Robert Shorr PhD DIC
28 Brookfall Road
Edison, NJ 08817
Office 609-409-7050 ext 200
Cell: (732)-236-0528
Company Email: rob@cornerstonepharma.com
Personal Email: rabbishorr@aol.com
OBJECTIVE
The discovery, development and bringing to market of life saving and life changing therapies for the
treatment of the most difficult diseases. Generating durable value for patients and shareholders.
Whatever it takes to get there.
SKILLS
Financing and management of science for start-up discovery, development stage and
commercialization activities supporting new therapies or diagnostics for life threatening or quality of
life challenging disease. Beginning with a strategic and tactical business plan modeled against
assumptions with definition of value that is recognizable and durable.
Science based opportunity and competitive market analysis of unmet needs. “Why do bad things
happen to good drugs?” Can market entry and domination be achieved? How will we make money?
Building a better mousetrap and the world will beat a path to your door assumes that people care that
they have mice.
Establishing market driven project “needs and wants” with emphasis on prioritization and achieving
value recognized and go-no go milestones. More specifically, planning of earliest stage activities and
study plan for de-risking program based on analysis of product opportunity by (i) does anyone care?
(ii) can you manufacture it? (iii) is it safe (iv) does it work?
Defining success and the strategy and tactics to achieve it. Guiding scientific studies for proof of
principle in R&D. Proof of concept in clinical trials showing safety and benefit with an ability to
prioritize first approvals by indication and patient sub-populations. Based on first clinical trials product
optimization and pipeline determination based on dosage form or formulation by disease indication as
well as follow on optimized NCE’s. Product design with emphasis on patient compliance post clear
demonstration of safety and benefit for value pricing.
Determining “how long will it take and how much will it cost?” With a mechanism for variance
management and audits.
Establishing an exclusivity strategic plan and its execution through patents, trade secrets, and
Orphan Drug Designations US and global where appropriate.
Generation of data to support patent applications. Provisional and utility conversion. Continuance inpart and international phases including triage and product cycle management.
Patent defense USPTO and challenge.
Working with key opinion leader physicians and CRO’s for product design (defining success), clinical
protocol design, clinical trial plan to achieve FDA approvals and basis for Breakthrough or Fast Track
designation from FDA.
Management of R&D activities for discovery and development to support IND filing. Including cGMP
production of material for clinical trial, assays, pharmacology and toxicology and evaluation in disease
models.
Management of CRO and vendor relationship for manufacturing and final fill and finish of drug
substance and product including assay invention and validation where needed.
Management of “in the trenches” activities supporting clinical development including protocol design
and implementation with principal investigators and clinical and regulatory affairs organizations to
achieve FDA and foreign regulatory agency approvals.
Research and development from discovery to implementation of biomarkers for response prediction
and demonstration of response based on MOA and correlated to clinical benefit for Phase I-IV
studies.
Evaluation and development of companion diagnostic opportunities emerging from biomarker-MOA
studies.
Web site management, including e-data rooms for due diligence.
Publications and keynote speaker presentations to establish basis for peer and public recognition.
Public news media both print and electronic format interviews.
Technology and product scope for the above learned and continuing to learn during career of
discovery and development for pharmaceuticals, cell therapeutics, nutritional supplements,
diagnostics, laboratory reagents and materials for assay-analysis and production of biological or small
molecule drug substances and products.
AWARDS
PhD Dept. of Biochemistry Imperial College University of London, England. Purification of
Acetylcholine Receptor from Mammalian Innervated and Denervated Muscle.
Diploma of Imperial College (DIC) Dept. of Biochemistry Imperial College of Science and Technology,
London, England. Purification of Acetylcholine Receptor from Mammalian Innervated and Denervated
Muscle.
US Muscular Dystrophy Foundation Student Fellowship.
Dong Sung Pharmaceuticals (Korea) award outstanding research in drug formulation with PEG and
delivery.
Howard Hughes Medical Institute Post-Doctoral Fellowship Duke University, Durham NC Dept.
Cardiology. Beta adrenergic receptor: purification structure and function.
SmithKline and Beckman Funding award ($960,000) for intrapeneurial research of analytical and
chromatography equipment and materials.
NJ Cancer Society Gallo Award for innovative research in cancer metabolism of arginine.
NJ Chapter AAPS PEG alpha interferon
Multiple inclusions in “who’s who” for the pharmaceutical industry and for business and finance in
biotechnology.
R&D Magazine award for most innovative research in analytical separation and manufacturing
chromatography materials for biologics and small molecule drugs.
EXPERIENCE
Serial entrepreneur starting or working with early stage companies to bring breakthrough technology
and products to market e.g. AT BIOCHEM (FMC), ENZON, ALTIRA CAPITAL and CONSULTING,
PRINCIPIA-HUMAN GENOME SCIENCES, UNITED THERAPEUTICS, CORNERSTONE
PHARMACEUTICALS, MITOMANAGE.
Briefly:
Beginning with an undergraduate education in biology and chemistry at SUNY Buffalo and moving to
a post graduate education with Eric Barnard FRS and Oliver Dolly elucidating neurotransmitter and
hormone receptor structure and function in signal transduction at Imperial College of Science and
Technology, London England. Publishing in Nature and other leading journals.
Moving to the Howard Hughes Medical Institute Duke University as a post-doctoral researcher
elucidating the structure and function of multiple beta adrenergic receptor subtypes with Robert
Lefkowitz and Marc Caron. Publishing in J. Biol. Chemistry, Biochemistry, PNAS and multiple leading
journals as well as abstracts and presentations at national and international conferences. First in
world determination of structure of G-protein linked hormone receptor and proof of mechanism of
function in adenylate cyclase activation.
