The Food & Drug Administration (FDA) regulatory landscape is evolving, and unless you keep a close pulse on these changes, it’s challenging to keep up. Getting your Biotech innovation through...
By Dr. Julie Rosenberg Bringing a new drug to market is a long, complex, and costly journey and regulatory approval is not guaranteed. For Biotech and pharmaceutical, companies, the New...
By Julie Rosenberg, MD Biopharma startups often need senior-level expertise as they navigate the drug development process. However, hiring a full-time executive can be financially out of reach. These companies...
By Jenny Thayer, BioBridges’ Medical, Regulatory, and Scientific Communications SME While an open-minded approach to onboarding new technology is essential to advancing drug and device development, a thoughtless approach...
The life sciences job market is experiencing significant shifts, and we anticipate this will continue throughout 2025 with a greater focus on roles that support product innovation, regulatory compliance, emerging...
MedTech companies have had challenges obtaining investor funding and have been operating with lean teams this past year. Will this continue into 2025, or will there be a resurgence of...
Working in life sciences is exciting because of the ever-changing landscape. In a constantly evolving industry, new regulations and legislation continuously emerge. As a life sciences professional, staying current is...
The client was preparing to start a major submission for a marketing authorization in a rare disease and was faced with critical timelines and a complex development program. They needed their Clinical Submission Team Lead to be decisive yet adaptive during what was expected to be a challenging submission process.
As an established pharmaceutical company focused on neurological diseases was preparing for a submission and realized that they had not fully completed the necessary quality GMP and GCP activities during the course of the program.
An emerging cellular therapeutics company was entering phase 1 clinical testing for their lead hematology candidate based on their antibody-coupled T-cell receptor (ACTR) technology. In order to move their vision for a singular therapeutic platform approach to treat many different cancers through the development process, they needed a plan, processes and hands-on support.
