Building a New Biotech Enterprise

Building a New Biotech Enterprise Building a New Biotech Enterprise - Start

2018-03-14 29K 29 0 0

Download Presentation

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.



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

Slide2

Biotech Entities Must Evaluate Multiple

Risk Factors to Ensure Impact & Success for All StakeholdersOctober 2016

Pivot Pharmaceuticals

2

Slide3

The Economics of Drug Development

October 2016Pivot Pharmaceuticals3

Slide4

Pharmaceutical R&D Expenditures to Develop New Prescription or Generic Drugs

October 2016Pivot Pharmaceuticals

From: World Review 2013-2018, Evaluate

Pharma

, June 2013

4

Slide5

Worldwide Total Market for Prescription Drugs

October 2016Pivot Pharmaceuticals

From: World Review 2013-2018, Evaluate

Pharma

, June 2013

5

Slide6

Growth 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

Slide7

October 2016

Pivot Pharmaceuticals7

Slide8

October 2016

Pivot PharmaceuticalsR&D Cost per Approved Molecule Compared: Biotech vs. Pharma

Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:469-79

8

Slide9

New 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

Slide10

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

Slide11

Summary of Drug Development & Evaluation

October 2016Pivot Pharmaceuticals

11

Slide12

Clinical Development Times Vary Across Therapeutic Classes, 2000-2013

* excludes AIDS antivirals

Source:

Tufts CSDD

October 2016

Pivot Pharmaceuticals

12

Slide13

Regulatory Approval Times Vary Across Therapeutic Classes, 2000-2013

* excludes AIDS antivirals

Source:

Tufts CSDD

October 2016

Pivot Pharmaceuticals

13

Slide14

FDA 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

Slide15

Pipeline & Revenue Challenges for Large Pharmaceutical & Biotech Companies

October 2016Pivot Pharmaceuticals15

Slide16

Rationale for Networked Model of Innovation for New Drug Development

October 2016Pivot Pharmaceuticals16

Slide17

Building Successful Biotech Enterprises

October 2016Pivot Pharmaceuticals17

Slide18

Common 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

Slide19

Successful New Biotech Ventures Leverage Innovation and Translate them into New Products

October 2016

Pivot Pharmaceuticals

19

Slide20

Successful

Biotechs harness the “Restless Discontent” of Entrepreneurs coupled with Networking

October 2016

Pivot Pharmaceuticals

20

Slide21

Bigger 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

Slide22

Biotech Alliances with

Large Pharmaceutical CompaniesOctober 2016Pivot Pharmaceuticals

22

Slide23

The Funding Climate (or Lack Thereof)

October 2016Pivot Pharmaceuticals23

Slide24

Funding 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

Slide25

Venture Financing Deals & Total Venture Financing Values

October 2016Pivot Pharmaceuticals

From: World Review 2013-2018, Evaluate

Pharma

, June 2013

25

Slide26

October 2016

Pivot Pharmaceuticals26

From: GLG

Pharma

- Diagnostics and Drugs

Slide27

Biotech 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

Slide28

Successful Biotech

Enterprise Rationale: Address Unmet Medical NeedsOctober 2016

Pivot Pharmaceuticals

28

Slide29

Building a New Biotech Enterprise

Pravin R. Chaturvedi, Ph.D.Pivot Pharmaceuticals, Inc.Woburn, MA 01801

October 2016

Pivot Pharmaceuticals

29

Slide30

Pravin

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


About DocSlides
DocSlides allows users to easily upload and share presentations, PDF documents, and images.Share your documents with the world , watch,share and upload any time you want. How can you benefit from using DocSlides? DocSlides consists documents from individuals and organizations on topics ranging from technology and business to travel, health, and education. Find and search for what interests you, and learn from people and more. You can also download DocSlides to read or reference later.