Phone: (+*) 310-***-**** **** Kelvin Ave., Apt ***3

E-mail: hw818v@r.postjobfree.com Irvine, CA 92614 USA

Medical Affairs (16 years)

- Senior executive role, leading/directing the overall medical affairs function for the company (pharmaceutical, medical device) in multiple therapeutic areas (oncology, urology, reproductive medicine, bone health, hematology, cardiovascular, CNS and pharmacogenetics)

- Liaising to payers, employer medical directors and medical policy personnel

- Locating, hiring and managing internal/external consultants

- Monitoring company-wide clinical quality, assuring accurate information communication and full compliance with legal/regulatory guidelines

- Regulatory affairs, filings (FDA, Health Canada, CE Mark), compliance regulations for clinical trials, new drug/device development (GLP, GMP, ICH-GCP certificates), data privacy laws, patient safety, adverse event reporting, site compliance and pharmacovigilence

- Regulatory writing including: SOP, clinical study protocol/report (CSP/CSR), clinical summary of safety/efficiency (CSS/CSE), clinical study overview (CSO), case report, pipeline drug compendia/dossier

- Instructional design for patient/doctor/sales rep educational material (CME), developing web/intranet content and e-learning web portals

- Managing CRM system, communication with physicians/health care professionals about investigational/approved products

- Literature surveillance for multiple molecules/compounds, competitor product/technology assessment/intelligence, KOL intelligence

- Supporting sales/marketing with new client acquisition/management, provider communication, marketing/social media strategies

- Medical marketing document development (editorial review, abstract, manuscript, proposal, product knowledge self-study material, poster)

- Global publication planning leadership in multidisciplinary team, social media marketing, medical writing/documentation, member of American Medical Writers Association( AMWA), AMWA certificate holder

Management (12 years)

- Project coordination/management (academia, pharmaceutical, medical device) across many interfaces including: medical affairs, regulatory affairs, R&D, clinical marketing, clinical development operations, intellectual property and business development

- Management/clinical practice in national/international medical and clinical setting

- Management of stakeholders, investigators, KOLs, budget allocation, staffing and peer relationship development

- strategic planning, Negotiation, organizational development, leadership and alliance building

- High level customer relationship, cross-departmental training/liaising

- Teaching and higher education in national/ international colleges/universities, mentoring, training/motivating a team of diverse professionals

Experience with Brand Names

Osteoporosis: Denosumab (PROLIA®), Zoledronic Acid (ZOMETA®) Pulmonary Embolism: KINLYTIC™

Raloxifene (EVISTA®), Teriparatide (FORTEO®) Sperm Sexing: LUMISORT™

Ibandronate (BONIVA®), Alendronate (FOSAMAX®) Migraine: Topiramate (TOPAMAX®)

Pain relief: Oxymorphone (OPANA®), Meperidine (DEMEROL®)

Cancer: DR-70 (ONKO-SURE®), Denosumab (PROLIA®) Genital wart: HPV Vaccine (GARDASIL®)

Education

Postdoctoral Fellowship, Reproductive Endocrinology, Infertility

Microbix Biosystems Inc., Dept. of Research and Production (R&D), Mississauga, ON, Canada

PhD, Molecular Biology, Reproductive Endocrinology, Ovarian Cancer Research

University of Toronto, Dept. of Physiology, Faculty of Medicine, Toronto, ON, Canada

MSc, Molecular Biology, Reproductive Physiology, Male Infertility

University of BC, Dept. of Obstetrics and Gynecology, Faculty of Medicine, Vancouver, BC, Canada

BSc, Obstetrics

Shahid Beheshti University of Medical Sciences, Tehran, Iran

Aug 2007 - Oct 2009

Jan 2001 - Sep 2006

Sep 1997 - Nov 1999

Sep 1987 - Dec 1992

Employment History

Senior Director, Medical Affairs, Oncology

Radient Pharmaceuticals Corp., Tustin, CA, USA

• Fulfilled the most senior executive role responsible for directing the company’s medical affairs function for ONKO-SURE®

• Monitored company-wide clinical quality, global publication planning, patient/doctor/MSL education and leadership initiatives

• Assured accurate communication of information and full compliance with legal/regulatory guidelines

• Oversaw the strategies for addressing the medical affairs requirements for the promotion/sales of the company’s approved products

• Supported sales/marketing with new client acquisition/management, provider communication, marketing/social media strategies

• Served as the liaison to payers, employer medical directors and medical policy personnel

• Led communication with physicians/health care professionals for design/production of training materials/CME

