IIn this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, Senior Advisor, Medical Affairs Consulting at Lumanity, speaks with Howard Rutman, MD, MBA, Chief Medical Officer at Xalud Therapeutics and former Global Medical Affairs leader at Pfizer and Daiichi Sankyo. Together they explore how engaging Medical Affairs early—from narrative development and KOL networks to site engagement, integrated evidence, and HEOR—creates a continuous line of value from development through commercialization.

Their discussion highlights how early Medical Affairs involvement strengthens trial enrollment, accelerates data generation, and prepares organizations for market adoption. They outline practical steps for building a lean “strike-force” team, what to look for in a first Medical Affairs hire, and how cross-functional collaboration between MA, clinical development, and operations can turn each trial into a launch-ready asset. The conversation also explores the growing importance of integrated evidence planning—bringing HEOR, RWE, and the patient voice into development sooner to ensure every study supports long-term access and value.

“Early on, most biotechs don’t think about having an independent medical affairs capability, but they need the kinds of activities that medical affairs provides—developing a scientific platform, engaging KOLs, investigator meetings—all of those are part of the development process … You’re trying to establish your KOL network and your lead investigators—people who will execute the trials and carry that knowledge into the medical community. There’s a very strong confluence between medical affairs and clinical development, particularly in the biotech space.”

Howard Rutman, MD, MBA

“Medical Affairs isn’t downstream—it’s the throughline connecting science, story, and strategy from the first patient to the first script.”

Peg Crowley-Nowick, PhD, MBA

“The narrative is just as important to enrollment as it is to commercialization.”

Howard Rutman, MD, MBA

Episode guest

Howard Rutman, MD, MBA
Chief Medical Officer, Xalud Therapeutics

Key Takeaways

  • Early Medical Affairs = faster trials
    A clear scientific narrative and trusted investigator relationships accelerate enrollment.
  • Hire the leader first
    A respected MA head as the company’s external face is more impactful than starting with MSLs.
  • Plan evidence early
    Build HEOR and RWE strategies into development—not as add-ons post-approval.
  • Keep it patient-centric
    Advocacy and patient insight are essential inputs for meaningful, inclusive trial design.
  • Align internally
    Strong collaboration between Clinical Ops, MA, and CRO partners prevents site friction and ensures one consistent message.