Gertrude Nonterah, Ph.D.

Cancer…an ‘umbrella’ term that encompasses over 200 different ‘types’ or ‘forms’ of cancer. What if there was the ability to generate a patient specific ‘vaccine’ to prevent the recurrence of a specific form of cancer? Well…researchers at Washington University School of Medicine may be on the path to that ‘solution’. Researchers recently released the results of a phase I clinical trial that looked at the potential of an neoantigen DNA vaccine for preventing the recurrence of tumors in triple-negative breast cancer. Neoantigen DNA vaccines are vaccines that make use of patient-specific cancer neoantigens. These neoantigens are mutant proteins or amino acid sequences that are arising from mutations within the DNA sequence that the tumors are expressing…and should hopefully be recognized by the immune system. There have been previous studies of neoantigen DNA vaccines looking at cancers that have higher mutation burden rates (more mutations than ‘normal’) such as melanoma, non small-cell lung cancer, bladder cancer, & glioblastoma. This was the first study to target triple-negative breast cancer, as it is typically considered to have a low-mutation burden rate. The phase I clinical trial enrolled eighteen patients, each of which got three doses of a tailor-made vaccine in monthly intervals. There was an average of eleven neoantigens per vaccine (numbers of neoantigens ranging from four to twenty); 97% of the neoantigens were in response to missense mutations; with 78% occurring within the TP53 protein. After approximately three years of follow-ups; 87.5% of the participants were alive & free from disease recurrence. Obviously…the tailored-made DNA vaccine needs to be tested in a larger study (than eighteen individuals)…but there is promise…that even cancers that have low mutation burdens can be ‘targeted’ by vaccines…and that the vaccine can keep the disease in check for (currently) years. It will be interesting to see how these tailored made DNA vaccines proceed through larger clinical trials…and if it marks a turning point in tailoring treatment plans to the individual patient. #dnavaccines #immuneresponse #clinicaltrials #cancerresearch #breastcancer #triplenegativebreastcancer

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I just started doing some writing and content creation for them. 👍🏼 If you are in #biotech, #pharma, #science, or #health and need assistance, I highly recommend ReadHealthy Communications, LLC! ☑ #marketing #media #communications #publicrelations #health #healthcare #entrepreneurs #healthcommunications #research #pharmaceuticals

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X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder in which individuals are highly susceptible to recurrent infections due to mutations in the cytochrome B-245 beta chain (CYBB). Individuals with X-CGD due to being susceptible to recurrent (and potentially invasive) infections, also suffer from hyper-inflammation, inflammatory bowel disease, and have a increased risk of morbidity & early mortality. Previous studies have tried to make use of autologous hematopoietic stem & progenitor cells transducer with lentiviruses (encoding the base editing ‘equipment’)—but came up against the limitation of ‘packaging’ as those particular Cas-9 enzymes required a protospacer adjacent motif (PAM). Researchers recently optimized an PAMless Cas-9 enzyme (SpRY) that has an adenine base editor (known as ABE8e-SpRY) and when used in cell culture models (derived from samples of patients with X-CGD) achieved up to 70% correction with an efficiency that was 3.5x higher than previous CRISPR enzymes & minimal off-target effects. Since the cell culture results looked so good…there is actually a clinical trial underway to test the benefits of this base-edited stem cell treatment approach works in patients with X-CGD. It will be interesting to see what the results of the initial clinical trial are…and if this treatment makes it all the way through all phase of clinical trials. #clinicaltrials #stemcell #genetherapy #CRISPR #XCGD #genemutations #basecorrections 

