FDD Section Newsletter: September 2008

FDD Section Vision

The Formulation Design and Development Section will be the premier worldwide forum for scientists dedicated to the design and development of all dosage forms.

Message from the Chair, Mansoor A. Khan, R.Ph., Ph.D.

Greetings! I am delighted to report that the FDD section has decided to publish news letters to keep the membership informed about our activities. I would like to take this opportunity to welcome and thank you all for selecting FDD as your section. In the first edition of this newsletter, I would like to introduce the section leaders to you. There is a lot to share and learn about the exciting developments in the science and technology associated with formulations design and development. The FDD team is eager to work with you and develop several programs for workshops, symposia, short courses, round tables etc.

Having served as the chair of PDD section, I am delighted to serve as the founding chair of the Formulations Design and Development (FDD) section. I am grateful to the outstanding team of volunteers who devote a significant amount of their time to build this section from ground up to connect very closely with the membership. My job is to interact with all the FDD section leadership, many focus group chairs, AAPS leadership and staff, and all other stakeholders to bring their collective wisdom and experiences to offer the cutting-edge programming that all FDD members deserve. Together, we serve to provide all aspects of workshops, short courses, symposia, round tables, sunrise schools, open forums in national meetings, NBC meetings, and other open meetings. I am confident that our team is ready to serve all the member needs in FDD.

I am proud to say that I have had the privilege to work with AAPS in various capacities for fifteen years. Prior to the current position as Chair, I was Chair-Elect, Vice-Chair and Secretary/Treasurer of the PDD Section. I was also a member or chair of Short Course and Workshop Committee, Nominations Committee, Program Coordination Committee, Awards Committee, Abstract Screening Committee, Strategic Planning Committee, Distance Learning Committee, and Program Committee of several national and international workshops. Prior to serving in the National Committee, I have served AAPS for several years as Secretary/Treasurer, Vice-Chair and Chair of the PT section, and Vice General Chair and General Chair in AAPS Midwest Regional Meetings. I have also been either a moderator or speaker in most of the AAPS meetings in the last 15 years. These experiences have given me a tremendous understanding of the AAPS member needs, and an ability to reach out to local, national, and international experts whenever their help is needed.

I am a licensed pharmacist, and have earned my PhD degree in industrial pharmacy from St. Johns University, New York in 1992. I have been an academic professor of pharmaceutics for 12 years, and received my promotion to full professorship in 2000 at Texas Tech University Health Science Center School of Pharmacy. I also served as the Director of Graduate Program from 1998 to 2004. In May of 2004, I moved to the FDA to serve as the Director of Product Quality Research in the Center for Drug Evaluation and Research. My research interests are in the area of drug delivery and formulations, Quality by Design with emphasis on target product profiles, risk analyses, design of experiments, control strategies with process analytical technologies, complex dosage forms and nanoparticles, and therapeutic equivalence of brand and generic drugs.

I would like to gratefully acknowledge Dr. William Chekan and his FDD communications committee for their time and commitment to publish newsletters regularly. If you have comments and ideas to promote the science or any activities in FDD section, please do not hesitate to contact me or any of the section committee leaders. Thank you.

Message from the Chair-Elect, Colin Minchom, Ph.D.

Welcome to the newly formed Formulation Design and Development section of the AAPS. As a way of introduction, I’d like to provide a little of my background, as well as my responsibilities in the AAPS.

A pharmacist by training from the UK, I spent three years with Squibb as a formulator, almost ten with Eli Lilly in formulations, analytical and then project management and two as head of pharmaceutical development with an emerging virtual-pharma that did not make it out of the pupal stage. Today I work for Patheon and head up the Canadian contract development group.

I joined the Pharmaceutical Technologies (PT) section’s leadership team about five years ago. I have undertaken paper screening for the annual meeting (AM) for the PT section (an excellent way to start to understand the processes that facilitate the AAPS), chaired the section’s membership committee for two years, represented the section on the central Membership Strategic Oversight Committee (MSOC) and latterly was elected vice-chair then chair-elect for the PT section.

The chair-elect’s main responsibility is managing the section’s programming submissions to the AM and representing the section on the Annual Meeting Programming Committee (AMPC) which has representation from all sections. At the time of writing most of the effort for the Atlanta 2008 meeting is completed and below you will see what awaits you as an attendee in Atlanta.

From the above I am sure that you will note the AAPS is rife with acronyms. I am still learning these, so don’t feel intimidated! Again, welcome.

Welcome from the Vice-Chair, Dave Wallick, Ph.D.

Hello, and welcome to the newly formulated FDD - Formulation Design & Development - Section of AAPS. I am Dave Wallick, the Vice-Chair for the Section, who with Mansoor and Colin and many others, are hard at work to get our new section up and running at world-class pace.

