Transla'onal)Funding)Opportuni'es)) at)the)Wellcome)Trust) - - PDF document

Transla'onal)Funding)Opportuni'es)) at)the)Wellcome)Trust)

Innova&ons(

February(2015(

2

Wellcome(Trust(Structure(

Investments Division Funding Divisions Innovations Science Medical humanities & Society and Ethics

Provides)funding)) through)grants) Provides)funding)) through)programme) related)investments)

(VC)

• Announced(towards(the(end(of(2014((
• Five(categories:(people,(seeds,(teams,(places(and(resources(
• People:(funded(through(our(Science(division.(
• New$Inves)gator$and$Senior$Inves)gator$Award$schemes$have$

merged$$

• increased$number$of$Sir$Henry$Wellcome$Postdoctoral$

Fellowship$and$Sir$Henry$Dale$Fellowship$schemes$$

• Seeds:(funded(through(Science,(Medical(Humani&es(and(Society(

and(Ethics(

• Innova)ons$team$equivalent$are$the$Pathfinder$awards$

Refreshed(Funding(Framework(

• Teams:(Collabora&ve(awards(in(Science,(Medical(Humani&es(and(

Society(and(Ethics.(

• Innova)ons$team$equivalent$are$the$PorColio$awards$

(

• Places:(ongoing(support(to(Wellcome(Trust(centres(in(the(UK(and(in(

lowO(and(middleOincome(countries( (

• Resources:(funding(for(shared(equipment,(facili&es(and(research(

resources,(including(support(for(longitudinal(studies.(

Refreshed(Funding(Framework(

Innova&ons(changes:((( Pathfinder(and(PorRolio(awards(

Innovations: Closing the funding gap

Fund applied research and development projects to a stage where they are attractive to a follow-on funder, such as venture capital firms, industry and public-private partnerships.

Innovations Funding: 2002 to present

£1.45 billion leveraged (£363m in FY 2013/14) 32 exits via M&A/listing

• r licensing

15 products launched 29 projects in clinic

Output) Input)

330 projects supported Range: £25K - £11.2M £592 million committed

200 400 600 800 1000 1200 01/2 02/3 03/4 04/5 05/6 06/7 07/8 08/9 09/10 10/11 11/12 12/13

TT Funding Commitment ( £ M) Total Follow-on Fundraising (£ M)

Therapeu&c(Areas( funded( ( Technology(Types(( funded(

Cardiovascular & Circulatory 10% Gastrointestinal 1% Infectious Diseases 31% Metabolic & Endocrinology 4% Musculo-skeletal 5% Neurology 11% Oncology 13% Ophthalmology 5% Respiratory 4% Veterinary 1% Other 15% Diagnostics 11% Enabling Technology 14% Medical Devices 23% Regenerative Medicine 4% Therapeutics 40% Vaccines 8%

Funding schemes

Translation Fund Affordable Healthcare in India Health Innovation Challenge Fund

(with Department

• f Health)

Seeding Drug Discovery Pathfinders Portfolio Awards

Typical)Applica'on)Process)

Translational Funding

(TFC, SDD, HICF JFP, SAC) Scientific & Technical Competitors Regulatory Competence Risk Analysis Milestones IP & Legal Commercial Strategy Corporate Background Triage

(Funding Committee)

Expert Opinions Due Diligence Funding Committee Full Application Preliminary Application Concept notes also required for AHI and TF

• The(Trust(does(not(currently(conduct(porRolio(analysis(to(priori&se(

funding(areas.(

• However,(we(do(emphasize(being(a(‘Gap’(funder.(
• As(part(of(the(applica&on(process,(the(projects(are(assessed(in(

terms(of(redundancy.(If(other(funders(or(industry(groups(are( funding(a(specific(drug(or(vaccine(target,(we(need(to(understand( clearly(how(another(approach(could(add(value.((

• Programmes(are(typically(3O4(years((early(SDD(and(Pathfinder(are(

excep&ons)(

• Funding(in(range(of(£2O4M((

Funding(–(Points(to(Note(

Delivering(value(:(Our(“rules”(

• Based(on(scien&fic(excellence(and(unmet(medical(need(rather(

than(commercial(objec&ve,(but(

• Route(to(market(important(
• Limited(exposure(to(infrastructure(costs((direct(project(costs,(

no(overheads)(

• Outsource(ac&vi&es(to(CROs(where(appropriate((
• Project(managed,(with(success(driven,(milestone(based(

programme(related(investment(

• Mul&disciplinary(teams(of(an(op&mal(size,(supported(with(

experienced(advisors(

• Scheme(for(truly(excep'onal,)paradigm)shi?ing)projects(that(O(due(

to(the(combina&on(of(poten&al(high(impact,(risk,(scale(or( complexity(O(warrant(strategic(status.(( (

• Wide(range(of(biomedical(developments(can(be(considered,(

including(therapeu&cs,(vaccines,(diagnos&cs,(enabling( technologies,(medical(devices(and(regenera&ve(medicine.((

