Project Manager Management

OMAR THIBAULT QURAISHI, PHD., MAPLEWOOD, NEW JERSEY

** ***** *****, #*, *********, New Jersey USA 07040 H. 973-***-**** C. 514-***-**** ********@*****.***

BIOCHEMIST/BIOANALYTICAL SCIENTIST WITH CLINICAL RESEARCH EXPERIENCE

“OPTIMIZING SCIENTIFIC RESEARCH, CONVERTING SIMPLE IDEAS INTO BIG RESULTS”

PROFESSIONAL SYNOPSIS

A driven research scientist and industry innovator with 12 years’ experience leading innovations in the pharmaceutical and biotechnology industry. Experience in bioanalytical method development, e.g. AKTA-FPLC, HPLC, LC-MS, SDS-PAGE, and Western Blots for ADME/DMPK. Purification of Protein-Drug Conjugates for ADME/DMPK and bioprocessing of clinical drug candidates. Formulation development for Injectables. Management of clinical trials involving Colorectal Cancer-Liver Metastasis, Solid-Organ Transplantation, Auto-Immune Diseases, Hepatocellular Carcinoma, Neuroendocrine Tumours.

10 years’ work experience in the pharmaceutical/biotech industry in Biochemistry Research labs; Experience in synthesis and purification of drug-protein conjugates using AKTA-FPLC; Bioanalytical Characterization of Protein-Drug Conjugates using LC-MS, SDS-PAGE, ELISA, etc.

Plus 2 years management of a large hospital division, including management of a team of clinical research nurses and coordinators to execute Phase II-IV clinical trials in accordance with GCP and ICH Guidelines;

Developed department policies and procedures necessary for rendering site ‘audit ready’ by FDA or Health Canada

Led cross-functional project teams (database, clinical trial planning and timelines, resource allocation);

Developed SOPs, Protocols and Informed Consent documents;

Assisted in the evaluation of potential staff members; mentored and guided clinical coordinators and RNs;

Outstanding academic achievement with a PhD in Biochemistry with several patents and patent applications;

Completed Kriger Research Training in Good Clinical Practice and ICH Guidelines (2009-2010)

Bilingual Professional: English & French Excellent Interpersonal, Communication and Presentation Skills

Open to Re-Location Can Accomodate Significant Travel Time

APPLIED COMPETENCIES

Protein Structure & Function Purification of Drug Conjugates Bioanalytical/Biological Chemistry

Cross-functional Team Player Project Management Formulation Development/Injectables

EXPERIENCE TIMELINE

• Royal Victoria Hospital/McGill University Health Center, Montreal May 2010-March 2012

o MANAGER, Hepatopancreatobiliary and Transplant Surgery

• Centre Médical Multinnova, Montreal, QC Sept 2009-April 2010

o MARKETING REPRESENTATIVE/LIAISON in Pain Research (8 month contract)

• ConjuChem Biotechnologies Inc., Montreal, QC 2001 – 2009

o ASSOCIATE DIRECTOR (Biological Chemistry)/PROTEIN PURIFICATION

• Merck Frosst Centre for Therapeutic Research, Montreal, QC 2000 – 2001

o POST-DOCTORATE RESEARCHER

FORMAL ACADEMICS

Doctor of Philosophy (PhD), MCGILL UNIVERSITY, Montreal, QC (Biochemistry-Major in Enzymology) 1999

Master of Science (MSc), MCGILL UNIVERSITY, Montreal, QC (Chemistry, Major in Protein NMR) 1994

Bachelor of Science (BSc), CONCORDIA UNIVERSITY, Montreal, QC (Honours-Analytical Chemistry) 1992

EXPERIENCE

Royal Victoria Hospital-McGill University Health Center, Montreal, QC May 2010-March 2012

A large team of surgeons, nephrologists and hepatologists specializing in solid organ transplantation, isolation of purified human islets of Langerhanns and islet transplantation, surgical resections, CRC, cancer of liver and pancreas, neuroendocrine tumours, and Hepatitis C-infected patients

MANAGER, HEPATOPANCREATOBILIARY AND TRANSPLANT SURGERY

Reporting to the Director of the Multi-Organ Transplant Program and of Hepatopancreatobiliary Surgery at the McGill University Health Center, I have been mandated to implement project management strategies for a large hospital division.

NOTABLE ACHIEVEMENTS TO DATE:

Managed team of 5 clinical research nurses, research coordinators, and assistants according to GCP/ICH guidelines. Responsible for both company sponsored and investigator-initiated clinical trials (over 40 trials total between HPB and Transplant) for the following lead investigators: Drs.Peter Metrakos, Marcelo Cantarovich, Steven Paraskevas, Jean Tchervenkov, Prosanto Chaudhury, Peter Kavan, Greg Knoll (Ottawa), Peter Ghali, Dana Baran, Juan Rivera.

