Transcript Pravin Chaturvedi, Founder and Chairman, IndUS Pharmaceuticals

Building a New Biotech Enterprise
Pravin R. Chaturvedi, Ph.D.
Pivot Pharmaceuticals, Inc.
Woburn, MA 01801
October 2016
Pivot Pharmaceuticals
1
Biotech Entities Must Evaluate Multiple Risk Factors
to Ensure Impact & Success for All Stakeholders
Enterprise
Risk
• Scientific (bio, chem, pharm, clin, reg)
• Commercial (partners, market, competition)
• Reimbursement challenges
Management
Risk
• Team (wrong mix of scientists and business)
• Inexperienced board & executive leadership
• Wrong kind of investors and shareholders
Patient
Impact
October 2016
• Defines Overall Success of the Enterprise
• For patients, physicians, employees,
partners, shareholders & society
Pivot Pharmaceuticals
2
The Economics of Drug Development
October 2016
Pivot Pharmaceuticals
3
Pharmaceutical R&D Expenditures to Develop
New Prescription or Generic Drugs
From: World Review 2013-2018, Evaluate Pharma, June 2013
October 2016
Pivot Pharmaceuticals
4
Worldwide Total Market for Prescription Drugs
From: World Review 2013-2018, Evaluate Pharma, June 2013
October 2016
Pivot Pharmaceuticals
5
Growth in Global Biopharma Sales
(billions of 2013 dollars) Has Slowed
CAGR (2001-2008): 8.1%
CAGR (2008-2013): 3.3%
CAGR = compound annual growth rate
Source: Statista (url: http://www.statista.com/statistics/263102/pharmaceutical-market-worldwide-revenue-since-2001/)
October 2016
Pivot Pharmaceuticals
6
October 2016
Pivot Pharmaceuticals
7
R&D Cost per Approved Molecule Compared:
Biotech vs. Pharma
Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:469-79
October 2016
Pivot Pharmaceuticals
8
New Drug and Biologics Approvals and R&D
Spending
R&D Expenditures
New Compound
Approvals
R&D expenditures are adjusted for inflation; curve is 3-year moving average for NMEs
Sources: Tufts CSDD, PhRMA, 2014
Net Returns Relative to R&D Cost for New
Compounds by Sales Decile (millions of 2000 $)
Source: Grabowski et al., PharmacoEconomics 2002; 20(Suppl 3):11-29
October 2016
Pivot Pharmaceuticals
10
Summary of Drug Development & Evaluation
October 2016
Pivot Pharmaceuticals
11
Clinical Development Times Vary Across
Therapeutic Classes, 2000-2013
* excludes AIDS antivirals
Source: Tufts CSDD
October 2016
Pivot Pharmaceuticals
12
Regulatory Approval Times Vary Across
Therapeutic Classes, 2000-2013
* excludes AIDS antivirals
Source: Tufts CSDD
October 2016
Pivot Pharmaceuticals
13
FDA Review Decisions and Phase 4 Studies
FDA Review Outcomes
Phase 4 Studies
• If not approvable, FDA sends
Sponsor a Complete Response
Letter
• If approvable, the FDA requests
additional information from
the sponsor to ensure
appropriate labeling
• The NDA is again reviewed to
specify label indication and
dose levels
• Following drug approval,
sponsors of the drug will be
required to continually assess
the safety of the drug
October 2016
• Post-market surveillance of
the drug to continually
assess the safety of the drug
• FDA may request following
the risk-mitigation (REMS)
strategies
• May include evaluation of
incidence and severity of
rare adverse reactions, costeffectiveness analyses,
comparative trials, and
quality of life studies
Pivot Pharmaceuticals
14
Pipeline & Revenue Challenges for Large
Pharmaceutical & Biotech Companies
October 2016
Pivot Pharmaceuticals
15
Rationale for Networked Model of Innovation
for New Drug Development
October 2016
Pivot Pharmaceuticals
16
Building Successful Biotech Enterprises
October 2016
Pivot Pharmaceuticals
17
Common themes in Successful Biotechs
•
•
•
•
•
•
•
•
•
•
Setting big ambitious goals
Assembling the right team members
Alignment of goals and incentives
Leveraging the right technologies
Perseverance through failures
Adapting to changing market climates
Respecting discontent towards seeking excellence
Culture of open and honest communication
Rapid decision making
Accountable leadership
October 2016
Pivot Pharmaceuticals
18
Successful New Biotech Ventures Leverage
Innovation and Translate them into New Products
October 2016
New
Technology
Partners
Target
profiles
Founders
Validate
$$$$
Seed
Capital
Core
Team
Translation
to Product
Pivot Pharmaceuticals
19
Successful Biotechs harness the “Restless Discontent”
of Entrepreneurs coupled with Networking
Academic &
Business
Interface
New
Technology
Mavens
“Spillover &
Brownian”
Effects
New Biotech Ventures
October 2016
Pivot Pharmaceuticals
20
Bigger is Definitely Not Better
•
•
•
•
•
•
•
•
•
Biotech initiatives require a small, committed teams
Disruption + chaos + discontent = Creativity
Key discussion topic: What to do?
