GUEST COLUMNISTS

• New FDA Program Adds Flexibility For Ultra-Rare Disease Submissions

  Life science legal experts Mark A. Tobolowsky and Frank J. Sasinowski discuss the FDA's new Rare Disease Evidence Principles (RDEP) initiative.

• Why Research Professionals Should Enroll In At Least One Clinical Trial

  Consultant and former director of the HHS Office for Human Research Protections (OHRP) Molly Klote, MD, implores clinical research professionals to enroll in a clinical trial to help them become more empathetic researchers.

• Combining RWD And Machine Learning To Determine Meaningful Patient Populations

  Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

• Bridging Community And Central Hospitals With Japan's DCT Model

  Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan, explains consultant Takuma Matsunaga.

• RWD Helps Abbvie Bridge Oncology Trial Data Gaps

  AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.

• FDA Issues New Guidance For Clinical Trial Dosage Of Oncology Therapeutic Radiopharmaceuticals

  The FDA has issued a draft guidance titled Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development and is accepting public comments through October 20, 2025.

• CISCRP's Mobile Health Exhibit Brings Clinical Trial Education To Communities

  CISCRP shares its mobile education project brings clinical trial awareness and information directly to communities.

• RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It?

  The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.