June 2017

Dear Colleagues,

I am honored to present my mid-year report as ASBMR President. Since we last met in February, we have maintained a high level of activity within the organization and I would like to thank all of you for your hard work and continued dedication to ASBMR. I am honored to work with you to achieve these goals.

As we continue to drive our overall mission of advancing bone, mineral and musculoskeletal science worldwide, promoting the translation of basic and clinical research to improve human health together, and celebrating forty years of scientific excellence within our field, let me reflect on how we have accomplished these objectives since February 2017.

ASBMR Strategic Plan
ASBMR continues to drive forward the four strategic priorities of our 2015-2018 strategic plan through numerous activities. Our four strategic priorities are:

• Closing the Treatment Gap, including Identification of an Improved Clinical Trial Endpoint
• Drive, Expand and Translate the Research Agenda in Musculoskeletal Science
• Increase International Outreach and Strengthen International Engagement to Create ‘One Global ASBMR Family’ 
• Develop New Strategies and Revenue Streams to Enable ASBMR to Invest in the Future of the Field

With the strategic plan as our roadmap, the following activities highlight our progress as it fits within the key strategic priorities.

Closing the Treatment Gap, including Identification of an Improved Clinical Trial Endpoint

Expand Communications to Members and the Public about Evidence on the Effectiveness and Safety of Treatments
Since leading the launch of the “Call to Action to Address the Crisis in the Treatment of Osteoporosis” last September, ASBMR has continued to work with our stakeholder partners to promote, advocate and educate on reducing the treatment gap. Currently thirty-nine organizations from around the world have signed the Call to Action.

In February 2017, the Multi-Stakeholder Initiative worked with the Center for Medical Technology Policy (CMTP) to convene a meeting of an Experts Group to advise on the initiative. The group, chaired by Sundeep Khosla, M.D. and Douglas P. Kiel, M.D., MPH, consists of the following members: Doug Bauer, M.D., Susan Bukata, M.D., Jane Cauley, DrPH, Juliet Compston, M.D., FRCP, Kristine Ensrud, M.D., MPH, Deborah Gold, Ph.D., Susan Ott, M.D., Cliff Rosen, M.D., Ken Saag, M.D., MSc, Elizabeth Shane, M.D., and Dan Solomon, M.D., MPH. The Experts Group confirmed that the four objectives of the Multi-Stakeholder Initiative Meeting scheduled for July 19, 2017 will be: 1) to bring together national and international representatives from affected stakeholder groups and facilitate open and frank discussion in order to gain a shared understanding of osteoporosis and its consequences; 2) to focus on secondary fracture prevention and foster consensus, based on this shared understanding, on the most appropriate approaches to reduce fractures in patients who have already experienced one; 3) to develop a strategy for implementing those approaches; and 4) to assess interest in continued dialog and collaboration to advance work on reducing fractures. The invitation-only “Fracture Prevention Stakeholder Summit” on July 19 will be held in Crystal, City, VA with approximately 60 individuals in attendance from a broad array of stakeholders. Following the meeting a strategic roadmap will be developed based on the consensus that is able to be achieved in the structured discussions. We anticipate that this will be ready for presentation at the ASBMR 2017 Annual Meeting in Denver.

At the urging of Sundeep Khosla, M.D. and Elizabeth Shane, M.D., who both sit on the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Council, NIAMS is partnering with multiple other federal stakeholders (NIA, NIDDK, NCATS, NCCIH, NIDCR, and the Office on Research on Women’s Health) to engage the NIH Office of Disease Prevention (ODP). ODP, through its program, Pathway to Prevention (P2P), will provide an objective, external review of current state-of-the-science related to fracture prevention and important gaps in knowledge. Research gaps and methodological and scientific weaknesses will be identified. A research agenda will be suggested to move our field further in addressing the crisis. This will involve working with the Agency for Healthcare Research and Quality (AHRQ) to solicit proposals from Evidence-Based Practice Centers to prepare an evidence report addressing the key questions being posed, followed by a conference (similar to previous NIH Consensus Conferences). The proceedings of this effort will be published and disseminated, with a key target being primary care physicians so that they can better provide the appropriate evidence to patients.

