Fred Pritchard, Ph.D.

For those interested in Physiologically Based Biopharmaceutics Modeling (PBBM) please check out our recently published article from the 2023 PBBM workshop. It proposes best practices for measuring solubility, dissolution, precipitation and permeability for parameterizing PBBMs, summarizes breakout sessions, and shares PBBM case studies. https://lnkd.in/gda_HH4F

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If you missed our poster presentation at #ASCO24 titled "Feasibility and Utilization of Electronic Patient-Reported Outcome Measures for Lung Cancer in Routine Clinical Care," in collaboration with our partners at the University of North Carolina and Takeda Pharmaceuticals, below are the key findings.   This study explored the feasibility of standardizing PRO measures among patients with lung cancer in US clinical practice. Using the ePRO and alerts data collected from Carevive RSM, we explored patient engagement, measured by survey compliance and data completeness, as well as clinical team engagement measured by the platform utilization time, time to alert response, and clinical action taken when patients reported moderate/severe symptoms (Figures 2 and 4). ✅ Results support the feasibility of integrating a standard set of multi-domain ePRO measures, comparable in breadth and scope to the Health Outcomes Observatory (H2O) Core Outcomes Set, into routine lung cancer care. ✅ Patient engagement was high, as indicated by survey compliance and completeness, particularly in the first 5 weeks of enrollment. The median survey follow-up was 8 weeks, with 85% median compliance over that time. ✅ The clinical team's engagement was high, as indicated by frequent usage of the platform and timely response to symptom alerts, with a median of 20 hours and 69.3% addressed in less than 2 days. ✅ Findings support the value of remote symptom alerts, when integrated into clinical workflow, for enhancing the timeliness of patient and care team communications, and timely addressing of symptoms to optimize care. Read more of the presentation here: https://lnkd.in/esFXwb69 Aaron Galaznik Emelly Rusli Keri Collette Mordecai Kramer Bruno Lempernesse #carevive #digitaloncology #cancer #cancercare #oncology #patientreportedoutcomes #oncologydata #clinicalinnovation #drugcommercialization #RWD #RWE #smartdata

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Project Optimus is revolutionizing early oncology trials, aiming to ensure more effective and safer cancer drugs and improve patients' quality of life. Parexel experts have identified three strategies to help sponsors overcome challenges in achieving dose-optimization requirements. Here’s what we know works: 1️⃣ Design an integrated first-in-human study 2️⃣ Reach agreement with FDA at each step 3️⃣ Challenge guidelines with a compelling rationale Let me know your thoughts below and read more in our New Medicines, Novel Insights report! https://lnkd.in/dmYADu-n #ProjectOptimus #Oncology #NovelInsights

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Mark your calendars for the 29th Annual Executive War College, where Labcorp thought leaders will join panels to discuss adding value to payers and health plans. We’ll discuss the latest trends in laboratory and pathology mergers and acquisitions as well. Our friends from Visiun will also be there. Check out the agenda. #EWC2024 #Pathology #Strategy

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Mark your calendars for the 29th Annual Executive War College, where Labcorp thought leaders will join panels to discuss adding value to payers and health plans. We’ll discuss the latest trends in laboratory and pathology mergers and acquisitions as well. Our friends from Visiun will also be there. Check out the agenda. #EWC2024 #Pathology #Strategy

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This content is for US audiences only.   Yesterday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that our IO treatment met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile.   Those potential benefits cannot be understated, as the majority of this patient population faces a disease recurrence even after surgery and chemo.   This announcement is welcome news to patients thanks to its flexibility before or after surgery and more time to live without progression or recurrence. Our patients are relying on us to deliver new powerful therapies that will allow them to live longer and better – and we won’t let them down. We look forward to our continued work with the FDA and the potential to bring safe, powerful treatments to even more patients facing a cancer diagnosis. Read more: https://bit.ly/46h4YiN   #USOnly #AstraZenecaUS

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Protocol-based disease registries are purpose-built for research, making them one of the most clinically rich sources of RWD - learn how to leverage them in this on demand webinar.

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Offering in-office biologic therapies 🧪 to ankylosing spondylitis patients is an innovative approach that can significantly ✅ enhance patient care.

