Featured Speakers from CTP 2017

This page will be updated shortly with our Speaking Faculty for CTP 2018.

Thank you for your patience!  If interested in joining our Speaking Faculty, please email us at info@canadatalkspharma.com.

Conference Chair & Host

Working with Purpose & Passion for Patients

Vatche Bartekian

Vatche Bartekian

President, Vantage BioTrials

Mr. Bartekian is President and Founder of Vantage BioTrials, a privately-held Canadian CRO specialized in clinical trial management services. Prior to this venture, he held several management positions with companies such as Pfizer, Covance, PPD, LAB Pharma, and MDS Pharma. He's contributed his strong drug development knowledge to the pharma and clinical research industry for over 18 years and has gained vast experience handling complicated trials across an array of therapeutic areas. He's an expert in Clinical Operations, Project Management, Quality Assurance and Monitoring, and holds a B.Sc. in Biochemistry and a M.Sc. Administration from Concordia University. Mr. Bartekian is also the Chairperson of the Clinical Research Association of Canada and has held this position for the past 5 years. He is an avid public speaker and an active member of SoCRA, CSPS (Canadian Society of Pharmaceutical Sciences), BioQuebec, Innovative Medicines Canada, the Society of Quality Assurance, and the Quebec Association of Clinical Research Nurses and Professionals. He recently got appointed as an Advisor to Global Affairs Canada's Life Science division.

Keynote Topics & Speakers

Focus on Why: Patient-Centricity and Team Engagement

Dr. Dawn Bell

Dr. Dawn Bell

Chief Scientific Officer and Vice-President, Medical Affairs, Novartis Canada

Dawn Bell is Chief Scientific Officer and VP Medical Affairs at Novartis Canada. In this role, she leads all aspects of clinical development and medical affairs leading a team of over 150 scientists, healthcare professionals and support staff. Prior to this, she was Sr. Global Program Head in Novartis Global Development where she was responsible for global registration and commercialization of a multi-billion dollar heart failure asset, which achieved fast track review from the FDA and the EMA, accelerating launch by one year.
Prior to Novartis, Dawn founded Cool~Bio—a privately held pre-clinical stage company focused on developing a novel hypothermia-activated fusion protein to prevent platelet activation during cardiac surgery. Prior to that, she was US General Manager for Canyon Pharmaceuticals, a privately held commercial stage biotechnology company, where she developed and executed the business strategy resulting in a US licensing agreement for Iprivask®, a novel anticoagulant. Prior to Canyon, Dawn held various roles of increasing responsibility in market access, medical affairs and clinical development at The Medicines Company, a publically traded hospital products company.
Dawn earned her Doctor of Pharmacy degree from the University of Florida and completed post-graduate residency training at the University of Illinois at Chicago and a post-graduate fellowship in Cardiovascular Medicine at the University of Florida focusing on the pharmacogenomics of heart failure. Prior to joining industry, Dawn was a tenured associate professor at West Virginia University where she maintained an active research and teaching program in cardiovascular medicine.

Making the Shift from Patient Focus to Patient Partnership

Bernadette Fernandes

Bernadette Fernandes

Director, Clinical Development, GSK

Bernadette Fernandes is the Head of Clinical Operations for GlaxoSmithKline (GSK) in Canada. She joined GSK in 1994 as a Clinical Research Associate and during the past 22 years has held progressive roles in Research and Development. Currently, Bernadette leads a dedicated group of 60 clinical development professionals and is accountable for the delivery of over 80 clinical trials supporting the registration efforts of innovative medicines and vaccines. Bernadette graduated with distinction from McMaster University with an Honours B.Sc. degree in Biology and Pharmacology. During her studies, she pursued internships with the Health Protection Branch of Health Canada and Bio-Mega Inc. Her work has been published in multiple peer reviewed journals. Bernadette’s studies and career have led her to develop a deep understanding and expertise in the field of scientific research and clinical development. As a leader within GSK’s Clinical Operations community, Bernadette understands the critical need for robust, high quality data and the importance of partnering with various stakeholder groups to develop medicines that will make a positive difference in patient’s lives. She is currently involved in supporting the Patients in Partnership initiative at GSK and facilitating the inclusion of patient perspectives in the development and delivery of new medicines and vaccines.

