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AAPS PAT Focus Group Membership Meeting


Applications of PAT during commercial manufacturing, tech transfer, scale-up and ... Volunteers needed (sign up sheet today and list serve) PATFG Going Forward ... – PowerPoint PPT presentation

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Title: AAPS PAT Focus Group Membership Meeting

AAPS PAT Focus Group Membership Meeting
  • Nashville, TN
  • 8-November-2005

  • History, Mission, Vision and Scope
  • Membership and Affiliations
  • Status on 2005 Goals
  • Programming activities
  • Meeting AAPS member needs in PAT going forward
  • Tenure and election process for PAT FG Officers
  • Decisions and Action Items

History of PATFG
  • Idea conceived at 2003 Arden House Meeting
  • Focus Group Established 2003
  • Achieved APQ and PT Section sponsorship
  • Obtained 50 potential members
  • PATFG Proposal submitted to AAPS EC
  • Focus Group approved by AAPS EC
  • Focus Group became operational in 2004
  • Established Mission, Vision, Goals and webpage
  • Established Steering Committee
  • Expanded membership
  • Held first members meeting 2004 AAPS meeting
  • First co-sponsored programming event Wed

PAT FG Mission
  • Providing an accessible forum for discussion
    across industry, regulatory agencies and academia
    for improved understanding, utilization and
    implementation of PAT.
  • Specifically for exchanging emerging scientific
    and technical accomplishments and experiences and
    the latest regulatory information on PAT (members
    use listserve!).
  • Proactively presenting position statements for
    APQ and PT sections of the AAPS with regard to
    PAT issues
  • Serving as a communication link on PAT between
    the AAPS Sections and IFPAC, ASTM, ISPE, and PDA

PAT FG Vision
  • Effectively raise awareness of the tools and
    opportunities for PAT which enable development
    and control of robust, high quality drug
    substances, drug products and their processes.
  • Further perpetuate the concept of PAT at a
    scientific level by providing programming that
    brings examples of PAT into the public domain
  • Be considered an excellent forum to communicate
    across Industry, Academia and regulatory groups,
    the technical advances, changes in regulatory
    viewpoint and new applications of PAT
  • Through programming and communications of the
    PATFG, affect industry standards for utilization
    of PAT in the Pharmaceutical Industry
  • Also through programming and communications of
    the PATFG, expand opportunities for targeted
    academic support of topics involving PAT

PATFG - Scope
  • Applications of PAT during commercial
    manufacturing, tech transfer, scale-up and RD
  • API and Formulation and process dev. and control
  • Raw materials/Excipients
  • Biologicals
  • Animal Health products
  • Generic products
  • Implications and Issues pertaining to PAT in
    regulatory, academic and industrial environments

PATFG Membership
  • Officers
  • 2004/2005 Chair, Leslie Hawley (Pfizer)
  • Chair 2006, Chris Watts (FDA)
  • Steering Committee
  • Charles Cooney (MIT, Dept Chem Engineering)
  • Gregg Harris (Alcon)
  • Anil Kane (Patheon)
  • Steven Laurenz (Abbott)
  • Members
  • Greater than 200 members from PT, BIO, APQ, RS

PAT FG - Affiliations
  • APQ and PT(primary) are sponsoring Sections
  • PATFG Liasons to Sections
  • To optimize partnership established FG Liasons
  • Steve Laurenz-PT, Gregg Harris-APQ
  • Affiliations of PATFG Officers
  • CAMP, ISPE, ASTM, FDA Pharmaceutical Sciences
    Advisory Committee
  • Interactions with other FGs
  • Animal Pharmaceutics and Technology (co-sponsors
    of Annual Meeting Symposium)
  • Discussions with Process Development and
    Manufacturing, Engineering and Quality Focus

Status on 2005 Goals
  • Continue to develop strong Section
    partnerships-good progress
  • Established PATFG liasons to PT and APQ sections,
    feedback from section chairs indicates this has
    been effective
  • Develop important programming opportunities-good
  • Develop Proposed AAPS 2006 Programming Strategy
    on PAT, including co-sponsored workshop with FDA

Goals Status Continued
  • All FG members have access to and utilize list to
    disseminate important info on PAT-recent email
  • Continue to expand Membership to obtain broad
    representation from across AAPS-progressing,
    still seeking better representation from Reg
    Sciences and Biotech sections
  • Strengthen FG by adding Steering Committee
    Members who are recognized leaders in PAT-will
    elect two additional Steering Committee members
    at Annual Business meeting of PATFG in November

