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Prevention

The MCS product offices responsible for vaccine and platformtechnology development engaged in multiple efforts to acceleratedevelopment of Ebola vaccine candidates. Of note, the WHO andMédecins Sans Frontières (MSF) utilized the Department of Defense-funded r-VSV∆G-ZEBOV vaccine in a ring vaccination campaign.MCS, in collaboration with the Defense Threat Reduction Agency,provided early testing and development activities for the vaccine.During the exercise, more than 3,000 people were vaccinated.MCS currently maintains a 23,000 multi-dose vial stockpile of theinvestigational vaccines in case additional doses are required.

DiagnosisThe WHO developed a National Laboratory Strategy in response tothe outbreak. As part of this effort, the Defense Biological ProductAssurance Office deployed two co-funded Nebraska StrategicResearch Institute personnel to support sequencing efforts. Thepersonnel took sequencing equipment, consumables, and reagentsto establish a sequencing capability at the Institut National deRecherche Biomédicale within the DRC. This capability sequencedEbola samples from the outbreak so the data can be shared with thebiodefense community on critical reagents for the Ebola virus.

Treatment

MCS’s biological therapeutics office worked closely with the WHOand MSF on their Ebola drug treatment in development. The drugRemdesivir, developed by Gilead Sciences and funded by theDepartment of Defense, was deployed to the DRC for emergencyuse during the outbreak.

In addition, the MCS platform technologies office partnered with theNational Allergy and Infectious Disease Vaccine Research Center torapidly manufacturing their VRC-114 anti-Ebola monoclonal antibodyin support of conducting clinical trials for a vaccine and therapeuticin the DRC. By leveraging the DOD’s existing monoclonal antibodyplatform and Advanced Development and Manufacturing facility

In the past decade, we have seen an increase in infectious diseaseoutbreaks, most notably with the West Africa Ebola outbreak in2014, which left more than 11,000 dead and 17,000 survivors,

many of whom still require post-recovery medical care. The threatcontinues today. Public health officials and business leaders likeBill Gates have long warned that the world is not ready for the nextpandemic.

Global health officials say it’s more imoutbreaks to be stopped at their souepidemics. And that is exactly what tcollaboration with the World Health Oand other international partners—didoutbreak in the Democratic Republic

On May 8, the Ministry of Health of tEbola virus outbreak in Bikoro HealtProvince. A total of 54 cases and 33900 identified contacts. The WHO wgovernment to rapidly scale up its opartners.

Ebola is endemic to the DRC. The laand was quickly contained. The WHquick testing of blood samples, anna rapid response from health author

Department of Defense ResThe Joint Program Executive OfficeRadiological, and Nuclear DefenseProgram Management Office for Me(JPM-MCS) played a significant roleresponse to the recent outbreak. ThDepartment of Defense’s single focafielding of chemical, biological, radiequipment and medical countermea

The JPEO recognized the importanceffort based on its previous and concountermeasures to protect, identifyare utilizing a whole-of-governmentour mission space is ultimately to suimperative to support our domesticpartners in this response,” said Mr.Executive Officer for JPEO-CBRNDcommunity in whatever way we can

Department of DefenseIntegral in the Democratic Republic of the Congo

Ebola Outbreak ResponseBy Dr. Clay Holloway & Hannah Feldman, Medical Countermeasure Systems

platform and anufacturing facility,MCS a C-114 to be

ng Eb ted individuals, t ating FDAoval o a ther p . . s an .

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To contact MCS i rnd.list.co unications@m

mportant than ever for diseaserce before they come full-blownthe Department of Defense—inOrganization (WHO), interagencd in response to the latest Ec of the Congo (DRC).

the DRC notified thth Zone in the no st3 deaths were teworked closel thoperations al

atest o ak occu ,HO att ed snoun th anritie

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of cont tin tued p ald t E v eroach to this r ile

u rt the w ht ia nter p hD las i gr. “ r s g l.”

1Portfolio Transformation and Late-Stage Clinical Development, Biogen, Cambridge, MA;

cherie.butts@biogen.com2Cornell BEST Program and Department of Microbiology and Immunology,

Cornell University, Ithaca, NY; averyaugust@cornell.edu

CORNELL

BESTPROGRAM

Phase 3+Exploratory Phase 2Discovery

Research & development technologies

Computation & data analytics

Translational biomarkers

Medical affairs

Assetmanagement

Business analytics

Portfolio management

Drug development pipeline

Regulatory

Clinical developmentProtein engineering

Phase 1

FIGURE 1.

Sessiontopics

For additional information and to explore future opportunitieswith

this drug development trainingmodel,please contact the authors:

cherie.butts@biogen.com and averyaugust@cornell.edu.