Session Topics & Speakers

Panel Discussion: Putting Patients First - What Does it Mean to Really be Patient-Centric?

(Panel Moderator) Dr. Durhane Wong-Rieger

(Panel Moderator) Dr. Durhane Wong-Rieger

President & CEO, Canadian Organization for Rare Disorders (CORD)

Dr. Wong-Rieger is President & CEO of the Canadian Organization for Rare Disorders (the umbrella organization of patients and patient groups) and chair of the Consumer Advocare Network (a national network for patient engagement in healthcare policy and advocacy). She is also President & CEO of the Institute for Optimizing Health Outcomes (providing training and direct service on health coaching and patient self-management) and Chair of FH Canada Patient Network. Internationally, Durhane is Chair of Rare Disease International (the global alliance of rare disease patient organizations), Past-Chair of the International Alliance of Patient Organizations, member of the Editorial Board of The Patient- Patient Centred Outcomes Research and member of Health Technology Assessment International Patient /Citizen Involvement Interest Group. She is a certified Health Coach and licensed T-Trainer with the Stanford-based Living A Healthy Life with Chronic Conditions. Dr. Wong-Rieger has served on numerous health policy advisory committees and panels and is a member of the Working Group for Ontario’s Rare Disease Strategy and member of the Patient Liaison Forum for the Canadian Drugs and Technologies in Health. Durhane has a PhD in psychology from McGill University and was professor at the University of Windsor, Canada from 1984-1999. She is married and has two children. She is a trainer and frequent lecturer and author of three books and many articles.

Dr. Chantal Lacasse, Ph.D

Dr. Chantal Lacasse, Ph.D

Senior Clinical Operations Manager, Abbvie

Chantal Lacasse has over 20 years of experience in the pharmaceutical industry. She began her career doing basic research at the CHUS working on platelet activating factor on epithelial cells which was her PhD thesis. She then moved to Montreal to perform her post doctorate in hematopoiesis at the Clinical Research Institute of Montreal. Chantal then joined Phoenix International as an Associate Director for Clinical Projects. In 1998 she moved to Abbott Laboratories/Abbvie Corporation in Clinical Research where she quickly rose through the ranks to the position of Senior Clinical Operations Manager, Global Medical Affairs. She now oversees all operational aspects of the Clinical Research Department in the conduct of observational studies across a diverse range of therapeutic areas. In this role Chantal supports her team in the development of innovative and strategic recruitment, engagement and retention initiatives. In her free time, Chantal enjoys cycling while enjoying the scenery

Lisa Machado

Lisa Machado

Founder, Canadian CML Network & Head, PatientSpeak

Lisa Machado is a former financial journalist who, after being diagnosed with a rare leukemia in 2008, now writes about the patient experience, and the challenges of living with illness. She is the head of PatientSpeak, a communications consultancy that helps organizations develop content strategy for patients, caregivers and healthcare professionals. She is also the founder of the Canadian CML Network, and the author of the award-winning ``Living Well with CML: What you need to know to live your best life with Chronic Myelogenous Leukemia.`` Lisa has been interviewed by CTV News, Rogers Media and the CBC on what it means to live with a serious chronic illness. She has also been featured in a number of newspaper articles, and has written for The Caregiver Network and Cure Today magazine. Lisa writes a regular column at CML-IQ.com and you can find her blog at cmlnetwork.ca. Lisa can be reached at lisa.machado@outlook.com

Cheryl A. Petruk, MBA, CHRP, B.Mgt.

Cheryl A. Petruk, MBA, CHRP, B.Mgt.

