minutes_june_13_2006 by yaofenji


                                        To:     PDA Science Advisory Board (SAB)
                                        From:   Martin Van Trieste, Chair
                                        Date:   June 20, 2006
                                        Re:     Minutes, June 13, 2006

                   Science Advisory Board Teleconference Meeting
                                        June 13, 2006
                                  10:00am – 12:30 p.m. EST

Next Teleconference:

The following are the meeting schedule dates for the balance of the year:

       July 11, 2006
       August 8, 2006
       October 10, 2006
       November 14, 2006
       December 12, 2006


Martin VanTrieste            Hal Baseman            Jens Eilertsen          Don Elinski
Jeanne Moldenhauer           John Shabushnig        Rich Levy               Bob Dana
Iris Rice


Technical Report #1 Update by Rich Levy. The ideal timeline or deadline for producing a
rough draft was by Mid-May of 2006 and to present this draft (No. 18) to the Executive
Committee and the heads of the SAB, RAQC, and potentially BioAB. The original draft 17 was
very comprehensive (around 183 pages); therefore the group formulated a directive to re-scope
the document and bring it in line with the high level of the first document. The due date for the
draft (May 18), received comments from John and others.
          Two meetings centered on this draft were held in Cork, Ireland and London. During the
meeting, a presentation outlined the new revision which consists of five (5) major sections:
Scope and Introduction, Science of Sterilization (Evans), Sterilization Cycle Development
(Trupp), Process Qualification (Sadowski), and On-Going Process Control (Sadowski). The
draft is a more consultative, focusing on validation, underpinning of science, moving into
sterility, and cycle development process. The group concurrently developed five presentations
related to the outline and solicited feedback. There were 68 paid attendees in Ireland; the total
number of participants was 80. There was a speaker on the docket from the Irish Medicines
Board, who spoke on on-going inspections and moist heat. On the whole, the majority of the
audience were not PDA members, the average age around 25 years, persons just beginning to
launch their careers; the group also consisted of seniors to include 3 inspectors from the Irish
Medicines Board. There were many questions; Gen Lovitt took notes and captured much of the
dialogue generated during the Question and answer session. The overall atmosphere was
         Questions raised:
             Would the dialogue would change the context? During the meeting in Ireland,
                most of the people did not have the opportunity to review the document ahead of
                time, so the dialogue was a good way to introduce the document.
             Was anything omitted?
             How steam sanitizing relates to lyophilization
             Loads
             Suitability of runs
The TR#1 Meeting in the UK: There was little participation from the chapter. Only 12 people
(paid registered) attended (including Paul Hargreaves and Keith Shuttleworth), but it was a
more productive meeting. The participants who attended were able to distribute the document
earlier; therefore those who attended were very well prepared. The document is much more
balanced between two approaches (bioburden combination and the specific approach) in
connection to physical size, autoclave of moist heat sterilization. The meeting took off on a
positive note, even though the gist of the comments was very intensive surrounding the details;
and it took ample time go review the document. Paul Hargreaves commented that this version
resembled an ISO document in terms of content and balance; and found this meeting to be one
of the best he attended in several years. There were no major changes mandated; there are a
numbers of areas to be addressed, but overall, there are no overtones of negativity. Paul also
agreed to support the meeting in Italy.
         Many of the goals have been accomplished. Rich would like to have a pre-meeting with
any of the prior authors to get their comments circulated.

Dialogue on Rich’s Report from SAB Team
    Hal: Jim Agalloco is not very pleased. He recommends having a conversation with
      him ahead of time before bringing him into the meeting
    Rich: Recommends not to re-scope but to listen for elements to be restored while not
      losing elements of the content. Russ Madsen advised publishing other portions through
      other avenues, and obtaining positive feedback from former task members. All
      comments will be addressed.
    Jeanne: Consider the opinions of Akers and Agalloco. The problem is that former
      authors have invested so much time in the project, and now, they may be feeling
      undervalued. This concern will be addressed. Additionally, there are comments about
      technical errors in draft 18.
    Hal: When does SAB vote and ballot on this draft?
    Rich: The group expects draft 18 to be completed by the end of this year. The SAB
      may not ballot this item until January 2007. The comments will be web-based. All
      comments can be made in the documents for posting, or the comments can be made in
      the database. PDA members can review the comments. There is a column for
      disposition and a resolution for recommendations, if there are recommendations for
      other materials, or a reference to things that may have been lost or displaced. A series
      of other reports could follow, also to include a meeting by WebEx and/or

