July 31, 2016
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AMR on the International Agenda

1. Member States at the United Nations continue to negotiate Outcome Document for upcoming High-Level Meeting on Antimicrobial Resistance
2. CARB-X, a new U.S.-U.K. partnership focused on antimicrobial drug development  launches through support from government agencies, universities, and industry
3. Codex Alimentarius Commission establishes an Intergovernmental Ad Hoc Task Force Committee on Antimicrobial Resistance, hosted by South Korea

Ensuring a One Health Approach to AMR
4. WHO publishes 4th revision of the Critically Important Antimicrobials List, ranks drugs according to importance in human medicine 
5. FDA calls for comments for new draft guidance in assessing human health risks from antimicrobials used in food animals 
6. ReAct Latin America and the Technical University of Ambato host academic and scientific regional meeting on the One Health approach to AMR


From the Research Bench

7. A second colistin-resistance conferring gene, mcr-2, detected in pork and beef meat products in Belgium
8. Researchers find increasing resistance to gonorrhoea in the United States
9. Representatives from low- and middle-income countries meet to discuss development and implementation of national action plans
10. Scientists discover potential new antibiotic from bacteria found in the human nose
11. Researchers demonstrate success of pilot antibiotic stewardship program across resourced-limited hospitals in South Africa
12. The Center for Infectious Disease Research and Policy launches an online, interactive resource on antimicrobial stewardship

AMR on the International Agenda

1. Member States at the United Nations continue to negotiate Outcome Document for upcoming High-Level Meeting on Antimicrobial Resistance

OIEIn lead up to the UN High-Level Meeting on Antimicrobial Resistance (AMR) on September 21, 2016, country missions in New York are laying the groundwork with both a modalities document and an Outcomes Statement that Heads of State coming to the UN General Assembly would support. This process was kicked off by a resolution introduced by the countries of the Foreign Policy and Global Health group, which includes Thailand, South Africa, Brazil, France, Indonesia, Norway, and Senegal. This resolution calling for a High-Level Meeting on AMR was adopted at the UN General Assembly in December 2015.

On July 19, Member States adopted the resolution entitled “Scope, modalities, format and organization of the high-level meeting on antimicrobial resistance”. Through this resolution, Member States decided that the High-Level Meeting on AMR would consist of two interactive, thematic panels-- one on the relevance of addressing AMR for the achievement of the SDGs, in particular the health-related SDGs and the other on addressing the multisectoral implications and implementation challenges of AMR in a comprehensive manner. Each panel will include six discussants, including three Heads of State and representatives from civil society, industry, and academia. Opening these panels will be remarks from the Directors-Generals from each of the organizations of the tripartite partnership - WHO, FAO, and OIE.Besides Member States, also invited to the High-Level Meeting are all relevant United Nations entities, intergovernmental organizations and other related entities that have observer status to the General Assembly, and non-governmental organizations that are in consultative status to ECOSOC. The President of the General Assembly will also create a list of other representatives from relevant AMR non-governmental organizations, civil society organizations, academic institutions, and the private sector who may also attend the High-Level Meeting and participate in the interactive discussion sessions. Member States are also encouraged to consider including within their national delegations other parliamentarians, civil society, private sector, academia, and other stakeholders working on AMR.

More importantly, country missions have begun to negotiate the resulting Outcome Document that would outline the principles, commitments, and follow-on process for global coordination to address AMR across both human and animal health. 

Providing background to these discussions, the appointed facilitator, Ambassador Juan Gomez Camacho of the Permanent Mission of Mexico to the United Nations, convened two separate panels briefing Member States on this important issue. The first convening was of civil society that was co-organized with the WHO office in New York. On the civil society panel, speakers across human and animal health were represented including (in speaking order):
  • Amanda Jezek, Infectious Disease Society of America (IDSA)
  • Timothy Jinks, Wellcome Trust
  • Kathy Tallkington, Pew Charitable Trusts
  • Molly Miller-Petrie, Center for Disease Dynamics and Economic Policy
  • Judit Rius Sanjuan, MSF Access Campaign
  • Jean Halloran, Consumers Union
  • Anthony So, ReAct-Action on Antibiotic Resistance/Center for a Livable Future
  • Tyler Smith, EarthJustice
The second convening was focused on industry and included speakers from 18 private sector companies from the pharmaceutical to biotechnology to agribusiness industries. Also present at this meeting was the Drugs for a Neglected Diseases Initiative (DNDi), a product-development partnership that incubates the Global Antibiotic R&D Facility. Since these meetings, Member States have been engaged in negotiation sessions around the Outcome Document, grappling with issues from innovation and access of antimicrobials, diagnostics, and vaccines across sectors, stewardship approaches to conserve existing and novel drugs, and a follow-on process to monitor progress towards curbing AMR.

