Our Experts & Topics
Conference Chair & Host
Opportunities out of Obstacles: Overcoming Barriers in Clinical Trials
Vatche Bartekian
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 20 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 6 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
Harnessing Curiosity and Serendipity to Drive Discovery and Translation
Dr. Andrew Pelling, CSO of Spiderwort
Award winning Scientist, Professor, Entrepreneur, TED Senior Fellow and TED Speaker, Andrew Pelling has built a career on unapologetic curiosity. Andrew is a Canada Research Chair and Professor at the University of Ottawa, where his research lab brings together scientists, engineers and artists to explore speculative living technologies of the future with low-cost materials and methods. For instance, his lab has created body parts made from plants, invented microscopes controlled through social media platforms and even grown living skins on LEGOs – all innovations with the potential to redefine the uses of biology. Andrew is also an entrepreneur, having spun out four technology companies from his research lab. Currently, Andrew serves as the co-founder and CSO of Spiderwort, a company developing plant-based biomaterials for repairing and regenerating the human body. Andrew’s work has gained international attention in outlets such as Wired, Motherboard, The Atlantic, Scientific American, PBS, Discovery Channel, BBC and many others. Andrew's thought leadership and experience is highly sought-after and he travels extensively for speaking engagements and to serve in advisory capacities. For example, Andrew is a Chief Scientist at the Creative Destruction Labs, member of the open source advisory board for the Federal Government of Canada, on the advisory board for the Max Planck Institute artist residency program, and is an editor at several peer-reviewed scientific journals.
The ``Why`` Behind Purposeful Patient Engagement
T.J. Sharpe
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog on http://www.philly.com/patient1/, on www.SkinCancer.net, www.oncology-central.com, and on www.Novartis.com. He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials. The initial failures, and subsequent complete response, have been chronicled in his blog posts since December 2012. In addition to writing, he is a keynote speaker and consultant to the biopharma and clinical research industries, bringing an educated patient voice as a true stakeholder in challenging healthcare's status and making a difference in patients' lives via his company, Starfish Harbor LLC. A South Jersey native, T.J. lives in Fort Lauderdale, FL, with his wife Jennifer and two young children, Josie and Tommy.
Session Topics & Speakers
Workshop: Innovation Planning for Integrity and Success in Clinical Trials
Janet McDougall
Janet is the founder of McDougall Scientific Ltd., a niche CRO based in Toronto providing statistical design, analytics, data management and sophisticated programming applications (e.g. EDC and IVRS) as well as eTMF to support healthcare research, since 1984. She is an accredited Professional Statistician (P Stat – with ASA and SSC) an active member of the American Statistical Association (ASA), the Drug Information Association (DIA) The Applied Biostatistics Association (TABA) and the Statistical Society of Canada (SSC), a contributor to the DIA initiative that resulted in the June 2015 release of the Trial Master File Reference Model (eTMF-RM v3) and recently the Chair of the ASA-DIA joint committee on Good Clinical Practices for Statisticians and Data Managers (2016). She has presented on statistical, data management and clinical research topics at over 25 venues and authored a number of articles. Her interests are in the design and analysis of clinical trials - especially the early phases, the intersection of regulatory requirements and statistics and data quality from the protocol design through to the final submission.
Betsy Fallen
Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations and applies her Six Sigma Green Belt skills to process and SOP development and efficiency. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight. Trained as an RN, Betsy is dedicated to ensuring the voice of the patient is heard as the drug development process continues the progression towards innovation and efficiency.