Chairperson, Canadian MPN Network Patient Advocacy Group

Cheryl Petruk is the Chairperson of the Canadian MPN Network, Patient Advocacy Group. This group was established in 2014 and has 13 directors and is a national/Canadian not for profit organization which is committed to improving the lives of Canadians affected my MPN’s. In 2010 when Cheryl’s husband was diagnosed with MF, Cheryl was determined to find out as much as she could about MPN’s. When the Canadian Organization of Rare Diseases, brought a group of patients and caregivers together to learn more about MPN’s, Cheryl knew that she needed to be involved. Cheryl is a Human Resources Professional holding a Certified Human Resources Professional Designation since 2006. She also holds her Bachelor of Management undergraduate degree and has just completed her MBA focusing in Community Economic Development. Cheryl has been active on many non-profit and not for profit boards within the city of Edmonton Alberta Canada. She currently sits on 2 other boards in the city of Edmonton. As well, Cheryl belongs to various service organizations that contribute to the social fabric of society. Cheryl has a wealth of board experience in governance, board development, strategic planning as well as her business acumen which includes a strong foundation in human resources.

Dr. Kathleen Starr, Ph.D.

Dr. Kathleen Starr, Ph.D.

Managing Director, Behavioral Insights, INC Research/inVentiv Health

Kathleen holds a doctorate in Clinical Health Psychology from the University of Miami and completed a post-doctorate fellowship at Duke University Medical Center. Over the span of her career, she has worked in a wide range of healthcare settings ranging from academic medical centers and government agencies to private multidisciplinary medical practices. She has more than 18 years of experience in the life science industry translating behavioral insight into commercial strategy. Leveraging expertise in human perception, decision-making, and the science of behavior, she has spent her career providing clients with an evidence-based framework to build engaging patient experiences across the product lifecycle. Kathleen leads a patient-focused communication agency that specializes in leveraging deep behavioral insights to inform clinical trial protocol development, recruitment and retention as well as post-launch disease management and adherence support programs.

Dr. Patrick Merel, Ph.D.

Dr. Patrick Merel, Ph.D.

Founder & CEO, Portable Genomics

Dr. Merel is an expert in molecular diagnostics and early developer of molecular testing automation. Long time academic at the Blood Bank Center then at University Hospital of Bordeaux, Dr. Merel has developed the concept of a wireless genomics platform designed to bring genomic data to professionals and consumers. This concept is now part of Portable Genomics, a digital health startup company he recently started, developing a mobile technology platform to enable the collection and aggregation on mobile devices of personal health data from medical to genomics, including lifestyle, behavior, and IoT data. His company has developed a sharing revenue model to incentivize patients to actively participating into data sharing for accelerating discovery in Precision Medicine. He received a Ph.D. in Molecular Biology from University of Bordeaux, and he is now based in San Diego, CA.

Dancing Tango: Supporting Parkinson’s Community Beyond Medication

Dr. Chantal Lacasse, Ph.D

Dr. Chantal Lacasse, Ph.D

Senior Clinical Operations Manager, Abbvie

Chantal Lacasse has over 20 years of experience in the pharmaceutical industry. She began her career doing basic research at the CHUS working on platelet activating factor on epithelial cells which was her PhD thesis. She then moved to Montreal to perform her post doctorate in hematopoiesis at the Clinical Research Institute of Montreal. Chantal then joined Phoenix International as an Associate Director for Clinical Projects. In 1998 she moved to Abbott Laboratories/Abbvie Corporation in Clinical Research where she quickly rose through the ranks to the position of Senior Clinical Operations Manager, Global Medical Affairs. She now oversees all operational aspects of the Clinical Research Department in the conduct of observational studies across a diverse range of therapeutic areas. In this role Chantal supports her team in the development of innovative and strategic recruitment, engagement and retention initiatives. In her free time, Chantal enjoys cycling while enjoying the scenery.

Health Canada's Clinical Trial Compliance Program

Caroline Gagnon

Caroline Gagnon

Senior Corporate Regulatory Compliance and Enforcement Advisor, Clinical Trial Compliance Program, Health Canada

Caroline Gagnon, M.Sc. is a Senior Corporate Regulatory Compliance and Enforcement Advisor for the Clinical Trial Compliance Program, Regulatory Operations and Regions Branch (RORB) of Health Canada. She joined the Public Service in 2011 where she has been active as a Regional Regulatory Compliance and Enforcement Officer (Inspector), Good Pharmacovigilance Practices (GVP). Prior to joining Health Canada, she has worked about 7 years in the pharmaceutical industry, as a Clinical Research Associate (CRA) and Senior Clinical Research Scientist. She has experience in preclinical and clinical (Phase I to IV) research, in various therapeutic areas. Caroline holds Master’s degrees in Pharmacology and in Pharmaceutical Sciences (Drug Development option, Clinical Research concentration), both from the Université de Montréal.