2. CARB-X, a new United States and United Kingdom partnership focused on antimicrobial drug development  launches through support from government agencies, universities, and industry

OIEOn July 28, CARB-X, a new global public-private partnership to accelerate antibiotic innovation was launched. CARB-X will be headquartered at Boston University and led by health law professor, Kevin Outterson. Alongside him as part of the Executive Team will Dr. John H. Rex, Senior Vice President and Chief Strategy Officer for AstraZeneca Pharmaceuticals and Dr. Barry I. Eisenstein, a physician within the antimicrobials division at Merck and previous Senior Vice President, Scientific Affairs at Cubist Pharmaceuticals. Dr. Eisenstein will assume the role of chair of the Scientific Advisory Board following his retirement from Merck in January 2017. This new $350 million initiative is supported by the U.S. government through the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), the Wellcome Trust, and the AMR Centre - a public-private partnership within the Alderley Park research facility. The name of the initiative came from the U.S. government’s initiative on Combating Antibiotic Resistant Bacteria (CARB) -- the initiative will also aim to address many of the key goals of the U.S. CARB National Action Plan developed in 2015. CARB-X’s product scope will include new antimicrobial therapies as well as vaccines, diagnostics, and other devices. Within the first year, the initial portfolio goal for new antimicrobials will be focused much more so on those therapies effective against Gram-negative bacteria. CARB-X will enter this space along with other existing product-development partnerships including:
  • ENABLE, funded by the New Drugs for Bad Bugs program within the Innovative Medicines Initiative (IMI) that targets Gram-negative bacteria; 
  • the antibiotic research partnership announced by the governments of China and the UK; and
the Global Antibiotic Research and Development (GARD) partnership launched by the World Health Organization and the Drugs for Neglected Disease initiative (DNDi).In a commentary published in Nature Review Drug Discovery announcing the launch of this initiative, the authors describe CARB-X as a “global accelerator, designed to provide significant research funding, research support services and business mentoring services with minimal bureaucracy.” The focus on this partnership will be on preclinical antibacterial research to more quickly advance potential compounds towards clinical studies. The partnership will also provide research support services with streamlined access to NIH, AMR Centre, and RTI International preclinical services and project management support. MassBio, California Life Sciences Institute, the Wellcome Trust, and the AMR Centre will also provide business support services. Within the Broad Institute of the Massachusetts Institute of Technology and Harvard University, a new Collaborative Hub in Early Antibiotic Discovery will be created that will help to foster interdisciplinary work. By the end of 2016, CARB-X will have a fully active application submission and review process for interested product developers. In the next months, they will also be presenting about the new initiative at various conferences. 

Commenting on this announcement, Kim Lewis, one of the scientists at Northeastern University who discovered teixobactin, a promising, first-in-class antibiotic through the creation of the iChip platform, stated that he has “mixed feelings” about CARB-X. While he supports greater funding going into the general area of antibiotics, he also worried that there might “another influx of funds into development rather than discovery” as the bottleneck in drug development is finding promising new molecules that can enter bacterial cell walls. Mr. Outterson, Executive Director of CARB-X agreed with this concern but felt that such funding and resources are within the scope of other funders including the NIH, while CARB-X will help to move potential products from university labs into clinical trials.