Make decisions, but open-minded about expectations
Non-bureaucratic and fluid execution
Impact-oriented philosophy – not career-oriented
Debate and disagreements welcomed
Core team members define the culture
Key members of the team become future leaders
October 2016
Pivot Pharmaceuticals
21
Biotech Alliances with Large Pharmaceutical
Companies
October 2016
Pivot Pharmaceuticals
22
The Funding Climate (or Lack Thereof)
October 2016
Pivot Pharmaceuticals
23
Funding challenges for therapeutic biotech
entities with available sources of investment
Choice of
Investors
Experience of Interaction
Expected Outcome
Family &
Friends
Divorce?? Lose family & friends?
Insufficient investment capital to fund therapeutic
biotech entities; seed capital at best
Patient
Foundations;
NIH, NSF
“Rare diseases”-focused foundations
more efficient; size of grants not usually
sufficient to fund biotech
Limited source of non-dilutive capital; provided that
there is already huge support from NIH or other
funding; good source for seed funding
HNIs; Angel
investor
groups
Too diversified and lack of focus; afraid
of regulatory approval uncertainty;
need proof of principle
Limited availability of capital and not suited for
therapeutic biotech entities due to their inability to
participate in future funding rounds
Venture
capitalists
Accede total control and incentives for
founders; inadequate capital resources
requires syndication; investor board not
always aligned
Require (their) focus on selected therapeutic areas
and possibility of early exit (preferably M&A);
partnership with large pharma increases likelihood
of financing; need to ensure future fund availability
Private equity
Usually fund growth-stage biotech
companies; need product to be
approved to have their attention
Not much different than public investors that will
focus on the bottom line (profits) and not
(generally) support new product development
Strategic
(pharma)
partners
Best alignment of incentives with
biotech entities; symbiotic in nature;
experienced and focused partners
Leveraging knowledge- and capital-resources from
strategic partners expands bandwidth and increases
likelihood of success for the new drug
October 2016
Pivot Pharmaceuticals
24
Venture Financing Deals & Total Venture
Financing Values
October 2016
From: World Review 2013-2018, Evaluate Pharma, June 2013
Pivot Pharmaceuticals
25
From: GLG Pharma - Diagnostics and Drugs
October 2016
Pivot Pharmaceuticals
26
Biotech Investment Timeline (of the Past and Today)
R&D
Preclinical
Phase I
Phase II
Phase III
Market
Family & Friends
Angel Investors
Venture Capital Funds
Foundations
Private Equity
Large Pharma & Biotech Companies
R&D
Preclinical
Phase I
Phase II
Phase III
Market
Family & Friends
Angel Investors
Venture Capital Funds (Extremely Limited)
Family Offices, Foundations, Venture Philanthropy, Patient Groups
Private Equity and Hedge Funds
Large Pharma & Biotech Companies, Corporate Ventures
October 2016
From Fundraising Manifesto, Ed. Dennis Ford, Life Science Nation, 2014
Pivot Pharmaceuticals
27
Successful Biotech Enterprise Rationale:
Address Unmet Medical Needs
Time
People
Potential
Leverage New
Technologies &
Innovations +
Global Economy
Build the Right
Team in a
Networked
Setting
Address Needs
of the Patient
Translation to New
Products for
Commercialization
Biologist, Chemist,
Pharmacologist,
Physician, Reg
Affairs, Business
Improve
Wellness and
Reduce
Hospitalization
October 2016
Pivot Pharmaceuticals
28
Building a New Biotech Enterprise
Pravin R. Chaturvedi, Ph.D.
Pivot Pharmaceuticals, Inc.
Woburn, MA 01801
October 2016
Pivot Pharmaceuticals
29
Pravin Chaturvedi Background: Drug
Development & Biotech Entrepreneurship
Current Portfolio of
Biotech Enterprises
My Role(s)
Development Program Focus
Pivot Pharmaceuticals*
President, CEO & BOD
Women’s Health – Oncology/Urology
Oceanyx Pharmaceuticals
Co-founder, BOD
Cancer, Bone, Neurodegeneration
Cellanyx Diagnostics
Chairman, BOD
Cancer Phenotypic Diagnostics
Previous Portfolio of
Biotech Enterprises
My Role(s)
Participation in Drugs Developed and
Commercialized
Napo Pharmaceuticals**
President & CSO
Crofelemer (GI)
Scion Pharmaceuticals***
President, CEO & BOD
(Neuropathic pain, atrial fib)
Vertex Pharmaceuticals
Head, Lead Evaluation
Telapravir (HCV), Fosamprenavir
(HIV), Amprenavir (HIV)
Alkermes
Pharmacokinetics
(Brain targeting, drug delivery)
Parke-Davis/WarnerLambert (now Pfizer)
Product Development
Scientist
Gabapentin (Epilepsy), Fosphenytoin
(Epilepsy), Tacrine (Alzheimer’s)
*Acquired IndUS Pharmaceuticals in 2015; **Acquired IndUS Pharmaceuticals in 2007 ***Acquired by Wyeth (now Pfizer) in 2005
May 2016
Pivot Pharmaceuticals Inc.
30