bessor-brightwaters pharma · • pipeline to mitigate risk, optimize returns • aligned,...
TRANSCRIPT
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Bessor-Brightwaters Pharma New drug development and value creation: uniquely translating university assets to innovative products
Joseph A. Boystak, Co-Chairman and Barry A. Berkowitz, PhD, Co-Chairman and CEO
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We are
• Nimble, semi-virtual Pharma development company • At the center of a novel and aligned ecosystem that integrates key
constituents • Highly experienced development and business team • Using accelerated development methods to bridge the “Valley of
Death” • Optimizing returns relative to risks for our ecosystem stake-holders • Operational and very capital efficient • Developing a portfolio of innovative projects with early and multiple
liquidity exits
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Ecosystem
Investors
Asset Evaluation and
Selection Advisors
Academic
Partners
Asset Pools Project LLC’s
Consolidators/
Acquirers
Industry Partners
Foundations
Bessor-Brightwaters
Pharma
Capital Markets
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The Problem
Foundations
Pharma/Big Biotech and Patients Pressing, unfulfilled need for innovative compounds
Wealth of projects, but not ready for pharma/big biotech
Finance • Early stage venture capital erratic • Business models broken
Our Solution
Bessor-Brightwaters Pharma
• Capital efficient project development • POC & pharma-ready drugs • Attractive returns to all ecosystem
stakeholders • Top R & D team/Plus FIPNET
Academia
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Bessor–Brightwaters Pharma Solves Key
Challenges • University and foundation focus
• Capital efficient
• Translational, project based
• Flexible, responsive, integrated
structure
• Efficient/standardized terms
• Pipeline to mitigate risk,
optimize returns
• Aligned, committed top team
• Scalable
Pharma/Big Biotech Products
Innovative drugs for patients
• Flow of innovative new drugs • Multiple and earlier returns/ & types to our ecosystem stakeholders
RESULTS
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An Aligned and Fully Integrated and
Pharmaceutical (FIPNET)
Yale
Texas A&M
Bessor- Brightwaters Pharma (Semi-virtual/efficient standardized terms)
•Launch, accelerate and add value to projects •Development know-how •Business development •Operations management •Fundraising /deals
Technology Experts
Development Network • Chemistry (AMRI)/Pharmacology • Regulatory/Project Management/Toxicology • Drug Supply/Clinical Development
Optimize Returns to Ecosystem Stakeholders
Pipeline Projects: Duke, Univ. of Fla., Univ. Manchester, Others
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Value Proposition: Foundations
• Value to Foundations/Disease Societies – Translate projects of HIGH interest to Foundation and their patients to
POC; Pharma ready packages; – Provide unique and accelerated means for important drugs to move from
the lab “bench” to reach patients. • What?
– Form focused teams optimized for results from each project--- with input from Foundation
– Active role in selecting projects for Pharma • Why Unique?
– Open to both “for profit” and “not for profit” outcomes – Greater alignment of ecosystem stakeholders
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Value Proposition: University
• Our Value to University – Accelerate University imperative to advance technology and ideas – Convert assets to pending products; Prompt, non-biased asset review – Highly efficient and accelerated path to proof of concept/value point – Added capital, grants and R & D resources for promising assets
• What? – Form top team dedicated to project; optimized for each step – With License, form project specific LLC’s
• Why Unique? – Straightforward, standard licensing terms with non-dilutive terms – Maximized return to all stakeholders - Each university receives full benefit of its own
success – R & D consultation “genius bar” for partners – Flexible, renewable and scalable strategy
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Value Proposition: Pharma and Biotech
Companies
• Our Value to Companies – Breadth and flow of innovative emerging products to fuel pipeline.
• What? – POC and Pharma assets ready for late stage development
– Flexibility for Pharma or us to further develop to desired value point.
• Why Unique? – Alignment and quality of team selecting and developing projects
– Option for risk sharing
– Ability to see/review all potential assets from a portfolio of top investigators and universities
– Flexibility to enrich portfolio with desired targets, drug leads, or advanced product candidates for any therapeutic area desired
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Top Team and Network Selects and
Develops Opportunities
• Team of industry and academic leaders/consultants- “best in class” for each project.
