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Isagani (Gani) M. Chico, M.D. thumbnail

Isagani (Gani) M. Chico, M.D.

VP and Global Head for Oncology

Fortrea

Talk to Gani about these topics and more:

  • Oncology clinical trials (early phase to post approval)
  • Oncology medical affairs
  • Pharmaceutical, academic and regulatory interactions
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John Doyle, DrPH thumbnail

John Doyle, DrPH

President, Consulting

Fortrea

Talk to John about these topics and more:

  • Tactics for driving health innovation
  • Optimizing market access strategies for new therapies
  • Demonstrating value through HEOR
  • Drug development life cycle strategies
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Tara Anne Kervin, MPH thumbnail

Tara Anne Kervin, MPH

VP Global Operations & Consulting

International Drug Development Institute (IDDI)

Talk to Tara about these topics and more: 

  • Independent Data Monitoring Committees (IDMCs; also known as Data and Safety Monitoring Boards [DSMBs])
  • Best practices in clinical data science and biometrics operations
  • Clinical trial design and interim analysis
  • Biostatistical consulting and regulatory interaction
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Jay W. Mason, M.D. thumbnail

Jay W. Mason, M.D.

Chief Medical Officer

Spaulding Clinical, LLC

Talk to Jay about these topics and more:

  • Understanding cardiac safety requirements, including protocol design 
  • Sponsor support at FDA meetings 
  • Early phase development 
  • Working with data and safety monitoring boards 
  • Cardiac arrhythmias and electrophysiology  
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Cassandra Erato, MSN thumbnail

Cassandra Erato, MSN

Chief Executive Officer

Spaulding Clinical, LLC

Talk to Cassie about these topics and more:

  • Navigating U.S. regulatory requirements, IND Submission, and Phase 1 startup and conduct 
  • Efficiencies and guidance in running Phase 1 of clinical development  
  • Understanding cardiac safety requirements and the best cost-saving methods 
  • Developing new service programs as needs emerge 
  • Rapid operational scaling/growth, strategic planning, and recapitalization 
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Christiane Bardroff thumbnail

Christiane Bardroff

Chief Operating Officer

Rentschler Biopharma

Talk to Christiane about these topics and more: 

  • Process development and cGMP manufacturing for clinical and commercial biopharmaceuticals 
  • Navigating international regulatory bodies for global pharmaceutical product releases 
  • Nurturing collaborative relationships with client partners to accelerate speed to clinic and market 
  • Automation and digitalization in biopharmaceutical manufacturing  
  • Trends and predictions in the biopharmaceutical industry 
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