• Located, hired and managed internal/external consultants

Director, Medical Affairs, Oncology

Radient Pharmaceuticals Corp., Tustin, CA, USA

• Managed/directed global medical affairs, global strategic planning, global business development/marketing for ONKO-SURE®

• Designed, drafted protocol, executed and directed clinical trials/R&D related to the company’s products

• Presented/communicated the clinical trial data in conferences, exhibitions and meetings

• Led global publication planning, developed slide decks/posters, abstracts, manuscripts, product knowledge self-study materials (CME), review articles, regulatory documents (SOPs, clinical study protocols/reports (CSP/CSR), clinical summary of safety/efficiency (CSS/CSE), clinical study overview (CSO), case reports, study databases, and pipeline drug compendia/dossier)

Senior Medical Affairs Analyst, Rheumatology, Oncology

Amgen Inc., Thousand Oaks, CA, USA

• Supported doctors/healthcare professionals with pipeline product (Denosumab:AMG162, PROLIA®) at the national level

• Led medical writing/instructional design for abstracts, medical information letters, MSL training materials, slide decks for PROLIA®

• Led updating case reports, clinical study databases, templates and pipeline drug compendia/dossier for PROLIA®

• Conducted literature surveillance and competitor product/publication/KOL intelligence for PROLIA®

• provided scientific review of promotional/scientific deliverables and maintained/updated electronic clinical study databases

May 2011 - Present

May 2010 - Apr 2011

Oct 2009 - May 2010

Senior Research Scientist, Post Doctoral Fellow

Microbix Biosystems Inc., Mississauga, ON, Canada

• Supported the medical affairs, drafted/updated SOPs, protocols, training manuals for KINLYTIC™, LUMISORT™

• Supported the global publication planning (review articles, slide decks, abstracts and proposals) for KINLYTIC™, LUMISORT™

• Managed technicians, supervised the completion of projects to meet the deadlines in a GXP compliant environment

• Established/managed an IVF lab (brought it to be fully operational with greater than 80% cleavage rate)

• Developed/optimized different assays utilizing a wide variety of molecular biology techniques including: tissue culture, cloning, plasmid construction, transfection, SYBR Green/TaqMan Real-Time/QPCR, antibody/monoclonal antibody characterization, FACS/Flow Cytometry, and assay development/optimization, confocal/flourescent microscopy, digital image capture/analysis Aug 2007 - Sep 2009

Clinical Research Scientist, Patent Consultant

Samuel Lunenfeld Research Institute, Toronto, ON, Canada

• Led publication planning in a multidisciplinary team (drafted abstracts, manuscripts, proposals, grants, review articles, slide decks)

• Led the clinical trial design, protocol writing, execution, statistical analysis and interpretation for ovarian cancer

• Presented the clinical results in conferences/publications

• conducted publication/KOL intelligence

• Developed/optimized assays in a GLP/GMP/GCP environment utilizing a wide variety of molecular biology techniques incl: Protein interaction assay, Affymetrix, cDNA/Tissue Microarray, database analysis, bioinformatics, drug candidate screening, primary/secondary tissue culture (neuronal/cancer/embryonic cells), cloning, plasmid construction, transfection, SYBR Green/TaqMan Real-Time PCR, RNA interference, Northern/Southern blotting, protein biochemistry assays (Western blotting, immunoprecipitation), FACS/Flow Cytometry, confocal/flourescent microscopy and digital image capture/analysis

• Supervised/mentor lab technicians/graduate students

• Advised Technology Transfer Department for scientific integrity of patents (drafted, filed, executed patent applications)

Clinical Research Scientist

General Hospital, In Vitro Fertilization (IVF) Lab, Vancouver, B.C., Canada

• Performed systematic literature reviews regarding the ongoing IVF projects

• Drafted abstracts, manuscripts, proposals, grants, protocols, training manuals, and review articles

• Developed PowerPoint slide/poster for presentations in scientific/medical conferences

• Published many peer-reviewed papers based on the results of the ongoing IVF clinical research

• Participated in a variety of clinical research involved in human/bovine IVF and male infertility

• Administered experimental design, data collection/analysis, trouble shooting and collaboration management

VP, Medical & Scientific Affairs

Neometrix Consulting Inc., Toronto, ON, Canada

• Fulfilled the most senior executive role for leading the medical affairs strategies, company-wide quality and leadership initiatives

• Led business development, sales and marketing with new client acquisition/management

• Supported provider communication goals, marketing materials and social media strategies

• Assured accurate information communication in projects and full compliance with legal and regulatory guidelines

