SARAH J B EVANS
Tel: + 1 212 810 7044 Email: sarahjbevans@me.com
A successful background in clinical trials and research project management utilizing cost effective technology; initially coordinating clinical studies in a hospital/clinic setting, to recently monitoring & project managing on-line clinical trials in industry; involved with all phases of the clinical research process for MedicalDevices and Pharmaceuticals, locally and internationally including:
- Collection, coordination and monitoring of Clinical & Regulatory data - including on-line
- Investigator/site selection, monitoring, education and internet based support
- Innovative patient recruitment and CME training programs (see Help at www.ebhealth.com)
- Protocol, CRF (eCRF) and Electronic Data Collection (EDC) Data-base development
- Regulatory communications and IRB/ethics submission and Reports
- Project and product management for medical device development
- Budget development and negotiations with sponsors and sites
- Presentations, posters and papers at an international and peer review level
Developed eCRF and web based data entry system (EDC) for Pilot, Pivotal & LTU clinical trials of a LVAD.
Feb 2008 – current Evidence-Based Health, CRA ACT LLC. NY USA
Develop multi-national on-line health economics & outcomes research for rare diseases for Novartis & NIH. Orphan drug trial project manager/monitor; protocol & eCRF development, investigator & subject recruitment.
Project manager/CRA in Implantable Stimulation Devices, Oncology, Neuropathy & Neurotechnology.
Peak industry body for the Australian Biotechnology and Medical Device Industry.
- Implementation of the Medical Device Industry Action Agenda (MDIAA), a government backed initiative to further develop the Australian medical device manufacturing industry
- Liaison with Regulators - Therapeutic Goods Administration (FDA) and Reimbursement Committee
- Biotech industry road map and grant applications
July 1997 – Nov 2005 UK Director, Area Manager, CRA Advanced Bionics Corp.
Responsible for setting up and direction of the UK & Irish Area Office for Advanced Bionics Inc, a Cochlear Implant & Neurostimulation Device manufacturer owned by Boston Scientific. General management of the Clinical (CRAs) and Marketing teams, including budgets, technical tender documents, consumer relations, clinical/surgical training programs, European level product and clinical trials management.
· Reach an untapped market by developing the unique internet site www.ci-4teenz.com.
· Increased Cochlear Implant sales over three fold, moved market-share from 6% to over 20%.
· Designed clinical and marketing trials to increase customer base by 20%.
· Organized over 40 professional Clinical, Surgical and Educational (CME) events a year.
Project management clinical research contracts and responsible for new projects for a specialist Contract Research Organization (CRO).
- Increased annual revenue from US$0.5m to >$5m.
- Pioneered & developed a unique world-wide-web site & multimedia, to recruit difficult to find subject.
- Recruitment and training of monitors and other clinical trials staff.
Clinical Research Coordinator/Monitor - USA
Country Manager - UK & Ireland
Global cardiac pacemaker manufacturer that merged with Cordis, owned by Pacific Dunlop.
- R&D project management and evaluation of the 1st Implantable Medical Monitor.
- Established the 1st UK Automatic Implantable Defibrillator (AICD) clinical trial and set price.
- Monitored 1st anti-tachycardia clinical trials in the UK & USA.
- Top regional sales area, a distributor network of 12 agencies, 64 reps and a revenue >US$10m.
- Industry record sales of over 900 pacemakers in one year.
Managed a large technical cardiac department including, catheter & exercise laboratories, a clinical research office, pacemaker clinic, echo and ECG departments. Provided technical services to the OR, ITU & ICU.
- Established the national pacemaker computer registry and an international training programme.
- Clinical trials coordination for the 1st coronary angioplasty and streptokinase in the UK.
Superintendent - Cardiac Laboratory Riyadh Military Hospital, Saudi Arabia
Set up and managed technical cardiac department in a totally new hospital including a cardiac catheter laboratory, cardiac theatre, exercise laboratory, pacemaker clinic, echocardiography and ECG services.
Student/post graduation University Hospital of Wales, UK
While studying; Student through to Senior grade Cardiac technician. Culminating in responsibility for the coordination & follow-up of the 2,000 pacemaker patient technical care throughout Wales.
Professional Education:
BS - Medical Physics/Physiological Measurement HNC, University of Wales Llandaff Institute Cardiff UK.
Cardiovascular Technology, MSCT - Post Graduate Diploma. Society for Cardiological Science and Technology.
Professional Diploma Management (2/3 MBA), Open University Business School, UK.
Recent/relevant Associations & Education:
Certificate - Human Participants Protection Education for Research Teams, National Cancer Institute, 2008
Healthcare Businesswomen’s Association, New York Metro Chapter Co-Chair 1st Medical Device Affinity group 2007-9
Leukemia & Lymphoma Society, NYC Patients Services Committee, & Clinical Trials Ambassador, Albany, 2008/9
Lymphoma & Myeloma, Weill Medical College of Cornell University, New York, Oct 2007-09
Multiple Myeloma Research Foundation - Investor Summit, New York, Sept 2007
Neurotechnology NIO Public Policy Tour - Capital Hill, NIH & FDA Washington, March 2007
Science & Research, Australian Market Trends, G’Day New York, Jan 2007
Ventricular Assist Devices - Office of Device Evaluation Vendor Day, FDA Washington, Nov 2006
MDIAA, Capability and Product Commercialization Working Groups, Sydney & Canberra, 2006
National Heart Foundation of Australia Forum, Advanced Technology (Devices) in Cardiac Care, 2006
Cancer Council – Skilled Volunteer Program, Software Project Management, Non-Profit Australia, 2006
Centre for Applied Economic Research, Summer Workshop in Health Economics, UNSW, 2005
Trustee - HearSay Charitable Trust, Deaf Relationship Charity, UK, 2004-2005
CRA/Monitoring training for multi-site phase I-IV clinical trials, Pharmatech, Denver CO, USA.
