Posted: October, 2008

This year, the annual AAPS meeting will be in Atlanta from November 16 to 20. Do not miss this opportunity to learn and, most of all, network. I hear from many APQ members that meetings are a time to gather with colleagues and find out about the latest scientific advances and regulations, the former sometimes being a little more important than the latter. Let me inform you of these networking opportunities. First, there is the APQ business meeting and reception on Monday night. Then there are the various Focus Group business meetings. The meeting rooms and times of these events will be in the final program, or just ask the Chair of your Focus Group. Don’t pass up the chance to visit with your Focus Group, as this is a great time to talk about issues that are important to you. Although the business meetings are short and do not provide much time to discuss technical issues, it may be useful to have dinner or just a side chat with other members. However, at the Focus Group meeting there will be an important item to bring up, the programming for the next Annual Meeting in 2009. The website is open now through December 2, 2008, and the FGs should be firming up their proposals. There is some very good programming at this year’s Annual Meeting, and hopefully, everyone will support our students and attend the Graduate Award Symposia on Tuesday at 8:30. The Open Forum, “Application of Principles of QbD to Analytical Methodologies, Specification, and Control Strategies,” is on Thursday at 1:30 p.m. Be sure to register for this event. The hot topic this year that will be of interest to APQ members is “How Safe is Your Global Pharmaceutical Supply Source? Quality and Regulatory Perspectives Based on Recent Glycerin and Heparin Events,” which will be held on Tuesday, November 18. Other APQ programs of interest are as follows:

Monday, November 17

• Leachables and Extractables in Solid Dosage Forms (Roundtable) Application of Bio-relevant USP IV Dissolution Method in Pharmaceutics Development (Symposium)

Tuesday, November 18

• Application of Design of Experiments to Analytical Method Development (Sunrise Session)
• Identification, Characterization, and Qualification for Impurities that Are Not Covered by ICH Q3A and Q3 Guidances (Peptides, Oligonucleotides, etc.) (Roundtable)
• Technologies and Science behind Enhancing Bioavailabilities of Poorly Soluble Compounds (Symposium)

Wednesday, November 19

• Root Cause Analysis During Out of Specification Investigation: a Step-by-Step Procedure (Sunrise Session)
• IVIVC/R for Solid Oral Dosage Forms: Objectives and Challenges (Symposium)
• Incurred Sample Analysis for Larger Molecule Therapeutics: Experiencing the Workshop in 2008 (Roundtable)
• Development and Maintaining a Biomarker Monitoring Program (Roundtable)

Thursday, November 20

• Dealing with Contamination and Carry Over in Analytical Research (Sunrise Session)
• Analytical Method Development Based on QbD Principles (Sunrise Session)
• Quality by Design and its Role in Developing Analytical Methods (Symposium)

I hope to see you there. Visit the APQ booth and sign up for committees for 2009.

Vivian Gray
Chair APQ

Posted: March, 2008

Let's Get Focused

Do you have a special technical expertise or interest? Then you should consider joining one of the many Focus Groups of the AAPS. If no focus group exists for your specialty then get together with some like minded colleagues and create a Focus Group (FG) of your own.

As a member of APQ there are many focus groups that are affiliated (primary or secondary affiliation) with your section. These are the In Vitro Release and Dissolution Testing; Stability; Nutraceuticals, Ligand binding Assay, Bioanalytical, PAT, Manufacturing, Engineering and Quality, Microdialysis, CMC, CRO, and Generics. Throughout the AAPS sections there are over 35 affiliated FGs. Surely there are one or more FGs that appeal to you? Click here for a complete list of FGs, or visit http://www.aapspharmaceutica.com/inside/focus_groups/fgap.asp to join any FG of interest to you.

When you join a FG you will find most have a steering committee that consists of the Chair and Chair-elect and several other highly involved people. The steering committee has a telecon once a month or so where the plans for future workshops, programming and publications are discussed. You should decide your level of involvement and either ask if there is space available on the steering committee or, if not, look for periodic communications from the steering committee, usually from the APQ listserv. I recommend to get full benefit from the FG you volunteer for getting more involved, especially in programming either as a speaker, moderator or an idea person.

