SLAWOMIR MAREK WOJTOWICZ-PRAGA, M.D.

                                                                                          August 17, 2004

 

PERSONAL INFORMATION

 

Work address:

           

Sankyo Pharma Development,

399 Thornall Street,

Edison, NJ 08837

 

Work phone:  (732) 590 5021

 

Work fax:  (732) 906 5690

 

E-mail:  swojtowicz(at)sankyopharma.com

 

 

EDUCATION

 

1983 – 89        Medical Degree - Medical School of Gdansk, Gdansk, Poland.

 

1990 – 93        Internship/Residency - Internal Medicine, Henry Ford Hospital, Detroit, Michigan.

 

1993 – 95        Oncology Fellowship - Medical Oncology, Vincent T. Lombardi Cancer Center,

Georgetown University Medical Center, Washington, D.C.

 

1995 - 96         Research Fellowship - Developmental Therapeutics Program, Vincent T. Lombardi Cancer Center, Georgetown University Medical Center, Washington, D.C.

 

 

OTHER TRAINING

 

1986                Rural Medicine - District Hospital, Bytow, Poland

1987                Cardiology - Marburg University Hospital, Marburg, Germany

1987                Hospice Training - Colman Hospital, Priscilla Bacon Lodge, Norwich, England

1988                Cardiothoracic Surgery - Albert Einstein Medical Center, Philadelphia, Pennsylvania

1989                Internal Medicine - St. Mary's Hospital, Newport (Isle of Wight), England

1993/ 94          Oncology - NCI, Biological Response Modifiers Program, Frederick, MD

1995                Fellow Medical Officer - FDA, Div. of Oncologic and Pulmonary Drugs, Rockville,  MD

 

 

POSITIONS

 

1996 - 2001                 Associate Director, Medical Affairs, TheradexÒ

2001 - 2004                 Director, Medical Affairs, Aventis Oncology

2004 – present             Senior Director, Clinical Development – Oncology, Sankyo Pharma

 

 

LICENSURE AND CERTIFICATION

 

ECFMG (1989)

MD Diploma (1989)

FLEX (1992)

Federal DEA license

American Board of Internal Medicine (1993)

American Board of Internal Medicine - Medical Oncology (1997)

Virginia license (inactive)

Washington D.C. License (inactive)

New Jersey license

New Jersey CDS registration

 

 

PROFESSIONAL AFFILIATIONS

 

Member, American Association for Cancer Research

Member, American Society of Clinical Oncology

Fellow, Society for Biological Therapy

 

 

HONORS AND AWARDS

 

Finalist, Polish National Biology Competition (1983)

Laureate, Annual Biochemistry Award, Medical School of Gdansk (1986)

Recognition Award, Scientific Camp, Medical School of Gdansk (1986)

Academic Achievement Grants, Medical School of Gdansk (1984-1989)

Finalist, ACP National Research Poster Competition (1993)

American Society of Clinical Oncology Merit Award (1995)

Grant Award, First ASCO/AACR Workshop on Methods in Clinical Cancer Research (1996)

 

 

EXPERIENCE

 

As an Associate Medical Director at Theradex, Dr. Wojtowicz-Praga reported directly to Theradex’s President, Meg Valnoski.  He was a Project Director for cancer drug trials in the United States and his duties included:

 

- Supervision of Clinical Trial Monitoring Service (CTMS) for the National Cancer Institute (including monitoring compliance with NCI guidelines, audit visits to Cancer Centers nationwide and to branches of the NCI).

 

- Evaluation of side effects, including SAEs, related to the cancer therapy on all studies monitored by Theradex,

 

- Negotiations and day-to-day contacts with pharmaceutical companies and investigators,

 

- Design and participation in design of cancer trials conducted in US and worldwide (Phase I - IV),

 

- Consultations for pharmaceutical and biotech companies, including review of pre-clinical data

 

- Management of Phase I – IV cancer trials,

 

- Selection of study sites, qualifying and initiation visits to study sites,

 

- Clinical input into development of CRFs, study manuals and other study materials and publication of study newsletters,

 

- Interactions with statisticians, Regulatory, Data Management and other Project Groups at Theradex,

 

- Supervision of CRAs and providing medical expertise to Project Managers,

 

- Coordination and conduct of Investigator Meetings,

 

- Setup and coordination of work of Data and Safety Review Boards (DSMB),

 

- Preparation of SOPs for DSMBs,

 

- Communications with DSMB members,

 

-  Preparation and clinical review of final study reports,

 

- Review of publications prior to submission to medical journals,

 

- Presentations to and negotiations with the FDA and other Government agencies.

