June 20-22 2017

Boston, MA

2 weeks to go!

 

Content Library

HPAPI Summit Content Library

Welcome to the HPAPI Summit Content Library – here you’ll find scientific articles, interviews and past presentations for critical insights to improve your highly potent API development.

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    Presentations Pack

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  • Manufacturing Support...Thumb

    Manufacturing Support for Antibody Drug Conjugates: Clinical and Commercial Scenarios

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  • Tools to address EMA ...Thumb

    Tools to address EMA manufacturing guidelines and hazard assessment for development and CMC timelines

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    How OELs & ADEs Develop Over the Life Cycle of a Drug

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  • 6487 Content Dean Thumb

    Speaker Interview: Dean Calhoun, Affygility Solutions

    Dean Calhoun, CIH is the President and CEO of Affygility Solutions, a consulting company serving the life sciences industry. He is a Certified Industrial Hygienist with over 30 years of experience. He is also an internationally known speaker on the topic of potent compound safety.
    We caught up with Dean to discuss how OELs and ADEs can be effectively incorporated into a broader HPAPI risk management approach.

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  • Bob Sussman Interview

    Speaker Interview: Bob Sussman, Safebridge Consultants

    We recently caught up with Bob Sussman, Managing Principal at Safebridge Consultants, for an exclusive interview.

    Bob shared with us his insights into the main challenges facing the field and some of the emerging therapeutics that will be increasingly important in the highly potent space.

     

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  • Fermion ContentThumb

    Fermion, Cleanroom Technology: CDMO Strategy Key to HPAPI Success

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  • API Cross thumb

    API Cross Contamination in Multi Product Facilities

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    Lessons Learned From The Early Development Of Linker-Payloads For Antibody-Drug Conjugates

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  • 6487 HPAPI Greg Past Presentation

    Proactive Integration of Occupational Toxicology Assessments

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  • Current Trends, Challenges & Opportunities In HPAPI Development & Manufacturing

    Current Trends, Challenges & Opportunities In HPAPI Development & Manufacturing

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  • Pfizer’s Strategy for the Development and Manufacture of Linker-Payloads Sperry

    Pfizer’s Strategy for the Development & Manufacture of Linker-Payloads in Antibody-Drug Conjugates

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  • Tools and Techniques for Assessment of Containment meiners

    Tools & Techniques for Assessment of Containment & Exposure in The Pharmaceutical Industry

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  • Improving Industry Consistency Presentation sussman

    Improving Industry Consistency: Defining & Maintaining Classification Boundaries

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  • Presentation Merck API Pilot Plant Improving S&IH Compliance through Enhanced Solids Handling

    Merck API Pilot Plant Improving S&IH Compliance through Enhanced Solids Handling

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  • Targeting inflammation by highly potent compounds to treat CNS conditions

    Targeting inflammation by highly potent compounds to treat CNS conditions

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    Establishing OELs for Potent & Highly Potent Compounds

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  • Presentation Choosing the right CMO for HPAPI manufacturing

    Choosing the right CMO for HPAPI manufacturing

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  • engineering controls richards

    Engineering Controls – Balancing Cost & Containment Hazard

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