MSCRF Commercialization Program

Transcription

1 REQUEST FOR APPLICATIONS (RFA) MSCRF Cmmercializatin Prgram INTRODUCTION: Stem cell research ffers extrardinary prmise fr new medical therapies and a better understanding f debilitating human diseases, injuries and cnditins. The develpment f new medical strategies fr the preventin, diagnsis, treatment and cure f human diseases, injuries and cnditins thrugh human stem cell research is a high pririty fr the State f Maryland. FUNDING OBJECTIVES The Maryland Stem Cell Research Fund (MSCRF) Cmmercializatin Prgram was created t fster the transitin f prmising technlgies having significant cmmercial ptential frm Universities, where they were discvered, t the cmmercial sectr, where they can be develped int prducts and services that meet identified market needs. Specifically, it is the intent f the Cmmercializatin Prgram t fster the cmmercializatin f such technlgies thrugh technlgy validatin, market assessment, and the creatin f University start-up cmpanies in Maryland. A University Start-up is a cmpany reliant n a technlgy licensed frm a University fr cmmencement f its peratins. ELIGIBILITY INFORMATION Applicants fr Cmmercializatin Prgram must be a Start-up meeting the fllwing criteria in rder t be eligible fr funding frm the Prgram: The new start-up has licensed technlgy frm a University r a research institute within twelve (12) mnths f applying fr a Prgram award; if the technlgy has nt yet been licensed, a fully executed license agreement will be required within 90 days f ntificatin f the MSCRF award. (A cpy f the license agreement will be required t receive any funds). An established cmpany wrking n a new prduct r new technlgy that they develped r licensed in. The cmpany must be lcated in Maryland. AWARD INFORMATION AVAILABLE FUNDS The MSCRF is currently budgeted t cmmit up t $8.2 millin, in aggregate, in FY 2018 t fund Grants under all f its RFAs. The number f Grants awarded will depend upn the quality, size and mix f Applicatins received. MSCRF Cmmercializatin Prgram Page 1 f 8 September 2018

2 AWARD SIZE, DURATION & TERMS Subject t meeting the Prgram requirements, awards f up t $300,000, may be made directly t a startup cmpany. Prject funding will be subject t the successful cmpletin f a number f prpsed prject milestnes. Applicants shuld be aware that prject funding culd be terminated at any pint during the prject if early prject data suggests that the technlgy will nt be sufficient fr the intended cmmercial applicatin r if the prject is nt reasnably prgressing as riginally prpsed. OVERVIEW AND PROGRAM DESCRIPTION: Cmmercializatin: Early-stage Develpment Early-stage Develpment includes crprate prduct develpment in preparatin fr a prduct launch r the advancement f a prduct technlgy t achieve a cmmercial milestne that significantly increases the cmpany s value and better psitins the cmpany fr fllw-n investment. Cmmercializatin awards are capped at $300,000. Cmmercializatin prjects, including all subcntracts, must be cmpleted within 12 mnths f the date f the award. All Cmmercializatin applicants wh are selected t mve n t the full review cmmittee will be required t present in persn t the MSCRF Review Cmmittee. See Review Prcess sectin fr details. Up t 10% f Cmmercializatin awards may be used by Start-up Cmpanies fr verhead csts, prvided, hwever, that nt mre than 50% f such verhead csts (i.e., 5% f the award amunt) may be used t pay the University fr patent r licensing csts. Any dmestic travel expenses must be detailed and justified, and included as part f the 10% verhead prtin f the budget. Internatinal travel is nt allwed. The executin f any subcntracts and jint arrangements included as part f an applicatin are ultimately the respnsibility f the PI. Each entity invlved in the prpsed prject set frth in the submitted applicatin is expected t meet the timelines and milestnes, as submitted by the PI, wh will be held accuntable as part f the mid-term and final reprt review. Cmmercializatin awards will be made in the frm a grant. CONTENT & FORMAT OF APPLICATION All Sectins f the Applicatin must be submitted thrugh the TEDCO n line submissin system.the dcument must be frmatted using pint size 12 Arial fnt, with margins n smaller than ne-half (0.5) inch n all sides. Upladed file must be limited t 5 (five) megabytes (MB). APPLICATION COMPONENTS The intent f the applicatin is t prvide enugh infrmatin s a grup f reviewers can sufficiently evaluate the cmmercializatin and business ptential f a technlgy start-up. The final dcument is limited t maximum f 15 pages including all sectins. Sectins B-E are limited t 5 pages. MSCRF Cmmercializatin Prgram Page 2 f 8 September 2018

