Phi therapeutics wk10 final nvp
 

Phi therapeutics wk10 final nvp

on

  • 861 views

 

Statistics

Views

Total Views
861
Views on SlideShare
861
Embed Views
0

Actions

Likes
0
Downloads
4
Comments
0

0 Embeds 0

No embeds

Accessibility

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Phi therapeutics wk10 final nvp Phi therapeutics wk10 final nvp Presentation Transcript

  • Phi Therapeutics A Probiotic Approach to Effective Acne Therapy Consumer interviews: 17 Pharma interviews: 19 KOL interviews: 14 Regulatory interviews: 14 IP interviews: 6 Other Interviews: 22 _____________________ Total Interviews: 92 December 10, 2013
  • Mentors: Bob Dunkle Karl Handelsman Yug Varma, PhD UCSF Postdoc, Microbiome Researcher Nancy Van Prooyen, PhD UCSF Postdoc, Immunologist Joan Zape UCSF PhD Candidate, Cell Biologist Nilam Patel Genentech, Technology Engineer
  • Week 1 • Non-toxic, fast clearing, highly specific bacterial killers • Can treat multi-drug resistant bacteria, and d drugs targeting emerging resistance can be found quickly and cheaply • More effective and penetrating than topical antibacterials • Can be used for antibacterial treatment in applications where antibiotics are banned (eg. Animal farms in the EU) • Analysis of initial samples • Regular monitoring of client site •Website •Site visits to collect samples • Direct mail to ship probiotics to client • Sanitization o Supermarkets o Hospitals o Animal feeding operations, aquaculture farms o Food processsing • Animal therapy o Animal feeding operations, aquaculture farms o Veterinary medicine • Human therapy o Treating multi-drug resistant bacterial infections o Niche bacterial infections o Skin conditions (acne, eczema) • Prophylactics o Anti-Staph nasal spray o Probiotics
  • Week 1 • Non-toxic, fast clearing, highly specific bacterial killers • Can treat multi-drug resistant bacteria, and d drugs targeting emerging resistance can be found quickly and cheaply • More effective and penetrating than topical antibacterials • Can be used for antibacterial treatment in applications where antibiotics are banned (eg. Animal farms in the EU) • Analysis of initial samples • Regular monitoring of client site • Sanitization o Supermarkets o Hospitals o Animal feeding operations, aquaculture farms o Food processsing • Animal therapy o Animal feeding operations, aquaculture farms •Website •Site visits to collect samples • Direct mail to ship probiotics to client o Veterinary medicine • Human therapy o Treating multi-drug resistant bacterial infections o Niche bacterial infections o Skin conditions (acne, eczema) • Prophylactics o Anti-Staph nasal spray o Probiotics
  • After an Important Interview I was happy … .. but Nancy had other ideas
  • Week 3: Focus on Acne • Skincare and cosmetic companies • Obtain probiotic strains • Obtain lead compounds • IP strategy • Dermatologists • Regulatory agencies (FDA) • Effective treatment of acne • Minimal side effects • Natural and probiotic • Non-intensive treatment regimen • Sales (direct relationship) • Online and customer service • People with moderate acne • Male and Female, 18 and above • Male and female 18 and below (but the decision maker/buyer are mothers) Pharmacies • Academic lab • People with severe acne • Mostly Male 18 and above • Cystic acne Probiotic collections Online Mass retail • Skincare/cosmetic companies • Probiotic selection and production • Formulation of probiotic cream • QC and testing • Antibacterial to kill „bad‟ acne-causing strains • Probiotic to add back „good‟ protective strains
  • Acne: History (Lack of Innovation in 30 Years) Sulfur Ancient Egypt Benzoyl peroxide 1920s Retin A 1970s Accutane Antibiotics 1980s
  • Who Are Our Customers? Archetype #1 Archetype #2 •30% of adults (20-35) • 80% Teenagers (13-19) • Persistent acne, affects daily life: social and school-related •Tried other treatments – either didn‟t work or relapsed • Willing to try regular skincare regimen • Persistent acne, serious therapeutics interventions: lessened acne, or relapse of chronic acne • Affects daily life – social and professional • Desperate for effective treatment, “will try anything”
  • Over the Counter (OTC) vs Prescription Estheticians Skincare Companies Dermatologists Online Pharmacies Store $2.5 Billion Market $4 Billion Market
