential. Is America’s future gray or silver? It depends on how quickly science and society can adapt." https://lnkd.in/eZXRn7aB #aging #caregiving

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Thoughts on this? >> Baby Girl Born Deaf Gains Hearing After Gene Therapy - U.S. News & World Report >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharmaceutical #pharma #competitivemarketing #biotech

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Happy New Year! The coming year holds the potential for major changes in pharma but for now, FirstWord is here to fill you in on what happened over the past week to close out 2024. #pharma #pharmanews #prescriptiondrugs #newyear #bigpharma #dealmaking #clinicalresearch #biopharma #biopharmanews #oncology #genetherapy #ophthalmology https://lnkd.in/en_Mb_YC

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Rho's latest blog post, by Kimberly Koehn, PhD, features recommendations on how to present a product's benefit-risk assessment within FDA's own structured benefit-risk format as part of your marketing application. Have you thought about this for your product(s) in development? Check it out here: https://bit.ly/3yD9V8y

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Gene&Cell Therapy >> Resilience cuts 120 employees at a former bluebird gene therapy site: National Resilience is laying off 120 staffers from its gene therapy facility in North Carolina, only a month after the San Diego-headquartered CDMO shrunk its headcount in Florida. This latest round of workforce cuts affects ... #lucidquest #genetherapy #celltherapy

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