At the end of April 2017, the FDA approved Radius Health’s new anabolic therapy drug, TYMLOS™ (abaloparatide). This is exciting news for the bone field as this is the first new osteoporosis treatment drug approved in over seven years. The FDA's approval of TYMLOS™ was based on results at 18 months from the landmark ACTIVE trial and first six months of ACTIVExtend trial that demonstrated consistent significant and rapid reductions in the risk of vertebral and nonvertebral fractures regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral) and bone mineral density (BMD) at baseline. TYMLOS is approved for the treatment of postmenopausal women with osteoporosis at high risk of fractures as defined as a history of an osteoporotic fracture, multiple risk factors or patients who were intolerant to other available therapies.

In early May and after the FDA’s approval of TYMLOS™, the Institute for Clinical and Economic Review (ICER) released its draft evidence report, Anabolic Therapies for Osteoporosis in Postmenopausal Women: Effectiveness and Value. The report attempts to evaluate the economic value and effectiveness of anabolic therapy treatment in comparison with other currently established treatments and make a recommendation as to their overall value. ASBMR and NOF have joined with the National Bone Health Alliance (NBHA) to form an NBHA Work Group to carefully review and interact with ICER staff on the ICER report. Representatives from the ASBMR include the Chair of the Professional Practice Committee, Benjamin Leder, M.D. as well as other ASBMR members. Many members of this Work Group believe that this report was issued prematurely, since much of the research on the new anabolic therapies is not yet in the public domain and thus could not be part of the evidence evaluated. Other concerns have been raised regarding the economic modeling for cost effectiveness. ASBMR issued a statement to the media regarding the report, as did several other organizations. Our Professional Practice Committee (PPC) is preparing comments on the report for submission by May 31 and Benjamin Leder, M.D. will be traveling to Los Angeles, USA at the end of June to present the Society’s comments in person at the California Technology Assessment Forum (CTAF). We are also working with some of our Southern California clinician members to identify patients including patients who have suffered a hip fracture who would be willing to testify. We believe the patient perspective on the consequences of their fracture is compelling and ICER needs to hear these personal stories. It is not clear what will happen with respect to the ICER report and romosozumab because of the news last week of the imbalance of serious cardiovascular events in the active comparator trial, ARCH, which compared romosozumab with alendronate. Serious CVD events were observed at a rate of 2.5% in the romo group compared to 1.9% in the alendronate group. In the FRAME placebo-controlled study, there were no excess CVD events in the romo compared to the placebo groups. We are hoping that Amgen/UCB submits a late breaking abstract to ASBMR on these CVD events.

Create a Research Agenda to Close the Treatment Gap
The research agenda around closing the treatment gap on the number of patients needing treatment continues to evolve and move forward. Accomplishments and areas to highlight include:

The Professional Practice Committee (PPC) reviewed the recent American College of Physicians (ACP) update to its 2008 clinical practice guidelines for the treatment of osteoporosis. The PPC comments were used to create an ASBMR statement to the media on the issue, which applauded the ACP with this step to lead more primary care physicians to screen and treat patients to prevent fractures but pointed out key areas where the recommendations fall short.

ASBMR continues to provide support for the FNIH Bone Quality Project, led by PI Dennis Black, Ph.D. In April the project filed a Letter of Intent (LOI) for the qualification of total hip bone mineral density as an efficacy response biomarker and surrogate for fracture risk reduction in clinical trials. This biomarker would be used to support a claim of hip fracture reduction in a placebo-controlled clinical trial. We look forward to their response and the establishment of additional collaborative exchanges in the near future. Last July, the FNIH group received an encouraging response to their letter from the FDA. Preparations are underway for the initial briefing document with a goal of submitting it later this year. In addition, the group submitted an abstract to the 2017 ASBMR Annual Meeting last month on the relationship between femoral strength from QCT-based finite element analysis and femoral BMD before and after treatment. The FNIH working group is developing four manuscripts describing their initial results. A manuscript on bone turnover markers as surrogates will be submitted to JBMR soon. Dennis Black provided an overview of their progress at the recent ECTS meeting.

