American Society For Clinical Pharmacology And Therapeutics Research Articles

Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop.

Extrapolation from adults to youth with type 2 diabetes (T2D) is challenged by differences in disease progression and manifestation. This manuscript presents the results of a mock‐team workshop focused on examining the typical team‐based decision process used to propose a pediatric development plan for T2D addressing the viability of extrapolation. The workshop was held at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in Orlando, Florida on March 21, 2018.

MID3: Mission Impossible or Model-Informed Drug Discovery and Development? Point-Counterpoint Discussions on Key Challenges.

MID3: Mission Impossible, or Model‐Informed, Drug Discovery and Development? At the 2019 American Society for Clinical Pharmacology and Therapeutics (ASCPT) annual meeting, point‐counterpoint discussions were held on key challenges that limit, and future directions that enhance the adoption of model‐informed drug discovery and development (MID3) across the drug discovery, development, regulatory, and utilization continuum. We envision that the opportunities discussed and lessons learned from having contrasting perspectives on issues that lack consensus may aid our discipline in more effectively implementing MID3 principles.

Toward Progress in Quantitative Translational Medicine: A Call to Action.

Quantitative translational medicine (QTM) is envisioned as a multifaceted discipline that will galvanize the path from idea to medicine through quantitative translation across the discovery, development, regulatory, and utilization spectrum. Here, we summarize results of an American Society for Clinical Pharmacology and Therapeutics (ASCPT) survey on barriers relevant to the advancement of QTM and propose opportunities for its deployment. Importantly, we offer a call to action to break down these barriers through patient-centered stewardship, effective communication, cross-sector collaboration, and a modernized educational curriculum.

Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care.

While efficacy and safety data collected from randomized clinical trials are the evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers, and payers) and guarantee long‐term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real‐world evidence (RWE) to substantiate benefit–risk assessment and support the value of a new drug. This review provides an overview of real‐world data (RWD) and related advances in the regulatory framework, and discusses their impact on clinical research and development. A framework for linking drug development decisions with the value proposition of the drug, utilizing pharmacokinetic–pharmacodynamic–pharmacoeconomic models, is introduced. The summary presented here is based on the presentations and discussion at the symposium entitled Innovation at the Intersection of Clinical Trials and Real‐World Data to Advance Patient Care at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 Annual Meeting.

