119th Meeting Minutes

Minutes - February 3, 2015

The National Advisory Council on Drug Abuse convened its 119^th meeting at 8:30 a.m. on February 3, 2015 in Conference Rooms C & D, 6001 Executive Boulevard, Bethesda, Maryland.  The closed portion of the meeting was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees.  The open portion, which was open to the public on February 3, 2015, began at 10:15 a.m.  The Council adjourned on February 3, 2015 at 3:30 p.m.

Council Members Present
Anne Andorn, M.D.
Laura Bierut, M.D.
Regina Carelli, Ph.D.
James Hildreth, Ph.D., M.D.
Robert Lenox, M.D. 
Kelvin Lim, M.D.
Michael Nader, Ph.D.
John Rotrosen, M.D.

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Federal Employees Present

Members of the Public Present

Michael Chaple, Ph.D. - NDRI, St. John’s University
Thomas Freese, Ph.D. - UCLA
John Magnuson - INFINITY- Signature Solutions
Sarah Mancoll, M.S. - Society for Research in Child Development
Geoffrey Mumford, Ph.D. - American Psychological Association
Nancy Roget, M.S. - National Frontier and Rural ATTC
Beth A. Rutkowski, M.P.H. - UCLA
Roy Walker, M.B.A. - Synergy Enterprises, Inc.

Closed Portion of the Meeting – February 3, 2015

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
   
   Dr. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff.  She reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public. 
   
   Dr. Susan Weiss, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies. 

2. Application Reviews
   
   In turn, the Director or a designee for the Division of Basic Neuroscience and Behavioral Research, the Division of Clinical Neuroscience and Behavioral Research, the Division of Epidemiology, Services and Prevention Research, and the Division of Pharmacotherapies and Medical Consequences of Drug Abuse presented their applications for consideration by the Council.  For each, Council provided concurrence with the initial scientific reviews en bloc.  Council also approved Method to Extend Research in Time (MERIT) Extension awards and Administrative Supplements. Relevant applications were presented to Council for Special Council Review, and Council agreed with program assessments. All Trans-NIH Initiatives, i.e., Common Fund applications and NIDA Secondary applications also received Council concurrence.
   
   Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is a conflict of interest, real or apparent.  Conflicts of interest statements were signed by each member of the Council.  Members were not required to leave if an application in conflict with that member was acted upon en bloc.

Open Portion of the Meeting – February 3, 2015

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed all attendees.  She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment.  She then called attention to future Council meetings:  May 5-6, 2015, and September 1-2, 2015.  She reminded all attendees that the CRAN Council meeting will take place on February 4, 2015 and will be held at Fischer’s Lane.

2. Consideration of the Minutes of Council

   The Minutes of the NIDA October 2014 meeting were unanimously approved as written.

3. NIDA Director’s Report - Nora Volkow, M.D., Director, NIDA

   Dr. Volkow began her presentation by recognizing the remarkable work of the recently deceased, Dr. Steven Goldberg, chief of NIDA's Pre-Clinical Pharmacology Section in the Intramural Research Program.  Dr. Goldberg made outstanding contributions to understanding the behavioral and neuropharmacological mechanisms triggered by drugs of abuse and also contributed to NIDA’s mission via his collegial partnership with the Medications Development program.  He will be greatly missed.

   Dr. Volkow announced the creation of a new Division of Extramural Research led by Dr. Susan Weiss.  Dr. Weiss will not only oversee the management of grants and the NIDA Advisory Council, but she will also lead trans-NIH activities.  She also welcomed Mr. David Daubert into the role of Acting Executive Officer, replacing Ms. Glenda Conroy who left NIDA recently.

   Dr. Volkow recognized Dr. Redonna Chandler’s extraordinary performance as Acting Director of the Division of Epidemiology, Services and Prevention Research as the search for a permanent director continues.

   Dr. Volkow moved on with an update on the budget.  The Presidential Budget was just approved on February 2^nd.  NIDA’s total budget remains constant at about $1billion and the AIDS allocation continues to be approximately one third of the total budget.  She presented data showing that when expressed relative to 1998 dollars, NIDA’s program level of appropriated dollars has been trending back down to the same level it was in 1998, approximately $600 million.  This in turn has decreased the success rate of awarded applications to 20%.