 

 

In his position at Aventis Dr. Wojtowicz-Praga reported to Michael Meyers, M.D., the Senior Director of Medical Affairs, Oncology.  His duties at Aventis included:

 

-         Responsibility for Taxotere studies in patients with NSCLC, SCLC, prostate cancer and HNC

 

-         Responsibility for Anzemet (5HT3 inhibitor) studies,

 

-         Design of new lung cancer trials conducted by US Medical Affairs,

 

-         Review and approval of investigator-initiated studies,

 

-         Copy review and approval for marketing and advertising materials,

 

-         Interactions and collaboration with Statistical Department, Global Medical Affairs, Global Marketing, R&D group, Regulatory, US Marketing and Clinical teams,

 

-         Review of educational grants,

 

-         Preparation and review of the final study reports,

 

-         Review and approval of journal articles, ASCO abstracts and posters and Medical Affairs’ monographs

 

-         Interactions and meetings with thought leaders,

 

-         Collaboration with other pharmaceutical and biotech companies on joint studies,

 

-         Input into development of new agents currently in Aventis pipeline, and participation in review of agents considered for in-licensing,

 

-         Participation in Global Labeling Committee meetings,

 

-         Training of Sales Representatives, Clinical Oncology Managers (COMs) and Professional Oncology Education Managers (POEMs),

 

-         Close collaboration with Clinical Oncology Managers and Professional Oncology Education Managers,

 

-         Educational lectures for oncology sales and marketing groups, COMs and POEMs

 

-         Preparation and modification/updates of the Clinical Development Plan for Taxotere in lung cancer,

 

-         Key role within the Lung Cancer Cross-functional team,

 

-         Supervision of the Lung Cancer Project Manager and his team of CRAs,

 

-         Participation in the Lung Cancer Advisory Boards,

 

-         Presentations of Lung Cancer studies and pipeline drugs within and outside Aventis

 

-         Corporate visits to Cancer Centers in the United States.

 

 

PUBLICATIONS

 

Articles and Abstracts

 

1.      Wojtowicz S.  Fast screening test for infectious mononucleosis not dependable. Consultant 33, 4:162-3, 1993.

 

2.      Wojtowicz S.  Multiple sclerosis and prions.  Medical Hypotheses 40:48‑54, 1993.

 

3.      Wojtowicz S, Ness E, Dickson R, Low J, Barter J, McCann P, Hawkins MJ.  Phase I trial of batimastat (BB-94), a novel matrix metalloproteinase inhibitor in patients with advanced cancer.  Journal of Immunotherapy, 16(3):249, 1994.

 

4.      Wojtowicz S, Ness E, Dickson R, Low J, Barter J, McCann P, Hawkins MJ.  Pharmacokinetics of batimastat (BB-94), a novel matrix metalloproteinase inhibitor in patients with advanced cancer.  Proceedings of American Society of Clinical Oncology, 14:474(#1536), 1995.

 

5.      Wojtowicz-Praga S, Verma UN, Wakefield L, Esteban M, Hartmann D, Mazumder A. Modulation of B16 melanoma growth and metastasis by anti‑transforming growth factor beta and interleukin-2.  Journal of Immunotherapy, 19(3):169-175, 1996.

 

6.      Wojtowicz-Praga S, Low J, Dickson R, Ness E, Barter J, McCann P, Cole A, Hawkins MJ.  Phase I study of batimastat (BB-94), a novel matrix metalloproteinase inhibitor in patients with advanced cancer.  Investigational New Drugs, 14:193-202, 1996.

 

7.      Wojtowicz-Praga S, Low J, Johnson M, Ness E, Sale M, Rasmussen H, Chiodo TA, Marshall J, Hawkins M. Pharmacokinetics of marimastat (BB-2516), a novel matrix metalloproteinase inhibitor administered orally to patients with metastatic lung cancer.  Proceedings of American Society of Clinical Oncology, 15:490(#1565), 1996.

 

8.      Wojtowicz-Praga S, Dickson RB, Hawkins MJ.  Matrix metalloproteinase inhibitors.  Investigational New Drugs, 15:61-75, 1997.

 

9.      Wojtowicz-Praga S.  Reversal of tumor-induced immunosuppression: a new approach to cancer therapy.  Journal of Immunotherapy, 20(3):165-177, 1997.

