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CV AUG 2009

Location:
Willingboro, NJ, 08046
Posted:
September 17, 2009

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Resume:

CAMBRIA Pharmacy, Philadelphia, PA- Part-time retail pharmacy work (temporary) PRN September 2008-ongoing

ENZON PHARMACEUTICALS, INC., Bridgewater, NJ 10/2006-2008

Medical Science Liaison, Medical Affairs, Mid-Atlantic/Southern US

• Oncology-Provide medical affairs support to ENZON oncology products, Oncaspar (PEG-aspargase) and Depocyt (intrathecal Ara-C) in the treatment of acute leukemia’s and leptomeningeal metastasis respectively

• Infectious Disease-Establish collaborative research and provide educational programs on patients with invasive fungal infections using lipid-based antifungal agents. (cancer patients, organ or BMT transplant patients)

ADVANCED MEDICAL MARKETING COMMUNICATIONS, Lambertville, NJ 10/05-02/06

Director, Medical Affairs

• Responsible for developing strategic clinical development programs and communication plans for pharmaceutical clients with hematology/oncology (i.e., leukemia. lymphoma) compounds in phase II/III development

• Provide medical support, provide input on product positioning, publication planning and KOL advocacy development

• Company experienced financial problems and went bankrupt 2/06

TEMPLE UNIVERSITY SCHOOL OF PHARMACY, Phila, PA 12/04- Actively Ongoing

Active Member Board of Directors, Alumni-Special Projects Creation, University Awards, CME Programs, Student Awards. I enjoy teaching new pharmacy students in cooperation with the University and have carried my desire to educate to my colleagues, sales personnel and subordinates.

CHIRON BIOPHARMACEUTICALS, Emeryville, CA 11/03 - 12/04

Medical Science Liaison III- Medical Affairs - Oncology

• Research focused on the use of high-dose interleukin-2 either alone or in combination/sequence with other agents for the treatment of malignancies, specifically melanoma and renal cell carcinoma.

• Facilitated investigator-initiated research trials in leading cancer institutions using these modalities. Assigned to Northeast region of US. Frequent interaction with Memorial Sloan-Kettering, Columbia, Cornell, Dana-Farber, Fox Chase, Penn and others. Evaluated novel approaches using bio-immunotherapy in patients with renal cell carcinoma and malignant melanoma in addition to other malignancies.

MICHAEL K. ROCK, Pharm.D / Page 2

AMGEN INC., Thousand Oaks, CA 3/01 - 6/03

Regional Medical Liaison - U.S. Medical Affairs - Oncology

• Developed positive relationships with key opinion leaders in major oncology centers in the Northeast region of US

Disseminated and presented clinical and scientific information on new, recently approved long-acting versions of colony-stimulating cytokines erythropoietin (for anemia) (Aranesp®) and filgrastim (PEG-filgrastim) for bone marrow support in patients receiving chemotherapy or undergoing BMT

• Recruited investigators for clinical trials

• Evaluated research proposals for funding consideration

• Recruited and developed speaker faculty

• Provided product information and clinical and research pipeline presentations to various medical audiences

BERLEX LABORATORIES, Richmond, CA 4/97 - 3/01

Scientific Liaison - Oncology, Scientific Affairs

• Supported scientific, educational and clinical initiatives for fludarabine and Campath1H for treating leukemia, lymphomas and in BMT procedures

• Interacted and built relationships with leaders in hematology/oncology

• Reviewed and assessed merit of investigator-initiated pre-clinical and clinical hematology/oncology protocols for funding consideration

• Provided product information and clinical and pipeline presentations to various audiences

• Trained new MSL’s

SCHERING PLOUGH RESEARCH INSTITUTE, Kenilworth, NJ 5/96 - 4/97

Independent Consultant - Oncology Clinical Research

Projects included:

• International multi-center clinical trial assessing the safety and efficacy of alpha-Interferon in patients with intermediate/high grade non-Hodgkin's lymphoma (NHL) undergoing BMT

• Reviewing and refining clinical study data of patients with Hodgkin's disease undergoing interleukin therapy

• Start up of an international clinical trial of patients with metastatic breast cancer undergoing treatment with a novel anthracycline delivery system (liposomal pegylated doxorubicin, Caelyx)

MICHAEL K. ROCK, Pharm.D. / Page 3

QUINTILES Transnational (formerly Innovex Inc.), Yardley, PA 4/94 - 5/96

Clinical Research Director / Manager

• Managed departmental operations, clinical drug development programs and project teams. Served as a liaison between clients and business development directors. Prepared time lines, budgets and clinical activity reports. Developed

organizational processes and procedures. Selected outside vendors. Served as a supervisor with up to 13 direct reports nationally. This involved interviewing candidates, training, educating and teaching CRAS.

Therapeutic areas and projects managed included:

• Cardiovascular –Managed International, multi-center survival trial in patients with CHF receiving ACE inhibitor therapy (ZESTRIL® (lisinopril)), 119 North American sites (ATLAS Study).

