We are excited to present to you our first newsletter: your opportunity
to explore a sampling of the achievements, perspectives and scientific projects
of our researchers, while keeping informed of funding deadlines and programs.
We hope you enjoy and encourage you to remain engaged with the PCC via our
newly launched social media channels.
In this quarter's
An interview with Dr. Mario Thevis regarding his Meldonium research, a look at
novel testing methodologies being explored by Dr. Jack Henion, and a sneak peek
at the date of our 2017 anti-doping conference held at MLB headquarters in New
PCC Newsletter Spring 2016.pdf
What a Drop Can Do:
Dried blood spot sampling (DBS) is a form of bio-sampling that has been used for decades to screen patients for diseases that can be identified via metabolic markers – such as congenital metabolic diseases in infants. More recently, the method has been tested in clinical pharmacokinetic studies, or the study of drug absorption, distribution, metabolism, and excretion. The technique involves collecting a drop of blood on a small piece of filter paper and allowing it to dry before being analyzed.
DBS has some clear advantages:
- Minimal volume requirements
- Easy sample attainment via finger stick
- Nominal training for sample attainment
- Ease of sample collection, transport, storage, and handling
- Highly stable samples – ranging from months to years once dried
A new weapon in the fight for clean sport?
For those working to enhance doping control programs across the athletic sphere, the above benefits make DBS an appealing proposition which offers both administrative and financial benefits. DBS methods replace the need for arduous shipping procedures involving dry ice with a simple envelope at room temperature, which may catalyze massive cost savings for testing agencies. As well, the small sample volumes mean the entire process is much less intrusive for athletes being tested – which may lead to more athletes embracing the process.
In fact, DBS's applicability to anti-doping initiatives has been of interest to the community for some time, especially to Dr. Jack Henion, who has been studying DBS for several years. Dr. Henion is Professor Emeritus of Toxicology at Cornell University in the Analytical Toxicology Section of the Diagnostic Laboratory within the College of Veterinary Medicine. He is also a co-founder, Chairman and CSO of Advion BioSciences (ABS), Inc., located in Ithaca, New York.
Dr. Henion is no stranger to bio-sampling. He has rigorous experience with method development and validation with Liquid Chromatorgraphy/Mass Spectrometry (LC/MS) analysis of real-world biological samples for numerous applications, and has received three Honorary Doctorate degrees in recognition of his international reputation in modern analytical techniques.
Renewing a Basic Approach:
The adoption of mass spectrometry as a tool for analysis enhanced the viability of DBS as a molecular assay tremendously due to the increased number of analytes able to be measured from just a dime-sized spot of blood – a simple finger prick, for most people. In fact, several studies using analytical methods such as LC/MS, sequencing and/or RT-PCR confirm DBS sampling works as well as tests performed with fresh blood samples across several classes of analytes – an encouraging truth for Dr. Henion and his team.
Currently, the team – located at Q Squared Solutions - is not only developing and validating methods for the bioanalysis of five classes of drugs using DBS (including opioids, THC, stimulants, beta blockers, and steroids – top candidates for use in doping), they are also developing a novel dried plasma spot (DPS) card which "can provide micro plasma samples from finger pick blood without the need for centrifugation or other laboratory techniques for producing plasma," according to Dr. Henion.
Both projects amount to easier sample collection in-competition and out, coupled with more cost effective transport to the laboratory for analysis.
Thanks to Dr. Henion and his team striving to develop innovative techniques for the analysis of biological samples, DBS and DPS could be the future of anti-doping collection and testing.
Learn more about the innovative development at Q2 Lab Solutions here.
The research we fund is driven by several factors, including a contemporary need for information on a substance or test, a need for new methodologies, or a researcher's passion on a given topic. In 2014/2015 many of the projects we funded focused on three major areas:
The goal of the PCC is to protect clean athletes through applied scientific research. Testing methods which are intrusive, inefficient, or costly are less likely to be performed with the regularity truly needed to deter athletes seeking an advantage. This is why it's so important for anti-doping researchers to consistently seek new technologies for detecting and measuring performance enhancing drugs and substances. While 2014 and 2015 focused on these three categories, 2016 has begun with a focus on two different alternate specimens: Dried Blood/Plasma Spots and Breath Analysis.
