Dr. Elizabeth Steels | Australia | Healthfocusgroup.info

Key Academic and Lecturing Positions

1. Currently, Senior Research Fellow – Department of Medicine, University of Sydney.
2. Currently, Editor and Reviewer for Dove Press Journal
3. Currently co-supervisor of Postgraduate Students
4. Currently conduct clinical trials in nutraceuticals and botanical extracts
5. 2005 to 2007 - Lecturer Department Medicine - University of QLD (part-time)
6. 1993 to 2014 - Developed the undergraduate degrees and taught in following subjects: Biochemistry, Microbiology, A&P, Nutrition, Pathological processes, Research Methodology and Introductory Statistics at the Endeavour College of Natural Wellness (formerly Australian College of Natural Medicine).
7. 1988-1992 – Lecturer in microbiology, biochemistry, pathophysiology classes and labs at Department of Biochemistry, University of New England.
8. 2005 to present - Deliver educational workshops to Health Professionals annually.
9. 2005 to present - Present at Industry Symposiums and Conferences

Key Industry Employment History

Position: Research and Education Manager, Director (Jan 2007 – Present)

Company: Integrated Health Group Pty. Ltd. Brisbane (formerly Applied Science & Nutrition Pty. Ltd) Company details: A contract research and development, clinical trial and regulatory organization to support the health industry.

Role and Responsibilities:

R&D/Product Pipeline

Develop research and development strategies for nutraceuticals and botanicals for clients.
Formulate nutraceuticals and herbal medicines.
Keep up to date with new emerging research (primary publications) to identify new ingredients, new indications and potential for new formulations for existing and new product categories.
Attend National and International Research Symposiums and Trade Shows.
Maintain industry presence as a member of CMA.
Develop clinical research protocols and manage clinical trials (budget, technical implementation) and analysis/reporting).
Work with relevant academic and medical professionals (find suitable clinical trial investigators) and monitor clinical trials.
Align clinical trial outcomes to comply with regulatory requirements and to optimize commercial outcomes.
Maintain a presence in Industry as an active member of the CMA.
Attend meetings on behalf of for clients - eg. represent clients at TGA and regulatory meetings, potential licensing partners and marketing companies, technical support for capital raising meetings.

Professional Education

Develop education and marketing strategies for clients (product sponsors).
Provide lectures to Practitioners and Industry /Research forums.

Regulatory and Compliance:

Ensuring that products meet Australian regulatory requirements (TGA) and labeling (ASMI).
Developing strategies (and writing expert reports) when required to defend marketing claims.
Prepared new substance applications for substances for use in listed medicines.

Technical Support (including teaching and curriculum design)

Work with marketing staff (for clients) to educate on technical product information.
Worked with regulatory staff (for clients) to teach research retrieval and analysis skills.
Train and supervise in-house regulatory and clinical staff and consultants.
Helped develop the Nutrition and Herbal Medicine Degree packages for Aust. College of Medicine.
Currently lecture at colleges and universities in nutrition, biochemistry, pathology and research methods when asked (UQ, ACNM / Endeavour College of Natural Wellness, Think Education).

Achievements

Have provided support in either R&D, research, regulatory and technical support for over 20 Australian and New Zealand companies including small biotech companies, raw material suppliers, most complementary medicine manufacturers, small – medium pharma companies.
Research including bioavailability studies and RCT’s (unpublished and published) provided marketing advantage for clients.
The educational packages for practitioners result in increased sales for relevant products.
Successful outcomes (expert reports) when responding to regulatory complaints.

Position: Technical Director

Company: Biologic Health Solutions Pty. Ltd. (Jun 2007 - Feb 2009)

Company Details: R&D and manufacturer of herbal medicines. The company developed herbal medicines, testing most formulations in clinical trials, developed patents around a number of products and developed an Australian and US distribution of products. Initially, contracted to conduct the Clinical Research as Applied Science and Nutrition Research (1995 – 2009), then became Technical Director (2007).

