2006 Annual Scientific Meeting:
Impact the Future of Pharmacopeial Standards

Opening and Closing Sessions

Wednesday & Friday, September 27 & 29, 2006
Marriott Denver City Center, Denver, Colorado

Notes

Opening Session
Wednesday, September 27, 2006

  1. Welcoming Remarks
    Dr. Roger Williams called the meeting to order at 8:30 a.m. and welcomed everyone to the third USP Annual Scientific Meeting.
    1. USP Convention Update
      • Dr. Darrell Abernethy discussed the Convention Committees and Council of the Convention (CoC).
      • The CoC comprises USP Convention members who bridge the gap between the Convention and the rest of USP.
      • The charge to the CoC is to enable better communication and understanding of USP so that USP better serves its stakeholders.
      • The CoC is considering sections that will address specific topics of interest by Convention members to guide USP. The sections may meet at the next Annual Scientific Meeting in Tampa, Florida, in 2007.
      • 2006 Annual Scientific Meeting attendees are encouraged to provide feedback to USP so that USP can better serve the members of the Convention.
    2. Board of Trustees (BoT) Update
      Dr. John Mauger discussed USP's Strategic Objectives and Resolutions.
      • The BoT includes members who have a history of activity with USP on Expert Committees and other volunteer bodies.
      • The BoT works within the context of the organizational structure and governance of USP. The Strategic Plan is taken very seriously by the Board. It is dynamic and revisable to respond to USP's changing circumstances.
      • Thirteen Resolutions were adopted at the 2005 Convention (http://www.usp.org/aboutUSP/resolutions.html).
      • USP's international strategy involves moving beyond English (translations), moving beyond current offerings (education, partnerships) and moving outside the US (international and through partnerships with USAID and others).
      • The BoT has approved the following initiatives:
        A USP site in China
        Verification of pharmaceutical ingredients
        Development of standards for medicines marketed outside of the US to treat neglected diseases
        Acquisition of the Food Chemicals Codex to assure quality of food additives.
      • USP understands the need to be sensitive to the needs of patients and practitioners in the regions where USP is expanding its role.
      • USP is providing monographs and Reference Standards to support first, second, and third party testing throughout the world. USP is participating in IMPACT, the international anti-counterfeit initiative of the World Health Organization (WHO).
      • The Institute of Medicine (IOM) has released three key reports on quality of care. USP wants to contribute to this effort and welcomes feedback from Annual Scientific Meeting participants.
      • Participants received USP's Grand Challenges document with their briefing materials. Participants are encouraged to read it and provide feedback.
    3. USP Update
      Dr. Williams explained how USP staff are translating the strategic objectives of the BoT into action.
      • USP is a science-based compendium that rejects ideology and anecdotal reports and seeks the best evidence to support its standards-setting activities.
      • USP is a standards-setting body. USP is not a voluntary consensus-based standards setting body. Volunteers represent their experience and wisdom but do not act on behalf of their organizations or companies.
      • USP's publications are expanding.
        USP-NF will become a three volume set.
        The USP-NF Spanish translation is being maintained.
        The USP-NF Russian Translation will be an abstraction of the official compendia.
        The Pharmacist's Pharmacopeia provides information to the compounding community.
        Pharmacopeial Forum facilitates transparency and public input into USP standards.
      • New initiatives and line extensions include the following:
        USP-NF Redesign
        Veterinary Compendium
        Dietary Supplements Compendium,
        Compendium of Safe Medication Practices
      • The internet, electronic, and informatics revolutions are transforming USP.
      • USP should learn from different sources of information in the quality of care arena.
      • USP's healthcare information program now focuses on voluntary standards for the Medicare Part D benefit through the development of the Medicare Model Guidelines, a structure for Pharmacy and Therapeutics (P&T) committees as they develop their drug plan formularies.
      • USP's patient safety programs also speak to quality of care.
      • As a 501(c)3 charitable organization, donations enable USP to exist. Donations include volunteer time, information, and bulk materials for Reference Standards. The BoT oversees the utilization of resources. USP has a stable financial base, as can be seen in its annual report.
      • USP's Resolutions drive USP into the future.
      • The new Director of Pharmacopeial Education, Toby Gouker, is guiding USP's educational efforts beyond the current offerings.
      • USP participates in the Pharmacopeial Discussion Group (PDG) to further efforts to harmonize the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the USP.
      • USP wants to reach out to regulatory compendia in other parts of the world and to regulatory agencies where we can provide service and support.
      • Nancy Blum works with USAID programs that speak to the special needs of developing countries.
      • USP's Memoranda of Understanding (MOU) with Singapore, India, and China represent partnering opportunities and contemplate the development of workplans for joint activities.
      • Regarding USP's MOU with India:
        The Indian Pharmacopoeia is becoming more independent.
        Dr. Nitya Anand, a Member of the Indian Pharmacopoeia Commission, heads the Joint Working Group of this MOU, with Dr. Williams. Working groups have been formed around the following hot topics: (1) monograph harmonization, (2) training, (3) biologics and biotechnology, and (4) reference standards.
      • USP has sites and offices where pharmaceuticals are manufactured, including India, China, and Europe (sales office in Basel, Switzerland).
      • Bulk pharmaceutical ingredients are being imported increasingly from India and China and shipped to dosage form manufacturers that make them into products. USP encourages feedback on what its role should be in this area.
      • USP's activities revolve around a set of meetings (Annual Scientific Meetings and Stakeholder Forums) or a "cycle of life" that relates to the USP Convention, which meets every five years.
      • Measurement Science and metrology was presented in a graphical slide. Scientific concepts of measurement will impact our compendia and quality control laboratories.
      • USP is ISO certified.
      • ISO defines a Certified Reference Material as the estimation of content of active pharmaceutical ingredient in the drug substance. Through collaborative testing, a measurement of uncertainty is determined.
      • USP is submitting three papers on performance verification and collaborative testing of Prednisone Lot P through the Biopharmaceutics Expert Committee to the Journal of Pharmaceutical Sciences.
  2. Keynote Panel: New Directions

