Allucent

We're thrilled to shine a spotlight on another Allucent A-Team expert, Leslie DeVos, MS, President, Regulatory & Drug Development Consulting! Leslie's deep expertise in regulatory strategy is informed by her over 35 years in the drug development industry. As the President of our Regulatory & Drug Development consulting team, Leslie offers essential guidance to our partners, enabling them to maintain tight timelines, uphold regulatory compliance, and deliver life-changing therapies to patients around the globe. Connect with Leslie and visit our website to learn more about how Allucent's regulatory A-Team can support your drug development program: https://lnkd.in/g367rPxc #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #FDAapproval #DrugDevelopment

?????????????? ???????????????? At Allucent, we know how important it is for new team members to feel welcomed and supported as they step into their new roles. That’s why we’re so proud of our?Work Buddy Program, which pairs new hires with experienced team members to help them acclimate, answer questions, and ???????? ???? ???????? ???????? ?????? ??????????. As Sathyasree R., one of our amazing Work Buddies, shared: "The role of a work buddy is about being supportive and approachable, and it’s been great to see how we’ve built a strong working relationship with new onboarding employees?and making the transition smoother and more enjoyable." ?????????? ?????? ???? ?????? ?????? ?????????????? ???????? ?????????????? ???? ?????? ??-????????! Here’s to making every first day at Allucent a great one! ?? #Allucent #ATeam #ShiningTogether #NewHireOrientation #GreatPlaceToWork

The ICH E11A guideline, adopted?under Step 4 of the #ICH process?on 21 August 2024, marks significant progress in pediatric drug development, addressing key challenges to developing innovative treatments for pediatric populations. Read our blog https://lnkd.in/gvSTh6tc where Allucent A-Team experts John McIntyre, PhD and Jessica K. Roberts, PhD, MSCI discuss the implications of this new guideline?on pediatric drug development and what it means for Sponsors. #Allucent #BringNewTherapiesToLight #Pediatrics #DrugDevelopment #RegulatoryStrategy #ICH

In the fast-paced world of infectious disease and vaccine development, our dedicated A-Team’s diverse therapeutic knowledge, government-funding experience and global regulatory expertise are key to expediting your trial—safely and successfully. Schedule a meeting with our team Bruce McClenathan, Sugato De, Lisa Thomas and Jamie Sischo?through this link https://lnkd.in/g7xERX8s, or visit booth 371 to find out how we can support your next clinical development journey. ? #WorldVaccineCongress?#WVCDC #Vaccine #Allucent #BringingNewTherapiesToLight

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