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.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
Clinical developments of medicines based on biomarkersFrancois MAIGNEN
The presentation provides an overview of the clinical development of new medicines based on biomarkers including basket, umbrella and platform trials. This is mostly relevant to oncology products.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
Clinical developments of medicines based on biomarkersFrancois MAIGNEN
The presentation provides an overview of the clinical development of new medicines based on biomarkers including basket, umbrella and platform trials. This is mostly relevant to oncology products.
This presentation explains the main features of medicines which will be developed and authorised via the adaptive pathways. It provides a definition of real world evidence and the caveats associated with the use and analysis of real world evidence in drug development.
Can target-based drug discovery be reconciled with phenotypic assays in the context of drug repurposing? One of the questions discussed at the SLAS Drug Repurposing SIG meeting at SLAS2013.
Presentation by MicroConstants at BIOCOM CRO event May 2013: Virtual Drug Dev...BIOCOMCRO
May 2013
8-10am
Location: BIOCOM
Speaker(s):
Joining the presenters for a follow-on panel discussion will be: Jennifer Spinella, Vice President, Regulatory Affairs & Quality Assurance at Rare Disease Therapeutics Greg Ruppert, Sr. Study Director and Director of Sales for MPI Research Richard Lin, CEO of Explora Biolabs.
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analy...David Peyruc
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analytical Capabilities with Knowledge Content
Sirimon Ocharoen, Thomson Reuters
To effectively analyze data in tranSMART, biological analysis/knowledge-based approach is needed. Through a case study, we will demonstrate how system biology content can be integrated in tranSMART to enable functional analysis and biological interpretation. We will also share our experience and user feedbacks from various projects.
10th International Conference Compound Libraries 2014Torben Haagh
VISIT THE CONFERENCE WEBSITE HERE:
http://bit.ly/CompoundLibrariesSlideshare
Maximizing information in early-phase R&D for an optimal library design and target selection
We are excited to conduct the 10th annual meeting of the formerly known Compound Libraries conference! Over the last decade we have provided the pharmaceutical R&D community with a wonderful platform for exchanging knowledge and ideas about how best to optimize the qualification of drug candidates.
We have hosted almost all major pharmaceutical companies and heard dozens of case-studies relating to important and acute issues. When returning back to the programs from previous years, it is interesting to look at the timeline of changing approaches, trends and market-related developments. Our topical spectrum ranged from compound management and acquisition to collaboration frameworks, open access, library design, screening and analysis.
This year we bring you 15 case studies about the most burning issues in early-stage discovery today and offer you a valuable trend-analysis and networking with peers and colleagues from pharmaceutical companies, biotechs, CROs and academic research institutes.
Don’t miss our 10th anniversary and join us in Berlin to take part at our legacy conference!
Benefit from participating in discussions about the following topics:
-10 years perspective on synthesizing and designing compound libraries
-What is the role of ligand efficiency metrics in drug discovery? Have your say in this controversial debate!
-Next generation library design - working towards better PPI and epigenetic libraries
-Exploration of bioactive and novel chemical space by application of privileged structure concept design
-Learn from Janssen’s experience with the assembly of the IMI European Lead Factory (ELF) library
-What is the real potential of macrocycles and are they the drugs of the future?
This presentation explains the main features of medicines which will be developed and authorised via the adaptive pathways. It provides a definition of real world evidence and the caveats associated with the use and analysis of real world evidence in drug development.
Can target-based drug discovery be reconciled with phenotypic assays in the context of drug repurposing? One of the questions discussed at the SLAS Drug Repurposing SIG meeting at SLAS2013.
Presentation by MicroConstants at BIOCOM CRO event May 2013: Virtual Drug Dev...BIOCOMCRO
May 2013
8-10am
Location: BIOCOM
Speaker(s):
Joining the presenters for a follow-on panel discussion will be: Jennifer Spinella, Vice President, Regulatory Affairs & Quality Assurance at Rare Disease Therapeutics Greg Ruppert, Sr. Study Director and Director of Sales for MPI Research Richard Lin, CEO of Explora Biolabs.
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analy...David Peyruc
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analytical Capabilities with Knowledge Content
Sirimon Ocharoen, Thomson Reuters
To effectively analyze data in tranSMART, biological analysis/knowledge-based approach is needed. Through a case study, we will demonstrate how system biology content can be integrated in tranSMART to enable functional analysis and biological interpretation. We will also share our experience and user feedbacks from various projects.
10th International Conference Compound Libraries 2014Torben Haagh
VISIT THE CONFERENCE WEBSITE HERE:
http://bit.ly/CompoundLibrariesSlideshare
Maximizing information in early-phase R&D for an optimal library design and target selection
We are excited to conduct the 10th annual meeting of the formerly known Compound Libraries conference! Over the last decade we have provided the pharmaceutical R&D community with a wonderful platform for exchanging knowledge and ideas about how best to optimize the qualification of drug candidates.
We have hosted almost all major pharmaceutical companies and heard dozens of case-studies relating to important and acute issues. When returning back to the programs from previous years, it is interesting to look at the timeline of changing approaches, trends and market-related developments. Our topical spectrum ranged from compound management and acquisition to collaboration frameworks, open access, library design, screening and analysis.
