presentación apointech s.l
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Agenda
• 1. Introducción
• 2. Quienes somos
• 3. Desarrollo de fármacos: Proceso
• 4. Recursos y capacidades
• 5. Desarrollo estratégico
BASIC
RESEARCH
PHARMACEUT
ICAL
INDUSTRY
APOINTECH´S RESOURCES
Infraestructures
• Laboratories: 160 m2 and 31,98 m2
• Offices: 16,65 m2 and 21 m2
• Autoclave Room
• Freezers Room
• Common laboratory
STAFF (100% Graduated)
Miguel Ángel Ávila, Agricultural Engineer. CEO
• Rubén Rosales, Biology PhD.
• Rósula García, Degree in Biology.
• Nuria Lucas, Lic. Degree in Biology and Biochemistry.
• Alba Dueñas, Degree in Biology.
1. Introducción
Investigación
Base
Apointech
Industria
Farmacéutica
2. Quiénes somos
– Empresa biotecnológica cuyo objetivo es identificar las dianas terapéuticas y conseguir tratamientos de enfermedades de base genética (Cáncer) e infectocontagiosas (Leishmania, Dengue, Malaria, Chagas)
2. Quiénes somos
• Misión: Consecución de fármacos para el tratamiento de enfermedades: – Infectocontagiosas
• Leishmaniasis • Dengue • Malaria
– De base genética
• Cancer de páncreas • Sarcoma de Ewing
– Otras aplicaciones
3. Desarrollo estándar de un fármaco
Investigación
Base
Desarrollo
Preclínico
Ensayo
Clínico
Distribución
del fármaco
I. Biotecnológica I. Farmacéutica
$150 Mill 2 Años
$50 Mill 1 Año
$250 Mill 8 Años
$400 Mill 4 Años
$850 Mill / 15 años
3. Desarrollo estándar de un fármaco
Investigación
Base
Desarrollo
Preclínico
Ensayo
Clínico
Distribución
del fármaco
I. Biotecnológica I. Farmacéutica
10.000 Compuestos 0,01%
1 Compuesto 100%
5 Compuestos 20%
250 Compuestos 4%
3. Nuestro modelo de desarrollo
Investigación
Base
Desarrollo
Preclínico
Ensayo
Clínico
Distribución
del fármaco
I. Biotecnológica I. Farmacéutica
10.000 Compuestos 0,01%
1 Compuesto 100%
5 Compuestos 20%
250 Compuestos 4%
Aumentar la tasa
de éxito Encontrar nuevas
aplicaciones
Eficacia
3. Nuestro modelo de desarrollo
Investigación
Base
Desarrollo
Preclínico
Ensayo
Clínico
Distribución
del fármaco
I. Biotecnológica I. Farmacéutica
$150 Mill 2 Años
$50 Mill 1 Año
$250 Mill 8 Años
$400 Mill 4 Años Reducir el tiempo Reducir el coste
Eficiencia
4. Recursos y Capacidades
Alianzas
Estratégicas
Infraestructura
Acuerdos de
Cooperación
Capital
Humano
4.1. Alianzas Estratégicas
• Multiplican los recursos de Apointech – Capital humano externo
– Acceso a Infraestructura
– Redes de colaboración
• Proveen de años de conocimiento en las distintas líneas de investigación
4.2 Acuerdos de Cooperación
• Proyectos conjuntos
• Prestación de servicios
• Colaboraciones de larga duración
• Sinergias en personal y equipamiento
• Formación globalizada del personal
SCIENTIFFIC EQUIPMENT
Equipment
• Cell Culture Room • 70 Human Tumor Cell Lines • Analyzer fluorescence, absorbance and luminescence. • Cryopreservation: N2, -80ºC and -20ºC freezer. • QPCR. • Centrifugue. Quality • Apointech is certified according to UNE ISO 9001:2008. • We work based on the Principles of Good Laboratory Practice (GLP) • Our staff is certified to work with experimental animals.