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Let's expose the culprits! 𝐒𝐡𝐢𝐧𝐲 𝐒𝐢𝐭𝐞 𝐒𝐲𝐧𝐝𝐫𝐨𝐦𝐞: Sponsors chase 𝐩𝐫𝐞𝐬𝐭𝐢𝐠𝐞 over 𝐚𝐜𝐜𝐞𝐬𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐲. A fancy research center doesn't guarantee the right patients! We need to select sites that are accessible to the target population. 𝐅𝐚𝐢𝐫-𝐰𝐞𝐚𝐭𝐡𝐞𝐫 𝐅𝐫𝐢𝐞𝐧𝐝𝐬: Sponsors seem to forget about patients until they need them! Where's the 𝐩𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐨𝐮𝐭𝐫𝐞𝐚𝐜𝐡? Where's the partnership with patient communities? 𝐒𝐢𝐥𝐞𝐧𝐭 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭: Patients are a wealth of knowledge! Involving them in protocol design and testing leads to more 𝐮𝐬𝐞𝐫-𝐟𝐫𝐢𝐞𝐧𝐝𝐥𝐲 and 𝐫𝐞𝐥𝐞𝐯𝐚𝐧𝐭 𝐭𝐫𝐢𝐚𝐥𝐬. 𝐋𝐨𝐬𝐭 𝐢𝐧 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧: Jargon-filled communication materials leave patients confused and uninformed. Clear, concise language is key to informed participation. 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐚𝐥 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐨𝐫𝐬 (𝐏𝐈𝐬) 𝐟𝐨𝐫 𝐒𝐡𝐨𝐰: We need PIs who are 𝐩𝐚𝐬𝐬𝐢𝐨𝐧𝐚𝐭𝐞about the research, not just in it for the resume boost. 𝐋𝐞𝐭'𝐬 𝐬𝐭𝐨𝐩 𝐚𝐜𝐜𝐞𝐩𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐬𝐭𝐚𝐭𝐮𝐬 𝐪𝐮𝐨! Demand better from sponsors, investigators, and the entire clinical trial ecosystem! #ClinicalTrialEnrollment #ClinicalTrials #PatientAdvocacy #ClinicalResearch

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🌟New webinar alert🌟 Register now for our upcoming webinar titled, "From the Lab to the Bench: Scaling up Regulatory T Cell Therapy." Register here: https://lnkd.in/gUS35bW5 🗓️ Date: Thursday, September 12th, 2024 🕗 Time: 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST Regulatory T cells (Tregs) play a critical role in maintaining immune balance and preventing autoimmune diseases. Join us to explore the potential of Treg expansion as a promising therapeutic approach. Our webinar will talk about a novel technology that provides an optimized activation signal for Treg expansion, ensuring a high-fold increase in suppressive Tregs with a stable FOXP3 phenotype and more! 1. Learn how a relevant number of regulatory T cells is achieved with 800-fold expansion after two stimulations 2. Hear how Tregs can be activated and expanded in a closed, automated system 3. How CAR-engineered Tregs can induce immune tolerance Register here: https://lnkd.in/gQFHyj3A ​

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A hot new entry in the Weight loss medications class! MariTide is a dual agent - both a glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist. 20% body weight reduction at 1 year, and still going down. In DM patients, 17% weight reduction and 2.2% HbA1c reduction.

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As we go through 2024, clinical research recruitment is evolving rapidly, shaped by technology and a heightened focus on diversity. Here are five key trends that are expected to lead the way in enhancing recruitment strategies: 💡 Targeted Social Media Campaigns - Precision in reaching potential participants will improve with social media's powerful data analytics. 💡 Patient Advocacy Partnerships - Relationships with advocacy groups will help trials reflect the true demographics of conditions. 💡 Mobile and Telehealth Integration - Digital tools will extend recruitment reach, making participation easier and more accessible. 💡 AI-Powered Screening: AI will refine the screening process, offering quick and precise participant selection. 💡 Diversity and Inclusion Initiatives - A push for diversity will ensure trial data is comprehensive and applicable to all patient groups. As these trends gain momentum, they promise to open new avenues for recruitment, making clinical trials more efficient, inclusive, and representative of the populations they aim to serve. 😊 #skycrng #clinicaltrials #healthcare #futureofmedicine #therapies #research #healthcareresearch

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To specialize or generalize — that is the question. (And fortunately, there is a clear answer if you want to build a successful medical writing business!) For new writers, it’s very tempting to assume that your services should be for everyone and anyone. But to become a trusted #CME/CE writer, you need to think more strategically — and that means honing in on your specialist skills and niching down your client base. * Building your authority as a leader in your chosen space * Streamlining high-value client acquisition and lead generation * Cracking the client mindset code to resonate with their core needs * Generating higher income by charging premium rates * Optimizing your marketing and key messaging If you’ve struggled to establish your niche, I’ve got you covered. Read my blog to learn more about establishing your medical writing niche now! (BONUS: grab your Niche Discovery Checklist). https://lnkd.in/gHBFu39R

