The Thera-Business Team

Meet The Team

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.

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Dr. Isabella Steffensen

Dr. Isabella Steffensen

President

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.

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Dr. Red Thaddeus Miguel

Dr. Red Thaddeus Miguel

Vice-President and Chief Technical Officer

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 completing his final year and undertaking his dissertation for his MSc in Evidence-Based Health Care at the University of Oxford. On his free time, he is a reviewer for a number of scientific journals and a regular contributor to health websites, where he writes about the cost effectiveness of technologies in health.

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Ms. Clare Fenwick Warren

Ms. Clare Fenwick Warren

Director of Operations

Ms. Warren 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. Ms. Warren has been involved in the tremendous success of Thera-Business by representing our company at conferences in both the US and the EU. At Thera-Business, Ms. Warren 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.

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Mr. Julien Carlone

Mr. Julien Carlone

Senior Medical Writer / Researcher

A Master of Public Health graduate from the University of Liverpool with a previous Bachelor of Science degree from Queen’s University, Mr. Carlone seeks to improve health outcomes through clinical research. He has 15 years’ of broad professional experience ranging from study design appraisals, systematic and narrative reviews, preparation of manuscripts and epidemiological surveys, and clinical registries, to policy development and strategic planning. Mr. Carlone is well-versed in EU regulatory policy, specializing in the production of audit-ready Clinical Evaluation Reports of medical devices to support submissions for CE Marking in accordance with MEDDEV 2.7/1 Rev 4, and EU MDR 2017/745. During his tenure with Thera-Business, Mr. Carlone has represented our company at various regulatory conferences including the American Medical Writers Association Annual Conference, the Med-Tech Summit, and RAPs Convergence. Previously, Mr. Carlone supported the establishment of a start-up clinical epidemiology consultancy in Scotland through study design, data analysis and manuscript development. He also gained further experience in healthcare policy analysis, having coordinated the development of policies for the opening of a women and children’s hospital in Doha, Qatar. Mr. Carlone offers a unique balance of research and strategic expertise and brings a pragmatic, patient, and collaborative approach—fostered in an international environment—to organizational objectives. Recognized as an affable, respected, and reliable professional with a passion for both learning and educating.

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Dr. Tanja Babic

Dr. Tanja Babic

Senior Medical Writer / Researcher

Dr. Babic received a PhD in Neuroscience in 2007 from the University of Western Ontario and has extensive experience in both academic and industry settings. She completed postdoctoral training at Pennington Biomedical Research Institute (Louisiana State University) and held a junior faculty position at the Pennsylvania State University College of Medicine. Her research focus was neural regulation of gastrointestinal function. During her academic career, Dr. Babic published nineteen research articles in scientific journals and won awards for her research contributions.


Since 2015, Dr. Babic has worked as a medical writer and consultant for pharmaceutical and medical device companies. Her experience includes development of value communications tools including value dossiers, value briefs, and evidence compendiums, as well as clinical summaries and review articles. Dr. Babic holds the Essential Skills of Medical Writing Certificate from the American Medical Writers Association.

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Dr. Pranavv Kumar

Dr. Pranav Kumar

Medical Writer / Researcher

Dr. Pranav Kumar is a biomedical scientist, with a PhD in Life Sciences from Jawaharlal Nehru University and an MBA in International Business from Laval University in Quebec. He is also a certified Project Management Professional (PMP) from the Project Management Institute. Dr Kumar has received training and certification in clinical research, pharmaceutical regulations, and bioscience management. Prior to joining Thera-Business, Dr Kumar worked as a medical writer and a business development consultant for pharmaceutical companies, and as a research professional at the Centre de recherche du CHU de Québec (Laval University). He previously completed a postdoctoral fellowship at the Centre de Recherche en Infectiologie (Laval University), and at the KECK Graduate Institute in California. Dr Kumar’s research interests were in the development of a point-of-care testing device for TB diagnosis in peripheral settings, and deciphering the molecular mechanism of drug action and resistance for infectious diseases. He has published thirteen research articles in scientific journals during his academic career and received various fellowships for his scientific research.

