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

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Preparation for ASCPT 2019 Annual Meeting “From Molecule to Patient” Underway

Last week, the ASCPT Scientific Program Committee (SPC) kicked off preparations for the 2019 Annual Meeting. I am very much looking forward to chairing this wonderful and diverse group of dedicated and talented ASCPT members together with President Dan Hartman, who showed his commitment by dialing in from Senegal for our first meeting.

The theme for the 2019 Annual Meeting is “From Molecule to Patient.” This reflects the critical role of clinical pharmacology in the translation of fundamental science to novel medicines that can transform the lives of patients. Dan and I hope to see session proposals which address the increased diversity of “molecules” and “patients”, as well as “methodologies”, in modern-day drug innovation. Possible topics therefore include clinical pharmacology of novel modalities (for example gene and cell therapies, vaccines, biologicals, novel for¬mulations), special populations (for example geriatrics and patients in developing countries) and application of meth¬odological innovation (for example organ-on-a-chip, real-world data, systems pharmacology and artificial intelligence).

I am also very pleased to announce the Pre-Conference programs scheduled for the 2019 Annual Meeting:

Advancing QSP Toward Predictive Drug Development: From Targets to Treatments

PBPK Modeling for the Development and Approval of Locally Acting Products

These will no doubt be very popular so make sure you register as soon as possible.

The ASCPT proposal submission site is now open, and we encourage you to submit a proposal for consideration by the Friday, June 1, 2018, 4:00 PM ET deadline. As a reminder, last year’s recording of “2018 Scientific Proposals- Secrets to Success” webinar by Ginny Schmith, PhD, is available as a valuable resource, as is the 2019 Call for Proposals brochure.

Mark your calendar now for the 2019 Annual Meeting, and watch for the Special ASCPT News message in September announcing the opening of Registration so that you can secure your place early!

We look forward seeing you in Washington DC in March 2019!

Piet van der Graaf, PhD, PharmD
Chair, 2019 Scientific Program Committee


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ASCPT Replay- Breaking Down Barriers to Knowledge

I do not watch TV shows or movies more than once. I am an information seeker, love to learn, and have a short attention span. Why would I purchase access to videos from a meeting I attended? When I arrived at the ASCPT 2018 Annual Meeting, I did not expect to purchase ASCPT Replay.

My opinion changed 15 minutes into Jack Gilbert’s State of the Art Lecture “Invisible Influence: The Microbiome in Precision Medicine.” I wanted to put my pencil down and listen to every word, but I also wanted to take detailed notes. Like many sessions at ASCPT, the information was cutting-edge and applicable to the role of clinical pharmacology and translational medicine in drug development. I quickly remembered I could purchase post-meeting access to the lecture, so I relaxed and listed to the speaker. By the end of the Innovation Forum Thursday afternoon, I knew ASCPT Replay was an essential resource. The three talks in the Innovation Forum addressed the role of modern technology in health care and drug development. Because of the inter-related nature of the talks, it is useful to go back and listen to them after hearing the panel discussion.

Of the ten sessions included in ASCPT Replay, I attended six in person. I intend to watch all of them at least one more time. I missed four of the sessions because of other excellent sessions that conflicted. It is a relief to have the opportunity to watch some of the sessions I missed. I was disappointed to miss the Rare Diseases Symposium on Saturday morning, but enjoyed watching it after Replay became available. Understanding perspectives from a regulator, patient advocate, drug developer, and research consortium provides a unique opportunity to appreciate the collaboration that helps address challenges related to development of drugs for rare diseases.

Finally, ASCPT Replay allows individuals who could not attend the 2018 Annual Meeting to enjoy a sample of the innovative programming. Did you hear about the Pharmacometrics Skills Competition? It is on ASCPT Replay, so you can watch the four talented teams communicate their solution to a complicated drug development dilemma and answer questions from a distinguished panel of experts.

Regardless of whether you attended the 2018 Annual Meeting, ASCPT Replay is a valuable resource that can break down barriers and increase knowledge related to the impact of clinical pharmacology and translational medicine.

Kellie Schoolar Reynolds, PharmD

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Are you interested in hearing the latest research that could impact the opioid crisis?

Are you wondering how we will develop drugs and appropriately interpret clinical trials in the era of n=1 studies?

Are you interested in learning more about how artificial intelligence, and even social media, might change the way that we practice medicine?

Do you want to hear the state of the art about how pharmacogenomic information is being applied at the point-of-care?

All of these topics – any many more – will dominate the landscape at the ASCPT 2018 Annual Meeting!

In addition, we have three tremendous State-of-the-Art speakers who will provide keynote addresses, we have another three amazing speakers who will discuss how innovation is changing scientific approaches in clinical pharmacology at the Innovation Forum, and numerous other symposia and workshops that will be sure to pique the interest of all members of the field of clinical pharmacology and translational medicine.

The Meeting also provides an unparalleled chance to network with industry, academic, and regulatory leaders from around the world.

And Orlando offers a beautiful venue for this exciting exchange of ideas and research knowledge.

Encourage your colleagues and trainees to attend ASCPT 2018! Visit the
Annual Meeting pages of the ASCPT website (https://www.ascpt.org/Meetings/Annual-Meeting) for more details and to register!

Peter H. O’Donnell, MD
Chair, ASCPT Scientific Program Committee 2017-2018

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Reverse Mentoring: What it is and Why it matters
Reverse mentoring has been around for decades. In contrast to a “typical” mentoring experience, reverse mentoring is where a leader gains a different perspective of the business from someone in a less senior role and from a different functional area.