3. Codex Alimentarius Commission establishes an Intergovernmental Ad Hoc Task Force Committee on Antimicrobial Resistance, hosted by South Korea

From June 27 to July 1, the Codex Alimentarius Commission discussed AMR at its 39th Session in Rome. During this meeting, the Commission adopted the recommendation of the Codex Executive Committee to establish an Intergovernmental Ad Hoc Task Force Committee on AMR that will be hosted by the Republic of Korea. This task force will be a dedicated body focused on AMR within Codex. In opening the meeting, the Director-General of FAO, Dr. José Graziano da Silva, welcomed the prominence of the agenda item on AMR, noting that at the recent G7 meeting held in Japan, world leaders had called for urgency in addressing the issue. He also emphasized that establishing scientific evidence for the Codex guidance on AMR was crucial to ensure a “credible and effective response to the complex causes” of this global issue. He also called for further capacity-building and technical assistance for countries at every level of development to address AMR.

Dr. Bruce Aylward, Deputy Director General of WHO, Executive Director ad interim of Outbreaks and Health Emergencies  and  Special  Representative  of  the  Director General  for  the  Ebola  Response, also offered welcoming remarks on the behalf of WHO Director-General Margaret Chan. He remarked that the WHO considered Codex as “one of the most unique joint ventures of the entire UN system.” The Global Action Plan on AMR adopted at last year’s World Health Assembly last year, he noted, also called upon Codex to pursue new work in this area. He also stressed the urgent need for there to be sustainable financial support for the joint work of WHO and FAO in developing scientific evidence to Codex.Prior to this session, Codex received public input into revising two AMR guidance documents from 11 national governments (from countries across Asia, Australia, the Americas, and Europe), the EU, Consumers International, the International Dairy Federation (a dairy industry group), and HealthforAnimals (IFAH - an animal health industry group). IFAH recommended that the focus not be focused on revisions of the guidance documents, but instead on the implementation. In regards to the guidance document on the "Code of Practice to Minimise and Contain Antimicrobial Resistance” that was adopted in 2005, IFAH also stated that this guidance is redundant with the OIE Terrestrial Code and that the issue of “responsible use of antibiotics at the farm level” is within the scope of OIE and only a side issue for Codex. They called for any recommendations taken by Codex on this guidance to be in full alignment with OIE and other relevant texts of the organization. Consumers International among other respondents called for Codex to incorporate language on medically important antibiotics, limit the use of antibiotics for routine disease prevention, strengthen language that discourages growth promotion, include recommendations on the potential for feed to spread resistant pathogens, and acknowledge the role of labeling in informing consumers to thereby reduce antibiotic use in food production. 

In response to these comments, Codex concluded that it needs to revise the 2005 Code of Practice to Minimize and Contain Antimicrobial Resistance. On the other hand, the agenda document suggests that since the 2011 Guidelines on Risk Analysis of Foodborne Antimicrobial Resistance are relatively new, countries need more time and experience to identify gaps for revision. Codex will also begin work on a guidance document for integrated surveillance across the entire food chain to complement the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) guidance document.

Ensuring a One Health Approach to AMR

4. WHO publishes 4th revision of the Critically Important Antimicrobials List, ranks drugs according to importance in human medicine

On July 6, WHO’s latest revisions to the critically important antimicrobials were published in Clinical Infectious Diseases. As an important step towards conserving existing antimicrobials considered “critically important” to human medicine, the WHO updated their rankings of these drugs according to their relative importance in human medicine. The purpose of such rankings is to inform regulatory and stewardship policies to reduce the overall use of these drugs, especially in the food animal production. In this revision, the WHO has categorized quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, as well as glycopeptides as among the highest priority among the critically important antimicrobials. In this publication, the WHO has called for the large scale use of these drugs in food animal production to be addressed urgently to minimize the transmission risk of drug resistance to humans.

