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Submitted URL: https://qtx.omeclk.com/portal/wts/uemcmQ6cjg|ba80cbdjPyfmM3rrd
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Submission: On May 19 via api from US — Scanned from DE
Effective URL: https://solutions.catalent.com/download_center?ContentID=2348&utm_term=RX&utm_campaign=FY22-RX-EDEV-Email-External-FierceBT-EU-...
Submission: On May 19 via api from US — Scanned from DE
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Text Content
WEBINAR-RECORDED WEBINAR-BETTER DECISIONS DURING PHASE 1 CLINICAL TRIALS WITH NIMBLE DESIGN STRUCTURES -------------------------------------------------------------------------------- A RECENT STUDY SHOWED THAT THE OVERALL SUCCESS RATE OBSERVED FOR DRUG CANDIDATES PROGRESSING FROM PHASE 1 TO PHASE 2 CLINICAL TRIALS WAS 66% (AND ONLY 58% IN ONCOLOGY). THERE IS CONSIDERABLE PRESSURE TO INCREASE THE SUCCESS RATE AND TO ADDRESS INEFFICIENCIES IN CLINICAL RESEARCH IN ORDER TO REDUCE THE COST OF DEVELOPMENT AND STRENGTHEN THE DRUG PIPELINE, YET AT THE SAME TIME, NEW MOLECULES ARE PRESENTING MORE AND MORE CHALLENGES THAT MAKE SUCH IMPROVEMENTS DIFFICULT. INNOVATIVE “ADAPTIVE” CLINICAL TRIAL DESIGNS UTILIZING “MANUFACTURING ON DEMAND” HAVE EMERGED AS A PROMISING SOLUTION TO IMPROVE SPEED AND EFFICIENCY OF THE DRUG DEVELOPMENT PROCESS, BUT THESE NEED TO BE SELECTED CAREFULLY, FOR EXAMPLE, WHEN THERE IS ALSO THE NEED FOR ENABLING TECHNOLOGIES TO RESOLVE BIOAVAILABILITY LIMITATIONS. JOIN THIS WEBCAST TO HEAR A PANEL OF DRUG DEVELOPERS DISCUSS HOW INNOVATIVE TRIAL DESIGNS, ON-DEMAND MANUFACTURING, REAL-TIME CLINICAL DATA-BASED DOSE ADJUSTMENTS AND PARTNERING WITH EXPERIENCED FORMULATORS AND CONTRACT RESEARCH ORGANIZATIONS (CROS) CAN ENABLE FASTER, BETTER DECISION MAKING DURING PHASE 1 CLINICAL TRIALS. LEARN MORE ABOUT: Understand the difference between adaptive and other phase 1 trial designs Learn how costs and timelines can be reduced through the use of formulation ‘design space’ and ‘manufacturing on demand’ approaches Identify the formulations best suited to this approach and review real-world case studies highlighting the benefits to innovator companies. 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WHY CATALENT? CATALYST + TALENT Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com. More products. 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