Application Requirementsand Guidelines forthe

FrancisS.CollinsScholars Programin NeurofibromatosisClinicalandTranslationalResearchSponsoredbytheNeurofibromatosisTherapeuticAcceleration Program(NTAP)ofJohnsHopkinsUniversity

Pleasereadtheseinstructionscarefully beforepreparingandsubmittingyourapplication. Pleasecontact

Sharad Verma, sverma20 @jhmi.edu,ifyouhaveanyquestions.

Allapplicationmaterials(withtheexceptionoflettersofsupportandthevideoclip)mustbecompleted andsubmittedasasinglePDFto ith thesubject line“Candidate Name Last,First-FCS-application- documents”.Thevideoclipshouldbesubmittedtothesameaddresswith thesubjectlineas “Candidate Name Last,First-FCS-application-video”. Lettersofsupportshouldbesubmitteddirectlybytheauthor ith thesubjectline“CandidatenameLast,First-LOS-MentornameLast,First”.A checklistisincludedforyourconvenience(Addendum2).ThefullycompletedapplicationandALL supportingmaterials(includinglettersofsupport,videoclipandsignaturepages)mustbereceived byMarch 26, 2018by5:00p.m.EST.

ELIGIBILITY REQUIREMENTS

1.Hold a health-professional degree that permits patient care with a commitment to including patient care in your career plan.

2.Commit a minimum of 75% and up to 100% of professional effort to the program for a minimum of two years and a maximum of three years.

3.Be in the last stages of post-doctoral training or a junior faculty member within seven years of the first faculty appointment.

4.Have a commitment to patient focused research in the field of neurofibromatosis type 1 (NF1). A redirection in focus from non-NF1 research to NF1-focused research is welcomed, but must be explained by the candidate and mentors.

5.Demonstrate prior research commitment and accomplishments.

6.Have a mentorship team that includes research, clinical, and career mentorship (these roles can be filled by up to three people) with expressed commitment to the candidate’s training, expertise in the research skill set required for the work proposed in the application, and in the clinical management of NF1.

7.Have the appropriate access to resources to complete the clinical and research work proposed in the application.

8.Agree to meet all of the requirements of the Francis S. Collins Scholars (FCS) Program in Neurofibromatosis Clinical and Translational Research, including participation in all required Collins Scholars meetings and activities.

9.Applications are encouraged from people around the world from all disciplines of science and medicine as long as all of the above criteria are met.

APPLICATION COMPONENTS

Pleaseincludea header withthecandidatename“Last,First”as well as page numbersthroughoutsectionsI-VIII.

I.COVERSHEETWITHDEMOGRAPHICS

A.Name

B.Address

C.Currentposition

D.Currentaffiliation anddepartment

E.Mailaddress

F.Emailaddress

G.Phone

II.PROFESSIONALHISTORY(1 page maximum)

Written background: Provideinformationaboutyourpriorresearchandclinical trainingexperiences beyondwhatis evidentin the biosketch.Describeyourpastscientific experience,indicatinghowtheawardfitsintoyourpast andfutureresearch career development.Pleasehighlightthethemesthathaveguidedyourprevious work. Ifyourworkischangingdirectiontofocus onNF1,explainthereasonsfor thechange.Itis importanttojustifytheaward andhowitwill helpyou developintoaleaderinthefieldofNF1researchas wellas helpyouachieve youroverall career goals.

Personalintroductionand missionstatementvideo:Please provideavideo clip(upto2minutes) inwhichyoudiscussyourclinicaland researchfocus,the rationalefortrainingin NF1clinical translationalresearch,whyyou have the potential tobealeaderintheNF1researchfield,andhowyouwill usethe time and resourcesoftheFCS PrograminNeurofibromatosisClinicaland TranslationalResearchto accomplishthesegoals.

