ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some...
Transcript of ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some...
![Page 1: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/1.jpg)
|
ADDALectureSeries:BusinessDevelopment
![Page 2: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/2.jpg)
2SouthernResearchDrugDiscovery
“BusinessDevelopment”:ABitofaBlackBox
SomeReallyCool,Innovative
ResearchResults
SomeOtherStuffHappensHere...
YougetaTONofmoneyfroma
pharma,biotechorVC!!
![Page 3: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/3.jpg)
3
• Allofourprogramsareveryearlyinthedrugdevelopmentarc
• We(ADDA)canonlytakeprogramstoacertainpoint:IND,maybePhaseI
SouthernResearchDrugDiscovery
“BusinessDevelopment”:WorkingDefinition
BusinessDevelopment:Findingindustrypartnersthatarewillingandableto
takeourprogramsforwardthroughclinicaldevelopmentandtothemarket
![Page 4: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/4.jpg)
4
ProspectingConfidentialScientificDiscussions
Negotiations DueDiligence DealClosing
SouthernResearchDrugDiscovery
PeekingInsidetheBlackBox...
Onpaper,licensingaprogramtoapharmaorbiotechcompanyisprettystraightforward:
![Page 5: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/5.jpg)
5SouthernResearchDrugDiscovery
PeekingInsidetheBlackBox...
Butinpractice,theprocesslooksabitmorelikethis:
![Page 6: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/6.jpg)
6SouthernResearchDrugDiscovery
RemembertheFairyTale......AbouttheprincesswhogoesaroundkissingfrogstofindtheonethatbecomesherPrinceCharming?
There’saLOTofthatinBusinessDevelopment....
![Page 7: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/7.jpg)
7
...it’simportanttoreducethe“Frog:Prince Ratio”asmuchaspossible!
SouthernResearchDrugDiscovery
Soifyouhavetokissfrogs...
Itisimportanttounderstand:• Thepotentialtherapeuticindication• Thecompetition• Ourprogram(goodandbad)
• Whoisinthistherapeuticarea?• Whohasacompetingprogram?• Whoisopento(very)early-stageassets?• Isthereanyinterestinourspecificprograms?
![Page 8: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/8.jpg)
8SouthernResearchDrugDiscovery
ReducingtheFrog/PrinceRatio
• BigPharma– includesBigBiotech• RegionalPharma– EU,JP,KR,etc.• SpecialtyPharma• ClassicBiotechs• “InBetweeners”• Investors
Evenwithallofthefiltersapplied,wetalkwithmanydifferenttypesofpotentialpartners
Andallofthediscussionsstartthesameway...
![Page 9: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/9.jpg)
9SouthernResearchDrugDiscovery
“Sotellmeaboutyourprogram”
![Page 10: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/10.jpg)
10
• “Howfaralongistheprogram?”• “WhatisyourIPstatus?”• “Doyouhaveanyinvivoproof-of-concept?”• “HowlongbeforeyougettoIND?”
• Plusanumberofquestionsthatarespecifictotheindication,targetand/ormechanism
SouthernResearchDrugDiscovery
StandardQuestionsfromCompanies
![Page 11: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/11.jpg)
11
• Withoutgoodscience,businessdevelopmenthasnothingtodo
• Basicscience– Novelinsightintodisease– Clearunderstandingofmechanism– Invivoproof-of-concept
• Appliedscience– Chemistry– Pharmacokinetics(includingoralbioavailability)– Toxicity– IntellectualProperty
SouthernResearchDrugDiscovery
ItAllComesDowntotheData
![Page 12: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/12.jpg)
12SouthernResearchDrugDiscovery
“Sothefirstmeetingwentwell–Nowwhat?”
ProspectingConfidentialScientificDiscussions
Negotiations DueDiligence DealClosing
“Youarehere”
![Page 13: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/13.jpg)
13
• Itisimportanttogetscientific“buy-in”fromthepotentialpartneronaprogram
• Iftheirscientistsaren’texcited,oriftheyhaveconcerns...
• Importanttohavetheirexpertstalktoourexperts–divedeepintothescience
SouthernResearchDrugDiscovery
MoreScience!
“Thereisnosuchthingastoomuchdata.”
