MARK J. HARVEY

ac45l0@r.postjobfree.com

Summary

Clinical operations personnel with diverse background including project and operations management, study startup activities, protocol and CRF development, regulatory document preparations, extensive onsite and remote monitoring, TMF maintenance, CRO and vendor oversight, safety reporting, and database cleanup experience inclusive of Phase I-IV clinical trials. Also experienced in providing on-site technical instruction to physicians and laboratory personnel as well as several years of drug and device research.

9+ years of oncology experience including leukemia, myeloma, and solid tumor. Therapies include bone marrow transplantation, drug and immune system modulation.

THERAPEUTIC EXPERIENCE

Genetic Therapy – RNA therapy aimed to provide a better quality of life for boys with Duchene’s Muscular Dystrophy (Phase II-III and confirmatory studies)

Cardiovascular - Preservation solution intended for transplantation (Phase I)

Neuromuscular - Spinal neuromodulator (Phase I – III)

Oncology – Solid tumors and bone marrow (myelomas and lymphomas) CD34+ isolations involved in bone marrow transplantation including vaccine therapy and gene therapy. (Phase I – III)

Dermatology – follicular regeneration (Phase IV)

Infectious Disease – MDR tuberculosis, leishmaniasis (Phase II)

Hepatic – stent (Phase IV)

Renal – transplant technology (Phase II)

Immunotherapy (Phase III)

EXPERIENCE

ShockWave (Medical Device – Cardiovascular) June 2017 to August 2017 (Contract)

Clinical Trials Manager

Responsibilities included vendor management including CRO oversight of key clinical trials, including study start-up activities and ongoing trials. Clinical document development and revisions, monitoring report review and approval, database creation for completed trial, review and cleaning, SAE identification, team leadership and support to upper management on day to day execution of clinical trials. Key contact for site personnel and CRO personnel.

Apexigen Inc (Oncology – CD40 Activation) June 2016 to June 2017 (Contract)

Senior Clinical Trials Manager

Responsibilities are vendor management including CRO oversight of key clinical trials, including study start-up activities, clinical document development and revisions, monitoring report review and approval, data review and cleaning, SAE identification, bio-samples management as well as team leadership and support to upper management on day to day execution of clinical trials. Key contact for site personnel and CRO personnel.

Prosensa Therapeutics Inc (Muscular Distrophy – RNA Therapy) May 2014 – January 2016 (Contract)

Regional Sr. Clinical Research Associate

Responsibilities of Regional Clinical Research Associate include independent site evaluation, all study start-up activities, site initiations, interim monitoring for Phase II, III, and confirmatory clinical trials for Duchene’s Muscular Dystrophy. Actions include performing monitoring responsibilities to support sponsor and investigator compliance with applicable country regulatory requirements, ICH/GCP guidelines and country specific SOPS. Establish and maintain professional and mutually goal-orientated relationships with investigational sites and sponsors. Contribute to effective project management by pro-actively and positively supporting the study team; meeting study timelines and submitting deliverables as instructed. Communicate regularly with the Project Manager, Lead CRA and Line Manager regarding study and monitoring issues. Participate in planning and execution of Investigator Meetings. Assist in identification of sites. Provide leadership and support for CTAs and CRAs. 100% source data verification, use of EDC, experience with Electronic Medical Records, regulatory review, Investigational Drug Accountability, site management of multiple sites for multiple studies, and situational problem resolution. Other responsibilities include travel planning, expense report generation, SOP training and documentation, ICH-GCP training, webinar presentations and contributions to corporate SOPs and trial procedures

Boston Scientific (Medical Device –Spinal Cord Neuromodulation) June 2012 - January 2014 (Contract)

Regional Sr. Clinical Research Associate

Responsibilities included independent site closure activities for a post-marketing device study with a modality of implantable Spinal Cord Stimulation to reduce chronic back pain, Site Evaluations, Qualification Visits and Site Initiation activities for a Phase III spinal cord stimulator for chronic migraine headaches. Other responsibilities include EDC data verification, regulatory compliance, device accountability, CTMS entry, and ICH/GCP compliance. Similar responsibilities are applied to an Epidemiology Study as well as an additional Phase III study involving implantable spinal cord devices.

