Commercialization and transfer assistance program



Yüklə 0,62 Mb.
səhifə7/11
tarix08.01.2019
ölçüsü0,62 Mb.
#92672
1   2   3   4   5   6   7   8   9   10   11

OUTSIDE OPINIONS

  1. Evaluator 1

    1. Independent scientific opinion







13.1.2.Summary CVs of the persons filing opinions and statement of independence regarding the project










      1. Answers to the questions raised in the outside opinions


During the different stages of the project, we will work with the external evaluator and certainly going to take into consideration the recommendations and advises that will come up.
    1. Evaluator 2



      1. Independent preliminary technical and commercial evaluation









      1. Summary CV’s of the persons filing opinions and statement of independence regarding


Anne-Marie Larose, Ph.D. MBA.

Manager, Business development, Life Sciences

Gestion Univalor, société en commandite

(514) 340-3243, poste 4239

anne-marie.larose@univalor.ca

www.univalor.ca

Civic address : 5160 Decarie Blvd. suite 770 Montréal (Québec) H3X 2H9 

Postal address : P.O. Box 6079, Station Centre-ville Montréal (Québec) H3C 3A7 


Professional Experience
2004-2008 Gestion Univalor, société en commandite

Manager, Business development, Life Sciences



2003-2004 Innovitech

Senior consultant, Life Sciences



2002 Solidarity Fund QFL

Senior Investment Advisor, Life Sciences



2001-2002 British Consulate General, Montreal

Commercial Officer, Biotechnology & Life Science sectors



1996–2001 Geneka Biotechnology Inc.

Chief Research Scientist, DNA microarray , 1999-2001

Supervisor of Quality Control Department, 1997-2001

Research Scientist, Development and production, 1996-1999



1986-1988 Cancer Research Center, Hôtel-Dieu de Québec

Research Assistant, Cellular and Molecular biology.


Formation
2003 MBA in Bio-Industry management

Université du Québec à Montréal, Quebec



1996 Ph.D. in Cellular and Molecular Biology

Medicine Faculty, Université Laval, Quebec



1990 M.Sc. in Cellular and Molecular Biology

Medicine Faculty, Université Laval, Quebec



1985 Certificate in Genetic Engineering

Sciences and Engineering Faculty, Université Laval, Quebec



1985 B.Sc. in Biochemistry

Sciences and Engineering Faculty, Université Laval, Quebec


Other training


  • Effective regulatory strategies and integrated drug development. BioQuébec, Biotechnology Research Institute & Cato Research, November 2005.

  • Le processus réglementaire des dispositifs médicaux et ses non-dits. Association de l’industrie des technologies de la santé & PARI-CNRC. April 2005.

  • Microarray Methods & Analysis Workshop. IB3- George Mason University, Manassas VA. October 1999.

  • Workshop : Bioinformatics – Integrating informatic tools for expression analysis and drug discovery. Chips to Hits ’99,. Berkeley, CA. November 1999.



Letters of support





Annex 1. Extended patent searches and comments


Pub. No.:WO/2007/017699

International Application No.: PCT/GB2006/050231

Publication Date: 15.02.2007

International Filing Date: 04.08.2006

IPC:C12Q 1/70 (2006.01)

Applicants: GENOMICA S.A.U. [ES/ES]; Alcarria 7, Coslada, E-28820 Madrid (ES) (All Except US).


Analytical information does not exist. Genomica (CLART® HPV 2) uses 450bp amplicon which is known to be more difficult to amplify (same region as Roche). This will cause resistance from the part of clinical experts due to the fact that the latest generation of DNA based HPV kits uses smaller PCR product (SPF, GP56…) in order to escape (false) negative results due to the quality of DNA extraction.

Specificity of detection is going to be a big issue, no single published validation of probes, but nice technological platform, totally compatible with our probes. The specificity (clinical accuracy of HPV typing) is not defined by the technological platform but by


the choice of probes.

Here is a segment of the probe selection strategy from their patent:


Specific probes for HPV type identification were designed as follows. Sequences for all reference HPVs deposited in GenBank, including known variants, for the amplified Ll region were aligned using a conventional nucleic acid alignment program, such as BioEdit (4,8.6. version; Hall. Nucl Acids Symp Ser. 1999, 41:95-98) and most variable sequences regions among different HPV types were located. Potential sequences of oligonucleotides to be used as specific probes were selected from these variable sequences regions, preferably having following features: length of 20 to 40 bases, preferably an approximate length of 30 bases; preferably with no secondary structures or strings of consecutive same nucleotide longer than 4; preferably with a G+C ratio of 50% and a Tm as much similar among all selected probes as possible; and preferably with the mismatched nucleotides among the different HPV types sequences as much in the centre of the oligonucleotide sequence as possible.

