buffalo biolabs (bbl) cro capabilities, march 2014
DESCRIPTION
Buffalo Biolabs (BBL) is a science-intensive Biotech company conducting preclinical contract research in a boutique fashion while solving intricate scientific problems, primarily in the field of cancer treatment, diagnostics and prevention; additional focus – infectious diseases.TRANSCRIPT
Contract Research Capabilities
Bridging the gap in biotech
73 High St. Buffalo, NY 14203 [email protected]
(716)849-‐6810
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Buffalo Biolabs (BBL) Mission ü Address the demand for early stage discovery that bridges the gap between Academia and Big Pharma
ü Provide clients with preclinical data to drive product development and support fundraising efforts from proof of concept to IND
PROFILE Science-‐intensive Biotech company conduc4ng contract research in a bou4que fashion while solving intricate scien4fic problems, primarily in the field of cancer treatment, diagnos4cs and preven4on; addi$onal focus – infec$ous disease.
EXPERTISE Highly educated, cohesive research team of 31 employees including 14 Ph.D’s with exper4se in target/drug discovery and preclinical valida4on. Over 1,000 years of combined experience in academia & biotech.
INCEPTION Integra4on of veteran research teams from Cleveland BioLabs, Inc. (CBLI) and Roswell Park Cancer Ins4tute (RPCI). Jointly, these teams have brought several drug candidates from hypothesis to clinical trials.
CUSTOMERS RPCI, CBLI, other local Western New York and East Coast biotech companies (Incuron, Tar4s, Everon, Panacela Labs, Felicitex, etc.)
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BBL Contract Types ü Fully outsourced research needs
Broad set of goals, ini$ally non-‐determinis$c, shi8ing scope
ü Problem solving Applying collec$ve exper$se towards a single issue
ü Proof of Concept Narrow goals, clearly desired outcomes
ü Streamlined, long term capability extension Ideal for clients that do not operate full-‐fledged research facili$es or need augmenta$on of their efforts with proven exper$se.
ü Project/Vendor Management Help clients manage disparate research segments, combined from BBL and external vendors including Shared Resources of Roswell Park.
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Unique Advantages ü Freeing seemingly “stuck” projects Sophisticated animal models at industrial scale – statistical signi6icance of border-‐line effects Integrated approach – combine modern molecular, cellular, tissue and organism-‐level methodologies
ü Access to array of exceptional facilities of Roswell Park Cancer Institute, close collaborator of BBL Research Genomics, microarrays, HTS, FACS, TMA, collection of primary tumors, access to clinical samples http://www.roswellpark.edu/shared-resources
ü Positioning project for investment/funding decision Equipped to handle complex PoC efforts Established track-‐record of bringing new drug candidates from early discovery to IND
ü State-‐of-‐the-‐art core facilities Sophisticated equipment and methodology Combining academic depth with industrial power and experience
BBL Labs
Corporate Customers
BBL Cores
Academic partners
Histology Core
Animal Core
Chemistry and
Bioanalytics
Immunology Lab
Preclinical Lab
Validation Lab
Cell Biology Lab
Microbiology Lab
RPCI SBMRI
Services & Sup
port Ap
plied Re
search
CBLI Incuron Felicitex Everon
Research/Service Contracts
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BBL Contract Research
Research Collaborators
…
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Examples of Research and Service Activities Customer: CBLI R&D tasks: Establish an4cancer efficacy of EntolimodTM (protein-‐based drug candidate) in preclinical models Service tasks: Bioanaly4cal support of EntolimodTM clinical trials Customer: Incuron, LLC R&D tasks: Assess in vitro and in vivo effects of combining CBL0137 (small molecule drug) with other an4cancer drugs Service tasks: PK/PD analysis in support of CBL0137 clinical trials
CBLI
Histology Core
Animal Core
Preclinical Lab RPCI
Incuron
Histology Core
Animal Core
Validation Lab RPCI
Chemistry and Bioanalytics
Chemistry and Bioanalytics
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Research Capabilities• extensive experience in mechanis4c and efficacy studies in a variety of
in vitro and in vivo models • iden4fica4on & valida4on of molecular/cellular PD biomarkers • establish therapeu4c window, assess impact of regimen, and
evaluate routes of administra4on • access to a variety of mouse models (incl. gene KO, chimera, etc.)