    Dr. James Akers, Chair of the Resolution 3 – New Science and Technologies Ad hoc Advisory Panel, introduced the keynote speakers, (Members of the Advisory Panel). Resolution 3 states the following:

    "USP resolves to work with appropriate stakeholders to track emerging sciences and technologies, and when appropriate, to develop information, best practices, and standards that have direct applications to the public health and patient care."

    The Resolution 3 Advisory Panel is a newly formed group of 17 distinguished members from the healthcare sciences, policy, and practice arenas. The Advisory Panel met the previous day with members of the Executive Committee of the Council of Experts and the Board of Trustees. Four of the members agreed to present to the attendees at the Annual Scientific Meeting on standards-setting opportunities for USP for new technologies.

    Dr. Rodney Ho – Challenges in Biotechnology

    • USP is faced with challenges resulting from technological progress. Expectations of stakeholders are diverse and their expectations are for faster, cheaper goods and services.
    • In the evolving paradigm of drug development, chemists need to determine how to integrate technological progress more efficiently and effectively.
      In the old paradigm, small companies were viewed as innovators that partner with large companies to market and produce drugs.
      Now, big pharmaceutical companies are trying to integrate biotechnology to produce products that are effective, safe, and low cost.
    • Standardizing testing for the neutralization of antibodies in biological products is a challenge being faced by USP.
    • USP should position itself to help set new standards for using biotechnology as a tool for drug discovery and development, safety and efficacy evaluation, and clinical use and practice. USP should develop strategies to critically evaluate the technologies as they are developed.

    Dr. Steve Leeder - Pediatric Pharmacogenenetics and Developmental Pharmacogenomics

    • Pediatric populations should benefit from the knowledge of the (post) genomic era.
    • New technologies most applicable to pediatrics include the following:
      Phenotyping probes
      Disease-related biomarkers
      Genotyping/genetic testing
    • Understanding of the developmental trajectory of patients is needed.
      Biological processes change as children grow and develop.
      The choice of measurement technologies should depend on the developmental stage of the child (except for children with genes that have a low ability to metabolize the drug).
    • Who will apply the new technologies and who will interpret the information? Monographs need to be clear and detailed.
    • Education is needed to utilize the new technologies.
    • How are the results of a genetic test converted to the appropriate dose for a child or adult? Who holds the companies accountable for the dosing information they provide? Responding to this issue presents an opportunity for USP, the Food and Drug Administration (FDA), and professional licensing organizations.
    • Children are a population with unique issues. There are other populations with their own unique issues such as geriatrics.