In Memoriam: Darrell R. Abernethy 1949–2017

We lost Darrell Abernethy on November 18, 2017 – two weeks after his 68th birthday. He was a fixture in the clinical pharmacology community for 40 years. Just two months before his passing, Darrell was with us at the September 2017 Annual Meeting of the American College of Clinical Pharmacology. He was his usual laid-back, understated, grinningly cynical self. Now he is gone. Darrell was a native of Beloit, Kansas – population about 4000. His Beloit High School Class of 1967 had some 60 graduates. With such small numbers, the school could field only a 6-man football team – Darrell was a 2-way star. From high school Darrell went on to the University of Kansas, where he received his undergraduate degree, and ultimately his combined M.D. – Ph.D. degree in 1976. His Ph.D. work, done under the mentorship of Dan Azarnoff, dealt with drug effects on cholesterol biosynthesis, and was published as papers in Steroids and in Biochemical Pharmacology. Darrell was 28 years old at the time. Darrell moved to Miami to do his internal medicine clinical training at Jackson Memorial Hospital and the University of Miami. In that two-year period, he saw, in his words, “some pretty gritty stuff.” Meanwhile, he became a lifelong Miami Dolphins fan. Inspired by Dan Azarnoff, Darrell developed a determination to become a clinical pharmacologist, and embraced the discipline with a tenacity that remained undiminished over the next 4 decades. He moved to Boston where he trained at Tufts University School of Medicine as a postdoctoral fellow for 2 years, followed by 2 years on the faculty as an assistant professor. During those years, one of us (DJG) worked with him literally every hour of every day, leading to a close professional and personal bond. His research work was intense and relentless, yielding some 80 original research publications, as well as many more reviews, editorials, chapters, and commentaries. His work touched several areas of clinical pharmacology – age and gender effects on drug disposition, pharmacokinetic drug interactions, and drug uptake into the central nervous system. Darrell's studies on drug distribution and clearance in obesity are of lasting impact on the field. He clearly demonstrated that drug distribution and drug clearance are independent entities, working in concert to determine elimination half-life. He thereby dispelled the notion that drug distribution depends on elimination. Darrell was of course a recruiting target for medical schools and hospitals across the country. In 1983 he moved to Baylor College of Medicine, joining their hypertension and clinical pharmacology program under the direction of Jerry Mitchell. On his first try, Darrell was awarded his first R01 grant in support of further basic and clinical studies of drug disposition in obesity. His next professional stop was Brown University and Rhode Island Hospital (1986–1994), then Georgetown University and Medical Center (1994–1999). Each stop in his professional career was marked by astounding research productivity, and a personal leadership style and work ethic that energized and inspired his colleagues and trainees to maximize available opportunities for personal skill development as well as service to the scientific community. Darrell moved to the public sector in 1999, serving as Chief of the Laboratory of Clinical Investigation (LCI) for the National Institute on Aging from 1999 to 2007. The LCI is a diverse lab, and he supervised its 3 major sections consisting of bioanalytical chemistry and drug discovery, diabetes, and magnetic resonance imaging and spectroscopy. His own lab continued research into calcium channel antagonists and the role of splice variants on the biophysical properties of calcium channels. Always looking for new and better methods to add insight into pharmacological systems, Darrell also explored the application of neural networks for antiplatelet pharmacodynamics, utilized wavelet and Fourier transforms in pharmacological imaging and heart rate variability analysis, and introduced the drug burden index for assessing the burden of medications in the elderly. Darrell was a post-doctoral advisor to one of us (DEM), and he is remembered as an outstanding mentor, a role that he took very seriously. He led by example, guided and inspired so many, and represented the ideal in what it means to be a mentor and leader. After a stay as Chief Scientific Officer of the United State Pharmacopeia (2007–2009), Darrell assumed his most recent position as Associate Director for Drug Safety in the Office of Clinical Pharmacology in the Food and Drug Administration. In the Office of Clinical Pharmacology, Darrell played the role of a senior adviser, and was a person who never hesitated to speak his mind. He took on numerous interns and fellows, and enjoyed the challenges of new therapies and technologies. In the later stages of his career, Darrell's research and writings took on clinical pharmacology issues and problems in a broader context: the drug burden index as it emerged as a predictor of adverse drug reactions, particularly in the elderly; and the use of systems analysis approaches to understand the risk of drug interactions and drug toxicity. Had Darrell lived to pursue and develop these ideas further, the benefit to the scientific community and the public health in general would have grown in parallel. The many years of creativity left in his mind were cut short by his failing health. A final striking feature of Darrell's life was how often he was sought after by his colleagues and peers to serve as a leader and advisor. His style was no-nonsense and no-frills. He rendered his opinions and assessments honest and concisely, yet always good-naturedly and with a tinge of cynical humor. His leadership positions over the years are too numerous to present in full, but by way of example he served as President of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), President of the United States Pharmacopeial Convention, and Chair of the American Association for the Advancement of Science. He was Editor-in-Chief of Pharmacological Reviews and of Pharmacology Research and Perspectives, and served on the editorial boards of many other scientific journals. Over the years he chaired numerous NIH study sections and review committees. He received the Rawls-Palmer Progress in Medicine Award as well as the Abrams Award in Geriatric Clinical Pharmacology from ASCPT, and the Nathaniel T. Kwit Distinguished Service Award from the American College of Clinical Pharmacology. No doubt many other recognitions and honors were in his future had he lived into his senior years. Many of us witnessed Darrell's extraordinary dedication to the discipline of clinical pharmacology at the recent 2017 Annual Meeting of the American College of Clinical Pharmacology in San Diego. Despite his deteriorating health, Darrell developed and co-chaired a scientific symposium on biosimilars, where he presented on biosimilar interchangeability, an area in which he again provided ground-breaking scientific leadership by contributing to the establishment of the FDA's regulatory framework in this emerging field of clinical pharmacology. Darrell was not all work. He had great affection for his Labrador Retrievers. He was a sailing enthusiast, and embraced the gadgetry, jargon, and swagger of the mariner. At his last ACCP Annual Meeting in September of 2017, Darrell took particular delight in watching the boats in the San Diego bay at dinner. He loved tractor pull competitions, and never missed an episode of The Dukes of Hazzard. He was always fit and trim, and was religious about his exercise program. What I remember vividly are holiday dinners at his home or mine, hiking to exhaustion in the White Mountains, hours spent on the bay waters of Rhode Island, and pre-dawn runs through the streets of inner-city Washington. We will miss him terribly.