3 Applicatins must include all f the fllwing sectins and address EACH f the criteria bulleted under the sectins: A. Header/Applicant Infrmatin (Cver page). Applicatin must include: The name f the University r cmpany that wns the subject Technlgy. The name f a principal investigatr wh will be respnsible fr the prject, including the cmpany s name and address. Title f the Prject. Shrt (300 wrds) abstract. The ttal amunt f funding requested. B. Technlgy Descriptin, Status, and Intellectual Prperty. A detailed descriptin f the assciated Technlgy shuld be prvided. The descriptin shuld fcus n hw the Technlgy is unique/nvel in its apprach t slve an imprtant cmmercial prblem relative t ther appraches in the scientific literature and ther cmmercial prducts. Describe the status f the Technlgy s develpment describe the studies cmpleted and the cnclusins derived. Any preliminary data r ther results suggesting that the Technlgy is likely t wrk as predicted shuld be included. Describe the intellectual prperty secured fr the Technlgy and strategies fr strengthening the Technlgy s intellectual prperty prtfli A brief summary f the intellectual prperty landscape (e.g., the results f a patent search) shuld als be included. C. Applicatin f Technlgy as a Prduct/Market Assessment. Describe ptential cmmercial prducts r services that culd be based n the technlgy. Describe hw these prducts will slve a prblem in the market and describe the verall imprtance f slving that prblem. Include a descriptin f the value that these prducts will bring t custmers cst savings, time savings, cnvenience, imprved utcmes, etc. Include a descriptin f the persn wh will buy the prduct r service and a brief summary f the size f the market pprtunity that these custmers represent. Outline a general descriptin f the applicant s cmpetitive advantages ver cmpeting prducts and services. D. Cmmercializatin Pathway and Risk Assessment. Prvide a detailed verview f the verall steps/milestnes needed t cmmercialize the Technlgy (beynd the MSCRF funding) including hw lng it will take and hw much it will cst t achieve each milestne. Describe the general apprach and ratinale fr cmmercializatin, identify ptential cmmercial partners and the level f interest thse partners have in the technlgy, if any. The majr risks f failure (beynd the prpsed MSCRF prject, e.g., technlgy risk, market risk, etc.) shuld als be described alng with the applicant s plans t manage that risk, i.e., what wuld be dne if the prpsed cmmercializatin apprach was nt successful. MSCRF Cmmercializatin Prgram Page 3 f 8 September 2018