Clinical Considerations for the Approval of Biosimilars in Canada: Health Canada's Perspective

Dr. Bradley Scott, Ph.D.

Dr. Bradley Scott, Ph.D.

Senior Clinical Evaluator, Health Canada

Dr. Scott is a Senior Clinical Evaluator at the Biologics and Genetic Therapies Directorate within the Health Products and Foods Branch at Health Canada. He received his B.Sc. degree in biology from the University of Waterloo. He then went on to study pharmacogenomics and cancer therapeutics at the University of Ottawa where he earned a Ph.D. for his work in the identification of novel genetic factors involved in chemo- and radio-therapy resistance. He joined Health Canada in the final year of his graduate studies where he spent several years working on the Government of Canada’s Chemicals Management Plan as Scientific Evaluator involved in human health risk assessment. In 2011, he made the transition to biologics regulation where he is actively involved in the review and authorization of biologics for use in hematology and oncology as well as in the regulation of biosimilars. He has authored publications on the Canadian approach to the regulation of biosimilars and is an active member of the biosimilar working group responsible for the most recent updates to Health Canada’s guidance on biosimilars.

Evaluating the use of Mobile Health Tech in Drug Development & Clinical Trials

Stella Stergiopoulos, M.S., M.P.H.

Stella Stergiopoulos, M.S., M.P.H.

Research Fellow, Tufts Center for the Study of Drug Development

Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University. Her publications can be found on publicationlist.org/stella.stergiopoulos

Medical Cannabis Clinical Trials - Are We at a Tipping Point?

Sabrina Ramkellawan

Sabrina Ramkellawan

Clinical Research Consultant

Sabrina Ramkellawan has 15+ years of experience in conducting clinical trials in a number of environments including overseeing CROs, and has worked for pharmaceutical companies and investigator sites (Physician Clinics). Sabrina has worked in various roles including Research Nurse, CRC, CRA and various management positions. Her previous positions have included various management positions at Apotex Inc. and she was the previous Director of Operations at Biopharma Services and INC Research. She is currently the Co-Founder of the Canadian Institute for Medical Advancement where she helps sites, research organizations and pharmaceutical companies with the conduct of clinical trials. During the last year and a half she has also worked in the area of medical cannabis research as well as managing a medical cannabis clinic. She has experience with utilizing technology in clinical trials including being the clinical lead in the implementation of an Electronic Data Capture (EDC) system at a CRO, implementing a new recruitment database to improve patient recruitment and has worked on three research studies that have utilized electronic consent

A New Look at Clinical Trials: Turning Principles & Reflections into Tools and Methods

Janette Panhuis

Janette Panhuis

Chief Operating Officer, Population Health Research Institute

Janette Panhuis is currently the Chief Operating Officer of Population Health Research Institute in Hamilton, Ontario, Canada. PHRI is a joint research institute with McMaster University and Hamilton Health Sciences Corp. She has held this position since April 2011 having joined PHRI in 2009 as the Director, Quality Assurance responsible for Quality Systems. Janette brings over 20 years of pharmaceutical industry experience in Clinical Trial operations and Quality Assurance. Prior to joining PHRI, Ms. Panhuis held positions in both healthcare and research environments starting in nursing in the Cardiovascular ICU at Toronto General Hospital and progressing to senior administrative roles at the hospital before moving into Clinical Trial Project Management and Research Administration in industry. Ms. Panhuis holds a Masters of Business Administration from York University and a Bachelor of Science in Nursing from the University of Western Ontario. Janette has participated in CTTI since 2011 as a SC member representing PHRI and is a Board member of N2 since 2012.