In Memoriam: Darrell R. Abernethy, 1949–2017

We lost Darrell Abernethy on November 18, 2017 – two weeks after his 68th birthday. He was a fixture in the clinical pharmacology community for 40 years. Just two months before his passing, Darrell was with us at the September 2017 Annual Meeting of the American College of Clinical Pharmacology. He was his usual laid-back, understated, grinningly cynical self. Now he is gone. Darrell was a native of Beloit, Kansas – population about 4000. His Beloit High School Class of 1967 had some 60 graduates. With such small numbers, the school could field only a 6-man football team – Darrell was a 2-way star. From high school Darrell went on to the University of Kansas, where he received his undergraduate degree, and ultimately his combined M.D. – Ph.D. degree in 1976. His Ph.D. work, done under the mentorship of Dan Azarnoff, dealt with drug effects on cholesterol biosynthesis, and was published as papers in Steroids and in Biochemical Pharmacology. Darrell was 28 years old at the time. Darrell moved to Miami to do his internal medicine clinical training at Jackson Memorial Hospital and the University of Miami. In that two-year period, he saw, in his words, “some pretty gritty stuff.” Meanwhile, he became a lifelong Miami Dolphins fan. Inspired by Dan Azarnoff, Darrell developed a determination to become a clinical pharmacologist, and embraced the discipline with a tenacity that remained undiminished over the next 4 decades. He moved to Boston where he trained at Tufts University School of Medicine as a postdoctoral fellow for 2 years, followed by 2 years on the faculty as an assistant professor. During those years, one of us (DJG) worked with him literally every hour of every day, leading to a close professional and personal bond. His research work was intense and relentless, yielding some 80 original research publications, as well as many more reviews, editorials, chapters, and commentaries. His work touched several areas of clinical pharmacology – age and gender effects on drug disposition, pharmacokinetic drug interactions, and drug uptake into the central nervous system. Darrell's studies on drug distribution and clearance in obesity are of lasting impact on the field. He clearly demonstrated that drug distribution and drug clearance are independent entities, working in concert to determine elimination half-life. He thereby dispelled the notion that drug distribution depends on elimination. Darrell was of course a recruiting target for medical schools and hospitals across the country. In 1983 he moved to Baylor College of Medicine, joining their hypertension and clinical pharmacology program under the direction of Jerry Mitchell. On his first try, Darrell was awarded his first R01 grant in support of further basic and clinical studies of drug disposition in obesity. His next professional stop was Brown University and Rhode Island Hospital (1986–1994), then Georgetown University and Medical Center (1994–1999). Each stop in his professional career was marked by astounding research productivity, and a personal leadership style and work ethic that energized and inspired his colleagues and trainees to maximize available opportunities for personal skill development as well as service to the scientific community. Darrell moved to the public sector in 1999, serving as Chief of the Laboratory of Clinical Investigation (LCI) for the National Institute on Aging from 1999 to 2007. The LCI is a diverse lab, and he supervised its 3 major sections consisting of bioanalytical chemistry and drug discovery, diabetes, and magnetic resonance imaging and spectroscopy. His own lab continued research into calcium channel antagonists and the role of splice variants on the biophysical properties of calcium channels. Always looking for new and better methods to add insight into pharmacological systems, Darrell also explored the application of neural networks for antiplatelet pharmacodynamics, utilized wavelet and Fourier transforms in pharmacological imaging and heart rate variability analysis, and introduced the drug burden index for assessing the burden of medications in the elderly. Darrell was a post-doctoral advisor to one of us (DEM), and he is remembered as an outstanding mentor, a role that he took very seriously. He led by example, guided and inspired so many, and represented the ideal in what it means to be a mentor and leader. After a stay as Chief Scientific Officer of the United State Pharmacopeia (2007–2009), Darrell assumed his most recent position as Associate Director for Drug Safety in the Office of Clinical Pharmacology in the Food and Drug Administration. In the Office of Clinical Pharmacology, Darrell played the role of a senior adviser, and was a person who never hesitated to speak his mind. He took on numerous interns and fellows, and enjoyed the challenges of new therapies and technologies. In the later stages of his career, Darrell's research and writings took on clinical pharmacology issues and problems in a broader context: the drug burden index as it emerged as a predictor of adverse drug reactions, particularly in the elderly; and the use of systems analysis approaches to understand the risk of drug interactions and drug toxicity. Had Darrell lived to pursue and develop these ideas further, the benefit to the scientific community and the public health in general would have grown in parallel. The many years of creativity left in his mind were cut short by his failing health. A final striking feature of Darrell's life was how often he was sought after by his colleagues and peers to serve as a leader and advisor. His style was no-nonsense and no-frills. He rendered his opinions and assessments honest and concisely, yet always good-naturedly and with a tinge of cynical humor. His leadership positions over the years are too numerous to present in full, but by way of example he served as President of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), President of the United States Pharmacopeial Convention, and Chair of the American Association for the Advancement of Science. He was Editor-in-Chief of Pharmacological Reviews and of Pharmacology Research and Perspectives, and served on the editorial boards of many other scientific journals. Over the years he chaired numerous NIH study sections and review committees. He received the Rawls-Palmer Progress in Medicine Award as well as the Abrams Award in Geriatric Clinical Pharmacology from ASCPT, and the Nathaniel T. Kwit Distinguished Service Award from the American College of Clinical Pharmacology. No doubt many other recognitions and honors were in his future had he lived into his senior years. Many of us witnessed Darrell's extraordinary dedication to the discipline of clinical pharmacology at the recent 2017 Annual Meeting of the American College of Clinical Pharmacology in San Diego. Despite his deteriorating health, Darrell developed and co-chaired a scientific symposium on biosimilars, where he presented on biosimilar interchangeability, an area in which he again provided ground-breaking scientific leadership by contributing to the establishment of the FDA's regulatory framework in this emerging field of clinical pharmacology. Darrell was not all work. He had great affection for his Labrador Retrievers. He was a sailing enthusiast, and embraced the gadgetry, jargon, and swagger of the mariner. At his last ACCP Annual Meeting in September of 2017, Darrell took particular delight in watching the boats in the San Diego bay at dinner. He loved tractor pull competitions, and never missed an episode of The Dukes of Hazzard. He was always fit and trim, and was religious about his exercise program. What I remember vividly are holiday dinners at his home or mine, hiking to exhaustion in the White Mountains, hours spent on the bay waters of Rhode Island, and pre-dawn runs through the streets of inner-city Washington. We will miss him terribly.

Crowdsourced Asparagus Urinary Odor Population Kinetics.

The consumption of asparagus is associated with the production of malodorous urine with considerable interindividual variability (IIV). To characterize the urinary odor kinetics after consumption of asparagus spears, we conducted a study with consenting attendees from two American Society for Clinical Pharmacology and Therapeutics (ASCPT) meetings. Subjects were randomized to eat a specific number of asparagus spears, and then asked to report their urinary odor perception. Eighty‐seven subjects were included in the final analysis. A mixed effect proportional odds model was developed that adequately characterized the dose‐response relationship. We estimated the half‐life of the asparagus effect on malodorous urine to be 4.7 hours (relative standard error (RSE) = 13.2%), and identified a dose‐response slope term with good precision (24.3%). Age was found as the predictor of IIV in slope estimates. This study design and tools can be used as a demonstration “crowdsourcing” project for studying population kinetics in organizational and educational settings.