The FGs are the driving force for programming and they are the core of the technical interests of the AAPS. Also FGs are the ideal networking vehicle for those in a particular field that is changing and/or growing.

So get focused and either join, re-energize an existing FG, or create your own.

Vivian Gray
Chair APQ

Posted: October, 2007

The last year has been an exciting one for the APQ Section, as we continue a tradition of strong programming initiatives. Our webinars earlier in the year were well received and provided a wealth of information on advances in HPLC. A number of white papers and supporting publications have come to fruition as a result of workshops on bioanalysis and dissolution held in 2006. A recent workshop on stability drew over 250 attendees, approximately 10% of which came from outside the US. Still to come just prior to the annual meeting is a workshop on degradation mechanisms, and in February of 2008, a workshop on incurred sample analysis in the regulated bioanalysis arena.

The website is open for submission of programming ideas for the 2008 annual meeting in Atlanta. Under Craig Lunte’s leadership, the programming committee continues soliciting ideas and working with interested submitters to find synergies with other proposed ideas both within and outside the Section. Your ideas for any format (symposium, round table, short course or workshop) are encouraged and welcome.

The time for the AAPS Annual Meeting is fast approaching. We hope many of you will be there and can attend our programming as well as our Membership Meeting and Reception on Monday evening November 12. Under the leadership of Vivian Gray, APQ has an abundance of great programs this year, many co-sponsored with other Sections. Members of our Section serve both as leaders in their areas as well as providers of critical services and measurement for others. The discussion of their work makes possible a wide variety of interesting program.

As my year as Chair of the Section ends, I want to thank the rest of the APQ EC, committee chairs, Focus Group leadership, AAPS Staff, and the literally hundreds of volunteers, speakers and moderators helping the Section produce the programming and other activities of interest to our members. A special thanks to Kristin Price, our Student Representative from the University of Kansas, for her service on the Executive Committee this year, for her tireless efforts to increase the interactions between the chemistry and pharmacy graduate students and for her work in helping us set up a Section speaker program to help Student Chapters find and select APQ members to speak at their events.

If you have not had the chance to do so, please check out our website. Under the guidance of Kim Huynh-Ba and Tahir Hashmi, we continue to add interesting and, we hope, useful content. Please send in ideas for other items, links or features you’d like to see.

Posted: June, 2007

Serving our Members – A Symbiotic Relationship

As with AAPS and all its associated Sections, the APQ Section exists to serve its members. As a whole AAPS returns over 85% of the revenue it received to its membership in terms of benefits, a rate comparable to the most effective and efficient non-profit organizations.

APQ Section has over 2400 members spanning a great diversity of experience and expertise. We work hard through Section efforts and the many Focus Groups we support to try to meet membership needs through Focus Group programming, webinars, workshops, short courses and Section programming at the Annual Meeting and the National Biotechnology Conference. Through travelships and funding for speakers, we make the meetings accessible to a wide range of participants. Our webinar series, which we provide at no cost to our members, provide outstanding learning opportunities at a price that is hard to beat.

Even given our wide-ranging activities, meeting the needs of our membership can be harder than it looks. At the Section level, we can provide Annual Meeting and NBC programming, but those are once-yearly events. Through our Focus Groups, we provide workshops and perhaps webinars, which meet more specific needs. Unfortunately, not all our membership belongs to a Focus Group, and not all Focus Groups provide fundable programming on a routine basis. Focus Groups can be an outstanding way to network and get answers to some thorny issues in your area of expertise, so if you don’t belong to one that is related to your job, I would encourage you to join, and if there is one we should be sponsoring but aren’t, I ask that you let me or another member of our executive council know so we can assess the feasibility of starting one up.

In the past two years or so we have sponsored or co-sponsored Focus Groups related to Stability, Dissolution, CROs and CMC. The first two have been very active, both sponsoring workshops. The CRO group has a workshop approved for February, 2008 and the newly-formed CMC group is off to a very fast start. Through these and our other Focus Groups, we hope to hear about the issues that are most important to you, and provide information that helps you deal with those issues. We can’t address your issues without knowing what they are so please let us hear from you.

