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ASCPT
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Advancing the science and practice of clinical pharmacology
Advancing the science and practice of clinical pharmacology

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Immediately before the ASCPT 2017 Annual Meeting, the International Transporter Consortium (ITC) will host its third workshop focusing on new research in membrane transporters, particularly as they relate to drug development. This workshop will take place on March 13-14, 2017, at the Omni Shoreham Hotel in Washington, DC. Research on membrane transporters has exploded, with approximately half of all scientific research articles on transporters published within the last 10 years. Increasingly, drug developers are interested in transporters as mediators of clinically important drug-drug interactions, and as pharmacologically relevant targets. The ITC continues to play a leading role in informing drug development strategies and regulatory sciences, especially relevant to drug-drug interactions. The ‘Third Workshop on Membrane Transporters in Drug Development’ is a two-day workshop, with speakers who are world-class transporter biologists from universities, regulatory agencies and pharmaceutical companies. The workshop will cover a range of topics in transporter biology, including the endogenous function of transporters, emerging transporters of importance in drug development, computational modeling, genomics and biomarker probes of transporters. As always, one of the most exciting parts of the workshop will be its concluding session on regulatory issues in transporter-mediated drug-drug interactions. Case studies representing perspectives of regulatory agencies (e.g., FDA and EMA) will be presented along with a panel discussion involving experts in the field to address questions from the attendees. Finally, there will be breakout groups of interested scientists who will focus on writing whitepapers and review articles to be published in a special issue of Clinical Pharmacology & Therapeutics.

Kathleen M. Giacomini, Lawrence Lin, Kim Brouwer, Aleksandra Galetin, Shiew-Mei Huang, Pär Matsson, Nilay Thakkar, Maciej X. Zamek-Gliszczynski, Lei Zhang, and Donald Tweedie

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The Clinical Pharmacogenetics Implementation Consortium (CPIC®) (cpicpgx.org) as part of the Pharmacogenomics Research Network (PGRN) (www.pgrn.org) will be hosting a one-day symposium on March 15, 2017, in conjunction with the 2017 Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) on March 15-18, 2017 (Washington, DC).

The CPIC-PGRN Meeting is open to all and features presentations from a world-class group of speakers who will describe current examples of implementation of pharmacogenomics in the clinic. There will also be panel discussions to summarize topics and encourage audience participation. Presentations will include “best cases” as well as challenging cases for implementation, and will include international perspectives on clinical use of pharmacogenomics. See https://cpicpgx.org/meetings/ for the meeting agenda, list of speakers and details on how to register (once available).

CPIC® is one of the enabling resources funded by the National Institutes of Health as part of the Pharmacogenomics Research Network, and is a shared project between PharmGKB (www.pharmgkb.org) and the PGRN. The mission of the PGRN is to catalyze and lead research in precision medicine for the discovery and translation of genomic variation influencing therapeutic and adverse drug effects. CPIC’s goal is to facilitate translation by overcoming some of the barriers to implementation of pharmacogenetic tests into clinical practice. Over 150 CPIC members from 19 countries participate to developing tools to facilitate clinical implementation of pharmacogenetics, primarily by developing freely available, peer-reviewed, updatable, and detailed gene/drug clinical practice guidelines.


Kelly E. Caudle, PharmD, PhD, BCPS
Teri E. Klein, PhD
Mary V. Relling, PharmD
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Need for Pediatric Clinical Trial Endpoints 
Designing a clinical trial involves collaboration and consensus.  Lack of agreed-upon clinical trial endpoints continues to plague pediatric clinical trial designs.  In order to determine if a drug is effective for a given condition, the natural history of the condition must be known so that change/improvement in the condition can be evaluated with the new intervention.  But if no natural history studies exist, nor agreed-upon clinical trial endpoints or validated outcome measures, then a valid clinical trial is not possible.  

In some cases, extrapolation from the adult to pediatric condition is possible; infectious disease is one example.  Our clinical trial of meropenem for complicated intra-abdominal infections in neonates did not require an efficacy trial, and so safety and pharmacokinetic data were sufficient for changes in labeling.

In the case of pediatric inflammatory bowel disease, the situation is more complex.  The US Food and Drug Administration has held a series of meetings on the topic of endpoints and clinical outcome assessments.  Despite these meetings, no agreement has been reached on either. A paper from 2014 (Sun H, Lee JJ, Papadopoulos EJ, Lee CS Nelson RM, Sachs HC, Rodriguez WJ, Mulberg AE. “Alternate Endpoints and Clinical Outcome Assessments in Pediatric Ulcerative Colitis Registration Trials”. JPGN 2014; 58(1): 12-17) summarizes the problem well for ulcerative colitis: “In summary, no existing outcome measures are adequate to measure pediatric UC treatment outcome. No preferred primary efficacy endpoints were identified…Consensus on definition of successful treatment outcome (disease response and/or remission) would facilitate pediatric drug development.”