III.CAREERDEVELOPMENTPLAN(4pagemaximum)

Thecareer developmentplanshouldaddress how the planned activities ofthetwo orthreeyearperiodofthe FCS awardwill support one another and fit together to support your development as a leader in the field of NF1. Mention should be made of how you plan to extendthese activities beyond the time of the award toensureongoingsuccess in NF1research. Please emphasizethenew,enhanced researchskills andknowledgeyouwill acquire as aresultof beingaCollins Scholar. Describethestructuredactivities suchas coursework,internships, workshopsandotherformal learningexperiencesthatwillbeincorporatedinto yourcareer developmentplan.Itisimportantthatyou discusswhatyouwilldo differentlyifyou areaCollinsScholarcompared toyourtrainingwithoutthe award,specificallyinrelationtothefieldofNF1research.Youmustincludea descriptionofhowyouwillmeettheNIH requirementsforinstructioninthe responsibleconductofresearch(

Finally,youmustincludeadetailed timelinethatincorporates allelementsof thecareerdevelopmentplan(including but not limited to specific educational goals,enhancing clinicaltraininginNF1,researchskill development,programdevelopment,networking, speaking, writing, education and mentorship skills,etc.). The careerplanshouldincludeplans toapplyforadditional grantsupportfor yourresearchandsubsequentgrantsupporttocontinueyourNF1focusedclinical translational researchattheconclusionoftheFCSaward. A table or graph is often helpful in conveying core aspects of the timeline for the elements of the career development plan.

In preparing the career development plan, please recall thatthegoalofthe FCS programis tosupportpeople preparedto perform groundbreakingworkthatwill alter thefieldofNF1 andwhoarepositionedto serveas leaders inthe NF1field. This should be reflected in the comprehensive career development plan.

IV.RESEARCHPROJECTDESCRIPTION(10 pagemaximum)

FortheProjectDescription,pleaseuseArialsize12point font.Marginsshouldbe1”onallsides,10pagelimit.Referencesarenotincludedinthe 10-pagelimit.

A.Title

B.TechnicalAbstract: Describeyourproposedresearchprojectin250 wordsor less.

C.LayAbstract:Describe the proposed research project for a lay audience in 250 words. Using plain language, emphasize what the proposed work would mean for a person with NF1.

D.ResearchPlan:

1.Hypotheses andSpecificAimsoftheproject.

2.Significanceoftheproblem(s)to beaddressedand howthe projectwill improvescientificknowledgeand/orchangethe NF1 field

3.PreliminaryFindingsthathelpdemonstratefeasibility. Highlight results that arespecificallya resultofthecandidate’s researchandefforts as well as those of the mentorship team.

4.Approach. Describethestrategy,methodology,and analysestobeusedtoaccomplishthespecificaimsofthe project,notingdetails about the proposed scientific methods including accuracy and reproducibility and a justification of how the work is clinical ortranslational.

Providestatisticaljustificationforsamplesizesand includestatisticalanalysisplansappropriatetothework proposed.

Discuss potentialproblemsandchallengestothe successful completionoftheresearch andpropose alternativestrategies to addresschallenges thatwill arise.

For projects with vertebrate animals and/or human subjects, please include details for addressing the variable of sex, as part of the research plan. Please consider the following:

If little is known about sex differences, the proposal should include both sexes. Sufficient numbers should be provided to inform the presence or absence of sex differences (or justification must be made for why this is not feasible or scientifically relevant) and findings should be reported separately by sex in future progress reports and publications

If sex differences are known not to exist, a justification should be provided if the project proposes to study just one sex.

If sex differences are known, experiments should be designed with appropriate group sizes to detect sex differences.

Specificallynotetheroletheresearchmentor(s)willplayin theexecutionoftheresearch.

5.Milestonesand deliverables.Createsuccinct, but appropriately detailed deliverablesfor each proposed aim with anassociatedtimelinefor expectedcompletion of each deliverable.

6.Innovation.Explain howtheprojectchallenges currentpracticeor createsanewapproachtoaproblemwithinNF1andwhyit has potentialtoimproveoutcomesforpatientswithNF1.