Matthew Hutmacher, MS (1969-2017).

Matthew Mehler Hutmacher began his career as a statistician, earning his bachelor's degree in graduate preparatory mathematics with departmental high distinction in 1991 at the University of Illinois and his master of science degree in mathematical statistics from Northwestern University in 1994. As an intern with G.D. Searle, Matt took an interest in pharmacokinetics/pharmacodynamics (PK/PD) modeling and quickly became an expert in the years that followed as a consulting statistician. His subsequent work with Amgen and then Pfizer was highlighted by developing complex modeling strategies and clinical trial simulations that led to the registration of several new drugs. Matt was unique in his ability to apply statistical principles to find novel ways to solve population modeling challenges, making key contributions to methods that have become the industry standard. For many years, Matt has been an active member of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), the International Society of Pharmacometrics (ISOP), and the NONMEM Users Group. He was also a founding member of ISOP. His scientific contribution to these organizations is immeasurable. He authored over 40 publications and several book chapters covering a wide range of topics including ordered categorical PD analysis using latent variables, analyses that involve bounded outcome data, repeated time-to-event analysis for incidence and severity, and data analysis under noncompliance, among others. In 2008, Matt was presented with the McKeen Cattell Memorial Award for an article published in the Journal of Clinical Pharmacology. His technical expertise was recognized as a member of the editorial board for CPT: Pharmacometrics & Systems Pharmacology (PSP), and he received the PSP Award at the ASCPT 2017 Annual Meeting for his outstanding service to the journal. He was also a member of the editorial advisory board for the Journal of Pharmacokinetics and Pharmacodynamics. Most recently, Matt was a partner of the Ann Arbor Pharmacometrics Group, a consulting company providing pharmacometric services to the pharmaceutical industry. He cofounded this organization with us in 2007, and we were looking forward to celebrating the 10th anniversary of our collaboration with him this year. Matt was a highly talented pharmacometrician, innovative and dedicated, with supreme integrity and generosity in sharing his knowledge. He was unassuming in his nature while contributing enormously to the science of quantitative drug development. He will be dearly missed. Born November 3, 1969, in Quincy, IL, and most recently residing in Ann Arbor, MI, Matt touched the lives of so many colleagues around the world, and even more numerous patients who never knew him.

The American Society for Clinical Pharmacology and Therapeutics (ASCPT)--A Rich Heritage En Route to an Exciting Future.