100 Molecules
20 Molecules
5 Molecules
1 Active Molecule
DRUGS SCREENING
FULL TEST or
SUB-PANELS
IN VIVO TEST
Apointech SL offers a fast, cheap and usefull study that let you know the most effective drugs and the sensitivity of tumoral and healthy endothelium (potential antiangiogenic activity indicator)
The Full Test let you know the IC50 and GI50 of selected compounds against our full panel or against the desired tumoral cell lines.
Apointech SL enables clients to use their budgets efficiently through in vivo efficacy evaluation of potential cancer therapies in human xenograft tumor models.
Apointech´s Preclinic Evaluation Services
IN VITRO SERVICES
Molecular Screening
Apointech SL offers four different in vitro services: • Pre-screening is a fast, cheap and usefull study that let you know the most effective drugs and the sensitivity of tumoral and healthy endothelium (potential antiangiogenic activity indicator)
• The Full Test let you know the IC50 and GI50 of selected compounds against our full panel or against the desired tumoral cell lines. • Also we can perform a “Combination Study” with other drugs of clinical use. • Active ingredients identification from natural extracts.
CELL LINES
HISTOTYPE CELL LINE
Breast BT-549; HS 578T; MCF7; MDA-MB-231/ATCC; MDA-MB-468; T-47D
CNS SF-268; SF-295; SF-539; SNB-19; SNB-75; U251
Colon COLO 205; HCC-2998; HCT-116; HCT-15; HT29;
KM12; SW-620
Leukemia CCRF-CEM; HL-60(TB); K-562; MOLT-4; RPMI-8226; SR
Melanoma LOX IMVI; M14; MALME-3M; MDA-MB-435; SK-MEL-2; SK-MEL-28; SK-MEL-5; UACC-257; UACC-62
Non-Small Cell Lung
A549/ATCC; CaLu-1; EKVX; HOP-62; HOP-92; NCI-
H226; NCI-H23; NCI-H2347; NCI-H322M; NCI-H460;
NCI-H520; NCI-H522; NCI-H596; NCI-H838; SK-Mes-
1
Ovarian IGR-OV1; NCI/ADR-RES; OVCAR-3; OVCAR-4;
OVCAR-5; OVCAR-8; SK-OV-3
Pancreatic Carcinoma BxPC-3; MIA-PaCa-2; PANC-1
Prostate DU-145; PC-3
Renal 786-0; A498; ACHN; CAKI-1; RXF 393; SN12C; TK-
10; UO-31
IN VIVO SERVICES
ANIMAL MODEL FOR CANCER
Human xenograft tumor models:
Apointech SL enables clients to use their budgets efficiently through in vivo efficacy evaluation of potential cancer therapies in human xenograft tumor models. Our broad range of tumor lines ensures a wide variety of testing alternatives for your agent. Our xenograft model portfolio is evaluated on a regular basis for response to standards of care and this data is available for designing combination studies. The xenograft cancer model of choice can be used, or our scientific staff can assist in selecting the most appropriate model for your agent. Complete profiling of agents can be carried out in a variety of tumor types or in combination with the appropriate clinical agent.
IN VIVO SERVICES
PRECLINICAL TRIALS
Apointech SL is developing its capacity of perform Pharmacokinetics and
biodistribution studies: • In vivo PK (AUC, clearence) and bioavailability (i.v/p.o.) • Compound analysis in biological material (blood, tissue)
IN VIVO SERVICES
ANIMAL MODEL FOR ALZHEIMER’S DISEASE Apointech can efficiently test the efficacy of your drugs against Alzheimer’s disease (AD) using transgenic mice with human mutations that result in familial AD.
The mice used develop cellular and histological signs of AD at 1.5 months of age. At 2 months of age they show cognitive impairment. Usually, treatments start at 3 months of age, to replicate real life where treatment starts after AD has been diagnosed.