The lack of clinical trial endpoints is true for many other pediatric conditions. There is a lack of consensus among  pediatricians and pediatric subspecialists on disease definitions,  clinical trial endpoints, and validated outcome measures for many pediatric conditions.  This impedes drug development.

 If you have any solutions to this difficult problem, let me know! 

-Anne Zajicek, MD, PharmD

The comments in this blog post reflect the views of the author and should not be construed to represent NIH’s views or policies.
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ASCPT Scientific Communities: An Opportunity to Shape the Organization. 
The strength and success of an organization is directly proportionate to the efforts of its members. ASCPT is no exception to this rule and its success as an organization is evidence of the commitment of its members.  Since joining the Society in 2012 I have searched for opportunities to contribute to the scientific mission of the organization and am very pleased with the recent restructuring of the Scientific Sections into Networks and Communities.  It is not that I necessarily believe the new structuring and categorization is preordained for success, but I do believe the mission embodied by this effort to establish a ‘rhythm of business’ within the Communities is an excellent opportunity for members (especially the newer members, like myself) to get involved and shape the future direction of the organization.  Following the announcement of this structural change at last year’s meeting in New Orleans, a simple e-mail volunteering to contribute put me in the position to coordinate the Society’s first Scientific Community webinar in October.  

Although this first webinar proved to be a bit arduous, as it required the efforts of many within our Community and those at ASCPT, this process will only get easier with repetition and will provide the framework necessary to maintain the high level of scientific discourse observed at our Annual Meeting and throughout the year.  Therefore, I encourage those of you interested in getting involved with ASCPT to embrace the efforts of your Communities to engage you throughout the year and to ultimately help shape the science of our organization.

Ryan Funk, PharmD, PhD
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A successful organization has the mode of its success built into the title—the organizing of the efforts of members.   A stable and logical set of rules smooths human interaction and maximizes members’ productive energy.  Modern professional organizations are structured according to bylaws and policies.  The ASCPT bylaws are analogous to a constitution and define the broad structure around which we organize ourselves—how the Board of Directors is structured, how officers are chosen, etc.   These contrast with the more detailed policies and procedures that guide the day-to-day administration of our Society business—the SOP’s (standard operating procedures) we all are familiar with.  A search with Google analytics reveals the use of the term bylaws in English books has been relatively stable since World War II, reflecting their near ubiquitous uptake in practice

Qualitatively, however, the best practices for bylaws have been evolving in recent years. Excessively wordy, overly prescriptive, and legalistic bylaws are out.  The key modern themes are simplicity and flexibility.  Rules which do not define broad organizational tenets are best defined in policies.  Since the bylaws describe the very nature of an organization, they should require alteration infrequently.   The ASCPT Board of Directors recently undertook a comprehensive review of the current ASCPT bylaws. One prompt for this review was the passage of time.  They were last revised in 2009.  The existing bylaws are well written and have stood up well over time, but there are a number of necessary changes that were identified.  The other trigger was the formulation of Scientific Networks to replace Scientific Sections.  These Networks, Quantitative Pharmacology, Translational & Precision Medicine, and Development, Regulatory & Outcomes, will better organize individuals and allow the best science to be developed and showcased.  Within Networks exists a Community structure that can aggregate and disaggregate to best reflect the advancement of our discipline over time.  The bylaws need to reflect this new structure.  

In parallel, the key role of Networks in nominating Society leadership was defined.  A full accounting of proposed changes (http://bit.ly/1CSli9l) and FAQs (http://bit.ly/1OrJiS6) are posted.  The other substantive proposed change is the method by which the bylaws themselves are amended.  The current ease and cost savings of electronic voting makes the sole use of this method preferred to the currently specified combined in-person, mail, and email voting.  The need for 2/3 majority of voting members to amend the bylaws is retained, but we are proposing to remove the need for 10% of our membership to vote, since this threshold has been difficult to achieve historically.  Students and trainees are also proposed to have the right to vote when amending our bylaws.  Students and trainees are the future of the ASCPT, and allowing their voice embraces our next generation.  Lastly, there are a number of minor changes, including changing of the title of “executive director” to “chief executive officer”, updating the role of the treasurer to reflect current practice, and a number of minor typographical fixes.  There is a bit of urgency to get you as a member to vote.  We are still bound by the current bylaws, which require at least 10% of our full members to vote.  Failure to reach this threshold would be a significant expense and it is critical that you vote, and that you engage every other full member you know to vote also.  Engaging the membership, communicating the rationale for the changes and getting member confirmation is key to ensure a strong ASCPT for the future.  See you at the polls!