Goals Status Continued
  • Convey to members current status of PAT
    activities within ISPE, IFPAC, CAMP, CPAC, PDA,
    ASTM, FDA-need to do better
  • Identify gaps in implementation of PAT and where
    FG can help-on-going
  • Work with FDA to better define how PAT data
    should be presented in regulatory file-2006
    co-sponsored Workshop

Goals Status Continued…
  • Work to better define appropriate level of risk
    and the impact of risk on testing strategies-
    2006 co-sponsored Workshop
  • Work to define what is an adequate level of
    process understanding- 2006 co-sponsored Workshop

Recommended 2006 AAPS Programming Strategy for PAT
  • By PATFG - June 14, 2005

PATFG Programming Strategy
  • Collect Programming ideas
  • Determine what programming would best meet needs
    of AAPS members and sections in 2006
  • Recommend 2006 programming strategy for PAT to
    pertinent AAPS Sections

Recommended 2006 Programming includes
  • Multiple Annual Meeting Sessions on PAT
  • Separate Cluster Workshop on PAT jointly
    sponsored by AAPS and FDA-Steve Laurenz, Chris
    Watts, Mike Yelvigi (MEQ)

PAT Cluster Workshop
  • Sponsored by the PAT and MEQ FG and the FDA

Goals and Objectives
  • The Food and Drug Administration took a proactive
    approach to bring a scientific and risk-based
    framework founded on pharmaceutical process
    understanding, which is essential for prediction
    of product quality attributes.
  • Quality by Design, PAT, Design Space.

Goals and Objectives
  • Many of the current conferences/workshops often
    lack clarity and are more strategic in focus.
  • Need more real world case study examples on how
    to actually apply these concepts to development,
    manufacturing and our filings.

Goals and Objectives
  • More specifically what we hope to achieve
  • Gain knowledge about application of PAT/QbD
    concepts in drug development.
  • Determine the critical issues related to API and
    Drug Products manufacturing using PAT and QbD
  • Learn how to approach regulatory submission
    strategies with PAT by case examples from
    companies who are well into such process.
  • Learn from regulatory bodies-their experience of
    reviewing such applications

Program Outline
  • Real world case study presentations on
  • Application of Design Space and QbD to
    pharmaceutical development and manufacturing.
  • Return on investment for PAT implementation.
  • Application of PAT to drug substance and drug
    product development.
  • Application of PAT to drug substance and drug
    product manufacturing.

  • Two day workshop with panel discussions
  • Location Washington DC area.
  • Timing September 06
  • Volunteers needed (sign up sheet today and list

PATFG Going Forward
Tenure and election process for PAT FG Officers
  • Chair, Chair-Elect, Past Chair positions are 1
    year positions3-5hrs/week
  • Steering Committee positions are 3 year
  • Maintain Steering Committee of 6-8 people at all
    times. SC Members must have experience and
    credibility in PAT.

  • Each year at PATFG Annual Business Meeting
  • Chair rotates to Past-Chair
  • Chair-elect rotates to Chair
  • Chair-elect nominated
  • Two SC members rotate off
  • Two new SC members elected
  • In 2005
  • Chris Watts becomes Chair, Leslie Hawley becomes
  • Elect 2-4 new SC members
  • Vishal rotated off, Anil rotate off

PATFG Officer Nominations
  • Chair-elect
  • Nominees today
  • Steering Committee Members
  • Ganapathy Mohan
  • Sonja Sekulic, PhD (Pfizer)
  • Others?
  • Vote on Steering Committee Members