 

10.  Durivage H, Wojtowicz-Praga S.  Paclitaxel (Taxol) and docetaxel (Taxotere).  Cancer Therapeutics Vol 1, 1: 66-70, 1998.

 

11.  Wojtowicz-Praga S, Torri J, Johnson M, Steen V, Marshall J, Ness E, Dickson R, Rasmussen HS, Chiodo TA, Hawkins MJ.  Phase I trial of Marimastat, a novel matrix metalloproteinase inhibitor administered orally to patients with advanced lung cancer.  JCO, Vol. 16(6):2150-2156, 1998.

 

12.  Durivage H, Wojtowicz-Praga S.  Liposomal daunorubicin.  Cancer Therapeutics, Vol 1, 5:326-328, 1998.

 

13.  Wojtowicz-Praga S.  Matrix metalloproteinases in disease:  the potential role of metalloproteinase inhibitors.  Leading article, Drugs in R & D, Vol 1, 2:117-129, 1999.

 

14.  Wojtowicz-Praga S.  Matrix metalloproteinase inhibitors.  Chapter 12, 251-259, in: Abelloff                 MD et al.(eds), Clinical Oncology, Second edition, 2000. 

 

15.  Wojtowicz-Praga S.  Transforming Growth Factor-β and tumor-induced immunosuppression. Electronic Journal of Oncology (http://www.elecjoncol.org/Archivage/PDF/142.pdf), 1: 52-63, 2000.

 

16.  Orringer E, Casella JF, Ataga KI, Koshy M, Adams-Graves P, Luchtman-Jones L, Wun T, Watanabe M, Shafer F, Kutlar A, Abboud M, Steinberg M, Adler B, Swerdlow P, Terregino C, Saccente S, Files B, Ballas S, Brown R, Wojtowicz-Praga S, Grindel JM.   Purified poloxamer 188 for treatment of acute vaso-occlusive crisis of sickle cell disease: A randomized controlled trial.  JAMA. 286 (17):2099-106, 2001.

 

17.  Marshall JL, Bangalore N, El-Ashry D, Fuxman Y, Johnson MJ, Norris B, Oberst M, Ness E, Wojtowicz-Praga S, Bhargava P, Rizvi N, Baidas S, Hawkins MJ.  Phase I study of prolonged infusion bryostatin-1 in patients with advanced malignancies.   Cancer Biol Ther 2002 Jul-Aug; 1(4):409-16

 

18.  Wojtowicz-Praga S.   Reversal of tumor-induced immunosuppression by TGF-β inhibitors.   Investigational New Drugs 21:1-12, 2003.

 

19.  Ramalingam S,  Dobbs TW, Avi I. Einzig AI, Wojtowicz-Praga S, Cascino M,  Bonomi P, Belani CP . Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter Phase II study.  Cancer Chemother Pharmacol 53(5):439-44., 2004

 

20.  Ballas S, Files B, Luchtman-Jones L, Wojtowicz-Praga S, et al.  Safety of purified poloxamer 188 in sickle cell disease: Phase I study of a non-ionic surfactant in the management of acute chest syndrome.  Hemoglobin. 28(2):85-102, 2004.

 

Posters

 

 1.        Wojtowicz-Praga, S.  Is tripartite manifestation of multiple sclerosis related to prional etiology?  Michigan ACP Meeting, Traverse City, September 1991.

 

 2.        Wojtowicz-Praga S. Vasquez J, Dickinson Z.  Takayasu's arteritis - case report.  Michigan ACP Meeting, Traverse City, September 1991.

 

 3.        Wojtowicz-Praga S.  Spectacular case of infectious mononucleosis - case report and review of accuracy of fast-screening tests used in outpatient setting to diagnose the disease.  38th Annual Michigan ACP Scientific Meeting, Detroit, October 1992.

 

 4.        Wojtowicz-Praga S.  Multiple sclerosis: pathomechanism of the disease.  38th Annual Michigan ACP Scientific Meeting, Detroit, October 1992.

 

 5.        Wojtowicz-Praga S, Bolton MB.  How to improve the quality of preventive care in a primary care clinic setting.  Evaluation of a new questionnaire. 76th Annual Session of the ACP, Washington, D.C., April 1993.

 

 6.        Wojtowicz-Praga S, Vasquez J, Dickinson Z.  Takayasu's Arteritis - Review of clinical presentations at Henry Ford Hospital.  15th Annual Michigan ACP Associates Meeting, Lansing, May 1993.