Pediatric Clinical Trials in Canada

Dr. Lauren Kelly, Ph.D.

Dr. Lauren Kelly, Ph.D.

Professor, School of Biological Science and Applied Chemistry, Seneca College

Dr. Kelly has a PhD in Pharmacology from the University of Western Ontario, completed two post-doctoral fellowships at the Hospital for Sick Children and Mount Sinai Hospital and is a Certified Clinical Research Professional. Lauren has been working in pediatric clinical research since 2008 with a focus on clinical trial methodology, opioid response, systematic reviews and education. Dr. Kelly currently coordinates the Clinical Research Graduate Program at Seneca, is a reviewer with Cochrane Neonatal Review Group and is a Clinical Research Project Manager at the Hospital for Sick Children where she is working on developing core outcome sets and outcome reporting guidelines for clinical trials. In collaboration with the European Medicines Agency, her research tool to justify the choice of control arm in pediatric trials was published last year and is available online from http://www.grip-network.org/uploads/assets//WP4/GRiP-D4.09-Recommendations_for_an_apporpriate_comparator_definition.pdf

The use of Real World Evidence & Data within Clinical Research and Post Marketing Safety Applications

Dr. Mary Jo Lamberti, Ph.D.

Dr. Mary Jo Lamberti, Ph.D.

Senior Research Fellow, Tufts Center for the Study of Drug Develoment

Mary Jo Lamberti manages multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine. She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at industry conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts, Dr. Lamberti was director of market research at CenterWatch. She has also worked on federally funded research studies in science education reform and has taught undergraduate courses at Boston University. She holds a B.A. from Wellesley College and a Ph.D. in psychology from Boston University.

It’s All About Digital Health, Privacy and Business Models: How to Leverage Engaged Patient Communities to Collect and Share Medical, Genomics, Lifestyle and IoT Data to Accelerate Precision Medicine Discovery

Patrick Merel, Ph.D.

Patrick Merel, Ph.D.

Founder and CEO, Portable Genomics

Dr. Merel is an expert in molecular diagnostics and early developer of molecular testing automation. Long time academic at the Blood Bank Center then at University Hospital of Bordeaux, Dr. Merel has developed the concept of a wireless genomics platform designed to bring genomic data to professionals and consumers. This concept is now part of Portable Genomics, a digital health startup company he recently started, developing a mobile technology platform to enable the collection and aggregation on mobile devices of personal health data from medical to genomics, including lifestyle, behavior, and IoT data. His company has developed a sharing revenue model to incentivize patients to actively participating into data sharing for accelerating discovery in Precision Medicine. He received a Ph.D. in Molecular Biology from University of Bordeaux, and he is now based in San Diego, CA.

Reinventing the Clinical Trials Process: Orphan Drug Experience for Precision Medicine

Dr. Candida Fratazzi, MD

Dr. Candida Fratazzi, MD

President, BBCR Consulting

Executive MD, specialist in Immunology, Inflammation, Oncology, CNS and Orphan Therapeutics, over 20-year experience in developing small and large molecule drugs. Dr. Fratazzi has extensive experience in Regulatory and Medical Affairs. Her experience includes drug safety, risk management and due diligence. Dr Fratazzi devised the concept of SCIO and founded the first SCIO –BBCR Consulting in 2009, with the objective of actively contributing to clinical process innovation. She acts as a consultant to drug and device companies, and investors. She worked on many drug development projects and the global market approval of 4 new drugs. Recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant, Member of Advisory Board and Board of Directors; Invited speaker and chairman at international conferences. Dr Fratazzi received her early training at Johns Hopkins University and Harvard University in the USA, and at Imperial College in London.

You Are Smarter Than your Statistician; How you Can Improve your Research

John Amrhein

John Amrhein

Vice President, McDougall Scientific

John Amrhein is Vice President of McDougall Scientific, a CRO focused on data related services. He previously was a Senior Statistician at SAS Institute (Canada) where he taught statistics and programming, and consulted with clients in health care, pharmaceuticals, finance, and government. John was a Mathematical Statistician with the U.S. Department of Agriculture where he designed probability-based surveys of the U.S. agri-business sector. John recently completed a role as Conference Chair of SAS Global Forum, where 5200 Global SAS Users met to trade ideas.