Workshop: Developing Full-Proof Strategies for Patient Recruitment & Retention
Sabrina Ramkellawan
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
Kim McDonald-Taylor
Kim McDonald-Taylor, MSc, CRPC operates a clinical consultancy, McDonald-Taylor Consulting, where her passion for her clients’ projects results in exceeded expectations for her training, project management, medical writing, teaching, meeting facilitation and strategic planning. Kim has worked in the clinical trials area for 30 years, including her 12-year tenure with Endpoint Research holding positions such as VP Operations and Managing Director of Canada. Kim has volunteered with the Clinical Research Association of Canada (CRAC) for the past 18 years. In her various roles, including President, Kim has provided leadership as CRAC went online, helped develop a certification program (CRPC) and continues to recommend quality speakers for the membership on topics of importance in Canadian clinical research. She is also on the Board of Directors for Brain Injury Canada where she volunteers as secretary and was named Volunteer of the Year for 2016. Kim earned her MSc in toxicology from the Ontario Veterinary College at the University of Guelph. She has presented and co-chaired sessions at DIA, DIA Canada, ACRP and other meetings over the past 15 years. In her spare time, Kim enjoys photography, birding, genealogy, music and downhill skiing.
Workshop: Aligning Clinical Operations to ICH GCP E6 R2
Peggy J. Berry
Ms. Berry provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin. She has also held a variety of senior level positions at Dyax (now Shire), MGI Pharma (now Eisai), AstraZeneca, and Dey Pharma (now Mylan). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd) and has worked in review divisions at the FDA. In addition, she consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).
How Artificial Intelligence is Transforming Clinical Trial Recruitment
Wout Brusselaers
Wout Brusselaers is the CEO and co-founder of Deep 6 AI. Wout started his career as a diplomat in the Middle East before joining global management consulting firm, McKinsey & Company, serving a wide variety of industries across Asia. Next, Wout founded an extreme sports adventure company in Singapore and then spent five years in the high-stakes world of international security, growing and leading a 22,000-headcount organization across four continents into a $500M global player. Wout co-founded Deep 6 AI as a cutting-edge AI platform for the Intelligence Community, arguably the most complex data environment in the world. Since 2016, Deep 6 AI has focused exclusively on healthcare, working with industry leaders such as Cedars-Sinai Medical Center. Deep 6 AI now uses its AI expertise to accelerate patient recruitment exponentially and get life-saving cures to people faster. Wout is a frequent speaker on artificial intelligence in healthcare and works closely with hospitals, pharma companies and research institutes on patient recruitment programs.
Igniting Awareness in Clinical Research: The Power Behind The Patient
Amanda Wright
Ms. Wright has been involved with Greater Gift since its inception in 2010. As of 2013, Amanda assumed the role of Executive Director for Greater Gift, and since that time, she has led program development and expansion to include more than 30 industry partners. Ms. Wright has a passion for patient engagement and believes that the patient needs to be the top priority for those innovating and collaborating. Ms. Wright serves on numerous boards and committees throughout the industry, many of which are centered around the engagement of patients and enhancement of the clinical trial process to address current industry trends. When she is not working, Ms. Wright enjoys cheering on her sons at sporting events and spending time on her farm.
Health Canada's GCP Inspection Program: On-going Initiatives and Strategic Changes
Flora Noitsis
Flora started her pharmaceutical carrier in 1986 working with the private pharmaceutical laboratory NucroTechnics as a bench microbiologist. During her 5 years with the company she also acted as the Quality Control person for several drug importing companies and represented these companies during Health Canada inspections. She was responsible for review and approval of batch production documents, finished product test results and stability test results as well as final approval and authorization of the distribution of pharmaceutical products. Flora started with Health Canada in 1991 with the Drug Compliance and Verification Units, formerly known as the Drug Investigations Unit. For 17 years she inspected large companies manufacturing injectable, oral, topical, drugs for human and veterinary use, to enforce legislative and Departmental policy requirements which ensured that products met prescribed standards. She conducted compliance verifications to resolve non-compliance issues of companies, and she successfully lead prosecutions of several non-compliant pharmaceutical firms. On many occasions she represented Ontario Region on the national committee for Compliance and Verification Issues.