For example, the PCC has recently funded a Micro-Grant to investigate the capabilities of a novel breath test from Swedish company Sensabues to detect PEDs. The test has already been proven to detect illegal drugs such as amphetamines, cocaine, and heroin, but more information is needed to determine if the test could be useful in the athletic sphere. If so, athletes would need only submit to breathing into the device for 20 inhale/exhale cycles – an incredibly non-intrusive process that requires very little time or cost that is traditionally associated with drug testing. Athletes can quickly and easily return to their schedule and administrative costs decline dramatically, making the test much more likely to be used with great frequency.
Whether it be through breath analysis, dried blood and plasma spots, or most likely a combination of both, we at the PCC will be on the cutting edge of anti-doping research in order to protect the clean athlete.
As the world leader in anti-doping research funding, the PCC's mission is driven by a global movement of scientists pursuing a single, noble goal: providing scientific data to protect the integrity of sport. The research we fund is conducted by scientists from diverse nations and it impacts athletes around the world. The PCC believes that in the scientific community, diversity makes a difference because it ensures various viewpoints are taken into account.
PCC working groups, in particular, combine the talents of researchers from several nations. This combination of knowledge exemplifies how an emphasis on common goals and international scientific standards can bridge divides and produce solutions for large-scale scientific challenges.
The bi-annual PCC conference, held in New York City, is another platform that strengthens international scientific ties through dialogue. The conference brings together scientists from all over the world to teach each other, collaborate, and share their views on tackling anti-doping concerns which transcend individual countries or sport. The next PCC conference will be in April 2017.
While working groups and the conference are vital to the mission of the PCC, there is nothing more critical than the grants program. In 2014 and 2015, grant applications were received from 15 different countries spanning four continents, including Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, South Africa, Spain, Sweden, Switzerland, the United Kingdom, and the United States.
Nearly half of the projects funded by the PCC (44%) were conducted by researchers from outside of North America. Not including North America, multiple projects were funded in Australia (5), Belgium (3), Denmark (2), and Austria (2). In 2016, the PCC hopes to see applications from additional nations to further enhance the anti-doping thought leadership currently amassed in our network.
While the PCC's emphasis is on funding high quality scientific anti-doping research regardless of geographical point of origin, we encourage a global effort in the fight for clean sport. A consortium of scientists from varying backgrounds may investigate different questions, or approach similar challenges in different ways. Thus, a diverse scientific community is most likely to balance bias, while advancing the field of anti-doping research.
Efforts to penetrate the scientific landscapes of more European, Asian, South American, and African nations are currently underway and include social media outreach, a quarterly newsletter with current funding opportunities distributed to a 1,200 person, global distribution list, and direct outreach to top international research universities. However, the value of word of mouth cannot be underestimated, and efforts can be furthered tremendously by current stakeholders sharing their knowledge about our available funding programs.
The more applications the PCC receives, the more potential to enhance anti-doping knowledge and improve upon testing methods and detection windows. We urge scientists from around the world - concentrating in any discipline - to expand their scientific and geographical reach by submitting their anti-doping research project by July 1, 2016 for consideration during our next funding cycle.
The PCC catalyzes an impact on sport through our funding. The research we support is conducted by scientists of the highest caliber, on topics exclusive to improving anti-doping knowledge. Often, the research we fund represents unique pilot projects not being explored elsewhere in the world.
That being said, understanding our funding process and how funds are distributed is important. Beginning with this article, the PCC will be highlighting various aspects of our 2014 and 2015 funding to provide insight into the types of projects we support, including breakdown by region, cost, program, and affiliation.
