Programming Highlights from the AAPS Annual Meeting and Exposition by SayreW

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									                            Programming Highlights from
               COVERSTORY
                            the 2005 AAPS Annual
                            Meeting and Exposition
   Analysis and Pharmaceutical Quality
   SPOD/Analysis and Pharmaceutical                discuss the scientific basis and regulatory     but also to the formulation, dosage form
   Quality Roundtable on GLP and                   requirement for qualifying instruments.         and interactions of the API with excipi-
   GMP in Drug Development                            This roundtable will be held Tuesday,        ents. Development of a new drug product
   The Student Postdoc Outreach and                November 8, from 9:00 to 11:00 am.              involves understanding of API stability
   Development Committee and Analysis                                                              through predictive and preventive degra-
   and Pharmaceutical Quality (APQ) round-         APQ Open Forum                                  dation studies. Several ICH/FDA guid-
   table on Good Laboratory (GLP) and              This year’s APQ open forum provides a           ances dealing with stability testing were
   Good Manufacturing (GMP) Practices in           unique opportunity for audience members         revised or are in the process of being
   drug development is intended to introduce       to interact and discuss with the partici-       revised. This short course will discuss sev-
   the fundamentals of current good regula-        pants, and the speakers, their experiences,     eral changes to the regulatory require-
   tory practices, review the role of regulatory   observations, and concerns regarding the        ments and will address designing a stabili-
   agencies responsible for developing these       setting of impurity specifications. The         ty program for global filling.
   regulations, and provide insights into how      agenda offers an exceptional set of topics         This short course will be held Sunday,
   and why these concepts can be integrated        that will inform this critical pharmaceuti-     November 6, from 8:30 am to 4:00 pm.
   into both academic and non-GLP/GMP              cal development activity. The implications      An additional fee is required to attend the
   research. The target audience is graduate       of the FDA’s Critical Path Initiative to set-   short course.
   students, postdoctoral fellows, and phar-       ting impurity specifications will be dis-
   maceutical scientists interested in an intro-   cussed. To complement this perspective,         Follow-On Biologics – Current Issues
   duction to Good Regulatory and Quality          the underlying science of specification set-    and Challenges
   Practices.                                      ting based on qualification through toxi-       Therapeutically Equivalent Biologics
      This roundtable will be held Tuesday,        cology studies, the analytical implications     (TEB), also known as follow-on biologics,
   November 8, from 12:00 to 1:00 pm.              of controlling suspected genotoxic impuri-      biogenerics, or biosimilars, are available
                                                   ties, and the relationship between forced       outside of the western markets, however,
   Roundtable on Analytical                        degradation studies and real-time stability     no TEBs have yet been approved in the
   Instrument Qualification (AIQ)                  data in specification setting will be pre-      U.S. or Europe. The absence of these
   Qualification of analytical instruments has     sented by recognized industry thought           products in the U.S. or Europe is due to
   been a complex undertaking, not because         leaders.                                        uncertainty regarding scientific and legal
   the process of qualifying instruments is           This open forum will be held Thursday,       issues associated with the development
   difficult, but because several opinions         November 10, from 1:30 to 5:00 pm. An           and submission of TEB. In addition, there
   abound on how to perform a successful           additional fee is required to attend the        is a lack of concise registration processes
   qualification. From a scientific perspec-       open forum.                                     for TEB as well as a need to establish
   tive, the qualification of instruments is one                                                   guidelines that will aid developers in
   of the vital components in assuring relia-      Degradation and Stability in Small              demonstrating pharmaceutical and thera-
   bility of data for the intended purpose. The    Molecule (API) Stability Testing for            peutic / clinical equivalence of a test bio-
   AIQ process for qualifying instruments          Global Filing                                   logic to a reference biologic. A roundtable
   has been described in some publications         Stability of the API and finished product is    with members of the pharmaceutical
   and in USP Pharmacopeial Forum (PF              one of the most important factors that          industry and the FDA, will discuss the cur-
   31(1):233-243, 2005). During this round-        affect the quality, safety and expiration       rent issues associated with producing and
   table, we will introduce the AIQ process        date of a product. The stability of the API     registering subsequent entry biologics.
   for qualifying analytical instruments,          in a formulated product not only relates to        This roundtable will be held Monday,
   review the comments received by USP, and        the physical/chemical attributes of the API     November 7, from 10:30 am to 12:00 pm.