Walter Kraft, MD
Director, ASCPT Board
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Looking Ahead to the ASCPT 2016 Annual Meeting

Dear ASCPT Colleagues,

As we look ahead to the ASCPT 2016 Annual Meeting in San Diego, CA from March 8 to 12, I would like to share my vision for the meeting and to offer some suggestions for developing successful session proposals.

“Advancing Therapeutic Horizons Through Global Collaborations” is the theme of the 2016 Annual Meeting, and the Scientific Programming Committee (SPC) chose this theme to highlight the importance of the global scope and collaborative nature of clinical pharmacology as a scientific discipline.  The SPC plans to include programming to address many important areas, including strategies and approaches to assess ethnic differences in PK, PD, and drug response; global regulations; unmet medical needs and therapeutic advances in developing countries; and additional global and collaborative aspects of therapeutic research and development.  In addition, we are working to increase the level of interaction and engagement during the meeting, so we have added a new roundtable session format to foster greater scientific exchange, collaboration, and Q&A than in traditional session formats.  At each roundtable session, a moderator will lead interactive discussions about an emerging area of significant scientific and/or policy interest. We trust that you will enjoy, and benefit from, this programming addition!

When it reviews session proposals for the Annual Meeting, the SPC carefully examines each proposal based on a number of factors.  First and foremost is the topic of the proposal.  Is it compelling, timely, and innovative?  Has a similar topic been covered at an Annual Meeting in the past three years?  Will the topic appeal broadly to attendees?   A second important consideration is the caliber and diversity of the prospective speakers.  Are they thought leaders in their field?  Do they represent a diverse range of sectors, institutions, and perspectives?  Naturally, the overall quality of the proposal is also taken into account.  Is it well written, and does it provide sufficient detail to assess its topic’s scientific merits?  Finally, we consider whether the proposal meets all of the submission requirements and guidelines.  While each proposal is considered on a case-by-case basis, the SPC applies this framework as it reviews and selects the most promising proposals.  Once each proposal has been scored on an individual basis, the SPC considers the topics of the top scoring proposals, then selects the final proposals to ensure a diverse, well-rounded educational program for the Annual Meeting.

I look forward to sharing with you the names of our State of the Art lecturers, along with details about Pre-Conferences and Special Sessions at the 2016 Annual Meeting.

Mark Dresser, PhD
Chair, Scientific Program Committee
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FINANCIAL FACTS ABOUT ASCPT:  Go Figure!
As many of you know from your professional and personal experiences, managing a budget is always a balancing act.  Imagine doing it for a professional organization with nearly 2,100 members!  Everything is driven by “the bottom line” and, preferably, one that is net positive (a.k.a. “in the black”).  To achieve this goal with multiple moving parts in the overall budget, there has to be “give and take” and “robbing Peter to pay Paul” has to be avoided whenever possible.  The overseers in all of this are the ASCPT members who have fiduciary responsibility to the Society; namely, the members of the Board of Directors (including the officers) and the Chief Executive Officer.  The day-to-day financial decisions which must be made for ASCPT to service its assets (the largest and most important being the membership) largely fall to the CEO and Treasurer.  Needless to say, all with fiduciary responsibility to ASCPT take this specific obligation very seriously.

There are several other important individuals when it comes to maintaining the financial health of ASCPT.  These folks include our General Counsel, our auditors and our investment advisor.  Collectively, this “team” of extremely qualified individuals makes certain that the business of ASCPT is conducted in strict accordance with all applicable State and Federal laws, that our finances are reviewed by skilled individuals (e.g., CPAs) who do it “at arm’s length” and finally, that we are investing ASCPT resources in a manner that balances risk with rate of return in such a way that the value of our corporately held assets increase over time; something required to support the continued growth of the Society.

