Clinical Research Manager

CURRICULUM VITAE

WILLIAM OFOSU-APPIAH, Ph.D.

**** ********* ***** ****: 856-***-****

Williamstown, NJ 08094 ******@*******.*** Cell: 609-***-****

CAREER OBJECTIVE

To obtain a position where my Clinical Research experience can lend itself to the success and profitability of an innovative company bringing novel compound/molecules to market.

SUMMARY

Highlights:

Solid experience in CART clinical trials and cell therapy logistics

Solid experience in managing multiple, phase I-III sites from study start-up to close out; independently writing 12 protocols, creating SOPs, and designing eCRFs; recruiting and qualifying investigators; training and mentoring multiple Clinical Research Associates; overseeing the adherence of ICH and GCP guidelines

Extensive experience in CROs/Vendor management including conducting performance appraisals and lessons learned reviews

Solid experience in clinical study startups and patient recruitment

Solid experience in monitoring independently as well as co-monitoring with CRAs

Extensive experience in creating budgets; managing timelines; writing IND and NDA submission materials; coordinating the ordering and distribution of drug supply; managing and selecti ng CROs, IVRS, and central laboratories

Extensive experience in interacting with Key Opinion Leaders, assisting in development of scientific presentations and training of the marketing/sales group

Industry therapeutic experience:

Oncology- Leukemia, multiple myeloma, Melanoma, Lung, Prostate (Phases I –III)

CNS-Parkinson’s, (Phase III)

Endocrinology/Metabolic Disorders - X-Linked Hypophosphatemia (XLH) disease (Phases 1-II)

PROFESSIONAL EXPERIENCE

Tmunity Therapeutics, Inc.

East Norriton, PA

Clinical Operations Lead 5/1/2019- 10/2019

Responsibilities

Plan and manage components of a solid tumor CART clinical study and/or program, to agreed time, cost and quality. This includes serving as leader of the cross-functional Clinical Study Team (CST) as well as develop & manage contingency risk plans and escalate issues to stakeholders as appropriate.

Drive negotiations and selection process of the Contract Research Organization (CRO) and other external service providers. In this capacity, liaise with CRO's and other external service providers, academic clinics identify and help to resolve operational feasibility issues

Lead the CST and provide efficient updates on trial progress to the Head of Clinical Operations and senior management with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation

Oversee and provide input to the development of study specific documentation including but not limited to: case report forms {CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.

Oversee set-up and maintenance of study systems including but not limited to Clinical Trial Management

System (CTMS), Trial Master File (TMF) and ensure compliance with company Standard Operating Procedures (SOPs), ICH/GCP guidelines, regulatory and clinical trial registry requirements.

Celgene Corporation

Summit, NJ

Sr. Manager, T Cell Operations, Biologics Development 7/2017 – 1/2019

Responsibilities

Provide CMC operational management support to all CAR T supply chain logistics operations, technical transfer and regulatory interaction/submissions

Manage collaborative CMC and supply chain workstream meetings, both internally, with Juno and with CMOs, using meeting management best practices, and be responsible for efficient conduct and follow through with action items

Sr. Clinical Trial Manager (Consultant) - Oncology, PI, PII, PH111 5/2015 – 7/2017

Provide strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.

Primary operational contact or support the primary contact for the study and lead the cross-functional global team for execution of the study.

Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams

Financial Planning and Management:

Development/management/reconciliation of overall study budget(s)

Development/management of vendor scope of work (SOW) per contract, quality, and budget

Review/approval of vendor invoices and management of accruals and SOW changes.

Project Management

Oversight of study execution

Oversight of clinical monitoring quality and adherence to established processes and plans

Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.]

Proactive identification of potential risks and development/implementation of actions to avoid or mitigate

Maintenance/updating of data as appropriate in project management tools including CTMS

Informing operational program lead/and other leadership (as appropriate) on overall clinical trial plans

Study Planning and Conduct

Facilitation of country and site feasibility/selection processes

Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.

Oversight of investigational product [IP]supply forecasting/management and study-level reconciliation [in collaboration with IMSC]

Development of the subject recruitment/retention strategy and related initiatives

Participation in clinical service provider (vendor) selection, specification development, and management/oversight

Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance

Development/coordination of study training for study team, investigational sites, and vendors

Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC

approvals/notifications

Participation in Serious Adverse Event (SAE) reconciliation process

Drive activities for efficient data cleaning and database closure.

Lead close out activities for sites and vendors.

Oversee CSR process to ensure timelines are being adhered to and functions are aligned

Coordinate provision of operational appendices to CSR

Address audit actions.

Relationship Management

Development/maintenance of collaborative relationships with:

Internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers.

