AMIR M. ABUSHAMAA, Ph.D.

*** ********** ****

Grayslake, IL 60030

847-***-**** (H)

ablrxj@r.postjobfree.com

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Highlights Medical/scientific affairs management across both

pharmaceutical and diagnostics industries

Personnel, project and territory management experience

Technical operations, product support and

assay/drug/clinical development experience

Test method and process validation experience

Bioanalytical method development experience using HPLC and

GC-MS

Experience

2008-Present Spectrum Pharmaceuticals, Irvine, CA (also previously at

Cell Therapeutics, Inc., Seattle, WA)

1 Medical Science Liaison, Medical Affairs for Hematology/Oncology

. Supported clinical development efforts through site

identification/selection, as well as led effort to improve

patient enrollment for rare diseases (included

collaboration with patient advocacy organizations).

. Provided training to company speakers, commercial team and

medical information partner/vendor.

. Developed presentations to address key clinical barriers

and delivered presentations on company products and

relevant disease states (including at advisory board

meetings).

. Represented medical affairs in decision-making on clinical

trial and medical education support.

. Supported both pre-launch and post-launch activities, as

well as assisted in medical information, publication

planning and pharmacoeconomics initiatives.

. Provided competitive intelligence on competing drug

products.

. Coordinated >6 clinical trials within the Midwest region

(~10 states) in the field of oncology.

. Developed relationships with >150 key opinion

leaders/healthcare providers in the hematology/oncology

field, primarily lymphoma, myeloma, transplant,

osteosarcoma, colorectal and lung cancer.

2007-2008 Pharmion Corporation, Boulder, CO (acquired by Celgene

Corporation in 2008)

2 Medical Science Liaison, Medical Affairs for Hematology/Oncology

. Coordinated >11 clinical trials within the Midwest region

(~6 states) through interaction with key opinion leaders at

key academic institutions in the field of oncology.

. Developed relationships with >40 key opinion leaders in the

hematology/oncology field, primarily MDS, leukemia, ovarian

and lung cancer.

. Supported post-marketing disease registry project.

. Supported national/regional/local scientific and advisory

board meetings.

. Executed medical affairs strategy in alignment with

commercial/clinical development.

1999-2007 Abbott Diagnostics Division, Abbott Laboratories, Abbott Park,

IL

3 Scientific Affairs Area Manager, US Scientific Affairs

. Presented diagnostics products and disease states to US

customers through lectures and/or posters, which occurred

at VIP sessions, hospital/lab visits, lab society meetings,

and scientific conferences. The areas covered included

instrumentation, cardiac, cancer, transplant, and hepatitis

diagnostics.

. Served as the key technical liaison between Abbott Labs and

its customers, as well as the sales force. Also supported

sales training and scientific marketing initiatives.

. Coordinated studies (both US and global) on company

products in support of marketing efforts with external

customers, including key opinion leaders.

. Supported company sales efforts through technical

presentations to hospitals or groups of hospitals (such as

Integrated Delivery Networks or Group Purchasing

Organizations). Played a key role in the closure of new

diagnostics business valued at several million dollars.

4

5 Senior Technical Support Scientist, Assay Technical Support/Senior

Technical Specialist, Transplant Business Team

. Performed activities required for maintaining on-market

immunoassay products, including transplant (cyclosporine,

tacrolimus), anticonvulsant and antibiotic assays.

. Performed investigations of product internal

nonconformances and external complaints within a cGMP

environment (included the writing of study protocols, data

analysis, validation packages, use of the CAPA system and

use of the Six Sigma Root Cause Analysis process).

. Interacted on a regular basis with a variety of functional

groups including Quality, Planning, Regulatory Affairs,

Marketing, R&D, Customer Support, etc. Also interacted

with external consultants, FDA, opinion leaders and

presented company technology to customers overseas.

. Served as the Interim Transplant Business Team Leader in

charge of a group of about 18 team members (which included

hiring of new employees, planning team manufacturing hours

and delegating tasks

Team Leader, Diafiltration Common Process Validation Team

. Managed a team of 10-15 people responsible for the common

process validation of microparticle and protein

diafiltration on four different systems used across the

entire diagnostics division.

. Managed timelines, resources, meetings, and presented

project status to senior/executive management. This

included overseeing characterization/validation runs and

required documentation for FDA submission.

Senior Scientist, Assay Development

. Developed a new technology for the measurement of glucose

and creatinine that allows clinical chemistry assays to be

used on Abbott's Architect immunodiagnostic instrument in a

chemiluminescent format.

. Applied the method successfully to human serum samples.

1996-1999 Postdoctoral Research Associate, Duke University Medical

Center, Durham, NC

. Designed and performed experiments to study the effects of

oxidative damage on the lung in various mouse models

(including transgenic mice), such as breast cancer

chemotherapy drugs, hyperoxia, ozone and residual oil fly

ash.

. Developed methods for biomarkers of oxidative stress by

HPLC in cell culture and animal models, and in

bronchoalveolar lavage fluid obtained from clinical trials.

. Investigated the role of inflammatory cytokines and

antioxidant enzymes in mediating lung toxicity.

1992-1996 Research Assistant, Northeastern University, Boston, MA

. Developed and optimized new, highly sensitive methods for

the trace detection of a class of alkyl DNA adducts in

human blood using GC-EC-MS.

. Simplified a method by both developing a new organic

derivative and modifying the separation conditions,

resulting in a reduction in time and cost of the method.

. Maintained a GC-MS system for the research group; trained

and supervised lab members on projects and instrumentation.

. Minor projects: Isolated/purified ribonuclease A from E.

coli and derivatized/purified the polysaccharide, chitin.

. Tutored graduate students in biochemistry.

Technical skills Abbott Diagnostics immunoassay platforms (DS/Architect,

TDx, IMx, AxSYM), HPLC, GC-MS, GC, ion exchange, size

exclusion, immunoaffinity, flash, thin layer, and fast

protein liquid chromatography, solid phase extraction, gel

electrophoresis, high performance capillary

electrophoresis, Western blotting, ELISA, enzymatic assays,

UV/VIS/IR, fluorescence spectroscopy, chemiluminescence,

FPIA and MEIA

Education

Ph.D. Biomedical Science, Northeastern University, Boston, MA,

1996

Specialization in Bioanalytical Chemistry (GPA: 3.9)

Thesis title: "The Trace Determination of an Ethylene

Oxide DNA Adduct by GC-EC-MS"

Advisor: Professor Roger W. Giese

M.S. General Biomedical Science, Northeastern University,

Boston, MA, 1992 (GPA: 3.9)

B.Sc. Biochemistry, Alexandria University, Alexandria,

Egypt, 1988 (GPA: 4.0)

Awards ADD Operations Award of Excellence (2003, twice in 2004)

Validation Teams Vice-President's Award (2001)

Gustel Giessen Advanced Research Award (1994)

Phi Kappa Phi National Honor Society (1994)

Miscellaneous Principal Investigator Training for Clinical

Specimen Acquisition

Courses including Clinical Pharmacokinetics, Design of

Experiments, Fundamentals of Marketing, Project Management,

Presentation Skills, Quality Systems Regulations and Six

Sigma Cause Analysis

Biochemistry graduate student, Alexandria University,

Alexandria, Egypt, 1988-1990

Fluent in English and Arabic; studied French, Swedish and German

1

2 Publications Several abstracts and published articles in peer

reviewed journals, in addition to numerous poster

presentations

References Available upon request

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