   Turning to what is new at NIH; Dr. Volkow spoke about the NIH BRAIN Initiative that was launched by President Obama and has generated an enormous amount of interest across multiple agencies, including the NIH.  Brain disorders are now a leading source of disease burden and cost in the United States.  NIH has focused its research on the development of new tools to better understand the complexities of the brain and transform how brain structure and function are being studied.  In FY 2014, $46 million were invested in 58 projects across 6 RFAs.  These projects focus on cell-type classification; novel tools- cells and circuits; next generation human imaging; large scale recording and modulation; and integrated approaches to understanding circuit function.

   FY 2015 funding for new grants for the BRAIN initiative will be $25 million, a decrease from the level of new funding in FY 2014.  The National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS) will reissue 5 out of the 6 funding opportunity announcements; and there are plans to fund short courses and projects in human neuroscience.

   The next trans-NIH program that Dr. Volkow spoke about was the Common Fund.  There are four new programs being funded for FY 2015:  1)  Stimulating Peripheral Activity to Relieve Conditions (SPARC), investigating peripheral nervous system to catalyze development of therapies based on neuromodulation of end-organ system function.  2)  4D Nucleome, investigating principles behind nuclear organization in space and time (the fourth dimension) and the role this organization has on health and disease.  3)  Glycoscience, developing accessible new tools and technologies for glycoscience biomedical research.  The term accessible was further defined as tools and technologies that are less complex, easily available, affordable, easy to understand and adaptable.  4)  Pediatric Research, building the capability to link genotypes, exposures, and phenotypes through data sharing across IC-supported pediatric cohorts.

   She then moved on to NIDA participation with NIH-led programs for FY 2016.  The first initiative is entitled Enabling Exploration of the Eukaryotic Epitranscriptome (E4).  The aim of the E4 is to develop new tools, technologies, and datasets to enable systematic study of covalent RNA modifications, also known as Epitranscriptomics.  This effort will be led by Dr. John Satterlee of NIDA, as this is a natural progression for the NIH Common Fund Epigenomics program that he is also leading.

   The final NIH initiative that NIDA is participating in for FY 2016 is the Mechanisms of Benefits of Physical Activity.  Dr. Wilson Compton, NIDA Deputy Director, will be representing the institute on this program.  This will be a very large scale clinical cohort to deliver a human data set from people exposed to various physical activity regimens and to conduct a detailed phenotypic characterization that will evaluate the proteome, the transcriptome, the epigenome, the metabolome, and microRNA.  It will also generate a data coordinating center to integrate and standardize all of these measures.  In parallel, animal studies will be conducted for molecular discovery in all tissues to understand mechanistic interactions.

   Dr. Volkow moved on to current activities at NIDA.  She began with the priority area of prevention by showing data from the 2014 Monitoring the Future Study.  Findings indicate that the percentage of 12^th graders drinking alcohol and smoking cigarettes has been trending downward for the past 15 years.  Similarly, there has been a significant decrease in the prevalence rate for non-medical use of prescription opioid medications, as well as the use of synthetic marijuana among high school aged adolescents.  However, use of other sources of nicotine, such as E-cigarettes has been on the rise.  NIDA sees this as an area for expanding research and is providing funding for the development of a standardized electronic cigarette that will allow the investigation of bioavailability and the pharmacokinetics of this type of delivery.

   In parallel, data from the CDC indicates a continued increase in the number of overdoses from heroin and stable or slight declines  in prescription opioid medication overdoses among adults.  Results of surveys and studies point to a significant portion of the individuals that start injecting heroin do so as a transition from prescription opioid abuse.  This is also associated with an increase in the incidence of Hepatitis C among this population.  Dr. Volkow emphasized that the need to implement treatment and shift focus from solely prevention in this area is NIDA’s second priority area:  Treatment Interventions.  She shared that NIDAis partnering with industry in an effort develop FDA approved medications for the treatment of addiction.

   Dr. Volkow presented data from a paper, which was recently published in Biological Psychiatry, on the effects of high frequency transcranial magnetic stimulation (TMS) on cigarette smoking.   Repeated exposure to high-frequency, repetitive TMS was beneficial in treatment-resistant smokers, who also showed decreased cotinine blood levels.

   She then presented New-Treatment related Funding Opportunity Announcements (FOAs).  The first: Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UH2/UH3), under RFA-DA-15-017.  This FOA will support outstanding basic and/or clinical researchers to translate research discoveries into medications for the treatment of Substance Use Disorders stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or other opiate use.  The second:  Reductions in Illicit Drug Use and Functional Outcomes (R21/R33), under PA-15-099.  This FOA will support projects to determine whether reductions in illicit drug use are associated with positive changes in health-related and other functional outcomes in individuals with SUD.

