AAPS Section News – Two new initiatives that will impact:

• The number of Sections available to AAPS Members
• The way AAPS Members can affiliate with Sections

There have been two major initiatives occurring in parallel that are now approaching the implementation stages.

The first initiative stems from the recent AAPS Section strategic visioning process. The PDD and PT Sections’ mutual strategic visioning teams have recommended that the current PDD and PT Sections be reformulated into three sections:

• Physical Pharmacy & Biopharmaceutics Section
• Formulation Design & Development Section
• Manufacturing Science & Engineering Section

This recommendation follows from several reasons:

• Greater sectional representation in pharmaceutics and pharmaceutical technologies
• Sectional representation for delivery sciences at the discovery/development interface
• Sectional representation for manufacturing science and engineering
• Focus formulation and product development into a single section

The formation of these three Sections was approved by the AAPS Executive Council during their November 2007 face-to-face meeting.

The second initiative stems from a recommendation submitted by the AAPS Membership Strategic Oversight Committee (MSOC) and approved by the AAPS Executive Council. The recommendation was based on the analysis of member survey data and the structures of other similar organizations. This recommendation eliminates the primary and secondary section designations, and allows AAPS Members to fully affiliate with up to two Sections. Additional Sections may be designated for a nominal cost.

AAPS Members will be presented with an opportunity to select Section affiliations structured under these two new initiatives beginning in April 2008.

PDD/PT Strategic Visioning Encapsulation

Summary:

The PDD and PT Section Leaderships recommend that the current PDD and PT Sections be organized into three sections that reflect science at the discovery/development interface, science in formulation development, and science in manufacturing, respectively.

Process and Rationale:

As a part of the AAPS Strategic Visioning program, a joint PDD/PT Strategic Visioning Committee was formed in May 2006. Two major outcomes were:

1. In 2006, a survey was deployed to PDD and PT Members, regarding how PDD and PT Sections could better serve members. The joint PDD/PT Strategic Visioning Committee concluded from the survey results, as well as comparisons of Section descriptions, SWOT analyses (August 2006), programming interests and abstract submissions, that the significant overlap between PT and PDD Sections in terms of members, interests and activities presented an opportunity to better align section practices with membership needs.
2. A recommendation to further study three topics that relate to possible reformatting of PDD and PT Sections:

   Topic #1: Increased communication and collaboration between PDD and PT
   Topic #2: Redefinition of the scope between PT and PDD
   Topic #3: Reorganization of the current two sections

From the three joint PT/PDD collaborative sub team studies, two potential recommendations emerged:

1. Maintain the PDD and PT Sections, with continued and greater cooperation, or
2. Form three new sections from the current PDD and PT Sections, where the newly formed sections would reflect science at the discovery/development interface, science in formulation development, and science in manufacturing.

Joint PDD and PT leadership SWOT analysis and review of these recommendations have led to a consensus for the formation of three sections. This recommendation was driven by the common interests between the sections in terms of programming, abstract submission topics, focus group alignment, and member demographics.

Conclusion:

In summary, all PDD/PT Strategic Visioning Committee members see long term benefits and opportunities in the formation of three sections from the current two.

Next Steps:

The AAPS Executive Council received the final recommendation on September 19, 2007 and appointed a task force to review finances, elections, and by-laws; and to examine whether the recommendation can be implemented and if so, how it will be done. Pat DeLuca is chairing the task force and members include Gene Fiese, Karen Habucky, Ron Sawchuk, Brad Clark, Jim Polli, Lynn Van Campen, Mei Lai, and AAPS staff.

Following are the section names:

Physical Pharmacy & Biopharmaceutics Section

PPB Section Description:
The Physical Pharmacy and Biopharmaceutics (PPB) Section is composed of members whose scientific interests are in the physicochemical and biological factors that impact the molecular design and delivery of small drug molecules. PPB provides a forum for the exchange of information pertaining to the selection of developable drug candidates at the drug discovery-drug development interface, intrinsic physicochemical properties of drugs, solid-state characterization of active pharmaceutical ingredients and excipients, preformulation testing leading to the selection of formulation strategies, and selection of delivery routes through the physiological considerations of drug delivery at the cellular, organ and whole animal levels. PPB is a multidisciplinary section which focuses on a quantitative understanding of the intrinsic properties of the molecule and the interacting biological system, enabling the selection of developable drug candidates and the identification of potential strategies for optimal drug delivery.

