Our A-Team is delighted to join regulatory colleagues at the upcoming RAPS Convergence in Long Beach, CA next week. Don’t miss our panel presentation, "Optimizing Health Authority Interactions and Outcomes" by regulatory experts Joshua Taylor, PhD, RAC, Sheila Plant, PhD, MHS, RAC, and Nadine Bouchard, who will be sharing insights to improve health authority interactions by effectively using an integrated strategy across the global regulatory and product development teams. Be sure to visit booth #1021 to meet the rest of our team: Tim Burrows, Nick Sanich, and Nick Boyce. Discover how Allucent’s partnership approach, coupled with our unparalleled regulatory expertise and Health Authority experience, sets us apart. Schedule a meeting: https://lnkd.in/gJFCsRAQ #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #rapsconvergence
Allucent
Pharmaceutical Manufacturing
Cary, North Carolina 86,087 followers
Helping bring new therapies to light
About us
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
- Website
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http://www.Allucent.com
External link for Allucent
- Industry
- Pharmaceutical Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- Cary, North Carolina
- Type
- Privately Held
- Specialties
- Drug Development, Regulatory Affairs and Submissions, Clinical Strategy, Cell & Gene Therapy, Rare Diseases & Orphan Indications, Oncology & Hematology, Study startup & Feasibility, Regulatory Strategy, Small and midsized biotech companies, Biostatistics, Pharmacokinetics (PK) / Pharmacodynamics (PD), Clinical Pharmacology, Medical/Scientific Writing, Protocol and study design, Medical monitoring, Patient recruitment, Pharmacovigilance, Data management, NDA/BLA/MAA, and Product development
Locations
Employees at Allucent
Updates
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Only two days left to register for our webinar on "Radionuclide Conjugate and Antibody-Drug Conjugate (ADC) Development Strategies." Don't miss this opportunity to gain a thorough understanding of innovative therapeutic agents, from research to clinical application – from Allucent experts Alex MacDonald PhD (VP, Model Informed Drug Development), Sugato De, MS (VP, Regulatory Strategy, Head of MedTech), Angela Brady, MHL (SVP, Project Leadership and Client Relations), and Brian Barnett, MD (Executive Medical Director) https://lnkd.in/ga5Miwpu Also streaming live on LinkedIn: https://lnkd.in/g8jNijXB #Allucent #BringNewTherapiesToLight #DrugDevelopment #ClinicalTrials #Radionuclides #AntibodyDrugConjugates
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Navigating the complexities of a #RegulatorySubmission for marketing approval demands a thorough representation of the entire product development process. Utilizing #Storyboarding during the authoring phase is a powerful approach that fosters collaboration among cross-functional teams, ensuring alignment on the critical messages throughout the submission." Our recent blog, 'Strengthen Your Regulatory Submissions Through Strategic Storyboarding,' explores how targeted storyboarding techniques can enhance your submission for marketing approval. Dive into the blog for more insights. https://lnkd.in/g4BeG9u3 #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #RegulatorySubmissions #ClinicalDevelopment
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Check out the latest issue of Allucent's Monthly Newsletter for the most recent updates in #DrugDevelopment and #Oncology Key Highlights in this month's Industry Spotlight: • Biopharma VC hits highest quarterly level since 2022,but challenges remain • FDA's Lykos Rejection Delays - But Doesn't stop Psychedelic Therapies • First-of-its-kind cell therapy approved by FDA for rare soft tissue cancer • Gene Therapies Break Through Against Genetic Hearing Loss in Children • Denmark's Adcendo signs $1B biobuck deal for Multitude's anti-TF ADC Click here to read the newsletter: https://lnkd.in/gEvjmyfe #Allucent #BringNewTherapiesToLight #ClinicalDevelopment #Newsletter
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In this next part of our series on formal FDA meetings, Allucent experts Matthew Hight, PhD, RAC, Joshua Taylor, PhD, RAC, and Marcus Delatte, PhD divulge how 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 Read the blog to learn more: https://lnkd.in/gTnykQef #Allucent #BringNewTherapiesToLight #ClinicalTrials #DrugDiscovery #FDAApproval #RegulatorySubmissions