   The third NIDA priority area is the HIV and drugs portfolio.  She presented the 2015 HIV/AIDS Avant-Garde Awardees:  Don C. Des Jarlais, Ph.D. from Mount Sinai Beth Israel Hospital in New York; Eli Gilboa, Ph.D. from the University of Miami School of Medicine; Nichole Klatt, Ph.D. from the University of Washington; Alan D. Levine, Ph.D. from Case Western Reserve University; and Tariq M. Rana, Ph.D. from the University of California at San Diego.  She then described their areas of expertise and research projects. 

   Dr. Volkow then spoke about the new HIV/AIDS-Related NIDA FOAs:  1) Integration of Infectious Diseases and Substance Abuse Intervention Services for Individuals Living with HIV (R01).  This is to support research to develop and test organizational and systems level interventions to determine how best to provide comprehensive, high quality, integrated, sustainable, cost-effective interventions to improve health outcomes of people with HIV and SUD.  2)  Seek, Test, Treat and Retain for Youth and Young Adults Living with or at High Risk for Acquiring HIV (R01).  This is to support research to examine delivery of HIV services (testing, linkage, engagement and retention in care) for high risk or already HIV positive youth and young adults.

   Next, Dr. Volkow moved onto the status of marijuana laws in the United States.  She showed a map of the U.S. that highlights the status of marijuana in each state in a color representing whether its use has been legalized for recreational use, medical use, both recreational and medical use; decriminalized; or if use remains fully illegal.  Data from a paper that was recently published show that not all states apply medical legalization in the same way.  States that provide dispensaries had the highest negative effects of marijuana and a higher prevalence of non-medical marijuana use.  Also, states that have legalized marijuana for recreational use were associated with the highest rates of use among young individuals. 

   There is strong evidence that the use of drugs is likely to have a deleterious effect on adolescents, as their brains are rapidly developing during this stage.  This suggests that the younger individuals are at the time of initiation of marijuana use, the worse the outcome.  Studies have also shown decreases in IQ levels after the regular use of marijuana by adolescents.  On the other hand, some studies have not shown cognitive impairment or brain abnormalities.  NIDA recognizes that there is a need for better understanding of the effects of not only marijuana, but other drugs on the adolescent brain.   

   This realization has led NIDA to partner with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Cancer Institute (NCI), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to develop what is now called the Adolescent Brain Cognitive Development (ABCD) National Longitudinal Study.  It will be a prospective study of 10,000 children ages 10 to 20 years to assess effects of drugs on individual brain development trajectories.  Efforts have been made to engage the scientific community, including a workshop at the Society for Neuroscience.  Since then, additional NIH components have joined including the National Institute of Mental Health (NIMH), National Institute of Neurological Diseases and Stroke (NINDS), National Institute on Minority Health and Health Disparities (NIMHD), Office of Research on Women’s’ Health (ORWH), and Office of Behavioral and Social Sciences Research.

   Dr. Volkow then spoke about the very successful NIDA Chat Day event.  This initiative was part of National Drug Facts Week.  It provided an opportunity for NIDA and NIAAA scientists to speak directly and provide expert and factual answers to teenagers across the country about drugs.  This event has the additional benefit of exposing teenagers to the value of science in resolving problems.

   She then highlighted a scientific finding that came out of the Intramural Program at NIDA.  It was led by Dr. Marisela Morales, where she was able to solve a seeming paradox.  It has been known that neurons in the Dorsal Raphe (DR) are serotonergic, and that serotonin is not rewarding.  Nonetheless, stimulation of the DR can lead to reward. Her research has found that there is a glutamatergic group of neurons in the DR that project to the Ventral Tegmental Area (VTA) and thereby provide a pathway by which the DR can lead to reward.  Stimulating the glutamatergic neurons was shown to stimulate the dopamine neurons in the VTA.    This is a great example, added Dr. Volkow, of how basic science can illuminate our understanding of the rewarding effects of drugs.

   Council thanked Dr. Volkow for her presentation.  One line of questions focused on medications development and the need to work closely with the FDA to allow outcomes for studies other than complete abstinence.  One possibility could be improved health outcomes, such as decreased prevalence of HIV/HCV due to decline in use and addiction to drugs.  Council members also recommended working with DEA to help reschedule marijuana in order to increase its use in research.  A final question encouraged NIDA to survey use of other forms of marijuana, such as edibles and vaping in its research studies.

