Stanford Research Park’s Post

The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s new lung cancer drug, Augtyro, which is designed to target lung tumors with alterations in the ROS1 gene. The drug was acquired through a $4 billion buyout of Turning Point Therapeutics and is expected to double the size of the ROS1 market, estimated to be around $500 million to $600 million. The approval was based on a trial where 79% of patients who had never been treated with another ROS1-targeting drug saw their tumors shrink or disappear, and they continued to respond for a median of 34 months. This drug is part of Bristol Myers’ pipeline renewal project as long-lived products like Revlimid, Abraxane, and Eliquis face generic competition due to patent expirations. Read more here: https://bit.ly/3QNTcEX Explore global opportunities: Director of Drug Product Development 📍 Pennsylvania, USA: https://bit.ly/3R5SjsV Project Manager QC (m/f/d) 📍 Munich, Germany: https://bit.ly/3QM8Pgf

We are an independent, minority-owned HEOR and market access consultancy, specializing in advanced analytics for global pharmaceutical access. We've backed over 300 HTA submissions worldwide across 175+ indications, covering diseases like oncology, rare conditions, and more, serving the pharma, biotech, and medical device sectors. #HEOR #marketaccess #HTA #healthtechnologyassessment #evidencesynthesis #realworldevidence #realworlddata #economicmodelling #machinelearning #AI #artificialintelligence  

In our blog post, Daniel Chancellor suggests that rather than becoming more risk-averse, drug developers should seek to shift attrition to the earliest stages of development. This allows for prioritization of the best assets with the most significant patient impact. Click to read about why clinical development success rates are falling on the Norstella blog: https://ow.ly/7eIp50RIMsC. #ClinicalDevelopment #DrugDevelopment #Biopharma #BiopharmaceuticalCompanies #BiopharmaTrends

In our blog post, Daniel Chancellor suggests that rather than becoming more risk-averse, drug developers should seek to shift attrition to the earliest stages of development. This allows for prioritization of the best assets with the most significant patient impact. Click to read about why clinical development success rates are falling on the Norstella blog: https://ow.ly/RB4950RIN9C. #ClinicalDevelopment #DrugDevelopment #Biopharma #BiopharmaceuticalCompanies #BiopharmaTrends

Fascinating insight into the trends in pharma R&D, highlighting the increasing difficulty in drug development and market success. In 2014, the clinical development success rate was 10.4%, with only one in every 10 drugs reaching patients post Phase I. Today, Citeline’s Biomedtracker analysis reveals a mere 6.7% likelihood of approval, reflecting the evolving landscape. Despite the apparent decline, the situation is nuanced, with oncology assets and heightened competition significantly influencing these figures. Encouragingly, there is a growing interest in high-risk candidates and innovative treatment options. #Pharma #DrugDevelopment #R&D #Biomedtracker #Innovation

We are delighted to announce our key speaker Sweety Mathew, Regulatory Professional, RA CMC Biotech & Rare Disease, Novo Nordisk for #Pharma #Regulatory Summit 2024 https://lnkd.in/g7fu9Uj4 For our upcoming conferences visit : https://lnkd.in/gjQY86dn Fen Castro #VIpry #RegulatoryAffairs #pharmaregulatoryAffairs #drugregulatoryaffairs #RegulatoryWriting #MedicalWriting #Publishing #Submissions #scientificwriting #pharmaceuticals #clinicaltrials #pharmacovigilance #biosimilars #virtueinsight #patientsafety #pharmaceuticalindustry #lifesciences 

Regulators are accelerating approval paths for biosimilars, but require clinical trials in patients. With 80+ biosimilar studies delivered across multiple therapeutic areas since 2009, partnering with IQVIA can help you to understand the biologics landscape, drive patient enrollment, navigate regulations, and conduct flexible trials. Learn more. https://bit.ly/43rfZg3 #biosimilars #clinicaltrials

Regulators are accelerating approval paths for biosimilars, but require clinical trials in patients. With 80+ biosimilar studies delivered across multiple therapeutic areas since 2009, partnering with IQVIA can help you to understand the biologics landscape, drive patient enrollment, navigate regulations, and conduct flexible trials. Learn more. https://bit.ly/49aHFH1 #biosimilars #clinicaltrials

Dr Prashant Bodhe, Director, CliniSearch will participate as a Moderator in our #Pharma #Regulatory Summit 2024 https://lnkd.in/g7fu9Uj4 For our upcoming conferences visit : https://lnkd.in/gjQY86dn Fen Castro #VIpry #RegulatoryAffairs #pharmaregulatoryAffairs #drugregulatoryaffairs #RegulatoryWriting #MedicalWriting #Publishing #Submissions #scientificwriting #pharmaceuticals #clinicaltrials #pharmacovigilance #biosimilars #biotech #virtueinsight #healthcare #pharmaceuticalmanufacturing #patientsafety #medicines #pharmaceuticalindustry #pharmanews #lifesciencesindustry #lifesciences 

Small molecule innovation and the #IRA ---------------------------------------- With the Inflation Reduction Act unfairly penalizing small molecule drugs by subjecting them to administrative at 9 years (v. 13 years for biologics), policymakers have multiple options to ameliorate this harm. Lots of diseases from diabetes to heart failure are treated with small molecule drugs. Development cycles are long, expensive, and burdensome to both patients and developers. #FDA policy levers can relieve this burden, including: 1. Targeting patient-reported outcomes (or real-world evidence of outcomes that actually matter to the patient, e.g. 6-min walk test in COPD) 2. Flexibility in assessment of outcomes (e.g. remote assessment, delayed assessment when appropriate) 3. Positive creativity in trial design See more below 👇 ------------------- https://lnkd.in/eP7ZvChs Vrushab Gowda, MD, JD Nisha Patel, MD, MPH Niraj Gowda Ted Cho John O'Brien Joseph Spear Terra Marie Jouaneh Shawn Rose MD, PhD Jeffrey Hamilton Kirsten Axelsen Janet Woodcock Gail Wilensky Michael Ybarra, MD Ryan Long Nolan Ahern Charlie Katebi Nina Owcharenko Schaefer Kevin Pham Andrew Marcel- Keyes Marcel Salive Ryung Suh Chelsea Cirruzzo Daniel Payne Tina Reed #healthpolicy #innovation #technology #drugpricing #IRA