bio-regulatory-affairs-995x60 bio-regulatory-affairs-995x60

FEATURED ARTICLES

  • Divergent Approaches To Stem Cell Regulation
    Divergent Approaches To Stem Cell Regulation

    Stem cells and other regenerative medicine products offer considerable benefits to patients as well as potential financial rewards for companies. At the same time, cell-based therapies present challenges to regulators because, in many cases, they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro with minimal to extensive manipulation, and then administering in some form the expanded (and possibly modified) cells population back into the patient.

More Featured Articles

WEBINAR

  • An Alternative To Achieve Speed And Scalability To Microbial Expression For Next-Gen Therapeutics

    The newly developed G1-3 fermentation process makes use of short, straightforward fermentation regimes for optimized space time yield.

  • Biosimilars: Regulatory Trends and Quality Control Testing Requirements
    Biosimilars: Regulatory Trends and Quality Control Testing Requirements

    This webinar will review regulatory expectations in assessing the comparability of biosimilars through protein chemistry techniques and cell based bioassays. Key considerations for developing robust bioassays for biosimilar comparison will be presented.

  • How To Make Novel Therapies A Reality In Tomorrow's Complex Biopharma Landscape
    How To Make Novel Therapies A Reality In Tomorrow's Complex Biopharma Landscape

    A recent survey conducted by the Economist Intelligence Unit highlights the new products that the biopharma industry identifies as most disruptive to their growth strategies in the next five years. The findings raise a challenge to biopharma to go beyond barriers to bringing new products to market by presenting ways to overcome these hurdles and make novel therapies a reality.

  • The Practical Application Of Home Healthcare

    Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.

More Life Science Webinars