• Led regulatory writing including: SOPs, CSP, CSR, CSS, CSE, CSO, case reports

• Led global publication planning for the contracting companies

• Led medical writing projects for KINLYTIC™, TOPAMAX®, OPANA®, DEMEROL®, LUMISORT™

• Led instructional design for educational material (CME), web content development, e-learning web portals

• Located, hired and managed internal/external consultants

Senior Director, Medical & Scientific Affairs

Neometrix Consulting Inc., Toronto, ON, Canada

• Directed projects (medical affairs) for national/international companies (pharmaceutical, medical device)

• Led regulatory affairs with respect to regulatory compliance regulations for clinical trials, data privacy laws, patient safety

• Led global clinical trial design, protocol writing, execution, statistical analysis and interpretation

• Presented and communicated clinical results in conferences and peer-reviewed journals

• Directed the medical writing/instructional design for educational material (CME), web content development, e-learning web portals

Obstetrician

Dr. Bahonar Medical Clinic, Tehran, Iran

• Established private clinic, performed obstetric patient care, deliveries, post-partum/neonatal care, family planning

• Administered prescription drugs, birth control pills and IUDs

• Performed systematic literature reviews, drafted proposal/protocol/patient consent forms for clinical trial design/execution Sep 2000 - Jan 2007

Sep 1996 - Aug 2000

Jan 2004 - Oct 2009

Sep 1996 – Dec 2003

Sep 1993 - Aug 1996

Training and Development

Medical Affairs:

• FDA Quality System Regulation, QSR Inc., Tustin, CA, USA, Oct 12, 2010

• Clinical Trial Code of Conduct (a package of 70 Certificates), Amgen Inc, Thousand Oaks, CA, USA, Nov 2009 to May 2010

• Introduction to the Clinical Drug Development Process: ICH GCP for Clinical Trial Sites, Sceptor Inc., Los Angeles, CA, USA, Feb 25, 2009

• Clinical Research Training (NIH), Los Angeles, CA, USA, Aug 17, 2008

• Improved FDA Prescription Drug Labeling (NIH), Los Angeles, CA, USA, Aug 15, 2008

• Clinical Research Training/FDA Regulations (NIH), Los Angeles, CA, USA, Aug 15, 2008

• Teaching Higher Education (THE500H1), The University of Toronto, Toronto, ON, Canada, 2004

• Instructional Skills Workshop, University of British Columbia, Faculty Development Program, Vancouver, BC, Canada, 1999

Clinical Development:

• Proteomics and Functional Genomics (JTB2010H), University of Toronto, Toronto, ON, Canada, 2003

• Statistical Learning & Data Mining, Georgetown University, Washington DC, USA, 2002

• Labeling and Hybridization of Microarray Chips, The Microarray Center Clinical Genomics Center, Toronto, ON, Canada, 2002

• Radiation Safety Course for Research Radioisotope Users, Mount Sinai Hospital, Toronto, ON, Canada, 2001

• Animal Care Course, University of Toronto, Toronto, ON, Canada, 2001

• Chemical Safety Course, University of British Columbia, Department of Health, Safety and Environment, 1997

Clinical Practice:

• Permanent Permit of Professional Clinical Practice, Ministry of Health, Treatment and Medical Education, Tehran, Iran, 1996

• Professional clinical Practice, Manzarieh Medical Clinic, Tehran, Iran, 1995

• Controlling Acute Respiratory Diseases of Children, Shemiranat Health Care, Tehran, Iran, 1995

Intellectual Property:

• NIH Technology Transfer Certificate, Toronto, ON, Canada, May 27, 2007

• IPIC Patent Agent Certificate, IPIC, Toronto, ON, Canada, 2006

• Understanding Patents: An Introduction to Intellectual Property, McGill University, Montreal, ON, Canada, 2006

Professional Memberships

American Association of Cancer Research (AACR) 2010 - Present

Iranian-American Life Sciences Network (IALSN) 2010 - 2010

Biotech & Pharma Professionals Network (BPPN) 2009 - 2010

US Food and Drug Administration (FDA) 2008 - Present

US Department of Health & Human Services (DHHS) 2008 - Present

Centers for Disease Control and Prevention (CDC) 2008 - Present

Agency for Helathcare Research and Quality (AHRQ) 2008 - Present

Centers for Medicare & Medicaid Services (CMMS) 2008 - Present

American Medical Writers Association (AMWA) 2008 - Present

Iranian-American Medical Association (IAMA) 2007 - Present

Toronto Biotechnology Initiative (TBI) 2005 - 2009

American Association for the Advancement of Science (AAAS) 2002 - Present

Board Memberships

Advisory Board for Program Advisory Committee (PAC)