Since 2008 Flora has worked in the Clinical Trial Compliance Program where she plans and conducts inspections and compliance verifications of the compliance of sponsors, investigators and establishments with Canadian Good Clinical Practices regulations and guidelines and has represented the Ontario region on the national committee for Good Clinical Practices
Out with the Old, In with E-Consent
Sabrina Ramkellawan
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
Overcoming Obstacles In The Drug Approval Process in Canada
Susanne Picard
Susanne Picard, is the founder and current president of SPharm Inc., a Regulatory/Product Development consulting firm servicing clients globally. She is a highly regarded expert trusted for over 26 years to be an “out of the box” strategic thinker with expertise in Drug Development activities in various therapeutic areas. Susanne’s work supports the growth of clients’ product portfolios through standard and innovative regulatory approaches; she has also successfully driven appeal processes on negative decisions by Health Canada, with positive/approval outcomes. Passionate about making a difference in the Health Product market access both on national and provincial levels, she and her team provide support during product lifecycle management and License maintenance activities including for innovative as well as generic & biosimilar products, in various therapeutic fields.
Augmented & Virtual Reality Applications in Clinical Trials: Are we Ready for the Future?
Dr. Keith Grimes, M.D.
Keith is a UK-based General Practitioner & Digital Health Consultant, with a special interest in Urgent Care, and a passion for Innovation and Technology. He has been involved in the creation and delivery of several award-winning services such as MyLittleOne, a neonatal camera & tablet system, and the Roving GP service in Brighton & Hove. Current projects include ‘See What I See’, an evaluation of the use of Google Glass for remote consultations, and “PREVENT-ICU-Delirium”, a study on the use of Virtual Reality to reduce Post-Operative Delirium. A self-professed Geek and a Gamer, he is the founder of ‘VR Doctors’, an online community dedicated to the exploration of Virtual & Augmented Reality in Healthcare, and the host of ‘The VR Doctor’ podcast. Dr Grimes has spoken internationally on Digital Health and the role of Virtual and Augmented Reality in Healthcare, and delivered the closing talk at the inaugural TEDxNHS 2016.
Getting Back on Track for Project Completion: Effective Strategies for Study Rescue
Vatche Bartekian
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 20 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 6 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.
Trends and Challenges in Designing Clinical Studies and Analyzing Complex Clinical Data
John Amrhein
Once a Mathematical Statistician with the U.S. Department of Agriculture, where he designed probability-based surveys of the U.S. agri-business sector, John moved to Toronto to become a Senior Statistician at SAS Institute (Canada) where he taught statistics and programming and advised clients in health care, pharmaceuticals, finance, and telecommunications. As VP of McDougall Scientific, John continues to be an active statistician designing and analyzing clinical studies. After more than 30 years as a professional statistician, John has learned that he is but one part of a unicorn. Find out the details of how that came to pass at this year’s CTP conference. John was Chair of SAS Global Forum 2017 and continues as a member of the executive board of the SAS Global Users Group.
Precision Medicine: Challenges Leading to New Opportunities & Innovative Clinical Trials
Dr. Andreas Orfanos
Dr. Andreas Orfanos is the Director of the Montreal Health Innovations Coordinating Center (MHICC), a full service clinical academic research organization, and division of the Montreal Heart Institute. He is also the CEO of Innovacor, responsible for the valorization and commercialization of products and technologies originating from the Montreal Heart Institute. Dr. Orfanos brings extensive global strategic, clinical development and operational expertise across pharma, biotech, biotech investment and healthcare/hospital management. He also established ORFANOS Global Healthcare Consulting Inc., which focuses on creating value for organizations through strategy development and advancement of medical products and technologies. Previously, Dr. Orfanos held senior executive positions at Thrasos Therapeutics, Neurochem, Picchio, Novartis, Sandoz and Lifecare. Dr.Orfanos obtained his Bachelor of Medicine and Surgery (MBBCh) and Master of Business Administration (MBA) in South Africa, and has a Fellowship with the Faculty of Pharmaceutical Medicine, Royal College of Physicians (FFPM) of the United Kingdom.
