Post on 25-May-2015
AffinityTherapeutics
“Affinity-based” microparticle formulations to prevent surgical site infections by the extended, local release of antibiotics
2 Minute NSF I-Corps Story
Team
Dr. Horst von Recum(PI)
Dr. Julius Korley(EL)
Dr. Thomas Facklam(IM)
Co-Founder and CSO of Affinity Therapeutics Translational Research Associate
Co-Founder Affinity Therapeutics Associate Professor, Case Western Reserve
University
PFI Advisor/Business Consultant Over 30 yrs of experience in roles from bench
scientist to CEO
Affinity Therapeutics' Technology Platform
• A tunable, sustainable drug release system
• Other applications for our platform:– Medical indications are very broad
and include regenerative medicine, oncology, etc.
– Advanced wound therapy market– Delivery of anti-cancer drugs and
anti-proliferatives– Any percutaneous implantable can
be infected; Applicable to most bio-materials and medical devices
History of Affinity Therapeutics
• Founded in November 2010
• PCT Application Published January 2011
• NIH Phase I SBIR awarded March 2012 ($400K)– 5 other Phase I
applications submitted
• Currently negotiating both an option license and space agreement
Case Western Reserve UniversityBiomedical Engineering
KeyPartners
Value Propositions
KeyActivities
Key Resources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Extended localDrug deliveryBioavailable and UnmodifiedInfection ReductionCost ReductionIncrease “Quality ofLife”
SBIRLicensingCo-DevelopmentStrategic Partnerships
Personal AssistanceTechnical Assistance
SurgeonsWound TherapySpecialistsHospitals
Cyclodextrin supplierClinical CollaboratorsMedical Device Cos.Manufacturers
Intellectual PropertyAccess to developersof technology
Formulation StudiesIn vitro analysisIn Vivo analysisLarge Animal ModelsPre-Clinical StudiesNon-Dilutive FundingClinical CollaborationsRegulatory PathIDE Submission
Infrastructure of Strategic PartnersSuch as Medical Device cos. Or “BigPharma”
ISO 10993 analysisClinical TrialsManufacturing
Canvas Version 1 (03/20/2012)
What We Thought…
– Be a medical device company focusing on at least 5 different indications
– Our customer was the physicians or surgeons– Gain device approval from the FDA– Manufacture the product (open our own plant)– Distribute the product (customer acquisition)– Sale the product (huge sales team)– Get reimbursement from both Medicare and
private insurance
Customers interviewed to test…
Research Scientist
Director, R&D
Program Manager
ConsultingMedical Device
Other companies
Associate Director
Associate Director
Marketing ManagerDirector, R&D
10
80
10
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
Licensing, Royalties, Co-DevelopmentMilestone payments, Strategic Partnerships
Personal and Technical Assistance• Educating EU“Market-driven studies”Support of KP’s marketing plan
Medical Device Companies• (Exclusivity for
initial indication)
CROsMedical Device Companies• Hernia Mesh• General Dev.
IPAccess to developersof technology
Key PartnerPre-Clinical StudyFund RaisingClinical CollaborationsRegulatory
Infrastructure of Strategic Partners (as Med. Dev. Co.)
CRO’s, CMO’s, Regulatory, Strategic Marketing, Education and Branding
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
Licensing, Royalties, Co-DevelopmentMilestone payments, Strategic Partnerships
Personal and Technical Assistance• Educating EU“Market-driven studies”Support of KP’s marketing plan
Medical Device Companies• (Exclusivity for
initial indication)
CROsMedical Device Companies• Hernia Mesh• General Dev.
IPAccess to developersof technology
Key PartnerPre-Clinical StudyFund RaisingClinical CollaborationsRegulatory
Infrastructure of Strategic Partners (as Med. Dev. Co.)
CRO’s, CMO’s, Regulatory, Strategic Marketing, Education and Branding
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
Licensing, Royalties, Co-DevelopmentMilestone payments, Strategic Partnerships
Personal and Technical Assistance• Educating EU“Market-driven studies”Support of KP’s marketing plan
Medical Device Companies• (Exclusivity for
initial indication)
CROsMedical Device Companies• Hernia Mesh• General Dev.
IPAccess to developersof technology
Key PartnerPre-Clinical StudyFund RaisingClinical CollaborationsRegulatory
Infrastructure of Strategic Partners (as Med. Dev. Co.)