Moving to SmithKline and French continuing the elucidation of the structure and function of receptors
in signal transduction with Stanley Crooke. Increasing levels of responsibility from Senior Scientist to
Associate Director for Department of Molecular Pharmacology. First in world isolation and
determination of structure and function of phospholipase activating protein in health and in
rheumatoid arthritis. Diagnosis and therapy. Participating in an "intrapeneurial program" with SKF and
Beckman Instruments for the discovery and development of products for use in genomic and
proteomic research. Inventing novel electrophoresis media, chromatography supports, protein
sequencing equipment and fluid handlers for preparative chromatography. Multiple publication in
leading journals. First patents.
Start-up of AT Biochem as Founder BOD member and Chief Scientist with technology emerging
from SKF-Beckman Instruments intrapeneurial program and development and launch of products
for electrophoresis (DNA sequencing and proteomics). Board members including Stanley Crook,
Hubert Shoemacher and venture capital investors ($3MM initial raise). Company sold in part to
Centacor and FMC as AT Biochem a Division of FMC. Contracted to Roche Molecular Systems
to supply parts for PCR kits.
Working with Joseph Hogan as consultant to Sepracor for design and development of equipment
and software for preparative chromatography as well as novel chromatography supports.
Including silica based and polymer based materials.
Moving to Enzon, Piscataway NJ, as Vice President R&D with increasing C-level responsibilities
including BOD member appointment working with Abe Abuchowski. Managing science and
participating in financing. Discovery of novel technology for PEG conjugations and extension to
peptides and small molecule drugs expanding patent portfolio. Application of technology to discovery
of PEG-Intron A and its manufacture as part of Schering Plough License Agreement. PEG-Adenosine
Deaminase clinical trial in HIV-AIDS and improved response and survival. PEG Hemoglobin in cancer
and blood transfusion medicine. Phospholipase Activating Protein in Cancer Therapy. PEGAsparaginase manufacturing and FDA approval. Cloning of asparaginase and arginine deiminase
genes. Acquisition of Genex and establishing dominance in single chain antibody space. PEG single
chain antibodies. PEG glucocerebrosidase in collaboration with NIMH for production of drug product
for clinical study in Gaucher disease with Ed Ginns as principal investigator. PEG taxanes as model
for small molecule PEG anticancer agents.
Forming ALTIRA CAPITAL and CONSULTING working with investors (private and venture) and
companies looking for financing and assistance with matters of science and intellectual property in
the US, Canada and Israel. Due diligence, business plans and negotiation of technology licenses as
well as nature of investments.
Joining UNITED THERAPEUTICS as Chief Scientist and business development executive
discovering longer acting prostacyclins for inhalation, stem cell therapy approaches, and products
and technology for acquisition or license.
Joining the faculty of Biomolecular Engineering and the Center for Biotechnology working with Clint
Rubin and Diane Fabel for the evaluation of emerging technology arising from the efforts of various
faculty throughout the university's campus looking for commercial potential. Working with the
Department of Technology Transfer and Licensing for patent prioritization as well as opportunities for
out licensing. A more specific emphasis placed upon providing grants, ranging from $25,000$100,000 each, as seed funding for specific projects being developed by faculty with interest in
commercialization. Participating with the New York Biotech Association and programs designed to
make New York State in general and Long Island in specifics attractive to entrepreneurs and
investors.
Based upon evaluation of the work of professors Bingham and Zachar (SUNY Stony Brook) regarding
a novel approach to cancer therapy and the in-licensing of nano emulsion technology for drug
delivery from Joseph D’Arrigo for the formation of Cornerstone Pharmaceuticals. The Bingham
technology was licensed from SUNY Stony Brook and Angel seed funding provided by
CORNERSTONE VENTURES and ALTIRA CAPITAL. Ultimately I joined the company as the
founding CEO and Chief Scientist. Drs Bingham and Zachar joining as VP and Director R&D
respectively. Together with my partners raising capital in excess of $60 million through private
investment, hiring a professional CEO, chief medical officer and business development professionals
after achieving proof of concept in research and human clinical studies to position the company for an
IPO. The use of proceeds to fund trials for first FDA approval of a breakthrough drug with a new
mechanism of action.
TEACHING
SUNY Stony Brook Department Biomedical Engineering 1999-2005 Graduate level course required
for understanding commercialization of technology, FDA process, Drug Development, business and
science connections. Job professionalism and personal growth. Training of graduate students, Post
Doc’s and interns.
Orthodox rabbi lecturing in Talmudic and legal or scientific aspects of Jewish theology and historical
or contemporary contextual issues.
CURRENT
As Founding CEO and CSO and Director of Cornerstone Pharmaceuticals focused on two technology
platforms both built on unique aspects of cancer nutrition and metabolism.
Platform 1: novel drugs that are selectively concentrated in cancer cell mitochondria and shut down
cancer specific ATP production.
Platform 2: nanoemulsion formulation of known and novel drugs for cancer selective uptake into
tumor cells and concentration of drug in tumor cell cytoplasm.
Two NIH SBIR grants received as well as three SUNY ITD awards. Multiple Phase I/II clinical trial
approved in US and Canada. ODD for AML, MDS and pancreatic cancer granted along with eligibility
for development grants and eligibility to apply for fast track and breakthrough designation. Nearly,
200 patients treated with escalating dose with first in class, first in man drug CPI 613 with safety and
benefit, including survival, published by investigators at ASCO, ASH, and AACR. Peer reviewed
CPI-613 named one of Top 100 most innovative anticancer agents for 2009 by Research Magazine.
Company featured as one of Top 50 innovators and one of Top 10 developing business opportunities
by the Wyndam Group.
BOARD AND SAB MEMBERSHIPS
Brainstorm Cell Therapeutics Inc. (NASDAQ BCLI)
Prolong Therapeutics
BDSI