**Note: The article is currently not open access, requiring a subscription to the journal to access the full manuscript. According to the WHO policy on open access, the organization does “[support] open access to the published output of its activities as a fundamental part of its mission and a public benefit to be encouraged wherever possible.” As of July 2014, any articles authored or co-authored by WHO staff would have to be published in an open-access journal or hybrid open-access journal, or in a subscription journal where the manuscript would need to be deposited into the Europe PubMed Central within 12 months of the publication date.The authors, who are members of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance, note that AMR is related to the levels of antimicrobials used. Globally, the largest volume of antimicrobials seem to be used in food animal production. In the United States, estimates of such use in food animals is 80 percent of the total volume of antimicrobials. While they do acknowledge that not all of these drugs used in food animal production are medically important, they posit that co-selection might cause those other animal-specific drugs to select for resistance to other antimicrobials that are used in human medicine. Although there are similar figures across other developed countries in terms of percentage of antimicrobial use by volume in food animal production, the authors do note that such figures in addition to antimicrobial resistance are largely unavailable in developing countries. Nevertheless, data from China suggests that over half of all antimicrobial drugs are used in food animal production with the overall volume of usage seemingly higher than in developed countries. This trend, according to the authors, is likely found in other developing countries with large populations. WHO AGISAR in their role promotes integrated surveillance of antimicrobial use and resistance across both the human and animal sectors.

At the international level, the WHO has recommended that the use of antimicrobials determined to be essential for human medicine should be restricted in food animal production, “justified by culture and susceptibility results”. Additionally, for those antimicrobials that currently have no veterinary equivalent, such as carbapenems, or new classes of drugs that have been developed for use in human medicine, the WHO also recommends that these drugs “should not be used in animals, plants, or in aquaculture.” Based on a specific set of criteria including:
  • whether the antimicrobial class is the sole or of among a limited number of available therapies to treat serious bacterial infections in humans; or
  • whether the antimicrobial class used to treat infections in humans is caused by either bacteria that is transmitted to humans from non-human sources or by bacteria that could acquire resistance genes from non-human sources.
Based on this criteria, drugs are classified as “important”, “highly important”, “critically important”, or “highest-priority critically important” drugs.

5. FDA calls for comments for new draft guidance in assessing human health risks from antimicrobials used in food animals

On July 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance on “General Principles for Evaluating the Human Food Safety of New Animal Drugs used in Food Producing Animals”. Through a Federal Register notice, the agency also began a 60-day comment period inviting feedback on these proposed revisions to its previous guidance for pharmaceutical manufacturers on assessing whether therapies administered to food animals pose a risk to humans. The guidance is meant to provide scientific evidence so that companies are able to determine residue of a new antimicrobial drug in or near food products “presents a reasonable certainty of no harm to humans”.The guidance also offers recommendations for industry for the types of information that should be provided “to address the human food safety of new animal drugs used in food-producing animals”. The draft guidance offers revisions to a 2006 version and comes in the midst of growing concern on the transmission of drug-resistance due to the use of antimicrobials in food animal production.According to the draft guidance, the FDA conducts a “human food safety assessment” of new animal medicines in food animals through “hazard identification, hazard characterization, and mitigation” to reduce the exposure of humans to drug residues in food products from animals treated with these medicines. The guidance provides an overview of this process of human food safety assessment for new medicines used in food animals including: 
  • the calculation of safe concentrations of medicines to be used in food products;
  • the acceptable daily intake (ADI) of food products;
  • an assignment of the maximum concentration of a drug marker residue that can remain in a specific edible tissue of a treated food animal;
  • the calculation of a withdrawal period of medicines as well as a milk discard time; and
  • the evaluation of carcinogenic compounds.
Electronic comments for this guidance can be submitted to http://www.regulations.gov and written comments can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. The deadline for comments is September 12, 2016.

6. ReAct Latin America and the Technical University of Ambato host academic and scientific regional meeting on the One Health approach to AMR

Bill O'Leary / Washington PostFrom June 13-17, ReAct Latin America, in collaboration with the Technical University of Ambato, hosted a scientific and academic regional meeting around a One Health approach to AMR in Ambato, Ecuador. The meeting was split into two sessions - the first being the 3rd International Seminar on “Microbial world, bacterial resistance, and food sovereignty in the context of Sumak Kawsay (well-being)” and the second being the 2nd International Workshop on “Research and Training for the Rational Use of Antibiotics and Antibiotic Resistance in humans.” The overall objectives of this meeting were to analyze, evaluate and discuss ideas about health, nature and Sumak Kawsay through the lens of academia as well as indigenous populations as well as to reflect on the role of research and training across human health, animal nutrition, and the environment towards containment of antibiotic resistance. The meeting brought together almost a thousand students, health professionals, professors, and researchers across disciplines including human and animal health, food production, and environmental sciences. The participants were from 19 public and private universities across 7 Latin American countries. During the four-day meeting, there was an exchange of knowledge, bridging the arts and sciences, and discussion around connecting the traditional knowledge of those indigenous populations in the region with the critical scientific evidence on AMR to provide a holistic perspective on the issue.