Novartis Pharmaceuticals Corporation 2/2012 – 4/2015

East Hanover, NJ

Clinical Trial Leader - Oncology, PI, PII, PH111

Responsibilities

Responsible for the overall coordination and management of the First-in-human (FIH) CIDH305X2101 (hematological malignancies and solid tumor) study (including timeline, resources etc) and management of the program from a day-to-day operational perspective to achieve strategic and operational objectives

Responsible for the overall coordination and management of the CAUY922A2206 (solid tumor) study (including timeline, resources etc.) and management of the program from a day-to-day operational perspective to achieve strategic and operational objectives. The key day-to-day operational activities include but not limited the following:

Ensures development, review, finalization and delivery of high-quality key clinical study documents in order to meet study timelines

Manages feasibility and determines global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives

Accountable for clinical vendor selection and contractual agreements

Accountable for all aspects of study management including supply management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines

For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and clinical for the entire study lifecycle

Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders

Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs

Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports

Amicus Therapeutics, Inc., Cranbury, NJ 2/2011 – 1/2012

Contract Project Manager – Rare Diseases, PI, PII

Responsibilities

Responsible for the overall coordination and management of AT1001-013, AT1001-014, and AT1001-015 clinical trials from start up through close out activities in rare diseases such as Fabry and Pompe diseases

Kyowa Hakko Kirin Pharma, Inc., Princeton, NJ 10/2004 – 12/2010

Clinical Trials Manager – Oncology, CNS Disease (Parkinson’s disease) & Metabolic diseases, PI, PII, PIII

Responsibilities

Managed global, multi-site phase 1-III clinical drug trials on the effect of small molecules and monoclonal antibodies in melanoma, leukemia, multiple myeloma, Parkinson disease and X-Linked Hypophosphatemia (XLH) disease

Managed investigator selection, site feasibility studies and patient recruitment issues

Mange clinical study start up and timelines

Manage outsourcing partners to ensure forward progression of clinical trials including CROs, central laboratories, IVRS, and randomization companies

Coordinate the ordering and distribution of study drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, SAEs, etc.

Lead, supervise, and motivate a 16-member cross-functional oncology and Parkinson global study team to ensure that the clinical trial meets the projected milestones and budget requirements

Coordinate global investigator and monitor meetings and workshops including developing agendas, preparing materials, and identifying, resolving, and communicating follow-up issues

Recruit and qualify investigators/sites/subjects for oncology, CNS and XLH studies

Conduct vendor and site feasibility meetings and audits to assess vendor/site capabilities for the study

Write SOPs for clinical research operation incorporating ICH/GCP

Train and mentor an international team of CRAs to ensure that clinical study sites strictly adhere to specific protocols and that sites follow all SOPs and ICH GCP guidelines

Perform independent monitoring as well as co-monitoring with CRAs

eCRF design for paper and electronic data capture (EDC) for phases I-III clinical studies

Review of clinical trial data, generation of study reports, and preparation of materials for scientific meetings and publication

Writing preclinical and clinical sections of clinical study reports

Interacting with Key Opinion Leaders, assisting in development of scientific presentations and training of the marketing/sales group

THERAPEUTIC AREAS: Oncology (melanoma and leukemia, multiple myeloma), CNS (Parkinson’s disease), Endocrinology/Metabolic Disorders - X-Linked Hypophosphatemia (XLH) disease

Medarex, Inc. Bloomsbury, NJ 2/2000 – 9/2004

Clinical Research Scientist - Oncology, PI, PII

Responsibilities

Design and writing of clinical study protocols for phase I and II studies using monoclonal antibodies as therapeutic agents

Prepare and submit documentation for IND

Plan, implement, and manage phase I-II clinical teams in melanoma and prostate cancer trials

Motivate, supervise, and lead a cross-functional team of clinical research professionals including project managers, CRAs and DMs

Contribute to the development of CIB (Clinical Investigator Brochure)

Review/revise investigator contracts

ICF and CRF design for phases I-II clinical studies

Assist the Director of Clinical Operations in determining resource requirements for planned studies in the clinical operations group e.g. field monitoring group, in-house CRAs, contract CRAs etc.