4. 2015 Biennial Advisory Council Report Certifying Compliance with the NIH Policy On Inclusion of Women and Minorities as Subjects in Clinical Research - Wilson Compton, M.D., M.P.E., Deputy Director, NIDA

   Dr. Compton began his presentation by informing NIDA Council members that he was seeking Council approval of the Biennial Report on NIDA’s compliance regarding the inclusion of women and minorities in NIDA-funded research.  He thanked NIDA staff for their support in gathering data, developing the report and the presentation.  Specifically, he thanked Ms. Christie Espinoza, from the Division of Basic Neuroscience and Behavioral Research and Ms. Quandra Scudder, from the Center for Clinical Trials Network for taking the lead on this report. 

   He then provided background information.  The NIH Revitalization Act of 1993 Public Law had within it a section entitled “Women and Minorities as Subjects in Clinical Research” that reinforced existing NIH inclusion policy, by stating:  Women and minorities must be included in all clinical research studies; women and minorities must be included in Phase III clinical trials and trials must be designed to permit valid analysis; cost cannot be allowed as an acceptable reason for exclusion; NIH needs to support outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies.  He then went on to add that NIDA staff play a critical role in implementing the policies and procedures; applications are not awarded without an adequate recruitment plan and targeted enrollment; and non-competing grant awards are not issued until program determines adequacy of inclusion.

   Dr. Compton discussed key changes at the NIH level with the implementation of the new Inclusion Management System (IMS).  This will shift entry of data responsibility to the investigators in a more easy to use automated system, while program staff will be responsible for ensuring target data are being met.  The IMS will now include the “more than one race” category in its Planned Enrollment Report; will allow distinction between racial and ethnic information to reduce confusion in preparing both the Planned Enrollment Report and the Cumulative Inclusion Enrollment Report; and will eliminate the need to attach enrollment tables on electronically submitted competing grant applications because those data will be collected on structured data forms for the Planned and Cumulative Inclusion Enrollment Reports.

   Next, Dr. Compton presented NIDA data from FY 2009 through 2014, compared with data on inclusion of minority, Hispanic/Latino, males, females and unknown gender categories from overall NIH results.  Data proved to be consistent with overall NIH information from FY 2009 through 2012.  There was a noted increase in the number of males in NIDA FY 2014 data, and that was the result of a large health services project that included several hundred thousand participants from the Veterans Administration.  This indicates that even one large project can shift results in an appreciable way.

   NIDA Council approved the report and found NIDA funded grants to be compliant with the policy.

5. Scientific Opportunities and Challenges in Genomics - Eric Green, M.D., Ph.D., Director, National Human Genome Research Institute (NHGRI).

   Dr. Green began his presentation by providing an update on the human genomics landscape and in particular, the NHGRI.  He said that he and the NHGRI are historically linked to the Human Genome Project.  He began his NIH career as a postdoctoral fellow and resident in clinical pathology, at the same time as the U.S. congress had tasked the institute with leading U.S.’s efforts with the Human Genome Project.

   The Human Genome Project ended in 2003, he continued, and since becoming the NHGRI Director he has expanded the mission of the institute from just studying genomes to applying genomics clinically and medically, or  as he has phrased it “Genomic Medicine.”  He went on to define Genomic Medicine as an emerging medical discipline that involves using genomic information about an individual as part of their clinical care, for example for diagnostic or therapeutic decision-making, and the other implications of that clinical use.  Dr. Green posited that the future of genomics, in particular as genomics is being considered within the clinical context, would spread beyond the NHGRI to other NIH institutes, as well as other agencies.

   He continued by sharing the “NHGRI Strategic Vision for Genomics” document that was created and presented to their national advisory council members in February 2011.  Genomics research activities were organized within five major domains.  1)  Understanding the structure of genomes, using genomic tools;  2)  Understanding the biology of genomes;  3)  Understanding the biology of disease;  4) Advancing the science of medicine;  5) and Improving the effectiveness of healthcare.  He showed a graphic describing how NHGRI’s portfolio, both intramural and extramural, has been aligned with projected timelines to these five domains.  In addition, success related to projects in the first three domains, including the genome-wide association studies (GWAS); the Technology Development Program that has resulted in tools that have reduced the cost of sequencing a genome; the ENCODE project, the Encyclopedia of DNA Elements, which aims to catalogue all of the functional elements in the human genome and make them accessible to the scientific community; and the recently launched Genomics of Gene Regulation program that aims to understand the choreography of the elements in the human genome to determine gene expression and determine regulation of gene expression.

