organizational gaps in reaching the desired state
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Organizational Gaps in Reaching the “Desired State”. Helen Winkle. OPS Organization. Office of Pharmaceutical Science Helen N. Winkle, Director Ajaz S. Hussain, Ph.D., Deputy. Process Analytical Technologies. New Drug Microbiology Team. Informatic Computational Safety Analysis.

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OPS Organization

Office of Pharmaceutical Science

Helen N. Winkle, Director

Ajaz S. Hussain, Ph.D., Deputy


Analytical Technologies

New Drug Microbiology Team

Informatic Computational

Safety Analysis

Office of Biotechnology Products

Keith Webber, Ph.D.

Office of Generic Drugs

Gary Buehler

Office of New Drug Chemistry

Moheb M. Nasr, Ph.D.

Office of Testing and Research

Ajaz Hussain, Ph.D.

Div. of New Drug Chemistry I

John Simmons, Ph.D.

Lab. of Clinical Pharmacology

Jerry Collins, Ph.D.

Div. of Monoclonal Antibodies

Steven Kozlowski, M.D.

Div. of Bioequivalence

Dale Conner, Pharm.D.

Div. of Applied Pharmacology Research

Jerry Collins, Ph.D.

Div. of Therapeutic Proteins

Amy Rosenberg, M.D.

Div. of New Drug Chemistry II

Eric Duffy, Ph.D.

Div. of Chemistry I

Rashmikant Patel, Ph.D.

Div. of Pharmaceutical Analysis

Lucinda Buhse, Ph.D.

Div. of New Drug Chemistry III

David Lin, Ph.D.

Div. of Chemistry II

Florence Fang

Div. of Product Quality Research

Robbe Lyon, Ph.D.

Div. of Labeling and Program Support

Peter Rickman

Div. of Chemistry III

Vilayat Sayeed, Ph.D.

organizational gaps
Organizational Gaps
  • Multi-dimensional
  • Between organizations
  • Within organizations
  • Outside of OPS - other parts of CDER organization
  • Organizational gap is what we need to consider and “resolve” within our process before we can adequately implement regulatory direction and support (through applications process and review) of the “desired state”
what constitutes the gap in ops
What Constitutes the Gap in OPS?
  • Appropriate utilization and focus of available human resources
  • Difference in products and regulatory requirements and review processes
  • Organizational structure - lack of consistency and flexibility
  • Process driven, not science driven
    • PDUFA
    • First in - first reviewed
    • Heavy workloads/Backlogs
    • Too many supplements
  • Interaction with inspection - lack of appropriate reviewer involvement - don’t get feedback
what constitutes gap
What Constitutes Gap?
  • Possibility of two-tiered system - how do you handle?
  • Guidances to accomplish consistency - sometimes too prescriptive
  • Organizational components too reactive not proactive (caused by workload - perpetuates problem)
  • Use of available scientific expertise and scientific collaboration
  • Challenge of focusing on appropriate questions (based on information received)
  • Lack of utilization of appropriate tools (e.g., statistics)
  • Lack of good communication between disciplines
closing the gap
Closing the Gap
  • Structural changes needed in some parts of organization
  • Reviewers on inspections or as consultants to inspections so have complete knowledge on product
  • Answering questions regarding manufacturing science and review including whether or not have QOS, what need in way of pharmaceutical development information, how does industry determine critical attributes, etc., and how we will review
closing the gap1
Closing the Gap
  • Better understanding of what constitutes design space across all products and when notification to FDA of change in manufacturing is warranted
  • Understanding of what constitutes risk for a product - development of a systematic risk-based approach to review processes
  • Guidances
  • Training
  • Determining process for working under a “two-tiered” system
  • Developing an internal system for handling differences in review decisions
  • Appropriate metrics
current steps
Current Steps
  • Across OPS
    • Working group under Manufacturing Subcommittee of

ACPS to address questions

    • ICH participation
    • Workshop on specification setting - March 2005 - broad scope
    • Collaboration with academics and PQRI
    • Internal review of current guidance
    • Developing a program for team interactions for inspections
    • Training for reviewers (scientific seminars, etc.)
    • Formation of OPSCC
    • Finish guidance on comparability protocol
current steps1
Current Steps
  • ONDC
    • Changing to an assessment program focused on quality attributes (chemistry, pharmaceutical formulation and manufacturing processes)
    • New organization structure (independent discipline)
    • Proposed QOS
    • Team approach
    • Establishing a peer review process
    • Implementing quality systems approach
    • Developing a mock NDA
    • Reducing supplement requirements
  • OBP beginning to identify where can reduce supplements
current steps2
Current Steps
  • OGD
    • Reorganization - additional chemistry division
    • Change in supplement review and evaluation to determine if some supplements can be eliminated
    • Team approach - better application of scientific expertise and consistency
    • Efficiencies in review - eliminating redundant or non-essential review activities
  • OBP
    • Review of supplement requirements to determine where can eliminate or reduce
additional steps
Additional Steps
  • Involve stakeholders in review of guidances, answering manufacturing science issues, etc.
  • Determine how to handle a “two-tiered” approach - if at all
  • Hold additional external workshops (e.g, QOS)
  • Develop a dispute resolution process
  • Review how handle PAI process
  • Develop appropriate metrics
  • Other?
observations and conclusions
Observations and Conclusions
  • Need to continue to address organizational gap issues
  • Culture is an important element of change management
  • Will take time!!
  • Depends on resolving some of the science gaps
  • Need to include stakeholders in making some of the decisions and developing some of the procedures
  • Training of reviewers important!!
  • Will identify more steps as move forward