Improved communication among KOLs (e.g. surgeons, nephrologists, hepatologists), and between KOLs and representatives from big pharma (e.g. Medical Advisors, MSLs, Product Managers) to help highlight Sponsor’s priorities and timelines.

Prepared investigator-initiated research proposals for both government peer-reviewed granting agencies and to pharma.

Utilized project management strategies for a large hospital division, e.g. surgeons, residents, graduate students, other trainees, etc, to improve project flow and help achieve deliverables.

Responsible for the recruitment and placement of surgical research fellows within the McGill University Health Centre, establishing long-term HPB and Transplant research collaborations with hospitals in the Kingdom of Saudi Arabia.

Attended HPB and GI Tumour Boards, Neuroendocrine Tumour Boards, M&M Rounds, and Transplant journal clubs on a regular basis.

Raised funds for the MUHC Clinical Islet Isolation Facility. Helped raise over $300K to support research and operational expenses.

Centre Médical Multinnova, Montreal, QC Sept 2009-April 2010

A team of physicians and healthcare professionals using a multidisciplinary approach to chronic pain management.

MARKETING REPRESENTATIVE/LIAISON

Reporting to the Director General, and Medical Director of the clinic, mandated to fill the information and awareness gap between the Montreal medical community and Multinnova’s unique approaches to chronic pain management and pre-habilitation and post-operative care. This was accomplished using non-biased, high-level scientific discussions with key opinion leaders to achieve better education and to advance pain research, with the ultimate goal of providing alternative treatment options and improved quality of life for chronic pain sufferers.

NOTABLE ACHIEVEMENTS:

Rapidly Identified key opinion leaders using a network of personal and industry healthcare contacts in Montreal including patient-advocacy support groups (e.g. for cancer, arthritis, HIV sufferers).

Nurtured relationships with KOLs.

Prepared and Shared direct to consumer (DTC) and physician aids (medical scientific information).

Developed regional market for one of the only private clinics in the Montreal area devoted to chronic pain management.

ConjuChem Biotechnologies Inc., Montreal, QC 2001 – 2009

ConjuChem creates novel, next-generation medicines using unique, long-acting therapeutic protein-drug conjugates.

ASSOCIATE DIRECTOR (Biological Chemistry)

Reporting to the VP Research & Development and to the Senior Director of Research, masterminded several innovative research projects while directly managing the performance of a team of four research/lab technicians. Focused on bioanalytical method development, e.g. AKTA-FPLC, HPLC, LC-MS, SDS-PAGE, Western Blots, ELISA, etc. for ADME/DMPK and purification of protein-drug conjugates for bioprocessing method development of clinical candidates.

NOTABLE ACHIEVEMENTS:

Developed a scalable manufacturing and purification processes of Protein-Drug Conjugates amenable to GMP standards for a new platform technology leading to phase II clinical studies. Research helped raise over $150M for the Company.

Designed formulation strategies for liquid and lyophilized drug products for clinical candidates, for sc and IV delivery. Co-inventor of a patent application for parental formulations

Directed HIV research and inhibitor experiments as Project Manager obtaining $1.5M in funding support over five years from the National Institutes of Health in the US. Published multiple scientific papers on inhibitor design for HIV and Type II diabetes.

Spearheaded innovative research projects as principal or co-inventor leading to seven patents or patent applications, including HIV-related inventions.

Transformed a team of junior researchers into a formidable force of knowledge increasing team productivity and efficiency by 50%. Empowered the team as an approachable mentor providing challenging and fun tasks.

Promoted on three occasions to leadership roles culminating in the appointment to Associate Director.

Merck Frosst Centre for Therapeutic Research, Montreal, QC 2000 – 2001

The largest private biomedical research facility in Canada and a premier laboratory in drug discovery with over 200 scientists.

POST-DOCTORATE RESEARCHER

Reporting to the Director, Department of Biochemistry and Molecular Biology, performed innovative research as a key member of a 10 person team mandated to characterize PGE synthase (2nd generation to VIOXX™) targeting solutions for rheumatoid arthritis and inflammation.

NOTABLE ACHIEVEMENTS:

Transformed an exploratory project for a novel protein into a core drug discovery program as a team effort.

Authored a comprehensive scientific paper describing how to inhibit the enzyme activity of PGE synthase.

Shire Biochem Inc. (formerly known as Biochem Pharma), Laval, QC 1999 – 2000

Biopharmaceutical focused on the development and commercialization of innovative products including 3TC.

