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