V.NIHFORMATTEDBIOSKETCHES

A.Applicant

B.LeadMentor

C.Allothermembersofyourmentorshipteamorkeypersonnel

D.Formattinginstructionscanbefoundhere:

Atemplatebiosketchform can befound here:

VI.MENTORSHIPPLAN(3pagemaximum)

A.Thementorshipplanshouldcoverthetwoorthreeyearperiodofthe awardwithdiscussionoftheroleofeachofthementorsduring and aftertheperiodofthisaward.

1.Researchmentorship–discusswhichofyourmentors willserve as your researchmentor, whytheyaresuitedforthisrole and their specific responsibilities and duties for completion of the research project as well as supporting each of the goals of the career development plan.

2.Clinicalmentorship–discuss whichofyourmentors willserve as yourclinical mentorto support you in becoming an expert in NF1 clinical management andwhytheyaresuitedfor thisrole.(The research andclinicalmentorshipcanbeperformedbyoneperson ifthis is justified).

B.Thementorshipteam mustconsistofa minimum ofthreemembers including:alead mentorandup to three additional mentors. The lead mentormustbethescientific research mentorfor the proposed project.Thispersonmustbeafaculty member(or equivalent) expertinthecandidate’sareaofresearch.This mentor will guidethedevelopmentandexecution ofthe researchproposal as well as playakeyroleinthe developmentand execution of the careerdevelopmentplan.Thispersoncan be atthehomeinstitution or anyother institutionaslongas thementor choiceis welljustified and plan for mentorship interactions are well articulated including details for scheduled meetings and supervision by the lead mentor.

1.Thelead/scientific mentorisresponsiblefor:

a)Guidingthe designandexecutionofanoriginal, highquality,clinicalortranslationalresearchproject

b)Supervisingthepreparationandsubmissionofresearchmanuscripts and progressreports

c)Guiding andsupervisingthe executionofthecareerdevelopment plan

d)Ensuring that the mentorship committee meets a minimum of every 6 months (by video conferenceor in person), and coordinating with the Collins Scholar to provide minutesfrom these meetings to NTAP.

e)AttendingNTAPsponsored events,includingamentortraining programandtheFCS Programin Neurofibromatosis Clinical and TranslationalResearchannualmeeting. Lead mentors must agree in their letter that they will meet these requirements (see section IX).

  1. The additional two (and up to three) membersofthementorshipteam shouldbeidentified and their specific roles and responsibilities relative to the career development and research goals should be stated.

Theadditionalmentorscompletethementorshipteamandare expected to provideexpertiseinthescientificareaofresearch chosenfor theproject(complementarytotheinterestsofthelead mentor)orclinicalpracticeexpertise withinNF1 or address specific aspects of career development. Itis advisablethatone mentorbewithinyour discipline,onebe outsideofyourdiscipline,andthatatleastonementor befocusedonyourcareerdevelopmenttrajectory.A minimumof onementormust haveexpertiseintheclinicalpracticeofcaring forpatientswithNF1.Thispersoncanbeatthehomeinstitution or anyother institutionas longasthementor choiceis well justified and a specific plan is provided for the logistics of meeting with this mentor.

  1. Youmustprovidethedetailsofhowthementorshipteamwill work together includingtheirrespectiverolesin designingand securingthesuccessoftheresearchproject,securing opportunitiesforyourtraininginspecificareas,oversightofyour career developmentplanandensuringthatyousuccessfullymeet the requirementsoftheFCS PrograminNeurofibromatosis Clinical andTranslational Research.Pleaseincludespecificdetails abouthowyouwill communicatewitheachmentorand howthementors will communicatewith each othertoachieve all ofthegoalsoftheCollinsScholar. Itis often helpful toaddthe mentorship meetings and interactionstoyour detailedtimeline(seesection III).