• Team nominated by both the Company and PI’s
• Our team has been Instrumental in developing 19 drugs on the market
– E.g. Tykerb®, Gemzar®, Coreg®, Hycamtin®
– Arranon®, Corlopam®
• Excellent project management and broad drug development expertise
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Road to Drug Development
Discovery
Full
Development
Registration
Scale up
Candidate Medicine
Synthesized
Project Team
and Plans Synthesis
of Compounds
Pharma
cology
Candidate Formulations
Developed
Toxicology
Screening
Phase 1 & POCV in
humansrs Phase I
Candidate Medicine Tested in
3-10,000 Patients (Phase III)
Studies in 100-300
Patients (Phase II)
Clinical Data
Analysis
Exploratory Development POC/
NDA/BLA
Rx
Adapted from J L LaMattina
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Road to Drug Development: Our Leadership
Examples
Discovery
Full
Development
Registration
Scale up
Candidate Medicine
Synthesized
Project Team
and Plans Synthesis
of Compounds
Pharma
cologyt
Candidate Formulations
Developed
Toxicology
Screening
Phase 1 & POCV in
humansrs Phase I
Candidate Medicine Tested in
3-10,000 Patients (Phase III)
Studies in 100-300
Patients (Phase II)
Clinical Data
Analysis
Exploratory Development POC/
NDA/BLA
Rx™
Adapted from J L LaMattina
BB, MR, TB, EO
RJ, HP, SM, WD
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Road to Drug Development: Our Leadership
Examples
Discovery
Exploratory Development
Full
Development
Registration
Scale up
Candidate Medicine
Synthesized
Project Team
and Plans
Synthesis
of Compounds
Pharma
cology
Candidate
Formulations
Developed
Toxicology
Screening
Phase 1 & POCV in
humansrs Phase I
Candidate Medicine Tested in
3-10,000 Patients (Phase III)
Studies in 100-300
Patients (Phase II)
Clinical Data
Analysis
POC/
NDA/BLA
Rx®
Adapted from J L LaMattina
POC and Pharma ready
packages
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Our R&D Team and Network
Team member Background Expertise Achievements
• Barry A. Berkowitz,
PhD
(Co-Chairman &
CEO)
• Pharmaceutical research
and development
• Project and company
management
• Biotechnology and big pharma
− Hoffmann LaRoche
− Smith, Kline & French
• Director of Translational
Research in Oncology, Duke
University
• Co-Director of the Experimental
Therapeutics Program Duke
Cancer Center
• Tykerb®
• Arranon®
• Neil Spector,
MD
• Pharmaceutical research
and development
• Group Research, Glaxo
SmithKline
• Director, in vitro and in vivo
pharma R & D
• Hycamtin® • Randall K.
Johnson, Ph.D.
• Pharmaceutical research
and development
• Vice President, Eli Lilly
− directed cancer drug research and
development
• Homer Pearce,
Ph.D.
• Pharmaceutical research
and development
• Co-Founder and/or CEO:
- Myco/Chemgenics
(acquired by Millennium)
- Fibrogen
- New Chemical Entities
(acquired by Albany Molecular
Research)
• Corlopam® program leader
• 25 INDs completed
• producing 3 NDAs
− Gemzar®
− Alimta®
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More R&D Team and Network
Team member Background Expertise Achievements
• Tony Barrett, PhD • Natural product based
pharmaceuticals
• Analytical and
medicinal chemistry
• Sir Derek Barton Professor of Synthesis,
Imperial College, UK
• Director of the Wolfson Centre for
Organic Chemistry in Medical Science
• Mark Roffmann,
PhD (VP Devel and
Reg Affairs)
• Pharmacology
• Regulatory
• Glaxo SmithKline
• President, Clinsearch (clinical and
regulatory CRO)
• 30+ years drug development &
clinical research experience
• Led filings of 4 NDAs and 20+
INDs
• Eliot H Ohlstein,
PhD (VP Devel and
Therapeutics)
• Pharmacology
• Drug development
• Wallace Dairman,
P hD • Drug development
• Toxicology
• Regulatory
• Senior Vice President of the
Cardiovascular Urogenital Center of
Excellence in Drug Discovery
(CEDD) at GlaxoSmithKline.
• Roche Institute Of
Molecular Biology
• Senior Toxicologist
Hoffmann La Roche
• PhRMA's Discoverer's Award,
for development GSK's
Coreg® (carvedilol),
• Leadership in taking seven
drugs to market
• Pioneering pharma industry
contributions. Co-founder
Argenta Discovery and iThemba
Pharmaceuticals
• Pioneering studies on molecular
biology of biogenic amines
• Toxicology and regulatory
advisor on numerous IND and
NDA submissions
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More R&D Team and Network
Team member Background Expertise Achievements
• John (Jack)
Edwards, MD
• Research and Clinical
Development of
Antiinfective Drugs
Chief Infectious Disease. UCLA
Medical Center, Harbor Branch;
Prof of Medicine UCLA
• Identity
Confidential, PhD
• Project Management
• Quality Assurance
• Clinical Development
• WW Management
Experience
• FDA interactions
• Protein Drugs
• Assay Development
• GMP Production
• Experts in a specific
project
• Co-founder
Myco/Chemgenics;
Novodyme
• Chairs/Coordinates NIAID
advisory group Infectious
Disease Head CNS & Endocrine Research
Senior Director Project
Management
Director Clinical Research
Senior Director Quality Assurance
• Project team leader
of several Blockbuster drugs
•WW leader in Quality
Assurance and Project
Management
∙ Satish Menon, PhD
(Director
Biotechnology)
· Other Project
Specific Advisors
Allergan- Director
Biopharmaceutical Processing
Schering Plough
Special advisors for each Project
Strong input from PI’S
