The Thera-Business Team

We are Thera-Business

Thera-Business has been involved in the development of evidence-based reports and regulatory documents for over 20 years. We are experts in developing Clinical Evaluation Reports for medical devices.

Years of Experience

Our team members have years of experience in performing systematic literature reviews and appraising clinical studies for suitability and data contribution. We have the ability to critically appraise and analyze clinical studies, and we are experts in interpreting and summarizing the results of those studies.

Why Choose Us?

We are driven and know that our work is of utmost importance to patient care! Our consultants are detail-oriented team players with the ability to work to tight deadlines. We are committed to understanding your needs and providing solutions that contribute to your success.

Dr. Isabella Steffensen, President

Dr. Isabella Steffensen
Dr. Steffensen is a biomedical scientist with a B.Sc. Honours Biology (cum laude) and Ph.D. in Cellular Biology from the University of Ottawa. She completed a postdoctoral fellowship with a leading neurologist at the Ottawa Health Research Institute where she performed research on stroke and spinal cord injury. Over the past 20+ years, Dr. Steffensen has assisted pharmaceutical, medical device, biotechnology and diagnostic companies with regulatory, marketing, technical, and business development issues. She has widespread experience preparing regulatory documents, as well as other evidence based-reports such as practice guidelines and systematic reviews. Dr. Steffensen has completed hundreds of projects in the life sciences sector, embracing biotechnology, pharmaceuticals and bio-pharmaceuticals, medical devices, technology and diagnostics. She is a specialist at Clinical Evaluation Report remediation and helping medical device companies fulfill current regulatory requirements in the European Union. Dr. Steffensen is responsible for the overall operations and performance of Thera-Business, where she mentors a highly-skilled group of executives and staff. She is a well-respected leader with the strategic foresight to develop and promote a compelling vision for the future of Thera-Business.

Dr. Lynley Pound, Director of Medical Writing and Research

Dr. Lynley Pound

Dr. Pound received her B.Sc. in Physiology and Metabolism from the University of California at Berkeley and Ph.D. from Vanderbilt University in Molecular Physiology and Biophysics. She completed postdoctoral fellowships at Oregon Health and Science University and Ottawa Hospital Research Institute, and subsequently worked as a scientific editor. With over 10 years of biomedical research experience and 19 publications, Dr. Pound joined Thera-Business, where, as a Medical Writer/Researcher she gained significant experience authoring reports for pharmaceutical and biotechnology products, medical devices, and public health initiatives. As the Director of Medical Writing/Research, she is now responsible for leading and managing a team of writers/researchers and for preparing high-quality clinical documents for pharmaceutical and biotechnology products, medical devices, and public health initiatives. Additionally, she contributes to both strategic and operational perspectives and makes significant contributions to department initiatives while collaborating with key functions across the organization.

Dr. Red Thaddeus Miguel, Director of Health Research Methods and Data Analytics

Dr. Red Thaddeus Miguel

Dr. Miguel provides leadership and builds the roadmap for health research projects and data analysis with a particular focus on creating customized solutions to best meet the clients’ diverse needs. As a specialist in evidence-based practices and health research methodologies, he directs and oversees health research initiatives including performing complex health research analyses using large datasets.

He began his career as a University Researcher for the Health Policy Hub and National Institutes of Health of the University of the Philippines. There he was the Lead Research Associate for a number of studies including the national valuation of EQ-5D-5L, the Philippines baseline study on child restraints, the modelling of the burden and cost for hepatitis B and hepatitis C, and the national evaluation of a health insurance package for catastrophic illnesses. During that time, he was also a Research Fellow for the Asia Pacific Center for Evidence Based Healthcare where he undertook studies on clinical practice guidelines and a Researcher for the Kalusugan ng Mag-Ina, Inc. (Health of Mother and Child). Dr. Miguel has since authored a number of papers in his field and won numerous awards in research. Most recently he received the Award of Excellence in recognition of winning People’s Choice Award at the global health conference hosted by the University of Ottawa, Faculty of Medicine.

