Phi therapeutics wk10 final nvp
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Transcript of Phi therapeutics wk10 final nvp
A Probiotic Approach to Effective Acne Therapy
Phi Therapeutics
December 10, 2013
Consumer interviews: 17Pharma interviews: 19KOL interviews: 14Regulatory interviews: 14IP interviews: 6Other Interviews: 22_____________________Total Interviews: 92
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
Mentors:Bob DunkleKarl Handelsman
Week 1
d
• Non-toxic, fast clearing, highly specific bacterialkillers
• Can treat multi-drug resistant bacteria, and 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
• Sanitizationo Supermarketso Hospitalso Animal feeding operations, aquaculture farmso Food processsing• Animal therapyo Animal feeding operations, aquaculture farmso Veterinary medicine• Human therapyo Treating multi-drug resistant bacterial infectionso Niche bacterial infectionso Skin conditions (acne, eczema)• Prophylacticso Anti-Staph nasal sprayo Probiotics
Week 1
d
• Non-toxic, fast clearing, highly specific bacterialkillers
• Can treat multi-drug resistant bacteria, and 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
• Sanitizationo Supermarketso Hospitalso Animal feeding operations, aquaculture farmso Food processsing• Animal therapyo Animal feeding operations, aquaculture farmso Veterinary medicine• Human therapyo Treating multi-drug resistant bacterial infectionso Niche bacterial infectionso Skin conditions (acne, eczema)• Prophylacticso Anti-Staph nasal sprayo Probiotics
I was happy …
.. but Nancy had other ideas
After an Important Interview
• Obtain probiotic strains
• Obtain lead compounds
• IP strategy• Effective treatment
of acne• Minimal side effects• Natural and
probiotic• Non-intensive
treatment regimen
Probiotic collections
• Sales (direct relationship)
• Online and customer service
• Skincare and cosmetic companies
• Academic lab
• Regulatory agencies (FDA)
Pharmacies
Online
Mass retail
• Dermatologists
• People with moderate acne
• Male and Female, 18 and above
• Male and female 18 and below (but the decision maker/buyer are mothers)
• People with severe acne
• Mostly Male 18 and above
• Cystic acne
• 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
Week 3: Focus on Acne
Acne: History (Lack of Innovation in 30 Years)
Ancient Egypt
Sulfur Benzoyl peroxide
1920s 1980s1970s
Retin AAccutane
Antibiotics
• 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
•30% of adults (20-35)
• 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”
Who Are Our Customers?
Archetype #1 Archetype #2
Store Online Pharmacies
Over the Counter (OTC) vs Prescription
EstheticiansSkincare Companies Dermatologists
$2.5 Billion Market $4 Billion Market
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Initial Hypotheses
Better!
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Regulato
ry“Must be regulated by the FDA”
Better!
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Customer
Segm
ent
“Cosmetic companies aren’t going to take drugs through clinical trials”
Better!
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Customer
Segm
ent
Better!J&JGSKBayer, Galderma
“Cosmetic companies aren’t going to take drugs through clinical trials”
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer SegmentsIP
“Add probiotic component to therapeutic”
Better!
Antibacterial
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer SegmentsIP
Better!
Antibacterial+ Probiotic
“Add probiotic component to therapeutic”
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer SegmentsPartners
“Use dermatologist advisors to prove clinical efficacy”
Better!
Antibacterial+ Probiotic
Other Discoveries
• Regulated under CBER division of FDASafety and Efficacy regulated under acne guidelinesCMC (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
DermatologistSalesforce
CreateDemand
Attractive Market Opportunity
TAM = $4 Billion
SAM = $2 Billion
650 million people globally
150 million people in USA
Target Market$500 Million
25% New branded drugs capture large share of the market
Preclinical Timeline
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
0 6Months
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
• Cosmetically elegant
• Formulation CROs
• $500K
• 6 Months
0 6 12Months
Preclinical Timeline
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
• Cosmetically elegant
• Formulation CROs
• $500K
• 6 Months
• Efficacy, penetration, safety data
• Safety and toxicology CROs• Hamsters, mini-pigs
• $100K
• 3 Months
0 6 12 15Months
Preclinical Timeline
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
• Cosmetically elegant
• Formulation CROs
• $500K
• 6 Months
• Efficacy, penetration, safety data
• Safety and toxicology CROs• Hamsters, mini-pigs
• $100K
• 3 Months
• Efficacy, endpoints, monitor microbiome
• IRB• Dermatologists• 20-100 volunteers
• $500K
• 3 Months
0 6 12 15 18Months
Preclinical Timeline
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
IRL4
Senior customer will endorse externally
First pass canvas
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
Week 1
d
• Non-toxic, fast clearing, highly specific bacterialkillers
• Can treat multi-drug resistant bacteria, and 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
• Sanitizationo Supermarketso Hospitalso Animal feeding operations, aquaculture farmso Food processsing• Animal therapyo Animal feeding operations, aquaculture farmso Veterinary medicine• Human therapyo Treating multi-drug resistant bacterial infectionso Niche bacterial infectionso Skin conditions (acne, eczema)• Prophylacticso Anti-Staph nasal sprayo Probiotics
Product Market Fit (Value Proposition)- Teens and chronic acne patients need a better acne treatment
IS OUR BUSINESS IDEA VALIDATED?
Discovery-Collaborate with KOLS
Regulatory-CROs and Regulatory Consultants
- Engage big derm
Marketing-
Dermatologists
KEY Partners to make this business happen
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