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A new home for industry

Mary Lou Gantzer, PhD, is director of clinical and scientific affairs in the chemistry/immunochemistry group at Dade Behring Inc. (Newark, DE) and president-elect of the American Association for Clinical Chemistry. She can be reached at gantzeml@dadebehring.com.

AACC's industry division looks to make it official

Leading up to this year's annual meeting of the American Association for Clinical Chemistry (AACC), which will be held in Chicago from July 29 through August 2, some of the association's members will be putting in a little overtime.

That's because this year marks the first official elections for officers of the association's industry division, a group that has had provisional status for the past three years and is now beginning its move to become a permanent division of the association. Ballots for the slate of candidates were expected to be sent to the division members in late June, and results of the election should be known this fall.

To find out more about the purposes of the AACC industry division, IVD Technology editor Steve Halasey talked with Mary Lou Gantzer, director of clinical and scientific affairs in the chemistry/immunochemistry group at Dade Behring Inc. (Newark, DE) and current chair of the provisional division. Gantzer has a long history of service to AACC in a variety of capacities, and is currently president-elect of the association.

IVD Technology: Where did the idea for an industry division in AACC originate?

Mary Lou Gantzer: A bunch of us in industry were sitting around at one of AACC's annual meetings and the idea just popped into our heads, "Gee, maybe we should have an industry division." Then it took probably another year and a half to two years of thinking and talking about it before we finally said, "Okay, we're really going to do this."

Was it hard to convince AACC that having an industry division was a good idea?

It wasn't hard. But the other AACC divisions are based on topics such as point-of-care diagnostics or therapeutic drug monitoring rather than on where the member works, so it was a unique concept that people had to think about. As they thought about it and talked with us, they became aware that industry-based members have concerns that nonindustry members don't have.

When I mentioned ISO 9000 several years ago, for example, other AACC members had no idea what I was talking about. Industry members knew because it was what they were embroiled in; every manufacturer was scrambling to get its quality systems in place and get its ISO certification.

Today, of course, people in clinical labs are very aware of ISO 9000. But it affected industry long before it affected them. So they gradually became aware that there are concerns that affect industry members that hospital-based people wouldn't appear to have any interest in.

The industry division changes AACC's constituency somewhat, doesn't it?

Compared to the traditional constituency, the membership that the organization has responded to primarily in the past, yes. You're correct.

How many members does the division have now?

It changes throughout the year, of course, as people join. The last I heard it was approximately 380.

Which is still a fairly small percentage of AACC's total membership?

Correct.

Is that company membership or individual membership?

Individual membership.

How many companies are represented in that group?

I'm not entirely sure. I would guess that the big six are definitely represented, and probably most of the major 25, and then a number of smaller companies also.

There are some nonindustry members, and it's interesting to try to figure out why. Last year, at least one physician from outside the United States attended the division meeting as a member. And yet he wasn't in industry. It might be that he was just exploring.

Education for Industry

What does having a division within AACC do for industry that wouldn't be or isn't being accomplished by other industry associations?

We're currently focused on educational programs that involve topics such as regulatory or test standardization issues. The IVD Task Force at AdvaMed would be interested in many of the same things. But there are certain programs that we may be able to mobilize faster because we don't have the same hierarchy to go through.

The major program that we organized last year was an audioconference on informed consent, in response to changes made at FDA that virtually none of us were aware of. That would also have been an excellent topic for AdvaMed to cover, but we were able to pull that program together very, very quickly.

We work with AdvaMed because it has a similar but somewhat different constituency. And a lot of times we'll partner and both support the same thing.

AACC has traditionally been very strong in providing educational activities for its laboratorian members. Is the organization equally committed to providing that for its industry members?

The impetus has to come from the industry members themselves. They have to identify what programs are important to them and let the division know what they want.

But because we have an industry division now, people in AACC are much more likely to know what concerns industry-based members might have. And that makes it more likely that they'll pass along information to the industry division and ask the division how it wants to proceed.

Who are the people within IVD manufacturing companies that are the most logical members of the industry division?

The people who are most likely to belong to the division would be R&D staff, regulatory affairs staff, clinical affairs specialists, quality control staff, manufacturing personnel, and possibly some people from marketing. And of course one of the requirements for membership in any of AACC's divisions is that you first have to be an AACC member.

Would the industry division appeal to medical professionals who are working with manufacturers in an R&D capacity, or laboratorians who are actually employed by industry?

Off the top of my head, the people I can think of who are most involved as consultants to industry are not members of the division. But if you were relatively new in the field and wanted to make contacts to look for that type of involvement with industry, the division might be a good way to do it.

