Samir Arora

Do you feel like you are managing your 340B program all on your own? What if I told you #SUNRx clients enjoy a complete team of #340B experts who work with you to optimize your program to be as compliantly productive as possible? It's true! #SUNRx doesn't just supply you with data, but actually works your program with you. Reach out to me today to learn more!

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DKP’s Director of Clinical Services, James Long PharmD MBA, attended #ASGCT24 this month alongside other clinical professionals, manufacturers, regulatory agency representatives, and patient advocates. There were many great takeaways and discussions, but these points resonated the most: 1. Patient access to gene therapies may be inhibited by lack of referring physician availability and awareness. 2. We’re seeing increased demand for AI for clinical trial design. 3. The high costs of gene therapies create challenges for alternative payment models. There’s no doubt that the future is bright in science, but access is still a challenge DKP continues to work toward solving. We aim to remove access barriers so manufacturers can focus on groundbreaking science and getting innovative treatments to the patients who desperately need them. #ASGCT #GeneTherapy #CellTherapy #CGT #cellandgenetherapy #geneandcelltherapy #complexconditions #marketaccess #patientaccess

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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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New Series Alert! Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, leads a panel discussion about CDK4/6 inhibitor use in high-risk early breast cancer with experts Naomi Dempsey, MD; Joyce O'Shaughnessy, MD; and Hope S. Rugo, MD, FASCO. Tune in to learn about trial updates, best practices in managing toxicity profiles, and financial challenges to navigate while optimizing patient outcomes. Watch here: https://bit.ly/4eGWTru #BreastCancer #ManagedCare

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Oncology practice consolidation is surging: A 2024 study published in an American Society of Clinical Oncology (ASCO) journal finds that between 2015 and 2022, the number of medical oncology practices decreased by nearly 20%. That's reason for concern. Evidence shows that reduced competition leads to higher prices for patients. In an interview with Medscape, AIMPA Vice President Dr. David Eagle and Dr. Jeff Patton, CEO of AIMPA member OneOncology, share how independent oncologists can navigate this increasingly complicated landscape and continue providing high-quality, lower-cost cancer care. Read more: https://lnkd.in/eSPKMCqM #Healthcare #Oncology #IndependentPhysician #HealthcareConsolidation #AIMPA

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For executives at rare disease drug developers, there remains uncertainty on how to best manage IRA risk in the context of product strategy. The IRA forces us to reconsider the traditional new product planning playbooks and instead incorporate a more nuanced assessment of IRA risk into decision making regarding indication prioritization, clinical development strategy, and forecasting. In our latest blog, we offer a framework to incorporate IRA risk into new product planning with our colleagues at Parexel. Read here: https://bit.ly/3xUFpXo Olivia (Dickey) Foroughi, MPH, Douglas Mullen, Brian M. Duda, Carrie Jones #raredisease #orphandrug #newproductplanning #NPP

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Biosimilars Battle Cancer: New Wins You Need to Know! Docs just dropped the mic on biosimilars in oncology! ️We're talking new research, doc success stories, and how these treatments are changing the game for patients. ‍⚕️ Want to know more? We've got the scoop in this month's Biosimilars Oncology Roundup! https://lnkd.in/ePPx3MDr

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Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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This article discusses sustained-delivery tyrosine kinase inhibitors currently in clinical trials and explores their potential as innovative treatment options for nAMD and DME. https://lnkd.in/eQv_9AgM