4 E. Prject Descriptin, Milestnes, and Detailed Budget/Justificatin. Include a detailed summary f the prpsed MSCRF prject and the anticipated milestnes and a clear timeline Indicate which milestnes will be cmpleted by the applicant s mid-term presentatin (6 mnths int the prject) and thrughut. Describe hw each f the milestnes leads t clear develpment f technlgy and hw it brings the prduct clser t the cmmercial market. Milestnes must be quantifiable and measurable s it will be bvius when they have been successfully, r unsuccessfully, met. A detailed budget f the csts required t cnduct the prject shuld be prvided in the general frmat prvided belw. A justificatin fr all f the prject csts shuld be prvided. F. Executive Summary - A tw (2) page executive summary f the Start-up Cmpany s business plan must be submitted. This executive summary must include: A clear utline f the management team expected t execute the cmmercializatin strategy and mve the cmpany frward (beynd MSCRF funding). A descriptin f the key players, and the plan t build and attract talent t the management team. An utline f what specific rle the inventr will play in the cmpany mving frward. A detailed descriptin f the market pprtunity, including a segmentatin analysis, and a descriptin f the cmpany s marketing strategy. An verview f the fundraising strategy. A descriptin f the Cmpany peratins including marketing strategy, prduct develpment, manufacturing, and ther peratins shuld be prvided. Any changes t the apprved budget (greater than 10%) must be submitted in writing t the MSCRF fr apprval prir t the cmpletin date. Internatinal travel is nt an eligible expense. Dmestic travel will be clsely scrutinized and must be justified as critical t the prject. If submitted, dmestic travel must be included as an Indirect Cst. The prject budget shuld be frmatted in tabular frm and justified, and each line item shuld be classified int ne f the fllwing categries: Persnnel Salaries, Persnnel Fringe Benefits, Equipment, Materials & Supplies, Other Direct Csts, and Indirect Csts, which shuld be indicated in the budget. Supplemental Materials In additin, Applicatins must include the fllwing a. A current signed letter frm the University s technlgy transfer ffice (if licensed) indicating their apprval f the prject, certifying the Technlgy s disclsure reference number and the status f the intellectual prperty described in Sectin B. f the Initial Applicatin (including its license status fr Cmmercializatin prjects). b. Recmmendatin/cllabratin letters. c. Supprting materials. D nt include infrmatin that shuld be in the 5 page limit f the prpsal. Applicants shuld understand that infrmatin required as part f the Applicatin, i.e., the bulleted criteria described abve (Sectins A-F), will nt be cnsidered by reviewers if included in the Supplemental Materials. MSCRF Cmmercializatin Prgram Page 4 f 8 September 2018

5 Web frm Infrmatin In additin, applicatins must cmplete all the web frm infrmatin in the nline system. This infrmatin may include biethics sectin as well as c-pis and ther infrmatin. Resubmissins Respnse t Reviewer s Cmments. In the event that an applicant s prpsal is initially rejected and the applicant chses t reapply fr Prgram funding, the applicant must submit a written respnse t the reviewers cmments including hw thse cmments were addressed in the resubmitted applicatin. The Respnse t Reviewer s Cmments may nt exceed ne (1) page and is nt cunted as part f the page cunt fr the resubmitted applicatin, which is limited t five pages, as described abve. APPLICATION AND SUBMISSION INFORMATION Applicatin infrmatin will be available electrnically n the MSCRF Web site (see ). SUBMISSION DEADLINES & REVIEW DATES Applicatin Submissin Deadline: January 17, 2019, by 5:00 p.m. Peer Review Date(s): March 2019 Cmmissin Review Date(s): May 2019 Earliest Anticipated Start Date: June 2019 METHODS OF SUBMISSION Grant Applicatin PIs, must register in the TEDCO n line submissin system at least ne mnth befre the Applicatin Submissin Deadline. Grant Applicatins must be submitted thrugh the TEDCO n line submissin system by January 17, 2019, n later than 5:00 p.m. One signed paper cpy f the Applicatin must be submitted by mail t the Maryland Stem Cell Research Fund (see address belw). The paper cpy f the Applicatin must be pstmarked n later than January 21, All submissins must be received by their respective due dates. Late submissins and hand deliveries will be NOT be reviewed. Paper cpies shuld be sent t: Maryland Stem Cell Research Fund Cmmercializatin Prgram Maryland TEDCO 7021 Clumbia Gateway Drive, Suite 200 Clumbia, Maryland REVIEW INFORMATION REVIEW PROCESS: All applicatins fr Cmmercializatin Prgram awards will be initially reviewed by the MSCRF staff t ensure that they meet the minimum requirements, as specified in this RFA (the Cmpliance Review ). Applicatins nt meeting the minimum requirements will be rejected withut further cnsideratin and the applicant will be s ntified. MSCRF Cmmercializatin Prgram Page 5 f 8 September 2018

