CURRICULUM VITAE: Bernard Mark SMITHERS

ACADEMIC ADDRESS: Department of Surgery, University of Queensland, Princess

Alexandra Hospital, Ipswich Rd., Brisbane, Australia 4102

PRIVATE PRACTICE: GIAST Clinic, Suites 30,31 Mater Medical Centre, 293 Vulture St.,

South Brisbane, Australia 4101

E MAIL:

PLACE

OF BIRTH: Brisbane, Queensland.

EDUCATION:

TERTIARY: University of Queensland 1972-1977 M.B.B.S.

POSTGRADUATE: Fellow Royal Australasian College of Surgeons, Feb 1985

Fellow Royal College of Surgeons of England, Jan 1986

QUALIFICATIONS: M.B.B.S.(Qld), F.R.A.C.S., F.R.C.S.(Eng).

PRESENT APPOINTMENTS:

ACADEMIC: Associate Professor of Surgery, University of Queensland (Part Time)

Level D, Academic (Point 0404)

Honorary Associate, NH&MRC Trials Centre, Faculty of Medicine,

University of Sydney

CLINICAL: Senior Visiting Medical Officer - Trauma/General Surgeon,

Director, Upper GI and Soft Tissue Unit, Princess Alexandra Hospital.

PREVIOUS APPOINTMENTS:

Consultant Surgeon Appointments.

• Locum Surgeon, Flying Surgeon Service, Longreach, Australia, Jan 1987.

• Locum Vascular Surgeon, Princess Alexandra Hospital, Jan-Feb 1988.

• Visiting Consultant Surgeon, Logan Hospital, June 1990-91.

• Clinical Lecturer, University of Queensland, Department of Surgery, Princess Alexandra Hospital, Brisbane. Sept 1987 - June 1988.

• Senior Lecturer in Surgery, University of Queensland, Department of Surgery, Trauma/General Surgeon, Princess Alexandra Hospital, Brisbane. June 1988 - April 1995.

• Associate Professor in Surgery, University of Queensland, Department of Surgery, Princess Alexandra Hospital, Brisbane. May 1995 -

• Visiting Surgeon, Upper GI and Soft Tissue, Unit Princess Alexandra Hospital, Brisbane. May 1995 - July 1996

• Senior Visiting Surgeon, Director, Upper GI and Soft Tissue Unit, Princess Alexandra Hospital, Brisbane. July 1996 – present time

LICENSURE: Medical Board of Queensland.

General Medical Council of England.

SPECIALTY CERTIFICATION: General Surgery

PROCEDURAL CERTIFICATION: Colonoscopy, Gastroscopy

PROFESSIONAL MEMBERSHIPS:

1978 Medical Defence Society of Queensland 1978-1997

1980 Australian Sports Medicine Federation 1980-2006)

1982 Visa Qualifying Examination of Educational Commission for Foreign Medical Graduates (E.C.F.M.G.)

1985 Royal Australasian College of Surgeons (Current)

1986 Royal College of Surgeons of England (Current)

1986 World Association of Hepato Pancreatico-Biliary Surgeons

1988 Gastroenterological Society of Queensland (Current)

1991 Clinical Oncological Society of Australia (Current)

1992 Gastroenterological Society of Australia (1992 – 2008)

1992 Surgical Research Society of Australasia (Current)

1994 Eastern Co-operative Oncology Group (E.C.O.G.) - Investigator (Current)

1997 United Medical Protection Society (1997 - 2007)

1998 International Association of Hepato-pancreaticobiliary Surgeons(Current)

1999 International Society of Diseases of the Esophagus(Current)

2000 Society of Surgical Oncology (USA)- (Current)

2007 Australia and New Zealand Gastro-Oesophageal Surgeons Association (Current)

2007 Avant Medical Insurance (Current)

AWARDS:

1992: Queensland Cancer Fund - E.S.A. International Scholarship

Study and Travel Programme:

MD Anderson Cancer Centre - Houston, Texas,

Department of Surgery, University of Kentucky, Louisville, Kentucky

Memorial Sloan Kettering Cancer Institute, New York.

Prince of Wales Hospital, Chinese University, Hong Kong.

2003: Philip Goatcher Surgeon in Residence – Royal Perth Hospital.

July, Perth

2007: Nimmo Visitor – Royal Adelaide Hospital

October 29 – November 1, Adelaide, Australia.