    Mr. Amir Attaran – Public Health Policy

    • USP is a powerful advocate for good use as well as good quality medicine.
    • It can be difficult to establish whether a product is good. Biologicals are a challenge, they are different from small molecules.
    • Abbreviated New Drug Applications (ANDAs) for biogenerics that are coming off patent in the next few years will present challenges. Regulation of these products will become more complex. USP could provide guidance and set standards in this area.
    • The needs of patients around the world are often overlooked. The problem of health has only recently been "medicalized" in developing countries, illustrated by mass malaria eradication campaigns.
    • Vaccines are purchased by international aid donors such as the United Nations Children's Fund (UNICEF) and the Global Alliance for Vaccines and Immunization (GAVI). The quantity and quality of the drugs purchased by these organizations is not equal to that of wealthier countries. USP could work with these agencies to develop a more principled approach to what is bought with western tax money.
    • USP is working in Vietnam and Zambia to monitor the quality of anti-malarial drugs. USP has found reports that many of the medications are substandard (see Trans R Soc Trop Med Hyg. 2006 Nov;100(11):1019-24; J Clin Pharm Ther. 2005 Dec;30(6):559-65; and Trop Med Int Health. 2004 Dec;9(12): 1241-6).
    • Standards-setting and surveillance exercises could be moved abroad in partnership with the WHO.
    • The relationship between information technology and medical treatment could be leveraged to improve care in the developing world. There are very few healthcare practitioners available to treat those in developing countries who are infected with the Human Immunodeficiency Virus (HIV). Information about HIV drugs along with a protocol checklist could be programmed into an electronic handheld device so that a nurse in Africa could provide safe HIV treatment.
    • The definition of a drug could be explored. Insecticides such as DDT are used to eradicate diseases like malaria. Malaria kills more children in Africa than any other disease each year. No one is setting standards for these insecticides. Could USP set standards for these public health insecticides?
    • Regulation and the harmonization of standards should be a top priority. The need to register a product in every country hampers the ability to get the drugs to the people who need them.
    • Global public health is getting better for the rich, but not for the poorest people.
    • A fear about vaccine product quality hampered the eradication of polio in the world, which was "cornered" in a small area of Nigeria. The availability of a quality standard, and the provision of drugs manufactured to these standards, could have made a difference. But with the lack of quality standards, the vaccine program was suspended and polio is on the rise again.

    Dr. Thomas Oliver

    • The US government's role providing healthcare includes the following:
      Filling gaps not filled by voluntary organizations
      Redistributing income through subsidies such as Medicare and Medicaid
      Allocating resources by underwriting research and development, often through partnerships with organizations
    • Participants in the policy process are generalists and specialists.
      Generalists are dependant on the specialists.
      Although health is a political issue, experts may ignore the politics of science and technology.
      The task is to achieve acceptance of a scientific conclusion across a wide range of stakeholders.
    • USP could influence policymakers who need to determine who is eligible for subsidies.
    • The tension between what is potentially valuable healthcare and who is going to pay for it will continue to increase.
      Interest in importing drugs from Canada and Mexico is causing rethinking about the pricing of US drugs.
      Change is needed to keep innovation engine running.
      More pressure on sharing the cost of drugs will be seen in the future.
    • USP could help determine uses of electronic records for diagnosis and treatment as well as accountability and post-marketing safety.
    • The economics and politics of healthcare are determining the provision of healthcare around the world. USP should bring together stakeholders from around the world to obtain full input on worldwide issues.
    • USP will need to maintain its independence as it makes connections to direct policy making.