Each potential probe sequence selected as aforementioned was compared against all known HPV sequences in the amplified Ll region using the BLAST program form the NCBI webpage (Altschul et al. Nucleic Acid Res. 1997, 25: 3389-3402). Finally, probes having at least three nucleotide mismatches when compared with all known HPV types (except when compared to the HPV type that the oligonucleotide probe is specific for) were chosen, with a preference for probes with greater than three mismatches.

=============================================================


Hybridization was suggested to be done at 55° C. Results showing specificity were not reported in the patent. Overall: Considering mode of probe selection, short time for validation (compared to 20 years for Roche) and unreported validation results, these probes are either the same or more likely worse than Roche’s set of probes.
US20070037137A1

Method and kit for quantitative and qualitative determination of human papillomavirus

QUANTOVIR AB 2007-02-15 2003-10-01 C12Q

Production of HPV L1 and HPV L2 using recombinant DNA cloning, expression and potential use in downstream production of Ab suitable for vaccination and/or diagnostics


US20060024686A1

Detection of human papillomaviruses 2006-02-02 2005-01-28 C12Q

Three sequences are derived from the highly conserved viral E1 genes. Use of the sequences SEQ ID Nos. 1, 2 and 3, for example as hybridization probes (DNA markers) or in the context of a DNA amplification method, is therefore particularly suitable for detecting any HPV infection. This invention claimed another set of conserved universal primers.
US6902899

A method for detection of human papillomaviruses 2005-06-07 2002-08-22 G01N

Eberhard-Karls-Universitat Tubingen Universitatsklinikum

Same as US20060024686A1


US20040214331A1

Papillomavirus vaccine 2004-10-28 2003-12-11 G01N

The University of Queensland and CSL Limited

Same as US20070037137A1


EP1471147A2

Method of making a recombinant molecule for the expression of HPV-16 L1 protein

THE UNIVERSITY OF QUEENSLAND 2004-10-27 1992-07-20 C12N

A method is described for making a recombinant molecule, for the expression of HPV-16 L1 protein


WO04031416A1

METHOD AND KIT FOR QUANTITATIVE AND QUALITATIVE DETERMINATION OF HUMAN PAPILLOMAVIRUS

QUANTOVIR AB 2004-04-15 2003-10-01 C12N

Inventors are claiming a kit for detection and quantification of human papillomavirus, comprising a) seven amplification primers and three probes for HPV 16,31, 18,45; and optionally b) eight amplification primers and three probes for HPV 33, 35, 39, 52, and 58. This is a PCR-based assay, not designed to perform multiplex testing and not covering the spectrum of HPV types.


US20030129585A1

Detection of human papillomaviruses

IFTNER THOMAS 2003-07-10 2002-08-22 G01N

Same as US20060024686A1


WO9513377A1

EPISOMAL EXPRESSION VECTOR FOR HUMAN GENE THERAPY

Not relevant
EP0302758B1

Viral expression inhibitors

Not relevant
WO9302184A1

PAPILLOMA VIRUS VACCINE

THE UNIVERSITY OF QUEENSLAND 1993-02-04 1992-07-20 G01N

Not relevant


WO9108312A1

DETECTION OF HPV TRANSCRIPTS

GENE-TRAK SYSTEMS 1991-06-13 1990-12-03 C12N

Detection of E6 gene, the E7 gene and spliced transcripts of the E6 or E7 gene, or both, under conditions appropriate for hybridization of complementary nucleotide sequences to occur. No early stage power of detection.


EP0402132A3

METHOD FOR THE DETECTION OF HUMAN PAPILLOMA-VIRUS

TAKARA SHUZO CO. LTD. 1991-05-08 1990-06-07 C12Q

Detection of human papilloma-virus HPV 16, HPV 18 and HPV 33. PCR-based.


WO9602563A1

EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN 1 PROTEIN AND ITS EXPRESSION AND RECOVERY

CORNELL RESEARCH FOUNDATION, INC. 1996-02-01 1995-07-13 C07K

Not relevant


EP0655091A1

HUMAN PAPILLOMAVIRUS DETECTION ASSAY

BAXTER DIAGNOSTICS INC. 1995-05-31 1994-05-06 C12Q

Amplification of specific gene E6/E7 messenger RNA from a biological specimen and hybridization to a biotinylated capture reagent. Limited predictive value in early stage cancer.


