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This Independence Day, we celebrate the innovation, perseverance, and spirit that has helped shape this nation. We hope you all have a spark-tacular and a safe holiday! #4thofJuly #IndependenceDay

Before the Orphan Drug Act (ODA) was signed into law, the FDA approved approximately two drugs per year for rare diseases. Now, 40 years after the ODA, hundreds of orphan drugs have been approved for use in the many diseases and conditions that are considered rare. What’s in store for the next 40 years? Read Gail Winslow, MS, APR take on insights shared during the panel, “Sustainability of Rare Disease Drug Development,” at #DIA2024 https://hubs.la/Q02F7rN60 #orphandisease #raredisease #orphandrugact #FDA #acceleratedapproval

Last year, the FDA released, “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.” This guidance is noted to expand on the prior guidance released over a decade ago. Our team has seen an interest from our life science community in our review of the guidance’s four key themes: questions concerning risk, developing your monitoring strategy, risk assessment as a continuous process, and the importance of a root cause analysis. https://hubs.la/Q02CDJsg0 If you are interested in further unpacking this guidance or have questions about your monitoring approach, we’re ready to start the conversation. #FDAGuidance #ClinicalTrials #ClinicalInvestigations #RiskBasedMonitoring #QMS #QualityManagement

Halloran is #hiring! Join our team! Click here to discover our available positions: https://hubs.la/Q02CKvcf0 #SalesJobs #ConsultingJobs #LifeScienceJobs #RegulatoryJobs

Are you sponsoring a clinical trial, wondering how to develop an Informed Consent Form? You’re not alone. In this on-demand webinar, our team reviews the principles and requirements of informed consent and shares common challenges and recommendations in the landscape of increasingly complex clinical studies. Ready? Watch our webinar and walk away with actionable steps to improve the clarity, simplicity, and transparency of Informed Consent Forms to improve participant experience and understanding. https://hubs.la/Q02CDy5z0 #ClinicalOperations #InformedConsent #FDAGuidance #ClinicalTrials

TOMORROW! Join our webinar, "Key Strategies for Development Stage Biotechs: Developing an Organization and the Talent Within". Our expert panel from The Leadership Edge, Halloran Consulting Group, and Inozyme Pharmaceuticals will share their insights for leading your team through development. Register now! https://hubs.la/Q02ClRCj0 #Biotech #Pharma #Webinar #TalentDevelopment #Leadership #LifeSciences

Leaders at biopharma companies often ask us, “what is a culture of quality and how do you build it?” and we encourage those leaders to consider the opportunity because the payoff is significant. Sheila Gwizdak identifies the key elements in a culture of quality, how to enable a culture of quality, and the benefits and impact. Whether you’re a CMO or an acting executive of your company, you have an opportunity to help shape your corporate culture for the better! Contact us to start the discussion. https://hubs.la/Q02CDrkN0 #CultureOfQuality #LifeSciences #BiopharmaLeadership #OrganizationalTransformation

As #DIA2024 wraps up, we wanted to share a big thank you to everyone who visited our booth or met with us during the week! Our team had an incredible time connecting with industry leaders, catching up with old friends, and making some time for team bonding. We're excited to continue these conversations and share our key takeaways through upcoming blogs and thought leadership. Stay tuned!

As we celebrate Juneteenth, we honor the resilience, strength, and contributions of Black Americans to our nation's history. In the life sciences industry, diversity fuels innovation and progress. We remain committed to fostering an inclusive environment where every voice is heard and valued, driving breakthroughs that improve health for all. #HappyJuneteenth from Halloran!