   Dr. Green moved into accomplishments within the fourth domain, advancing the science of medicine, such as the NCI partner program called the Cancer Genome Atlas.  The goal of this program is to catalogue the most common derangements in the genome of many different types of cancer.  The Centers for Mendelian Genomics aims to look at rare diseases for which the genomic basis is not yet known and use new technologies for sequencing.  He added that, as the Director of NHGRI, his goal is to launch the earliest research programs that will directly investigate how to actually implement genomic medicine with pilot projects and feasibility efforts.    

   He then listed the “Hot Areas” in Genomic Medicine, including cancer genomics; pharmacogenomics, which he believes NIDA and NHGRI could partner on; ultra-rare genetic disease diagnostics, such as the Undiagnosed Diseases Program that spans the NIH and has currently been adopted by the NIH Common Fund as the Undiagnosed Diseases Network; genomic medicine test drive programs, such as the Clinical Sequencing Exploratory Research Network, as well as the IGNITE program that helps disseminate genome related information to health care delivery systems across the nation, not just focusing on major medical centers; prenatal and newborn genomic analysis, which focuses on methods for sequencing fetal DNA via non-invasive methods such as a simple blood draw.  In addition, he described a joint program with the National Institute on Child Health and Human Development called the Insight program to improve newborn screening, while taking into account ethical dilemmas related to sequencing children.  And the final hot topic he discussed was clinical genomic information systems.  This is a long term goal for building improved information management systems that can be used by healthcare professionals to obtain actionable information related to individualized genomic information and variants.

   Dr. Green then shifted his presentation to President Obama’s new Precision Medicine Initiative that was just presented to congress and the nation on January 20, 2015 during his State of the Union Address.  Dr. Green talked about President Obama’s longstanding interest in genomics, spanning his career as a senator in 2006 through today.  The New England Journal of Medicine also posted a paper on-line written by Dr. Francis Collins, Director of the NIH, and Dr. Harold Varmus, Director of the NCI that describes the proposed initiative and NIH’s role in leading it. 

   He then described what he believed to be the five top catalysts for the President’s initiative.   They are: genomics, electronic health care records, technologies related to lifestyle monitoring, compute power and data science, and patient partnerships.  The Precision Medicine Initiative is divided into three major components:  1) Near Term with cancer as a model of precision medicine; 2) Longer Term that expands the model to other diseases, such as creating a national research cohort of greater than one million volunteers; and 3) Policy Changes to remove barriers to clinical implementation.  This would include updating federal rules protecting research participants and advancing FDA oversight of precision medicine products.

   The proposed FY 2016 budget for this initiative is a total of $215 million, with $200 million appropriated to the NIH.  The NCI will lead the first component of the initiative.  The second initiative will be the focus across the NIH, and in particular the NHGRI.  Dr. Green stated that he and other IC directors have begun strategic planning and plan to combine many existing cohorts, such as the Department of Veterans Affairs’ Million Veteran Program, and recruit new volunteers to meet the greater than one million volunteer’s goal.  Participants will share genomic data and lifestyle information.  Biological samples will also be obtained and linked to their electronic health records to develop databases useful for big data analyses, and to provide scientists with a ready platform to conduct observational studies of drugs and devices, as well as more rigorous intervention studies.  Researchers from many institutions will have access to the data.  Their work will propel understanding of health and disease; forge new ways of doing research through engaged participants and open, responsible data sharing; and expand the benefits of precision medicine beyond cancer to other diseases.  Finally, Dr. Green ended his presentation by sharing an announcement for the upcoming NIH Workshop “Building a Large U.S. Cohort for Precision Medicine Research” to be held on February 11 and 12, 2015 and encouraged the audience to attend.

   Dr. Volkow and Council members thanked Dr. Green for his presentation and applauded NHGRI’s efforts in leading the Precision Medicine Initiative.  Council recommended the need to diversify study cohorts to include more than European descent participants.  Another suggestion made by council, was to expand the use of social media and new technologies to reach out to younger volunteers; and to provide the needed training for staff collecting and analyzing data.

6. NIH Transformative Approach for Scientific Workforce Diversity - Hannah A. Valantine, M.D., MRCP, Chief Officer for Scientific Workforce Diversity, National Institutes of Health

   Dr. Valantine began by presenting her background at Stanford University as a clinical researcher in the field of cardiac transplantation for 30 years.  During her tenure at Stanford, she was asked to set up a new effort to expand diversity among the faculty.  She joined the NIH one year ago to work on a similar opportunity.  The NIH Transformative Diversity Initiative stemmed from a report that was published in Science in August, 2011 that points to great disparities in the recipients of NIH R01 grants along racial and ethnic groups.