Better Patient Engagement leading to Lasting Relationships in Clinical Trials
Kim McDonald-Taylor
Kim McDonald-Taylor, MSc, CRPC operates a clinical consultancy, McDonald-Taylor Consulting, where her passion for her clients’ projects results in exceeded expectations for her training, project management, medical writing, teaching, meeting facilitation and strategic planning. Kim has worked in the clinical trials area for 30 years, including her 12-year tenure with Endpoint Research holding positions such as VP Operations and Managing Director of Canada. Kim has volunteered with the Clinical Research Association of Canada (CRAC) for the past 18 years. In her various roles, including President, Kim has provided leadership as CRAC went online, helped develop a certification program (CRPC) and continues to recommend quality speakers for the membership on topics of importance in Canadian clinical research. She is also on the Board of Directors for Brain Injury Canada where she volunteers as secretary and was named Volunteer of the Year for 2016. Kim earned her MSc in toxicology from the Ontario Veterinary College at the University of Guelph. She has presented and co-chaired sessions at DIA, DIA Canada, ACRP and other meetings over the past 15 years. In her spare time, Kim enjoys photography, birding, genealogy, music and downhill skiing.
Integration of Medical Cannabis into Mainstream Pharmaceuticals
Dr. Neilank Jha, MD, FRCSC
Dr. Neilank K. Jha pursued his undergraduate studies at the University of Toronto, completed his medical school training at McMaster, completed a 6 year residency in neurosurgery at McMaster University and subsequently completed a 2 year fellowship from the University of Toronto in complex spinal disorders. He is a board certified Neurosurgeon FRCS(C) and a fellowship trained Spine Surgeon. He received his MBA from Western’s Ivey School of Business and is completing his MSc in Behavioural Sciences at the London School of Economics. Dr. Jha is staff at The University Health Network (UHN) in Toronto. He is one of the international concussion experts, participating in multiple national/international level interviews and press conferences with CBC, CTV and Global, regarding head and spine injuries in sports; was invited to the House of Commons and Parliament to meet with federal leaders regarding this issue; is a Political consultant for federal leaders on national strategy. Dr. Jha has published numerous articles, papers and book chapters, as well as presenting various abstracts at scientific meetings in Canada and the United States. Dr. Jha is also the recipient of the Best Paper Award, NASS (North American Spine Society), For: “Cost effective analysis of CSM (cervical spondylitic myelopathy) Surgery”, Chicago, Illinois. Dr. Jha is the Founding Editor-in-Chief of ‘Current Research: Concussion’; an international peer reviewed journal with a focus on traumatic brain injury.
Opportunities for Streamlined Study Start-up: How can we get there?
Susan Marlin
Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established by the Province of Ontario in 2012 to make Ontario a preferred location for global clinical trials while maintaining the highest ethical standards. Susan led the establishment of the CTO and the implementation of a province-wide streamlined research ethics review system. Prior to joining CTO served as the Associate Vice-Principal at Queen’s University. Susan worked with the National Cancer Institute of Canada Clinical Trials Group for many years, initially coordinating cancer clinical trials and later leading the development and implementation of the Ethics and Regulatory Office. Susan has been actively engaged in research ethics over the years and has served on several research ethics committees. She served as President of the Canadian Association of Research Ethics Boards, as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research Ethics Board and the Tri-Agency Panel on the Responsible Conduct of Research. Susan serves on several boards and committees supporting clinical research and innovation in health care including the board of Life Sciences Ontario, the National Advisory Group for the Canadian Clinical Trials Coordinating Centre, and the Management Team for the Ontario SPOR (Strategy for Patient Oriented Research) Support Unit. Susan was born and raised in Halifax, Nova Scotia. She holds a BSc (Hons) from Dalhousie University, and an MSc in Community Health and Epidemiology from Queen’s University. She was awarded the Queen’s Elizabeth II Diamond Jubilee medal in 2012 in recognition of her work in support of military and veteran health research.