In 1900, 20 physicians met in Washington, DC, to form the American Therapeutic Society (ATS) as a means of advancing rational therapeutics through “the application of any method or agency which might ameliorate, cure, or prevent disease.”1 This mission, articulated over a century ago by the ATS, which eventually evolved into our modern day American Society for Clinical Pharmacology and Therapeutics (ASCPT), has remained a focal point of our mission. Over the past 20 years, ASCPT has developed several 5-year strategic plans to further build on this mission and to articulate a vision for the Society that would guide us into the future. These plans have been underpinned by a solid set of core principles and tactical plans to ensure that ASCPT progressed as intended. Our current strategic plan (2015–2020) “ASCPT: Transforming Translation” builds on previous strategic plans and intends to broaden the Society's reach to those disciplines closely aligned with translational medicine.2 As stated in this plan, ASCPT's mission is to “Advance clinical pharmacology, translational medicine, and therapeutics for the benefit of patients and society.” Our vision to become the authority on the science and practice of translational medicine, by building on a foundation of clinical pharmacology and therapeutics, will require us to build and be recognized for our leadership and influence in these areas. Therefore, it seems completely appropriate in this inaugural issue of Clinical and Translational Science (CTS) published under the aegis of ASCPT, to highlight our current strategic plan, given the explicit inclusion of translational medicine in ASCPT's mission and vision. This mission and vision is presented with our Society's core principles and goals in Table 1. Guided by these core principles, ASCPT has developed five major goals, which it is working diligently to achieve within the next 5 years.2 Doing so will fulfill our mission and represent a major step in achieving our lofty vision. These goals are highlighted below. As stated above, a core strength of ASCPT lies in our multidisciplinary nature and our ability to be a catalyst for emerging science. In order for us to embrace and lead in the translational medicine arena, it is critical that our programming, publications, and collaborative relationships are relevant and valuable to translational scientists working in academic, industrial, consulting and regulatory settings, and that these individuals consider ASCPT a professional home where their work can be highlighted and they can interact with other colleagues working within the translational sciences, clinical pharmacology, and therapeutics. In order to achieve this goal, our Society will seek to deepen existing successful partnerships, as well as forge new collaborative opportunities with domestic and federal agencies committed to advancing the global healthcare landscape, and with precompetitive initiatives, industry groups, and other professional organizations. Our acquisition of Clinical and Translational Science (CTS) provides an excellent venue for our members and others working in closely aligned fields to advance our mission and vision through the publication of their clinical and translational research. ASCPT further aims to attract informatics and clinical trial design expertise to benefit the research domains of translational medicine, systems pharmacology, and drug development through programmatic offerings at our annual meeting and online. Achievement of this goal requires fairly substantial changes within ASCPT and in its roles and work in various external communities. Since the launch of our Strategic Plan, the structure of ASCPT has been significantly changed, and the current structure is thriving! We have migrated from our traditional structure comprised of Sections and Special Interest Groups to a structure of three broadly defined “Networks” (Translational and Precision Medicine; Quantitative Pharmacology; and Development, Regulatory, and Outcomes), that capture the historical and current scientific strengths our members have enjoyed, and have extended beyond them, in keeping with our strategic ambitions. These Networks serve as the “Home Base” for our members. Within each Network, “Communities” have been established as member-driven hubs of innovation around specific scientific areas. Communities are dynamic in their existence and will be formed in keeping with the emergence of important scientific fields within clinical pharmacology, therapeutics, and translational medicine and will be “sunsetted” as interest in a particular area wanes or becomes irrelevant. Although Communities are primarily affiliated with a specific Network, the hope is that they will reach across Networks to create collegial, programmatic, and innovative synergies. This reinvigorated structure for ASCPT will permit changes in the way programmatic offerings are generated and vetted, resulting in a scalable process whereby Networks and their Members and Communities will work closely with our Scientific Program Committee to develop the best programmatic offerings possible. As we look more externally, ASCPT aims to take a leading role as a convener at the forefront of advancing bio-innovation on issues that are of interest to the membership. It is our hope that we can leverage our membership to share data and research on issues important to our discipline, in collaboration with our scientific and regulatory partners. Although the knowledge within the membership of ASCPT is impressive, the Society has not done a good job of consistently promoting this knowledge base to external entities involved in healthcare decision-making. As a result, we are infrequently looked to as “the” scientific resource that influences decision-making on the therapeutic use of drugs. ASCPT wishes to change its global standing in this regard and feels strongly that it can and should make substantial and long-lasting contributions to improving the healthcare landscape as it relates to the development and rational use of drugs. Successful professional organizations, such as ASCPT, continually seek to enhance member value by building on its programmatic and educational offerings and providing ways for its members to receive this information continually and efficiently. To this end, ASCPT has added new programming formats and networking opportunities at our annual meeting with much positive feedback. We are also exploring ways to extend the annual meeting experience by providing some of its programming online both during the meeting and throughout the year. In a similar way, we are exploring avenues whereby the mentoring experience for our students can continue beyond the annual meeting. Building on its two highly successful Journals, Clinical Pharmacology & Therapeutics (CPT) and CPT: Pharmacometrics & Systems Pharmacology (CPT: PSP), ASCPT has acquired CTS to round out its Journal offerings. Work is underway to develop our portfolio of Journals in a way that is complementary and offers our members and subscribers a world class differentiated offering in clinical pharmacology, therapeutics, and translational medicine. The scope of CTS has been substantially changed since ASCPT acquired it, and is now focused on publishing original research that bridges laboratory discovery with the clinical diagnosis and treatment of disease. Therefore, as a combined offering, our portfolio of Journals provides unparalleled value and publishing opportunities for those working within clinical pharmacology, therapeutics, and translational medicine. Achieving this goal will help us to ensure that ASCPT has the human, physical, technologic, and financial resources to operationalize our ambitious strategic plan. For example, we have substantially broadened our volunteer involvement and leadership ranks on Committees and Task Forces when compared with last year and, as stated earlier, have completely redesigned ASCPT's structure. We are also revamping our electronic offering to ASCPT members, including a redesign of our website to enhance its capabilities and make it more user-friendly. We have also embarked on a communication plan to inform current and prospective members of the exciting changes occurring in our Society. The first “foundational” year of our 5-year strategic plan “ASCPT: Transforming Translation” has been truly transformative with regard to the broadening of our mission and vision, the reorganization of our Society to best serve our members, and the substantially enhanced member involvement in leading these positive changes. We have witnessed a significant increase in ASCPT membership in response to these changes, helping to confirm that we are on the right path. Future years of our plan will focus on fully achieving each of our five goals, to create maximum value for our members, and to establish a substantial, contributing role for ASCPT in improving the development and rational therapeutic use of pharmaceutical products globally. I would like to acknowledge the members of the 2015–2020 ASCPT Strategic Planning Task Force who developed the plan: Richard Lalonde, PharmD, Chair; John A. Wagner, MD, PhD, President; Antoinette Ajavon, PhD; Kathleen M. Giacomini, PhD; Dan Hartman, MD; Anne C. Heatherington, PhD; Sean Hennessy, PharmD, PhD; Julie A. Johnson, PharmD; Lang Li, PhD; Donald E. Mager, PharmD, PhD; Min Soo Park, MD, PhD; Kellie Schoolar Reynolds, PharmD; Mario L. Rocci Jr, PhD; Michelle A. Rudek, PharmD, PhD; Virginia (Ginny) D. Schmith, PhD, FCP; Valentina Shakhnovich, MD; Aubrey Stoch, MD; Pieter H. van der Graaf, PhD, PharmD; Satsuki Yamada, MD, PhD; with support from ASCPT staff Sharon J. Swan, FASAE, CAE; Elise Laffman-Johnson; Megan McBeath Hay; and Lisa Williamson. The author also acknowledges the members of the 2015–2020 ASCPT Tactical Planning Task Force who developed ways to operationalize the strategic plan: Mario L. Rocci Jr, PhD; William “Doug” Figg, PharmD, MBA; David Y. Mitchell, PhD; Anu Ramamoorthy, PhD; Ronda K. Rippley, PhD; Michelle Rudek, PharmD, PhD; with support from ASCPT staff Sharon J. Swan, FASAE, CAE; Elise Laffman-Johnson; Megan McBeath Hay; and Lisa Williamson. The author declared no conflict of interest.

