Allucent

Check out the March edition of Allucent's Industry Spotlight, featuring key updates in clinical research and drug development. Inside this issue: ?? 5 CAR T-Cell Therapies With Autoimmune Readouts in 2025 ?? Navigating Regulatory Uncertainty: Adapting to FDA Changes in 2025 ?? Challenges in Neuropsychiatric Trials: Strategies for Solutions ?? Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda ?? Cell Therapy Biotech Axes Cancer Trial, Turns to Autoimmune ? Click here to read the full issue for more industry highlights: https://lnkd.in/eurmhjYW #ClinicalResearch #DrugDevelopment #HealthcareInnovation #AllucentIndustrySpotlight

Immunogenicity assessment requires a multidisciplinary approach. Key features include assay methodology, study design and sampling scheme and any resulting impact on safety, efficacy or pharmacokinetics.?The guidance on development of an ISI for regulatory review facilitates a totality of evidence approach. Learn about requirements and see how Allucent’s experience can help optimize your regulatory submission: https://lnkd.in/eiMDxDWh #Allucent #BringingNewTherapiesToLight #Immunogenicity #ClinicalTrials #Pharmacokinetics

?????? ?????? ?????????? ???? ??????-???????? ???????????????? ???????????????? ?????? ????????????’?? ?????????????????? ???? ?????????? ?????? ?????????????????? ???? ????????????? In a recent interview with Onyx Co-founder, Adil Ali, MD, Paula Brown Stafford, CEO of Allucent, shared valuable insights on how emerging biotech companies can bridge this gap. Watch the full conversation to learn more about: ?? The agility of small to mid-size biotechs and how Allucent’s ???????????? approach to support their innovation ??How Allucent delivers ???????????????? ???????????????? ???????????????? ?????????????? to accelerate development ??The power of ?????????????????? ???????????????????????? in navigating the complexities of drug development #Allucent #BringingNewTherapiestToLight #BiotechInnovation #CRO #Onyx

Clinical trials in acute ischemic stroke (AIS) pose several patient enrollment challenges that can hinder the development of new drugs or devices for this indication. Check out our blog, ???????????????????? ?????????????? ?????????????????????? ???????????????????????? ???? ?????????? ???????????????? ???????????? ????????????, where Allucent expert, Gilad Rosenberg, MD, MSc, discusses how deferred consent, permissive inclusion criteria, novel trial designs, and extended temporal treatment are helping researchers overcome these challenges and foster success for patients in need.? Click here to read:?https://lnkd.in/gCepE-vJ #Allucent #BringNewTherapiesToLight #Neuroscience #Stroke #ClinicalResearch ???????????????????

?????????????? ?? ?????????? ???? ?????????????????? ???????????????? Meet?Oksana Fabri MD PhD, Senior Medical Director, Therapeutic Area Medical Lead, Hematology/Oncology, at Allucent. With extensive experience in hematologic oncology, Dr. Fabri leads our cross-functional team within the????????????????? ???????????? ???? ?????????????????? (??????): ???????????????? & ????????????????????, providing expert guidance to advance complex clinical programs. In this brief video, Dr. Fabri shares insights on the fundamentals of?CAR T-cell therapy, its role in transforming cancer treatment, and the promise it holds for patients with difficult-to-treat malignancies. As an oncology CRO, Allucent is committed to supporting the development of innovative therapies like CAR T, shining a light on the innovations that bring life-changing treatments to patients in need. ?? Connect with Dr. Fabri or learn more about our hematology and oncology expertise:?https://lnkd.in/eSPPPD8B #Allucent #BringNewTherapiesToLight #CARTCellTherapy #DrugDevelopment #PrecisionOncology

Ensuring your drug development project is on time, on budget, and aligned with strategic goals is no easy feat. How can your team achieve regulatory and clinical milestones while effectively managing costs and adhering to tight timelines? Read our blog to learn how a clinical development plan (CDP) can ensure that you project is headed for success (https://lnkd.in/gfmvezr7). #Allucent #BringNewTherapiesToLight #CRO #RegulatoryAffairs #ClinicalTrials #FDAApproval

Effective project management in clinical trials isn’t just about strategy—it’s about communication. Clear, proactive dialogue is the foundation for navigating challenges, aligning stakeholders, and driving success. In the second installment of our Expert Insight Series,????????? ?????????????? ???? ?????????? - ?????? ?????? ???? ?????????? '??????????,' Angela Brady, SVP, Project Leadership and Client Relations, explores why prioritizing communication is essential in clinical trial management. From anticipating risks to fostering collaboration, she shares insights on how thoughtful, transparent communication can be the difference between setbacks and solutions. Follow along as we continue to highlight the expertise that keeps clinical trials on track. #Allucent #BringNewTherapiesToLight #ProjectManagement #ProjectLeadership #ClinicalResearch

?????????????? ?????? ???????????? ???? ?????????????????? ???????????????? Join Allucent’s experts for an insightful webinar on development strategies that harness the power of?radionuclide conjugates?and?antibody-drug conjugates?to advance precision oncology. Alex MacDonald, PhD (VP, Model Informed Drug Development), Sugato De, MS (VP, Regulatory Strategy and Head of MedTech), Angela Brady, MHL (SVP, Project Leadership and Client Relations), and Brian Barnett, MD (Executive Medical Director) share their expertise and real-world perspectives and provide a comprehensive understanding of innovative therapeutic agents, from early research to clinical application. Watch now: https://lnkd.in/gQ4RvJSR #Allucent?#BringNewTherapiesToLight?#DrugDevelopment?#ClinicalTrials #PrecisionOncology

We're thrilled to introduce you to Vanessa Beddo, PhD, VP, Global Head of Biostatistical Consulting at Allucent! Vanessa is a key leader in our biostatistical consulting team, bringing over 19 years of experience in clinical trial design and analysis. As a seasoned statistician, she has played a pivotal role in numerous Phase I-IV clinical trials, contributing to successful FDA and EMA drug approvals. Her expertise spans a wide range of therapeutic areas, including oncology, rare diseases, vaccines, and neurology. With her deep statistical knowledge and strategic insights, Vanessa helps sponsors navigate complex regulatory pathways and optimize study designs for success. Connect with Vanessa and visit our website to learn more about Allucent’s biostatistical consulting services: https://lnkd.in/gxp_hPba #Allucent #BringNewTherapiesToLight #Biostatistics #StudyDesign #RegulatoryAffairs

Check out part 2 of our series on formal FDA meetings (?https://lnkd.in/gTnykQef ). Allucent experts, Matthew Hight, PhD, RAC, Joshua Taylor, PhD, RAC, and Marcus Delatte, PhD, share key insights to help sponsors prepare for discussions with the FDA for their upcoming new drug application (NDA) or biologic license application (BLA), following the completion of related pivotal clinical studies. ? This blog delves into topics such as: ??Objectives of the Pre-NDA/BLA meeting ??Crafting effective FDA Meeting Requests and Packages ??Important topics to discuss during pre-NDA/BLA meeting ? #Allucent #BringNewTherapiesToLight #ClinicalTrials #DrugDiscovery #FDAApproval #RegulatorySubmissions