Sonja Sekulic, PhD
  Dr. S. Sonja Sekulic is Associate Director in
Analytical RD, Pfizer Global Research and
Development, Pfizer Inc in Groton, Connecticut.
She received her B.S. in Analytical Chemistry
from the University of New South Wales, Sydney,
Australia (1984), continued her education at the
University of NSW under the direction of
Professor Paul Haddad and received a Ph.D. in
Analytical Chemistry in 1989. From 1989 to 1991
she held the position of Research Scientist in
the Analytical Development Support unit of the
ICI Pharmaceuticals Manufacturing Division (now
AstraZeneca) in Macclesfield, UK. From 1991-1993
she completed a postdoctorate at the University
of Washington (Seattle, WA) under the direction
of Professor Bruce Kowalski in the research area
of multivariate calibration. She has published
and presented in the following areas of research
multivariate calibration and process analytical
technology (API and drug product), computer
optimization of chromatographic systems, solid
state characterization methodologies and metrics,
polymer characterization, spectroscopic
characterization methods. Her current
responsibilities include the management and
technical direction of the Technology Development
group, which is responsible for evaluation, and
establishment of appropriate techniques and
practices for incorporation into routine
operations of PGRD. These areas include Process
Analytical Technology, Vibrational Spectroscopy
Imaging, Data Analysis and Applied Chemometrics,
and Solid State Characterization.  
Ganapathy Mohan, PhD
Mohan received his Ph.D in Analytical Chemistry
from Kansas State University in Manhattan,
Kansas. Mohan has over 21 years of experience in
pharmaceutical research and development. He
joined Sanofi Aventis Research and Development in
1984 in the Analytical Sciences Department and
has held several positions including the head of
quality control. In 2003, he was appointed Site
Director for Quality Assurance.   Currently,
Mohan is a Senior Director in the Global
Analytical Sciences Department, with
responsibilities for all managing the Analytical
Sciences Department in the US Region. He is also
responsible for a global scientific working group
on NIR/PAT within the global analytical sciences
department.   He is a member of the Editorial
Advisory Board for The Journal of Process
Analytical Technology and is a steering committee
member of the GMP Round Table conference.   His
interests are in the area of separations and
vibrational spectroscopy, and application of PAT
for understanding and control of processes.
Important Questions
  • Do members want this FG to exist as separate
    entity or should it merge MEQFG or PDFG?
  • Should PATFG maintain affiliation with APQ and
    PT, expand to include RS or reduce to single
    section affiliation? Is liason model the best
    way to partner with sponsoring sections?
  • What can make this FG more effective? Specific

  • At this point, PAT Focus Group members would like
    to have PATFG be maintained as separate focus
    group rather than merging with MEQ or PD
  • Shilpa Thosar will be programming chair for PATFG
    in 2006. She will help to make sure that we
    publish information to explain FG (where?). She
    will work on advertising for 2006 workshop
    including getting it on PT website and once
    approved in AAPS magazine. Shilpa will work with
    Steve Laurenz to determine role of vendors in
    workshop that is acceptable to AAPS.

Decisions/actions continued…
  • Members (Rajeev Garg) feel that we need to go
    outside of Pharma to find speakers and case
    histories to bring back into the Pharma realm.
    Other industries are ahead of Pharma in
    utilization of PAT.
  • Get volunteers to put case histories on website
    like FDA has done with one example.
  • Add Regulatory Sciences Section liason ,
    Jean-Marie Geoffroy

Decisions/actions continued…
  • New Steering Committee Members
  • Sonja Sekulic, PhD (Pfizer)
  • Ganapathy Mohan, PhD (Sanofi-Aventis)
  • E. Kwame Obeng, PhD, MSE (BMS)
  • Jean-Marie Geoffroy, PhD (TAP Pharmaceutical
    Products, Inc.)
  • Andrea Weiland, PhD, Europe Liason to PATFG
    (Explicat Pharma)
  • Remaining Steering Committee Members
  • Steve Laurenz, PhD (Abbott)
  • Gregg Harris, PhD (Alcon)
  • Charles Cooney, PhD (MIT)

Decisions/actions continued…
  • Chris Watts becomes chair
  • Chair-elect will be assigned during 2006
  • Leslie Hawley will get website updated to reflect
  • To make PATFG maximally effective member and
    officers must more routinely use listserve for
    communicating technological and regulatory
    advances, experiences, issues involving PAT

Backup Information
How to use listserve
  • The AAPS Listserv has been populated by the AAPS
    membership database with participants of various
    sections and focus groups.
  • These lists are open to AAPS members and can be
    joined by anyone wishing to participate in a
    discussion to further the interest of other
  • To send a message to the PAT Focus Group, all you
    have to do is send an email to fg_process_analytic
    al_tech_at_list.aaps.org. Or, members may visit
    /index.asp to view all the listserv addresses.
  • Any discussion email sent to a listserv should
    have a subject line to inform readers of the
    topic of your email.

Working Definition of PAT
  • Process Analytical Technology is a system for
    designing, analyzing, and controlling
    manufacturing processes through timely
    measurements (i.e., during processing) of
    critical quality and performance attributes of
    raw and in-process materials, to ensure final
    product quality.
  • The term analytical in PAT is viewed broadly to
    include chemical, physical, microbiological,
    mathematical, and risk analysis conducted in an
    integrated manner.
  • The emphasis in PAT is on the manufacturing
    process to amplify the basic premise of the
    current drug quality system Quality cannot be
    tested into products it should be built-in or
    should be by design.

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