ARIZONA CENTER
FOR INNOVATION
Innovation Center
The Arizona Center for Innovation (AzCI) assists technology companies turning their innovative ideas into successful businesses through:
• Focused programs • World-class expertise • High-quality facilities
Access:• Other technology
entrepreneurs• Collaborative,
creative environment
• Advantage of hands-on support
• Successful business leaders
Arizona Center for Innovation
AzCI
Startup and emerging technology companies• Community and UA spin-outs
Technology• Aligned with UA Tech Parks and UA
International• Softlandings
Who
AzCI
Technology Areas: • Security and Defense• Mining• Agriculture and Water• Biotechnology• Intelligent Transportation and Vehicles• Renewable EnergyInformatics/Big Data/Advanced Manufacturing/Imaging/Optics/Photonics
Focus
Barbara H. Wuebbels, RN, MS
How to Move your Product Across the World
Arizona Center for Innovation
Where Is Your World?
Markets Can Not Be Identified By Populations Alone
Market Analysis
Patients KOLs Countries Orphan drug legislation Registration Reimbursement
Patients
Publications Prevalence
Consanguinity Isolated population Migration
Founder effect Patient Advocacy Groups
KOLs
Expertise in disease diagnosis and treatment
Interest in your product Academic support Number of patients Patient relationships Relationship to patient advocacy
groups Previous research experience KOL network
Countries
Hospitals Clinics Physicians who treat the disease Health care system Importation Reimbursement
Orphan Drug Legislation Country specific policy Length of designation Requirements to register Formulary requirements
Reimbursement
Patient Hospital Local government National government
Now what???
Distributors vs. Own Network
Key Questions
Do I have the money to build my own network
Do I have the time Do I have the staff How well do I know the market Can I find a suitable partner
Developer vs. Distributor
Developer Advantages
Choose your own staff Target selected markets Direct feedback from customers Able to rapidly change personnel,
marketing plans Receive all the product revenues Ego factor More incentive to find patients
Developer Disadvantages
Own all the financial risk Responsible for all revenue collection May not have backup products to
generate revenue stream until new product is established
Hard to have initial in-depth market knowledge in multiple regions
Responsible for all regulatory filings Responsible for HR regulations in each
country
Distributor Advantages Less costly Quicker to establish May cover a larger geographic area May be known to local KOLs May be known to patient advocacy
groups May be able to introduce product to
a larger audience You are not alone in the universe
Distributor Disadvantages May be difficult to find appropriate
one Your product is only one of their
products Sales force can be distracted by
activities in other products- launch, recall, adverse events
Less feedback from customers Harder to measure marketing efforts Potential to loose market if
relationship sours Revenues are shared
Other Options
Find other VC investors Share ownership with development
team Sell the product at some stage of
development Relinquish distribution rights Share distribution rights Hybrid plan- developer and
distributor network
Hybrid Model
Develop greatest potential or best resourced market on our own
Partner with distributors for other markets
Hybrid Model Challenges
Partner may want large profit Potential patient market is too small Large geographic area Culturally diverse No financial interest in company Will promote their most lucrative
products Regulatory filings
Finding Distributors
Consultants KOLs Other companies Exhibitors at meetings Patient Advocacy groups Rare Disease Organizations
Rules
Rule # 1 Think out of the box Rule # 2 Talk to everyone Rule # 3 There are funding options Rule # 4 Be willing to share Rule # 5 Partner
Final Thoughts
Don’t be afraid to ask for helpDon’t be afraid to share Every successful company had a beginning and it wasn’t always prettyOrphan pharma is a small worldKeep your nose clean!!!
https://techparks.arizona.edu/azci
©Arizona Center for Innovation 2015