CRO’s, CMO’s, Regulatory, Strategic Marketing, Education and Branding
Market Research• Surgical Site Infections (SSIs)
– Market Size• SSIs occur in 1.5 million surgeries annually1
• $10 billion in annual U.S healthcare expenditures1
• SSIs account for16% of hospital-acquired infections2
– Market Drivers• SSIs not reimbursable• Growing patient population in U.S.• Prevention of infection and prevention of readmission (40%) 2
• Reduction of SSI incidence ratios by 25% by 20142
– Market Dynamics• Surgical Infection Prevention project (2002)
– Reduce SSIs by 90%2
• New CDC standards on prevention and regulation• Diverse application opportunities
1. Frost and Sullivan - Surgical Site Infections Pose Serious Threat and Increase Demand for Advanced Infection Control Technologies2. http://www.nj.gov/health/healthfacilities/presentations/prevention_lindenauer.pdf
Market Opportunity Hernia Mesh Repair
TAM=$1.1BHernia Mesh repair
SAM = $650MVentral Hernias
TM ≤ $650M
Lessons Learned about Value Prop
• Needs= prevention of SSI– Synthetic Mesh vs. Biological Mesh– Antimicrobial mesh sold by Gore– Protection that lasts 7-21 days
• Solution= Affinity Therapeutics’ Antimicrobial formulation– Formulated to be used with the stronger synthetic
meshes– antimicrobial activity for ~30 days
Lessons Learned about Value Prop
• We thought that SSIs were a big problem– We asked several the customers
• This was confirmed but other markets proposed– So we move forward
• We thought, “Focus on the total SSI Market”– We spoke with clinicians and industry experts and
ran the numbers• We decided it best to focus on one market
– We chose the Hernia Mesh Market
Stage 1 Safety study Stage 2 Effectiveness trial
Regulatory Pathways (Class II)
$2-3MM1-2YR
$3-5MM30 patients
1-2YR
US IDEUS 510(k)
$5-8MM2-4YR
Stage 1 Preclinical study
Stage 2Pilot trial
Stage 3Pivotal trial
Regulatory Pathways (Class III)
$2-3MM1-2YR
$3-5MM30 patients
1-2YR
US IDE$15-22MM
150 patients2-3YR
US PMA$20-30MM
4-7YR
Lessons Learned about Key Partners
• Critical for the following:– Regulatory hurdles– Clinical trials– Reimbursement– Manufacturing– Distributions– Marketing– Market penetration and Customer Acquisition
• Our new target is technology to “Proof of Concept” then partner
Lessons Learned about Key Partners
• What Makes Affinity an attractive partner?– True Platform technology
• Why will the partner? Customer Relationships– Have established relationships that they would like
to cultivate (i.e. surgeons or other clinical collaborators)
• At what cost to us?– Exclusivity vs. “Right to play”
AffinityTherapeutics
Case WesternReserve TTO
FDA
StrategicPartner/OEM Hospitals
Patients
ContractManufacturers
Surgeons
DistributorsClinical
Collaborators
Business Ecosystem
= Revenue/Feedback= Information/Product
AffinityTherapeutics
StrategicPartners
Business Ecosystem (In Hospital)
HospitalsInsurance
CompaniesStrategicPartners
Patients
ServicesRendered
InsurancePremiums
Reimbursement
Co-PaysOther fees
Group Purchasing Org. (GPO)
= Revenue/Feedback= Information/Product
AffinityTherapeutics
StrategicPartners
Business Ecosystem (In Hospital)
HospitalsInsurance
CompaniesStrategicPartners
Patients
ServicesRendered
InsurancePremiums
Reimbursement
Co-PaysOther fees
Group Purchasing Org. (GPO)
= Revenue/Feedback= Information/Product
Newly Refined Business Strategy
• True Platform technology– Multiple products with broad range of uses and
clinical indications• Exclusivity on Hernia Mesh Repair infection
only to provide revenue for product development in other areas
• Company owned products
Summary
• Capital Efficiency– Using CROs– Strategic Partners
• Targeting growing unmet needs– Hernia Mesh market continues to increase
• Obesity and age
• License initial products to strategic partners and retain right to market future products under Affinity brand
Affinity is Open for Business!
Future Home of Affinity Therapeutics
KeyPartners
Value Propositions
KeyActivities
Key Resources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Extended localDrug deliveryBioavailable and UnmodifiedInfection ReductionCost ReductionIncrease “Quality ofLife”
SBIRLicensingCo-DevelopmentStrategic Partnerships
Personal AssistanceTechnical Assistance
SurgeonsWound TherapySpecialistsHospitals
Cyclodextrin supplierClinical CollaboratorsMedical Device Cos.Manufacturers
Intellectual PropertyAccess to developersof technology
Formulation StudiesIn vitro analysisIn Vivo analysisLarge Animal ModelsPre-Clinical StudiesNon-Dilutive FundingClinical CollaborationsRegulatory PathIDE Submission
Infrastructure of Strategic PartnersSuch as Medical Device cos. Or “BigPharma”
ISO 10993 analysisClinical TrialsManufacturing
Canvas Version 1 (03/20/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Extended localDrug deliveryBioavailable and UnmodifiedInfection ReductionDevice capable of preventing infection without impacting surgeryCost ReductionIncrease “Quality of Life”
SBIRLicensingCo-DevelopmentStrategic Partnerships
Personal AssistanceTechnical Assistance
SurgeonsWound TherapySpecialistsHospitals--Surgeons--Wound Therapy SpecialistsOutpatient SurgeryCentersMedical Dev. Cos.Veterinary Med.