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In a world where medical breakthroughs are happening faster than ever, understanding science deeply and communicating clearly are key to making an impact. As a neuroscientist-turned-freelance medical writer, I help organizations transform complex science into actionable content. Here’s what I bring: 🧠 In-depth expertise: With a Ph.D. in neuroscience, I have a strong background in neuroplasticity, spinal cord injuries, and cognitive disorders. This expertise allows me to craft precise and insightful content for even the most complex projects. ✍️ Clear communication: Transitioning from academia to freelance medical writing has helped me learn how to bridge the gap between intricate scientific data and its practical application. I tailor content—whether for clinical trials, CME material, or patient education—to meet the specific needs of the audience. 🌐 Adaptability Across Audiences: Whether working with clinicians, pharmaceutical companies, or creating content for the public, I ensure that every piece of writing is rooted in evidence-based science and is accessible to the intended audience. 👋 My name is Vedangana Saini, and I am the founder of Intelligible Scientific Writing LLC (based in Maryland, USA). In Q4 this year, I will be available for 1-2 new projects (scholarly publications, CME writing, grant writing, patient education). Let’s discuss how I can support your goals!

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89% of cancer centers in the U.S. are reporting shortages of one or more of the more commonly used oncology drugs. While the shortages are nothing new, they are continuing to prevent patients from receiving the help and care they need in the more trying time of their lives. As providers, it's our job to figure out new treatments, therapies, and opportunities that can replace these drugs (at respectable costs), bringing back accessibility to the field of oncology. #Oncology #DrugShortages #SupplyChain #FutureOfHealthcare

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💥Finally! FDA Guidance Provides New Details on Diversity Action Plans This is a major step towards ensuring that studies include participants from historically underrepresented populations. Here's why this matters: ➡️More generalizable results: Diverse trials lead to findings applicable to a wider range of patients. ➡️Deeper understanding: Studying a broader population provides valuable insights into the disease or treatment. ➡️Safer & more effective treatments: Data from diverse populations helps ensure safe and effective use for everyone. The draft guidance outlines: ▪️What a Diversity Action Plan should include ▪️When and how to submit it ▪️How the FDA will evaluate waiver requests This is just one of many efforts to improve diversity in clinical trials. Let's work together to ensure everyone benefits from medical advancements! 📢Want a quick breakdown of the FDA's Diversity Action Plans? I've created a summary to help you navigate the key points. Check it out here: https://lnkd.in/g945QzUv Ina Burgstaller #diversityactionplan #clinicaltrials #healthequity

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Clinical lab leaders and instructors must be wary of telling young medical lab scientists to "suck it up" and get the job done. "That doesn't work any more," says Dr. Rodney E Rohde, SV, SM, MB (ASCP), on the eLABorate Topics podcast. A lot of us can learn from this episode, regardless of what industry you're in. Stephanie Whitehead, MBA, MPH, MLS(ASCP) Lona Gordon Small, MBA, PMP, CPBPM, MT(ASCP) Tywauna Wilson, MBA, MLS (ASCP)CM Today's Clinical Lab #clinicallaboratories #labweek

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🌟New webinar alert🌟 Register now for our upcoming webinar titled, "From the Lab to the Bench: Scaling up Regulatory T Cell Therapy."   Register here: https://lnkd.in/gbYgfq5e   🗓️ Date: Thursday, September 12th, 2024 🕗 Time: 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST   Regulatory T cells (Tregs) play a critical role in maintaining immune balance and preventing autoimmune diseases. Join us to explore the potential of Treg expansion as a promising therapeutic approach.   Our webinar will talk about a novel technology that provides an optimized activation signal for Treg expansion, ensuring a high-fold increase in suppressive Tregs with a stable FOXP3 phenotype and more!   1. Learn how a relevant number of regulatory T cells is achieved with >800-fold expansion after two stimulations 2. Hear how Tregs can be activated and expanded in a closed, automated system 3. How CAR-engineered Tregs can induce immune tolerance   Register at the link above.