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Onco-This-Week (OTW) is here with the oncology clinical development weekly updates. 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz 🔬REGULATORY NEWS 📌FDA:ODD Candel Therapeutics CAN-2409 Pancreatic Cancer;Type C Meeting Request Registration-Enabling Trial Oncolytics Biotech Inc. Pelareorep in Breast Cancer,NDA Shorla Oncology SH-201 leukemia & other cancers; Clearance to Initiate Ph1/2 TransCode Therapeutics, Inc. TTX-MC138 Solid Tumors; FTD Syros Pharmaceuticals Tamibarotene AML;ODD Lisata Therapeutics, Inc. LSTA1 Osteosarcoma;IND to initiate Ph1/2a Lamassu BioTech SA53-OS 📌NMPA: sNDA for Shanghai Junshi Biosciences Co Ltd Toripalimab 1L Renal Cancer 📢TRIAL RESULTS 📌Roche Columvi meets PE  of OS in R/R DLBCL in PhIII STARGLO   📌AIM ImmunoTech +ve Top-Line Interim Data Ampligen+Pembrolizumab Ovarian Cancer 📌MEI Pharma Initial Data Clinical Study ME-344+Bevacizumab Relapsed Metastatic CRC 📌Ferring Pharmaceuticals 3 yr Follow-up Data NMIBC durable Response to ADSTILADRIN 📌Viracta Therapeutics, Inc. +ve Topline Nana-val Results Stage 1 NAVAL-1 Trial in R/R EBV+ PTCL 📌Enliven Therapeutics +ve proof of concept data Ph1 CT ELVN-001 CML   📊TRIAL STATUS 📌Clinical dev of MEI Pharma voruciclib and new formulation ME-344 to be advanced & enabled 📌Innate Pharma NK Cell Engager SAR443579/IPH6101 progress to Ph2 Blood Cancer 📌First Patient Dosed:Boundless Bio Ph1/2 CT of BBI-825 in Cancer with Resistance Gene Amplifications   💼BUSINESS NEWS 📌Adaptimmune & Genentech collab for Cancer-targeted Allogeneic T-cell Therapies Terminated 📌Collaborations: Arvinas & Novartis for PROTAC Androgen Receptor(AR) Protein Degrader ARV-766 Prostate Cancer;Nurix Therapeutics & Sanofi Protein Degraders of STAT6 📌Novartis implements manufacturing adjustments for ribociclib to align with latest regulatory standards in eBC by end of Q2 📌Atossa Therapeutics, Inc. & Quantum Leap Healthcare Collaborative Announce I-SPY 2 CT  (Z)-Endoxifen + Abemaciclib in ER+/HER2- Breast Cancer 📌Merck acquires ADC startup Abceutics Inc. in potential $208M deal 📌OSE Immunotherapeutics Receives €8.4 M in Public Funding for Registration Ph3 CT of Cancer Vaccine Tedopi Lung Cancer 2024 AACR Annual Meeting highlights from Aprea Therapeutics, Atossa therapeutics, Astrazeneca, Akeso Biopharma Inc., BriaCell Therapeutics Corp., edison oncology, EpicentRx, Inc., Geneos Therapeutics, BMS, Regeneron, Medicenna Therapeutics Corp., Sichuan Kelun Pharmaceutical Co., Ltd., Notable, Nurix therapeutics, Poseida Therapeutics, Inc., RAPT Therapeutics, Henlius | 复宏汉霖, BioNTech SE, Transgene, Transthera ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers

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Onco-This-Week (OTW) is here with the oncology clinical development weekly updates. 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz 🔬REGULATORY NEWS 📌FDA grants BTD Roche inavolisib for HR+ve, HER2-ve BC with PIK3CA mutation 📌FDA Updates Action Date for Bristol Myers Squibb Subcutaneous Nivolumab, new PDUFA: December 29, 2024 📌Verastem Oncology Rolling Submission of NDA to FDA initiated for Avutometinib + Defactinib for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer 📌FDA Granted FTD Theriva Biologics, Inc. VCN-01 for Metastatic Pancreatic Cancer 📌RMAT & PRIME Designations granted Wugen WU-CART-007 📌FDA grants ODD Cantex Azeliragon for Pancreatic Cancer 📌NMPA: Granted Priority Review Designation to the NDA for Jacobio Pharma Glecirasib 📢TRIAL RESULTS 📌AstraZeneca Datopotamab deruxtecan showed clinically meaningful OS improvement vs. chemo in NSCLC TROPION-Lung01 Ph III 📌Verastem Oncology +ve Initial Interim Safety and Efficacy Results Announced RAMP 205 Trial Avutometinib, Defactinib, Gemcitabine and Nab-paclitaxel combo in 1L Pancreatic Cancer​ 📊TRIAL STATUSES 📌Tango Therapeutics Development of TNG348 program to be discontinued 📌First Patient Dosed: Tyligand Bioscience Ph 1/2 CT TSN1611; Indaptus Therapeutics, Inc. Decoy20 trial & GigaGen Inc Ph1 Trial GIGA-564 in Advanced Solid Tumors; Adlai Nortye Randomized Ph II CT Palupiprant for Rectal Cancer; Edgewood Oncology Ph2a BTX-A51 in BC 💼BUSINESS NEWS 📌Dragonfly Therapeutics, Inc. Announces Clinical Collaboration to Evaluate DF9001 + KEYTRUDA in Solid Tumors 📌Nanobiotix and Janssen Inc. aligned at the collaboration’s Joint Strategy Committee to transfer the global sponsorship of the Ph 3 pivotal head and neck cancer trial 📌Genmab Completes Acquisition of ProfoundBio 📌Nona Biosciences Announces Global License and Option Agreement with AstraZeneca for mAb development for Novel Tumor Targeted Therapies 📌Collaborations: OSE Immunotherapeutics & Boehringer Ingelheim to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases ; Achilles Therapeutics plc & Arcturus Therapeutics for Personalized mRNA Cancer Vaccines 📌Indapta Therapeutics Awarded $4.5 M by CPRIT to Advance Clinical Development of its Allogenic NK Cell Therapy 📌ReEngage Therapeutics Launches to Develop ACSS2 Inhibitor Compounds for Cancer Indications ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers

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📊 𝑬𝑳𝑨𝑽𝑨𝒀 𝐔𝐧𝐯𝐞𝐢𝐥𝐬 2024 𝐎𝐧𝐜𝐨𝐥𝐨𝐠𝐲 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐑𝐞𝐩𝐨𝐫𝐭: 𝘋𝘳𝘪𝘷𝘪𝘯𝘨 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘢𝘯𝘥 𝘈𝘥𝘷𝘢𝘯𝘤𝘦𝘮𝘦𝘯𝘵𝘴 𝘪𝘯 𝘊𝘢𝘯𝘤𝘦𝘳 𝘛𝘳𝘦𝘢𝘵𝘮𝘦𝘯𝘵 Archo Advocacy, LLC, proudly presents this comprehensive report highlights the latest trends, innovations, and top contributors in oncology, emphasizing advancements in cancer treatment from patient perspectives. Key Areas Include ⬇ ☑ Partnership Support ☑ Policy Activities ☑ Corporate Reputation ☑ Health Equity & Social Determinants of Health. Discover top performers like The Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer, and Merck, and gain strategic insights essential for driving success in the oncology landscape. 📈 #OncologyResearch #CancerTreatment #HealthcareInnovation #PatientAdvocacy #HealthcareInnovation #Pharma #Biotech

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Should MRD negativity be accepted as a surrogate endpoint for clinical trials in myeloma - Ben Derman https://lnkd.in/gaYMuZkh #oncodaily #oncology #cancer #MRD #myeloma #clinicaltrials #FDA #surrogateendpoint #OverallSurvival #PFS #mmsm #mmMRD

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🦠🧬Learn how QSP principles can be applied when planning FIH studies in oncology 💊 ⏩ Use safer and efficacious doses and reduce clinical development by 3-6 months. 🔎 📄 View our case study on T-cell Engagers: https://lnkd.in/dtkbgYVY 🔎 📄 View our case study on ADCs: https://lnkd.in/d9aj5rP2 #qspmodeling #systemsbiology #mechanisticmodeling #FIH #oncology #clinicaldevelopment #drugdesign #drugdevelopment

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Did you know that using quantitative systems pharmacology (QSP) principles can completely transform how we plan First-in-Human (FIH) studies in oncology? By integrating QSP methodologies, we can optimize dosing strategies for improved safety and efficacy, potentially shortening clinical development timelines by 3-6 months. Check out two case studies by Applied BioMath showcasing how QSP is accelerating the transition from preclinical research to groundbreaking cancer therapies. #qspmodeling #systemsbiology #mechanisticmodeling #FIH #oncology #clinicaldevelopment #drugdesign #drugdevelopment #Certara #ADCs #QSP

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#DidYouKnow that biosimilars are one of the fastest-growing classes of medications, with no clinically meaningful differences from originator biologics? ⤵️ #Biosimilars are safe and as effective as the originator biologic, and, on average, less expensive than their brand-name counterpart. Cordavis™️, a CVS Healthspire™️ company, works directly with manufacturers to bring these innovative medicines to market. We’ve seen exciting early market results from Cordavis’ first product, Hyrimoz, a Humira biosimilar brought to market with Sandoz with a list price more than 80% lower than Humira’s list price at time of launch. Learn more from our Chief Medical Officer, Dr. Sreekanth Chaguturu: https://cvs.co/44omQqO

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𝐁𝐢𝐨𝐬𝐢𝐦𝐢𝐥𝐚𝐫𝐬 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐁𝐫𝐢𝐠𝐡𝐭 𝐅𝐮𝐭𝐮𝐫𝐞 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐒𝐞𝐜𝐭𝐨𝐫 𝐚𝐧𝐝 𝐈𝐧𝐯𝐞𝐬𝐭𝐨𝐫𝐬 𝐚𝐧𝐝 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬𝐞𝐬 𝐋𝐨𝐨𝐤𝐢𝐧𝐠 𝐭𝐨 𝐈𝐧𝐯𝐞𝐬𝐭 𝐢𝐧 𝐭𝐡𝐞 𝐃𝐨𝐦𝐚𝐢𝐧 💊 Biosimilars are game-changers that reduce patient and payer health bills. Biosimilars are made of large molecules and living cells. They show similar pharmacokinetics (P.K.) and pharmacodynamics (P.D.) results identical to their reference listed biologics/drug (RLD). Biosimilars and sustainability go hand in hand. 💊The biosimilar market is poised for substantial growth, projected to surge by a staggering US$10 billion. With such promising prospects, numerous companies are gearing up to capitalize on this lucrative sector, eagerly eyeing the opportunities it presents. #Biosimilars #HealthcareInnovation #Biotechnology #HealthcareSector #InnovativeMedicine #BiosimilarMarket #HealthcareCosts #Stellarix #StellarixConsultancyServices Read More: https://lnkd.in/dhZcsDjG

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