The Social Media Blueprint: Top 3 Tips for the New Patient Advocacy and Recruitment

Sam Haiden

Sam Haiden

Executive Director of Strategic Partnerships, StudyKIK

Sam Haiden is a leader in patient recruitment and marketing at StudyKIK. He currently oversees strategic partnerships, community growth, and social product development - specializing in Facebook and Instagram platforms. He received his master's degree from UCI and currently lives in Southern California where he enjoys spending time outdoors.

Leveraged Mobile for Connected Clinical Trials

Dr. Michelle Longmire

Dr. Michelle Longmire

CEO, Medable

Dr. Longmire is a Stanford-trained physician-entrepreneur dedicated to transforming healthcare through innovation. Dr. Longmire has a background in epigenetics, novel diagnostics, and imaging. She has published over 20 peer reviewed articles and holds patents in machine learning as applied to mobile health applications. Dr. Longmire's vision is to enable health technology to be as adaptive, seamless, and integrated as the human body.

Need for Speed: Solutions for Quick & Efficient Study Start-up

Franca Cantini

Franca Cantini

President, Groupe Cantini Inc.

Franca Cantini is the President, CEO, and founder of Groupe Cantini Inc., and most recently served as the Chief of the Office of Human Research and Regulatory Affairs at the Jewish General Hospital inaugurated in February 2015. Over the past 20 years, she has contributed to the field of Research Ethics and regulatory affairs at an academic, governmental, and Health Ministry Network level. This experience has also allowed her to fully appreciate and understand the multitude of aspects inherent in clinical research.
Mrs. Cantini received her Master’s in Science of Nursing/Research Ethics at the University of Montreal. Since then, she has held appointments such as Chief Operating Officer at the Lady Davis Institute for Medical Research, Faculty Lecturer at McGill University, Chief of the Research Ethics Office, and Research Contract Specialist. These leadership positions enabled her to work as an advocate for the adherence to the highest ethical standards as well as a proficient businesswoman at ease with managing budgets, contracts, and commercialization. Her diverse expertise resulted in the Quebec Ministry of Health and Social Services mandating her group to develop a web-based educational program in research ethics for all Research Ethics Boards in its jurisdiction. For more information about this program, click here. Mrs. Cantini continues to be an active member of several working groups mandated to enhance the quality of research that meets the highest ethical standards. Mrs. Cantini’s experience and proficiency in the field has led to the founding of Groupe Cantini, a service provider to Pharmaceuticals, Clinical Research Organizations (CRO), Biotechs and Researchers (University affiliated Research Centers) working together to ensure efficient and effective streamlined start-up phase of clinical trials. Our specialty is bridging the gaps and building relationships between clinical site and drug developers, expediting the process and ultimately allowing access to novel therapies to those who need them.

Vatche Bartekian

Vatche Bartekian

President, Vantage BioTrials

Mr. Bartekian is President and Founder of Vantage BioTrials, a privately-held Canadian CRO specialized in clinical trial management services. Prior to this venture, he held several management positions with companies such as Pfizer, Covance, PPD, LAB Pharma, and MDS Pharma. He's contributed his strong drug development knowledge to the pharma and clinical research industry for over 18 years and has gained vast experience handling complicated trials across an array of therapeutic areas. He's an expert in Clinical Operations, Project Management, Quality Assurance and Monitoring, and holds a B.Sc. in Biochemistry and a M.Sc. Administration from Concordia University. Mr. Bartekian is also the Chairperson of the Clinical Research Association of Canada and has held this position for the past 5 years. He is an avid public speaker and an active member of SoCRA, CSPS (Canadian Society of Pharmaceutical Sciences), BioQuebec, Innovative Medicines Canada, the Society of Quality Assurance, and the Quebec Association of Clinical Research Nurses and Professionals. He recently got appointed as an Advisor to Global Affairs Canada's Life Science division.