Our initial foray into the PCC's funding process is a snapshot of our total accomplishments for the past two years (see below). The PCC is very proud to have funded over $6.5 million in quality scientific anti-doping research. Many of our studies have already spurred real-world changes in anti-doping testing or policy. For instance, the PCC funded a human growth hormone (HGH) biomarkers working group, which developed an impressive new method for detecting HGH to be instituted in WADA labs this year. The impact of several other studies will be announced in the coming months.
The PCC boasts an overall funding percentage of nearly 40% for 2014 and 2015, which is above our average funding percentage of 28%. Our research priorities (found here) guide our decision-making when it comes to funding scientists and projects. The PCC, through its Scientific Advisory Board, also provides technical assistance to applicants whenever possible. Often, when a study has scientific merit but requires some additional clarification, it is recommended for resubmission in our next cycle. Resubmissions made up 9% (3/34) of studies funded in 2014 and 2015.
Funding is also allocated across several different programs apart from our traditional grants, including our micro-grants program, working groups, and fellowships. The PCC hopes to increase funding to each of these programs in upcoming years.
In each of 2014 and 2015, the PCC funded a higher than average number of projects thanks to an increased number of quality applications from world anti-doping experts and applications from new scientists entering anti-doping for the first time. In 2016, the PCC hopes to build on this success through the support of innovative research and scientists, to include growing the field of talent through our fellowship program and facilitating collaborative efforts through our working groups.
While we are proud of our recent work, the PCC will remain steadfast in our commitment to innovation in 2016 and beyond.
The integrity of sport is worth protecting.
The science of anti-doping must be flexible enough to stay ahead of athletes and other support professionals who make the wrong choices when it comes to the use of performance-enhancing substances. Anti-doping science and research must work to protect clean athletes in a timely manner.
New substances and methods that athletes can use to seek competitive advantages are constantly emerging. Rapid responses to these threats to clean sport are essential. So too is staying ahead of the curve.
Anti-doping and other sport organizations seeking to protect clean athletes must be vigilant in unearthing and predicting agents of performance enhancement. From testing, to investigations, education, and results management, there is one common need to protect integrity of sport: that of quality scientific research.
This is why the PCC pioneered the micro-grant: funding with a quick turnaround for projects requiring less than $75,000 and fewer than six months to complete. When scientific information is needed by the anti-doping community to make policy decisions, develop tests, or produce reference materials, waiting for a formal grant cycle can be detrimental to clean sport.
PCC micro-grants can be funded in as little as one week to advance anti-doping science.
In one case, a project was funded within days to assess athlete usage of and develop a method for the detection of Mildronate. The results of the study were provided to the World Anti-doping Agency (WADA) within weeks of completion of the study, and the total project timeline was less than a year from submission of the application to publication in a peer-reviewed scientific journal
If you are a scientist with a project related to contemporary anti-doping research, submit a two page project overview, complete with scientific methodology and project budget for micro-grant consideration. Please e-mail Michael Pearlmutter at firstname.lastname@example.org with any inquiries.
Learn more about micro-grants here.
In the world of anti-doping, 2016 is a critical year. On January 1st of this year, the World Anti-Doping Agency (WADA) made several changes to its prohibited substance list. One of those was the addition of Mildronate (aka Meldonium) due to "evidence of its use by athletes with the intention of enhancing performance." (WADA Statement on Maria Sharapova case)
The evidence referenced is research funded by the PCC and conducted by Dr. Mario Thevis of Germany in early 2015.
Since January 1, over 110 samples have tested positive for Mildronate. While there are many unanswered questions surrounding the implications of the substance's usage, here's what PCC researchers have confirmed:
(For an in depth look into the PCC funded Mildronate research, visit: http://onlinelibrary.wiley.com/doi/10.1002/dta.1788/full)
The Mildronate case highlights the rapidly changing dynamic of the anti-doping sphere and the importance of an efficient and credible scientific response. Substances – whether newly created for doping or which exist already for medical purposes – are constantly being provided to athletes with an intent to gain an unfair advantage. Mildronate went from a virtually unknown substance in America to being present in 2.2% of samples studied in Cologne – a concerning metric in the anti-doping world. In this case, the speed and efficiency of the PCC process provided WADA decision makers the quality scientific research it needed to make an informed decision on Mildronate.