  3. Question and Answer Session
    • Question: If USP was to set standards for insecticides such as DDT to help eradicate malaria, what kind of risk/benefit analysis would be needed?
    • Answer (Dr. Attaran):
      There are misperceptions on how DDT is used in this context. It is never used outdoors for malaria control. A few grams are sprayed on interior walls. For example, to treat one hectare of cotton, two tons of DDT would be needed. Only 200 grams are needed to treat a house.
      DDT could be harmful to the people in the house. WHO recently called for increased residual spraying and there are discussions about including toxicity studies.
      DDT is the most studied chemical over the last few decades. During that time, no health effects have been replicated.
      If a risk was found in an epidemiological study with an odds ratio of two or three, those findings would not be ruled out. A risk/benefit analysis would then be needed.
      Radiation is used in oncology because it has a benefit profile that exceeds the risk of using it.
    • Comment: The UN procurement process faces challenges related to neglected diseases. Many countries are using the prequalification process when purchasing medications for tuberculosis (TB), malaria, and HIV/AIDS.
    • Answer (Dr. Attaran):
      The present WHO program is not adequate as it only covers those three diseases. Poor countries should not spend their money on regulation as they won't be able to meet the standards met around the world. A regional or sub-regional mechanism is needed to regulate medications throughout the region.
    • Comment: In Africa, Nigeria is working on HIV/AIDS drugs. USP could play a big role in reducing the fear of compromised quality for HIV/AIDS drugs. People would take any drug that was labeled for the treatment of HIV/AIDS. An independent organization like USP would be effective in many countries as it would transcend politics.
    • Question: People are being eliminated from risk pools because the risk pool can't afford it. We have eliminated people from poor countries from the risk pool. The US has eliminated the uninsured. Won't it get worse?
    • Answer (Dr. Oliver):
      A technical advisory committee in Maryland has struggled with a variety of plans to provide universal healthcare for state residents due to the inability of the federal government to provide such care.
      Attempts have been made to get companies to provide healthcare coverage for their workers.
      It will take a vast majority of Americans feeling insecure about health coverage for the federal government to do anything about it.
      American leadership needs to set the tone for priority issues.
      Politicians need to see that they will get political rewards for doing this, even though the beneficiaries are usually not voters.
    • Question: We care about efficiency in the system. Do we need to get better mileage out of the money that is being used in the system?
    • Answer (Dr. Oliver): No. Universal coverage would provide the budgetary pressures for getting the people together to make the hard choices.
    • Question: Humans are not stable systems over time. How will animal studies be integrated? Answer (Dr. Leeder):
      The time span where a person's development is changing dramatically is short compared to the time that a person's development is stable. Gene marker studies have been done in animals. Which markers would be used for humans? The challenge is to determine how things can be done in a human context so that these questions can be answered.
    • Answer (Dr. Ho): As people age, enzyme activities decrease. How will we educate the public about safety issues? How will we deal with increased expectations of the public around drug safety?

      • Dr. Williams thanked the Annual Scientific Meeting attendees for their input. He noted that the Advisory Panel will continue to work with these questions. Members of the Advisory Panel could be part of the future volunteer leadership of USP.

  4. Overview of Annual Scientific Meeting Topics
    Dr. Todd Cecil noted that the Annual Scientific Meeting provides an opportunity for constituent users of USP-NF to have a voice in how the standards are set. Expert Committee Members will attend the tracks. Open feedback and discussion is encouraged. He then reviewed the focus of each of the seven tracks.

Dr. Williams thanked the participants for attending the meeting. The opening session was adjourned at 11:30 a.m.



Closing Session
Friday, September 29, 2006

  1. Welcoming Remarks Dr. Todd Cecil called the meeting to order at 11:00 a.m. and welcomed everyone to the closing session of the third USP Annual Scientific Meeting. He thanked everyone for coming to the Closing Session and for attending the sessions over the past few days. The workshop track leaders provided summaries of the sessions.
  2. Session Reports

    Track I – Biologics and Biotechnology (Dr. Lynn Yeoman)

    • The role of USP is to continue to foster forums to work toward the harmonization of monographs to continue to pursue USP's global initiatives.
    • USP is developing General Chapters on antibody methods, binding assays, and functional and surrogate assays, as well as monographs and Reference Standards for Protein A.
    • Challenges in replacing bioassays were discussed.
    • USP should continue to provide this kind of forum for the sharing of knowledge and insight to address problems of intellectual property for the innovator and producer.
    • USP should continue to provide reliable and meaningful tests and general guidance, convene workshops, expand understandings, and develop guidance in areas not covered by compendial assays.

    Track II – Dietary Supplements (Dr. Gabriel Giancaspro)

    • The fast growing dietary supplements market was discussed.
    • The science behind vitamin D, fish oils, multivitamins, and noni juice was presented.
    • Quality topics included a discussion of how particular dietary supplements analyzed by different labs often yield different results.
      Reference Standards are needed for dietary supplements.
      USP could generate uniform methods for analysis, including dissolution and testing of performance characteristics of dietary supplement dosage forms.
    • The global regulatory framework for dietary supplements was discussed.
      Although Europe has a regulatory framework where herbals are considered drugs or traditional medicines, there is a need for further regulation because different countries have different standards.
      In Latin America, there are different levels of regulation in different countries. Harmonization and a focus on developing local plans for herbal medicine are needed.
      The situations in Canada, China, Japan, and India were discussed.
    • Regarding the reporting of adverse events, the safety classification of dietary supplements may change. Input was received from participants on what USP can do to improve reporting for dietary supplements.
    • An analysis of dietary supplement legislation in the US Congress was presented.