 

7.         Wojtowicz-Praga S, Ness E, Dickson R, Low J, Barter J, McCann P, Hawkins M.  Phase I trial of batimastat (BB-94), a novel matrix metalloproteinase inhibitor in patients with advanced cancer - preliminary results.  Georgetown University Research Day, September 1994.

 

 8.        Wojtowicz-Praga S, Ness E, Dickson R, Low J, Barter J, McCann P, Hawkins M. Pharmacokinetics of batimastat (BB-94), a novel matrix metalloproteinase inhibitor in patients with advanced cancer.  Annual Meeting of American Society of Clinical Oncology, Los Angeles, May 1995.

 

 9.        Wojtowicz-Praga S, Ness E, Marshall J, Hawkins M.  Phase I trial of BB‑2516, a novel matrix metalloproteinase inhibitor (MMPI) in patients with advanced or metastatic lung cancer - preliminary results.  Georgetown University Research Day, September 1995.

 

10.       Wojtowicz-Praga S, Verma U, Wakefield L, Hartmann D, Esteban JM, Mazumder A.  Anti-tumor effects of TGF-β antibody alone and in combination with interleukin-2.  Georgetown University Research Day, September 1995.

 

11.       Wojtowicz-Praga S, Verma U, Wakefield L, Hartmann D, Esteban JM and Mazumder A.  Anti-tumor anti-TGF-β antibody in combination with IL-2 inhibits B-16 melanoma growth and metastasis.  X Annual Meeting of Society for Biological Therapy, Williamsburg, VA, November 1995.

 

12.              Wojtowicz-Praga S, Torri J, Johnson M, Ness E, Sale M, Rasmussen H, Chiodo TA, Marshall J, Hawkins M.  Pharmacokinetics of marimastat (BB‑2516), a novel matrix metalloproteinase inhibitor administered orally to patients with advanced or metastatic lung cancer.  Annual Meeting of American Society of Clinical Oncology, Philadelphia, May 1996.

 

13.              Ramalingam S, Bonomi P, Dobbs T,  Einzig A, Wojtowicz-Praga S, Cascino M, Belani CP. Docetaxel and Carboplatin for advanced Non-Small Cell Lung Cancer (NSCLC): Dose  of Carboplatin influences outcome. Abstract No: 1263.  Annual Meeting of American Society of Clinical Oncology, Orlando, May 2002.

 

14.              Dragnev KH, Clamon G, Raez L, Jahanzeb M, O'Rourke M,  Perry  M, Carey M, Benedetto J, Wojtowicz-Praga S, Rigas JR. Docetaxel and cisplatin as induction therapy for stage IIIA (N2) non-small cell lung cancer (NSCLC).  Abstract # 2652.  Annual Meeting of American Society of Clinical Oncology, Chicago, May 2003.

 

 

Lectures and Oral Presentations

 

 1.        Wojtowicz-Praga S.  Suicide and physician-assisted suicide.  Primary Care Conference, Henry Ford Hospital, November 1990.

 

 2.        Wojtowicz-Praga S.  Lung cancer - screening and management.  Primary Care Conference, Henry Ford Hospital, November 1991.

 

 3.        Wojtowicz-Praga S.  Multiple Sclerosis - New pathophysiological model and hypothesis.  Grand Rounds, Henry Ford Hospital, March 1992.

 

 4.        Wojtowicz-Praga S.  Multiple sclerosis - review of pathophysiology and the latest hypotheses on etiology.  International Symposium of Neurologists and Internists.  Elblag, Poland, December 10, 1992.

 

 5.        Wojtowicz-Praga S.  Preventive care in the United States.  International Symposium of Neurologists and Internists.  Elblag, Poland, December 10, 1992.

 

 6.        Wojtowicz-Praga S.  Idiopathic thrombocytopenia - case presentation and review of the disease pathophysiology.  Grand Rounds, Henry Ford Hospital, February 23, 1993.

 

 7.        Wojtowicz-Praga S.  Community Resources Team Presentation.  Meeting of the Department of Internal Medicine, Henry Ford Hospital, April 19, 1993.

 

 8.        Wojtowicz-Praga S.  Multiple Sclerosis - Pathomechanism of the disease.  Michigan ACP 15th Annual Associates Meeting, Lansing, May 7, 1993.

 

 9.        Wojtowicz-Praga S, Bolton MB.  Improving the quality of preventive care in a primary care clinic setting - Evaluation of a new questionnaire.  Michigan ACP 15th