LSL Web-Exclusive Content

81. Cell & Gene Therapy COGS: Progress & Pitfalls In Our Quest For Affordability 2/28/2023

    We regularly talk about “getting to know” our products. This can mean a lot of different things depending on the functional area in which we work. But as conversations about affordability and commercial sustainability increase pressure on manufacturing teams, I wanted to get Spink’s thoughts on how we can understand our products from a COGS standpoint and how this will continue to challenge us in the years ahead.

82. Sites Look To Unravel The Tech Tangle Of DCTs 2/28/2023

    Decentralized clinical trials and all their elements are touted as flexible options for patients. But what about the sites carrying them out? Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) says sites are looking for clarity and consistency when it comes to the tech being thrust upon them by sponsors and CROs.

83. Biotech's Market Outlook In 2023 & Beyond 2/23/2023

    This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.

84. Insulin's 100-Year History Inspires Today's Biotech Industry 2/22/2023

    Former FDA regulator Jeffrey C. Baker, Ph.D., has been speaking on the history of insulin, the first biologic, at seminars and conferences for years. This year, those talks seem more important as we mark the 100th anniversary of this life-saving drug. Baker says insulin's story holds inspiration for today's biotech companies.

85. Trends In FDA FY2022 Inspection-Based Warning Letters 2/21/2023

    We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.

86. Gene Therapy Uptake: The Elephant In The Room 2/17/2023

    This article examines in detail why the product-level drivers of uptake – including efficacy, burden of administration, and durability expectations – are crucial for maximizing revenue potential and market share, particularly in markets with multiple competitors.

87. 2023's Market Outlook For Cell And Gene Therapies 2/14/2023

    This article discusses quantifiable market trends, clinical developments, regulatory landscape analysis, and investment trends for cell and gene therapy companies in 2023.

88. Donating Surplus Clinical Trial Supplies Drives Pharma Sustainability Success 2/7/2023

    Corporate sustainability efforts have been the hot topic since this decade began. However, some clinical operational professionals think that there's no place for sustainability in their role of conducting clinical trials. However, there is one simple way to implement a sustainability initiative within your organization's clinical trial conduct. 

89. January 2023 – CDMO Opportunities And Threats Report 2/3/2023

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

90. After Decades Of Biomanufacturing Workforce Development, What's Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.