Mildronate is an excellent case study of the real world impact on policy and testing methodology the PCC makes.
And PCC funded research is just ramping up.
The addition of Mildronate to the Prohibited List is simply the forerunner of several policy updates and augmented testing methodologies that will be the direct result of research conducted by PCC experts.
In 2014 alone – the year the Mildronate research was carried out – more than $4.4 million was distributed to researchers. Despite its massive impact on contemporary athletics, the Mildronate study represented one of more than 20 projects in the 2014 year.
The PCC expects significant future impact from several other studies carried out in the same year and will continue to update stakeholders about developments resulting from our labs around the world. For now, we'll leave you with a partial list of projects funded in 2014. Which of these do you expect to make the biggest impression on athletic policy in the future?
Dr. David Chen at the University of British Columbia for his work entitled "Capillary Electrophoresis-Mass Spectrometry Glycoscreening for Detection of Doping."
Dr. Daniel Eichner at Sports Medicine Research & Testing Laboratory for his work entitled "Evaluating Hepcidin as a Biomarker of Blood Doping."
Dr. Daniel Eichner, Dr. John Higgins, and Dr. Jaime Watkins at Sports Medicine Research & Testing Laboratory and Massachusetts General Hospital for their work entitled "Detecting Autologous Transfusion by Measuring Alterations in the Dynamics of Red Blood Cell Maturation and Recycling."
Dr. Peter Van Eenoo at the Doping Control Laboratory at Ghent University for his work entitled "Detection of new Rev-erbα agonist as potential doping agents: SR9009 and SR9011.
Dr. Jack Henion at Quintiles for his work entitled "Screening for Drugs via LC/MS Analysis of Dried Blood Spots and Dried Plasma Spots."
Dr. Benjamin Levine at University of Texas Southwestern Medical Center for his work entitled "Safety, Efficacy, and Detection of Xenon Supplementation for Increased Red Cell Mass in Highly Trained Athletes."
Dr. Kara Lynch at the University of California, San Francisco for her work entitled "Optimization of High Resolution Mass Spectrometry for Identification of Novel Doping Agents and Metabolites."
Dr. Tony Butch at the UCLA Olympic Analytical Laboratory for a Center of Excellence grant.
Dr. Daniel Eichner at Sports Medicine Research & Testing Laboratory for a Center of Excellence grant.
We're excited to make more big announcements. Stay tuned.
The Partnership for Clean Competition (PCC) will turn eight years old on May 9th, 2016. This marks eight years of funding pre-eminent research related to enhancing anti-doping testing methodologies and demonstrating (or debunking) performance enhancing properties of a myriad of substances. The PCC's pride in our work stems from the real-world impact we've catalyzed: the ability to take our research outside of the lab and truly protect clean athletes, worldwide.
Two unique advantages make our organization the world leader in anti-doping research:
1. Access to the world's utmost anti-doping expertise on our Scientific Advisory Board (SAB).
2. The opportunity to fund researchers who combine first-class scientific knowledge with a passion for protecting the integrity of sport.
These stakeholders are the pillars of our impact and the driving force behind the PCC's ability to efficiently and effectively provide quality scientific research on a range of subjects and substances. Our SAB is able to identify substances of urgency and connect crucial research needs with the scientific talent to pursue such projects. The board is also adept at funding projects with potential real-world application, such as policy change or less invasive testing methods, coinciding with the PCC's mission to truly provide an objective voice for clean sport worldwide.
We at the PCC are incredibly proud of our researchers and the work they have done to preserve athlete health, welfare and honor through their work. It is not the published work that motivates these scientists – though a large majority of PCC research does result in publication and presentation opportunities – but rather the knowledge they are protecting the very integrity of athletics.
If you'd like to join our research team or learn more about our fellowships and working groups, please email email@example.com.