BiSP Program, ICET Dept, School of Engineering Technology & Applied Science, Centennial College, Toronto, ON, Canada (Feb 22, 2011 to present)

Director, Board of Directors

NuVax Therapeutics Inc., San Diego, CA, USA (Dec 07, 2010 to present)

Scientific Conference Exhibitions

ONKO-SURE® (colorectal cancer monitoring), Radient Pharmaceuticals, ASCO, Chicago, IL, USA, Jun 3-7, 2011

ONKO-SURE® (colorectal cancer monitoring), Radient Pharmaceuticals Corp., NCCN (Gastrointestinal Cancers), Philadelphia, PA, USA, Sep 14, 2010

ONKO-SURE® (colorectal cancer monitoring), Grifols Inc., American Association for Clinical Chemistry (AACC), Anaheim, CA, USA, Jul 25-29, 2010

ONKO-SURE® (colorectal cancer monitoring), Grifols Inc., American Association of Clinical Oncology (ASCO), Chicago, IL, USA, Jun 3-7, 2010

Computer skills

• EPICWeb, Sales Cloud Customer Relationship Management (CRM), Siebel Customer Relationship Management (CRM)

• HTML/Web publishing, Blogger, WordPress

• Basic/Turbo C Programming

• EndNote, Reference Manager

• Microsoft Office (Access, Front page, PowerPoint, Word, Excel, Outlook)

• Adobe Photoshop CS4, Illustrator, Acrobat, CorelDraw

• Affymetrix/cDNA microarray analysis software (Scan Array, Genepix, Quant Array, Cluster, Tree View, SAM, Array Assist)

• Real-Time PCR capture/analysis software (Mx3005P, ABI prism 7900HT, REST, X-REST)

• Flow Cytometry capture/analysis software (FCS Express, CFlow, FlowJo)

• Vector NTI, Primer Design software (Primer 3, Primer Express)

Invited Conference Chair/Presenter

1st International Conference in Notch Targeting in Cancer, Invited Speaker

Mykonos, Greece; June 22-24, 2011

28th International Conference in Advances in the Applications of Monoclonal Antibodies in Clinical Oncology, Invited Speaker

Mykonos, Greece; June 20-22, 2011

BIT’s 4th World Cancer Congress 2011, track 5-2 (Cancer Diagnostics, Therapy and Clinical Update), Invited Session Chair

Dalian, China; May 22-25, 2011

The Validation of DR-70 Efficiency in Early Detection of Lung Cancer (Abstract #515), Invited Poster Presenter

R Grimes, DF Weber. European Multidisciplinary Conference in Thoraci Oncology (EMCTO). Lugano, Switzerland; February 24-26, 2011

BIT’s 3rd World Cancer Congress 2010, Invited Speaker

Singapore Expo, Singapore; June 22-25, 2010

The Signs and Preventive Measures of Stroke, Invited Session Chair

Heart and Stroke Foundation of Ontario Meeting. Toronto, ON, Canada, May 27, 2007

Androgen Effects in Ovarian Epithelial Cells Potentially Involved in Cancer Predisposition or Progression, Invited Speaker

Persian-Canadian Biomedical Scientists (PCBMS), Toronto, ON, Canada, February 23, 2007

State-of-the-Art High throughput Array Technologies, Invited Speaker & Work Shop Conductor

National Research Center for Genetic Engineering and Biotechnology. Tehran, IR, February 23, 2005

Peer-Reviewed Publications

A novel cost-effective strategy for colorectal cancer screening with higher patient compliance. Motamed-Khorasani A, Small-Howard A, Beart R. J Clin Oncol, February 2012;30(4):407.

A new strategy for the early detection of colorectal cancer recurrence. Motamed-Khorasani A, Small-Howard A, Etemadi H, Beart H. J Clin Oncol, February 2012;30(4):416.

The validation of DR-70 marker (Onko-Sure) efficiency in early detection of lung cancer. Motamed-Khorasani A, Grimes R., Weber DF. Lung Cancer. 2011;71(2):S29.

Differentially Androgen-Modulated Genes in Ovarian Epithelial Cells from BRCA1 Mutation Carriers and Control Patients Predict Ovarian Cancer Survival and Disease Progression. Motamed-Khorasani A, Jurisica I, Letarte M, Shaw PA, Parkes RK, Zhang X, Evangelou A, Rosen B, Murphy KJ, Brown TJ. Oncogene. 2007 January 11;26 (2):198-214 (Epub Jul 10, 2006).

Cholesterol inhibitory effects on human sperm-induced acrosome reaction. Motamed-Khorasani A, Cheung AP, Lee CYG. Journal of Andrology, July-August 2000,21(4):586-594.