• Responsible for process
development for new
biotechnology based drugs
• Allows “best in class”
project teams
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Initial Business Advisory Board
Team member Background
• Robert Morgan (our CFO)
• PriceWaterhouseCoopers (manager, small business group)
• Co-Founder NewCoGen (Flagship VenturPartners)
• Co-founder – Chemgenics, New Chemical Entities
• Marc Goldberg *
(Chairman, Business Advisory Board)
• BioVentures Investors (co-founder & general partner )
• Mass Biotech Council (co-founder)
• John Canepa • PathoGenetix (CEO); Stemgent (CFO)
• Arthur Anderson (senior partner and head of worldwide life science practice)
• Elliot M. Olstein • Carella, Byrne, Cecchi, Olstein, Brody & Agnello, P.C. (Partner)
• Patent and licenseing
• Jon Soderstrom*
• Joseph A. Boystak* (Co-Chairman)
• Managing Director, Yale University Medical School, Office of
Cooperative Research
• President and Chief Executive Officer of Brightwaters Capital, LLC,
• Founder & Managing Director Global Life Sciences, Jefferies & Co
• University Board Member, UCLA and Johns Hopkins
* Board of Directors
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CASE STUDIES FROM OUR DEVELOPMENT PORTFOLIO
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Our Initial Therapeutic Areas
Under Development
• Inflammation
• Cancer
• Cardiovascular – Renal
Other Areas – Case by case for outstanding opportunities
– Early review and adoption by Pharma Partner(s)
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Stem Cells and Stem Cell Proteins
• Novel stem cell signaling protein: TSG-6
• New Mechanism of Inflammatory modulation with broad anti-inflammatory indications – initially in ophthalmology
• Dr Darwin Prockop, Director Institute of Regenerative Medicine, Texas A & M, PI
• POC established, sponsored research, licensed, 12-18 months from IND
• Clear metrics of Therapeutic Activity
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TSG-6 Prevents Corneal Damage Following Injury in
Preclinical models: Novel Anti-inflammatory Mechanism
Day 3 Day 7 Day 21
PBS
rTSG-6
• Project Team includes: B. Berkowitz M. Roffman, D. Prockop, W. Dairman; Plus project specific advisors: Prof Anthony Day (WW leader TSG-6), U Manchester; and Armand Keating (WW leader cancer and biological therapy, past president Am Soc. Hematology).
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New Generation Vinca for Cancer • Potential 1st in class Therapeutic Index • Preclinical POC shown • Completing Phase 1 clinical trial
– Promising Safety Profile (46 patients) – Peripheral Neuropathy a serious side effect of other Vinca’s not
apparent to date.
• Biomarker identified; NIH interactions • Licensed, partnered with AMRI, for all chemistry and GMP
supply in hand thru phase 2 needs.
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New Drugs for Renal Injury
• Innovative project with biomarker/diagnostic and linked therapeutic for personalized medicine – Novel mechanism
– Meets key need: effective therapies for Renal Failure
– Gary Desir, MD Yale (Nephrology/Medicine) PI
– Licensed, preclinical POC shown, 12-18 months to IND; sponsored research
• Project team – M. Roffman, E. Ohlstein (former head of CV/Renal GSK), W. Dairman, S,
Menon, Gary Desir
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R & D Genius Bar
• University and Foundation Projects frequently “stuck” at translational stage • Biological Target or Drug Lead– What to do next?
• Patent? Publish? Proof of Concept? More Resources? License?
Bessor-Brightwaters Pharma in synergy with the University or Foundation will provide R & D guidance • “Real time” response and advice on drug discovery, IP and development issues • Questions may come from selected Universities or Foundations where we have established
an R & D relationship; optioned/licensed technology to us or emerging technology from other labs/assets at the University or Foundation
• Replies will be prompt, coordinated and provided from our expert, integrated drug discovery and development network
• No cost or obligations to University or Foundation • IP and confidentiality are protected
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University Portfolio
• Yale
• Texas A & M
• Emerging relationships: – Duke
– Univ. of Florida
– Univ. of Manchester (UK)
• Others Pending – Initial Focus in Northeast USA
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We are Open for Business: Universities,
Foundations, Pharma, Investors
• Ecosystem, development and business model yielding RESULTS • Growing network of >20 key advisors and companies • Partnering with major universities, including Yale, Texas A&M, • Building a pipeline of in-licensing ready additional projects with R
& D leaders at five universities; opening discussions with disease foundations
• Awarded a competitive grant from the NIH • Sponsored research @ 2 Univ. sites accelerates development • Launched and advancing novel projects in inflammation (12
months to IND), CV/kidney disease (18 months to IND), and cancer (completing Phase 1 clinical trial)
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THANK YOU AND WE WELCOME FURTHER DISCUSSION
Joseph A. Boystak, Co-Chairman and Barry A. Berkowitz, PhD, Co-Chairman and CEO