Drive, Translate and Expand the Research Agenda in Musculoskeletal Science

Creation of Standards and Definitions Around Significant Research Tools
To address standards for high resolution peripheral quantitative computed tomography (HR-pQCT), ASBMR representatives Mary Bouxsein, Ph.D., and Eric Orwoll, M.D. were added to the International Osteoporosis Foundation project on HR-pQCT co-chaired by Mary Bouxsein, Ph.D. The group met in March 2017 at WCO-IOF-ESCEO to continue work on a draft manuscript.

For Mesenchymal Stromal Cells (MSC) Standardization, the Strategic Direction Work Group and staff have held conversations with several experts within ASBMR on this topic to ensure there is no overlap with the current Task Force on Cell Based Therapies, as well as to identify and refine the charges to guide the direction of this project and set an agenda, and to identify organizations outside the bone field that might be tapped to partner with ASBMR on this priority. The ASBMR-ORS Task Force on Cell Based therapies is expected to complete its work in Q3 of 2017. Once the report is finished, recommendations will be communicated to leadership on next steps to seek formal approval for an initiative on MSC standards. We are discussing the idea of a joint task force on MSC standardization with ECTS, ORS and perhaps other member societies in the IFMRS.

Advance Knowledge on Functional Genomics
Five hands-on workshops, developed in conjunction with the IFMRS Big Data Work Group, ASBMR Program Committee and Strategic Plan Team, are being planned for our 2017 Annual Meeting. One of these hands-on workshops will focus on genomics. Additionally, the IFMRS Big Data Work Group continues to compile and expand its inventory of existing databases for musculoskeletal research. We are also very excited about one of the new hands-on workshops focused on muscle with both a basic/translational and clinical perspective.

US Budget Implications
The 2018 US budget proposal was announced last week and recommends a 17% cut to the NIH budget, from $31.6 Billion to $26 Billion. The budget also requests an 11% cut to the NSF and a 17% cut to the CDC. In March, the Trump administration submitted a “skinny” budget for the remainder of 2017 and fortunately Congress ignored the proposed cuts for NIH, NSF and CDC. We are hoping that lawmakers will ignore these proposed cuts, since we could lose a whole generation of young scientists. Eddie Bernice Johnson, a Democrat from Texas, is a ranking member of the House Science and Technology Committee and has noted: “Instead of preserving and promoting America’s leadership in science and technology, this budget would put our nation on a path of decline.” All of our US members need to maintain an active communication with their legislators advocating for science and research.

The Launch of JBMR Plus
JBMR® Plus successfully opened for submissions in January and has already published five articles in the first quarter. Five review articles from prominent ASBMR members have also been commissioned and these are due to be submitted over the next 2 months. Nearly 25% of authors who have been offered a transfer to JBMR® Plus have accepted this transfer, a very good referral rate for a new cascade journal. We look forward to a reception to celebrate the successful launch of JBMR® Plus at the Annual Meeting in September.

New Edition of the ASBMR Primer
The manuscripts are all in for the 9th Edition of the Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. The Section Editors, Senior Associate Editors, and Editor-in-Chief John Bilezikian have our thanks for the tireless acquisition, peer review, and finalization of 135 new and updated chapters for this edition. While print copies of the new Primer will not be quite ready in time for the Annual Meeting, Wiley staff will be previewing chapters and multimedia features on the companion website, as well as taking customer inquiries and preorders on site.

Increasing JBMR Visibility
The Editors-in-Chief and ASBMR staff met at Wiley headquarters in April to set JBMR® strategy for the year ahead. The coming months will focus on campaigns to show appreciation for reviewers and highlight the extraordinary work they do for the journal, increase content visibility in China and Japan through cross-community campaigns and newsletters, grow usage globally by 5%, and increase submissions by 3% in repeat authors and international early career researchers. These campaigns are designed to fortify JBMR’s position in its peer group in preparation for the Editor transition at the end of this year.