  • Initial Hypotheses Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • “Must be regulated by the FDA” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • “Cosmetic companies aren‟t going to take drugs through clinical trials” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • “Cosmetic companies aren‟t going to take drugs through clinical trials” Value Proposition Customer Relationships Customer Segments Channels Better! Revenue Streams J&J GSK Bayer, Galderma
  • “Add probiotic component to therapeutic” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • “Add probiotic component to therapeutic” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • “Use dermatologist advisors to prove clinical efficacy” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • Other Discoveries • Regulated under CBER division of FDA Safety and Efficacy regulated under acne guidelines CMC (Chemistry, Manufacturing, and Controls) regulated under live vaccine division • Regulatory consultants and CROs are partners • Virtualize Operations • Human Pilot Trials • Salesforce required to create demand Create Demand Dermatologist Salesforce
  • Attractive Market Opportunity TAM = $4 Billion 650 million people globally SAM = $2 Billion 150 million people in USA Target Market $500 Million 25% New branded drugs capture large share of the market
  • Preclinical Timeline Drug Discovery Concept Validation Requirements Formulation • Validate active ingredients • Incubator space • Lab equipment Cost • $200K Time • 6 Months 0 6 Months Animal Studies Human Pilot Trials
  • Preclinical Timeline Drug Discovery Concept Validation Animal Studies Formulation • Validate active ingredients • Cosmetically elegant • Incubator space • Lab equipment • Formulation CROs Cost • $200K • $500K Time • 6 Months • 6 Months Requirements 0 6 Months 12 Human Pilot Trials
  • Preclinical Timeline Drug Discovery Concept Validation Animal Studies Formulation • Validate active ingredients • Cosmetically elegant • Efficacy, penetration, safety data • Incubator space • Lab equipment • Formulation CROs • Safety and toxicology CROs • Hamsters, mini-pigs Cost • $200K • $500K • $100K Time • 6 Months • 6 Months Human Pilot Trials • 3 Months Requirements 0 6 Months 12 15
  • Preclinical Timeline Drug Discovery Concept Validation Animal Studies Formulation Human Pilot Trials • Validate active ingredients • Cosmetically elegant • Efficacy, penetration, safety data • Efficacy, endpoints, monitor microbiome • Incubator space • Lab equipment • Formulation CROs • Safety and toxicology CROs • Hamsters, mini-pigs • IRB • Dermatologists • 20-100 volunteers Cost • $200K • $500K • $100K • $500K Time • 6 Months • 6 Months • 3 Months • 3 Months Requirements 0 6 Months 12 15 18
  • What Are We Going To Do Next? • Financial SBIR grants, VCs Corporate Partners • Operational Lab space, hire technical team • Structural Incorporate, freedom-to-operate analysis, provisional patents
  • Therapeutic Investment Readiness Level Senior customer will endorse externally Customer partners highly interested Talent recruited to fill gaps Cost analysis and KOL network Proof of relevance data path defined Timeline and cost to data points Identify strategic need/fit at company level Base technology independently confirmed First pass canvas IRL4
  • Week 1 • Non-toxic, fast clearing, highly specific bacterial killers • Can treat multi-drug resistant bacteria, and d drugs targeting emerging resistance can be found quickly and cheaply • More effective and penetrating than topical antibacterials • Can be used for antibacterial treatment in applications where antibiotics are banned (eg. Animal farms in the EU) • Analysis of initial samples • Regular monitoring of client site •Website •Site visits to collect samples • Direct mail to ship probiotics to client • Sanitization o Supermarkets o Hospitals o Animal feeding operations, aquaculture farms o Food processsing • Animal therapy o Animal feeding operations, aquaculture farms o Veterinary medicine • Human therapy o Treating multi-drug resistant bacterial infections o Niche bacterial infections o Skin conditions (acne, eczema) • Prophylactics o Anti-Staph nasal spray o Probiotics
  • IS OUR BUSINESS IDEA VALIDATED? Product Market Fit (Value Proposition) - Teens and chronic acne patients need a better acne treatment Competition -Epiduo (leader) is simply a combination of benzoyl peroxide and retinoic acid - This market space has not seen a novel and more efficacious treatment of acne in the last 30 years KEY Partners to make this business happen Discovery -Collaborate with KOLS Regulatory -CROs and Regulatory Consultants - Engage big derm Marketing -Dermatologists