Preclinical Lab
Validation Lab
Cell Biology Lab
• iden4fica4on, targe4ng, and valida4on of novel pharmacological targets and drugs
• development of cell-‐based assays for targeted drug screening • bio-‐potency and target specificity of drug candidates in mul4ple cell
lines • efficacy vs. dose-‐limi4ng toxicity, drug combina4ons in animal models
• assessment of cellular drug response • cul4va4on, frac4ona4on and iden4fica4on of drug-‐sensi4ve and
resistant cell types • analysis of cellular pathways, prognos4c, diagnos4c, and efficacy
markers • ex vivo phenotype and drug response analysis of target 4ssues
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Research Capabilities (contd)• extensive experience in molecular and applied immunology developing
and tes4ng new reagents for immunotherapy and immunodiagnos4cs • development of sensi4ve and robust immuno-‐assays, other
bioaffinity assays, screens • custom diagnos4c and therapeu4c an4bodies • protein-‐based, virus-‐based and other immunomodulatory
drug research
Immunology Lab
Microbiology Lab
A typical research project involves contribuTon of experts from 2-‐3 Lab teams as well as Core faciliTes. AddiTonal experTse and resources (e.g. TMAs, HTS, genomics) are
engaged via subcontracTng of academic partners (such as Roswell Park Cancer InsTtute)
• in vitro and in vivo (mouse models) support of an4-‐infec4ve drug development
• experienced with bacterial and fungal pathogens • in vitro tes4ng of an4microbial potency and toxicity on human cells,
support of SAR • an4-‐infec4ve efficacy by survival and/or pathogen burden readouts
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Core Service Capabilities• access to state-‐of-‐the-‐art animal facility • unique colonies of mice including syngeneic and xenogra_ models • variety of animal models including cancer, infec4on, irradia4on,
chemical tox • expertly designed and conducted animal studies of desired scope (tox,
survival efficacy, etc.), scale (from single to thousands of mice), types of treatment (surgical, various admin routes)
Animal Core
Histology Core
Chemistry Bioanalytics
• pathology, histomorphology and immunohistochemistry • prepara4on and histological analysis of samples from all 4ssues types • rou4ne & customized methodology, experienced interpreta4on of results • high-‐end histology microscopes, microtomes, cryostats
• professional analy4cal support of pharmacological studies • formula4on and analysis of drug substances for in vitro and in vivo studies • solubility, stability, toxicity, PK and PD studies of chemical and biological
drug candidates • specialized equipment including HPLC and LC-‐MS
Providing robust methodology support of integrated research projects and direct services to customers.
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Example Featured Research Area Antimicrobial Drug Development
Chemistry Core
Animal Core
Microbiology Lab RPCI In Vitro Evalua9on
Potency of drug candidates ⇒ MIC against major fungal pathogens Candida and Aspergillus spp. ⇒ MIC and MBC against aerobic bacterial pathogens (Staphylococcus, Enterococcus, etc.) Toxicity ⇒ on a panel of representa4ve mammalian cell lines Acquired drug resistance ⇒Drug candidate tes4ng vs. standard-‐of-‐care In Vivo Evalua9on Toxicity, PK ⇒ formula4on, maximum tolerated dose (sMTD and rMTD) ⇒ pharmacokine4cs, 4ssue distribu4on Potency ⇒ mouse models, including immunosuppressed mice models of candidiasis and aspergillosis ⇒ compare administra4on routes (i.v., i.p., oral, oropharyngeal), treatment regimens ⇒ endpoints: survival, pathogen burden, 4ssue damage ⇒ biomarkers of efficacy, mechanis4c studies