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Mr. Sheldon Yu

Mr. Sheldon Yu

Research Analyst

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.

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Mr. Vladimir Kuznetsov

Mr. Vladimir Kuznetsov

Programmer / Data Analyst

Mr. Kuznetsov received his B.Eng. in Electrical Engineering from Carleton University in 2015. Mr. Kuznetsov is an expert with programming languages such as JavaScript, SQL, and PHP. Mr. Kuznetsov has performed multiple subcontracting projects which has allowed him to diversify his knowledge with MongoDB, Express, React, and Node frameworks. During his time at Carleton University studying electrical engineering, Mr. Kuznetsov participated in an internship at Ericsson in Ottawa working on product debugging, as well as testing of logic circuits. In addition to his academic credentials, he has taken multiple courses to update and improve his knowledge on various topics relating to software languages.

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Ms. Drashti Thaker

Ms. Drashti Thaker

Health Research Analyst

Ms. Thaker is a Biomedical Engineer with specialization in Regulatory Affairs. She holds a master’s degree in Biomedical Engineering from University of Ottawa with certification in Regulatory Affairs from AAPS, Toronto. She believes applying engineering principals to medicine and health care is a revolutionary and lifesaving concept. In her childhood she was fascinated with the idea of combining biology and mathematics, which inspired her to pursue a Bachelor’s degree in biomedical engineering. Drashti has worked with several organizations in India as an intern while pursuing her Bachelors. Her keen and innovative insights on integrating engineering science into health care helped develop EECP (Enhanced External Counter Pulsation) prototype, which showcased the ability to provide lifesaving support without performing complex surgery. In her spare time, she loves to explore and capture the world through the lens, with a belief that photography helps people to see.

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Ms. Deborah Akpoguma

Ms. Deborah Akpoguma

Junior Medical Writer / Researcher

Ms. Akpoguma is a Dean’s Honour List graduate from the University of Ottawa. She holds a Bachelor of Science degree in Biomedical Sciences. During her undergraduate studies, she served as a research assistant in an Evolutionary Biology Lab. She has a strong passion for science and healthcare. Some of her areas of interests include genetics, physiology and psychology. She is currently completing an Applied Clinical Research program at McMaster University. In her spare time, she volunteers for several organizations in the Ottawa area. She also loves taking on the challenge of trying new food recipes.

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Ms. Yi Li

Ms. Yi Li

Health Research Analyst

Ms. Li holds a master’s degree in Statistics from University of Ottawa after completing B.Sc. in Applied Mathematics. With a strong background in math and statistics, Ms. Li practiced and built her skills in handling pooled datasets with theoretical and advanced knowledge (such as machine learning, time series, etc) by using Python, R, SQL and Tableau. By assisting a project for Climate Center of Guangdong Province in China, she constructed a CNN model to predict the daily precipitation for the extended-range and the paper had been submitted to Mathematical Theory and Application. As a data enthusiast, Ms. Li likes to extract information from data, discover features, and use concrete results to explain abstract phenomena. When approaching the area of bioscience and healthcare, she is ready to contribute and take on challenges.

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Mr. Rami Ali

Mr. Rami Ali

Health Research Analyst

Mr. Ali is a MSc in Public Health graduate from McGill University, with a BSc in Biomedical Science from the University of Ottawa. He was initially drawn into this field of work by discovering a great interest in working to elevate and promote the population’s health through the application of epidemiological principles. To date, Mr. Ali has gained both knowledge and experience in data analysis, narrative and systematic reviews, epidemiological surveys, and the preparation of manuscripts and technical reports. While completing his undergraduate degree he did a placement at the University of Ottawa Heart Institute, where he used administrative data to examine the effect of different cardiovascular surgery procedures on various patient outcomes. Most recently, he worked with a team of experts at the Division of Cancer Epidemiology at McGill University to develop multiple reviews and a pan-Canadian survey aimed at analyzing the impact of the COVID-19 pandemic on cancer care and control services. Mr. Ali is a motivated professional in the field of Public Health and Epidemiology who is always looking to put his skills and knowledge into practice in order to tackle difficult public health issues with the goal of improving health outcomes.

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