22 AAPS NEWSMAGAZINE          Oct.-Nov. 2005
                                               Clinical Sciences
                                               CS Open Forum Pharmacogenomics                 must be separated from the effects of other
                                               - Barriers and Drivers to Clinical             confounding factors. The placebo effect is
                                               Applications                                   one such potential confound. However,
                                               This open forum will address progress          despite the wealth of data available about
                                               and future prospects for incorporating         this phenomenon, there is no universal
                                               genomics technologies into clinical prac-      agreement in biomedical research about the
                                               tice. The experts will examine some of the     role, extent and causes of the placebo effect.
                                               ways in which genomics could directly          The placebo effects presence is very tightly
                                               contribute to clinical practice and evaluate   intertwined with the study design and out-
                                               scientific and regulatory issues that will     comes, but how to address its presence in
                                               have a significant impact on the future        both drug development and in interven-
                                               adoption of genomics in clinical settings.     tional trials is still unclear. The purpose of
                                               A discussion will be presented of opportu-     this symposium is provide conference
                                               nities and barriers to the widespread          attendees with a comprehensive picture of
                                               application of genomics to drug develop-       modern knowledge about the placebo
                                               ment and clinical practice.                    effect.
                                                  This open forum will be held Thursday,         This symposium will be held Monday,
                                               November 10, from 1:30 to 5:00 pm.             November 7, from 2:00 to 4:30 pm.

                                               This year the PPDM and CS are sponsor-
                                               ing symposia and roundtables at the
                                               annual meeting.

                                               Ask the Professors: Population
                                               Pharmacokinetics

BIOTEC
Combination Product Approval:
                                               This is a new type of programming event
                                               for AAPS, one that is used by more clini-
                                               cally-oriented meetings with much suc-
Focus on Protein-Containing                    cess. Six to eight experts in the area of
Products                                       population PK-PD modeling will be iden-
Combination products have been targeted        tified shortly before the meeting and will
by the FDA as a potentially innovative         be asked to participate. Weeks before the
area of development for new therapies.         meeting an email will be sent to the
The BIOTEC Section has organized a             PPDM and CS sections via the listserve
roundtable entitled “Combination Product       asking members for any questions that
Approval: Focus on Protein-containing          they might have for the experts. The ques-
Products” that promises to provide valu-       tions will be collated by the PopPK Focus
able insight into considerations for           Group and ranked in order of importance.
approval of combination products that          At the meeting, the questions will be pre-
encompass development, manufacturing,          sented and the experts will then have
regulatory, clinical, and economic areas.      some period of time to answer. The idea
We are fortunate to have Mark D. Kramer,       for this event is to have a true roundtable
Director of the FDA Office of                  between experts and attendees with little
Combination Products, as a speaker. He         didactic teaching.
will review the regulatory implications of         This roundtable will be held Monday,
this relatively new category and participate   November 7, from 2:00 to 4:00 pm.
in the panel discussion. The session will
focus on combination products that have a      Now You See It, Now You Don’t: A
protein component, and will include a case     Multidisciplinary Look at the
history of a successful application.           Placebo Response
   This roundtable will be held Monday,        For the effect of a drug or of an interven-
November 7, from 2:00 to 4:00 pm.              tion to be unambiguously quantified, it