A Hospital Clinical Investigation Unit – The Science, The Technical and The Practical

Michelle Dennehy, PhD, MBA

Michelle Dennehy, PhD, MBA

Director, Clinical Investigation Unit, Ottawa Hospital Research Institute (OHRI)

Since its inception over 30 years ago, the CIU at OHRI has been conducting Phase I through Phase IV clinical trials with a strength in the execution of procedurally intensive Phase I and II, drug-drug interaction (DDI), pharmacokinetic and pharmacodynamics studies (PK/PD). Prior to her work at the Ottawa Hospital, Michelle spent close to ten years as a drug metabolism and pharmacokinetic research scientist in both drug discovery and drug development at Novartis Institutes for BioMedical Research in Cambridge, MA, and at GlaxoSmithKline in Philadelphia, PA, respectively. Michelle holds a BSc Hons from Saint Mary’s University, Halifax, NS, and a PhD from the University of Missouri, Columbia, MO. She performed her post-doctoral training in proteomics at Vanderbilt University, Nashville, TN and recently obtained her executive MBA from the University of Ottawa, Telfer School of Management.

Inspection Readiness for Sites: Prioritizing Data

Nathalie Bourgouin, PMP

Nathalie Bourgouin, PMP

Director, Compliance, Skillpad

With over 25 years of experience in Pharmaceuticals and Biotech in North America, Nathalie Bourgouin is a leader in Compliance, Quality and Project Management with a solid background in risk-based clinical quality assurance processes, training and auditing. She has planned and audited numerous sites and vendors as part of several global studies. At Skillpad, Nathalie leads the Compliance Consulting group with a focus on Clinical Trials and Research compliance. She is the content expert of the new Premium Suite of Clinical Inspection Readiness e-Lessons supporting sponsors. Nathalie did her B.Sc. at McGill University and her M.Sc. at the University of Guelph and is a certified Project Management Professional (PMP).

Collaborating with Hospitals on Recruitment for Clinical Pharmacology Studies

Gregory K. Reid, M.Sc., MBA

Gregory K. Reid, M.Sc., MBA

Director, Medical Science Liaison Ph. I/II, Altasciences Inc.

Gregory Reid has amassed 30 years’ experience in the pharmaceutical industry, chiefly in
oncology drug development. He has graduate-level training in immunology and business.
In addition to substantial operational experience in large pharma and large CROs across
multiple therapeutic areas, including late phase Oncology development, much of Mr. Reid’s
experience has been acquired in the small biotech environment, where he most recently guided small teams to successfully bring three novel molecules (2 targeted oncology agents and 1 antifungal drug) from the bench through IND-enabling studies, initial IND and CTA filings and to Phase I and II clinical development. Mr. Reid was directly involved in the development and execution of clinical strategies for company assets, participated in Steering Committees overseeing oncology partnerships for out licensed assets, and was involved in the generation and review of multiple types of regulatory documents. He has over 20 peer-reviewed manuscripts and abstracts to his name, and, as Director, Medical Science Liaison, Phase I/II at Altasciences Clinical Research, is currently assisting drug developers in formulating and executing strategies around FIH and NDA-enabling clinical studies.

Remodeling the Line of Work in a Phase II-III Unit: a Worthy Exercise to Increase Efficiency?

Pierre Gervais

Pierre Gervais

President, Q&T Research

Pierre Gervais is a registered pharmacist and a pharmacologist graduated from the University of Montreal. Pierre has 17 years of diversified R & D experience with drug companies as CRA, Clinical Scientist, Research Manager and Associate Medical Director. He was involved in the strategic planning and development of key compounds like Nicoderm, sucralfate and diltiazem. Pierre founded Q & T Research – Sherbrooke in 1996, a private research centre dedicated in clinical research with drug companies. Q & T is now a research group made of 27 employees, health professionals or consultants and is active in 11 therapeutic areas. As research director, Pierre is involved in establishing and maintaining the high quality standards supporting pivotal Phase II – III multi-therapeutic clinical research groups. Pierre is a founding member and ex-President of the Quebec Association of Clinical Research (AQRC) an association dedicated in promoting excellence in clinical research.