Effect of Pre-Treatment of Sperm with Progesterone and Cholesterol on In-Vitro Embryo Production in Cattle. Giritharan G, MK Afsaneh, Mohan M, Lee CYG, Rajamahendran R. Theriogenology, January 1999;51(1):318-329.

Assessment of Progesterone-Induced Acrosome Reaction by Biotinylated Monoclonal Antibody Probes. Lee CY, Khorasani AM, Dorjee S. The American Journal of Reproductive Immunology. 1998;39:3,164-171.

Books

Androgen Effects in Ovarian Epithelial Cells and Cancer Predisposition. Motamed-Khorasani A. LAP LAMBERT Academic Publishing; May 12, 2011. ISBN: 978-384-***-**** (Available for sale)

Research Abstract Conference Presentations (a selection of 10 out of 40)

- Combined DR-70 and CEA Testing is advantageous Over CEA Alone in the Detection of colorectal cancer and specifically the Right-Sided type. Motamed-Khorasani A, Beart R. 2012 American Society of Colon and Rectal Surgeons Meeting (ASCRS). San Antonio, TX; June 02-06, 2012.

- Further validation of DR-70 blood biomarker in the early detection of non-small cell lung cancer. Motamed-Khorasani A, Etemadi H. 2012 3rd European Lung Cancer Conference (ELCC). Geneva, Switzerland; April 18-April 21, 2012.

- Clinical Advantages of Combined DR-70 and CEA Testing Over CEA Alone in the Detection of Right-Sided Colorectal Cancer. Motamed-Khorasani A, Small-Howard A, Beart R. 2012 American Association of Cancer Research (AACR). Chicago, IL; March 31-April 4, 2012.

- A novel cost-effective strategy for colorectal cancer screening with higher patient compliance. Motamed-Khorasani A, Small-Howard A, Beart R. 2012 Gastrointestinal Cancers Symposium (ASCO). San Francisco, CA, USA; January 19-21, 2012.

- A new strategy for the early detection of colorectal cancer recurrence. Motamed-Khorasani A, Small-Howard A, Etemadi H, Beart H. 2012 Gastrointestinal Cancers Symposium (ASCO). San Francisco, CA, USA; January 19-21, 2012.

- The Validation of DR-70 Efficiency in Early Detection of Lung Cancer (Abstract #515). A. Motamed-Khorasani, R Grimes, DF Weber. European Multidisciplinary Conference in Thoracic Oncology (EMCTO). Lugano, Switzerland; February 2011.

- VEPH1 is a Novel Regulator of TGF Beta Signaling in Ovarian Cancer Cells. P Shathasivam, A Motamed-Khorasani, J Wrana, I Jurisica, T Brown. 25th Annual Research Day. Department of Physiology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; May 2, 2008 (Abstract #P-A5).

- Integrated Analysis of Androgen-Altered Genes in Epithelial Ovarian Cancer Using a Predicted Human Protein-Protein Interaction Network. KR Brown, A Motamed-Khorasani, TJ Brown, M Letarte, I Jurisica. 95th Annual Meeting of American Association of Cancer Research (AACR). Orlando, Florida, USA; 2004 (Abstract #3268), Published in Proc Amer Assoc Cancer Res, Vol 45, 2004.

- Mechanism of Natural and Induced Apoptosis in Human and Mice Testis. Motamed-Khorasani A, Rajamahendran R, Lee CYG. 1999 Annual Meeting for the Department of Animal Science. University of British Columbia, Vancouver, BC, Canada; 1999.

- Role of Progesterone and Cholesterol in In Vitro Embryo Production and Zona-Binding Assay in Cattle. Motamed-Khorasani A, Rajamahendran R, Lee CYG. 32nd Annual Meeting of the Society for the Study of Reproduction. July 31-August 3, 1999. Pullman, Washington, USA (Abstract #40). Biology of Reproduction Journal. May 1999;60(5):106.

Extracurricular Activities

Group Founder, Iranian Life Sciences and Medical Graduates of California, Irvine, California, USA Jan 2010

Invited Speaker, Heart & Stroke Foundation of Ontario May 2007 Seminar, Toronto, ON, Canada May 27, 2007

Distinguished Member (Holder of Editor’s Choice Award), The International Society of Poets, MD, USA Sep 05, 2006

Founder/President/Directing Manager, University of Toronto Choir Group, University of Toronto, Toronto, ON, Canada Feb 2004

Supervisor (up-rooting polio in Iran), Shemiranat Health Center, Tehran, Iran Aug 15-18, 1994

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