    Track III – Excipients (Dr. Chris Morton)

    • A proposed General Chapter on excipient performance tests was discussed.
    • The results of a USP survey on excipient performance testing was reviewed. The consensus among participants was that sections on differentiation for labeling and identity testing should be included in monographs, but performance testing should not be included.
    • There is a need for universally accepted definitions of excipient, additives, and other components.
      Europeans use the term "functionality related testing" for performance testing.
      There is a need for harmonization.
      Stakeholders need to be involved in the harmonization process.
      A grandfathering clause will be needed.
    • The different regulatory treatment of co-processed excipients compared to additives was discussed.
    • New excipient technologies were discussed, including the following topics.
      Progress in developing new technologies
      The need to improve and add appropriate tests and specifications with more definitive procedures
      Raman and Near-Infrared Spectrometry (NIR) will be utilized.
      Revisions to <911> and the development of <912> and <913> are expected.
    • The nature of drug/excipient interactions and types of methods to detect them were discussed.
      Not much work has been published in this area.
      A General Chapter could be done.
      Experiences could be posted on the web.

    Track IV – Impurities (Dr. Judy Boehlert)

    • Representatives from USP and the EP discussed compendial and regulatory issues. Standardization of terminology should be a high priority, including the following:
      Response factors vs. correction factors
      One vs. two decimal place
    • The FDA is preparing guidance on impurities in drug substances and is revising guidance on impurities in drug products.
    • The safety of inorganic impurities should be studied.
    • Generic manufacturers are concerned that the FDA will review the original monograph when their Abbreviated New Drug Application (ANDA) is filed.
    • Some new technologies are robust, others are good research tools. Although there is a paucity of these methods in USP, there is no need for General Chapters on techniques that are not referred to in monographs.
    • Three documents on genotoxic impurities were reviewed.
      Known genotoxic impurities are addressed differently than those that are unknown.
      The As Low As Reasonably Practicable/Possible (ALARP) concept was discussed.

    Track V – USP Working for You (Dr. Todd Cecil)

    • A discussion of the essentials of USP-NF received positive feedback.
    • There was interest in the ingredient verification system and the new USP sites in India and China.
    • Standards for Articles Legally Marketed Outside the US (SALMOUS) monographs were discussed. USP wants to move these monographs and their associated Reference Standards through the process quickly.
    • Standards for Articles Pending FDA Approval (SAPFA) monographs will allow generic manufacturers to submit their monographs to USP prior to FDA approval.
      When a SAPFA monograph is approved for publication, it is published on the USP Web site. When the drug is approved by the FDA, the monograph is then published in the USP-NF.
      Allowing Drug Master File (DMF) material into SAPFA directly could dilute the impact and increase the workload of industry.
    • New rules were discussed.
    • The redesign of USP-NF was presented.
      A prototype of the redesign that will appear in USP 32 was presented.
      Participants generally liked the format and style.
      There was concern about moving tests and insuring that they were in the correct locations.
      As USP transitions to the new style, the scientific significance of the process should not be changed.
    • Participants brainstormed on ways to interact with industry more effectively.
      More transparency for proposals for review was requested.
      There could be restrictions on who can comment.
      The ability to view the current status of proposals was requested.
    • USP will consider the comments of participants as it improves its interactions with industry and pursues the redesign of the USP-NF.