Karine Cote

Karine Cote

Director of Operations & Communications, Q&T Research

Karine is registered nurse with a keen interest in business as shown with a baccalaureate in business administration and a Master degree in development & management of organisations. After a hospital experience in cardiology, neurology and general surgery she joined Q&T Research in 2002 as research nurse. Karine is director of recruitment, communication and operations. Karine was leading the group in a lean management analysis and is a key leader in implementing selected solutions with the objective of increasing productivity of the research unit.

How Intelligent eCRF Design Is A Key Success Driver - From Protocol to Study Completion

Dr. Nicholas Fields

Dr. Nicholas Fields

President, Sagecon Inc

Nicholas Fields is a drug development consultant/medical writer with over 25 years of experience in the pharmaceutical industry. His expertise spans the drug development spectrum from non-clinical development, through to data management/report writing and regulatory interactions/submissions, with significant experience in several therapeutic areas. Nicholas believes that “success leaves clues” and enjoys sharing his knowledge and experience to help companies achieve drug development success. Prior to founding Sagecon Inc, Nicholas held senior level positions at GlaxoSmithKline and Hemosol. Nicholas has a Ph.D. in pharmacology from the University of Western Ontario.

Lulu Chen, Hon. B.Sc., CCDM

Lulu Chen, Hon. B.Sc., CCDM

Clinical Data Manager, McDougall Scientific

Lulu Chen has progressed from post-graduate studies to lead Clinical Data Manager at McDougall Scientific. She has made positive and impactful contributions to front-line patient care and research projects working alongside medical professionals in various therapeutic areas. Her work in pharmacovigilance includes improving document standardization and processes for safety reporting of diagnostic and therapeutic products. Lulu manages multiple clinical studies at McDougall and is a key contributor to developing standard operating procedures for integrating eCRF technologies with risk-based monitoring applications to maximize value and efficiency for study sponsors.

Workshop on Clinical Research Compliance: The Time Is Always Right To Do What Is Right

Dr. Caroline Mosessian, Ph.D.,DRSc., FACMPE

Dr. Caroline Mosessian, Ph.D.,DRSc., FACMPE

COO, Clinical Research, Providence & Health Services

Dr. Caroline Mosessian, PhD., DRSc., FACMPE is the Chief Administrative Officer of John Wayne Cancer Institute and Providence St. Johns’ Health Center Oncology programs. She is also the COO of Clinical Research at Providence & Health Services for the LA Region, with oversight for 7 different hospital facilities. Dr. Mosessian is an adjunct Clinical Associate Professor at University of Southern California, and a frequent contributor on national media outlets. Her research and expertise are in clinical trials, healthcare ethics and compliance, quality and patient safety policy, regulatory affairs and reimbursement strategies, value-based care models and health technology assessments, as well as health economics and access to care. Fluent in several languages, Dr. Mosessian worked as a translator for the United Nations/FAO in Rome before relocating to Los Angeles.
University of Southern California alumna, Dr. Mosessian, holds a master degree in health administration, a doctorate in healthcare policy, masters and doctorate degrees in regulatory life sciences. In 2016, she was honored with the prestigious Top Ranked U.S. Executive Award presented by the National Council of American Executives. The national honor is awarded to the top 1% of the millions of active executives in the United States. In 1994, she was awarded Mayor Richard Riordan’s Leadership Development Fellowship for serving on nonprofit and public boards. Dr. Mosessian is actively involved in local, national and international charitable organizations and foundations that emphasize humanitarian aid. She has led various delegations to “underdeveloped” countries to provide public health education. She is a co-founder of Focus on Children Now, a nonprofit organization that works to break the poverty cycle for children worldwide. She serves as the local ambassador for UNICEF and provides other noteworthy charitable efforts to organizations such as Children’s Hunger Fund and Habitat for Humanity, Swim with Mike and Doctors without Borders. She also serves as executive board member on Lions Sight & Hearing Foundation, which provides cataract surgeries and refurbished hearing aids to the needy and working poor.