My primary role this year will be to coordinate our FDD 2009 AMPC (Annual Meeting Program Committee). In this capacity my focus will be to lead our FDD-aligned Focus Groups towards program contributions for the 2009 Annual Meeting. The 2009 AAPS Annual Meeting will be held in Los Angeles, and early program development efforts suggest that it will be very fruitful for FDD Section members.

My professional background includes training as a chemist, with graduate thesis work at Penn State University sorting out enzyme mechanisms. I have worked at The Dow Chemical Company for 24 years in five different specialty businesses, with the last five years in Dow's polymer excipients supply business. My current role is to lead the identification and development of new applications for existing METHOCEL™, ETHOCEL™, and POLYOX™ excipients, as well as identifying new functional excipient materials of interest to drug formulators and manufacturers.

I have enjoyed wonderful opportunities for participation in AAPS over the past few years, having served as Co-Chair and Chair for the Modified Release Focus Group (MRFG), participating on the AAPS Member Group Coordination Committee (MGCC), and serving as Vice-Chair of the PT Section and, now, as Vice-Chair of the FDD Section. Having grown from a solid base in a very active Focus Group, I am a strong supporter of the role of Focus Groups in the FDD Section (and the role of the FDD Section in helping the Focus Groups). Let's work together to shore up the Section-FG interface and make the Formulation Design & Development Section as active and useful as we can; this will well serve the needs and interests of our FDD membership.

Our FDD future is bright, and the ride there is guaranteed to be interesting and exciting. Together, we will earn our place as a leading Section in AAPS. Thank you for your support of our new FDD Section and for your confidence in our Section leadership.

Greetings from the Secretary/Treasurer, Lori Hilden, Ph.D.

Greetings!  My name is Lori Hilden, and I am proud to be on the first management team of the newly formed FDD section. As Secretary/Treasurer, my primary responsibilities are to record and distribute the minutes of all FDD meetings and to maintain and review FDD financial records through the FDD staff liason. 

I joined AAPS and the Pharmaceutics and Drug Delivery (PDD) section as a graduate student and began volunteering as a reviewer for annual meeting poster abstract submissions.  I served as vice-chair of the Annual Meeting Abstract Screening Committee in 2006 and chair in 2007.

While I’m not sure whether the following list of my professional experience will help me with my Secretary/Treasurer function, I do hope it tells you a little bit about me! After earning a PhD from the Industrial and Physical Pharmacy Department at Purdue University (under the direction of Ken Morris), I spent nearly 5 years in the exploratory pharmaceutics (Preformulation) group at Bristol-Myers Squibb before accepting my current position in the Solid State Preformulation group at Eli Lilly and Co.

Again, welcome to the FDD section! I look forward to serving all of our members and expect the upcoming year to be full of activity as we continue to build our new section.

Preview: Atlanta 2008 Annual Meeting

As the PT section’s chair-elect my main responsibility last year was to manage the Annual Meeting (AM) programming for the section. In this article, I’d like to first provide a synopsis of the process for selecting programming; and then to provide information on the sessions in Atlanta from both PDD and PT sections as the FDD membership has come from both these historical sections.

For the task of selecting programming, a committee of nineteen individuals was formed of representatives from each of the PT section’s affiliated focus groups (FG) along with independent members. The stated objective of this committee was: “To provide the best possible programming of particular interest to members of the PT section of AAPS.”

This committee spear-headed the effort to encourage programming submissions from each of the Focus Groups and the section’s general membership.

Individuals then submitted their proposals via a website which was open for about two months. After closure of the website in November of last year, the committee debated and rank ordered the 42 sectional submissions. These were submitted for approval to the section leadership.

PT had an allocation of 7 slots over which the section had sole discretion; PDD had an allocation of 8. An additional 42 open slots were available for which program submissions from all sections competed, and over which there was much debate!

Below is listed all the programming from both the PT and PDD sections. Many of these will likely be of interest to you when you come to Atlanta in November. I look forward to meeting you there and hope you find the meeting of great value to you, both professionally and personally.