Pharm-Olam International (CRO) March 2011 June 2012 (Full Time Employment)

Regional Sr. Clinical Research Associate

Responsibilities of Regional Clinical Research Associate include independent site evaluation, site initiations, interim monitoring and close-out visits for Phase I-III studies. Perform monitoring responsibilities to support sponsor and investigator compliance with applicable country regulatory requirements, ICH/GCP guidelines and country specific SOPS. Establish and maintain professional and mutually goal-orientated relationships with investigational sites and sponsors. Contribute to effective project management by pro-actively and positively supporting the study team; meeting study timelines and submitting deliverables as instructed. Communicate regularly with the Project Manager, Lead CRA and Line Manager regarding study and monitoring issues. Participate in planning and execution of Investigator Meetings. Assist in identification of sites. Provide leadership and support for CTAs and CRAs. Conduct on-site training and evaluation of new CRA employees and CRA in training. 100% source data verification, use of EDC, experience with Electronic Medical Records for in-patient oncology studies, regulatory review, Investigational Drug Accountability, report generation, site management of multiple sites for multiple studies, and situational problem resolution. Other responsibilities include travel planning, expense report generation, SOP training and documentation, ICH-GCP training, webinar presentations and contributions to corporate SOPs and trial procedures.

Abbott Labs (Renal – medical device) April 2008 – September 2009 (Contract)

Sr. CRA, Phase III kidney stent implantable device trial.

Responsibilities included site selection and validation, Investigator selection and verification, preparation and verification of all site regulatory documents, review of regional monitor’s site visits trip reports, drug supply and tracking, attending team meetings and company sponsored training courses, monitor oversight and training of jr. CRAs, data input and management of clinical database, site management and primary in-house point contact for all clinical concerns. All clinical activities were performed according to FDA and ICH guidelines.

BioMarin January 2007 to April 2008 (Contract)

Clinical Trial Manager, Phase I bioavailability trial.

Primary responsibilities included the development of the clinical protocol, investigator brochure, and clinical reports forms, essentially leading the project from inception to day-to-day activities. Additional responsibilities included establishing study milestones, working with cross-functional teams, leading and attending team meetings, contracting the CRO and oversight of vendors. All clinical activities were performed in accordance to FDA and ICH guidelines.

Exelixis (Oncology – Solid Tumor) June 2007 to October 2007 (Contract)

CTM, Phase II solid tumor trials (renal, prostrate, ovarian, lung, head and neck).

Primary responsibilities included review of regional monitors trip reports, site management, collection and verification of site regulatory documents, patient tracking, attending team meetings, development of the clinical department’s SOPs.

One World Health (Vaccine Therapy) May 2007 to June 2007

Contracts associate, Phase III, infectious disease.

Responsibility included the development of the Clinical Trial Agreement, attending team meetings and CRF design.

Y's Therapeutic (Transplantation – Renal) January 2007 to April 2007 (Contract)

Sr. CRA a Phase II kidney transplant trial, a Phase I percutaneous coronary intervention trial.

Development of the clinical protocol, investigator brochure, clinical report forms, CRO management, including site selection and validation, investigator selection and verification, preparation and verification of all site regulatory documents, review of regional monitor’s site visits trip reports, drug supply and tracking, attending team meetings and company sponsored training courses, monitor oversight and training of jr. CRAs, data input and management of clinical database, site management and primary in-house point contact for all clinical concerns. All clinical activities were performed according to FDA and ICH guidelines

Cell Genesys (Oncology – Attenuated, IL-2 upregulated vaccine therapy) November 2005 July 2005 to November 2006 (Contract)

Sr. CRA, Phase II lung cancer vaccine trial.