2008: Distinguised Invited Visitor - Combined Royal Australasian College

of Surgeons and College of Surgeons of Hong Kong Annual Scientific

Congress. May 13 – 18, Hong Kong

CLINICAL INTERESTS:

UPPER G.I. SURGERY - I am one of four Surgeons and the Chairman/ Director of the Upper G.I./Soft Tissue Unit at Princess Alexandra Hospital.

My interests and research include:

(i)Malignant diseases of the oesophagus and stomach. In 1994 we established a multi-disciplinary Upper GI Oncology Clinic, involving surgery, medical oncology and radiation oncology. We presently run a weekly multidisciplinary meeting to discuss all new and problem cases of cancer of Gastric and Oesophageal Malignancy. All oesophageal and gastric malignancies are documented onto a prospective database. We see over 100 new patients with malignant dysphagia each year and operate on 45%.

(ii) Benign conditions notably Gastro-oesophageal Reflux. In collaboration with my colleagues Professor David Gotley and Les Nathanson we are documenting all patients who have had surgery.

(iii) We are a tertiary referral centre for complicated upper GI problems including patients with Achalasia and those who have had previous surgery with functional problems.

MELANOMA - I am the Senior Surgeon in the Melanoma Clinic at Princess Alexandra Hospital. This is a multi-disciplinary clinic with medical oncology and radiotherapy, and is the base for the initiation of a number of clinically based research projects and trials. I am Chairman of The Queensland Melanoma Project which is the research arm of the Melanoma Clinic. This group runs and co-ordinates the clinically based trials for patients managed through the Melanoma Clinic.

ENDOSCOPY - DIAGNOSTIC - I am accredited in colonoscopy and gastroscopy with the combined committee of the G.E. Society of Australia and the Royal Australasian College of Surgeons.

ENDOSCOPIC SURGERY - I am experienced in advanced Laparoscopic Surgery including cholecystectomy, Nissen fundoplication, oesophageal resection, adrenalectomy and splenectomy. At the time of the introduction of laparoscopic surgery, I had been on the teaching faculty for practical courses, as well as attending many workshops.

I have coordinated a prospective randomised trial of open versus laparoscopic appendicectomy.

TRAUMA - The Princess Alexandra Hospital is a major metropolitan hospital dealing with primary, secondary and tertiary referrals of patients with major trauma. I am interested in the assessment, care and documentation of these patients. In the past I had the responsibility to organize the trauma roster and service with my earlier appointment to the hospital including the title of Trauma surgeon.

I have been a Director and Instructor of the Early Management of Severe Trauma Course which is run by the Australasian College of Surgeons. I have taught on a number of courses in Australasia and more recently have directed a number of participant and instructor courses. From January 1995 to February 2000 I was on the national EMST Committee.

RESEARCH

OESPHAGUS – Active

NH&MRC:

APP 1011782 – Docetaxel with or without radiation therapy for resectable oesophageal adenocarcinoma based on early PET response to induction chemotherapy. (DOCTOR trial)

CIA Andrew Barbour; CIB Bernard Smithers, CIC Bryan Burmeister, CID Euan Walpole, CIE John Zalcberg, CIF Nigel Spry, CIG Garett Smith

2011 – 13: $791,991.44

·  “Prospective assessment of Quality of Life after Intervention for oesophageal cancer”.

Chief Investigators: Assoc. Prof. M Smithers, Professor D Gotley

Support: Mater Private Hospital

·  Prospective documentation of Oesophageal and Gastric cancers managed within Princess Alexandra Hospital and the Mater Medical Centre.

OESPHAGUS – COMPLETED

NIH

Molecular epidemiology of Barrett’s oesophagus and cancer.

Chief Investigator: David Whiteman

Associate Investigators: G. Jameison, A Green, D Purdie, D Gotley, BM Smithers, D. Watson

Support: National Institute of Health, USA - $US 1,250,000 2003 – 08.

NHMRC

Towards Prognostic Markers for Oesophageal Cancer

Chief Investigator: David Whiteman

Associate Investigators: Assoc Prof BM Smithers, Prof DC Gotley, Prof A Green

Support: NH&MRC: 2006-8

Randomized trial of Surgery alone compared with chemoradiation prior to surgery for operative oesophageal carcinoma. This was a National multicentred trial co-ordinated by a management committee under the auspices of the Australasian Gastro Intestinal Trials Group and the Trans-Tasman Radiation Oncology Group.