WO9426934A3

HUMAN PAPILLOMAVIRUS DETECTION ASSAY

Same as EP0655091A1
CA2139623AA

HUMAN PAPILLOMAVIRUS DETECTION ASSAY

Same as EP0655091A1

WO9220702A1

PEPTIDE NUCLEIC ACIDS

BUCHARDT 1992-11-26 1992-05-22

Not relevant
WO02103050A2

VIRUS DETECTION METHOD, PRIMERS THEREFOR AND SCREENING KIT

UNIVERSITY OF WALES COLLEGE OF MEDICINE

2002-12-27 2002-06-13 G01N

Real-time PCR – scorpion probes
WO0168915A1

GENOTYPING KIT FOR DIAGNOSIS OF HUMAN PAPILLOMAVIRUS INFECTION

BIOMEDLAB CORPORATION 2001-09-20 2000-10-26 G01N
Korean chip for HPV detection, full match design of probes, PCR amplification and hybridization with chip over slide. Not impressive performance, but straightforward.
WO9110675A1

PRIMERS AND PROCESS FOR DETECTING HUMAN PAPILLOMAVIRUS GENOTYPES BY PCR

STICHTING RESEARCHFONDS PATHOLOGIE 1991-07-25 1991-01-18 C07H

GP5/6 primers protected and few other sets of universal primers in the same region of L1 gene.


US7294488

Amplification-hybridisation method for detecting and typing human papillomavirus

Genoid KFT 2007-11-13 2003-03-10 C12P

Hungarian variant of real-time multiplex PCR assay.


CA2183758C

HUMAN PAPILLOMA VIRUS DETECTION IN A NUCLEIC ACID AMPLIFICATION PROCESS USING GENERAL PRIMERS

STICHTING RESFONDS PATHOLOGIE 2007-09-25 1995-02-20 C07H

Same as WO9110675A1

US20070207456A1

Multiplexed assay and probes for identification of HPV types

The Board of Trustees of the Leland Stanford Junior University

2007-09-06 2007-02-13 C12Q

A 20-plex hybridization with primer extension. The array contains probes for HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 66, 69, 6, 11, 34, 40, 42, 43, and 44. The probes are preferably between 30 and 60 nucleotides, but may be as small as 20 nucleotides and up to several hundred nucleotides in length. Preferably, each probe comprises a sequence at least 90% identical and is approximately (within 10 percent) the same length. A large mixture of primers may be used simultaneously because the primers are designed to be similar in sequence so as to prevent dimerization and amplification artifacts. As described above, the method may comprise the step of contacting the probes with a positive control hybridizing to each probe. The method can simultaneously detect all known HPV genotypes, i.e. genotypes 1 through 89, by binding unique probes under stringent conditions to E1 gene target sequences. REAL 35-40 MULTIPLEXING not documented!
KR5017703A

PRIMERS AND METHOD FOR DETECTING HIGH RISK HUMAN PAPILLOMAVIRUS(HPV) BY PCR

USING TWO KINDS OF PRIMERS CONSISTING OF GENERAL PRIMER AND SYNTHESIZED PRIMER

Limited multiplexing with 3 different primer sets. PCR based method using complement probes for typing.


KR5014494A

PCR GENERAL PRIMERS AND METHOD FOR DETECTING DIVERSE TYPES OF HUMAN PAPILLOMAVIRUS(HPV) BY PCR AT ONE TIME TO DIAGNOSE HPV AT EARLY STAGE

PCR-based detection, not prone to multiplex. Uses 8 different primer sets for different types.
US20040248085A1

General primers and process for detecting diverse genotypes of human papillomavirus by PCR

LEE SANG-WHA 2004-12-09 2003-11-24 C12Q

Set of general primers for amplifying and detecting Human Papillomavirus genotypes is claimed. DNA sequence homology studies were performed with the derived DNA sequences using Clustal W computer program (DNSSTAR, MegAlign.TM. 5, DNASTAR Inc.) for pairwise alignment, multiple sequence alignment and phylogenetic tree to screen representative base sequences of groups. PCR general primers based on the screened base sequences were designed using another computer program (primer premier 6, PREMIER Biosoft International Co.). The primers were set as a nucleotide sequence of about 27 +/- 3 bps or about 31+/- .2 bps and their amplification products at about 200.about.500 bps. 30 PCR general primer pairs were designed.