Perform independent monitoring as well as co-monitoring with CRAs - 5 direct CRA reports

Assist in the evaluation and assessment of sites selection criteria

Recruit and qualify investigators/sites/subjects for oncology studies

Responsible for negotiating contracts and developing customer-oriented relationships with all sponsors and vendors and to report the progress and/or issues to the parties throughout the course of the study

THERAPEUTIC AREAS: Oncology (melanoma and prostate cancer)

Other Related Experience

WYETH-AYERST RESEARCH, Princeton, NJ

Senior Research Scientist II – Pre-Clinical (Rheumatoid Arthritis)

MASONIC MEDICAL RESEARCH LABORATORY, Utica, NY

Director, Immunology Program

MAIMONIDES MEDICAL CENTER & SUNY HEALTH SCIENCES CENTER, Brooklyn, NY

Postdoctoral Research Fellow - Dept. of Immunology

Education

Ph.D., Immunology, University of Manitoba, Winnipeg, Canada

- Emphasis on autoimmunity (Rheumatoid Arthritis)

M.S., Immunology, Univ. of Manchester, U.K

Professional Affiliations

American Association of Immunologists

American Society of Clinical Oncologists

American Heart Association

International Society of Cardiovascular Immunology

Medical Research Addendum

Summary of Scientific Expertise:

Cellular Immunology

Cell/tissue culture techniques including cloning, long-term maintenance of T cell clones, T cell receptor (V ) gene usage analysis.

Functional studies of T cells – proliferation, cytokine synthesis and cytotoxicity assays.

Immunoassay of antibodies and cytokines and using ELISA and ELIPSOT technology, radioimmunoassay (RIA), bioassay of cytokines using specific cell lines.

Purification of proteins and analysis of purity by 1 and 2-diamensional gel electrophoresis and/or immunoblotting (Western blotting), immunoprecipitation and immunohistochemistry.

Extensive experience in hybridoma technology involving monoclonal and polyclonal antibody production, screening, cloning, growth and maintenance of hybridoma cell lines.

Experience with fluorescent-activated cell sorter or flow cytometry.

Use of computer to analyze data and statistical analysis of data.

Molecular Immunology

Experience in the full range of molecular biology techniques including, PCR, PCR-ELISA, RT-PCR, northern blot analysis, southern blot analysis, ribonuclease protection assays, in situ hybridization.

Non-radioactive detection systems and gene expression system for proteins.

Patents:

I have a patent for oral tolerance to kidney extracts as treatment for systemic lupus erythematosus (US patent # 5,695,785; date of patent: 12/9/97).

Publications for the past 8-9 Years: (Refereed Articles: 5 of 26 selected since 1997)

1.Ofosu-Appiah, W., Aiello, V. Sfeir, G and Viti, D (1997). Isolation and functional characterization of IL-2 responsive T cell clones from NZB/NZW F1 mice. J. Autoimmunity 9: 617-627.

2.Ofosu-Appiah, W., Sfeir, G., Kennell, A., and Todd, R. (1997) Characterization of arterial antigens utilizing arterial antigen-reactive T cell clones from Spontaneously hypertensive rats. Am. J. Hyperten. 10: 355-540.

3.Ofosu-Appiah, W., Sfeir, G., Smith, D., and Richard, T (1997). Neutrophil-mediated Damage to vascular endothelium in the spontaneously hypertensive rat. Clin. Immunol. Immunopathol.83: 293-301.

4.Ofosu-Appiah, W., Sfeir, G., Viti, D., and Burahnikova, E (1998). Induction of systemic lupus erythematosus-like disease in mice by immunization with heparan sulfate. Cell. Immunol. 187: 22-31.

5.Ofosu-Appiah, W., Sfeir, G., Viti, D and Burahnikova, E (1999). Suppression of systemic lupus erythematosus disease in mice by oral administration of kidney extract. J. Autoimmun. 13: 405-414.

Abstracts:

Phase II activity of HSP90 inhibitor AUY922 in patients with ALK-rearranged (ALK+) or EGFR-mutated advanced non-small cell lung cancer (NSCLC) 2013. E. Felip, E. Carcereny, F. Barlesi, L. Gandhi, L. Sequist, S-W Kim, H.J.M. Groen, B. Besse, D-W. Kim, E. Smit, M. Akimov, E. Avsar, S. Pain, W. Ofosu-Appiah and E.B. Garon ESMO, Abstract # 4380, Annals of Oncology 23 (Supplement 9): page 152-ix174 2013

Phase II activity of HSP90 inhibitor AUY922 in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) 2013. Fabrice Barlesi, Benjamin Besse, Leena Gandhi, Quincy Chu, Frank Griesinger, Enriqueta Felip, Jin Hyoung Kang, Sang-We Kim, Rafael Rosell, Lecia V. Sequist, Ross Soo, John Wallmark, Emin Avsar, W. Ofosu-Appiah, Scott Pain, Mikhail Akimov, Edward.B. Garon: WCLC, Journal of Thorcic Oncology. Volume 8, Supplement 2, November 2013, Abstract #PI.11-037, page S611.

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