VII.BUDGETANDBUDGETJUSTIFICATION

Adetailedbudgetaddressingthepersonnelcost(within NIH cap) fortheapplicant’s salarysupport(thepercentsalarysupportandthedurationofsupport) aswellas theanticipatedresearchcosts(nottoexceed$20,000/year), travel costs (nottoexceed $10,000/year)andeducational costs (notto exceed $10,000/year)per year mustbeincluded. Pleaseincludea detailedbudgetjustificationforeachcategory ofspending(personnel, research,travel and education). Nojustificationis requiredfor the mentorstipend ($10,000/year).Pleasealsodescribewhatadditionalfunds outsideof theFCSprogramwill beusedtosupportthe researchprogram. Applicants must provide details of current or expected support outside of the FCS program and describe areas of overlap and non-overlap.

VIII.SIGNATUREPAGES(Addendum3)

A.Applicant

B.Authorizedofficialfor theUniversity

IX.LETTERSOFSUPPORT

A.A minimum of three lettersofsupportare required.Theseshould beaddressedto:

The Francis S. Collins Review Committee andbe emailedin PDF format by

March 26,20185pm with thesubjectline“Candidatename Last,First.LOS.Letter Writer Name Last, First”. Theseletters eachhaveaspecificareaoffocus (pleasesee below); however,all letters shouldcommentonthepotentialforthecandidateto bealeader inclinical translationalresearchinNF1,whytheyareexcellent candidatesforthe FCSPrograminNeurofibromatosis Clinicaland TranslationalResearch,andwhybeingaCollinsScholarwill securetheir successful careerinclinical translationalscienceinNF1.

B.Lead/scientific mentor

Thisletter shouldhighlightwhythementoris suitedtoserveas thelead mentorforthecandidate’sproject.Theletter shouldalsoincludea statementaboutthementor’s commitmentto providingcareer developmentandcounseling;guidingandencouragingthedesignandexecutionofanoriginal,highquality,clinical ortranslational research project;supervisingthepreparationofreports to NTAP and for publication;andcollaboratingwiththe mentorshipteamtosupporttheCollins Scholar in all aspects of the FCS program activities.Thementorshouldalso agreetomeettherequirements oftheFCSPrograminNeurofibromatosisClinicalandTranslationalResearchincludingattending a requiredorientationsessionfor mentors andattendanceoftheannual meeting(seesectionVIB).

C.Asecondmentor ofyourmentorshipteam.

Thislettershoulddetailtherolethementorwillplayinthe candidate’s research project, NF1 clinical training,and career development,andspecificallydiscusshowthementorshipteamwillbe coordinatedtoensurethe candidate is performing optimally acrossallofthe domains oftheCollinsScholarship(education,clinical expertise,scientificexpertise,leadership development).

D.DepartmentChairperson or Director

A letterfromthedepartmentchairpersonshoulddetail theplanforthe dedicationofaminimumof75%andamaximumof100%of professional timetotheFCSprogram forthedurationoftheaward as wellas whatthecandidate’sexpected activities outside oftheFCS Programin Neurofibromatosis Clinicaland TranslationalResearchare likelytoentail. Itshouldalsoinclude discussionabouttheroleofthecandidateinthedepartment, the departmental and institutional commitmenttothecandidateduringandafterthe completionoftheaward including plans for faculty position as appropriate.It should also discussthe department’s position on the applicant’s focusonNF1researchand clinical care,andthe resourcesavailabletothecandidatetofurtherclinicaltranslational scienceandprogramdevelopmentinNF1 at the institution. This letter should be independent of any other mentor letter.

E.Additional lettersofsupportmaybesubmittedatthecandidate’sdiscretion.

Addendum 1: Additional Details of the FCS Program Requirements and Application Process

1.Theawardrequires aminimumof75% andamaximumof100%effortfor theFCS program.

2.Theperiodoftheawardis aminimum of2years andamaximumof3years. Time commitmentanddurationoftheawardmustbewell justified(seebudgetjustification, IX).

3.InadditiontosalarysupportfortheCollins Scholar(based on NIH cap) the following funds are available:

  • Atotalof$10,000/yearis provided asamentorstipend
  • Uptoa total of$20,000/year isprovided tosupport researchcosts
  • Uptoatotalof$10,000/year isprovidedtosupporttravel
  • Uptoa totalof$10,000/yearisprovidetosupporteducationexpenses.