*40 Ph.D. students, postdocs, and medical students from Boston University;Cornell University; Emory University; Georgia Institute of Technology; JohnsHopkins University; Meharry Medical College; Michigan State University; NewYork University; Rutgers University; Universities of California at Davis, Irvine,and San Francisco; Universities of Colorado at Anschutz and Denver; Universityof North Carolina at Chapel Hill; University of Massachusetts Medical School;University of Rochester; Vanderbilt University; Virginia Polytechnic Institute andState University; andWayne State University.

Teams receive topics and supportinginformation to generate business case.

Team-building emphasizes value ofshared responsibility.

Feedback assesses impact of conference.

FIGURE 2.

Participants complete preconference surveys toidentify expertise and professional interests.

Session leaders discuss their career paths, current roles,and contributions to project teams.

Teamselection

Topicselection

Tailoredteam

experience+

Conference format

ADVERTORIALPRODUCED BY THE SCIENCE/AAAS CUSTOM PUBLISHING OFFICE

Purposeful outcomesParticipantswere introduced to the drug development process (from

concept to approval), and sessionswere led by individuals from acrossBiogen,who offered insight on their rolesóincluding how they supportproject teams. The topics included asset management, biomarker de-velopment, business and data analytics, clinical development,medicalaffairs, portfolio management, protein engineering, and regulatory af-fairs and policy (Figure 1). In addition, participants served on teams

that generated a business case and recommendations for progressionof a mock project to the next drug development stage (Figure 2).

Reˇning and reframingA new training model is needed to strengthen and reˇne the neces-

sary skills for those who wish to translate new biomedical discoveriesinto beneˇcial drugs. More trainees with the right experience will in-crease the pace of drug development, reducing the burden of debili-tating medical conditions on society. Such a reframing of the trainingexperience will positively change the conduct of science and expandthe ways that meaningful contributions to biomedical science are

deˇned. This conference emphasizes the importance of experientiallearning and serves as amodel for such training.

References

1. G.A. Van Norman, JACC: Basic to Translational Science 1, 170ñ179 (2016).

2. J. R. Katzenbach,D. K. Smith, Harvard Business Review 71, 111ñ120 (1993).

Demand for a qualiˇed biomedical science workforce totackle the challenges of making better medicines remainshigh; however, few scientists and clinicians learn about drug

development during their training. To assist trainees with ap-preciating differences between basic science (understandingdisease mechanisms) and applied science (drug development),Biogen and the Cornell Broadening Experiences in Scientiˇc Train-ing (BEST) program convened a conference in June 2018 at theBiogen headquarters in Cambridge, Massachusetts (#BiogenBESTDDConf2018).

Selection processParticipants were identiˇed primarily from academic institutions with

U.S. National Institutes of Health (NIH) BEST programs (www.nihbest.org;https://commonfund.nih.gov/workforce),as they are familiarwithbiophar-ma career pathways. Trainees* were exposed to key drug developmentquestions, different roles in and out of the laboratory or clinic, and skillsneeded to be successful in biopharma. To ensure that information fromthe conference extendedbeyond thosewho attended,a requirementwasthat trainees share key conceptswith others at their home institutions.

Unique approachThe average time for developing a new drug is approximately 12

years and costs over USD 1 billion, predominantly due to failures ateach stage of drug development (1). An appropriately trained work-force is onemechanism for accelerating timelines and reducing the riskof failure.Asmany biomedical sciences training programs do not offeractivities related to drug development, traineesmust opt for additionalspecialized fellowships (ranging in duration from several weeks to a

few years) or transition to industry with little knowledge of the skillsnecessary to be successful in this sector. As an initiative of BiogenísPortfolio Transformation, a short-term, intensive conference was devel-oped to demystify drug development for academic trainees. The goalwas to create amodel for similar events across the country.High-performing project teams are a hallmark of biopharma, but

are less common in academia (2). Conference activities, therefore, fo-cused on providing participants with a project-team experience thathighlighted key drug development questions; stage-appropriate com-position of project teams; the importance of team dynamics and ofmaximizing the strengths of each member; and how the biopharma

ecosystem supports project teams.

A novel target for accelerating drug development:Biomedical science trainingCherie Butts1 and Avery August2

Kong-YanWKong-YanWu et al. (Zhen-Ge Luo), “Semaphorin 3A activates the guanosine triphosphataseRab5 to promote growth cone collapse and organize callosal axon projections”, Sci. Signal. 7, ra81 (2014).

Rat Brain Slice. Image: Kong-YanWu and Zhen-Ge Luo, Chinese Academy of Sciences.

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