Chief Investigator: Assoc. Prof. B Burmeister

Principle Investigators: Assoc. Prof. M Smithers, Prof. J Denham, Dr S Ackland

Support: NHMRC 1996-1998 - $73,000 per annum

Epidemiology of Oesophageal Cancer.

Chief Investigator: David Whiteman

Associate Investigators: Prof Adele Green, Assoc Prof M Smithers, Prof. David Gotley

Support: Queensland Cancer Fund - $60,000 per annum 2001- 2002

NH&MRC programme grant to Queensland Institute of Medical Research

Randomised Phase II trial of preoperative chemotherapy compared with preoperative chemoradiation for operable carcinoma of the oesophagus

Investigators: Assoc Professor B. Burmeister, Assoc Professor M. Smithers, Prof D. Gotley, J. Harvey, E. Walpole, D. Thomson.

Support: Internal

GASTRIC CANCER - Active

Cancer Australia

Randomised phase III study of preop-chemoradiotherapy vs preop-chemotherapy for resectable gastric cancer.

Support: Cancer Australia 570996 (app ID) $596625, 2009-2011

Chief Investigator: Trevor Leong,

Associate Investigators: Val Gebski, Mark Smithers, David Watson, Nigel Spry, John Zalcberg, Michael Michael, Alex Boussioutas

GIST – Completed

Intermediate and high risk localized, completely resected, gastro-intestinal stromal tumours (GIST) expressing KIT receptor: a controlled randomized trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery. Intergroup study (EORTC 62024). – 5%

Australian sponsor; Australasian Gastrointestinal Trials Group (AGITG)

Trial Management Committee: Dusan Kotachek, BM Smithers, B. Mann, G Van Hazel,

Garret Smith, D Porter, D Watson, S Pieterse, J Simes, J Zalcberg, D Miller, M Hall

2005 - $90002, 2006 - $87002, 2007 - $76168

ENDOSCOPIC SURGERY - Active

• “Pre and post-operative assessment for laparoscopic fundoplication”.

This study utilizes oesophageal physiology studies and quality of life instruments to objectively assess the results of all patients who have anti-reflux surgery, both in the short and long term.

• Prospective documentation of advanced laparoscopic surgery – cardiomyotomy, splenectomy, adrenalectomy

MELANOMA - Active

NH&MRC:

APP 1004999: Effects of nevogenesis susceptibility genes and phenotype correlation with dermoscopic characteristics of nevi.

CIA Peter Soyer, CIB Richard Sturm, CIC David Duffy, CID Bernard Smithers.

2011 -13, $535,206

Multicenter Selective Lymphadenectomy for Melanoma Trial II: A Phase III Multicenter

Randomized Trial of Sentinel Lymphadenectomy and Complete Lymph Node Dissection versus Sentinel Lymphadenectomy Alone in CutaneousMelanoma Patients with Molecular or Histopathological Evidence of Metastases in the Sentinel Node.

Multicentre trial co-ordinated by John Wayne Cancer centre.

PI Donald Morton

Local Investigators: BM Smithers, Gerard Bayley, Andrew Barbour

A phase 2 study of intralesional PV-10 in the treatment of metastatic melanoma.

Sponsor – Provectus Pharmaceuticals, Delpharm Consultants

Chief Investigator (Qld) – BM Smithers

Co-investigators – A Barbour, G. Bayley

A phase I study of Genvax for Stage IV metastatic Melanoma.

Sponsor –

Chief Investigator – BM Smithers

Co-investigators – A Barbour, G Bayley, D. Thomson

DERMA Study - A phase III study of MAGE for patients with stage III metastatic melanoma.

Sponsor – GlaxoSmithKline Biologicals

Chief Investigator (Qld) – BM Smithers

Co –investigators – A Barbour, G Bayley, D Thomson

MELANOMA RESEARCH - COMPLETED

NH&MRC

Treatment of recurrent malignant melanoma by limb infusion of cytotoxic drugs and other techniques.

Chief Investigator: Prof M Roberts

Principle Investigators: A/Prof BM Smithers, A/Prof J Thompson and A/Prof C Anderson

Support NHMRC #981314: 1998 – 2000 $273,453

Preclinical development of a melanoma – selective drug:

Chief Investigator: Dr P Parsons

Principle Investigator: Assoc. Prof M Smithers

Support: NHMRC 1998 – 2000 - $60,000 per annum

The role of TAPP and MHC Class ! expression in the response to melanoma immunotherapy using dendritic cells.