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Genentech, a member of the Roche Group, announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, 2024 in San Diego, California. The data underscore Genentech’s commitment to advance patient outcomes in lymphoma with long-term follow-up of its approved medicines Polivy® (polatuzumab vedotin-piiq), Lunsumio® (mosunetuzumab-axgb) and Columvi® (glofitamab-gxbm) as well as new investigational combination data. Key presentations include: 👉 Five-year data from the Phase III POLARIX study (abstract # 469) reinforce the potential of Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions and for the first time show a positive trend in overall survival (OS) for people with first-line diffuse large B-cell lymphoma (DLBCL), an area that previously had little advancement in nearly two decades. 👉 Extended follow-up data of up to four years from the pivotal GO29781 study of Lunsumio (abstract # 4407) and NP30179 study of Columvi (abstract # 865) show long-lasting remissions and immune system recovery after the end of treatment, supporting the use of fixed-duration bispecific antibodies for third-line or later (3L+) follicular lymphoma (FL) and DLBCL, respectively. 👉 First presentation of data for a subcutaneous formulation of Lunsumio monotherapy from the pivotal Phase II GO29781 study (abstract # 1645) show high rates of deep and durable responses and low rates and severity of cytokine release syndrome in people with 3L+ FL. Subcutaneously administered Lunsumio could further improve the patient experience by combining shorter administration time with the existing benefits of a fixed-duration and outpatient therapy. 👉 New patient-reported outcomes data from the Phase III STARGLO study (abstract # 5132) indicate comparable health-related quality of life between treatment arms, despite higher median number of cycles received with the Columvi combination (11 versus 4). Together with the significant improvement in OS observed in the study, these data support the potential benefit for patients with second-line or later DLBCL. 👉 New and updated data from investigational study combinations of Polivy with bispecific antibodies Lunsumio and Columvi in relapsed or refractory DLBCL, including the Phase Ib/II NP39488 (abstract # 988) and Phase II GO40516 (abstract # 989) studies, add to the growing body of evidence demonstrating the potential of novel bispecific antibody/Polivy combinations in earlier treatment lines, and support their ongoing Phase III development. #Hematology #ASH2024 #Polivy #Lunsumio #Columvi  #Genentech #Roche

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FDA Final Guidance: Conducting Clinical Trials With Decentralized Elements. September 2024. With great honor I share this final guidance as it was a project that I led along with my supervisor during my work at the FDA. I had the privilege of working with brilliant FDA colleagues to bring to fruition the vision of modernizing clinical trials through DCT approaches. This DCT FDA guidance is important due to the following: 1. Regulatory clarity: It provides clarity on how to conduct DCTs while complying with existing regulations. This gives sponsors and investigators more confidence in implementing DCT elements. 2. Expanded access: It enables trials to reach more diverse and representative patient populations remotely, including those with limited mobility or access to traditional trial sites. 3. Improved efficiency: DCTs can potentially streamline recruitment, enrollment, and retention processes, leading to faster and more cost-effective trials. 4. Patient-centricity: The guidance aligns with the industry trend towards more patient-centric trial designs by allowing participation from home or local healthcare providers. 5. Technology integration: It provides recommendations on incorporating digital health technologies (DHTs) and remote data collection, paving the way for more innovative trial designs. Key regulatory and clinical research implications going forward include: 1. Protocol design: Sponsors will need to carefully consider DCT elements from the outset of protocol design, rather than retrofitting traditional protocols. 2. Data integrity: There will be increased focus on ensuring data quality and integrity in remote settings, requiring robust processes and technologies. 3. Patient safety monitoring: New approaches to safety monitoring and adverse event reporting will need to be developed for decentralized settings. 4. Informed consent: The guidance supports electronic informed consent, which may become more prevalent in future trials. 5. Investigator oversight: Principal investigators will need to adapt their oversight practices for remote trial activities and participants. 6. Vendor management: With more decentralized elements, there will likely be increased reliance on and scrutiny of third-party vendors providing remote services. 7. Regulatory submissions: Sponsors will need to clearly document and justify DCT elements in their regulatory submissions. 8. Site selection: The traditional concept of a "site" may evolve, with implications for site selection and management processes. 9. Training: There will be a need for extensive training of trial staff, local healthcare providers, and participants on DCT procedures. 10. Global harmonization: As other regulatory bodies develop their own DCT guidances, sponsors will need to navigate potentially differing requirements for global trials. #FDA #Regulatory #DCTs https://lnkd.in/gvGWtKe7

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