Prior to joining Thera-Business, Dr. Miguel worked as a consultant for health economics and insurance evaluation studies. His research interests include health insurance, clinical practice guidelines development, and methods for quantitative data synthesis. He holds a B.Sc. in Health Sciences from the Ateneo de Manila University, and a dual degree of M.D. and M.B.A. from the Ateneo School of Medicine and Public Health and the Ateneo Graduate School of Business. While obtaining his degrees, Dr. Miguel was elected National President of the Association of Philippine Medical Colleges – Student Network. Currently, Dr. Miguel is a matriculated student at the University of Oxford undertaking an MSc in Evidence-Based Health Care. He is a regular contributor to health websites, where he writes about the cost effectiveness of technologies in health.

Ms. Clare Fenwick Warren, Director of Operations

Ms. Clare Fenwick Warren

Clare began her career as a Paralegal in 1994 and worked in many different practice areas, including business, civil, family and criminal law. At Soloway, Wright she enjoyed her role as Marketing Coordinator for five years, then moved onto another firm in the role of Office Manager. It was a natural evolution to go from traditional law firms to a regulatory environment when she joined Thera-Business as Director of Operations in 2017. At Thera-Business, Clare collaborates with senior management and supervises the business office functions. She performs general administrative, client, and marketing support duties for the purpose of building the business and creating stronger client relationships for the betterment of the business.

Mr. Julien Carlone, Medical Writer/Researcher

Mr. Julien Carlone

Mr. Carlone graduated with Honours from Queen’s University in 2005 with a Bachelor of Science, majoring in Biology. In 2013, he received his Master of Public Health from the University of Liverpool, United Kingdom. He is well-versed in healthcare policy analysis, having coordinated the development of policies and procedures for the opening of a women and children’s hospital. He supported the establishment of a start-up clinical epidemiology consultancy through study design, data analysis and manuscript development. Mr. Carlone is an Associate Member of the UK Faculty of Public Health. A dynamic bilingual Master of Public Health graduate with thirteen years’ experience, Mr. Carlone seeks to improve health outcomes through clinical or epidemiological research. He offers a unique balance of research and strategic expertise and brings a pragmatic, patient, and collaborative approach—fostered in an international and multicultural environment—to organizational objectives. Diverse experience ranges from study designs appraisals, systematic and narrative reviews, development of clinical registries, and preparation of manuscripts, epidemiological surveys and data management and analysis reports to policy development and strategic planning. Recognized as an affable, respected, and reliable professional with a passion for both learning and educating.

Dr. Alexandra Iliescu, Medical Writer/Researcher

Dr. Alexandra Iliescu

Dr. Iliescu holds a B.Sc. in Biochemistry from Université de Montréal and a Ph.D. in Biochemistry from McGill University. Prior to joining Thera-Business, Dr. Iliescu worked as a biomedical consultant editing, critically reviewing, and assessing biomedical manuscripts. She also worked as a medical writer developing educational material for the pharmaceutical and life sciences industries. Following her Ph.D., Dr. Iliescu was a recipient of the prestigious Canadian Institutes of Health Research (CIHR) science policy award and a fellow at the Public Health Agency of Canada (PHAC). Her research interests included human and molecular genetics and her doctoral work focusing on Neural Tube Defects has been presented at numerous conferences and published in several peer-reviewed scientific journals. Since 2012, Dr. Iliescu has also shared her passion for science with youth by volunteering with Let’s Talk Science, an award winning, national, non-profit organization.

Dr. Gokul Raj Pullagura, Medical Writer/Researcher

Dr. Gokul Raj Pullagura

Dr. Pullagura is a health practice researcher with a Doctor of Pharmacy from JSS University, India and a Ph.D. in Pharmacy from the University of Waterloo. He has over 4 years of experience conducting health research using quantitative, qualitative, and pharmacoeconomic research methodologies. His past research interests included improving community vaccine uptake through the design and evaluation of novel interventions. Prior to joining Thera-Business, Dr. Pullagura served as a research assistant and contributed to data accrual and analysis for multiple health research projects. Dr. Pullagura has authored and presented award winning scientific research and has served in several leadership and volunteer positions. He is an avid public speaker and a self-proclaimed coffee aficionado.