From the Research Bench

7. A second colistin-resistance conferring gene, mcr-2, detected in pork and beef meat products in Belgium













Image from: Xavier BB, Lammens C, Ruhal R, Kumar-Singh S, Butaye P, Goossens H, Malhotra-Kumar S. Identification of a novel plasmid-mediated colistin-resistance gene, mcr-2, in Escherichia coli, Belgium, June 2016. Euro Surveill. 2016;21(27):pii=30280. DOI: http://dx.doi.org/10.2807/1560-7917.ES.2016.21.27.30280

A new colistin-resistance conferring gene, mcr-2, has been detected in beef and pork meat samples in Belgium. Following the November 2015 emergence of the first colistin-resistance conferring gene, mcr-1, in China that has also now been detected in 32 countries, researchers decided to screen known colistin-resistant Escherichia coli isolates from calves and piglets. None of these isolates demonstrated the presence of mcr-1, but did show the presence of a novel, plasmid-mediated colistin resistance-conferring gene, mcr-2. Additionally, the researchers do note that the samples screened were from different regions in the country. This new gene was also detected at even higher prevalence than that of mcr-1 within the colistin-resistant pork isolates. Based on the initial tests which show a high transfer frequency of the mcr-2 gene compared to that of mcr-1, scientists recommend that screening of this gene also be included immediately in ongoing epidemiological surveillance to determine the global dissemination of this gene in both human and animal colistin-resistant bacterial isolates. Colistin is a last-line antibiotic rarely used in human medicine, but is the fifth most commonly sold drug in food animal production among 19 European countries, including Belgium, in which sales data are available. 

8. Researchers find increasing resistance to gonorrhoea in the United States

In mid-July, a surveillance study was published in Morbidity and Mortality Weekly Report (MMWR) on gonorrhea, a sexually transmitted disease, finding increasing resistance to first- and second-line antibiotics across all regions in the United States. Although gonorrhea is the second most commonly reported disease in the United States, treatment has become increasingly challenged by the lack of definitive diagnostic testing in clinical care and increasing resistance to both first- and second-line medicines. Screening of gonorrheal bacterial isolates collected by the Gonococcal Isolate Surveillance Project (GISP) showed a significantly high percentage of resistance to various antibiotic therapies including tetracycline (25.3% of samples), ciprofloxacin (19.2%), and penicillin (16.2%). Additionally, they also found an increase in the percentage of bacterial samples resistant to the second-line treatment, azithromycin, as well as cefixime and ceftriaxone between 2013 and 2014. Within the National Strategy for Combating Antibiotic-Resistant Bacteria, the prevention, rapid detection, and control of ceftriaxone-resistant gonorrhea bacterial strains have been prioritized. The paper suggests that federal, state, and local agencies can use such data to develop national treatment recommendations as well as set priorities for research, prevention, and awareness-building campaigns.

9. Representatives from low- and middle-income countries meet to discuss development and implementation of national action plans

From June 29 to July 1, representatives from low- and middle-income countries as well as from civil society and academia attended the Wilton Park meeting on “Antimicrobial resistance: building national responses in middle and low income countries.” The aim of this meeting was to share experiences among those engaged in the development and implementation of national action plans across LMICs. Participants discussed various aspects of AMR policy including behavior change strategies to prescribe appropriately and administer antibiotics in human medicine and in agriculture, build political support to develop effective national action plans; develop surveillance and evaluation systems across sectors; ensure access as well as stewardships of antimicrobials; and enable successful implementation of national action plans. The meeting concluded with the following points:
  • Incentives through funding, institutions, and level of political interest to enable collaboration across existing programs should be institutionalized to safeguard AMR policy amidst changes in the political climate at the national and global level;
  • Sustainable funding for AMR relies on sustained political action on the issue;
  • Many LMICs will require funding from donor agencies, and so it will be necessary to under donor and country priorities in developing and implementing national action plan;
    • For instance, many LMICs wish to build AMR into their broader health agendas around health systems strengthening and universal access and need technical as well as financial assistance for interventions and surveillance in the agriculture sectors. Donors, however, prioritize the health sector over the agricultural sector, emphasizing interventions that would strengthen surveillance and laboratory infrastructure. Therefore, alignment of these two agendas is necessary.
  • Sustainable action on AMR will require behavior change interventions for stewardship across a number of stakeholders including patients, consumers, healthcare professionals, veterinarians, farmers, and the agricultural industry.
While governments can drive such change, civil society should also continue keeping pressure on governments to ensure political momentum so that commitments in the national action plans and beyond are carried through.
A full meeting summary can be found here