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Check out our recent infographic where Allucent expert Jessica K. Roberts, PhD, MSCI (Director and Head Quantitative Translational Pharmacology) disseminates the transformative role of pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation in overcoming challenges in pediatric drug development (https://lnkd.in/gkeNyqee). This infographic covers topics including: - Leveraging adult clinical trial data - Modeling and simulation of adult data for pediatric use - Predicting successful doses in pediatric patients #Allucent #BringNewTherapiesToLight #CRO #Pharmacology #ClinicalTrials #PKPD #Pharmacokinetics #ModelingAndSimulation
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Allucent is proud to celebrate #womensequalityday2024! This day of commemoration marks a powerful turning point in the United States. Through the ratification of the 19th Amendment to the US Constitution in 1920, women were given the right to vote. Today, we encourage you to reflect on the strength, resilience, and achievement of women all over the world. #Allucent #BringNewTherapiesToLight #CRO #Equality #ClinicalTrials
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Our A-Team is excited to partner with Biomedical Advanced Research and Development Authority (BARDA) DRIVe's D-COHRe program! By participating in the D-COHRe program, Allucent will leverage the shift toward decentralized healthcare and enhance decentralized clinical study capabilities to build sustainable solutions and evaluate medical countermeasures in real-world environments. #Allucent #BringNewTherapiesToLight #BARDA #ClinicalDevelopment #DecentralizedTrials #Healthcare #ClinicalTrials
We are excited to announce BARDA DRIVe’s first three partnerships with Allucent, Care Access, and Walgreens through the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. We are partnering with organizations that provide access to clinical care sites and leverage how patients seek care in places like retail pharmacies, through telemedicine, mobile clinics, urgent care clinics, and more. This DCT approach will help medical countermeasure developers recruit, enroll, and retain patients in settings outside the hospital and closer to the patient. D-COHRe has the potential to boost preparedness for future public health emergencies by enabling greater access to clinical study participants and promoting equity through access to diverse populations. Interested in partnering with our D-COHRe program? We are accepting proposals on a rolling basis until December 9, 2024. Read more about the program and how to apply: https://ow.ly/oOmN50T5kZY
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Join Allucent expert, Rachel (Tyson) Rozakis, PharmD (Sr. Clinical Pharmacologist) at the ACCP Annual Meeting on Monday, September 9th as she shares her team's informative phase 1 study on the pharmacokinetic and cardiac effects of the riluzole prodrug, Troriluzole, on healthy human subjects. Dr. Rozakis and team emphasize the importance of conducting cardiac safety assessments during the drug development journey to ensure that all potential heart-risks are identified, and proper action is taken to mitigate risks for patients. Learn more about this session on the ACCP website: https://www.accp1.org/ #Allucent #BringNewTherapiesToLight #DrugDiscovery #Pharmacokinetics #ClinicalPharmacology #2024ACCP #AmericanCollegeOfClinicalPharmacology
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The most significant reform of European pharmaceutical legislation in over two decades began in April of 2023 when the European Commission proposed a New Directive and Regulation to revise and replace the existing legislation. In October of 2023, the European Parliament proposed their revisions, and on the 10th of April 2024, the Parliament adopted its position on the draft texts. READ more: https://lnkd.in/gHMzzz_m While further steps remain before the legislation comes into effect, these reforms still have major implications for the sector. They will be instrumental in shaping the pharmaceutical landscape in the following decades. Read our blog, "EU Pharmaceutical Reform – Towards a Resolution," where Allucent experts John McIntyre, PhD (Director, Clinical Strategy) and Sugato De, MSc (VP, Regulatory Strategy) summarize some of the key changes that you need to be aware of and what actions need to be taken to plan your future regulatory roadmaps. #Allucent #BringNewTherapiesToLight #EMA #ClinicalTrials #DrugDevelopment #RegulatoryAffairs #RegulatoryStrategy