Linnea Aasen-Johnston
Linnea has 10+ years of clinical research and clinical marketing experience in the medical device industry. Linnea works for Clinical Trials Ontario as an Industry Outreach Associate where she is currently leading the Streamlined Study Start-up Pilot and Research Education & Mentoring pilot programs. Linnea is a Clinical Business Consultant and owner of BESPOKE Business Solutions, providing services to medical device companies, contract research organizations and physician research networks. In her past role as Clinical Director for St. Jude Medical, Linnea focused on bringing research opportunities to Canada by identifying and developing strategic alignments in research specialties, and improving processes to better position Canadian sites for research opportunities. She also previously served as the Clinical Marketing Manager with BIOTRONIK Canada, focusing on clinical strategy and new product launches into the Canadian market.
Are Clinical Trial Patient Compensations a Taxable Benefit? Lessons Learned From a Canada Revenue Agency Inspection
Pierre Gervais
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.
Big Data, RWD & RWE: What’s the Difference and How is it Changing the Research Landscape?
Karri Venn
Karri Venn brings over 19 years of clinical research experience working at LMC|Manna Research. Ms. Venn has brought experience, knowledge and drive to many of the positions held at LMC Healthcare. In 2006, Ms. Venn was promoted to Director, Research of LMC Clinical Research and subsequently in 2015 to President, Research of LMC|Manna Research with a key responsibility of integration of Manna Research with LMC to create the largest clinical community research site network in Canada. Additional responsibilities include the successful openings of 11 LMC Diabetes clinics across Canada which is now the largest Endocrinology group practice in the world and the opening of Canada’s only Diabetes Clinical Pharmacology Research Unit. In total, there are 18 sites that include expertise in all phases of research from Primary Care to Metabolic Focus. Ms. Venn has led the project management teams for > 1500 clinical trials and led the response to > 40 Sponsor & Regulatory audits. LMC|Manna has become a reputable program and has received the distinct award as a Centre of Excellence in Diabetes clinical research, awarded in the Top 50 Great Places to Work for Canada in 2014 & 2015 and SPRIA winners at the 2017 SCRS conference. Ms. Venn has been certified in project management through the Project Management Institute, as well as longstanding certification as a Clinical Research Coordinator and Diabetes Educator.
Today, she is a founding Board member of the Canadian Association of Independent Clinical Research Sites (CAICR) and on the global committee for Society for Clinical Research Sites (SCRS).
Clearing Hurdles for Drug Discovery and Clinical Trials in Concussion and Traumatic Brain Injury
Dr. Jamie Hutchison, MD
Dr. Jamie Hutchison is a Senior Scientist in the Neuroscience and Mental Health Research Program and the lead Neurocritical Care physician in the Department of Critical Care at the Hospital for Sick Children. He is also a Professor of Paediatrics and Associate Scientist in the Institute of Medical Science at the University of Toronto. He is the Co-Chair (with Dr. Alexis Turgeon) of the Canadian Traumatic Brain Injury Research Consortium funded by the Canadian Institutes of Health Research and the Ontario Neurotrauma Foundation. Dr. Hutchison’s research focus is the discovery of molecular blood and neuro imaging biomarkers that help us predict long term outcome and risk stratify patients for future therapeutic trials in patients with concussion and traumatic brain injury. This research is funded by a Platform Support Grant from Brain Canada and partners – A National Biobank and Database for Patients with Traumatic Brain Injury (CanTBI).