                                                                                              Oct.-Nov. 2005      AAPS NEWSMAGAZINE 23
   Clinical Sciences (CS) Research
   Achievement Award Winner Lecture
   Sponsored by PRACS Institute, Ltd.
                                                Pharmaceutics COVERSTORY
   The scientist whose work has been recog-
   nized by the CS Research Achievement
   Award will present a summary of his/her
                                                and Drug Delivery
   research at this informal event. Attendees   The 2005 AAPS Annual Meeting and               delivery barriers for orally administered
   will have the opportunity to discuss the     Exposition and will again serve as a forum     drugs, and will provide various examples
   work and exchange ideas.                     for scientists to share ideas and experi-      of prodrug approaches and their varying
      This lecture will be held Tuesday,        mental results in the areas of pharmaceu-      degrees of success. The case studies will
   November 8, from 12:00 to 1:00 pm.           tics and drug delivery. Presentations in       involve prodrugs to improve water solubil-
                                                these areas will cover topics of interest to   ity, prodrugs to overcome permeability
   Sunrise Session Experimental and             pharmaceutical scientists, including physi-    limitations, prodrugs to reduce toxicity,
   Computational Advances in CYP                cal and chemical characterization of drugs     and other applications.
   Enzymology                                   and drug formulations, design and evalua-         This symposium will be held on
      This sunrise session will be held         tion of specialized drug delivery systems,     Tuesday, November 8, from 2:00 to 4:30
   Wednesday, November 9, from 7:00 to          and examination of the biological barriers     pm.
   8:15 am.                                     to drug delivery.
                                                    One symposium sure to attract the          Another symposium will discuss “Drug
   Sunrise Session Missing Data in              attention of many attendees is “Orally         Delivery Options for Biopharmaceuticals.”
   Longitudinal Studies: A Review               Administered Prodrugs: Identifying New         Therapeutic proteins, peptides, DNA, and
      This sunrise session will be held         Successful Delivery Strategies.” This sym-     other biologicals generally are not effective
   Wednesday, November 9, from 7:00 to          posium will highlight the latest develop-      when administered orally and require or
   8:15 am.                                     ments in the use of prodrugs to overcome       may benefit from specialized drug delivery
                                                                                               systems. This symopsium will update
                                                                                               attendees on recent advances in thech-
                                                                                               nologies used for parenteral delivery sys-
                                                                                               tems such as pens, needle-free injectors,
                                                                                               and autoinjectors. New formulations for
                                                                                               sustained release delivery will be dis-
                                                                                               cussed, and a re-examination of the possi-
                                                                                               bilities of oral protein delivery will be
                                                                                               given.
                                                                                                  This symposium will be held on
                                                                                               Thursday, November 10, from 8:30 to
                                                                                               11:00 am.

                                                                                               A separate symposium, “Advances in
                                                                                               Delivery of Proteins via the Lungs,” will
                                                                                               focus on the recent and significant
                                                                                               advances made in this field. Currently, six
                                                                                               inhaled protein products for systemic drug
                                                                                               delivery are in Phase III trials, with many
                                                                                               others in Phases I and II. By bringing
                                                                                               together experts from academia and
                                                                                               industry, attendees will be provided with
                                                                                               information on cutting-edge research
                                                                                               methods required for development
                                                                                               and optimization of inhaled protein
                                                                                               formulations.
                                                                                                  This symposium will be held on
                                                                                               Monday, November 7, from 2:00 to
                                                                                               4:30 pm.

                                                                                               A very common problem in the pharma-
                                                                                               ceutical industry is poorly water soluble

24 AAPS NEWSMAGAZINE          Oct.-Nov. 2005
drug candidates. A critical step in evaluat-
ing drug candidates is evaluation of toxici-
ty in preclinical species, which often
requires exposure many-fold greater than
the exposure required for efficacy. For
poorly soluble compounds, novel formula-
tions or excipients may improve oral expo-
sure, but must be acceptable for toxicity
studies. A roundtable discussion session
titled “Challenges and New Approaches to
the Formulation of Poorly Water Soluble
Compounds for Support of Toxicology
Studies” will be held to exchange views
and practices among participants.
    This roundtable will be held on
Monday, November 7, from 10:30 am to
2:30 pm.