Allcostsmustbe justifiedand supporting invoices submitted (seebudgetjustification,IX).

4.Amaximum of10%indirectcostsarepermitted. Noindirectcostsarepermittedon patientcare associatedcosts.

5.Milestonereports explainingprogress (or limitations and requested changes)inresearch,clinical andcareerdevelopment activitieswill berequiredatsix-monthintervals. Each report will consist of a detailed narrative, organized according to the deliverable tasks for the milestone period. Please note: milestone payments are directly linked to the completion of milestone deliverable tasks.

6.Several meeting opportunities are created for the Collins Scholars to meet the program mission of building community and advancing career development for clinical translational science in NF1. All efforts are made to maximize the value of these meetings by minimizing inconvenience and maximizing content. These meetings are required and include:

(a) an orientationmeeting thatwill reviewtherequirements of the FCS program as well as topics such as the state of the field for NF1, specific requirements in clinicaltranslational science training, and an overview of the end to end process for drug discovery and medicines development with exposuretoexperts in the pharmaceutical industryandregulatoryagencies.

(b) an annualscientific meetingoftheCollinsScholars (often scheduled with theannual Children’sTumorFoundation CoNFerence)

(c) anannualacademicmeetingwithin theirspecialty

(d) semi-annual virtual laboratorymeetings.NTAP will organize and oversee a ‘virtual’ laboratory meeting amongst ALLof the Collins Scholars and mentors, during which time two of the scholars who are in at least the 2nd year of the program will present their research findings to the entire group for discussion. Emphasis should be placed on focused presentations which highlight interesting observations and/or recent challenges that will inspire discussion amongst the group. Presentations will follow a template to be provided by NTAP, should be no more than 20 minutes in duration, and should be made available to NTAP at least 2 days before the meeting, for dissemination to the group. The Collins Scholar and at least one member of their membership team are required to participate.

(e) quarterly NF Education/Mentorship program administered by Dr. Vic Riccardi. This will entail participation in a group call with Dr. Riccardi in which Dr. Riccardi will lead a discussion around a specific topic of interest that is germane to NF1. Topics are provided beforehand, and scholars are encouraged to suggest discussion topics from the list (or new ones) for the calls. Scholars are also given the opportunity for individual calls with Dr. Riccardi to review project progress and receive feedback from Dr. Riccardi about topics in NF1 clinical care and research as well as their specific projects.

10.TheFCSPrograminNeurofibromatosis ClinicalandTranslationalResearchis administered bytheNeurofibromatosisTherapeuticAccelerationProgram(NTAP)of JohnsHopkins University,DepartmentofNeurology. Allapplicationswill undergo peer review by at least three reviewers orchestrated byNTAP (see point 10, below).This isnotanNIHsponsored awardandthe NIH is notinvolvedintheselectionprocessoradministrationoftheprogram.

11.Allapplicationswill undergoinitial reviewbyNTAPstaffandiftheapplicationis complete,itwill beforwardedtoareviewpanelfor detailedreview. Reviewersare seniormedical andscientific leaders recruited across disciplinespertinenttoNF1 researchthathave expertiseinclinical or translational science.Somereviewerswillalsohave expertiseinNF1. Reviewersareinstructedto evaluate eachapplication for:

a.Thestrengthoftheapplicants’ researchhistory includingresearchtrainingto date,evidenceofcommitmenttoclinical or translationalresearch,publications and other demonstrations of scientific contributions as well as overallaccomplishments to date.

b.Thestrengthofthe careerdevelopmentplanincludingclearlydelineated plans toacquirecriticalresearch andclinicalskills,structuredactivitiesthatservethe careerandprojectgoals,plansforbecomingan expertandleaderinNF1, andaclearvisionofthecareer trajectoryin NF1 research and clinical care aftercompletionoftheFCSprogram.

c.Thestrengthofthe researchproposal includingfeasibility,innovation,potential impactfor patientswithNF1,and abilitytorecognize andaddressproblems that mayarise.

d.Thestrength and applicabilityofthementorshipplan,thecommitmentofthementorstothe applicant andtheirFCSresponsibilities, and the details for mentorship interactions and responsibilities.

e.Appropriateness of budget and budget justification including complementary awards and support.