- Managed International, multi-center trial in patients with ischemic events (MI, CVA, PAD) receiving an antiplatelet compound clopidogrel (Plavix®), 31 studies sites (CAPRIE Study).

Supervised site management and monitoring of a clinical trial in obese patients with hypertension, 7 study sites.

- Organized and initiated a clinical trial of patients undergoing PTCA (unstable angina) to evaluate an IIb/IIIa platelet receptor antagonist – 31 studies sites (3 in the UK).

• Oncology - Management of a cervical cancer vaccine trial (National Cancer Institute - Biologic Response Modifiers Program).

- Brain Tumors-Managed and monitored phase I/II trials of patients with glioblastoma multiforme receiving viral vector gene therapy.

• Infectious Disease - Project Manager for a phase I trial in patients with HSV (vaccine);

• Radiological Diagnostic Imaging – Implemented and managed:

• Phase I trial in normal healthy volunteers evaluating a novel contrast agent utilizing ultrasound technology.

• Diagnostic research trial evaluating gadolinium- based contrast agents in patients with malignant brain tumors (astrocytoma, GBM) patients

COVANCE DRUG DEVELOPMENT SERVICES (formerly Besselaar Associates), Princeton, NJ 1987 - 1994

Senior CRA / Project Manager

• Supervised and directed the clinical development plans, time and cost estimates. Performed budget management, protocol development, CRF design and investigator selection. In charge of AE reporting, preparing reports, training and supervising multiple CRAs. Conducted investigator and client meetings. Led cross-functional development team, (Regulatory, data management, monitoring, etc)

MICHAEL K. ROCK, Pharm.D./Page 4

ISS reports, FDA InteractionManaged clinical trial projects and conducted extensive field monitoring in several therapeutic areas, primarily:

Oncology - developed and implemented CPT-11 (CAMPTOSAR®) IND program and First-in-Man Phase I/II trials in the United States, which ultimately led to full global marketing approval for the treatment of metastatic colorectal cancer

- Monitored Prostate cancer study evaluating anti-androgen therapy

Other therapeutic areas: Cardiovascular and pulmonary medicine; gastroenterology ( Calcium channel blocker for IBS) and diagnostic imaging.

Granted 14-month leave of absence in 1988 to complete graduate school.

AH ROBINS / ELKINS-SINN, INC., Cherry Hill, NJ 1984 - 1987

Coordinator of Professional Services

• Large generic injectable sterile product manufacturing. Provided drug information to healthcare practitioners, investigated product complaints, received and reporting of adverse experiences, maintained product and literature database.

Development Scientist

Coordinated scale-up from laboratory to manufacturing for oncology and the drugs coming off patent. Developed and compounded chemotherapeutic agents.

• Manufactured and generated chemical and physical stability data on injectable oncology and other drugs for generic drug approval

KENNEDY MEMORIAL HOSPITAL PHARMACY DEPARTMENT Cherry Hill, NJ 1980-1984

Staff Clinical Pharmacy duties. Interpreted physicians orders, prepared various intravenous admixtures, in-patient and out patient prescription dispensing and chemotherapy

Pharmacy Internship

VILLAGE APOTHECARY, Burlington, NJ 1979-1981

LONG-TERM CARE FACILITY

U.S. NAVY REGIONAL MEDICAL CENTER, Orlando, Florida 1974-1979 Pharmacy Technician National Training Center- Inpatients and Out-patient > Dispensed 1000Rx’s /day)

MICHAEL K. ROCK, Pharm.D./ Page 5

Navy Hospital Corpsman,

Responsible for advanced field first and emergency trauma care for assigned Marine units in the field.

U.S. NAVY – Petty Officer Second Class-Honorable Discharge, 1979 - Disabled Veteran, Vietnam era

PROFESSIONAL ASSOCIATIONS

American Society of Clinical Oncology (ASC0)

Hematology Oncology Pharmacy Association (HOPA)

American Pharmaceutical Association (APhA)

Drug Information Association (DIA)

The Chemotherapy Foundation

Temple University School of Pharmacy, Member, Board of Directors, Alumni Association 2001- Present

EDUCATION AND LICENSURE

EDUCATION:

Auburn University, Auburn, AL

Doctor of Pharmacy, Pharm.D. 1989

Temple University School of Pharmacy, Philadelphia, PA

Bachelor of Science, Pharmacy, Registered Pharmacist 1984

U.S. Navy - Naval School of Health Sciences, VA and CA

o Pharmacy Technician School

o Hospital Corpsman School

o Fleet Marine Force

MICHAEL K. ROCK, Pharm.D./ Page 6

LICENSURE:

Registered Pharmacist / Certified Consultant Pharmacist,

State of New Jersey Lic# 18121

Registered Pharmacist (R.Ph.)