To see our current team of Scientific leaders, visit our leadership page. Visit our site regularly for features on individual researchers, SAB members and exciting research projects.
Since 2009, the Partnership for Clean Competition (PCC) has been funding the world's preeminent anti-doping experts, providing over $15 million to date. Projects funded by the PCC support clean competition while standing up to the scientific scrutiny and oversight of our expert advisory board.
The impact of the PCC transcends geographic region, sporting event, and level of athlete. PCC research has informed policy for professional leagues, The Olympic Movement, and amateur associations around the world. We go beyond the research paper and protect clean athletes through the frequent real-world application of our projects and working groups.
We're incredibly proud to fund scientists contributing to an even playing field for current and future athletes through their research. We've created this overview to showcase some of the attributes that contribute to our status as a global leader in anti-doping research.
In 2016, the PCC will continue its focus on funding researchers devoted to furthering clean competition, while expanding the field of anti-doping expertise through our unique working groups and fellowship programs. If you are a researcher in anti-doping or a related field, we encourage you to apply for our next round of funding here.
If you are interested in getting involved in anti-doping research, apply for a fellowship here, or reach out to our team to gain more information.
Whether you are a scientist, anti-doping advocate, athlete, coach, sporting federation, or one of our incredible partners, we hope you will continue to follow our progress as we engage the power of science to support clean competition.
Sign up for our newsletter for exclusive updates and content through our contact form, and follow us on Facebook and Twitter to ensure you don't miss upcoming behind the scenes features and interviews with our scientific team.
FOR IMMEDIATE RELEASE October 22, 2015
Michael Pearlmutter Partnership for Clean Competition Executive Director 719.866.3307 firstname.lastname@example.org
COLORADO SPRINGS, Colo. – When the 2016 WADA Prohibited List of performance enhancing substances and methods was released earlier this month, mildronate (meldonium) was a notable new addition to the list. Earlier this year, a special research project funded, in part, by the Partnership for Clean Competition, was tasked with evaluating global athlete usage of mildronate, which was not previously prohibited, to determine if the rates of use indicated any potential performance-enhancing concerns. Analysis of 8,300 random, anonymous urine samples collected at doping control sessions revealed that 182 (2.2%) contained the energy-shifting drug mildronate, a substance first discovered and used in the 1980s as a cardioprotective agent.
"From an anti-doping perspective, the 2.2% rate in this study was concerning," said Dr. Larry Bowers, Chairperson of the PCC Scientific Board, "This figure represents more than twice the overall rate of laboratory findings for a single drug than any of the substances on the Prohibited List."
While mildronate was not on the World Anti-Doping Agency (WADA) Prohibited List at the time of the study, it was included in the WADA substance monitoring program in order to assess its prevalence and misuse in sport. The results of the special research project were provided to WADA as part of the monitoring program.
"This project shows both the impact of our work and the quality of the PCC funding process. A substance with this high a prevalence needs to be identified quickly through a flexible research funding process. Thankfully, we were able to respond to a potential situation within weeks and the results were known less than one month later," said Michael Pearlmutter, Executive Director of the PCC.
This special research project was conducted by five scientists led by Dr. Mario Thevis, who reviewed and tested thousands of urine samples stored at the WADA lab in Cologne, Germany in order to identify how many athletes may be using the substance for its potential performance-enhancing characteristics rather than its intended medical purpose. The study results showed that the use of mildronate was not limited to a particular sport or group of sports, but was found in a wide range of samples.
The results of this study suggested that further action was warranted to protect the rights of clean athletes around the world. The study concluded, "Due to the growing body of evidence (black market products and athletes' statements) concerning its misuse in sport, adequate test methods for the reliable identification of mildronate are required, especially since the substance has been added to the 2015 World Anti-Doping Agency (WADA) monitoring program."
By adding mildronate to the 2016 Prohibited List, WADA has taken the steps necessary to protect clean athletes and guard them against any competitors who may choose to cheat by misusing this substance.
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