GUEST COLUMNISTS

• FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors

  Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.

• Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials

  BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.

• Synaptic Regeneration And The Future Of Alzheimer's R&D

  For too long, treating Alzheimer’s disease has been a case of “managed decline.” We need to move beyond slowing disease progression toward achieving tangible functional recovery.

• FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control

  ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

• Judgement-Based Project Management Builds Partners' Trust

  Project managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships.

• How Did You End Up In Clinical Research?

  To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"

• From CRO Management To Networked Governance: The New Quality Imperative

  The clinical research industry once emphasized transactional vendor management, but now it requires broader governance to enable the level of quality that enables scalability and success.

• Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

  FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.