POST-DOCTORATE RESEARCHER

Reporting to the Director of Virology, hired as a protein specialist to identify new targets for HIV inhibitor design.

NOTABLE ACHIEVEMENTS:

Obtained $50K in funding from the Natural Sciences and Engineering Research Council of Canada after successfully initiating the submission of a 20 page proposal for HIV research, despite being new to the field.

Designed a high-throughput screening assay for novel HIV inhibitor design. Developed companywide SOP.

PUBLICATIONS

(HIV)- Stoddart C.A. et al., “Preexposure Prophylaxis with Albumin-Conjugated C34 Peptide HIV-1 Fusion Inhibitor in SCID-hu Thy/Liv Mice (2012) Antimicrobial Agents & Chemotherapy, Vol. 56, Number 4: 2162-2165

(HIV)- Yi H.A. et al., “Covalent Entrapment of HIV gp41 Permanently Inhibits HIV Viral Entry (2011) Biochemistry, Aug.16; 50(32):6966-72

(HIV)- Corresponding Author: “Albumin-Conjugated C34 Peptide HIV-1 Fusion Inhibitor: Equipotent to C34 and T-20 In Vitro with Sustained Activity in SCID-hu Thy/Liv Mice” (2008) J. Biol. Chem., 283, 340**-*****

(HIV)- Corresponding Author: “A covalent HIV entry inhibitor” (2007) J. Biol. Chem., 282, 324**-*****

(Diabetes)- Thibaudeau K et al., “Synthesis and evaluation of insulin-human serum albumin conjugates” (2005) Bioconjug. Chem., 16, 1000-8

(Diabetes)- Léger R et al. “Identification of CJC-1131-albumin bioconjugate as a stable and bioactive GLP-1(7-36) analog” (2004) Bioorg. Med. Chem. Lett., 17, 4395-8

(Oncology)- Léger R et al. “Kringle 5 peptide-albumin conjugates with anti-migratory activity” (2004) Bioorg. Med. Chem. Lett., 4, 841-5

(Cardiovascular)- Léger R et al. “Synthesis and in vitro analysis of atrial natriuretic peptide-albumin conjugates” (2003) Bioorg. Med. Chem. Lett., 20, 3571-5

(Inflammation)- Quraishi O et al. “Inhibition of inducible prostaglandin E(2) synthase by 15-deoxy-Delta(12,14)-prostaglandin J(2) and polyunsaturated fatty acids” (2002) Biochem. Pharmacol., 63, 1183-9

(Enzymology)- Quraishi O et al. “Identification of internal autoproteolytic cleavage sites within the prosegments of recombinant procathepsin B and procathepsin S. Contribution of a plausible unimolecular autoproteolytic event for the processing of zymogens belonging to the papain family” (2001) J. Biol. Chem., 276, 8118-24

(Enzymology)- Quraishi O et al. “The occluding loop in cathepsin B defines the pH dependence of inhibition by its propeptide” (1999) Biochemistry, 38, 5017-23

(Enzymology)- Illy C et al. “Role of the occluding loop in cathepsin B activity” (1997) J. Biol. Chem., 272, 1197-202

(Solid-Dose Formulation)- Béchard SR et al. “Film coating: effect of titanium dioxide concentration and film thickness on the photostability of nifedipine” (1992) Int. J. Pharmaceutics, 87, 133-39

PATENTS AND PATENT APPLICATIONS AS PRINCIPAL OR CO-INVENTOR

PROJECT PUBLICATION # FILING DATE TITLE

1) HIV 12/122,627-****-**-** - Cysteic Acid Derivatives of Anti-Viral Peptides

2) HIV 11/964,313-****-**-** - Long Lasting Fusion Peptide Inhibitors for HIV Infection

3) GMP Parenteral Formulations (Diabetes) 61/007,346-****-**-** - Formulation of Insulinotropic Peptide Conjugates

4) HIV 60/938,403-****-**-** - Long Lasting Inhibitors of Viral Infection

5) GMP Bioprocessing PCT/CA2006/002**-****-**-** - Process for the Production of Preformed Conjugates of Albumin and Therapeutic Agent

6) HIV WO 05/108418

Europe 1-747-***-****-05-06 - Compounds for Specific Viral Target

7) GMP Bioprocessing WO 05/103087

US-200*-****** 2005-04-22 - Method for the Purification of Albumin Conjugates

8) HIV

Shared IP between Conjuchem Biotechnologies, NIH/NIAID, and UCSF - Preexposure Prophylaxis with Albumin-Conjugated C34 Peptide HIV-1 Fusion Inhibitor

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