News and Notes

The election manifesto of the Liberal Party, recently elected in Canada, stated “We will legalise, regulate, and restrict access to marijuana. Canada's current system of marijuana prohibition does not work. It does not prevent young people from using marijuana and too many Canadians end up with criminal records for possessing small amounts of the drug.” The new Prime Minister, Justin Trudeau, has instructed Justice Minister Jody Wilson-Raybould to begin the process of legalizing and regulating cannabis in Canada by “working with the Ministers of Public Safety and Emergency Preparedness and Health, create a federal-provincial-territorial process that will lead to the legalization and regulation of marijuana.” Sources: https://www.liberal.ca/realchange/marijuana https://www.civilized.life/trudeau-gives-justice-minister-mandate-to-legalize-1453717497.html A European Monitoring Centre on Drugs and Drug Abuse (EMCDDA) Insight report provides an analysis of the available information on the prevalence and treatment of comorbid drug use and mental disorders in Europe, drawing on data provided by national focal points. The report also provides a review of the theoretical background of comorbidity and the main instruments available to assess comorbid mental disorders among drug users. Source: http://www.emcdda.europa.eu/attachements.cfm/att_245096_EN_TDXD15019ENN.pdf The Telegraph reports that alcohol prohibition will be introduced to Bihar in northern India from 1 April 2016. Bihar is India's third-most populous state and the ban will affect nearly 100 million people. Bihar's Chief Minister, Nitish Kumar, said he was honouring the pledge he made to women's groups ahead of recent state elections. “Women in the state started an anti-liquor campaign,” said Kumar, announcing the ban. Kumar added, “Increasing liquor consumption was a major cause for domestic violence, particularly against women, and had contributed to a rise in crimes.” Source: http://www.telegraph.co.uk/news/worldnews/asia/india/12018930/Alcohol-ban-third-largest-Indian-state-of-Bihar-to-begin-next-year.html The court of The Hague has ruled against the Youth Smoking Prevention Foundation in its case against the Dutch State over illegal contacts of the government with the tobacco industry and its lobby. The case argued that the Dutch government was not complying with Article 5.3 of the Framework Convention on Tobacco Control (FCTC). The article requires that “in setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.” The court judged that legally the Youth Smoking Prevention Foundation is not in a position to request that the Dutch government complies with the article. But the Dutch government sent a policy document called ‘Clarification implementation Article 5.3 WHO-Framework Convention’ to both chambers of the Dutch Parliament just days before the case was heard. “Of course it is disappointing that the court didn't rule otherwise, but nonetheless this case has yielded a lot,” said Wanda de Kanter, co-founder and chair of the Youth Smoking Prevention Foundation. “Although the wording of the document is at some points a little vague, it is now written down how government at all levels – national, regional and local – must behave in relation to the tobacco industry. That document is here to stay, indifferent from today's court ruling.” she added, “It means that from now on the doors of government are closed for the tobacco industry and its lobbyists.” Source: http://ash.org/court-case-against-dutch-state/ The Huffington Post reports that the U.S. Food and Drug Administration approved a nasal-spray version of naloxone in November. The nasal version, commonly sold as Narcan, will make it easier to administer naloxone and less intimidating than the previously approved injectable form. “Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, acting FDA commissioner, “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.” Robert Childs, executive director for the North Carolina Harm Reduction Coalition, said the new nasal-naloxone model could be a ‘‘game changer for overall access.’’ Sources: http://www.huffingtonpost.com/entry/fda-naloxone-heroin-overdose_564dec69e4b031745cf008ec https://www.drugabuse.gov/news-events/news-releases/2015/11/fda-approves-naloxone-nasal-spray-to-reverse-opioid-overdose The New Zealand Herald reports that the police in New Zealand attach conditions to the release to academics of publicly-owned crime data, which has led to a debate about academic freedom being under threat. The police contract with researchers includes an obligation for academics to show police a draft of their work and to work on ‘‘negative results’’ with police to ‘‘improve its outcomes,” and threatens a ‘‘blacklist’’ for those not complying. The contract also grants police the ‘‘sole right to veto from release any project findings that relate to NZ Police or any privileged NZ Police information,” with consideration to security issues or any potential impact on police inquiries, operations, prosecution or public safety. The New Zealand Green Party police spokesman David Clendon said Police Minister Michael Woodhouse and Justice Minister Amy Adams needed to explain why the police set such conditions. ‘‘Basic data about offending - I would have thought that would be readily available,” Mr Clendon said. The contract issue emerged in a disagreement between the police and University of Canterbury lecturer Dr Jarrod Gilbert, a criminologist seeking data on crimes committed near licensed liquor outlets in Christchurch. Dr Gilbert was denied access to the data because he was considered ‘‘associated with gangs.’’ In a statement, police strategy deputy chief executive Mark Evans said police placed ‘‘a high value on academic research’’ and that the police had contacted Dr Gilbert to say ‘‘that further consideration will be given to our decision regarding the security clearance (police vetting) check.’’ Mr Evans added, ‘‘Our priority is always to ensure that an appropriate balance is drawn between the privacy of individuals and academic freedom. To date police have not prevented access by any academic under this clause in the agreement.’’ Sources: http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11551016 http://www.stuff.co.nz/national/74381812/Dr-Jarrod-Gilbert-Police-trying-to-control-research Mexico's Supreme Court has ruled that growing, possessing and smoking cannabis is legal under the right of “free development of personality.” The ruling comes in a case brought to the court by four people in the Mexican Society for Responsible and Tolerant Personal Use. The plaintiffs want to form a cannabis club and grow and smoke their own cannabis. According to Latino Fox News if the court rules the same way on five similar petitions, it would then establish the precedent to change the law and allow general recreational use. Mexican President Enrique Peña Nieto said in a speech that “for me, it would not be desirable, I am not in favor of an eventual legalization of marijuana.” Sources: http://www.bbc.co.uk/news/world-us-canada-34726693 http://latino.foxnews.com/latino/news/2015/11/10/after-court-ruling-on-medical-marijuana-mexico-pena-nieto-just-says-no-to-legal/ Substance Use Disorders: A Comprehensive Review and Update, 14-16 February 2016, Orlando, Florida, USA. Website: http://mghcme.org/courses/course-detail/substance_use_disorders_a_comprehensive_review_and_update American Academy of Pain Medicine (AAPM) 32nd Annual Meeting, 18-21 February 2016, Palm Springs, California, USA. Website: http://www.painmed.org/annualmeeting/main.aspx Preventive Medicine 2016 (American College of Preventive Medicine), 24-27 February 2016, Washington, DC, USA. Website: http://www.acpm.org/events/event_details.asp?id=596311 Society for Research on Nicotine and Tobacco (SRNT) 22cd Annual Meeting, 2-5 March 2016, Chicago, Illinois, USA. Website: https://www.srnt.org/conferences/index.cfm American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2016 Annual Meeting, 8-12 March 2016, San Diego, California, USA. Website: http://www.ascpt.org/ASCPT-2016-Annual-Meeting 24th European Congress of Psychiatry, 12-15 March 2016, Madrid, Spain. Website: http://www.epa-congress.org/ Society of Behavioral Medicine 37th Annual Meeting and Scientific Sessions, 30 March - 2 April 2016, Washington, DC, USA. Website: http://www.sbm.org/meetings/2016 American Society of Addiction Medicine (ASAM) 47th Annual Conference, 14-17 April 2016, Baltimore, Maryland, USA. Website: http://www.asam.org/education/live-and-online-cme/the-asam-annual-conference Addiction Medicine 2016 Conference, 22-23 April 2016, Asheville, North Carolina, USA. Website: http://addictionmedicine.sa4docs.org/#&panel1-3 UK and European Symposium on Addictive Disorders (UKESAD), 2-4 May 2016, London, UK. Website: http://www.ukesad.com/ American Psychiatric Association (APA) 169th Annual Meeting, 14-18 May 2016, Atlanta, Georgia, USA. Website: http://annualmeeting.psychiatry.org/ National Association of Addiction Treatment Providers (NAATP) Annual Leadership Conference, 15-17 May 2015, Fort Lauderdale, Florida, USA. Website: https://www.naatp.org/events/annual-conference/ Society of Clinical Trials 37th Annual Meeting, 15-18 May 2016, Montreal, Quebec, Canada. Website: http://www.sctweb.org/public/meetings/2016/home.cfm International Society for the Study of Drug Policy (ISSDP) 10th Annual Conference, 16-18 May 2016, Sydney, Australia. Website: http://www.issdp2016.com/ The Australian and New Zealand Addiction Conference 2016, 18-20 May 2016, Gold Coast, Australia. Website: http://addictionaustralia.org.au/ 12th European Opiate Addiction Treatment Association Conference (EUROPAD), 27-29 May 2016, Leiden, The Netherlands. Website: http://www.europad.org/europad16.php Kettil Bruun Society (KBS) 42nd Annual Meeting, 30 May - 3 June 2016, Stockholm, Sweden. Website: http://www.kettilbruun.org/ 2016 National Institute on Drug Abuse (NIDA) International Forum, 10-13 June 2016, Palm Springs, California, USA. Website: http://www.drugabuse.gov/international/international-forum The College on Problems of Drug Dependence (CPDD) 78th Annual Meeting, 11-16 June 2016, Palm Springs, California, USA. Website: http://www.cpdd.org/ 39th Annual Research Society on Alcoholism (RSA) Scientific Meeting, 25-29 June 2016, New Orleans, Louisiana, USA. Website: http://www.rsoa.org/2016meet-indexAbs.htm The International Narcotics Research Conference (INRC), 10-14 July 2016, Bath, UK. Website: http://www.inrcworld.org/2016/2016mtg.htm 21st International AIDS Conference (AIDS 2016), 17-22 July 2016, Durban, South Africa. Website: http://www.aids2016.org/ International Conference and Exhibition on Dual Diagnosis, 21-22 July 2016, Chicago, Illinois, USA. Website: http://dualdiagnosis.conferenceseries.com/#sthash.FlWaH3JS.dpuf International Society of Addiction Journal Editors (ISAJE) Annual Meeting, 25-27 July 2016, Windsor, UK. Website: http://www.parint.org/isajewebsite/meetings2016.htm 29th European College of Neuropsychopharmacology (ECNP) Congress, 17-20 September 2016, Vienna, Austria. Website: http://www.ecnp-congress.eu/ Global Addiction Conference, 13-15 October 2016, Venice, Italy. Website: http://www.globaladdiction.org/ 21st International Council on Alcohol, Drugs, and Traffic Safety Conference, 16-19 October 2016, Gramado, Brazil. Website: http://www.t2016.org/ American Association for the Treatment of Opioid Dependence (AATOD) 2016 Conference, 29 October - 2 November 2016, Baltimore, Maryland, USA. Website: http://www.aatod.org/2016-aatod-conference-baltimore/ The Australasian Professional Society on Alcohol and other Drugs (APSAD) 2016 Conference, 30 October – 2 November 2016, Sydney, Australia. Website: http://www.apsad.org.au/apsad-conference/current-conference 9th European Public Health Conference, 9-12 November 2016, Vienna, Austria. Website: http://ephconference.eu/ News and Notes welcomes contributions from its readers. Send your material to John Witton, News and Notes Editor, Addiction, National Addiction Centre PO48, 4 Windsor Walk, London SE5 8AF. Fax +44 (0)20 7848 5966; e-mail john.witton@kcl.ac.uk Conference entries should be sent to Jean O'Reilly at jean@addictionjournal.org. Subject to editorial review, we will be glad to print, free of charge, details of your conference or event, up to 75 words and one entry only. Please send your notification three months before you wish the entry to appear.