Mr. Sheldon Yu, Research Analyst

Mr. Sheldon Yu

Mr. Yu received his M.Sc. in Statistics from Carleton University after completing his BSc in Statistics and Economics. Mr. Yu is an expert in theoretical and applied statistics, with extensive experience in mixed modelling, survival analyses, data mining, and using software (R, SAS, Python, Matlab) to analyze large datasets. During his graduate studies he worked as a research assistant studying the associations between long term exposure to air pollution and the incidence of dementia and cognitive impairment. Previous experience includes working as a data analyst with the University of Ottawa Heart Institute, where he analyzed diagnostic scanning methodologies, as well as working as a data analyst with Health Canada, where he used statistical analyses to perform risk assessments of chemical substances. In addition to his academic credentials, he is an SAS Certified Base and Advanced Programmer, and has completed the actuarial exam for probability.

Mr. Ibragim El-Sakhli, Junior Medical Writer/Researcher

Mr. Ibragim El-Sakhli

Mr. El-Sakhli is a molecular biologist with interests in model organisms and pharmacology. He has received his B.MSc from University of Western Ontario with majors in pharmacology and medical sciences as well as a minor in microbiology and immunology, and his M.Sc. from University of Ottawa with focus in physiology and molecular biology. During his undergraduate studies, Mr. El-Sakhli worked as a junior research associate at an imaging lab in Biotron, University of Western Ontario. There he gained extensive knowledge of microscopy as well as virology, by studying infected plants. His extensive molecular biology experience encompasses protocol designs, RT-PCR, flow cytometry and fluorescence-activated cell sorting (FACS), and his Master’s thesis proposes a novel method of FACS sorting of fish ionocytes that he designed and tested. During his Master’s, Mr. El-Sakhli worked as a teaching assistant for a variety of biology-related courses, ranging from botany to genetics. During that time, he gained experience on the topics, as well as in writing and grading assignments and reports. Mr. El-Sakhli is now starting a new chapter in his life where he will utilise his knowledge in the field of medical consulting.

Mr. Joseph Salvatore, Junior Medical Writer/Researcher

Mr. Joseph Salvatore

Mr. Salvatore received his B.Eng in Biomedical Engineering from Stony Brook University as a University Scholar and an M.A.Sc. in Biomedical Engineering from Carleton University. During his studies, he specialized in biomechanics and biomaterials. His research interests focused around orthopaedic implants, culminating in the development of silver-based antimicrobial coatings for cobalt-chromium alloys for his master’s thesis. These were produced via plasma-spraying and a novel method of pressureless sintering, with one demonstrating over 99% antibacterial efficacy. His work was funded in part by an NSERC Engage Grant. Mr. Salvatore was able to observe the application of biomedicine through a surgical shadowing program at Hackensack Meridian Health Ocean Medical Center in Brick, New Jersey. Mr. Salvatore is also an avid promoter of blood and organ donation programs in the United States and Canada.

Mrs. Anna Podlesnaia, Junior Medical Writer/Researcher

Mrs. Anna Podlesnaia

Mrs. Podlesnaia received her Master of Medical Biotechnology from the University of Windsor in 2017, a certificate in Management and Economics in Pharmacy from the Saint-Petersburg State Medical University in 2012, and a degree in Pharmacy from the Saint-Petersburg State Chemical Pharmaceutical University in 2011. She began her career as a Pharmacist and worked as a Medical Specialist at a large sized international pharmaceutical company. In this role, Mrs. Podlesnaia developed business relationships with local key opinion leaders, supported the efficacy study of a newly marketed drug, and organized promotional events for medical professionals. Prior to joining Thera-Business, Mrs. Podlesnaia worked as a Science Project Co-ordinator in the R&D Department at one of Canada’s largest cannabis companies, where she managed multiple scientific and clinical research projects, ensured that research activities and documentation were in compliance with HC Cannabis Regulations, as well as developed cannabis-based formulations. Her research interests include the formulation of pharmaceuticals, nanoemulsion and microencapsulation technologies to enhance the stability and bioavailability of API, as well as the development of topical dosage forms.

Mr. Milad Nabizada, Medical Writer/Researcher Intern

Mr. Milad Nabizada

Mr. Nabizada graduated in 2018 with an Honours Bachelors of Biomedical Science from the University of Ottawa. During his studies, he completed an option in neuroscience. He is a Dean’s Honour List graduate with a passion for scientific research and healthcare. Some of his areas of interest include behaviour, cognition, connectomics, and brain imaging. In his time since joining Thera-Business, he has gained epidemiology experience while working on numerous evidence-based public health mandates.

We've completed 500+ projects for leading medical device and pharmaceutical companies, as well as government health agencies.