Applicants willbe notifiediftheyhavebeenadvanced for considerationoffunding after completion of peer review. Theapplications advancedforconsiderationwill benotifiedinMay2018.The funding willstartJuly 2018.

Please note, applicants advancedfor considerationoffundingmaybe askedtoaddress commentsandrevisetheirproposalbasedonthe reviewers’ commentspriorto submittingafinalprojectplan,scopeofwork,deliverables, timeline, andbudget that will comprise the final project award. Such revisionsoccur aspartofaconstructive,collaborative process between NTAP leadership, the reviewer teamand theapplicant andtheirteam.

12.NTAPhasagoal ofappointingtwoscholars each year,however,onlythemost exceptional candidateswillbeawardeda positionwithintheFCSScholarsProgram inNeurofibromatosis ClinicalandTranslationalResearch. Itis possiblethatgreater or than less than 2 awards will begiveninsomeyears. Allapplicants will receivedetailed reviewercomments regardless of the award decision.Applicants who arenotselectedareencouragedtore-applythefollowingyear addressing the reviewer critiques (assumingthatthey stillfulfilleligibilityrequirements).

Addendum 2: Application Checklist

Coversheetwith demographics(page1)

Professional background history(page 2)

Personal introductionandmissionstatementvideo (max 2 min)

Careerdevelopmentplanincludingdetailedtimelineforthe periodofthereward(4 page maximum)

Researchprojectdescription(10pagemaximum)

NIHformattedbiosketches

  • Applicant
  • Mentorship team members

Mentorship plan(3 pagemaximum)

Budgetandbudgetjustification (including competing and complementary funding)

Signaturepages

At least three lettersofsupporttobesubmittedvia emailto romyour:

  • Leadmentor
  • Another memberofyourmentorshipteam
  • Departmentchairperson
  • Additionallettersatyourdiscretion

Please completeallsectionsofthe applicationsavedas asingle PDF(exceptforthevideoandlettersofrecommendation) andloadtoanemail addressedto iththesubjectline:"Candidate Name Last,First.FCS.application". Pleasesendthevideoclip as aseparateemail iththesubjectline:"Candidate Name Last,First.FCS.video". Please haveall letters ofrecommendationsentbytheirauthors iththesubject: "CandidateLast,First.LOS.MentorLast,First". Allmaterialsmustbereceivedby5pmESTonMarch 26,2018. PleasecontactSharad Verma,r Rhonda Jackson, ,foranyquestionsorconcerns. Applicants will be notified when completed applications are received. Award notification will be given May 2018.

Addendum 3: Signaturepages

Applicant:

Icertifythatthestatementshereinaretrueandcompletetothebestofmyknowledge andthatIwill complywith all applicableNTAPterms andconditionsgoverningmy potential appointment. Iamaware thatanyfalse,fictitious,orfraudulentstatementsor claimsmaysubjectmetocriminal,civil, oradministrative penalties.

Applicant’s signature:

______

Date:______

Authorized officialfortheUniversity or Institute

This individualisqualifiedforthisprogramandwillreceiveimmediatepriorityforclinic coverage(ifapplicable),all requirementsforprotectedtime,and allfinancial needs accordingtotheprogramannouncement.Asanauthorizedofficialof

I, ______, agreetogrant______therequired% dedicatedtimeto NF1relatedclinicalcareandresearchasrequiredbytheFrancisS. CollinsScholars PrograminNeurofibromatosisClinical and TranslationalResearch and agreethattheUniversity or Institutewill supporttheindividual’ssalary,benefits,andresearch supportasprovidedthroughtheFrancisS.CollinsScholarsProgramin NeurofibromatosisClinical and Translational Researchstarting______without overlap,for thelength of the awardiftheindividual is namedaCollins Scholar.

Signatureofuniversity authorizedofficial:

______

Title

______

Date:______