IN VIVO SERVICES
ANIMAL MODEL FOR HYPERTENSION
Cardiovascular Diseases Animal model:
Apointech SL enables you to evaluate the anti-hypertensive activity of your drugs on a well-known hypertensive rat model, spontaneously hypertensive rats (SHRs). The animal´s body weight, blood pressure, and heart rate are measured 2 h after each administration. Blood pressure and heart rate are measured by using a tail-cuff device connected to a computerized oscillometer. This noninvasive method allows repeated measurements throughout the treatment period. Body weight is assessed daily.
IN VIVO SERVICES
ANIMAL MODEL FOR DIABETES
Diabetic Disease Animal model: Apointech SL offers evaluation of test agents in models of type 1 and type 2 diabetes. Type 1 diabetes is typically modeled in streptozotocin-treated mice. The Zucker Diabetic Fatty (obese) is our genetic models of type 2 diabetes. A defect in the leptin receptor is responsible for the diabetic phenotype exhibited by ZDF rats. Procedure: Effects of test agents on blood glucose and insulin levels, along with glucose or insulin tolerance tests and assessment of plasma biomarkers (glucagon, insulin and leptin), comprise standard endpoints.
IN VIVO SERVICES
SCREENING TOXICOLOGY IN A FLY
Toxicology Studies (Drosophila melanogaster): These flies allow a rapid, quantitative and inexpensive evaluation of the toxicity of a compound. Apointech SL offers toxicology studies with Drosophila melanogaster flies. Conservation of fundamental cellular and developmental mechanisms between flies and man are extensive enough to warrant a central role for the Drosophila model in toxicological testing of today. An experiment in which a reference drug is compared with several doses of our drug under development gives a precise indication of the relative toxicity of both compounds.
EDELFOSINE
Edelfosine (ET-18-O-CH3 ; 1-octadecyl-2-O-methyl-glycero-3-phosphocholine) is a synthetic alkyl-lysophospholipid (ALP). It has antineoplasic (anti-cancer) effects. Like all ALPs, it incorporates into the cell membrane and does not target the DNA. In many tumor cells, it causes selective apoptosis, sparing healthy cells.
5. Desarrollo Estratégico
• 5.1. Desarrollo de fármacos
• 5.2. Participación en proyectos
• 5.3. Internacionalización
•
•
•
Enfermedades Infectocontagiosas
5.1. Desarrollo de fármacos
•
•
Enfermedades de base genética
• Neuroprotección • Anti-inflamación
Otras Aplicaciones
Leishmaniosis Dengue Malaria
Cancer de Páncreas
Sarcoma de Ewing
Pipeline
Fases
Fármacos
Actividad
Screening
Preclínica in
vitro
Preclínica in
vivo
Preclínica
regulatoria
Fase I Fase II Fase III Fase IV Patente
Leishmania
Humana
Leishmania
Canina
Cáncer de
Páncreas
Sarcoma de
Ewing
Dengue
Malaria
5.2. Proyectos
• Participación en PROYECTOS REGIONALES
– Proyecto en investigación Colaborativa – Plan ADELANTA, Proyecto I+D+i – Fase Pre-clínica
en Leishmaniasis • Participación en PROYECTOS NACIONALES
– INNPACTO – Ensayo Clínico GFC en Fase I – Investigación Colaborativa Aplicada en Parques
Tecnológicos – Fase Pre-clínica en Tumores sólidos y hematológicos
• Participación en PROYECTOS EUROPEOS – FP7 PANACREAS – Fase preclínica en Cancer de
Páncreas
5.3 Internacionalización
• Acuerdos para la realización de ensayos clínicos de Leishmaniasis con el gobierno Brasileño y el CIDEPRO de Colombia
• Desarrollo conjunto de fármaco contra el cáncer de páncreas con la Universidad de Bonn y Debiopharm en Alemania
• Desarrollo de fármacos huérfanos contra enfermedades infectocontagiosas con DNDi
• Participación en las principales ferias biotecnológicas Europeas – BioEUROPE, CPHI, BioSPAIN
GRACIAS POR SU ATENCIÓN
“De razones vive el Hombre pero de sueños sobrevive” Miguel de Unamuno
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