6 A cmplete submissin (all sectins) cannt exceed a ttal f 15 pages r it will be rejected withut cnsideratin. APPLICATION REVIEW PROCESS: Fllwing the Cmpliance Review, all Applicatins will be assigned by the MSCRF SRO t a number f reviewers fr review and preliminary scring. All Applicatins, receiving average scres abve a threshld determined by the Prgram will be brught t the full MSCRF Review Cmmittee. The MSCRF may bring Applicatins scring belw the threshld t the Review Meeting under special circumstances, which shall be determined as the sle discretin f the Prgram. All Applicatins will be ranked accrding t their final scres and the tp scring applicatins will be recmmended t the Cmmissin, which will have the final authrity t apprve funding. The MSCRF Review Cmmittee will cnsist f representatives f the research, business and investr cmmunity and are all frm utside f the state f Maryland. Each applicant will receive a cpy f the reviewer cmments and scres at the end f the prcess, whether the applicant is apprved r declined. Review Criteria: Applicants will be evaluated n each sectin f their prpsal and the applicant s ability t address each criterin listed in the sectin. Cnsideratin will be based n hw cmpletely the applicant has prvided infrmatin requested fr the sectin and hw cnvincingly the applicant has made a case fr the cmmercial pprtunity based n the subject Technlgy. Other criteria that will be cnsidered: Fr all applicants wh have received prir funding, the reviewers will cnsider the utcmes f the prir awards, and the PI s ability t meet the stated timelines and execute n the plan. Mrever, the applicant s ability t meet the prgram requirements n a timely basis, including the milestnes, mid-term reprting and final reprting (including accunting and budget submissins) will als be cnsidered when reviewing applicatins. Significance: Des this Prject address an imprtant prblem? Is it relevant t human stem cells? What is the relatinship between the prpsed prject and the etilgy, preventin, diagnsis r treatment f human diseases r cnditins? If the aims f the Applicatin are achieved, hw will this mve yu clser t cmmercial r clinical practice and treatment f human diseases r cnditins? Apprach: Is there adequate preliminary data t supprt the Cmmercializatin Prject? Are the cnceptual r clinical framewrk, design, methds and analyses adequately develped, well integrated, well-reasned and apprpriate t the aims f the Prject? Is relevant literature apprpriately referenced? Are anticipated results discussed and justified? Des the Applicant acknwledge ptential prblem areas and cnsider alternative tactics? Are the experiments as designed likely t significantly advance the technlgy? Biethics: Des the prpsed prject use adult, embrynic, ips r ther human stem cell lines? If an existing line is t be used, what are the justificatins fr that line? If human dnrs are invlved, have they been prperly cnsented? If human subjects are invlved, what prtectins will be in place t ensure their rights and welfare? If animal subjects are t be used, what measures are taken t cmply with IACUC guidelines? SCORING: MSCRF Cmmercializatin Prgram Page 6 f 8 September 2018

