Presentations text content in Building a New Biotech Enterprise
Slide1
Building a New Biotech Enterprise
Pravin R. Chaturvedi, Ph.D.Pivot Pharmaceuticals, Inc.Woburn, MA 01801
October 2016
Pivot Pharmaceuticals
1
Slide2Biotech Entities Must Evaluate Multiple
Risk Factors to Ensure Impact & Success for All StakeholdersOctober 2016
Pivot Pharmaceuticals
2
Slide3The Economics of Drug Development
October 2016Pivot Pharmaceuticals3
Slide4Pharmaceutical R&D Expenditures to Develop New Prescription or Generic Drugs
October 2016Pivot Pharmaceuticals
From: World Review 2013-2018, Evaluate
Pharma
, June 2013
4
Slide5Worldwide Total Market for Prescription Drugs
October 2016Pivot Pharmaceuticals
From: World Review 2013-2018, Evaluate
Pharma
, June 2013
5
Slide6Growth in Global Biopharma Sales
(billions of 2013 dollars) Has Slowed
Source: Statista (url:
http://www.statista.com/statistics/263102/pharmaceutical-market-worldwide-revenue-since-2001/
)
CAGR (2001-2008): 8.1%
CAGR (2008-2013): 3.3%
CAGR = compound annual growth rate
October 2016
Pivot Pharmaceuticals
6
Slide7October 2016
Pivot Pharmaceuticals7
Slide8October 2016
Pivot PharmaceuticalsR&D Cost per Approved Molecule Compared: Biotech vs. Pharma
Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:469-79
8
Slide9New Drug and Biologics Approvals and R&D Spending
Sources: Tufts CSDD, PhRMA, 2014
R&D expenditures are adjusted for inflation; curve is 3-year moving average for NMEs
R&D Expenditures
New Compound Approvals
Slide10Net 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
Slide11Summary of Drug Development & Evaluation
October 2016Pivot Pharmaceuticals
11
Slide12Clinical Development Times Vary Across Therapeutic Classes, 2000-2013
* excludes AIDS antivirals
Source:
Tufts CSDD
October 2016
Pivot Pharmaceuticals
12
Slide13Regulatory Approval Times Vary Across Therapeutic Classes, 2000-2013
* excludes AIDS antivirals
Source:
Tufts CSDD
October 2016
Pivot Pharmaceuticals
13
Slide14FDA Review Decisions and Phase 4 Studies
October 2016Pivot PharmaceuticalsIf 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 levelsFollowing drug approval, sponsors of the drug will be required to continually assess the safety of the drug
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, cost-effectiveness analyses, comparative trials, and quality of life studies
Phase 4 Studies
FDA Review Outcomes
14
Slide15Pipeline & Revenue Challenges for Large Pharmaceutical & Biotech Companies
October 2016Pivot Pharmaceuticals15
Slide16Rationale for Networked Model of Innovation for New Drug Development
October 2016Pivot Pharmaceuticals16
Slide17Building Successful Biotech Enterprises
October 2016Pivot Pharmaceuticals17
Slide18Common themes in Successful
BiotechsSetting big ambitious goalsAssembling the right team membersAlignment of goals and incentivesLeveraging the right technologiesPerseverance through failuresAdapting to changing market climatesRespecting discontent towards seeking excellence
Culture of open and honest communicationRapid decision making
Accountable leadership
October 2016
Pivot Pharmaceuticals
18
Slide19Successful New Biotech Ventures Leverage Innovation and Translate them into New Products
October 2016
Pivot Pharmaceuticals
19
Slide20Successful
Biotechs harness the “Restless Discontent” of Entrepreneurs coupled with Networking
October 2016
Pivot Pharmaceuticals
20
Slide21Bigger is Definitely Not Better
Biotech initiatives require a small, committed teamsDisruption + chaos + discontent = CreativityKey discussion topic: What to do?Make decisions, but open-minded about expectationsNon-bureaucratic and fluid executionImpact-oriented philosophy – not career-orientedDebate and disagreements welcomedCore team members define the culture
Key members of the team become future leaders
October 2016
Pivot Pharmaceuticals
21
Slide22Biotech Alliances with
Large Pharmaceutical CompaniesOctober 2016Pivot Pharmaceuticals
22
Slide23The Funding Climate (or Lack Thereof)
October 2016Pivot Pharmaceuticals23
Slide24Funding challenges for therapeutic biotech entities with available sources of investment
October 2016Pivot Pharmaceuticals24
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 attentionNot 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
Slide25Venture Financing Deals & Total Venture Financing Values
October 2016Pivot Pharmaceuticals
From: World Review 2013-2018, Evaluate
Pharma
, June 2013
25
Slide26October 2016
Pivot Pharmaceuticals26
From: GLG
Pharma
- Diagnostics and Drugs
Slide27Biotech Investment Timeline (of the Past and Today)
R&DPreclinical
Phase IPhase II
Phase III
Market
Family & Friends
Angel Investors
Venture Capital Funds
Foundations
Private Equity
Large Pharma & Biotech Companies
October 2016
Pivot Pharmaceuticals
27
From Fundraising Manifesto, Ed. Dennis Ford, Life Science Nation, 2014
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
Slide28Successful Biotech
Enterprise Rationale: Address Unmet Medical NeedsOctober 2016
Pivot Pharmaceuticals
28
Slide29Building a New Biotech Enterprise
Pravin R. Chaturvedi, Ph.D.Pivot Pharmaceuticals, Inc.Woburn, MA 01801
October 2016
Pivot Pharmaceuticals
29
Slide30Pravin
Chaturvedi Background: Drug Development & Biotech EntrepreneurshipCurrent 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
May 2016
Pivot Pharmaceuticals Inc.
30
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/Warner-Lamber
t (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
Slide31
Building a New Biotech Enterprise
Download Presentation - The PPT/PDF document "Building a New Biotech Enterprise" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.