Cyclodextrin supplierClinical CollaboratorsMedical Device Cos.Manufacturers
IPAccess to developersof technology
Formulation In vitro and in vivo analysisPre-Clinical StudyFund RaisingClinical Collab.Regulatory ANDAIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysisClinical TrialsManufacturing
Canvas Version 1 (03/21/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Device capable of preventing infection without impacting surgeryCost ReductionIncrease “Quality of Life”Prophylaxis of SSI
SBIRLicensingCo-DevelopmentStrategic Partnerships
Personal AssistanceTechnical Assistance
SurgeonsWound TherapySpecialistsVeterinary Med.Hospitals--Surgeons--Wound Therapy SpecialistsOutpatient SurgeryCentersMedical Dev. Cos.Insurance Cos.Medicare
Cyclodextrin supplierClinical CollaboratorsMedical Device Cos.Manufacturers
IPAccess to developersof technology
Formulation In vitro and in vivo analysisPre-Clinical StudyFund RaisingClinical Collab.Regulatory ANDAIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysisClinical TrialsManufacturing
Canvas Version 1 (03/22/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of SSI
LicensingCo-DevelopmentStrategic Partnerships
Personal AssistanceTechnical Assistance
Hospitals--SurgeonsMedical Dev. Cos.Insurance Cos.Medicare
Cyclodextrin supplierClinical CollaboratorsMedical Device Cos.Manufacturers
IPAccess to developersof technology
Pre-Clinical StudyFund RaisingClinical Collab.RegulatoryIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysisClinical TrialsManufacturing
Canvas Version 1 (03/28/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
LicensingCo-DevelopmentStrategic Partnerships
Personal AssistanceTechnical Assistance• Educating EU
Hospitals--Pharmacy andTherapeuticsCommittee--SurgeonsMedical Dev. Cos.Insurance Cos.Medicare
Cyclodextrin supplierClinical CollaboratorsMedical Device Companies• Hernia Mesh• General Dev.Contract ManufacturersRegulatory Consultant
IPAccess to developersof technology
Pre-Clinical StudyFund RaisingClinical CollaborationsRegulatory(Class 1 or 2 vs. 3)US vs. EUIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysisClinical Trials• 30 days; end point infection rateManufacturing, Distribution. Education of EU
Canvas Version 1 (04/04/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
Licensing, Royalties, Co-DevelopmentMilestone payments, Strategic Partnerships
Personal and Technical Assistance• Educating EU“Market-driven studies”Support of KP’s marketing plan
Hospitals--Pharmacy andTherapeuticsCommittee--SurgeonsMedical Dev. Cos.Insurance Cos.Medicare
Cyclodextrin supplierClinical CollaboratorsMedical Device Companies• Hernia Mesh• General Dev.Contract ManufacturersRegulatory Consultant
IPAccess to developersof technology
Key PartnerPre-Clinical StudyFund RaisingClinical CollaborationsRegulatory(Class(1-3), USvsEUIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysis, Clinical Trials• 30 days; end point infection rate,Manufacturing, Distribution, Education of EU
Canvas Version 1 (04/11/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
Licensing, Royalties, Co-DevelopmentMilestone payments, Strategic Partnerships
Personal and Technical Assistance• Educating EU“Market-driven studies”Support of KP’s marketing plan
Medical Device Companies• (Exclusivity for
initial indication)
Group Purchasing OrganizationsHospitals--Pharmacy andTherapeuticsCommittee--SurgeonsMedical Dev. Cos.Insurance Cos.Medicare
Cyclodextrin supplierClinical CollaboratorsMedical Device Companies• Hernia Mesh• General Dev.
IPAccess to developersof technology
Key PartnerPre-Clinical StudyFund RaisingClinical CollaborationsRegulatory(Class(1-3), USvsEUIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysis, Clinical Trials• 30 days; end point infection rate,Manufacturing, Distribution, Education of EU
Canvas Version 1 (04/18/2012)
Key Partners
ValuePropositions
KeyActivities
KeyResources
Cost Structure
CustomerRelationships
Channels
CustomerSegments
Revenue Streams
Cost ReductionProphylaxis of Hernia Mesh Repair Infection
Licensing, Royalties, Co-DevelopmentMilestone payments, Strategic Partnerships
Personal and Technical Assistance• Educating EU“Market-driven studies”Support of KP’s marketing plan
Medical Device Companies• (Exclusivity for
initial indication)
Group Purchasing OrganizationsHospitals--Pharmacy andTherapeuticsCommittee--SurgeonsMedical Dev. Cos.Insurance Cos.Medicare
Cyclodextrin supplierClinical CollaboratorsMedical Device Companies• Hernia Mesh• General Dev.
IPAccess to developersof technology
Key PartnerPre-Clinical StudyFund RaisingClinical CollaborationsRegulatory(Class(1-3), USvsEUIDE Submission
Infrastructure of Strategic Partners (as Med. Dev. Co. or “Big Pharma”
ISO 10993 analysis, Clinical Trials• 30 days; end point infection rate,Manufacturing, Distribution, Education of EU
Canvas Version 1 (04/25/2012)