• The(Trust(will(normally(ac&vely(par&cipate(in(the(stewardship(of(

the(project(and(lead(on(intellectual(property(management(and( exploita&on.((

Transla&on(Fund(

(

• Invite(only,(following(considera&on(of(a(concept(note((
• PorRolios(as(well(as(single(projects(are(considered((

(

• Can(support(first(in(man(studies((
• Two(commifee(mee&ngs(a(year(

(

• Next(concept(note(deadline:(15(April(2015(

(

Transla&on(Fund(

(

• (Shortage(of(blood(donors(plus(recipients(of(blood(transfusions(are(at((

(((risk(of(transmission(of(infec&ous(diseases(and(incompa&bility.(

• (Problems(might(be(solved(using(stem(cells.(
• (Free(from(infec&on,(can(be(grown(indefinitely(in(the(laboratory(and((

(((can(be(“turned(into”(many(different(cell(types,(including(red(blood(( (((cells.((

• (Professor(Marc(Turner(and(colleagues(awarded(transla&onal(funding((

(((to(op&mise(the(produc&on(of(red(blood(cells(from(stem(cells.

Case(study((

Case(study(

• £210M,(10(year(fund(launched(in(2006(to(facilitate(earlyAstage)

smallAmolecule)drug)discovery(

• Aim(is(to(develop(drugOlike,(small(molecules(that(will(be(afrac&ve(

to(followOon(investors( (

• Two(entry(points(to(scheme:(Early((£1(to(£2M(for(1(to(2(years)(and(

Late((~£3O4(M(for(3(to(4(years)(( (

• Successful(Early(Stage(projects(can(come(back(for(Late(Stage(

funding(without(having(to(go(through(the(triage(stage( (

• Two(calls(per(year,(triage(commifee(then(full(commifee.((

Next(preliminary(applica&on(deadline:(5)June)2015) (

Seeding(Drug(Discovery((

Target Discovery Lead Optimisation Hit to lead Assay Development Pre-clinical Evaluation IND filing years 3-6 month 6-12 month 12-24 month 12 month Development (years)

“To develop drug-like, small molecules that will be the springboard for further R & D by the industry in areas of unmet medical need”

Seeding(Drug(Discovery(

Early Late

• Trust(provides(expert(advisor(to(sit(on(research(steering(group.((
• Organiza&on(expected(to(employ(a(dedicated(project(manager.(
• Research(steering(groups(are(implemented(to(keep(projects(on(

track(to(preOdefined(milestones.((

• Intellectual(property(management(groups(implemented(as(a(forum(

to(discuss(IP(and(commercialisa&on(strategy.( ((

Seeding(Drug(Discovery((

(

• Professor(Malcolm(Walkinshaw(at(the(University(of(Edinburgh(has(

been(awarded(funding(for(a(programme(to(target(trypanosome( phosphofructokinase(for(the(treatment(of(Human(African( Trypanosomiasis( (

• £3.5M(award,(30(month(programme(through(to(iden&fica&on(of(

preOclinical(candidate.(((

Case(Study((

Case(Study((

Health(Innova&on(Challenge(Fund(

Translational Funding

The Wellcome Trust

Focus)on:)

• (Innova&ve(healthcare(products,(technologies(and(interven&ons.(
• (Unmet(healthcare(needs(in(the(NHS(
• (Projects(that(are(within(three(to(five(years(of(launch(or(adop&on.((

( Themed)calls:)

• (Surgical(technologies(
• (Innova&ve(diagnos&cs(
• (Trauma(and(cri&cal(care(medicine(
• (Informa&cs(to(assist(clinical(decision(making(
• (Repurposing(of(technologies(and(medicines(
• (Biological(therapies(
• (Usually(two(calls(per(year(but(no(deadline(currently(published(

(

• (Immediate(Point(of(Care(Molecular(Diagnos&cs(for(Lung((

(((Inflamma&on/Infec&on(in(Cri&cal(Care.(

• (At(least(40%(of(all(pa&ents(in(ICU(need(a(ven&lator(to(support(their((

(((lungs,(with(many(associated(complica&ons.(Once(established(on(( (((mechanical(ven&la&on,(cri&cally(ill(pa&ents(are(at(risk(of(Acute(Lung(( (((Injury((ALI)(and(secondary(infec&on(resul&ng(in(ven&lator(associated(( (((pneumonia((VAP).(

• (Professor(Chris(Haslef(and(colleagues(at(the(University(of(Edinburgh((

(((are(developing(smart(probes(to(detect(the(presence(of(neutrophilic(( (((infiltra&on(or(the(presence(of(bacteria(at(sites(of(lung(injury.