Breaking Down Barriers: A Patient’s Perspective on Improving Clinical Trial Opportunities
Cheryl Petruk
Wife, Mother, Care Partner, Human Resources Professional, Patient Advocate, Superwoman! Cheryl has a long-standing career in Human Resources, that has transitioned her to Patient Advocacy. With the diagnosis of her husband, having a rare blood cancer, called Myelofibrosis, part of the Myeloproliferative Neoplasm Blood Cancers, Cheryl has become a very well versed and articulate patient advocate. Working with the Canadian MPN Network, the Canadian MPN Research Foundation, Canadian Blood Cancer Network, Global MPN Advocates Network, and the MPN Research Foundation in Chicago, Cheryl speaks to other patients, advocates, medical and pharma professionals, on patient centricity, patient focused care, being a caregiver/carepartner, changes in the current life sciences and health care eco system; where patients need to become the center of their treatment. Engaging audiences in talking about empowerment of the patient in their own journey with a blood cancer, and encouraging patients and their family members to become their own advocates in their health journey; because being your own advocate will provide you the control you need to have when you have no control in having a rare incurable disease.
Cheryl has her Certified Human Resources Professional Designation, a Bachelor of Management Undergraduate Degree, and holds her MBA. Cheryl has been public speaking since she was the age of 16, speaking in front of audiences ranging from 2 to 1000. Patient Advocacy has become a passion for Cheryl. Assisting people in navigating their journey, and empowering patients and their families has enabled Cheryl to navigate her own family journey with her husband’s diagnosis with a rare blood cancer. Cheryl speaks to audiences from her heart and is seen as very genuine when she speaks.
How Investigative Sites Can Integrate Patients in the Clinical Development Process
Nazneen Qureshi
Nazneen Qureshi is the manager of patient engagement at LMC|Manna Research. In this role, she manages study start-up activities, focusing on recruitment and retention strategies. Her objective is to increase the understanding of patient perceptions to improve clinical research processes such as study design, experience, and motivation to participate. Qureshi is the recipient of the SCRS 2017 Site Patient Recruitment Innovation Achievement Award. She holds an HBSc in neuroscience and psychology from the University of Toronto and is completing her MBA at Lazaridis School of Business & Economics
The Patient Group Pathway Model to Accessing Cancer Clinical Trials: a Canadian Initiative
Filomena Servidio-Italiano
Filomena is the Director of Education & Clinical Information at Colorectal Cancer Canada (‘CCC”), a national non-profit organization dedicated to increasing awareness and education of colorectal cancer. She oversees the national patient support programs (which include the Cancer Coach Program and Information/Support Groups), all educational initiatives (including the Patient Values Program and Clinical Trials Initiative) HTA Submissions and management of clinical information. Her undergraduate and graduate work lie in the biological sciences and pedagogical studies, all of which were completed at the University of Toronto.
Filomena has been a strong patient advocate for equal and timely access to effective therapies to improve colorectal cancer patient outcomes, as she works tirelessly with health care professionals in Canada along the entire continuum of colorectal cancer care. As a caregiver to her father who was afflicted with metastatic cancer, her journey has served as the impetus for the development of CCC’s unique and highly successful patient support programs. Her previous experience (11 years) in Education has permitted the expansion of CCC’s educational initiatives for both the general public and health care professionals.
Using Machine Learning and Augmented Intelligence To Overcome Difficulties in Phase III Clinical Trials
Dr. Joseph Geraci, Ph.D
Dr. Joseph Geraci is a mathematical physicist, medical scientist, and entrepreneur. He is currently the CEO of NetraMark Corp and an Assistant Professor of Molecular Medicine at Queen’s University. His focus has been on novel algorithm development for quantum computation, machine learning, and biomarker discovery. Dr. Geraci developed a novel set of machine learning methods to help pharmaceutical companies who are having difficulties during their clinical trials. One of the methods involves setting up a simple to use environment where machine and human can collaborate on exploring patient populations. The goal: to create models that can either predict safety, placebo response, and/or predict sub-populations that respond well to a potential medication. He is currently working with several pharmaceutical companies.