AAPS PAT Focus Group Membership Meeting

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AAPS PAT Focus Group Membership Meeting

• Nashville, TN
• 8-November-2005

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Agenda

• 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

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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
  9-Nov-2005

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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

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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

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PATFG - Scope

• Applications of PAT during commercial
  manufacturing, tech transfer, scale-up and RD
  of
• 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

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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

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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
  Groups

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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
  progress
• Develop Proposed AAPS 2006 Programming Strategy
  on PAT, including co-sponsored workshop with FDA

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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
  2005-TODAY!

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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

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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

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Recommended 2006 AAPS Programming Strategy for PAT

• By PATFG - June 14, 2005

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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

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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)

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PAT Cluster Workshop

• Sponsored by the PAT and MEQ FG and the FDA

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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.

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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.

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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
  concepts.
• 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

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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.

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Logistics

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

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PATFG Going Forward
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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
  positions1-2hrs/week
• Maintain Steering Committee of 6-8 people at all
  times. SC Members must have experience and
  credibility in PAT.

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Continued

• 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
  Past-Chair
• Elect 2-4 new SC members
• Vishal rotated off, Anil rotate off

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PATFG Officer Nominations

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

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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.  
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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.
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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
  activities?

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Decisions/Actions

• 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.

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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

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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)

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Decisions/actions continued

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

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Backup Information
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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
  members.
• 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
  http//www.aapspharmaceutica.com/inside/listserves
  /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.

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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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Link to Webpage
http//www.aapspharmaceutica.com/inside/focus_grou
ps/PAT/index.asp