State of Florida Lic# 21445

Registered Pharmacist (R.Ph.)

State of Pennsylvania

Currently under reciprocation

PUBLICATIONS

1. Turco SJ, Rock MK. The effects of microwave radiation on frozen parenteral antibiotics: A review. Parenterals, 2:1-7 (1984).

2. Rothenberg ML, Kuhn J, Burris HA, Morales MT, Nelson J, Eckardt J, Rock MK, Tereda K, Von Hoff D. A Phase I and pharmacokinetic trial of CPT-11 in patients with refractory solid tumors. Proc. Am. Soc. Clin. Oncol., 11:A273 (1992).

3. Rowinsky E, Grochow L, Ettinger D, Hendricks C, Lubejko B, Sartorius S, Hurowiz L, McGuire W, Rock M, Donehower R. A Phase I and pharmacologic evaluation of CPT-11, a semi-synthetic topoisomerase I - targeting agent, on a single dose schedule. Proc. Am. Soc. Clin. Oncol., 11:A281 (1992).

4. Tristen-Morales M, Hyman J, Rothenberg ML, Burris HA, Nelson J, Eckardt JR, Rock MK, Terada K, Von Hoff DD. Pharmacokinetics of CPT-11: Plasma and urine levels. Proceedings of the 2d Annual Symposium on Cancer Research, San Antonio, TX, 1992:27.

5. Rothenberg, ML, Kuhn J, Burris HA, Tristen-Morales M, Nelson J, Eckardt JR, Rock MK, Von Hoff DD, CPT-11: Phase I experience using a weekly schedule. Proceedings of the 7th NCI-EORTC Symposium on New Drugs in

Cancer Therapy, Amsterdam, The Netherlands, March 17-20, 1992:3 (Suppl/1):

6. Rothenberg, ML, Rowinsky E, Kuhn JG, Burris HA, Rock MK, Terada K, Donehower RC, Von Hoff DD. Clinical Trials and Pharmacokinetic Studies of CPT-11 in the U.S. Presented at the 4th Conference on DNA Topoisomerases in Therapy, New York, October 26-29, 1992.

7. Rothenberg ML, Kuhn JG, Burris HA, Nelson J, Eckardt J, Tristen-Morales M, Hilsenbeck SG, Weiss GR, Smith LS, Rodriquez GI, Rock MK, Von Hoff DD. A

MICHAEL K. ROCK, Pharm.D./ Page 7

Phase I and pharmacokinetic trial of weekly CPT-11. J. Clin. Oncol., 11:2194-2204 (1993).

8. Rowinsky EK, Growchow LB, Ettinger DS, Sartorius SE, Lubejko BG, Chen TL, Rock MK, Donehower RC. Phase I and pharmacologic study of the novel topoisomerase inhibitor CPT-11 administered as a 90-minute infusion every 3 weeks. Cancer Res., 54:427-436 (1994).

9. Czuczman M, Joans C, Stephan M, Scarpace A, Brown K, Rock M, Kunkel L, Grillo-Lopez, A, Bernstein S. Pilot study of Rituxan in combination with fludarabine chemotherapy in patients with low-grade or follicular lymphoma. Proc. Am. Soc. Clin. Oncol., 18:A61 (1999).

10. Czuczman MS, Fallon A, Mohr A, Stewart C, Klippenstein D, Loud P, Lamonica D, Bernstein ZP, McCarthy PL, Skipper M, Brown K, Miller K, Wentlinh D, Rock MK, Benyunes M, Grillo-Lopez A,Bernstein SH, Phase II Study of Rituximab plus Fludarabine in Patients with Low-Grade Lymphoma: Final Report. Submitted to Blood (2001).

11. Savage D, Cohen S, Hesdorffer CS,Oster M, March R, Lonberg M, Garret TJ, Flamm M, Mears G, Taub RT,RuizJ,Talbot S, Keenan K, Heitjan DS,Nichols G, Rock MK Combined fludarabine and rituximab for low grade lymphoma and chronic lymphocytic leukemia. Blood 2001 Abstract # 4723.

12. Czuczman MS, Fallon A, Mohr A, Stewart C, Bernstein ZP, McCarthy P, Skipper M, Brown K, Miller K, Wentling D, Klippenstein D, Loud P, Rock MK, Benyunes M, Grillo-Lopez AJ, Bernstein SH. Rituximab in combination with CHOP or fludarabine in low-grade lymphoma. Seminars in Oncology 29(1) (suppl 2): 36-40, 2002.

13. Czuczman MS, Koryzna A, Mohr A, Stewart C, Donohue K, Blumenson L, Bernstein ZP, McCarthy P, Alam A, Hernandez-Ilizaliturri F, Skipper M, Brown K, Chanan-Khan A, Klippenstein D, Loud P, Rock MK, Benyunes M, Grillo-Lopez A, Bernstein SH. Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma. J Clin Oncol. 2005 Feb 1;23(4):694-704.



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