Clinical Drug Development Workshops

SCiAN recently opened its Pennsylvania office at 3675 Market Street, Philadelphia.  As a niche North American CRO, we have worked with established biotech and pharmaceutical companies as well as early clinical stage Biotechs/Biopharma for over 30 years.  

We are hosting a complimentary 4 part-series of Clinical Drug Development workshops from May to June, 2019.  Each workshop will be 1 hour duration, consisting of a 45 min presentation and 15 mins for Q&A.  A light lunch will also be served.

To register for one of the workshops below, please contact Barbara Tweddle at btweddle@scian.com.

Workshop Topic Date Time CIC Room
Study designs for Phase I/II trials: regulatory considerations, current practice, options & recommendations 

  • Routine designs (SAD and MAD), PK/PD sub-studies and assessment of therapeutic activity (PoC)
  • Traditional MTD designs in oncology and model-driven dose-finding trials
  • Designs in immuno-oncology, gene and targeted therapies (e.g., expansion cohorts in FiH studies)
  • Presenters: Miklos Schulz & St. Clare Chung, SCiAN Services Inc.

    May 22 12:30 pm – 1:30 pm Delaware (3rd Floor)
    Considerations in selection of a lead indication in oncology 

  • Mechanism of Action/Target
  • Anticipated Product profile vs Competitive landscape/unmet medical need
  • Clinical/Regulatory Factors
  • Attractiveness of Market
  • Presenters: Patricia Griffin & Wendy Hill, Biocatalyst 4 Development Inc.

    May 29 12:30 pm – 1:30 pm Delaware (3rd Floor)
    Compelling, scientifically credible data graphics for communicating with investors and clinical/scientific advisory boards May 30 3:30 pm – 4:30 pm Venture Café
    Sample size / power calculations: decoding the intricate dance of power, clinical significance and variability  

    Presenters: Fiona Liu & Andy Koh, SCiAN Services Inc.

    June 12 12:30 pm – 1:30 pm Schuykill
    EDC / Clinical Data System challenges in trials for immuno-oncology, gene and targeted therapies, with special considerations on expansion cohorts in FIH studies  

    Presenters: Miklos Schulz & Pamilla Cheema, SCiAN Services Inc.

    June 19 12:30 pm – 1:30 pm Delaware (3rd Floor)