Associate Director Program Management

C L A U D I A M A T U R O, M.Sc.

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Associate Director – Program Management

BIOTECHNOLOGY ~ DRUG DEVELOPMENT ~ PROJECT MANAGEMENT ~INVESTIGATIONAL NEW DRUGS (INDS)

CLINICAL TRIAL MATERIAL SUPPLY CHAIN ~ CHEMISTRY MANUFACTURING AND CONTROLS (CMC) ~ C LINICAL TRIAL MANAGEMENT

~ CONTRACT & VENDOR NEGOTIATIONS ~ IN VIVO PHARMACOLOGY

P ROFILE

• Offer significant background in program and project management with specialization in biopharmaceutical

research and drug discovery.

• Adeptness across pre-clinical research, clinical trial operations, clinical trial supply management, ensuring

FDA/regulatory compliance, and budgeting.

• Well-versed Good Clinical Practice (GCP), ICH guidelines, as well as well versed in the complete drug

development process from discovery to CMC to IND/CTA/NDA filings.

• Considerable managerial skills and proven performance in directing clinical staff and contractors in meeting

strict targets for productivity and quality.

• Demonstrated expertise in contract and budget negotiations for clinical and pre-clinical activities, clinical site

qualification assessment, laboratory equipment validation, Good Manufacturing Procedures (GMP), and

Chemical, Biological & Radioactive (CBR) safety.

• Full list of publications, acknowledgements and affiliations issued provided upon request.

C T

AREER RACK

Cornerstone Pharmaceuticals 2002 to Present

Associate Director, Program Management (2006 to Present)

Clinical / Regulatory Operations (2006 to Present)

• Project-manage two of Cornerstone’s INDs including submissions/clinical sites for Phase I, and II studies.

• Proficiently conduct all SIVs and SQVs (site initiation visits and site qualification visits).

• Train and instruct staff involved in proper handling of CPI-613 according to GCP guidelines.

• Leverage polished organizational skills toward managing 100+ FDA and Health Canada submissions.

• Prepare SOP and oversee full-scope clinical trial management including reporting of adverse and serious

adverse events of investigational drugs.

• Formulate in-depth Safety Management Plan between Brightech and Cornerstone for Phase I/II study.

• Prepare mandatory research subject information and consent form for Cornerstone’s Phase I/II studies, and

Phase II clinical study.

• Project-manage Phase I/II and Phase II studies by efficiently interacting with all clinical study sites, principal

investigators, and clinical support teams.

• Generate SOPs for human samples (PK and optional blood samples) and in-house storage.

• Coordinate Wake Forest’s four INDs; administer FDA submissions of IND annual report, SAE expedited

reporting protocols, and protocol amendment submissions for Wake Forest clinical studies involving

Cornerstone’s investigational drug.

• Manage all shipments of investigational drug and PK-related supplies to clinical sites.

Clinical Supply Chain Operations (2006 to Present)

• Receive, store and ship investigational drug to investigational sites.

• Assemble SOPs to facilitate validation of GLP refrigerator storage systems for investigational drug.

• Prepare SOP and manage packaging and labeling of over 60,000 vials for clinical trials.

• Orchestrate the complete spectrum of clinical trial management including shipment, receipt and disposition of

investigational drugs.

• Facilitate domestic and international (Israel, Canada) shipments of investigational drug to clinical sites.

• Negotiate GMP-compliant investigational drug depots for Cornerstone’s Phase II/Phase III clinical studies.

(Sharp Clinical Services, Fisher Clinical Services).

Continued …

Professional Experience continued … Claudia Maturo, M.Sc. – Page 2 of 2

Chemistry Manufacturing and Controls (CMC) (2006 to Present)

• Retain samples of investigational drug lot and drug substance in GMP-validated refrigerator system.

• Coordinate shipment of drug product, drug substance, and reference standard to contact labs and CMOs.

• Conduct QA/QC audit of batch records from CMC section of an IND/NDA project.

• Administer contracts with vendors for production of drug substance and drug product Phase I/Phase II.

• Complete special project with company’s president and COO to identify potential CMOs for manufacture of

Phase III/post-approval drug substance.

• Assemble CMC documents for potential vendors of both drug product and drug substance.

• Manage remote audit of CMO for drug product and drug substance (i.e. PCI, Patheon.)

• As project manager, hold accountability for contracts, negotiations, timelines and deliverables with CMO for

characterization, qualification and annual re-qualification of reference standard for our investigational drug and

with GMP vendor for validation assays related to drug product and drug substance.

•

Pre-Clinical Pharmacology In Vivo Pharmacology

• Championed development and implementation of company’s in vivo pharmacology program for cancer drug

platforms including staff hiring and positive relationships with animal facilities.

• Serve as Principal Investigator on all IACUC (Institutional Animal Care and Use Committee) protocols.

• Lead tumor growth inhibition studies, tumor regression studies, and acute and chronic toxicity studies.

PRIOR ROLES WITH CORNERSTONE PHARMACEUTICALS:

Manager – Research & Development Pharmacology (2004 to 2008)

Senior Scientist & Manager (2002 to 2004)

EARLIER BACKGROUND:

Associate Scientist, OSI Pharmaceuticals, Uniondale, NY

Research Biologist, Research Division, Veterans Administration Hospital, Northport, NY

Laboratory Manager, University Laboratory, Long Island University at C.W. Post, Brookville, NY

Research Biologist, Bioresearch, Inc., Farmingdale, NY

Research Biologist, University Laboratory, Stony Brook University, Stony Brook, NY

Medical Biologist, Naval Hospital, Department of Defense, Bethesda, MD

E DUCATION

Master of Science Medical Biology, Long Island University at C.W. Post Campus

Bachelor of Arts in Biology & Bachelor of Arts in Psychobiology, Long Island University at Southampton College

C ERTIFICATIONS

Dangerous Goods Certification for IATA Air, and CRF49 Ground

Biomethodology of the Laboratory Rat/Mouse/Swine

Rules & Regulations for Writing IACUC Animal Protocols

Survival Surgery Methodology

T E

ECHNICAL XPERTISE

Assay Development/Molecular Biology: PCR, RT-PCR, QPCR, assays, virus purification, transfection, Baculovirus,

plaque assay, Western Blots, RNA & DNA purification, autoradiography

Cell Culture: aseptic techniques, establishment of cancer cell lines & primary cell lines, cytotoxic assays, Luciferase

assays, cell proliferation assays, signal transduction assays, focus assays, immunohistochemical procedures, Soft Agar

Assays, immunoprecipitation, ELISA

Software: Microsoft Office (Excel, Word, PowerPoint, Publisher), Sigma Plot, Prism Graph Pad

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