![Page 14: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/14.jpg)
14
• TermSheet:Asummaryofeachside’srolesandresponsibilitiesinthepartnership
• Whopayswhatandwhen?• Whatistheterritoryandindication(s)?• Whomakesdecisions?• Whoisresponsiblefor
– Furtherdevelopmentsteps– Patentapplications/persecutions– Regulatoryfilings
• Whathappensifthepartnerchangestheirmind?• Howarepotentialconflictsresolved?
SouthernResearchDrugDiscovery
ComingtoTerms
![Page 15: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/15.jpg)
15
Diligence:WhereEVERYTHINGisShared
• Scientific– Experiment-by-experiment
– Notebook-by-notebook– Animal-by-animal
• Clinical– Dose-by-dose– Patient-by-patient– Alllabvalues
• Manufacturing– Yields– Batch-to-BatchComparisons
– Stability
• IntellectualProperty– PatentsIssued– PatentApplications– “FreedomToOperate”
SouthernResearchDrugDiscovery
![Page 16: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/16.jpg)
16
• Allagreed-uponterms,wrappedinlegalese
• Alsoincludesextensiverepresentationsandwarranties– “Yes,wereallydohavetherighttoenterintothisdeal...“
– “Weguaranteetouseourbestefforts...“– “Wewon’tsueyouifourpeoplemessup...“
• Lotsofbillablehoursforthelawyers• Legalcontract,signedbyappropriateofficersfrombothsides
SouthernResearchDrugDiscovery
DefinitiveAgreement
![Page 17: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/17.jpg)
17
• Gettingfinalsignatures(Hint:Avoidholidays)• HSR:“Hart– Scott– Rodino”,or“There’snodealuntilthegovernmentweighsin”
• Cashingthecheck• Hittingthebar– hopefullywithyournewpartners!
SouthernResearchDrugDiscovery
ClosingtheDeal
![Page 18: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/18.jpg)
18
• Alliancemanagement– “Nowthatwe’reworkingtogether,howdowekeeptrackofthings?”
–Meetings,agendas,budgets,reportstoseniormanagement,etc.
• Hittingmilestones–Whatresourcesdowehavetocommittohitthegoalsthatwecommittedto?
–Whatcanwedotohelpourpartnerhittheirgoals?
SouthernResearchDrugDiscovery
Andthenthenextmorning....
![Page 19: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/19.jpg)
19
DealTimeline
InTheory
• Sixmonths
• Discussionswithoneortwocompanies
InReality
• 18– 24months
• Discussionswithupto40companies(wehear“No”inmanydifferentforms!)
SouthernResearchDrugDiscovery
![Page 20: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/20.jpg)
20
• Theyhaveagapintheirpipeline• Theyareinvestedinthetherapeuticarea• Theywanttobroadentheirpipeline• A programclearlyshowsvalue– Scientifically– Commercially/Financially
• “Keepingupwiththepack”
SouthernResearchDrugDiscovery
WhyCompaniesSay“Yes”
![Page 21: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/21.jpg)
21
• Programistooearly• Theyarelookingatmultipleprogramsforthisindication– andpickanotherone
• Theyaresimplygatheringalittlecompetitiveintelligence
• Questions/concernsabout:– Targetand/ormechanism– Chemistry– Pharmacokinetics– Toxicology
• Financialsaretooriskyordon’taddupSouthernResearchDrugDiscovery
WhyCompaniesSay“No”
![Page 22: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/22.jpg)
22
ThingsChange:“Frog”↔“Prince”
• “There’sbeenachangeinstrategy”
• “WehaveanewCSO”• “We’regettingbought”• “Weneedtoraisemoney”
• “Theteamisbeingrelocated”
• “WehaveanewCEO”• “We’rebuyingsomeone”
• “Ourprogramfailed”• “Someoneelse’sprogramfailed”
• “We’regoingthroughareorganization”
SouthernResearchDrugDiscovery
Someofthesecanbegoodnews,somenotsogood
![Page 23: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/23.jpg)
23
Collectcompanyfeedback
Provideinformationtoresearchersongaps&drivers
Researchteamsuseinputtorefine
program
Presentprogramstocompanies
SouthernResearchDrugDiscovery
AVirtuousCycle
![Page 24: ADDA Lecture Series: Business Development · “Business Development”: A Bit of a Black Box Some Really Cool, Innovative Research Results Some Other Stuff Happens Here . . . You](https://reader033.fdocuments.us/reader033/viewer/2022042222/5ec88a37fa146116dd23ab69/html5/thumbnails/24.jpg)
SouthernResearchDrugDiscovery