The two main forms will normally evolve around either an educational or a diversity way of a reverse mentoring. Either way, reverse mentoring is a dynamic, two-way flow of learning with the duality of roles being at the forefront of its nature.

I, as the Director of Clinical Pharmacology and Life Cycle Management at GSK, have experienced being a Reverse Mentor.

It was early 2017 when I decided to get involved in a Reverse Mentoring program and it didn’t take long until I found myself partnered with a senior executive within the company. The driving force was a desire to share my personal experience and at the same time learn something new and from a different functional area. Throughout this journey, I have been providing my mentee with a deeper understanding of my part of the business and in return I get a better understanding of the company’s strategy more broadly and how decisions are made at the executive level.

My Reverse Mentoring experience evolved toward the following main pillars:
1. Willingness to learn: In a reverse mentoring relationship, both parties act in the capacity of a mentor as well as a mentee; so they must both "genuinely want to learn from and share with the other.
2. Trust: Reverse mentoring requires the trust of each party. The goal is to "push one another outside of their comfort zones and try new ways of thinking and working."
3. Transparency: Both parties must be open with their feelings and with what they are thinking. They must be able to overcome differences in communication style (since different generations communicate differently) and be open to seeing situations from different angles.
4. Mutual benefit: The more senior person will benefit by being on track with emerging technologies or science whereas the more junior person will get to learn about what it takes to become a good leader.

I have really benefitted from Reverse Mentoring and would recommend such a process to anyone. Reverse Mentoring gave me the chance to step out of my comfort zone and learn something different. I now feel I can implement the company’s strategy and share its morals and ethics in an even more committed and engaged way than before. I would highly recommend Reverse Mentoring as it gives everyone the opportunity to learn, share knowledge and grow.

Georgios Vlasakakis, PhD

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Pharmacometrics Skills Competition: MIDD Gran Prix

As a member of the ASCPT Scientific Program Committee, I am pleased to bring a very exciting new initiative, the Pharmacometrics Skills Competition: MIDD Gran Prix, to your attention. This exciting competition is now underway, with the data set now available for formed teams. The Gran Prix competition will let both early career (student/trainee) and experienced teams compete using their pharmacometric, analysis, decision, and communication skills, with two teams from each team category to be selected to present live at the 2018 Annual Meeting in Orlando, FL.

Let me try to explain:
• You form a pharmacometrics team with your friends and/or colleagues and submit your team online (Deadline: November 15, 2017)
• You are given access to the data set and scenario
• Your team analyzes the data to support a drug development decision
• Your team summarizes the analysis and decision in a report (Deadline: January 31, 2018)
• If your team is selected as one of the two top teams in your category, you will be invited to present the decision to a mock clinical development team during the Gran Prix session from 7:00 AM - 9:00 AM on Saturday, March 24 at the ASCPT 2018 Annual Meeting*

* At least one team member from each of the four top teams must register and attend the ASCPT 2018 Annual Meeting.

This Pharmacometrics Skills Competition is the first of its kind in the ASCPT and ISoP community, and it promises to lead to lively and inspiring discussions, and may be the start of a new tradition. Moreover, you will be able to work as a self-chosen, dedicated team on a realistic scenario from a drug development perspective. It is all about experiencing model-informed drug development in practice through pharmacometrics and communication.

This initiative is a joint effort between Certara, the UNC Eshelman School of Pharmacy, and ASCPT. You can find detailed information on the competition, and register here (http://www.ascpt.org/ASCPT-2018-Annual-Meeting/Pharmacometrics-Skills-Competition-MIDD-Gran-Prix).

Be encouraged, be engaged, and participate in this competition!

This will be a great experience!

Sandra Visser, PhD

Important Dates:
Team entrance deadline: November 15, 2017
Report submission due: January 31, 2018
Finalist teams notified: February 28, 2018

For questions please contact meetings@ascpt.org.
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The ASCPT Scientific Program Committee (SPC) is announcing a change in procedures this year that may be important to investigators considering the various Abstract Submission deadlines for the 2018 Annual Meeting.
In prior years, ASCPT would permit submission of abstracts by one of two different deadlines—the “regular” abstract deadline, and a second, “late-breaking” abstract deadline (which typically occurred about 2 months after the regular deadline).

Although these two distinct submission deadlines remain in 2017, abstracts being submitted for consideration for the 2018 meeting should, in almost all cases, be submitted by the REGULAR abstract deadline. Late-Breaking abstract submissions are not encouraged unless they truly meet the strict criteria for Late-Breaking abstracts published here: http://bit.ly/2v9CsRQ

In particular this year, Late-Breaking abstract submissions will be accepted (before the Late-Breaking abstract deadline of November 16, 2017, 4:00 pm ET) only for select abstracts that report a major finding which has a clear impact on patient care, usually from a clinical trial for which outcomes data were not mature prior to the standard abstract deadline.

We encourage any individuals who are considering submitting a Late-Breaking abstract to contact the SPC chair in advance (Peter H. O’Donnell, MD, podonnel@medicine.bsd.uchicago.edu) to discuss whether their abstract would meet these very strict definitions.

All other submitters are encouraged to submit their abstracts prior to the regular submission deadline of September 7, 2017, 4:00 pm ET.

Instructions regarding the third category of abstracts – “Encore Abstract” submissions (http://bit.ly/2vj5w5a) – have not changed for 2017-18.
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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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