10. Scientists discover potential new antibiotic from bacteria found in the human nose

Scientists published results in Nature this month suggesting that a bacteria commonly found in human nasal passages have antibiotic properties. The study suggests that the human microbiome could be considered as a source of novel antibiotic therapies. The nasal bacteria Staphylococcus lugdunensis strains produce lugdunin, a new antibiotic that prevents the colonization of Staphylococcus aureus. Nasal colonization of S. aureus often predisposes to invasive infection and scientists discovered that the presence of S. lugdunesis in the human nose was associated with significant reductions in the carriage rate of S. aureus. This suggests that bacteria which produce the bactericidal lugdunin may be effective in preventing staphylococcal infections. They also found that in animal studies, this compound could be as powerful as vancomycin, an antibiotic that treats resistant staphylococcal infections. Lugdunin also seems to be effective without inducing further drug resistance as S. aureus has been exposed to this compound for thousands of years in the nose without showing any resistance. The team of researchers from the University of Tübingen in Germany have patented this compound and are in the process of finding partners to bring it to market.

11. Researchers demonstrate success of pilot antibiotic stewardship program across resourced-limited hospitals in South Africa

A recent study in The Lancet examined the implementation of an antimicrobial stewardship program across 47 hospitals in South Africa with limited infectious disease resources. To establish a baseline, researchers conducted a survey among pharmacists at the clinical sites before implementation of the stewardship program. Following this, a stewardship program was implemented across hospitals, which enabled pharmacists to monitor different measures of antibiotic prescribing and then intervene before dispensing the medications to reduce antibiotic use. These measures included whether the drugs are prescribed for a prolonged duration, whether multiple antibiotics are being prescribed, and whether the patient had redundant antibiotic coverage. Changes in antibiotic consumption between phases were measured between the pre-implementation and post-implementation phases. Of the over 100,000 patients reviewed who received antibiotics across 47 hospitals, almost 8000 interventions by pharmacists were recorded. This suggests that almost one in 15 prescriptions required a stewardship intervention. Among these, 39% of these interventions were for excessive duration for an antibiotic dose. The program led to a reduction in mean antibiotic defined daily dose per 100 patients days, demonstrating that healthcare facilities with limited resources can implement successful stewardship programs through basic interventions.

12. The Center for Infectious Disease Research and Policy launches an online, interactive resource on antimicrobial stewardship

Through a grant from the pharmaceutical company, Merck and Co., the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota has launched the Antimicrobial Stewardship Project (ASP). ASP will offer free, up-to-date information on antimicrobial stewardship practice, research, and policy through their newly launched website. The website will also feature other media around stewardship including expert webinars and podcasts featuring the ASP Advisory Committee members. The Advisory Committee includes experts across human and animal health from the U.S. government agencies, think tanks, and academia with experience in antimicrobial stewardship, AMR, clinical and veterinary medicine, clinical pharmacology, and public health. ASP will also host an online journal club, highlighting recently published research on antimicrobial stewardship and resistance and bibliographies as well as other online resources. The newly launched ASP website can be found here

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Note: The ARC Newsletter will periodically capture key meetings and developments, as well as news and resources, on antibiotic resistance for Coalition members and partners. This newsletter is prepared and published through ReAct North America/Strategic Policy Program at Johns Hopkins Bloomberg School of Public Health. The ARC Declaration on Antibiotic Resistance can be found here. Please share items for consideration for inclusion in future newsletters by writing to Reshma Ramachandran at rramach9@jhu.edu.