Responsibilities included site selection and validation, investigator selection and verification, preparation and verification of all site regulatory documents, review of regional monitor’s site visits trip reports, site monitoring including initiation, interim and close-out visits, drug supply and tracking, attending team meetings and company sponsored training courses, monitor oversight and training of jr. CRAs, data input and management of clinical database, site management and primary in-house point contact for all clinical concerns, in-house clinical master file audit and maintenance. All clinical activities were performed according to FDA and ICH guidelines.

Intermune (Vaccine) February 2005 June 2005 (Contract)

Sr. CRA, Phase III, infectious disease.

International trial involving review of clinical document translation verification, development of the clinical protocol, investigator brochure, clinical report forms, CRO management, including site selection and validation, investigator selection and verification, preparation and verification of all site regulatory documents, review of regional monitor’s site visits trip reports, drug supply and tracking, attending team meetings and company sponsored training courses, monitor oversight and training of jr. CRAs, data input and management of clinical database, site management and primary in-house point contact for all clinical concerns. All clinical activities were performed according to FDA and ICH guidelines. Additional activities included temporary safety officer responsible for filing all adverse events to the Food and Drug Administration in accordance with existing guidelines

AmCell (T-cell modulation) March 2004 – October 2004 (Full Time)

CTM, Phase II bone marrow transplantation aimed at multiple myeloma and lymphomas (6 mo).

Development of the clinical protocol, investigator brochure, clinical report forms, CRO management, including site selection and validation, investigator selection and verification, preparation and verification of all site regulatory documents, review of regional monitor’s site visits trip reports, drug supply and tracking, attending team meetings and company sponsored training courses, monitor oversight and training of jr. CRAs, data input and management of clinical database, site management and primary in-house point contact for all clinical concerns. All clinical activities were performed according to FDA and ICH guidelines

Roche Palo Alto (Oncology – Gene therapy) March 2002 – September 2002 (Contract)

Clinical Operations Manager, Phase II gene therapy aimed at lymphoma (6 mo).

Primary responsibilities included the development of the clinical protocol, investigator brochure, and clinical reports forms, CRO selection, site budget negotiation, overall clinical project budget management, timeline development, clinical monitoring plan development, and overall clinical development plan, essentially leading the project from inception to day-to-day activities. Additional responsibilities included working with cross-functional teams, leading and attending team meetings, CRO and vendor management, transfer of study-specific direction to Clinical Site Managers, Trial Associates and mentoring of project team support staff. All clinical activities were performed in accordance to FDA and ICH guidelines.

BioEnterics (Obesity) June 2001 to December 2001

CRA, database cleanup, Phase II obesity trial (6 mo).

Database review and clean-up activities.

CCSA Associates, Mountain View, CA February 1999 to August 1999

Senior Clinical Research Associate

Responsibilities included site management, regulatory document tracking and collection, site initiation, interim monitoring, drug supply and accountability, query generation and resolution, and site closure(s)

Area of involvement consisted of therapeutics aimed at meeting precancerous conditions.

SCIREX Corporation (CRO) November 1997 – January 1999 (Full Time)

Regional Clinical Research Associate

Responsible for Regional CRA activities and site management

Activities performed on a regular basis include site initiations, interim monitoring visits, query generation/resolution, site closure, drug accountability and all associated correspondence for multiple sites and projects

Other responsibilities associated with this position include attending team meetings, project meetings, making travel arrangements, billing time, and submission of expense reports

LXR Biotechnology Inc. (Cardiovascular) March 1997 to October 1997 (Full Time)

Clinical Research Associate

Responsible for all CRA activities.

AIDS Trial Phase I - Monitor and verify data for all subjects (33) using Datafax, perform drug accountability, and site closure activities

AIDS Trial Phase II/III - Contract negotiation with CRO, site section, CRF development, clinical protocol development, Investigator Brochure development. Heart Transplantation Phase III/Cardioplegia Phase I - Involvement with CRO selection and contract negotiation, site selection, protocol and CRF development

Terrapin Technologies (Oncology) February 1996 to February 1997 (Full time)

Project Manager/Research Associate

Responsible for the following aspects of the Bone Marrow Transplant Project:

Design and implementation of critical experiments including short and long term progenitor assays, flow cytometry analysis, liquid culture expansion/analysis and murine model experiments. Data analysis and presentation

Procurement of human tissue samples for experimentation. Budget projections

Establishment of new collaborations

Participation on the Diabetes Research Project

Member of the Corporate Culture Task Force

Geneic Sciences Inc (Oncology, T- Cell modulation) May 1994 to November 1995 (Full Time)

Senior Research Associate

Characterization of a novel class of bone marrow cells which facilitate allogeneic bone marrow transplantation without GVHD

Design and implementation of critical experiments including functional, in-vivo experiments using murine models

Establishment of scientific collaborations

Supervision of research assistants

Design of laboratories

Procurement of biological materials and product evaluation

Responsible for technology transfer between collaborators and GSI

Design and implementation SOPs

Assay development

Monoclonal antibody development against novel antigens.

Applied Immune Sciences (BMT and Gene Therapy) July 1990 to March 1994(Full Time)

Clinical Research Associate

Design and implementation of critical experiments involved in bone marrow transplantation and gene therapy in human subjects

Monitoring of clinical bone marrow processing

Data verification at clinical sites

Data analysis

CRF and LRF (Laboratory Report Forms) design

Clinical protocol development, evaluation and implementation

Site qualification and laboratory evaluation

Evaluation of outside testing facilities used for analysis of our clinical trial sample

Involvement in a gene therapy trial conducted in the Netherlands. This involved transduction of the ADA gene into highly purified CD34+ cells as the gene recipient. Participation in clinical trials/collaborations/negotiations. The above actions are applicable to the US, Canada, and Europe

Research Associate

Developed and implemented the CD34 MicroCELLector and CELLector devices (currently in clinical trials in the U.S. and Europe

Conducted experimental procedures to evaluate the properties of the CD34+ cell (short and long term analysis, expansion, phenotype analysis, cytokine assays)

Developed experimental procedures to enhance and assay viral transduction of the human stem cell design/synthesis, PCR, RNA/DNA manipulation, PAGE, FISH, and other standard techniques. Transfer of technology to clinical institutions

Manipulation of murine bone marrow/stem cells for allogeneic and autologous bone marrow transplantation experiments

Presentation of abstracts at select conferences

Maintenance of bone marrow stromal layers and basic tissue culture

Lab maintenance and ordering of necessary supplies

EDUCATION

Chico State University, Chico, CA. BA degree in Chemistry

PUBLICATIONS

Rapid Isolation of Human CD34 Hematopoietic Stem Cells: Purging of Human Tumor Cells, Transplantation, vol. 53 1011-1019

Direct Isolation and Expansion of Human CD34+ Hematopoietic Stem Cells. Advances in Bone Marrow Purging and Processing. (p 487-***-****)

Modulation in CD8+ T-Cell Differentiation State Following Stimulation with IL-7. FASEB. 4-92. Vol. 2, #4411, pg. A1698

Stem Cell Factor Enhances the Hematopoiesis of Purified CD34+ cells in Long Term Bone Marrow Culture. BLOOD. Vol. 80, No 10 Suppl 1, Nov. 15, 1992

Rapid Isolation of CD34+ Cells: Purging of Human Tumor Cells. Journal of Cellular Biochemistry, Suppl 16A, Jan. 1992, pg 191

Gene Therapy in Three Patients With Adenosine Deaminase Deficiency. Submitted and in review with Lancet.

ABSTRACTS

Serum free culture of purified CD34+ Cells yields large expansions of both Myeloid and Erythroid Progenitors. (ISH 1993, ASH 1993, Science EXPO 1993, International Symposium on Bone Marrow Purging and Processing 1993)

ADENO-ASSOCIATED VIRUS: HIGH EFFICIENCY PRODUCTION OF RECOMBINANT TRANSDUCING VECTORS. (UCLA AIDS Symposium 1993, Keystone Symposium 1993)

ISOLATION AND EXPANSION OF CD34+ CELLS IN THE AIS CELLector yields large increase in committed progenitor cells

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