This year we bring you 15 case studies about the most burning issues in early-stage discovery today and offer you a valuable trend-analysis and networking with peers and colleagues from pharmaceutical companies, biotechs, CROs and academic research institutes.
Don’t miss our 10th anniversary and join us in Berlin to take part at our legacy conference!
Benefit from participating in discussions about the following topics:
-10 years perspective on synthesizing and designing compound libraries
-What is the role of ligand efficiency metrics in drug discovery? Have your say in this controversial debate!
-Next generation library design - working towards better PPI and epigenetic libraries
-Exploration of bioactive and novel chemical space by application of privileged structure concept design
-Learn from Janssen’s experience with the assembly of the IMI European Lead Factory (ELF) library
-What is the real potential of macrocycles and are they the drugs of the future?
10th Anniversary Compound Libraries
VISIT THE CONFERENCE WEBSITE HERE: http://bit.ly/CompoundLibrariesSlideshare
Maximizing information in early-phase R&D for an optimal library design and target selection
We are excited to conduct the 10th annual meeting of the formerly known Compound Libraries conference! Over the last decade we have provided the pharmaceutical R&D community with a wonderful platform for exchanging knowledge and ideas about how best to optimize the qualification of drug candidates.
We have hosted almost all major pharmaceutical companies and heard dozens of case-studies relating to important and acute issues. When returning back to the programs from previous years, it is interesting to look at the timeline of changing approaches, trends and market-related developments. Our topical spectrum ranged from compound management and acquisition to collaboration frameworks, open access, library design, screening and analysis.
This year we bring you 15 case studies about the most burning issues in early-stage discovery today and offer you a valuable trend-analysis and networking with peers and colleagues from pharmaceutical companies, biotechs, CROs and academic research institutes.
Benefit from participating in discussions about the following topics:
- 10 years perspective on synthesizing and designing compound libraries
- What is the role of ligand efficiency metrics in drug discovery? Have your say in this controversial debate!
- Next generation library design - working towards better PPI and epigenetic libraries
- Exploration of bioactive and novel chemical space by application of privileged structure concept design
- Learn from Janssen’s experience with the assembly of the IMI European Lead Factory (ELF) library
- What is the real potential of macrocycles and are they the drugs of the future?
CHI’s Thirteenth Annual High-Content Analysis meeting, the premier event showcasing the latest advancements in HCA applications and technologies, returns to San Diego with a new program. Over the years we have observed the technology mature and its adoption spread into many areas of compound screening/evaluation and functional analysis. The High-Content Analysis meeting will focus on the next steps of technology development, including screening of 3D and physiologically relevant complex models, ultra-high resolution and high-throughput imaging, more advanced image analysis and data management, and new assays and applications. The co-located Second Annual Phenotypic Screening meeting will address the advantages of phenotypic screening vs. target-based screening, and focus on assay development, selection of physiologically relevant models and subsequent target identification, as well as case studies of phenotypic screens from leading pharma. Join the original High-Content Analysis event and get access to two tracks featuring a cutting-edge scientific agenda, expanded exhibit hall and technology showcases, and an offering of technology demonstrations and dinner courses.
Tumour models London 1-3 December 2015 AgendaDiane McKenna
Tumour Models London 2015, now in its 4th year,is the leading meeting dedicated to improve preclinical predictability and translational success of oncology discoveries. Tackling clinical failures rates, preclinical strategies and translational challenges, this Summit will enable you to translate your discoveries from model to human studies with superior predictability to future proof clinical success. [Read More…]
We can aid decision making from the pre-clinical to the clinical setting, supporting line of sight to the clinic, by identifying and translating crucial biomarker approaches into the real world.
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...MedicReS
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: Preclinical Considerations for Cell and Gene Therapy Products
Patrick Au, Ph.D., (CBER)
Proteomics Modules designed to bring clinically relevant data, at any point, into the Drug Discovery Process. 1000s of proteins are plated from primary cells and are used to trap autoantibodies from diseased patients' blood sera. Results put a spotlight on highest probability targets.
Scientific Validity of Replacements for Animal-Derived AntibodiesRebeccaClewell
Summary of the recommendations by the EURL-ECVAM Scientific Advisory Committee (ESAC) on the Scientific Validity of Replacements for Animal-Derived Antibodies. Presented at the ICCVAM Communities of Practice Webinar 2020, "Use of Animal-free Affinity Reagents", January 2020.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Buffalo Biolabs (BBL) CRO capabilities, March 2014
1.
Contract
Research
Capabilities
Bridging
the
gap
in
biotech
73
High
St.
Buffalo,
NY
14203
pgrifAin@buffalobiolabs.com
(716)849-‐6810
2. 2
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.)
3. 3
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.
4. 4
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
5.
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
&
Support
Applied
Research
CBLI Incuron Felicitex Everon
Research/Service
Contracts
5
BBL
Contract
Research
Research
Collaborators
…
6. 6
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
7. 7
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
8. 8
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
9. 9
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.
10. 10
Example
Featured
Research
Area
Antimicrobial
Drug
Development
Chemistry
Core
Animal
Core
Microbiology
Lab
RPCIIn
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