   Dr. Valantine has been tasked as the Chief Officer for Scientific Workforce Diversity (COSWD) to enhance the diversity in the NIH intramural research program, and to offer coordination, evaluation and accountability.  The goal of the COSWD will be to enhance diversity of the NIH-funded workforce by building infrastructure leading to diversity; establishing a national research mentoring network; as well as a coordination and evaluation center; in addition, the COSWD will ensure fairness in peer review.  The Office of the COSWD’s primary mission is to build a diverse trans-NIH scientific workforce that is a model for capturing the most talented into biomedical research. 

   She began her focus as the COSWD by reviewing evidence from the NIH Intramural Research Program as a Laboratory for Testing Interventions to Diversify the Biomedical Workforce evaluation.    The results, as of October 2014 showed that among intramural tenure track investigators 38 % are female and 1.4% are African American,  10% are Hispanic, and 0.5% are Native American compared to approximately 61% being both males and white.

   The COSWD strategy to expand diversity in the IRP includes cluster hires and targeted recruitments; to enhance diversity in Stadtman, Lasker and other targeted searches; to build resources for hiring the most talented; and to establish a program to create a climate of belonging.  

   Dr. Valantine then spoke about the Diversifying and Accelerating Research Excellence (DARE) program, which was created to help narrow the gap and number of diversity postdoctoral fellows progressing to early career investigators.  This program is modeled after Stanford’s successful DARE Program, with some components of the UC Presidential Fellows Program.  The goals of this program are to give a cohort of fellows the tools for success:  Develop skills for career advancement; establish a forum for developing lab management skills; build skills for those aspiring to non-bench careers; train on strategies to support one another; and design and implement an evaluation component to track and measure outcomes over time.

   She then transitioned into enhancing diversity of the NIH-funded workforce, and presented her collective vision and goal.  The vision is to transform the way all biomedical researchers are trained to overcome unconscious bias.  Unconscious bias is a result of societal attitudes towards leadership, especially in the sciences.  This phenomenon can be ameliorated, as she showed based on recent studies, by raising awareness.  Dr. Valantine then presented the goal, which is to develop and test new approaches to training and mentoring on a large scale, and on a nationwide level.  By meeting this vision and goal, students from underrepresented backgrounds will be primary beneficiaries; and ultimately, all students will benefit and this will result in a stronger biomedical research enterprise.

   Program initiatives that have been set up to meet the above listed goal are the Building Infrastructure Leading to Diversity (BUILD) program.  This program uses experimental training awards to attract and retain students from diverse backgrounds into the biomedical research workforce.  National Research Mentoring Network (NRMN), which is a nationwide network of mentors from a variety of disciplines that will: define best practices for mentoring at all career stages; provide training for mentors; and offer networking and professional development for mentees.  And lastly, the Coordination and Evaluation Center (CEC), which will rigorously evaluate BUILD and NRMN program to determine what works and for whom; and disseminate successful training and mentoring strategies.  These awards were made in October 2014 for all three programs with a total funding of $31.3 million over five years.

   In addition, the newest funding opportunity, the NIH Big Data to Knowledge (BD2K) Enhancing Diversity in the Biomedical Data Science (R25) has been integrated into the BUILD program.  The primary purpose of this is to provide resources for eligible institutions to implement innovative approaches to research education for faculty and diverse students in Big Data science, including students from underrepresented backgrounds in biomedical research.

   Finally, Dr. Valantine spoke about integrating many successful and independent programs focusing on diversity and developing a national strategy to enhance scientific workforce diversity.  NIH is leading and catalyzing scientific workforce diversity through data-driven innovations to recruit and retain the most talented scientists.  NIH’s National Comprehensive Plan for Hubs of Innovation aims to achieve sustainable transformation by creating seamless transitions across biomedical research career paths with an overarching goal to eliminate transition barriers.   She then described in detail the strategy and essential components, such as a strategic partnership with research intensive institutions, and tracking and evaluation.  Program deliverables, would include: a national network to support career transitions; evidence-based literature to eliminate/reduce barriers to key career transition points; Individual access to the network in support of career development success; organizational infrastructure to support career development and transitions; and tools and resources to catalyze and sustain career transition success.  Dr. Valantine shared with Council webinars that the COSWD had conducted on November 12 and 18, 2014 to solicit feedback from and engage the academic community.