Chief Investigator: Assoc Prof R Thomas

Principle Investigators: Dr. Jabbar, Assoc Prof BM Smithers, E Walpole

Support NH&MRC # 102515: 2000 – 2002 $104,000 per annum

Clinical trial of Autologous Melanoma Vaccine in Patients with Stage IV melanoma

Chief Investigator: Dr R Thomas

Associate Investigators: Assoc. Prof M Smithers, Dr E Walpole, Clinical Prof R McLeod

Support: Queensland Cancer Fund – 1999 – 2000 $40,000 per annum

NH&MRC 2000 – 2002 $103,000 per annum

Phase III trial of an immunotherapy for stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell analysis.

Investigators: Prof Michael O’Rourke, A/Prof BM Smithers, Prof K. Ellem, C Schmidt, B O’Loughlin, D Lincoln

Support: 2003-05 NH&MRC project grant to Queensland Institute of Medical Research

2006 – MS Principle Investigator - Queensland Cancer Fund (Grant Q57) – 2 years 71,700 per annum.

A trial of surgery versus surgery plus adjuvant radiotherapy in patients with resected nodal metastatic melanoma.

Chief Investigator: M. Henderson, Peter MacCallum Cancer Centre, Melbourne

Associate Investigators: W. McCarthy, J. Thompson, B. Burmeister, BM Smithers

Support: NH&MRC - $305000, 2003 – 06

"Physiological Pharmacokinetics in the Isolated Limb".

Chief Investigators: M. Smithers / Prof. M. Roberts

Associate Investigator: Prof. W. Egerton

Support: Queensland Cancer Fund 1993 - $60,000

University of Queensland - Cancer Research Fund 1994 - $31,400

Queensland Cancer Fund 1995-97 - $45,000 per annum

Princess Alexandra Hospital Foundation 1997 - $10,000

Publications: 7 Posters: 4

Pharmacokinetics and pharmacodynamics of isolated limb perfusion and isolated limb infusion.

Chief Investigator: Prof. M Roberts

Principle Investigators: Assoc. Prof J Thompson, Assoc. Prof M Smithers, Dr C Anderson

Support: Princess Alexandra Hospital Foundation 1998 - $10,000

Development of Autologous Melanoma Vaccine for patients with stage IV metatastic melanoma.

Chief Investigator: Dr R Thomas

Associate Investigators: Assoc. Prof M Smithers, Dr E Walpole, Clinical Prof R McLeod

Support: University of Queensland – Cancer Research Fund – 1998

Queensland Cancer Fund – 1999 – 2000 $40,000 per annum

Phase III multicentred trial of wide excision alone versus wide excision and selective lymphadenopathy for malignant melanoma

Investigators: Assoc. Prof. M Smithers, Clinical Prof R McLeod

This trial is co-ordinated by the John Wayne Institute – California, USA

Commenced 1998. Accrual closed, follow up continues.

Support: John Wayne Cancer Institute - $73,400 (to 2004)

A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy with

BCG plus a Polyvalent Melanoma Vaccine, CancerVaxTM Vaccine, versus BCG plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma. (Multicentred trial)

Principle Researcher: BM Smithers

Associate Researchers: S. Jones, B. Burmeister, G. Bayley

Sponsor: CancerVax Corporation, Santa Monica, USA

A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy with

BCG plus a Polyvalent Melanoma Vaccine, CancerVaxTM Vaccine, versus BCG plus a Placebo as a Post-Surgical Treatment for Stage IV Melanoma. (Multicentred trial)

Principle Researcher: BM Smithers

Associate Researchers: E Walpole, G. Bayley

Sponsor: CancerVax Corporation, Santa Monica, USA

A Phase II Trial of Immunotherapy with BCG plus a Polyvalent Melanoma Vaccine, CancerVaxTM Vaccine, in patients with in-transit metastatic melanoma. (Multicentred trial)

Institutional Principle Researcher: BM Smithers

Associate Researchers: E Walpole, G. Bayley, S. Jones, A. Barbour

Sponsor: CancerVax Corporation, Santa Monica, USA

Phase I open label cohort study of two doses of Cavatak (coxsackievirus A21) given intratumorally in stage IV melanoma.