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         Teleconference. The group has attempted to cover as much material as possible, and to
         move back in closer connection with the original version vs. the more extensive version
         of the report. There has been dialogue and speculation of having a meeting at
         PDA/FDA; and, it is probable a draft 19 could exist by then. The proposal is to have
         Jeanne be an editor of the content through DHI.
        Jeanne:        The issue generates around the prior authors; in that they feel their work
         is being “thrown away.” Again, there is the mention of technical errors; however, this is
         not the main focus of the commentary.
        Rich: Final publication could be at the end of January 2007 or early February 2007.

SAB Membership Solicitation. The question was raised about whether to include another
FDA individual on SAB. There was no opposition to this as long as that person would provide a
different spectrum representing a different technical issue within the industry. If someone from
the industry had the expertise the SAB is looking for, they would, in turn, add value to the board.
Jeanne noted a bigger concern: what if their vote means more because they are on the board?
Hal inquired what would their charge be? Technical input or a regulatory perspective out of the
agency or both? Martin conjectured it would be both, because what has occurred is that the
individual would represent the agency, not themselves. Most participants represent themselves,
but they are also always looking out for their company’s best interests. This may not have been
explained to Dr. Uratani or Mr. Famalare. Hal inquired whether FDA would even allow another
participant (which brings up nominee Kristen Anderson, a Microbiologist). Jeanne inquired
(from an intellectual standpoint) as to why SAB would need another person from compliance.
Rich articulated that there could be a duplication of skill sets to some degree, possibly
overlapping those skill sets of Brenda Uratani. Bob inquired about Roger Dabbah’s status now
that he has left USP; would SAB want another representative from USP? Bob would follow up
with Angie Long from USP. Jeanne brought up Gary Ritchie, who may offer a different
perspective, in that he is focused upon the global manufacturing point of view. Hal stated that
Gary sits on the ASTM and referred the group to the website.

                                                 THE NOMINEES

Mike Long. Mike long works on the PDA Risk Management Task Force, as a risk expert. He is
also a contributor to TR#1. He has worked with Gail Sherman (TRI) on Kazakhstan training.
His base of operations is AstraZeneca, a Validation Manager, working with engineering and
device training. He is also on the audit committee. He is a very active PDA member, and has
been with the industry about 15 years. Resolution: The SAB decided to submit a ballot to vote
on his nomination.

Christopher Smalley. Chris is a long-standing member of PDA. His expertise lies in
compliance, and he is active in helping with the training initiative within PDA. He is the Head of
the Facilities and Engineering Interest group, drawing upon an operational focus with a strong
validation and Quality Assurance background. He has served as a Lt. Col. In the Air Force, and
runs the pharmacy program in the Air Force Reserves. Resolution: The SAB decided to submit
a ballot to vote on his nomination.

Lisa Hornback. Lisa has experience in devices. She is a Medical Technologist, Chemistry and
Microbiology, and has been with the FDA for 6-8 years. She is focused on Medical Devices in
the Chicago District. Her specialties include diagnostics, combination devices, and now to get
manufacturing to be in a compliance state of affairs. She has not been a very active PDA
member. Lisa is very personable, and can work well with others. Currently, she is doing private

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consulting work. She is a very high level professional, the second top person in the medical
device group at KMI. She is very professional and knowledgeable. Resolution: The SAB
decided to submit a ballot to vote on her nomination.

These three are named on one ballot and CVs are to be included.

Alaparthi Lakshmi Prasad. This individual nominated herself. She is very junior. There may
be an opportunity in one of the Interest Groups or Task Forces, but not for SAB. Her
experience leans toward laboratory methodology and validation. Martin will call Lynn and
Stephan Krause to determine their needs for volunteers. Resolution: The SAB decided to table
this item.

Sandeep Nema. Sandeep is one of the Section Heads for the PDA Interest Groups. Iris Rice
will circulate his CV to SAB and he will be discussed at the next meeting.

Recent SAB Ballots:

Ballot #105: This ballot goes “back to the drawing board.” It has been circulated three times.
There is a fundamental disagreement as to whether the approach is appropriate. Does SAB
need to table this item or move on? There are concrete suggestions about ways it could be
revised. SAB needs the bulletin; however, the comments appear to be in conflict. Can these
comments be addressed? There is the absence of philosophical harmony, and no one agrees
on standardized testing. Hal suggested submitting the bulletin as a commentary in the Journal.
Martin recommended redrafting it and placing it on the web and request comments, rather than
stating it as a position.