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❔ How do we position regional and community sites for success and mitigate risks for sponsors? ❔ In our new Oncology report, Parexel’s Karen McIntyre and Angela Hirst weigh in on why the traditional approach to site selection in oncology has created bottlenecks at major centers, potentially limiting patient access to life-changing therapies. 🚧 That’s why Parexel is bridging the gap by partnering with regional and community sites while still ensuring the high-quality standards of academic centers. Find out how: https://lnkd.in/dRuWPrWb #ResearchSites #Oncology #NovelInsights

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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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Alyssa Boschen from IMA Clinical Research shares her perspective on the investigator shortage and the challenge of engaging new investigators in trials. Hear her advice on on leveraging advanced practice providers to help bridge the gap and support trial operations, bringing new professionals into clinical research ⇢ https://lnkd.in/gkRw7_DC

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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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Are you attending the DIA RWE in Philly? Stop by our booth or reach out to schedule a meeting with our experts. Custom Prospective data collection and Retrospective RWE Solutions with direct access to the largest nationally representative dataset! #RWE #RWD #EHR #Claims #PatientSurveys #ProductRegistries #UnstructuredData #ClinicalNotes #DataAnalytics #HEOR #MedicalAffairs #MarketAccess #LinkedData

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Important oncology news of the week: ✖ BMS $BMY pulling out of its collaboration with Agenus $AGEN to develop the AGEN1777 bispecific is another hit for the troubled TIGIT class. https://lnkd.in/ejdvSmbK 💊 Some good data from Boehringer in CRC and NSCLC G12C-mutant xenografts showing that combining the KRASi adagrasib with the SOSi BI-3406 results in much better anti-tumor activity. https://lnkd.in/eJmi64iy 💰 Merck $MRK and Daiichi Sankyo join forces to co-develop the DLL-3 targeting tri-specific antibody MK-6070 going mostly after small-cell lung cancer. Daiichi paid $170 million upfront for the Phase I/II asset https://lnkd.in/eVugSzUp ↘ Another failure for Ultimovacs results in stock price drop and forces the company to downsize. The combination of its cancer vaccines UV1 for head & neck cancer in combination with Keytruda failed to show additional synergy in the Phase II FOCUS study. https://lnkd.in/edCBRfQq ☑ Servier's Voranigo (vorasidenib) becomes the first FDA approved medicine for IDH-mutant Grade 2 astrocytoma or oligodendroglioma in over 20 years. The approval was based on the Phase III INDIGO study where Voranigo led to 27.7 mos mPFS vs 11.1 for placebo. https://lnkd.in/eym3n9FY ↘ Exelixis' $EXEL Cabometyx (cabozantinib) + Roche's Tecentriq (atezolizumab) failed to provide an OS benefit in mCRPC compared to 2nd novel hormonal therapy in the final analysis of the CONTACT-02 Phase III trial. Despite this, Exelixis plans to submit an sNDA regardless in a risky move where rejection is more likely. https://lnkd.in/emK4Sw9m ↖ Sanofi's $SAN PFS wing for the quadruplet Sarclisa + RVd regimen in transplant-eligible MM make a label expansion in the 1L almost certain, but will only complicate the treatment selection further without a head-to-head comparison with Darzalex. https://lnkd.in/eaVVavMG

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This post is intended for a US audience only: Eliminating cancer as a cause of death begins with regular screenings and early detection. And in Maryland, where our US Oncology team is based, unfortunately only 3% of eligible residents receive lung cancer screenings. AstraZeneca is partnering with the University of Maryland Medicine to connect more Marylanders with early interventions to detect lung cancer and treat it effectively. Our partnership over the next 5 years will establish a state-based steering committee ofacademic, industry and community partners. We’ll work together to: -       Expand screening programs and tobacco cessation programs -       Improve early detection in at-risk populations -       Drive research in cancer health disparities, especially for minority and rural communities Health equity starts in our own backyard: no one should miss out on vital lung cancer care because of their socioeconomic status or where they live. When patients are diagnosed early, they have more effective options available to treat their lung cancer. We’re proud to make a meaningful impact to people across the state and hope that the University of Maryland Medicine’s work will be a model nationwide.#AstraZenecaUS #AZUS

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#asgct2024 is the premier event for gene and cell research! If you missed the annual meeting, read highlights from Chris Learn, Ph.D., for a concise summary of the big news, informed guidance and future indicators. Dive in:

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⚕ Potentially curative gene therapies such as these will play a pivotal role in relative market positioning and overall treatment landscape compared to legacy interventions. ✅ Just announced, a new #GeneTherapy US FDA approval: Pfizer scores for their 'one-time' treatment for adults with moderate to severe Hemophilia B, BEQVEZ (fidanacogene elaparvovec-dzkt). 💉 This single-dose treatment intends to replace the need for prophylactic/ongoing administration of blood clotting factors. 🤔 For therapeutic areas seeing an uptick in forthcoming gene therapies in development (or, having already launched), how might these innovations affect the #BrandStrategy moving forward? #Innovation #RareDiseases #Strategy #CompetitiveIntelligence #MarketIntelligence #Pharma #Healthcare https://lnkd.in/eVk38c7P

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Bristol Myers Squibb has queued a Phase 1 study of Orum Therapeutics’ ORM-6151 (BMS-986497), a first-in-class, anti-CD33 antibody-enabled GSPT1 degrader for the treatment of patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. The study will enroll an estimated 35 patients and is due to start in late May 2024. Orum Therapeutics has developed a new class of ADC payloads, called neoDegraders, to specifically degrade intracellular target proteins within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death. https://lnkd.in/edTcDRFj

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