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By Outsourced Pharma
Darren Dasburg, a long-tenured executive at GSK, Medimmune/AZ, well-regarded consultant, and currently chief business officer at CRISPR Biotech, didn’t write the book on outsourcing. He did, though, design and teach the defining class on the subject. The “Outsourcing Master Class” is a capstone-case-review, team-based course sanctioned by the International Association of Outsourcing Professionals (IAOP).
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By Kate Cook, Catherine M. Cook Group, LLC
It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.
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By Elizabeth McGuire and Linda Plumley, Clarkston Consulting
In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
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Article
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By Adara Kurtz, Jerrad Tosti, and Patti Fiscus,
Singota Solutions
Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.
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White Paper
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By Christian Cattaruzza, Steven Strubbe, Laure Valognes, Corinne Lavie-Cambot, Laetitia Botrel, and Muriel Richard,
MilliporeSigma
Our experts share key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations, and regulatory compliance.
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Case Study
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By Kimberly Shepard, Ph.D.,
Lonza
Learn more about spray drying as well as two case studies detailing its success as a critical tool in developing innovative and effective lung cancer therapies.
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Article
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Lonza
Dr. Michiya Hayakawa shares strategies for manufacturing HPAPI (highly potent active pharmaceutical ingredient) drugs and key points for promoting projects that utilize special formulation technologies.
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Article
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Andelyn Biosciences
Since the early 1990s, gene therapy has revolutionized medicine. In the coming years, it will continue to become more relevant in the treatment and cure of some of the most severe diseases and disorders.
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Article
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Pfizer CentreOne
Some of pharma’s top brands developed their own responses to the demand for strategic outsourcing, creating a distinct class of contract development and manufacturing services suppliers.
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Article
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AcuraBio
World-class researchers, state-of-the-art facilities, a streamlined regulatory framework, and generous tax incentives have made Australia a prime location for the biotech industry.
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White Paper
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Asymchem
Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.
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Application Note
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Cytiva
Discover how we automate the optimizing cell harvesting process and further minimize the potential for cell loss during wash steps.
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Case Study
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Cambrex
A pharmaceutical company sought a CMO partner with commercial manufacturing capabilities and expertise and exemplary quality systems to find a cost-effective process to produce the API for a new drug.
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e-book
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Thermo Fisher Scientific
Bioavailability challenges are an inherent part of the drug development process. Review some risky assumptions surrounding bioavailability issues during development and key considerations for addressing them.
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Q&A
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Quotient Sciences
The role of clinical operations plays an important part in the overall drug development process. Ian Nisbet, global vice president of clinical operations at Quotient Sciences, shares more about clinical operations.
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Webinar
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Pfizer CentreOne
Pfizer CentreOne’s oral solid dose experts discuss how advances in the mathematics and engineering involved in understanding the process can tackle challenges and ensure functional coating and drug layering continue to be a viable solution for the next generation of OSD drug products. Discover how coatings expertise could transform your OSD drug.
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Webinar
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Catalent
Explore how spray-dried particles provide an attractive, carrier-free option for highly dispersed delivery of API to deep lung regions, utilizing an alternative approach to large, porous particles.
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West Pharmaceutical Services, Inc.
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Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.
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Connect With Outsourced Pharma:
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