Conference Sessions


  • Beyond Cures

    Beyond Cures

    The 2016 Agenda for FDA Reform
    03.21.17

  • Biopharmaceutical Contract Manufacturing

    Biopharmaceutical Contract Manufacturing

    Purpose Overview of selected findings from HighTech Business Decisions’ latest studies: Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2016 Biopharmaceutical Contract Manufacturing 2015: Improving Markets, Servi…
    10.04.16

  • PHARMACEUTICAL PROCESSES: BATCH OR CONTINUOUS

    PHARMACEUTICAL PROCESSES: BATCH OR CONTINUOUS

    MANUFACTURING WORLD • DEMAND DICTATES MANUFACTURING TECHNOLOGIES • SAME FOR BRAND AND GENERIC PHARMA WITH ADDED NUANCE: DOSE…
    10.04.16

  • R&D Sourcing Panel Discussion

    R&D Sourcing Panel Discussion

    Global Sourcing Latest Trends Internal vs. External Managing Risk…
    10.04.16

  • Custom CMO solutions From Concept to Commercialization

    Custom CMO solutions From Concept to Commercialization

    Topics WDPrx Overview And History Pharmaceutical Development Commercial Manufacturing Services Regulatory Support Primary And Secondary Packaging Appendix…
    10.04.16

  • Serialization CMO Onboarding: Governance, Process And Lessons Learned

    Serialization CMO Onboarding: Governance, Process And Lessons Learned

    TOPICS > Allergan Global Serialization Program > Allergan CMO Workstream Structure & Governance > Standard CMO Onboarding Process > Roles and Responsibilities: CMO, MAH, Solution Vendors > CMO Serialization Implementation Ch…
    10.04.16

  • Investigator Insights— Preparing for and successfully facilitating an FDA Inspection

    Investigator Insights— Preparing for and successfully facilitating an FDA Inspection

    OVERVIEW • What Investigations Branch is Tasked With • Systems Based Inspections • Other Inspectional Tasks • Tips for Preparation/Facilitation of an Inspection • Common Requests • FDA-­483 Trends…
    10.04.16

  • The CMO Landscape: Trends Update

    The CMO Landscape: Trends Update

    Agenda • How is the drug product (DP) CMO industry doing? • Is the DP CMO industry consolidating? • What is the outlook for the DP CMO industry?…
    10.04.16

  • Ensuring Data Integrity at CMOs and API Makers

    Ensuring Data Integrity at CMOs and API Makers

    Agenda data integrity basics supplier responsibility data integrity oversight tactics…
    10.04.16

  • GDUFA I and GDUFA ll Present and Future Challenges

    GDUFA I and GDUFA ll Present and Future Challenges

    PRIMARY GOALS OF GDUFA LEGISLATION The three primary goals of the GDUFA legislation: • Safety: To help FDA ensure that participants in the U.S. generic drug system whether foreign or domestic, comply with U.S. quality standards (via bienni…
    10.04.16

  • Serialization
    Some Practical Considerations for Implementing Serialization

    Some Practical Considerations for Implementing Serialization

    Debunking some common serialization myths: • History and Compliance Timelines • Infrastructure • Governance • Serialization Impacts • Cost / Value Proposition • Business as Usual…
    Kurt Wieditz, Global Serialization PMO, Pfizer, External Supply Operating Unit 09.22.15

  • Inspections
    Inspection Trends

    Inspection Trends

    Top 10 Citations for FY 2014: • Based on 645 FDA 483 observations issued for FY 2014 • Does not include FDA 483’s manually prepared outside of Turbo EIR (i.e. API inspections) • Includes the percentage the citation was issue…
    Douglas Kovacs, Supervisory Investgator, FDA New Jersey District 09.22.15

  • Best Practices in Supplier Quality Management

    Best Practices in Supplier Quality Management

    The pharmaceutical quality system, including the management responsibiliAes described in this section, extends to the control and review of any outsourced activities and quality of purchased materials.…
    Linda Evans O Connor, Director, Lachman Consultants 09.22.15

  • CMO Industry Update

    CMO Industry Update

    Presentation: • Dose CMO industry size and growth • Growth drivers • Mitigating factors • Industry outlook Key Points: • Robust recent growth in CMO industry • Strong tailwinds driving industry • Headw…
    Jim Miller, Founder and President, PharmSource Information Services 09.22.15

  • Keeping a Culture of Quality and Compliance in Tight Economic Times

    Keeping a Culture of Quality and Compliance in Tight Economic Times

    Agenda: true cost of being compliant five sustaining steps to lean quality…
    John Avellanet, Founder and Principal, Cerulean Associates LLC 09.22.15

  • The Potential Impact of Biosimilars on Biomanufacturing Capacity

    The Potential Impact of Biosimilars on Biomanufacturing Capacity

    Outline: Current global biopharmaceutical capacity landscape: • Geographical distribution • Balance of supply and demand Biosimilar trends and pipeline: • Data from marketed products • Pipeline and forecasts Future gr…
    Dawn M. Ecker, Consultant, BioProcess Technology Consultants, Inc. 09.22.15

  • External Capabilities Build in Drug Discovery: Experiences and Challenges in Global Outsourcing

    External Capabilities Build in Drug Discovery: Experiences and Challenges in Global Outsourcing

    Current Challenges: • Upcoming onslaught of expiring patents • Increasing demands from payers and third party providers to demonstrate differentiation (therapeutic, cost etc.) • More stringent regulatory requirement Given the eco…
    Ajai K. Chaudhary, Ph.D., Director, Merk Research Laboratories 09.22.15

  • Operational Excellence – A Win/Win for Supplier Collaboration

    Operational Excellence – A Win/Win for Supplier Collaboration

    We are innovating to bring therapies to patients that significantly improve their lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. We are On a mission to be the premier,…
    Sunil Ghogre, Team Leader Operational Excellence, Pfizer 10.01.14

  • Setting Up an FDA-Compliant Data Integrity Program

    Setting Up an FDA-Compliant Data Integrity Program

    (What’s So Funny ‘Bout) Part 11 and Data Integrity
    John Avellanet, Cerulean Associates LLC 10.01.14

  • FDA Inspection Trends

    FDA Inspection Trends

    Topics: • Quality Agreements • Inspection Trends • Field Alert Reporting Trends…
    Michael Klapal, Drug Specialist - U.S. FDA 10.01.14