7 The Scientific Peer Review Cmmittee will review all Applicatins and rank them based n scientific merit. Similar t the NIH scring system f 1-9 will be used t rate the verall impact/pririty f the prpsed research. In this system, 1 indicates the highest impact/pririty and 9 indicates the lwest impact/pririty. The Cmmissin will then review the ranked Applicatins and will make the final funding decisins. Cmpanies Selected Fr Review: All Cmmercializatin applicants wh scre high enugh preliminary scre will mve n t the full cmmittee review and will be required t present in persn at the MSCRF Review Meetings. The PI and the CEO (if nt the same persn) listed n the Cmmercializatin Applicatin must plan t present n the stated review dates. Other team members may attend; hwever, the PI and CEO must attend. All presentatins will be scheduled as part f standing MSCRF review days listed belw. Due t the number f applicatins n any given review day, presentatin times will be assigned by MSCRF. The PI will need t hld the review day pen until the time is assigned. This may be cnfirmed as clse as a week befre the review day, s PI s will need t remain flexible during this prcess. The Cmmercializatin cmpany applicant will be alltted a 10 minute timed presentatin, fllwed by 20 minutes fr Q&A. We recmmended n mre than 10 slides. Fllwing are the required slides fr the presentatin: What is the Prblem? What is the Slutin? Technlgy Outline Intellectual Prperty Target Market? Segmentatin Analysis Target Custmer Prfile Prduct Develpment Prcess Timeline and Csts Risks and Mitigatin Plan Cmpetitin G-T-Market Strategy? Partnering? Prductin? Marketing? Distributin? Sales? Finances Revenue and Cst Prjectins Financing Needed fr the MSCRF Prject? Fllw-n Financing fr the Next Steps, Beynd MSCRF? Management Team Advisrs? Bard f Directrs? After presentatin f the preliminary scres and discussin f applicatins at the MSCRF Review Cmmittee Meeting, applicatins will receive a final scre based n an average f all the verall scres prvided by the MSCRF Review Cmmittee Members. Applicatins will be ranked by average final scre and submitted t the Cmmissin fr review and final apprval. MSCRF Cmmercializatin Prgram Page 7 f 8 September 2018

8 AWARD ADMINISTRATION INFORMATION NOTIFICATION The PI's affiliate rganizatin will be ntified electrnically when the Applicatin is received. After the TEDCO Bard has apprved the Cmmissin's recmmendatins, a frmal ntificatin, in the frm f a Ntice f Award ("NOA"), signed by the MSCRF Executive Directr, will be sent via t successful Applicants. Clsing and Award Payments: Once the prper apprval fr a prject has been btained, Applicants will be asked t execute an agreement and the Principal Investigatr will be asked t immediately start wrking n the Prject. The agreement will detail the cnditins f the award and it will include an agreed upn number f mid-term and final milestnes fr each prject and the dates that Mid-term and final prject reprts (as described belw) are due. Award payments fr Cmmercializatin prjects will be made as fllws: 25% fllwing executin f the agreement, 50% upn submissin and apprval f a Mid-term Reprt and the successful cmpletin f apprved milestnes, and 25% upn submissin and apprval f a Final Reprt. In all cases, any unused funds must be returned t TEDCO serving in its capacity as the administratr f the Prgram. POST AWARD REPORTING Cmmercializatin Prgram awardees must submit the fllwing reprts t the MSCRF Prgram including: a. Award Manager Meeting each applicant is required t meet with the MSCRF Award Manager at least nce, prir t the mid-term. This is t assist each awardee in understanding and meeting expectatins fr the prgram. This is als an pprtunity fr the awardee t share feedback, discuss ideas and ask fr additinal assistance. b. Mid-Prject Reprts, (in-persn PwerPint presentatin at TEDCO s ffices) which must include a descriptin f prject activities and results t date, the prgress tward meeting mid-term milestnes, an accunting f expenditures charged t the award, and details n the prpsed Cmmercializatin Plan and budget; c. Final Reprts, which must prvide an verview f all activities undertaking during the curse f the funded prject, a descriptin f the results f the prject, the impact n cmmercializatin, the success with achieving the prpsed milestnes, jbs created, fllw-n-funds raised during the prject, and a full accunting f all expenditures charged t the award, and suggestins fr ways t imprve the Prgram; d. Sympsium presentatin - The MSCRF will cnduct an in-state Annual Sympsium t reprt t the scientific cmmunity and the public the prgress f the MSCRF prgram. All PIs must present, rally r in pster frmat, their n-ging r cmpleted MSCRF-funded research at each Annual Sympsium, during and immediately fllwing their Grant perid. AGENCY CONTACTS Questins abut this RFA must be submitted by t: mscrfinf@tedc.md. Telephne inquiries will nt be accepted. MSCRF Cmmercializatin Prgram Page 8 f 8 September 2018