Role and Responsibilities:

R&D/Product Pipeline

Strategic development of new products and marketing of a range of herbal medicines internationally.
Developed clinical trial budgets, protocols and clinical trials to support patent applications of key products and oversee the patient process.
Work with raw material suppliers and assess raw materials for suitability for formulations.
Assessed manufacturing facilities (US) for manufacture of products for US market (NorthStar Nutritionals, Doctor's Best and Purity Products).
Attended board meetings, negotiations with suppliers and sponsors, industry meetings and trade shows as required.

Professional Education and Technical Support

Provided technical direction and regulatory guidance to staff.
Review regulatory and technical documentation to ensure adherence to regulatory standards.
Represent the company as an active member of the CMA.
Handled the responsibilities of patient process and publishing the results of significant research projects.

Achievements

US Nutrition Business Journal Product Merit Award for the research.
Successful registration of patents of key products, and distribution of products in US

Position: Regulatory Affairs Associate (May 1994 – Dec 1997)

Company: Alphapharm Pty. Ltd.

Company details: Alphapharm is a leading generic pharmaceutical manufacturer based in Brisbane.

Role and Responsibilities: My role was to report directly to the R&D manager, and to work strategically develop generic pharmaceuticals, prepare and submit NDAs to the FDA and follow though the approval process including in-house QA audits in preparation for the FDA audits. We were a department of 20+, with 2 assistants to help with US submissions.

R&D/Product Pipeline

Strategic 3 year development of generic products (coming off patent within 3-5 years).
Work with R&D formulation and laboratory team to formulate generic pharmaceutical.
Liaison with the universities to conduct the necessary bioavailability studies.
Compile the Drug Dossiers for the FDA (with my assistants).
Conduct the in-house QA audits in preparation for the FDA audits.
For both Australian and FDA products, reviewed regulatory and technical documentation as required to ensure adherence to regulatory standards, including the Patient information Leaflets.
Work with the in-house pharmacist in relation to reported adverse events.
Reviewed job applications for R&D and QA laboratory positions.

Professional Education and Technical Support

Write relevant SOP’s and provided necessary training to staff

Achievements

- Contribute to successful (timely) launching generic products as pharmaceuticals came off patent.

Position: Clinical Research Associate (Sept 1992 - May 1994)

Company: Department of Medicine, University of Queensland.

Role and Responsibilities: I was employed in the Endocrine Department, to (1) specifically run a RCT clinical trial report for the treatment of Growth Hormone deficiency and (2) help develop and validate the first Bio-electrical Impedance (BIA) machines for clinical use.

R&D

Learnt processes for Good Clinical Practice for clinical trials.
Trained in body composition, metabolism studies (oxygen saturation, D2O analysis).
Worked with the endocrinologists in the recruitment of patients.
Conducted testing on patients including the body composition analysis, anthropometry, BIA, pathology blood collection.
Worked with the specialists to organize all specialize testing including the bone density scans etc.
Analysis of the data from the study.

Position: Staff Member and PhD candidate (1988-1992)

Company: Department of Biochemistry, University of New England / Queensland Medical Institute Role and Responsibilities: My PhD was conducted under a grant (which covered a laboratory assistant). I taught microbiology, biochemistry, pathophysiology classes and labs.

Current Appointments / Affiliations

Senior Research Fellow of Sydney University, Faculty of Medicine.
- Registered TGA regulatory consultant
- Member of ARCS (Australian Research and Clinical Sciences)
- Dove Press Journal Editor and Reviewer
- PhD Supervisor
- Ethic committee member (QCTN)

Nominated for Awards

Life Sciences QLD – Rose-Anne Kelso Commemorative Award, 2015 CMA Research, Education and Training Award, 2015.

Publications / Presentations

Detering M, Steels E, Koyyalamudi S, Perelli P, Vitetta L Ageratum conyzoides reduces symptoms of Benign Prostatic Hypertrophy on RCT and inhibits alpha-5-reductase gene expression in human prostate cells. Manuscript in preparation for Aging Male Journal

Steels E, Harold M, Adams L, Steele M, Coulson S.A Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of an Ayurvedic Botanical Formulation (Genopause®) in Reducing Menopausal Symptoms in Healthy Women. Submitted for publication October 2016.