Does having an industry division provide an interface between the professional community and industry that isn't available through other trade or professional associations?

Nobody's really approached us from that point of view. And maybe it's just that nobody's thought about it. Outside the United States, in organiza- tions similar to AACC, they're very sur- prised at the involvement of industry in AACC because it's something that does not typically happen in their professional societies.

Many, many years ago there was a sentiment that industry members weren't real members, but I think that has undergone a tremendous change. Everybody is very comfortable these days with the notion that people from industry are also valid scientists with a lot to contribute, and that industry and the laboratorian community share many of the same concerns.

Are there particular issues—such as the regulation of genetic testing—where there is likely to be a great difference of opinion between the professional laboratorian community and the manufacturing community?

The major conflicts are currently in how to regulate point-of-care testing and genetic testing. Many of our customers indicate that they want us to get CLIA-waived status for our technologies. But on the laboratorian side there's great concern about more and more tests becoming CLIA waived.

This is one of those areas that still requires a lot of discussion. Initially, in many people's minds, CLIA-waived status meant that the product would be approved for home use. But clearly there are many products that are truly simple to use and unlikely to result in wrong answers—which are the essential criteria for waived status—and yet they would never be suitable for home use. They're still professional-use products.

Even so, because people tend to think that as soon as something has waived status it's going to be used in the home, the trend toward creating more waived products still causes a lot of concern and conflict.

A Process for Permanence

To initiate the industry division you first had to get it established as a provisional division within AACC, is that correct?

Right, and there is a limit on how long a provisional division can exist. During that period the group has to demonstrate a number of things so that the organization knows it has the likelihood of being a viable division. Having bylaws and having had officers and some turnover in the leadership of the division are important considerations.

We're now in the process of sending the division's initial bylaws and slate of officers for a vote by the division's members. The division has to have those in place and functioning in order to apply for full status.

What is AACC's formal process for making a provisional division into a permanent one?

The division submits its application to become a permanent division to the divisions management group, which determines whether all the requirements for obtaining permanent status have been met. Then the AACC house of delegates and board of directors both look at the application. Ultimately, it is the house of delegates that gives final approval for a division to transfer from provisional to permanent status.

Is all of that procedure accomplished at the annual meeting or is it done in steps beforehand?

It's done in steps. The final step is the vote by the house of delegates, which only comes together at the annual meeting. For the industry division, we're anticipating that vote would take place at next year's annual meeting, because we have to have gone through our first elections and had our bylaws in place for a year.

Are the industry division members strongly committed to the division, or are they more standoffish at this point?

As with most divisions throughout the entire association, we have a small group of people who are very committed to the industry division and are willing to step up anytime we need something done. The majority of members participate in some programs, but otherwise have a wait-and-see attitude. And then there are some members we never hear from. In this respect, I don't think this division differs from other divisions.

Is there a formal program committee within the division?

Yes, but so far this year we have been concentrating on getting the bylaws written and the slate of officers elected.

Last year, we had a division workshop in conjunction with the Oak Ridge Conference, but we didn't have quite the turnout we had hoped for. We've also tried to do programs on AACC's "Division Focus Day," which is the Saturday before the annual meeting, but we discovered that a lot of industry members don't come in until Monday.

So we're still trying to find a time slot that would be acceptable within the annual meeting structure, and when we could have a division meeting in which more of the members would be able to participate.

When is the industry division meeting scheduled at this year's meeting?

It's on Monday at 10:00. That seems to be the day that is most open for industry members.

Of course IVD Technology is a sponsor of the Oak Ridge Conference, which has a focus on emerging technologies that seems especially appropriate for industry members.

I agree, and in the minds of AACC's meeting developers the Oak Ridge Conference is the meeting for industry. And yet, that's not where you see a lot of the industry members coming. Part of that may be related to the fact that in today's environment there is very limited funding for attending meetings.

But there is much more of an interest in going to the annual meeting, because it combines a large number of scientific and clinical presentations with an exhibit hall. And that's really important for industry members also; it's their chance to see competitors' offerings and to interact with the supplier companies in the OEM section.

How can AACC members get involved in the industry division?

For members of the association, the additional fee for any division membership is $15. Each of the divisions has a home page on the AACC Web site (http://www.aacc.org), and the officers and contact information are listed there.

The industry division home page lists the goals and objectives of the division. It also includes a survey of members asking what sector of industry they work in and what activities they're interested in. That's one way we're continuing to get more information about what our members are interested in.

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