WO04050917A1

GENERAL PRIMERS AND PROCESS FORDETECTING DIVERSE GENOTYPES OF

HUMAN PAPILLOMAVIRUS BY PCR

Same as US20040248085A1


US6583278

Nucleic acid probes complementary to human papilloma virus nucleic acid

Gen-Probe Incorporated

2003-06-24 1996-11-14 C12Q

Typing HPV 16 and/or HPV 18 using hybridization assay probes, helper probes, and/or amplification primers.
US6509149

HPV-specific oligonucleotides

Hybridon, Inc. 2003-01-21 1995-06-06 C12N

Synthetic oligonucleotides complementary to a nucleic acid spanning the translational start site of human papillomavirus gene E1, and including at least 15 nucleotides.


US6503704

Method, reagent and kit for genotyping human papilloma virus

Visible Genetics Inc. 2003-01-07 2001-06-25 C12Q

Amplifycation and sequencing a portion of the L1 open reading frame of human papillomavirus genome with the claimed amplification primers.


EP0746627B1 HUMAN PAPILLOMA VIRUS DETECTION

IN A NUCLEIC ACID AMPLIFICATION

PROCESS USING GENERAL PRIMERS

And US6352825 Human Papilloma Virus detection in a

nucleic acid amplification process

using general primers

same as WO9110675A1
US6265154

Nucleic acid primers and probes for detecting oncogenic human papillomaviruses

Abbott Laboratories 2001-07-24 1996-10-25 C12N

Probe sequences that are useful for detecting oncogenic HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 are herein provided. These sequences can be used in hybridization assays or amplification based assays designed to detect the presence of these oncogenic HPV types in a test sample. Additionally, the sequences can be provided as part of a kit.


US6218104

Method of detection of carcinogenic human papillomavirus

Biosearch International Pty 2001-04-17 1997-12-30 C12N

High risk carcinogenic human types 16, 18 and 33 are distinguished from low risk

human papillomavirus types 6 and 11 in a sample of human cervical tissue. A selected characteristic portion of the E6 region of the virus defined by specific oligonucleotide primers is amplified using a polymerase chain reaction. The presence or absence of the characteristic portion of the E6 region is detected by gel electrophoresis or using a labeled oligonucleotide probe.
US6045993

Method, reagent and kit for genotyping of human papillomavirus

Visible Genetics Inc. 2000-04-04 1998-05-30 C12Q

The sequence of human papillomavirus present in a sample is determined by amplifying a portion of the L1 using sequence ARRGGAWACT GATCWARDTC


US5783412

Method of detection of carcinogenic human papillomavirus

Biosearch International Pty. Ltd. 1998-07-21 1989-08-25 C12N

PCR amplification of types 16 and 18


US5705627

Detection of human papillomavirus by the polymerase chain reaction using specific L1, and E6 probes

1998-01-06 1995-05-26 C12Q

The primers used in this method are consensus primers that can be used to amplify a particular region of the genome of any HPV. The presence of HPV in a sample is

indicated by the formation of amplified DNA. The HPV nucleic acid is detected by consensus probes that may be short oligonucleotide probes or long generic probes. The HPV is typed by the use of type-specific DNA probes specific for the amplified region of DNA.
CA2074069AA, WO9110675A1, US5364758 and CA2183758AA 1995

STICHTING RES FONDS PATHOLOGIE

GP5+/6+ primers protected and few other sets of universal primers in the same region of L1 gene.

Small if any variation of 1991 patent.

EP1287165B1

Method for detection and localization of genes in situ using branched-DNA hybridisation

BAYER CORPORATION 2007-06-13 2001-06-01 C12Q
WO06117076A1

USE OF INDOLIN-PHENYLSULFONAMIDE DERIVATIVES

BAYER HEALTHCAREAG 2006-11-09 2006-04-19 A61P

Not relevant

==============================================================

Neither Institute de Pasteur nor Roche patents are relevant for our method of probe selections

==============================================================


Yüklə 0,62 Mb.

Dostları ilə paylaş:
1   2   3   4   5   6   7   8   9   10   11




Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©muhaz.org 2024
rəhbərliyinə müraciət

gir | qeydiyyatdan keç
    Ana səhifə


yükləyin