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![Page 1: Entrepreneurial Track, “Developing Your Product” Target Product Profiles Medical & Development Considerations and Challenges Barbara Wirostko, M.D., Jade.](https://reader036.fdocuments.in/reader036/viewer/2022062802/56649e845503460f94b85946/html5/thumbnails/1.jpg)
Entrepreneurial Track, “Developing Your Product”
Target Product Profiles Medical & Development Considerations and Challenges
Barbara Wirostko, M.D.,Jade Therapeutics, Inc2013 BioUtah Life Science SymposiumNovember 6, 2013
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• Co Founder and Chief Scientific Officer of Jade
Therapeutics, Inco Based at Echelon, University of Utah Research Park, Salt
lake City
• Adjunct Clinical Associate Professor; Moran Eye
Center, University of Utah, Salt Lake City, Utah
• Consult for various drug delivery companies
focused in ophthalmology
Disclosures
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• Medical need in Ophthalmology
• What is a Target Product Profile (TPP)?
• What is the purpose of the TPP?
• How did we use it?
Objectives
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• Chronic diseases + aging population = attractive area to be in
• Aging population o chronic ocular pathologies: glaucoma, diabetic retinopathy, and
macular degeneration,
o many require chronic therapy
• Daily self application is difficult
• The ability to develop new drugs and deliver them through
novel technology is attractive
Recognized unmet medical need
Ophthalmology – $ 23 Billion
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A lot of different deliveries in development
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Topical eye drops
Confidential 6
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This can’t always be easy….
Confidential 7
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• Where is the unmet need?
• What is the unmet need?
• Confirm it….
• Nail it then Scale it. The Entrepreneur’s Guide to Creating and
Managing Breakthrough Innovation• Nathan Furr & Paul Ahlstrom
o “Entrepreneurs don’t necessarily invent – they innovate”
o Go out into the field
o Don’t propose the solution
o BUT ask the questions
• Is there a need?• Could we solve it ?• What would the solutions look like?• Would this solution work?
Identify the Unmet Need
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• The Target Product Profile (TPP) is the cornerstone
of pharmaceutical product development.o Represents the envisioned product
o Think about what will the eventual label be
• Help guide development to get to this label• Living document
Help you to fulfill that unmet need of the
customer!!
Develop the TPP
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• Traditional TPPs have served as an R & D tool used to
guide the clinical program
o Patient population
o Endpoints
o Safety and efficacy
o Phase 3 comparator
Also serves as a business tool for determining asset
value and capital commitment.
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Target Product profile for XXXcompound
compound
Active Ingredient
Indication
Target population
Mechanism of Action
Dosage
Route of Administration
Safety
Efficacy
Competitive Advantage over Other Therapies
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Jade’s unmet need: Sustained Delivery of Antibiotics for Bacterial Keratitis
A corneal-blinding condition (scarring/perforation)
Most common cause in US is contact lens wear
Standard of care is topical antibiotics
dosed as often as hourly
No marketed/ approved drug product in U.S. Likely orphan drug indication
U.S. Army interest
NSF Phase I SBIR funded grant
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• No current eye drop for this indicationo Off label use and or compounding of approved antibiotics
• Difficult to administer topical drops every hour x 2-3
days
• Rapidly blinding condition
o Ocular emergency
• Compliance and Adherence are NOT GOOD
o Poor compliance with topical drops
Confirmed with end users & customers
Is there an unmet need?
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Initial Target Product Profile(s)
4-7 day drug-eluting strip/film Use of approved ocular antibiotics to treat bacterial keratitis
(also known as corneal ulcers)
Applied in-office by M.D.
Local topical placement Inferior Cul de sac
under bandage contact lens
Improved efficacy and safety over
“Off label” compounded drops (SOC)
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Key Messages
Focus on an attractive area Ophthalmology
Orphan diseases
Address a critical unmet need Increased compliance/drug exposure Improved outcomes
Mitigate risk Focus on local administration of already-approved drugs (505(b)2)
Proprietary polymer-based platform for novel delivery (strong IP)15
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Thank You!
“It is Fun to do the impossible”
Walt Disney
Confidential 16