Now that I have given you all a 30,000 ft view of the “who and how” of ASCPT’s financial process, let me provide you with some facts that you may or may not know:

• While the Board and CEO have fiduciary responsibilities for managing the finances of ASCPT, any member of the organization in good standing can have access to examine the organization’s financial reports.
• The financial information about ASCPT is in the public domain in that we are required as a 501c3. corporation to file a Federal 990 tax form every year.
• The overall net worth of ASCPT is approximately $5 million, which includes our property (e.g., office building, equipment) and our operating and investment accounts.  
• Our financial policy has been to maintain liquid assets in an amount sufficient to cover 180 days of operating expenses for the Society.
• For fiscal year 2014, ASCPT revenues included approximately $1.3 million for the Annual Meeting, $1 million from our journals (CPT and CPT:PSP) and $675K from member dues.  Expenses for each of these categories were approximately $1.6 million for the 2014 Annual Meeting, $667K to support our journal-related expenses and $350K for the provision of direct member services.
• The annual budget for ASCPT is built on a model that targets a minimum net income of 3% over all budgeted expenses.  Annual salary merit increases of staff are tied to the attainment of this overall financial goal.
• Individual donor contributions to ASCPT from January 2014 to date were approximately $15,000 (or appx. $7.00 USD per member which represents a nearly 3.5 fold decrease from 2013 donations)

Now that you have these facts, let me transition to my musings (i.e., my personal comments and not those of the Board of Directors, the Officers or the staff) which are offered from the perspective of being an ASCPT member for some 35 years and privileged to serve the Society.  First and foremost, the financial health of ASCPT is sound and compared to other professional organizations of our size, is very good.  This is an important achievement for which the credit goes to the membership, our larger professional audience (e.g., those non-members who buy our journals and support our Annual Meeting) and the capable management of our Staff.   It is premature, however, to rest upon our laurels.  Second, to create the future which we envision and desire as an organization (e.g., that articulated in our Strategic Plan), more of the same will just not get it!  What then, will?  It is my intention that over the next 5 years, there are several “must dos” for ASCPT which are summarized as follows:

• We must grow our membership through becoming increasingly inclusive and reaching out to all professionals in many countries who have a part in the evolving field of Translational Medicine.  Clinical Pharmacology can’t just be another kid in the class with their hand forever in the air but rather, we must become the teacher!
• It will be essential for ASCPT to diversify and expand its product line (which is now limited to our Annual Meeting and journals).  This will require creativity and just might require our reaching across an isle or two and making some strategic and, potentially, compromises when they prove to serve us.   We must understand that the costs associated with goods, services and employees will likely increase over time.  If ASCPT cannot grow and meet its financial targets, the viability of the Society can only be maintained by acts similar to sequestration or cutting the budget for state-funded higher education as some governors have recently done. 
• We must critically examine what we expect from our Annual Meeting.  Can we maintain the presentation of excellent science in a fashion that is effective but do it in a way that reduces the costs of staging what has become an international meeting?  Being close to Kansas, maybe the answer is to put wheat (a sustainable crop) on the stage for the opening session instead of decorative plants.  I’m being half-way serious here.  Would we be willing to change the “look and feel” of the Meeting to a way that is different from what we have been accustomed to and, therefore, have come to expect?
• We must be increasingly cognizant of the true (and real) costs and benefits of ASCPT and begin to value it in a fashion that is consistent with current (and future) market forces and influences.  Despite the Dow Jones being above 17,000 and the US in the midst of an apparent economic recovery, there continues to be belt tightening in both the academic and industrial sectors.  For example, the expected annual salary increase in many institutions is going the way of the Dodo Bird.  It is often presented as a “gift” as opposed to an adjustment needed for people to have income which in some instances keeps up with inflation.  This makes the cost of all professional memberships and meetings a continuing challenge, not to mention the added burden for individuals in a diverse field such as Translational Medicine.  (Now you understand why my first bullet above got the pole position in this blog piece!)
• Finally, we must create and nurture a culture of giving throughout the membership.  I realize that some of you reading this will consider this challenge little more than a thinly veiled “ask” for increased member contributions.  Let me assure you, however, that it is more than that.  For example, I am about to end this piece and go to a nice restaurant to enjoy a wonderful meal (and perhaps some nice French wine) with my wife and life partner.  I have an idea about what I am going to spend and I will spend it because the experience is valuable to me.  If we make the experience of ASCPT increasingly valuable to our members, they too will support what they enjoy.  This is our real challenge.

In closing, this is the first blog I have ever written.  It might very well be my last (and it is a good thing that it won’t influence the impact factor of any of our journals)!  I hope, however, that it will be both entertaining and stimulating as you think about ASCPT, your membership and what you can do individually and collectively improve the Society. 

Gregory L. Kearns, PharmD, PhD, FCP, FAAP
Secretary-Treasurer, ASCPT
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