Formulation Design & Development Section

FDD Section Description:
The Formulation Design & Development (FDD) Section is comprised of members from many diverse backgrounds in industry, regulatory and academia who share a common interest in the area of formulation design, research and development - a multidisciplinary field drawing upon the physical, chemical, biological and engineering sciences. The primary goal of this section is to unite multiple scientific disciplines in a forum where they can share experimental results, consider new formulation and dosage form technologies, and discuss issues and concerns regarding the design and development of formulations/drug products for small molecules. This Section collaboratively interfaces with other sections which focus on pre-formulation, biopharmaceutics, formulation strategies, and manufacturing process optimization. Aspects of formulation design and development include the study of dosage forms for drug delivery via all routes of administration wherein the dosage form encompasses the formulation, process by which it is made, and primary packaging. The Section’s focus on product development includes evaluation of dosage form manufacturability, stability, quality and performance both in vitro and in vivo that is appropriate to its development stage.

Manufacturing Science & Engineering Section

MSE Section Description:
The Manufacturing Science & Engineering (MSE) Section of AAPS is composed of scientists and engineers interested and involved in the application and advancement of science and technology to the manufacture of pharmaceutical and pharmaceutically related products. It will provide a forum for exchange of information and networking between members and with members of allied Sections and organizations. Areas of specific interest include pharmaceutical product manufacturing (both investigational and commercial), quality assurance and engineering principles as applied to manufacturing, process optimization, scale-up and technology transfer, manufacturing technical support, and quality by design.

The New Structure for AAPS Section Affiliation

Summary:

AAPS will be transitioning to a new section affiliation structure; the section affiliation policy for all members will be as follows:

1. No primary or secondary section affiliation distinction
2. Membership of up to TWO sections included in annual dues
3. Each additional section affiliation would cost $5 per year (There is no limit to the number of sections members can be affiliated )

Why the change?

In 2004, the Executive Council (EC) of AAPS charged the newly formed Membership Strategic Oversight Committee (MSOC) to examine the benefits being provided by the Association to its membership and provide recommendations for improving them. The MSOC worked with the AAPS staff and conducted a membership satisfaction survey in May 2005. Among the many useful findings from the survey was one observation made by many of the members that the present structure of primary and secondary section affiliation was confusing and created conflicting interests for individuals in selecting section affiliation.

Based on analysis of data from the survey, one of the recommendations made by MSOC was to “develop plans for distinguishing between primary and secondary membership for all sections”. This recommendation was accepted by the EC with a further charge for MSOC to look for alternative ways of providing multiple section affiliation. MSOC conducted several meetings and did considerable research into the structures of other similar organizations.

Following these deliberations and after looking into several alternative options for primary and secondary section affiliation MSOC selected one recommendation that was considered to be a better alternative. The recommendation was to eliminate the primary and secondary section designation, while still providing members the choice of affiliating with more than one section. This recommendation was sent to the leadership of all sections for their comments. Based on the input received from the section leadership the proposed recommendation was modified slightly, and was presented to the EC, which communicated their support of the recommendation.

Section leadership concerns were considered during the final proposal review phase. The EC asked for further research and clarification on the financial consequences of this new structure in terms of distribution of budgeted funds among the various sections. Once the AAPS Finance Committee felt comfortable with the new proposed structure and how the sections will receive their finances, the EC provided the final approval for implementing the new structure as outlined above.

Advantages of this new structure:

The new structure simplifies the section selection options available to the members. Members affiliate with the section(s) of their main interest and do not have to make the choice of which should be their primary and secondary sections. Administration of the new structure is also simplified for AAPS staff members.

The budgeting process would me more equitable for smaller sections and simplified since it would be based on one class of ‘affiliated members’. The sections can focus on technical issues and the advancement of sciences rather than financial concerns.

The new section affiliation structure would provide a better opportunity for interaction between sections as they would deal with a level field. The sections will be motivated to provide competitive benefits to increase and satisfy their membership. Focus group interests would be better served by more direct affiliation to appropriate section(s)

For those members who feel strong affiliation towards multiple sections and desire to participate actively in more than one section would be allowed to do so with equal opportunity, including voting and eligibility to participate in section leadership