Case(study((

Affordable(Healthcare(in(India(

• To(fund(transla&onal(research(projects(that(will(deliver(safe(and(

effec&ve(healthcare(products(for(India(O(and(poten&ally(other( markets(O(at(affordable(costs.( (

• Encourages(innova&ons(that(bring(together(researchers(from(both(

the(public(and(private(sectors(to(extend(access(to(care(to(the( greatest(numbers(of(beneficiaries,(without(compromising(on( quality.(( (

• Principal(Inves&gator(must(be(based(in(India(but(can(have(overseas(

collaborators(

(

• (Collabora&on(between(the(LV(Prasad(Eye(Ins&tute(in(Hyderabad((

(((and(Sheffield(University.(

• (Developing(novel(biocompa&ble(materials(for(a(stem(cellObased((

(((therapy(to(restore(sight(in(eyes(where(the(cornea(is(damaged(by(( (((chemical(or(burns(injury.((

• (Ins&tute(is(a(ter&ary(eye(care(centre(offering(highOquality,((

(((comprehensive(eye(care(on(an(equitable(basis(to(millions(across(( (((the(state(of(Andhra(Pradesh.(

Case(study(

• Pilot(funding(to(catalyse(earlyOstage(applied(R&D(projects(in(areas(
• f(unmet(need.(
• Average(award(expected:(£100,000(but(up(to(£350,000(in(

excep&onal(circumstances.((

• Partnerships(between(academic(ins&tu&ons(and(industry(are(

encouraged(but(not(required(for(UK(ins&tu&ons.((

• If(an(applica&on(comes(from(a(partnership,(the(Wellcome(Trust(

contribu&on(will(be(capped(at(£100,000(and(there(must(be( evidence(of(a(matched(funding(contribu&on(from(the(Industry( partner.((

• Four(rolling(calls(a(year(with(rela&vely(quick(decision,(‘light(touch’(

approach(to(funding(agreement.((

• Next(deadline:(6(February(2015(

Pathfinders(

• (Pfizer(and(the(Structural(Genomics(Consor&um(at(the(University((

(((of(Oxford((

• Inves&ga&ng(methods(of(restoring(normal(metabolism(to(

prevent(progression(of(a(rare((metabolic(disorder(called( Homocys&nuria.(

• (Lilly(and(University(College(London((
• Developing(a(human(stem(cell(line(to(study(a(rare(group(of(

severe(neurological(disorders(called(Neurodegenera&on( with(Brain(Iron(Accumula&on((

Case(studies(

• To(fund(ambi&ous(programmes(which(require(a(porColioDapproach(to(drive(

R&D(synergies.(

• The(programme(of(projects(should(have(a(common(theme,(e.g.(a(disease(or(

target(focused(programme(of(projects((including(drug(discovery)(or(a(suite(of( projects(underpinned(by(a(core(plaRorm(technology.(

• Programmes(that(bring(together(mul&ple(disciplines(e.g.(life(sciences,(physical

( sciences,(engineering,(and(crossOborder(collabora&ons(are(encouraged.(

• A(PorRolio(Award(programme(is(expected(to(deliver(more(than(one(

innova&on(or(contribute(to(significant(advances(in(the(field( (

• More(informa&on(from:(hfp://www.wellcome.ac.uk/Funding/Innova&ons/Awards/

PorRolioOAwards/index.htm(

( (

(

PorRolio(Awards(

• Not(a(Grant(but(an(‘Investment’(
• Except(for(Pathfinders(
• Fund(the(“Direct(Project(Related(Costs”(
• Funding(provided(in(advance(but(in(tranches(
• Tranches(released(on(successful(comple&on(of(a(Milestone((
• Go/No(Go(Decision(Point(

(

• Reten&on(amount(for(the(end(of(grant(report.(

Funding(Model(

Funding(Model(O(Returns(

Academia(

• Revenue(and(Equity(sharing(

SME((

• Unsecured(Conver&ble(loan(
• Equity(conversion(at(20%(

discount(at(an(investment( round(

• Direct$Equity,$Revenue$Share,$

Milestone/Royalty$

Pharma/Listed(Companies(

• Milestone/Royalty(based(funding(

(

Consor&a,(Matched(Funding(etc."

• Bespoke(funding(terms(

Top(&ps(–(what(to(consider(

Healthcare)Impact)

Risk) Milestones) IP) Commercial) Regulatory) Clinical)

Business)

Technical)

Model,"revenue"genera/on,"" further"funding"requirements" Informing" clinical"prac/ce" Awareness," prepara/on" Feasibility," valida/on" Current"assets,"" poten/al"new"IP"" Timings,"content," suitability" Feasibility,"" team,"market" Compe//ve"advantage,"

• pportunity,"reimbursement"

Risk) Milestones) IP) Commercial) Technical)

Innova'ons) The(Wellcome(Trust( 215(Euston(Road( London(NW1(2BE( ( E(((innova&ons@wellcome.ac.uk( $ $ ((((((((((( (((((((((((((Email(us(to(join(our(mailing(list.( (

( ( (

For(further(informa&on(