Increase International Outreach and Strengthen International Engagement to Create ‘One Global ASBMR Family’

ASBMR International Outreach and Engagement
The Membership Engagement and Education Committee, chaired by Nicola Napoli, M.D., have continued to work with staff to implement some of the recommendations presented at the Winter Council Meeting. An extensive survey of the current membership, along with recently lapsed members, was conducted this spring and the results with recommendations will be presented during our Summer Council Strategic Discussions Evening Session. Upon recommendation from MEEC, the Executive Committee also approved several new travel grant initiatives aimed toward increasing engagement:

• Modified the amount of funding for young investigator travel grants to increase the amount for international recipients to $750 USD and maintain the amount for North Americans at $500 USD. Previously $500 USD was awarded to all recipients, regardless of geography.
• Created twenty new travel grants for Mid-Career Faculty Investigators in the amount of $500 USD for North American recipients and $750 USD for international applicants.
• Created five new travel grants for Research Teams geared toward mid-career and senior investigators plus one individual from their team to attend the meeting. These grants range from $1,000 USD for North American recipients and $1,500 for international applicants.

We have been actively increasing our participation in a number of international meetings. In March 2017 we reprised the joint ASBMR/IOF session from our 2016 Annual Meeting on “Fracture risk assessment to target treatment: Effectiveness and cost-utility” at the WCO-IOF-ESCEO meeting in Florence, Italy with Bo Abrahamsen, M.D., Ph.D. serving as the ASBMR Co-Chair for the session along with John Kanis, M.D. as the IOF Co-Chair. A session on “Reducing the Treatment Gap,” jointly moderated by myself and Cyrus Cooper, the new IOF President, at this year’s Annual Meeting in Denver will continue this partnership.

In May 2017 Steve Harris, M.D. and I participated in the ECTS 2017 ECTS/ASBMR Clinical Debate, “This house believes that anabolic therapy should be first line therapy for all patients with established osteoporosis,” as presenter and co-chair, respectively. Bente Langdahl, M.D. and Claus C. Glüer, Ph.D. were the ECTS presenter and co-chair representatives. Bente was for the motion and Steve was against the motion. Both presenters did an outstanding job and Steve Harris made ASBMR proud. However, the trend is to be more aggressive with anabolic therapy despite the cost implications and the fact that the statement referred to all patients, not just high risk patients, and the “Golden Femur Award” went to ECTS. Our Annual Meeting will also feature a Clinical Debate with ECTS, entitled, “Anti-Resorptive Therapy during the menopausal transition prevents bone fractures later in life” with Dolores Shoback, M.D. (ASBMR) and Richard Eastell, M.D. (ECTS) as co-chairs and Gail Greendale, M.D. (ASBMR) (against the motion) and Erik Eriksen, M.D. (ECTS) (for the motion) as the presenters.

In June 2017 Carolyn Crandall, M.D. and Charles Farber, Ph.D. will represent ASBMR making presentations on “Screening for osteoporosis and fracture risk: a primary care perspective” and “Systems approaches to investigate the molecular basis of bone strength” at the ANZBMS-IFMRS-JSBMR meeting in Brisbane, Australia. In August 2017 we will participate in a joint symposium with the Fragility Fracture Network at their FFN Global Congress in Sweden. Nicola Napoli, M.D., and Bente Langdahl, M.D., DMSc will represent ASBMR at the session on “Under-Treatment of Patients at Risk of Fractures.” And in October 2017 we will participate in a joint session on osteo-anabolic therapies with SIOMMM at their 2017 Meeting, with John Bilezikian, M.D., Nicola Napoli, M.D., and myself representing ASBMR. The current plan is for me to discuss identifying the high risk patient and John and Nicola, anabolic therapies.

International Federation of Musculoskeletal Research Societies (IFMRS)
The International Bone and Mineral Society (IBMS) is in the process of completing its dissolution and the transfer of its assets to IFMRS. The IFMRS Board of Directors held a strategic planning retreat in Boston earlier this year. As previously noted, IFMRS is partnering with ANZBMS this year on a joint meeting in Brisbane, Australia in June 2017. IFMRS will continue to expand the Big Data Initiative and collaborate with other societies on educational programs. Initiatives in the planning stage include the development of research and travel grants and a Future Global Leaders Committee for early career investigators.