Steels E, Steele M, Harold M Coulson S. A Double Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of LIBIFEM®, a standardized Trigonella foenum-graecum seed extract, in Reducing the Vasomotor Symptoms of Hot Flushes and Night Sweats in Healthy Perimenopausal and Postmenopausal Women. Submitted for publication October 2016.

Hines S, Steels E, Chang A, Gibbons K, 'Aromatherapy for treatment of postoperative nausea and vomiting' Cochrane review, Submitted for publication 2015

Rao A, Steels E, Inder W, Vitetta L, Abraham S, 2015 Testofen, a specialized Trigonella foenum-graecum seed extract reduces age-related symptoms of androgen decrease, increases testosterone levels and improves sexual function in healthy aging males in a double-blind randomized clinical study. The Aging Journal, 20: 1-9, 2016.

Rao A, Steels E, Beccaria G, Inder W, Vitetta L, 2015 Influence of a specialized Trigonella foenum-graecum seed extract (Libifem), on testosterone, estradiol and sexual function in healthy menstruating women, a randomized placebo controlled study. Phytotherapy Research (accepted for publication, April 2015).

Coulson S, Rao A, Beck S, Steels E, Gramotnev H, Vitetta L, 2013 A phase 2 randomized double-blind placebo- controlled clinical trial investigating the efficacy and safety of ProstateEZE Max: A herbal medicine preparation for the management of symptoms of benign prostatic hypertrophy. Complementary Therapies in Medicine, 21 3: 172-179.

Steels E, Coulson S, Vitetta L 2016 Novel combination of chemically defined herbal extracts Terminalia chebula, Curcuminoids BetaSorb and Ginger BetaSorb (Zinova) for the prevention of dysmenorrhea., a pilot study. Submitted November 2016

Rao A, Hammer KA, Steels E, 2012 Leptospermum scoparium (manuka) essential oil – Evidence for anti-bacterial activity and a topical treatment of acute herpes labialis outbreaks. 21st EADV Congress Prague Czech Sept 2012.

Laslett L, Quinn S.J., Darian-Smith E, Kwok M, Fedorova T, Korner H, Steels E, March L, Jones G, 2012 Treatment with 4Jointz reduces knee pain over 12 weeks of treatment in patients with clinical knee osteoarthritis: a randomised controlled trial. Osteoarthritis and Cartilage 20 11:1209-1216.

Hines S, Steels E, Chang A, Gibbons K, 2012 Aromatherapy for treatment of postoperative nausea and vomiting.

Cochrane Database of Systematic Reviews Issue 4. Art. No.: CD007598.

Steels E, Rao, A, Vitetta L, 2011. Physiological Aspects of Male Libido Enhanced by Standardized Trigonella foenum-graecum Extract and Mineral Formulation. Phytotherapy Research. 25 9:1294-1300.

Houghton C, Steels EL, Fassetta RG, Coombes J.A, 2011 Effects of a gliadin-combined plants Superoxide dismutase extracton self-perceived fatigue in women aged 50–65 years. Phytomedicine 18: 521–526.

Hines S, Steels E, Chang A, Gilshenan K, 2009 Aromatherapy for treatment of postoperative nausea and vomiting (Protocol). Cochrane Database of Systematic Reviews 1. Art. No.: CD007598. DOI: 10.1002/14651858.CD007598.

North P & Steels E, 2008 “The Clinic Detective” Published by Applied Science and Nutrition Pty. Ltd. Version 3.

Steels E, Rao A, Seipel T, Deed G, 2005 “Reduction of symptoms associated with menopause: the efficacy of Biogest Menopause Relief Cream, IJNM July

Steels E, Rao A, Seipel T, 2003 “Treatment of symptoms associated with menopause with a herbal preparation”. 10th Annual Symposium on Complementary Health Care, Londo

Rao A, Detering M, Steels E, 2003 “Workbook and Laboratory Manual for General and Organic Chemistry, Publ. Applied Science and Nutrition, Brisbane Australia.

Steels E, Rao A, Detering M, 2003 “Workbook and Laboratory Manual for Biochemistry, Published. Applied Science and Nutrition, Brisbane Australia.

Steels E, Ryan, J, Seipel T, Rao A, 2002 "Crataeva and Equisetum reduce urinary incontinence symptoms."