    Track VI – Reference Standards (Dr. Ray Cox)

    • This was the first major USP meeting where the Reference Standards topic has had such a large focus with a broad topic range in all of the sessions.
    • The Reference Standards Expert Committee is seeking input. Suggestions on how the program should progress and improve were encouraged.
    • Continued Suitability for Use was discussed.
      The transparency of the program is good.
      USP's program is getting better with time.
      There is improvement in the amount and frequency of testing, the number of actual programs, fewer failures, on-time shipment of Reference Standards, and evaluations of what happens to a Reference Standard when it is shipped.
    • Standards for performance specifications were discussed.
      Dissolution has been around for a long time. Interest in this test procedure has never waned.
      Lots of research is still going on to evaluate dissolution and other performance testing.
    • Although there is a move to replace bioassays, there will still be a need for bioassays in the foreseeable future. Reference Standards for bioassays are complex and require special handling and understanding.
    • Reference Standards are critical to the USP standards program. Other tracks discussed Reference Standards.
    • It is important for USP to look into Certified Reference Materials (CRM). Concern was expressed regarding how CRMs will be used from a regulatory standpoint. The USP CRM program should be of high quality.

    Track VII – Chromatography (Dr. Horacio Pappa)

    • The USP column equivalency project was discussed. A new classification for HPLC columns as well as a Web site for column equivalency are being developed.
      A prototype for the Web site, which will become operational in 2007, was presented.
    • Two-dimensional chromatography topics were discussed, including the following:
      The reproducibility of HPLC columns
      The use of bioavailability of column packing by manufacturers
    • New advancements in Thin-Layer Chromatography (TLC) were discussed.
    • Old techniques in compendial methods are still important due to the potential simplicity of the techniques.
    • Techniques used to scale down the HPLC method to micron technology were well received.

    Special Topic – International Quality and Performance Topics (Dr. Sol Stavchansky)

    • This track represented a time to reflect on tremendous innovation.
    • USP should not contribute to the principle causes of inequity in the world, which are rapid technological advances and globalization.
    • USP should be careful when discussing types of equipment and infrastructure.
    • Discussion of the quality of multisource products included the following topics:
      Activities of the Pan American Health Organization (PAHO) The Biopharmaceutics Classification System (BCS) and how it will accelerate the interchangeability of drug products in the world – USP has the opportunity to develop permeability and solubility standards for BCS waivers. USP initiatives related to global reference products to allow regional interchangeability in the world
    • The following topics relating to impurities were discussed:
      A challenging presentation about the Chinese pharmacopeia and the FDA perspective on impurities and ANDAs
      Flexible monographs and the compounding perspective
    • USP should be pragmatic when talking about impurities.
      The cost of access to pharmaceuticals as they relate to standards setting activities in the monographs
      In the case of monographs on antiretroviral agents, a pragmatic approach is used by the international pharmacopeia.
      The FDA takes another approach by applying ICH guidelines (intended for new drugs) to ANDAs.
      USP limits may be used for known impurities only.
      Reference Standards for impurities are needed.
    • Topics discussed pertaining to flexible monographs included the following:
      Must the required tests be on the label?
      How would more than one method be selected?
      Are metabolites as impurities cost effective or needed?
    • Consensus among participants was that USP should concentrate on toxic impurities for multisource products.
      Experience obtained from the innovator's product should be used. A global comparator (e.g., Reference Standards) is needed to establish the interchangeability of multisource products.
    • The difference between compliance and testing was discussed. If a company complies, it doesn't need the flexible monograph.
    • Qualifying is not equal to acceptance criteria.
    • Pharmacopeias should not be barriers to trade.
    • Most countries have "similares", not generics, and they are usually substandard.
    • What happens in the USP impacts the world.
    • It is the creativity of our community that allows us to impact the world in a positive way.

    Discussion

    • Question: The last session on Reference Standards left the impression that processes were already underway and it would be difficult to stop them. Industry's voice may not have been heard.
    • Answer (Dr. Cox): Industry's voice was heard. A lot more discussion and investigation around Reference Standards will be pursued. Industry is encouraged to continue providing feedback to USP.
    • Comment: Future programs should consider the impact of our changing environment on Reference Standards. Drug standards vs. the stability of products in hot environments and the impact of global warming on the stability of products should be investigated.

  3. Closing Remarks
    Dr. Williams noted the dates for the following USP meetings:
    • January 17–19, 2007: PDA-USP Joint Conference: Residual Solvents (Bethesda North Marriott Hotel & Conference Center, North Bethesda, Maryland)
    • September 25–28, 2007: USP 2007 Annual Scientific Meeting (Hyatt Regency Tampa, Tampa, Florida)
    • September 23 – 26, 2008: 2008 USP Annual Scientific Meeting (Westin Crown Center, Kansas City, Missouri)

Dr. Williams thanked everyone for a wonderful meeting. The meeting was adjourned at 11:50 a.m.