LAVA Therapeutics N.V.’s Post

Many factors impacting the success rates of clinical trials are avoidable with better planning and study design.   Despite this, only 0.005% of a trial's budget is allocated to de-risking study design.   Our latest blog explores how better planning and study simulation tools can transform clinical trial outcomes.   Read the article at: https://lnkd.in/dYYwzA-i Enhancing Clinical Trial Efficiency through Simulation-Guided Study Design: A Path to Faster Drug Development and Regulatory Approval #ClinicalTrials #DrugDevelopment #Biosimulation #KerusCloud #Pharma #HealthcareInnovation #RegulatoryApproval

PPD, a renowned leader in clinical research, has been honored with the prestigious CRO Leadership Award for the 13th consecutive year. This recognition underscores PPD's unwavering commitment to innovation and excellence in the industry. The company's recent panel at the Drug Information Association (DIA) emphasized the pivotal role of real-world data (RWD) and technology in expediting drug development processes. Through the convergence of RWD and cutting-edge technologies like artificial intelligence and wearable devices, PPD showcased how real-world evidence (RWE) is transforming drug development by providing crucial insights for informed decision-making. PPD's comprehensive suite of drug development services caters to pharmaceutical and biotech companies, offering integrated CRO and CDMO solutions that span the entire development journey, from molecule to medicine. The company's recognized expertise across capabilities, compatibility, expertise, quality, and reliability has solidified its position as a trusted partner in the industry. For more details on PPD's latest achievement and industry insights, click here: https://lnkd.in/gK6NGPW5 #PPD #ClinicalResearch #DrugDevelopment #CROLeadershipAward #RealWorldData #Innovation #Excellence

Accelerating Healthcare Innovation: FDA’s Fast-Track Programs The FDA offers several programs to speed up the development and review of drugs for serious conditions: 1. Fast Track: Speeds up development/review for drugs addressing unmet needs. 2. Breakthrough Therapy: For drugs showing major improvement over existing treatments. 3. Accelerated Approval: Early approval based on surrogate/intermediate endpoints. 4. Priority Review: Cuts review time from 10 to 6 months for significant advancements. 5. Priority Review Voucher: Rewards development of drugs for rare diseases. These programs help bring new treatments to patients faster. #FDA #FastTrack #BreakthroughTherapy #AcceleratedApproval #PriorityReview #HealthcareInnovation #Pharma #Biotech #MedicalResearch #PatientCare

Exploring Expanded Access & Compassionate Use in Healthcare Let's unravel the nuances of "Expanded Access" or, interchangeably, "Compassionate Use." This involves utilizing investigational medical products outside the clinical trial setting. **Definition:** Expanded access, often synonymous with compassionate use, extends access to investigational therapies when clinical trial participation isn't feasible. For instance, when a patient is ineligible for ongoing trials or when no trials are available. **Key Factors:** 1. **Patient Eligibility:** Access is granted to those unable to participate in clinical trials, ensuring inclusivity for various medical scenarios. 2. **Product Range:** Encompassing investigational drugs, biologics, or devices, expanded access addresses a broad spectrum of therapeutic options. 3. **Mechanisms:** The utilization of investigational products in expanded access is facilitated through designated treatment mechanisms. **Balancing Act:** Successfully navigating expanded access and compassionate use requires a delicate balance between patient needs, regulatory considerations, and the collaborative efforts of healthcare professionals. As we progress in the healthcare landscape, let's foster a deeper understanding of these pathways to enhance patient care and contribute to the evolution of our industry. Like the post and share your insights! If easily consumable yet informative content like this is helpful for you, subscribe to my monthly newsletter 📩 #HealthcareEducation #MedicalInnovation #earlycareer #lifescience

Join us on 20th May for an insight into understanding how patient-centricity has a valuable part to play in the evolution of clinical trials and fostering positive outcomes within drug development. Register via the link! #webinar #patientfocus #patientcentricity #puttingpatientsfirst #clinicaltrials #drugdevelopment #alifeinaday

Elevate your Clinical Trials Expertise! Join us at the 19th BioPharma Clinical Trials Nexus Conference on April 25-26, 2024 at Basel Marriott Secure your spot now as seats are limited! Embrace the future of clinical research. #NEXUSconference #ClinicalTrials #InnovationInHealth #BioPharmaEvent #ClinicalResearch #DrugDevelopment #MedicalAdvancements #PatientCentricity #ResearchLeadership #SanDiegoConference #BiotechRevolution #HealthcareInnovation #DataIntegrity #RegulatoryCompliance #DigitalHealth #PrecisionMedicine #TherapeuticInnovation #PatientSafetyFirst #ResearchExcellence #FutureofMedicine #ScientificDiscoveries #CROPartnerships #BioscienceFrontiers #PharmaLeaders #LifeSciences #Biopharmaceuticals #DrugDiscovery #GlobalHealthImpact #NetworkingOpportunity #ResearchCollaboration #SheratonMissionValley #LimitedSeatsAvailable

Phases of Clinical Trials (part 2) Clinical Research Series - Day 7 👉 Follow to get more knowledge on Clinical Research #au3macademy #learnwithau3m #au3mlifesciences #pharma #clinicaltrial #clinicalresearch #lifescince #clinicaldata #clinicalresearchjobs #clinicalresearchmatters #healthcare #clinicalresearchers #clinicalresearchtrials #clinicalresearchcareers #clinicaltrials #clinicalresearchtraining #clinicalresearchassociate

Robust clinical supply chains to support global trials are essential to ensure investigational drugs are readily available at clinical sites when needed.   As clinical trials become increasingly complex in design and seek to include various populations and reach patients worldwide, having a robust end-to-end supply chain solution is vital.   Read the latest article by PCI Pharma's Ed Groleau published in the Journal of Clinical Studies to uncover the key areas to consider in helping build a clinical supply chain that supports global trials effectively and efficiently.     https://lnkd.in/eycvuCUq   #ClinicalTrials #SupplyChain #CDMO   #LetsTalkFuture

The cost of running a clinical trial is enormous. Controlling the cost of comparators is crucial to meeting budget and waste targets. We buy comparator drugs and adjunctive therapies through AmerisourceBergen’s established sourcing network, ensuring you receive fair, transparent pricing. Learn how our #ComparatorSourcing solution helps biotech innovators control costs for clinical trials: https://bit.ly/3iooWOz