Australian Continence Journal. 8(3): 46-50

Steels E, Seipel T, Rao A, 2001 "Treatment with Biologic Preparation containing craeteva nurvala and equisetum arvense reduce urinary incontinence symptoms in women – mechanisms of action." IURA 26th Annual Congress and CFA 10th National Conference, Melbourne, Australia.

Steels E, Seipel T, Rao A, 2001 "Herbal essential oils for urinary incontinence." Australian Continence Journal. 7 2:34-37.

Steels EL., Learmonth P. R, Watson K, 1994 "Stress tolerance and membrane unsaturation in S. cerevisiae

grown aerobically and anaerobically". Journal of Bacteriology. 140: p569-576.

Steels EL, Watson K, Parsons PG, 1992 "Relationships between thermotolerance, oxidative stress responses and induction of stress proteins in human tumor cell lines." Biochemical Pharmacology. 44: 2123-2129.

Steels EL, Learmonth PP, Watson K, 1990 "Heat shock and oxidative stress in Aerobic and Anaerobic S. cerevisiae." International Symposium on Heat Shock, Rayello, Italy, 17-20.

Steels EL, Learmonth PP, Watson K, 1990 "Stress responses in Aerobic and Anaerobic S. cerevisiae." Annual Meeting, Australian Society of Biochemistry and Molecular Biology, 25-28 September 1990, Proc. Aust. Soc. Biochem. Molec. Biol. 22, SP72.

Presentations at conferences and meetings:

Steels E, 2016 “The Clinic Detective Series 2016 – Immune System, pathology and nutrition” – presented in Brisbane, Gold Sydney, Melbourne, Adelaide, and Perth - Sponsored by Integria Healthcare, Sydney, Australia.

Steels E, 2016 Integria Healthcare Symposium, Gold Coast September 2016.

Steels E, 2015 “The Clinic Detective Series 2015 – Non-alcoholic Fatty Liver” – presented in Brisbane, Gold Sydney, Melbourne, Adelaide, and Perth - Sponsored by Integria Healthcare, Sydney, Australia.

Steels E, 2015 “Integria Healthcare Symposium, Gold Coast September 2015.

Steels E, 2014 “The Wellness Potential” – Presented at the Integria Healthcare Symposium, Gold Coast September 2014.

Steels E, 2014 “The Clinic Detective Series 2014 – Nutritional Pathology” – presented in Brisbane, Gold Coast, Sunshine Coast, Newcastle, Sydney, Melbourne, Adelaide, Perth - Sponsored by Integria Healthcare, Sydney, Australia.

Steels E, 2012 “Nutrients in Health” – Presented in Brisbane, Sydney, Melbourne, Adelaide, Perth - Sponsored by Nutrition Care, Sydney, Australia.

Steels EL, Learmonth PP, Watson K, 1991 "Heat and Oxidative Stress as a function of Membrane Lipid Composition in Yeast." Annual Meeting, Australian Society of Biochemistry and Molecular Biology, 8-11 July 1991, Proc. Aust. Soc. Biochem. Molec. Biol. 23, C46.

Steels EL, Learmonth PP, Watson K, "Stress-induced Antioxidant Enzymes in S. cerevisiae." Annual Meeting, Australian Society of Biochemistry and Molecular Biology, 8-11 July 1991, Proc. Aust. Soc. Biochem. & Molec. Biol. 23, SP51

Referees

Professor Luis Vitetta

Director of Medical Research, MedLab Clinical Pty. Ltd. Sydney, Australia Professor, Sydney Medical School, University of Sydney, Australia

Email: luis_vitetta@medlab.co

Professor Denis Crane

Professor, School of Biomolecular and Physical Sciences, Griffith University, Australia Email: d.crane@griffith.edu.au

Dr John Ryan MD

Director of Clear Mountain Lodge Health

Practice: Aspley Medical Centre, 1311 Gympie Rd, Aspley, Australia Email: drjohnryan@ecn.net.au Phone: +61 7 3862 8811

Mario Pennisi

CEO Queensland Clinical Trials Network Inc. Brisbane, Australia Phone: +61 7 3331 3930

Email: mariopennisi@qctn.com.au