Pharmaceutical Technologies
The Pharmaceutical Technologies section           Also on Monday, a roundtable will pro-      Also Tuesday morning, the trend of
has compiled an outstanding scientific         vide discussion on “Lyophilization Cycle    developing line extensions earlier in the
program for the upcoming annual meet-          Development and Scale-Up with an            overall lifecycle of a molecule will be
ing. A two-day short course on the             emphasis on stabilization of the API.”      addressed during the “Formulation
“Fundamentals of Preformulation in             This roundtable will be held on Monday,     Approaches to Life Cycle Management”
Pharmaceutical Product Development”            November 7, from 2:00 to 4:00 pm.           mini-symposium. This symposium will be
will discuss practical in vitro approaches                                                 held on Tuesday, November 8, from 8:30
for biopharmaceutical evaluation and cri-        Tuesday will begin with the Bristol-      am to 11:00 am.
teria for developability assessment.           Myers Squibb-sponsored AAPS Graduate
This short course will be held on Novem-       Student Symposium in Drug Delivery and         Tuesday afternoon offers a roundtable on
ber 5-6, from 8:00 am to 5:45 pm and           Pharmaceutical Technologies. This sym-      “Process Optimization and Scale-Up of
from 8:30 am to 4:00 pm, respectively.         posium will be held on Tuesday,             Parenteral Products” and will focus on
                                               November 8, from 8:30 am to 11:00 am.       lyophilized and suspension products. This
   A roundtable discussion on Monday                                                       roundtable will be held on Tuesday,
morning will provide an overview of                                                        November 8, from 2:00 to 4:00 am.
major applications of “Atomic Force
Microscopy in the Analysis of Solid Oral                                                      Be sure to attend the PT Membership
and Inhaled Dosage Forms.” This round-                                                     Meeting and Reception on Tuesday evening
table will be held on Monday, November                                                     to hear a summary of the Section’s past
7, from 10:30 am to 12:30 pm.                                                              achievements and goals for the coming
                                                                                           year. This event is a great opportunity to
   A second roundtable will feature indus-                                                 become more involved with the PT section.
try experts discussing “High Concentra-                                                    The reception will be held on Tuesday,
tion Protein and Antibody-Based                                                            November 8, from 5:00 to 6:30 pm.
Formulations.” This roundtable will be
held on Monday, November 7, from 10:30                                                        Wednesday begins early with a Dow-
am to 12:30 pm.                                                                            sponsored sunrise session on “Drug-Silicate
                                                                                           Interactions.” This session will address how
   Monday afternoon offers a symposium                                                     silicates affect dosage form characteristics
on “Miniaturization in Pharmaceutical                                                      and performance and will be held on
Processing” and will focus on reducing the                                                 Wednesday, November 9, from 7:00 to
amount of API utilized in preformula-                                                      8:15 am.
tion/formulation development. This sym-
posium will be held on Monday,                                                               Various aspects of transitioning from
November 7, from 2:00 to 4:30 pm.                                                          batch to continuous processin, including

                                                                                           Oct.-Nov. 2005     AAPS NEWSMAGAZINE 25
                                                Roundtables on Wednesday morning                 On Thursday morning, analytical, for-

         COVERSTORY                           will cover “Current Challenges in
                                              Pharmaceutical Suspensions,” “Taste
                                                                                              mulation and regulatory issues related to
                                                                                              microdose drug products will be high-
                                              Science,” and the “Approval Process for         lighted during a roundtable on “Low
                                              Biologics.” These roundtables will be held      Dose Drug Products.” This roundtable
                                              on Wednesday, November 9, from 9:00 to          will be held on Thursday, November 10,
                                              11:00 am.                                       from 9:00 to 11:00 am.

                                                The Pharmaceutical Technologies                  Thursday afternoon is the PT Open
                                              Research Achievement Award Winner               Forum on “Regulatory and Intellectual
                                              Lecture, sponsored by GlaxoSmithKline,          Property Issues Related to
                                              will be held on Wednesday, November 9,          Pharmaceutical Material Science.”
                                              during the lunch hour from 12:00 to 1:00        Recent advances in characterization
                                              pm.                                             technologies have led to a greater under-
                                                                                              standing of material properties and their
                                                 Molecular simulations as both quantita-      impact on dosage forms, which in turn
                                              tive and qualitative tools for predicting       have affected both intellectual property
                                              performance will be the subject of a            and regulatory aspects of product devel-
                                              Wednesday afternoon symposium held              opment. This session will discuss these
                                              from 2:00 to 4:30 pm. A second sympo-           issues and serve as a continued dialogue
   regulatory and PAT aspects, will be dis-   sium on Wednesday afternoon from 2:00           to the 2005 Pharmaceutical Technologies
   cussed during the AstraZeneca-sponsored    to 4:30 pm will focus on “Implementation        Conference at Arden House. An addi-
   symposium on continuous processing in      of Process Analytical Technology,” where        tional fee is required to attend this event.
   pharmaceutical manufacturing. This sym-    presenters will relate their experiences and    This open forum will be held on
   posium will be held on Wednesday,          provide discussion on how PAT tools have        Thursday, November 10, from 1:30 to
   November 9, from 8:30 to 11:00 am.         impacted R&D efforts.                           5:00 pm.




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