Develop New Strategies and Revenue Streams to Enable ASBMR to Invest in the Future of the Field

ASBMR Fund for Research and Education
The ASBMR Development Committee, co-chaired by Bart Clarke, M.D. and Shonni Silverberg, M.D., has worked hard over the last year to develop an individual giving campaign for the ASBMR Fund for Research and Education. In acknowledgement of the 40th Anniversary of ASBMR, the Fund is launching a “$40 for 40” campaign in 2017, encouraging members to donate $40 (or more!) in support of the Society.

We are pleased to announce that as a result of donations to the Fund, a new Research Grant Program has been created to provide funding in the amount of $7,500 USD to promising young scientists and physician-scientists in the bone field who are currently seeking to learn a new technique or to obtain additional funding to successfully complete a project. Grant submissions can be basic, clinical or translational and the primary focus must be on bone, mineral and musculoskeletal research. Two of these grants will be awarded in 2017. Award recipients will present their abstracts at the 2018 Annual Meeting. Future grants will be dependent upon the amount of individual donations received in 2017.

ASBMR Rising Star Award
The ASBMR Rising Star Award Committee is currently in the process of reviewing the nineteen applications received for this year’s award. The award provides funding to our most promising young scientists and physician-scientists in the bone field who have already been recognized by NIH “K awards” and other similar international career development programs. The award provides $60,000 USD in funding for each awardee – three US-based and three international – to help them successfully implement their programs, stay in the field and transition to become independent investigators. The program is co-chaired by Teresita Bellido, Ph.D. and Richard Eastell, M.D. We are planning to highlight last year’s Rising Star awardees at the upcoming ASBMR meeting.

ASBMR 2017 Annual Meeting
The ASBMR Annual Meeting is the highlight of each year. I have truly enjoyed working with my colleagues Anna Teti, Ph.D., Teresita Bellido, Ph.D. and Kenneth Saag, M.D. and ASBMR staff to develop the scientific program for this year’s meeting in Denver. Some highlights of the program include:

• Gerald D. Aurbach Lecture on “Cellular Senescence: Yin and Yang”, Judith Campisi, Ph.D.
• Louis V. Avioli Lecture on “The Quest for Osteoporosis Mechanisms: How Far We’ve Come, How Much Further We Need to Go”, Stavros Manolagas, M.D., Ph.D., University of Arkansas for Medical Sciences (USA) 
• Two Clinical Evening Sessions: “Treating the Treatment Gap” and “Management and Treatment of Rare Bone Diseases”
• Basic Evening: “The Bone Marrow Niche and Hematopoiesis”
• ASBMR/ECTS Clinical Debate: “Anti-Resorptive Therapy During the Menopausal Transition Prevents Bone Fractures Later in Life”
• ASBMR-IOF Session: “Reducing the Treatment Gap”
• A 40th Anniversary Plenary Symposium
• A variety of symposia on CRISPR, Sleep, Energy Metabolism and Musculoskeletal disease, Testosterone Treatment, Bone Muscle Interactions, and Rare Bone Diseases are planned.

In addition to the Annual Meeting, we will again host a pre-meeting symposium, ASBMR Symposium – Current Concepts in Bone Fragility: From Cells to Surrogates, organized by Mary Bouxsein, Ph.D., Claus Glüer, Ph.D. and Marjolein van der Meulen, Ph.D. Highlights of the program include:

• Hierarchical Materials in Nature: How Bone is Tough
• Interaction of Skeletal Traits Determines Long Bone Fragility
• Tissue-to-Material Level Contributions to Bone Mechanical Behavior 
• Contribution of Bone Microstructure to Bone Mechanical Behavior
• Translation of Bone Strength Assessments to Clinical Utility
• Surrogate Endpoints for Clinical Outcomes in Osteoporosis

Thank you all for your efforts to support the ASBMR mission to advance bone, mineral and musculoskeletal science worldwide and to promote the translation of basic and clinical research to improve human health.
Sincerely,

Jane A. Cauley, DrPH
ASBMR President