Roland Stieger’s Post

Dive into the power of QSP modeling next week with Michelle Przedborski, PhD, and Saheli Sarkar, PhD! In this webinar they will discuss how we developed a QSP model to mechanistically link the drug exposure profile to the pharmacodynamic effects for Atacicept and ALPN-303 for the treatment of autoimmune disease. Learn more and register at: https://lnkd.in/eYkBdxNc Date: Thursday, March 21st Time: 12pm - 1pm EST #qsp #mathematicalmodeling #biosimulation #autoimmunedisease

🌍 𝟭,𝟴𝟬𝟬+ 𝗔𝗧𝗠𝗣 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 are currently underway worldwide, but only about 100 are in Phase III, the last stage before regulatory approval. 𝗪𝗵𝗮𝘁 𝗰𝗮𝗻 𝘄𝗲 𝗹𝗲𝗮𝗿𝗻 𝗳𝗿𝗼𝗺 𝘁𝗵𝗶𝘀? Since the approval of the first ATMP in 2009, only ~30 ATMP treatments have reached the market. This reveals two realities: - 𝗘𝘅𝗰𝗲𝗽𝘁𝗶𝗼𝗻𝗻𝗮𝗹 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻: ATMPs offer groundbreaking potential and life-changing opportunities, pushing the boundaries of modern medicine. - 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀: High failure rates after Phase I and II, complex regulatory pathways, and logistical hurdles make the journey from trial to approval extremely challenging. Want to explore these challenges and uncover the potential of ATMPs? 👉 Join this 𝗳𝗿𝗲𝗲 webinar on Sept 19th at 4.00 pm CET to dive into the complexities and opportunities of ATMP clinical trials! Let’s make this webinar interactive and valuable for everyone! Share your challenges with running ATMP trials in the comments or via DM, and I'll make sure to address them during the webinar. Register now! 🔗 https://lnkd.in/ey-aCGdg

https://lnkd.in/e3SUw5WV We know how important clinical validation is when it comes to biomarker developments, diagnostic assay developments and more over understanding disease development research. Biospecimens have always been used in the forefront of such developments but has remained a key challenge in terms of ethical and faster accessibility when it comes to disease state or targeted demographic clinical sample collection. 2BScientific Ltd. have joined hands with Medix Biochemica to make the process easier, reliable, and efficient in terms of offering a wide range of biospecimens from not just plasma, serum, but also non-traditional specimens like faecal matter, cerebrospinal fluids, clinical swabs, sputum from individuals with rare disease that are usually hard to obtain. Let’s take your research potential a step forward in unlocking new insights, speak with our product specialist today NAYANI PRAMANIK (PhD) #biospecimens #clinicalvalidation #hereforyou #2bscientific

In ERA 2024's best-ranked abstract, we presented 72-week eGFR stabilization from our Phase 2b clinical trial for #IgANephropathy. We also showed rapid hematuria improvement and significantly higher hematuria resolution compared to placebo during the 36-week randomized period. Read the press release here: https://lnkd.in/eRcDMqd5 #ERA24

Exciting developments in DLBCL treatment! Genmab and AbbVie’s EPKINLY (epcoritamab), an IgG1-bispecific antibody developed with Genmab's DuoBody technology, is showing promise in newly diagnosed #DLBCL. At European Hematology Association (EHA) 2024, data from the Phase Ib/II EPCORE NHL-5 study (NCT05283720) highlighted the combination of epcoritamab with pola-R-CHP. As of November 2023, 37 patients exhibited an impressive overall response rate (ORR) of 100% and a complete response rate (CRR) of 89%. Many patients achieved minimal residual disease (MRD) negativity early and maintained it. #Epcoritamab demonstrated a manageable safety profile, with most cytokine release syndrome (CRS) events being low-grade and predictable. #Neutropenia, the most common Grade 3/4 adverse event, occurred in 65% of patients without causing discontinuations. These results, combined with favorable comparisons to standard treatments, underscore the potential of epcoritamab + pola-R-CHP as a promising first-line treatment for DLBCL. Read the detailed analysis of the abstract here @ https://lnkd.in/g7AXRYnt #DLBCL #Epcoritamab #Genmab #AbbVie #EHA2024 #ClinicalTrials #CancerResearch #healthcare #business #clinicalstudies #clinicaltrials #results #phases #top #abstracts #pharmacautical #hematology #eha24