   NIDA Council members thanked Dr. Valantine for her dedication to this issue and for implementing so many diverse and potentially transformative programs.  Council members encouraged, as applicable by the research, efforts to measure success with endpoints other than “tenure”.  A suggestion that was made by Council was to request demographic data in the eCommons system to help NIH better track data and progress.

7. NIDA Council Subcommittee Working Group on Diversity in the Extramural Research Workforce: Final Report and NIDA’s Initial Response - Albert Avila, Ph.D., Director, Office of Diversity and Health Disparities, NIDA

   Dr. Avila began his presentation by showing data from 2010 on the landscape of the NIH-funded workforce by race and ethnicity.  NIDA’s data is proportionate to NIH data overall.  He also displayed a graphic representing 2012 data from the Society for Neuroscience Survey of Neurosciences programs on the higher attrition rate for underrepresented minorities (URM) compared to whites at all levels of neuroscience education, but most pronounced at the graduate to postdoctoral level.  These data were the impetus for charging the NIDA Subcommittee Working Group on Diversity in the Extramural Research with providing concrete recommendations to the NIDA Director on effective strategies to 1) increase the number of underrepresented minorities conducting drug abuse research, and 2) increase the number of grant applications submitted and funded from underrepresented minority investigators.

   The committee was made up of five non-NIH experts, including the National Advisory Council on Drug Abuse’s (NACDA) members: Dr. James Hildreth (Chair) and Dr. Carl Hart, as well as Dr. Suzanne de la Monte, a current National Institute on Alcohol Abuse and Alcoholism (NIAAA) Advisory Council member.  The committee met several times and developed the following three major topic recommendations:  1) Increase the pipeline of new investigators.  This goal would be achieved by a) increase funding of the Diversity Supplement Program and strengthen program practices; b) fund up to 5 K99/R00 awards per year to URM investigators; c) ensure T32 programs use slots for URMs and provide diversity supplements for quality T32 programs; d) initiate a coordinated and collaborative training network with multiple locations strong in substance abuse research; e) increase funding for URM to travel and network at scientific conference; and f) ensure that NIDA conference grants (R13) include minorities as panelists and speakers.

   The second goal was to increase NIDA grant applications from URMs.  This could be achieved by a) demystify the NIH and NIDA grant process; b) create a long term NIDA grant writing and mentoring program; c) increase the scientific personnel within the NIDA Office of Diversity and Health Disparities (ODHD); d) implicit bias training for all Scientific Review Group (SRG) members and NIDA staff; e) establish Funding Opportunity Announcement (FOA) for Community Based Participatory Research (CBPR) and research areas relevant to the underserved communities; f) current race/ethnicity data for NIH funding should be made readily accessible to the public.

   And the last and third goal was to re-organize the NIDA Diversity Workgroups so that there is a single steering committee to NIDA and to develop opportunities common to all diversity groups while preserving their individual needs.

   Dr. Avila then went on to present NIDA’s initial response to the subcommittee’s recommendations addressing the Increase the Pipeline for New Investigators goal.  Examples of some efforts that have begun are the ODHD set up initial teleconferences with the Diversity Supplement Program PI and trainees to encourage them to enter an independent funding path.  In addition, Notice of Award (NOA) language was changed to strongly encourage trainees to apply for independent funding, short of requiring it.  The ODHD is also continuing its annual diversity supplement workshop to instruct about the grant process and offer mentorship in application writing techniques and is considering a new FOA focused on mentor-mentee substance abuse research and grant writing.  The ODHD, he continued, has also been funding travel to URM to attend and network at scientific conferences such as the CPDD, APA and SfN.  The CPDD conference also targets the recommendation to provide additional grant writing and diversity mentoring workshops. 

   He then moved into future directions and highlighted the focus on mentor-mentee opportunities for career development leading to independent funding for early stage investigators; the need to   increase support and rigor within the NIDA diversity supplement program; and to build on the NIDA grant writing program.  And finally, work with NIH OD Diversity Office, NRMN and BUILD programs to leverage their increased outreach efforts. 

   Council thanked Dr. Avila for his presentation and for the efforts that ODHD and NIDA have already put in place to ensure diversity in NIDA funded investigators and trainees.  One recommendation that was presented by Council was tracking productivity of trainees via use of the T32 mechanism.  The endpoint of this could be the effect on underrepresented minority students and the number of publications they co-author.