Colin Minchom

Listing of PT section contributions for Atlanta AAPS:

• Harnessing Drug-polymer-Excipient Interactions for the Rational Design of Modified Release Formulations (Short Course)
• Quality Agreements (Sunrise Session)
• Biomarkers of Local Drug Delivery from Pulmonary Drug Products (Sunrise Session)
• Parenteral Controlled Release Invited Poster-podium Session (Poster/Podium)
• Approaches To First-in-Human Formulation Development (Symposium)
• Emerging Technologies For Development Of Oral Delivery Systems (Symposium)
• Advancing Technologies in Nutraceutical Research (Symposium)
• Outsourcing - Mechanisms and Case Studies for Development and Manufacturing at a Contract Facility (Symposium)
• Outsourcing Drug Product Development to India and China (Roundtable)
• Emerging Technologies: Liquid Filled Hard Capsule Technology in the Pharmaceutical Industry (Roundtable)
• Working at Risk in Drug Product Development. Understanding, Measurement and Evaluation of Risk in Driving Decisions (Roundtable)
• Iin Vitro Bioequivalence Testing for Aerosol Products: from Today to Tomorrow (Roundtable)
• PATability of Excipients (Roundtable)
• Particle And Powder Technologies For Solid Dosage Forms (Open Forum)

Listing of PDD section Contributions for Atlanta AAPS:

• Application of Biopharmaceutics in Modeling and Simulation (Short Course)
• Tumor Imaging and Targeted Drug Delivery (Sunrise Session)
• Pharmaceutical Co-crystals (Sunrise Session)
• High Energy Solids For Delivering Poorly Water-soluble Drugs: Opportunities And Challenges (Symposium)
• 25th Anniversary Of Pharmaceutical Research: Impact On Drug Development And Roadmap To Future Innovations (Symposium)
• Why Absorption And Pharmacokinetic Models Are More Important in Future Drug Development (Symposium)
• Drug Discovery And Drug Developability For Lead Optimization (Symposium)
• Drug Substance And Drug Product Interface: A Critical Step Toward Quality By Design For Pharmaceutical Products (Symposium)
• In Vitro Oral Drug Transport Data: Approaches to Data Analysis and Modeling (Roundtable)
• Food Effect or No Food Effect: from Bench Findings to Reality (Roundtable)
• Quality by Design: Defining Clinically Relevant Design Goals (Roundtable)
• Need for New Product Development Model in Generic Pharmaceutical Industry: Science vs. First to File Opportunities (Roundtable)
• Transporters as Prodrug Carriers for Oral Drug Delivery (Roundtable)
• The World Within and Beyond P-gp: Do we Underestimate or Overestimate P-gp? (Roundtable)
• Bioavailability Enhancement During Lead Optimization: Enabling Discovery or Encouraging Challenges in Developme (Roundtable)
• Particle Size Analysis and Specification of Pharmaceutical Powders (Roundtable)
• Challenges in Developing Inhalation and Nasal Products: Linking to Quality by Design (Roundtable)

Reminders for Speakers & Moderators at the Annual Meeting

As you prepare for speaking, moderating, or attending programs at the November Annual Meeting, keep these suggestions in mind:

• GET THERE EARLY: Moderators should arrive prior to their session start times to check on suitability of Audio Visual (AV) equipment.
• MOVE AROUND: The availability of wireless microphones allows the speakers to move amongst the audience during the presentation, which leads to better audience engagement.
• SPEAK UP: Voice projection for speakers is important in large meeting rooms. Speakers should be prepared for this fact.
• WATCH THE CLOCK: Maintaining session times – at both start and finish – is critically important to facilitate audience attendance at consecutive meetings.
• GET THE AUDIENCE INVOLVED: Strong audience interaction in Q & A sessions adds considerably to the quality of the sessions.

FDD Volunteers: A New Way to Help Our Section

First of all, I would like to extend my sincere thanks to those who have joined the Formulation Design and Development (FDD) section of AAPS! I am Rakhi Shah, Ph.D., the Chair of the FDD Membership Committee. I work for the US FDA in Silver Spring, Maryland, and am honored to have this opportunity to serve our new section.

For those readers who may not already be member of AAPS, you should consider joining and making the FDD Section your primary membership section. Membership will put you in contact with pharmaceutical scientists from around the world. Visit www.aaps.org.

If you are already a member of AAPS, are you a member of the FDD Section? If not, consider joining it. Please contact AAPS Membership Services via the FDD section page. This will take only seconds and is free.

The FDD Section provides service to AAPS and the FDD Section membership by:

1. Providing a forum for the open interchange and dissemination of scientific knowledge in the research, design, development, and manufacture of drug delivery systems.
2. Promoting the continued growth and development of formulation design.
3. Fostering career growth and personal development of the membership through training, educational services, and cooperative programs with other organizations.
4. Providing recognition for excellence in individual achievements of its members.

AAPS and the FDD Section depend on the contributions of its members. We would like to make it easier for our members to become involved. We have an initiative that may appeal to you, which we call FDD Volunteers. Please contact me (rakhi.shah@fda.hhs.gov) to volunteer to help out with FDD section activities. In your message, please provide your name, title, company/institution, phone number, address and volunteer interests.

In addition, please remind any interested colleagues about the FDD section. You can find more information about the section by visiting our home page. Please check back frequently for information about our new and exciting programs and updates.