Annual meeting programming is now being accepted for the 2008 meeting. If you have ideas for programming, I encourage you to contact Craig Lunte, our 2008 Annual Meeting Programming chair and join the programming committee. Working through the committee helps get buy-in for your programming, and provides a group of people that can help flesh out the program and find speakers. We find that programs that are developed through the committee have a better chance of getting broad-based support from other Sections, thus a better chance at being accepted for presentation. The collaborative nature of our work has served us in good stead regarding programming, and we have often managed more programming than our size suggests we should get because other Sections found it of sufficient value to their members to vote for it or sponsor it with us.

As always, we thank you for your support and look forward to your active participation and to helping you make the most of your AAPS membership. Please feel free to contact me (Tony DeStefano) with any ideas or suggestions you have. Finally, be sure to check out our new and improved website and give us suggestions for making it even better. We want to make it a site you can’t do without, but as usual can’t do it without you and your continued support!

Posted: March 19, 2007

APQ – Supporting Our Members

The primary goal of the APQ Section is to support our members. We do that through a number of venues including supporting our affiliated Focus Groups, distance learning, NBC and Annual Meeting programming, workshops and short courses, among others. To date, we’ve been quite successful on all fronts.

Our Focus Groups are strong and have consistently provided outstanding programming. We are secondary sponsors of the newly-formed CRO Focus Group and will be secondary sponsors of the soon-to-be formed CMC Focus Group, bringing our total number of affiliated Focus Groups to 10. Still, as of last year, less than a third of our members belonged to a Focus Group. That’s the level where the Section can help you on a day-to-day basis as you interact with your co-workers on real-world problems in real time. If you don’t belong to a Focus Group, we urge you to join one most applicable to your work. If you don’t see an applicable one, let one of the Executive Committee members know, and perhaps we can help for one!

Thanks to the efforts of our speaker, Dr. Michael Dong, we had a very successful six-session Distance Learning webinar series on Advanced HPLC. Attendance throughout the six sessions was outstanding, as were Michael’s lectures. The positive comments we got from the series clearly demonstrated its value to our members both in the United States and overseas.

Our Annual Meeting programming for 2007 is once again outstanding, thanks to our Program Chair, Vivian Gray and her excellent committee. I’m sure you’ll agree when you get your preliminary program, sessions of interest to APQ members abound. Programming for the 2008 meeting will begin shortly. If you have ideas and what to be part of the committee, please contact our 2008 Annual Meeting Programming Chair, Craig Lunte.

There are several sessions of interest to Section members at this year’s NBC meeting, and I hope those of you interested in large molecule work have an opportunity to attend this growing meeting. Under the careful guidance of our 2008 NBC Program Chair Steve Colgan, prospects for several terrific symposia and roundtables at the 2008 meeting look very good.

Overall, APQ Leadership is proud of the Section’s accomplishments. When we think about what has made us successful, essentially all of our success is due to those of you who have unselfishly volunteered your services to chair sessions, put together programs, serve on committees or otherwise help us accomplish our goals. In addition, our Section Sponsors, featured on our newly-launched website, have provided invaluable help, allowing us to fund programming and speakers that otherwise would not be possible. The Section can only be as good as its level of member participation. We need to know what you need, and we can always use your help in providing it. Please send any ideas to any member of the Executive Committee, or provide feedback on the website. We can promise you that every idea gets considered. Thank you very much for your on-going support of the Section!

Tony DeStefano
For the APQ EC

Posted: December 19, 2006

Getting the Most Form Your AAPS/APQ Membership - The Value of Focus Groups

With any relationship, the more you invest in it, the more you get out of it. That’s true as well for your relationship with AAPS and its Sections, Focus Groups and Discussion Groups. At a very high level, you can simply elect to be a member of AAPS, read the Newsmagazine and perhaps attend the Annual Meeting. That can be of substantial value given the excellent programming and networking opportunities that membership and meeting attendance provide, especially now that learning opportunities are available year round at little or no cost through the Distance Leaning Program.