115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Atlanta, Georgia, USA - March 19-22, 2014

115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Atlanta, Georgia, USA - March 19-22, 2014

115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Atlanta, Georgia, USA - March 19-22, 2014

115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Atlanta, Georgia, USA - March 19-22, 2014

114th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Indianapolis, Indiana - March 6-9, 2013

114th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Indianapolis, Indiana - March 6-9, 2013

114th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Indianapolis, Indiana - March 6-9, 2013

114th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Indianapolis, Indiana - March 6-9, 2013

Advancing Pharmacometrics and Systems Pharmacology

Pharmacometrics and systems pharmacology are emerging as principal quantitative sciences within drug development and experimental therapeutics. In recognition of the importance of pharmacometrics and systems pharmacology to the discipline of clinical pharmacology, the American Society for Clinical Pharmacology and Therapeutics (ASCPT), in collaboration with Nature Publishing Group and Clinical Pharmacology & Therapeutics, has established CPT: Pharmacometrics & Systems Pharmacology to inform the field and shape the discipline.

ASCPT Task Force for Advancing Pharmacometrics and Integration into Drug Development

Traditionally, medical and biostatistical experts have played a central role in ensuring validity of pharmaceutical testing. The science of pharmacometrics provides powerful approaches for supporting important drug development and regulatory decisions. Numerous case studies published by academic, industry, and US Food and Drug Administration scientists attest to the significant contribution of pharmacometrics to decision making. The economic and public health benefits of applying this discipline to clinical trials far outweigh the cost associated with its implementation. The purpose of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Task Force is to build on the momentum and accelerate dissemination of its impact and adoption into drug development. We describe briefly the contributions of pharmacometrics and the specific goals of the Task Force.

Why the United States Still Needs Improved Dietary Supplement Regulation and Oversight

It has been 3 years since the American Society for Clinical Pharmacology and Therapeutics (ASCPT) issued a position statement regarding dietary supplement safety and regulation. I was the Chair of the ASCPT task force charged with issuing the statement. At the time, after careful review of available data, the other members and I concluded that dietary supplement legislation in the United States was lacking and that enhanced oversight was essential to increase the safety of these products for the American consumer.

Poster Session (PI1-103)Displayed 7:30 am - 5:00 pm

Clinical Pharmacology & TherapeuticsVolume 81, Issue S1 p. S12-S46 Supplement Poster Session (PI1–103) Displayed 7:30 am - 5:00 pm First published: 26 February 2007 https://doi.org/10.1038/sj.clpt.6100174AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Clinical Pharmacology & Therapeutics (2007) 81, S12–S46. doi:10.1038/sj.clpt.6100174 Volume81, IssueS1Supplement: Abstracts of the 2007 ASCPT (American Society for Clinical Pharmacology and Therapeutics) annual meeting, Anaheim, California, USA.March 2007Pages S12-S46 RelatedInformation

Oral Session III-A (OIII-A)Approaches to Modeling9:00 am - 10:00 am

Clinical Pharmacology & TherapeuticsVolume 81, Issue S1 p. S84-S85 Supplement Oral Session III-A (OIII-A) Approaches to Modeling: 9:00 am - 10:00 am First published: 26 February 2007 https://doi.org/10.1038/sj.clpt.6100177AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Clinical Pharmacology & Therapeutics (2007) 81, S84–S85. doi:10.1038/sj.clpt.6100177 Volume81, IssueS1Supplement: Abstracts of the 2007 ASCPT (American Society for Clinical Pharmacology and Therapeutics) annual meeting, Anaheim, California, USA.March 2007Pages S84-S85 RelatedInformation

Poster Session III (PIII 1-105)Displayed 7:00 am - 12:00 pm

Clinical Pharmacology & TherapeuticsVolume 81, Issue S1 p. S85-S120 Supplement Poster Session III (PIII 1–105) Displayed 7:00 am - 12:00 pm First published: 26 February 2007 https://doi.org/10.1038/sj.clpt.6100178AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Clinical Pharmacology & Therapeutics (2007) 81, S85–S120. doi:10.1038/sj.clpt.6100178 Volume81, IssueS1Supplement: Abstracts of the 2007 ASCPT (American Society for Clinical Pharmacology and Therapeutics) annual meeting, Anaheim, California, USA.March 2007Pages S85-S120 RelatedInformation