Business Administration, University of Denver, Woman’s Collage, CO, USA.
Science O levels (5-GCSE), Lady Margaret Grammar (High) School & College of Technology, Cardiff, UK.
Licenses: Clean Car Driving, RYA Crew & Day Skipper, Private Pilot (lapsed) & NSW Boat Licenses
Resource Use in the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). RJG Arnold, SJB Evans, A Ferreira, J Kümmerle-Deschner, M Gattorno, I Koné-Paut, submitted American College of Rheumatology Scientific Meeting 2009
Background Research in Preparation for A Multinational, Prospective, Observational Study of Osteoarthritis. SJB Evans, RJG Arnold. For Rinat Ariely, Global HE&OR Novartis Pharmaceuticals Corporation, June 2009
Evidence-Based Medicine, Devices, diagnostics & pharmaceuticals; moderator, New York Biotechnology Association meeting, 2009
Frequently Asked Questions in Lymphoma: Answers from the Expert – Dr Owen O’connor, Mantle cell Moderator, LLS, 2009
Venture Philanthropy - Innovative funding for orphan drugs. Evans SJB & Witts N. Australian Biotechnology Vol 17 no 4, 2007.
Taking Neurotechnology to Washington DC. Evans SJB, Australian Biotechnology Journal, in print 2007.
International mutual recognition arrangements for medical device assessments and considerations for the role of 3rd Party assessment, particularly for Australian manufacturers. Brandwood A, Evans SJB, Lavelle A. TGA TICC. Nov 2006
Therapeutic Goods Administration (TGA) encourages application a year in advance of the October 2007 deadline to ensure continuation of product. Evans SJB, Lavelle A, Australian Biotechnology, Vol 16, no 3, Oct 2006
Market Profile, Cochlear Implants & Neurostimulation in Australasia, Evans SJB, for Advanced Bionics/Boston Scientific, 2005
Pushing the Boundaries – Battery Technology, Hughes R, Evans SJB, NCIUA, Imperial College, London, June 2004
A Web Site for Cochlear Implant Teenagers www.ci4teenz.com. Beadle E, Booth CL, Horler W, & Evans SJB, European Society of Pediatric Cochlear Implants, Geneva, May 2004
Composting in Cambridgeshire: Evans SJB, Hamilton A, Barrington Garden Society, Cambridge, March 2004
Agony & Ecstasy – The Deaf Teenager, Chairperson, The Science Museum, London, March 2004
Advances in Cochlear Implants. Evans SJB. Advanced Cochlear Implant Workshop, The Ear Foundation & Nottingham Paediatric Programme, 1997, 1998, 1999, 2000, 2001, 2003 & 2004
Chairperson; Children & Cochlear Implants. Cochlear Implant Children Support - Science Museum, March 2003
Music with Cochlear Implants. Maltan A, & Evans SJB. British Cochlear Implant Group - Annual Meeting, Institute of Child Health, London, Sept 2003
The creation of a web site for teenagers - www.ci-4teenz.com. Booth CL, England R, Horler W, Evans SJB British Teachers of the Deaf Journal, Dec 2002 & 7th International Cochlear Implant Conference, Manchester, Sept 2002 – Poster prize
Cochlear Implants Manufactures Round Table. Evans SJB. 3rd International Symposium on Electronic Implants in Otology & Conventional Hearing Aids, Birmingham June 2000
Modern Cochlear Implants. Evans SJB. AIHHP, Möller Center, Cambridge, Sept 2000
BCIG web site. Martin J, Aleksy W, Jamison L, Adams T & Evans SJB. British Cochlear Implant Group, Bristol, Sept 2000
Launching the Electrode Positioner System (EPS) Advanced Bionics. Evans SJB, Braidwood D, Goldring JE, Amiel C. April 1998
Taking Advantage of Today’s Technology - Use of the Internet for Product Development Clinical Studies. Carr (Evans) SJB, Wiener MB, Dodd DS. Drug Information Association Meeting, San Diego, 1996 (Sarah JB Carr name used 1980~1996)
Information Technologies in Medical Product Marketing: - Pharmaceutical/Biomedical Roundtable. Carr (Evans) SJB. Annual Medical Marketing Association Meeting, Keystone, May 1996
Exploring the Information Superhighway: Use of the Internet in Clinical Drug Trials. Carr (Evans) SJB, Foster V, Wiener MB, Blagg A. Society for Clinical Trials 17th Annual Meeting, Pittsburgh, May 1996
The Use of the Internet as a Recruitment Tool For Asthma Drug Development Studies. Wiener MB, Carr (Evans) SJB, Blagg A. American Academy of Allergy, Asthma and Immunology Meeting, New Orleans, 1996
The Power of Pharmacoeconomics for the Biopharmacutical Company of the 21st Century. Carr (Evans) SJB, Hopper N, Wiener MB, 8th Annual Biotechnology Symposium, Boulder, CO, 1995
An Implantable Medical Monitor - Feasibility Study. Carr (Evans) SJB, Daniel K. Telectronics, Inc. 1992
Coronary Angioplasty - A Market Overview. Carr (Evans) SJB. Clinica Reports, PJB Publications Ltd. 1993
Percutaneous Coronary Angioplasty – a 1st in the UK - a technical description of the first procedure in the UK. Carr (Evans) SJB, Addington N, Balcon R, British Cardiac Society Technical Meeting.