Ballot #106. Bob Dana will finalize this month. The Board of Directors needs to be aware of
the procedures of the SAB. There is more visibility in terms of process in gaining endorsement.
These SOPs can also be utilized for RAQC and BioAB. After finalization, the SOP draft will be
submitted to the BoD.

Ballot #107. This item is moving forward. There were very minor comments and high approval
ratings. Blair’s team, however, may be a little thin, so he will be asked to consider a larger,
more diverse team. Bob Dana will follow-up with Blair.

Ballot #108. This item is also moving forward, with the help of Jeanne Moldenhauer and Jim
Akers. The Technical Report #22 Task Force concurs with their efforts. The modus operandi is
to work on an elaboration of a rationale, due to the suppositions that many are not aware of the
type of justification that is involved with the project.


A proposal was made to PQRI. PQRI is interested, however, a final decision is pending. Helen
Winkle articulated that this project is premature, time-wise, and prefers to wait until their
guidance is issued. Based on the contents of the guidance, she recommends that PQRI looks
at the topic at the time of issuance. A team will be populated to review the guidance. The
question was raised as to whether a team should be created within PDA to develop the skeleton
of what Parametric Release should model for Bulk Sterility. If so, it would prepare SAB by
providing a list of interested individuals. The Agency is waiting for implementation for regulation
of sterile processes; therefore, anything done in the interim may be moot, perhaps? It is

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probable that a representative from FDA may not be supplied. Becky Devine has come forth to
work on this, and SAB is asked to provide any thoughts on a leader.
ACTION: Martin will draft up a ballot pertaining to this item. Please send all names to Martin.

New Action Items:

FDA Rapid Sterility Testing News

Jeanne Moldenhauer notified SAB that two clients who have missions in various stages at FDA
are no longer submitting Microbiological Rapid Methods/Rapid Sterility for PAT unless it is an
“in-lying” test. Expedited reviews can no longer be requested. Therefore, what are the
approaches? Does FDA understand the consequences to industry in modifying PAT? What are
the underlying causes? There are different methods of interpretation at FDA and alternative
advice is given. Who is “calling the shots?” What is the purpose? Concurrently, it appears this
was a CDER decision which included generics and new drugs. Additionally, it appears
something major is occurring regarding comparability, protocol, and guidance documents. John
will bring this up to the committee and ascertain their reaction. Does this mean new rules are
being arranged from rapid microbiological methods? Clear guidance is needed. What about
RAQC’s role? Does RAQC have any routine interaction with FDA on PAT? Bob Dana
suggested submitting questions to FDA’s Q&A for GMP Notes. Jeanne could ask the group to
submit a question (e.g. Paul Motise’s inquiry). This inquiry must be submitted anonymously,
and the effect this inquiry will have on the review process should be taken into consideration.

PDA Student Scholarships: Rich Levy

Each year, PDA forecasts a certain budget for doctoral students. $40,000 US dollars are
available, and PDA uses about ¾ of that money for student fellowships related to students
obtaining their doctorate degrees. $30,000 was left this year for a scholarship. Working with
Lee Kirsch, and a review committee solicited through an advertisement for proposal for work,
Rich created a format, which is now being utilized. Under the directorship of Lee Kirsch, there
are experts in the field to provide six (6) reviewers who deciphered through each of the
elements. Each student is given a score from 1-4 and then an average is created for an overall
merit. A total of fifteen (15) were submitted. Students (about 3) from various universities with
economic hardships came to the South Africa site Bob Dana also participated in the process. It
was decided that five students would be funded (funding of $6000.00 each), consisting of a
good selection of the top five universities. There was a good response from the review team
and broad coverage. Once the notifications have been finalized, a brief article will be published
in the PDA letter. Solicitations for next year will begin in September. Jeanne inquired about
other schools that have pharmaceutical degrees in their academic background. Rich articulated
that PDA is expanding in other areas, and there is an extensive list. The marketing campaign
was not as effective in comparison to advertising by word of mouth. PDA will seek Biotech and
Engineering schools.

Project Updates:

Science Advisory Board Project Status Report (June 2006)

Martin VanTrieste
Co-Chairman Science Advisory Board

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