Investing a little more energy and joining the APQ Section and one or more of its affiliated Focus Groups can pay even more dividends. At the Section level, being a member allows you to participate in, for example, proposing and presenting Annual Meeting or NBC programming, organizing workshops or short courses, or presenting distance learning events. These activities provide valuable networking opportunities, and a way for issues you’re interested in to be discussed in a candid way in a public forum.

While participation at this level is terrific, and certainly valued and appreciated, participation at the Focus Group level can be eve more rewarding. Our goal with focus groups is to provide you help and information at the level of your daily work. Our focus groups, including Bioanalytical, Ligand Binding, Stability, Dissolution, Neutraceuticals, PAT, MEQ, Microdialysis and CRO provide programming such as workshops and short courses, Annual Meeting programming, excellent networking opportunities, and a forum to discuss issues important to you on a daily basis that are likely also of importance to your colleagues. If you’re new to your field, this is an excellent way to learn from the veterans. If you’ve been in your field for a while, focus groups provide both a way to train new people, and a mechanism to deal with cutting edge issues in real time.

Want to learn more about one of our Focus Groups? Check out the links on the APQ Homepage to visit the sites, join, or send an email to the Focus Group Chair. Don’t see a focus group that fits your area of expertise? Use the Feedback button on this page to propose one to us.

Thank you very much for your ongoing support of the Section and its activities, and best wishes for a wonderful holiday season.

Tony DeStefano
2007 APQ Chair, for the APQ EC

Posted: September 28, 2006

Welcome to the newly-revamped APQ Section Home Page!  I hope you'll agree it's a vast improvement over our old one.  The APQ Executive Committee would like to thank the members of our Website Committee and Liz Crescioli and the staff at AAPS for all their efforts to get us to this point.   As part of the new design, we've set up a Leadership Column, where, throughout the year, APQ Executive Committee members will provide you with updates on Section and AAPS initiatives and activities that we hope will be of interest to you.  In this column I'll highlight the new website redesign, APQ volunteer opportunities and APQ Sponsorships.

The website redesign project has been under way for several months.   We're launching the new version just in time for the annual meeting.   Our goal is to have a home page that you look to as a one-stop place to come to keep up to date on the latest developments in your field and to quickly find the links and content you need to help you more efficiently accomplish your day-to-day activities.  You'll notice links to our Focus Groups and other AAPS activities and sites, but also links to vendor, CRO, and regulatory sites.

We have begun to populate the site with links and other content proposed by our hard-working website committee, but for the site to be truly effective, it needs to contain information YOU think is important.  Please help us by giving us your ideas for new links, new content, upcoming meetings or events the APQ community should know about, or anything else you wish you had found when you got to this page (click here for the Feedback form).  We'll make every effort to incorporate your feedback, and will update the site on a regular basis to keep the content current.

If you have even more interest in the website's health and well being, we invite you to join our Website committee to help us continue to make it useful to our membership.   More generally, we need ongoing help and feedback to keep the Section vibrant.  First, we need to know what you need from the Section to feel we're of value to you.  Second, we need your help in accomplishing our goals.  Programming, whether it's the Annual Meeting, the National Biotech Conference, Workshops, Short Courses or Distance Learning opportunities, is the lifeblood of the Section, and we need help with everything from proposing and developing programming to screening papers.  If you're a Section member, you either have, or will be, receiving a request to volunteer.  We welcome your help in making this a better Section, and welcome any ideas you have, even they aren't within the scope of what we are now doing.

We've also established the concept of Section Sponsors.  This will allow sponsors to get recognition throughout the year and at a number of APQ events, as well as at specific events they are helping us with.  We thank all our sponsors for their on-going support of Section's activities.  If you're interested in the benefits of sponsorships, please contact Grace Jones for details.

Tony DeStefano
Chair Elect (2007 APQ Chair)
For the APQ EC