8. NIDA Mentored Career Development Awards: State of the Program - Susan Weiss, Ph.D., Director, Division of Extramural Research, NIDA

   Dr. Weiss began by stating that her presentation is a direct response to Council’s request for an evaluation of the successes of NIDA funded career development awards over time.  She provided an outline of the types of Mentored K awards that NIDA funds and described each of them.  NIDA supports the following mechanisms:  K01, K08, K23, K25 and the K99/R00s.  The number of mentored career development awards that NIDA supports had been increasing since 1992, but has flattened out over the last 5 or 6 years, and now averages around 150. 

   She then presented the evaluation criteria for the analysis that was conducted on the Mentored K awardees (K01, K08, K23, K25 and K99s) supported in 2007.  This included: their subsequent NIH applications and awards until 2013; analysis by degree (M.D., Ph.D., and M.D. /Ph.D.); other indicators of research involvement (publications and current position); and trajectories for their success.

   The 2007 cohort, n of 153, was further divided by NIDA divisions (Division of Basic Neuroscience and Behavioral Research (DBNBR), Division of Clinical Neuroscience and Behavioral Research (DCNBR), Division of Epidemiology, Services and Prevention Research (DESPR), and Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DMMCDA)), with DCNBR, followed by DBNBR supporting the majority.

   All analyses were based on the last year of K support through 2013.  Of the 153 mentored K awardees supported in 2007, 128 submitted subsequent applications, and of those, 89 received funding; 60 obtained R01s.

   The next chart was an analysis by degree.  90% of PhDs (total n of 111) submitted applications and slightly over 60% of both the MDs (total n=36) and MD/PhDs (total n=6) submitted applications.  Of those, 62% PhDs had funded applications, and 50% of MD and MD/PhDs received funding.  The majority of K awardees are currently affiliated with an academic institution/university--over 90% in each degree category.  Nearly all of the awardees have multiple publications; and most have first authored publications.

   Dr. Weiss provided a summary of the evaluation of the mentored career development awardees, which show that K awards may contribute to increasing age for obtaining first R01 grant, typically around 40 years of age; but even in difficult fiscal budget times, the K awardees are highly successful, and most remain in their respective research careers. K awardees submit multiple applications in order to get funding; and the results of this analysis were consistent with the earlier cohort from 2000/2001 who entered the field in a better fiscal climate.

   Finally, she thanked her team Drs. Ish Amarreh, Ericka Boone and Mimi Ghim, for their help in gathering and analyzing the data and preparing the presentation; and  Dr. Genevieve deAlmeida-Morris’ for her advice and consultation.  Dr. Weiss stated that in light of the prior presentations focusing on diversity, future analyses of K awardees will also include demographic information, such as race and ethnicity to better track diversity.

   Council thanked Dr. Weiss for her informative presentation.  One suggestion that was requested from Council was establishing strategies to get MDs to commit to research long term post receiving a K award.

9. Concept Clearances:

   Two new program concepts received Council clearance.  Dr. Ivan Montoya, Deputy Director, Division of Phamacotherapies and Medical Consequences of Drug Abuse at NIDA presented a concept entitled “Fast Track Medications for Cannabis Use Disorders (CUDs).”  Given the extent of cannabis use in the general population and its medical and psychological consequences, there is a public health need to develop safe and effective medications to treat Cannabis Use Disorders (CUDs). Currently, there are no FDA-approved medications approved for this purpose. However, advances in understanding the cannabinoid systems and the effects of marijuana on the brain, coupled with the availability of both novel and marketed medications that may be efficacious, offer unprecedented opportunities to develop safe and effective pharmacotherapies for CUDs. The purpose of this initiative is to accelerate the discovery and development of medications to treat CUDs. The objective is to advance medications toward the ultimate goal of obtaining FDA approval.

   Dr. John Satterlee, Health Science Administrator from the Division of Basic Neuroscience and Behavioral Research at NIDA presented a concept entitled “Harnessing Genome Editing Technologies to Functionally Validate and Characterize Gene Variants for Substance Use Disorders.” The purpose of this FOA is to support projects that exploit genome editing technologies to rapidly generate knock-out and knock-in strains of animals.  These genetically altered animals will be tested in addiction-relevant phenotypic assays.  NIDA staff will ensure that these new genetic resources for drug abuse research will be made broadly available to the community.

   Studies supported by this FOA will generate genetic model organism resources that can be utilized by NIDA investigators to functionally validate human genetic findings.  These genetic resources will also allow researchers to probe more deeply into the neurobiological mechanisms involved in the function of a gene variant, and provide critical foundation al knowledge for the development of future prevention, diagnostic, and therapeutic strategies.

10. There were no Public Comments

11. Adjourn

    The 119^th meeting of the National Advisory Council on Drug Abuse was adjourned at 03:30 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.