SphingoTec announces a new #partnership with Beckman Coulter Diagnostics Inc. Through this collaboration, the companies will bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (#penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers. This alliance marks the first central laboratory #license for a penKid assay and aims to significantly enhance the diagnostic capabilities for acute kidney injury (#AKI) globally, by leveraging Beckman Coulter’s global installed base of instruments. “Acute kidney injury exerts a profound impact on patients globally, complicates acute and chronic illnesses frequently resulting in poor outcomes, and rivals many other critical diseases in its severity and consequences,” said Kevin O’Reilly, President, at Beckman Coulter Diagnostics. “The published evidence for penKid testing combined with SphingoTec’s scientific expertise provides an exciting opportunity to improve kidney health management. Working with SphingoTec, our goal is to expand access to and improve workflow from this important kidney health innovation underscoring our commitment to enhancing patient care worldwide.” Read the press release here: https://lnkd.in/dPeECxgy #diagnostics #innovation #IVD

We're proud to share that JAMA Neurol has published the results of batoclimab (HBM9161) phase 3 clinical trial, which examined the efficacy and safety of batoclimab, a fully human anti-FcRn mAb, in patients with generalized myasthenia gravis (gMG).   In this randomized clinical trial, batoclimab demonstrated sustained efficacy evaluated by MG-ADL (Myasthenia Gravis Activities of Daily Living), QMG (Quantitative Myasthenia Gravis) and other outcome measures. The results also revealed that batoclimab was safe and well tolerated in gMG patients.   With these groundbreaking data, batoclimab is expected to set a new benchmark for the treatment of gMG and bring benefit to patients in need.   Read more: https://lnkd.in/g35nqKf4 #gMG #HarbourBioMed

Join us for a free UCB-sponsored webinar on Wednesday, April 24, 2024, with Wendy Cantrell, DNP, CRNP, Kara Gooding, MMS, PA-C, Joe Gorelick, MSN, FNP-C, and Andrea Nguyen, PA-C, MPAS. - Get NP/PA perspectives and real-world insights as panelists present and discuss their own patient cases managed with IL-17 inhibitors. - Learn about the science of IL-17 inhibition and key therapeutic considerations for this growing class of biologic agents. - Explore the latest data on treatment outcomes with a focus on patient and prescriber expectations of “treatment success.” - Discover key considerations related to patient selection and screening, as well as treatment initiation and monitoring. Register for FREE: https://lnkd.in/eyckBZUu

Exciting developments in DLBCL treatment! Genmab and AbbVie’s EPKINLY (epcoritamab), an IgG1-bispecific antibody developed with Genmab's DuoBody technology, is showing promise in newly diagnosed #DLBCL. At European Hematology Association (EHA) 2024, data from the Phase Ib/II EPCORE NHL-5 study (NCT05283720) highlighted the combination of epcoritamab with pola-R-CHP. As of November 2023, 37 patients exhibited an impressive overall response rate (ORR) of 100% and a complete response rate (CRR) of 89%. Many patients achieved minimal residual disease (MRD) negativity early and maintained it. #Epcoritamab demonstrated a manageable safety profile, with most cytokine release syndrome (CRS) events being low-grade and predictable. #Neutropenia, the most common Grade 3/4 adverse event, occurred in 65% of patients without causing discontinuations. These results, combined with favorable comparisons to standard treatments, underscore the potential of epcoritamab + pola-R-CHP as a promising first-line treatment for DLBCL. Read the detailed analysis of the abstract here @ https://lnkd.in/gwtivNZV #DLBCL #Epcoritamab #Genmab #AbbVie #EHA2024 #ClinicalTrials #CancerResearch #healthcare #business #clinicalstudies #clinicaltrials #results #phases #top #abstracts #pharmacautical #hematology #eha24

Register now for the March ACCP Virtual Journal Club "Edoxaban Exposure in Patients With Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min-". Why is this webinar important to you?  There is a lack of clear understanding of high creatinine clearance on pharmacokinetic/pharmacodynamic (PK/PD) outcomes. Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling any dose-reduction criteria. As edoxaban is partially renally cleared (≈50%), it was postulated that edoxaban exposure may be lower in patients with high creatinine clearance (CrCL >100 mL/min); thus, efficacy could hypothetically be lower in this subpopulation. In this webinar, the author will discuss a prospective, randomized, double-blinded study comparing the pharmacokinetics, pharmacodynamics, efficacy and safety outcomes of edoxaban 60 mg once daily versus edoxaban 75 mg once daily in patients with CrCL exceeding 100 mL/min. The presentation will also illustrate the utility of population PK modeling to account for variability and estimate steady-state PK values based on the sparse PK concentrations collected in the study. https://lnkd.in/ePS63Xps #ACCPVirtualJournalClub #Pharmacokinetics