Regulatory Articles. App Notes, Case Studies. & White Papers

81. Painkiller And Sedative Demands: Effects On Bupivacaine HCI Supply 1/20/2022

    As global authorities work to fill gaps, drug manufacturers and CDMOs have become critical in the efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.

82. AVROBIO's Geoff MacKay On Cell & Gene Scalability 10/4/2021

    Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

83. bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches 10/4/2021

    bluebird bio's Scott Cleve sat down with The Business of Biotech podcast to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

84. Apply For A Breakthrough Therapy Designation (And Win It!) 10/4/2021

    GlaxoSmithKline's Dr. Ira Gupta and Gilead Sciences' Dr. Shanthi Ganeshan break down breakthrough designations, winning them, and bouncing back from rejection.

85. Regulatory Services For Accelerated Development And Commercialization 7/27/2021

    Breakthrough therapy designations and other expedited regulatory reviews enable more innovation on shorter timelines to the clinic and commercialization, but they require careful navigation.

86. How Fulcrum Therapeutics Protects Its Data 4/20/2021

    Maintaining GxP compliance, creating a secure environment for collaboration, and ensuring there is a single source of truth are becoming more and more of a hassle. Read how Fulcrum has turned to technology to help automate many of these processes in order to streamline collaboration with third-parties and the organization of data into a single repository.

87. Current Data Privacy Regulations Impacting The Life Sciences Industry 4/20/2021

    The GDPR is a significant advancement of consumer data protection rights. The European member states agreed to a set of principles that would penalize organizations that don’t safeguard personal identifying information (PII). If your team or clinical trial operates in the EU, California, S Korea, Australia, or a dozen other countries, your data could be subject to strict privacy laws. Violating GDPR, PIPA, APP, or CCPA, among others, have serious consequences for your program. Learn how to mitigate risk and keep on the right side of regulators.

88. How To Attract Investors – Funding Advice For Biotechs From VC Experts 4/9/2021

    How do you find the initial capital and attract new investors to hit your milestones and stay solvent? Experts share their experiences and offer advice for companies on the path towards bringing a potentially life-changing therapy to patients.

89. Reducing CMC Risk From IND To Commercial Manufacturing 4/1/2021

    Experts in the cell and gene therapy field share their experiences and discuss emerging trends to accelerate life-saving therapies from the bench to the bedside.

90. Bench To Bedside And FDA Submission Strategies For Cell And Gene Therapies 4/1/2021

    Cell therapies have the potential to transform global healthcare by providing curative therapies for once incurable diseases, but there are major challenges to their widespread adoption. Industry experts share their experiences and discuss emerging trends to accelerate life-saving therapies from the bench to the bedside.