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1 month ago | 
outsourcedpharma.com | Louis Garguilo |Brandon Haigh |WuXi Advanced Therapies |Raul P. Lima
Join Outsourced Pharma Live for an in-depth examination on how the BIOSECURE Act is impacting risk management, compliance, and the future of global outsourcing in drug development and manufacturing. Our supply-chain experts will provide actionable insights to ensure your outsourcing strategies align with the greater legal, regulatory and geopolitical environment.
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2 months ago | 
outsourcedpharma.com | Louis Garguilo |Raul P. Lima |inSeption Group |Joonman Hong
Webinar: From Research to Reality: Overcoming CMC Challenges in Cell & Gene TherapyJoin us on February 20th to learn how to overcome manufacturing and regulatory challenges in cell and gene therapy by developing robust CMC strategies, employing Quality by Design, and implementing phase-appropriate GMP processes. This webinar is ideal for small biopharma companies and institutions seeking to bridge research and commercial development effectively. Click here to learn more.
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Nov 6, 2024 | 
clinicalleader.com | Dan Schell |Raul P. Lima |inSeption Group |Cheri Pettey
Digging Through the Hype: Can AI/ML Assist Clinical Development? Join us on November 14th at 11:00am EST to learn approaches to leveraging AI and machine learning when handling clinical data, how to approach the use of Generative AI for analyzing clinical trial data, and how to approach human-in-the-loop data mapping with machine learning. Register here.
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Oct 22, 2024 | 
outsourcedpharma.com | Louis Garguilo |Raul P. Lima |inSeption Group
Components of the WuXi global organization are for sale. It’s a forced divestiture. WuXi AppTec is marketing some of its U.S. and European operations. The ill-advised BIOSECURE Act targeting several China-based biopharma companies is having its intended effects, even before the legislation is fully passed by the U.S. government. Where do you stand? A Supply-Chain Woman Of IranArezou Mehrabi has a spellbinding supply-chain case study. It transpired, of all places, in Iran.
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Oct 8, 2024 | 
outsourcedpharma.com | Louis Garguilo |Raul P. Lima |inSeption Group |A Focus
Your Trusted Biologics Testing PartnerSGS Supports biopharmaceutical clients from discovery to clinical development and commercialization, through a comprehensive scope of expert-led quality control testing for raw materials, APIs, and finished products.
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Aug 1, 2024 | 
cellandgene.com | Erin Harris |Raul P. Lima |inSeption Group |Grant Merrill
Digital Data: Your Roadmap To Supply Chain EfficiencyJoin the eData movement! Learn how life science manufacturers are embracing digital transformation as they see it as the pathway to a patient-focused future of high-quality therapeutics. Learn more. Raj Bandaru, Associate Director in Regulatory Affairs and U.S. Regulatory Affairs Lead at Accenture provides rich context on parts of the recent FDA Draft Guidance, Rare Diseases: Considerations For The Development Of Drugs And Biological Products.
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Jul 30, 2024 | 
outsourcedpharma.com | Louis Garguilo |Raul P. Lima |inSeption Group
Not really into choosing extended time away and exhibit halls over the simple pleasures of summertime? No reason to put your CDMO search on hold – Outsourced Pharma Capacity Update’s PARTNER WEEK is now available on-demand. Take the travel and headache out of your plans and tune in right from your computer. Assess potential fit for your next drug development project in convenient 20-minute segments – all grouped by molecule type.
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Jun 21, 2024 | 
cellandgene.com | Raul P. Lima |Clinical Operations |inSeption Group
By Raul P. Lima, Executive Vice President, Clinical Operations, inSeption Group
Gene therapy has existed for decades, but the field is not as mature as it may seem. Its unique pace, structure, and funding dynamics present distinct challenges. Raul P. Lima, Executive Vice President of Clinical Operations at inSeption Group, addresses these challenges in a series of articles.
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Feb 22, 2024 | 
pharmaceuticalonline.com | Mark Witcher |Brian Ball |Nikka Densok USA |Raul P. Lima
This overview article takes a look at each product development stage for biopharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers. 6 Reasons To Consider HVLD Vs. Vacuum Decay For Pharma ProductsHere, we compare two of the more common methods for container closure integrity testing: high voltage leak detection (HVLD) and vacuum decay.
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Feb 12, 2024 | 
cellandgene.com | Erin Harris |Raul P. Lima |inSeption Group
Cell therapies require specialized distribution strategies to safeguard sensitive materials and can be complicated by varying regulations for global shipments. Ensuring the product is delivered on time and within temperature specifications to the hospital is critical and requires meticulous planning across multiple teams.
