ACRP Canadian Chapter Presents:

LEVERAGING TECHNOLOGY FOR CLINICAL TRIAL SUCCESS

Thursday, May 12, 2016

Registration/Breakfast: 7:30am-8:30am Sessions: 8:45am-4:45pm

Toronto Airport West Hotel

5444 Dixie Rd. Mississauga, ON

Target Audience: This program will be of interest to Investigators, Coordinators, Monitors, Project Managers, Regulatory and Quality Assurance personnel, and REB members.

Learning Objectives: Upon completion of this conference, participants should be able to:

1. Recognize the benefits of implementing technology in clinical trials 2. Identify regulations that technologies have to satisfy 3. Understand the processes involved in developing, using and maintaining technology in your organization

ACRP Canadian Chapter Conference LEVERAGING TECHNOLOGY FOR CLINICAL TRIAL SUCCESS

Thursday, May 12, 2016

Toronto Airport West Hotel, 5444 Dixie Rd., Mississauga, ON

7:30am – 8:30am Registration and Breakfast

8:45am – 9:00am Welcome and Introductions Liana Di Marco, BSc, CCRP, CCRT, Co-President, ACRP Canadian Chapter Jovana Vojnovic, MSc, Co-President, ACRP Canadian Chapter

9:00am – 9:45am E-Consent: The E is for Empowerment Jack Corman, BSc, BEd, Principal, JHC Consultants

9:45am – 10:30am eTMFs and You: The AHRC Example Amr Sharaf, Research Compliance and Education Specialist, Applied Health Research Centre, St. Michael’s Hospital

10:30am – 10:45am Networking Break

10:45am – 11:30am Building and Validating EDC and ePRO Systems in Clinical Trials with Compliance and Quality in Mind Jerry Legierski, BComm, President and CEO of HealthDiary Inc.

11:30am – 12:15pm Quality and Compliance in an Electronic World: A Cautionary Tale Patricia Jones, ART, RAC (CAN/US/EU), Director, Clinical Quality and Compliance Therapeutic Products Inc.

12:15pm – 1:15pm Lunch

1:15pm – 2:00pm Stop letting your scientific training get in the way of recruitment success. Engaging patients via social media and other channels to drive differentiation and recruitment David Chapin, CEO Forma Life Science Marketing

2:00pm – 2:45pm Clinical Trials 2.0 – How Wearables and Other Innovations Will Impact Clinical Trial Design and Management Martin Sumner-Smith PhD, Senior Advisor, Health Venture Services, MaRS Discovery District

2:45pm – 3:00pm Networking Break

3:00pm – 3:45pm The Future of Clinical Research Terri Hinkley, RN, BScN, MBA, CCRC, Deputy Executive Director, ACRP

3:45pm – 4:30pm Hot Topics Panel All speakers

4:30pm – 4:45pm Closing Remarks and Wrap-Up Liana Di Marco, BSc, CCRP, CCRT, Co-President, ACRP Canadian Chapter Jovana Vojnovic, MSc, Co-President, ACRP Canadian Chapter

PRESENTATION SUMMARIES E-Consent: The E is for Empowerment Jack Corman, BSc, BEd, Principal, JHC Consultants Of all the attributes of legal, ethical clinical research, meaningful informed consent of participants remains perhaps the most important. While the necessary elements of informed consent and the legal requirement to document consent in writing have been in place for decades, numerous studies have consistently shown that true informed consent remains a highly elusive goal. At the same time, there are increased pressures at all levels to streamline and improve the clinical trial process by adoption of new technologies, and to adopt a patient-centric approach to clinical research. E-consent promises to provide the desired efficiencies while simultaneously enhancing subject understanding by putting patients in charge, with better documentation and a superior audit trail. eTMFs and You: The AHRC Example Amr Sharaf, Research Compliance and Education Specialist, Applied Health Research Centre, St. Michael’s Hospital This presentation will discuss the increasing trend of utilizing an electronic trial master file, as opposed to a traditional hardcopy file, in clinical trials. Topics covered include the rules and regulations surrounding eTMFs in the U.S., Canada and EU, the pros and cons of using these types of systems, and how the Applied Health Research Centre has implemented eTMF’s into their daily operations.

Building and Validating EDC and ePRO Systems in Clinical Trials with Compliance and Quality in Mind Jerry Legierski, BComm, President and CEO of HealthDiary Inc. Electronic Data Capture (EDC) and electronic Patient Reported Outcomes (ePRO) are slowly but surely replacing paper based data collection in clinical trials. However, to be effective and compliant, electronic systems have to be carefully planned, built and validated to suit a robustly regulated industry such as clinical research. This session will outline the applicable laws and regulations such as FDA 21 CFR Part 11, HIPAA/HITECH, and describe the necessary planning, building and validation processes behind an effective and compliant EDC and ePRO System. Quality and Compliance in an Electronic World: A Cautionary Tale Patricia Jones, ART, RAC (CAN/US/EU), Director, Clinical Quality and Compliance Therapeutic Products Inc. In the past, Clinical Trial documents and files were all paper hard copies, but now electronic files, and web-based applications are taking over. Technology is far outpacing the regulations, designed to ensure that quality systems are in place, and that processes remain compliant. Are we moving too fast? What are the pitfalls that we must watch out for? This presentation will include actual and potential audit/inspection findings that raise these questions. Do we have the answers? Let’s talk! Stop Letting Your Scientific Training Get in the Way of Recruitment Success. Engaging Patients via Social Media and Other Channels to Drive Differentiation and Recruitment David Chapin, CEO Forma Life Science Marketing Many people see social media as a perfect recruitment tool for clinical trials. But thinking that a Twitter (or Facebook) account will drive recruitment is like thinking that owning a stethoscope makes you a physician. The secret to recruitment is engagement, but while the scientific worldview is powerful in determining the effectiveness of drugs in clinical trials, it actually impedes creating compelling engagement. Scientists have actually studied this topic and actually know a great deal about creating effective and compelling engagement. Attend this session and learn how to harness these insights to communicate more clearly and drive engagement. Clinical Trials 2.0 – How Wearables and Other Innovations Will Impact Clinical Trial Design and Management

Martin Sumner-Smith, PhD, Senior Advisor, Health Venture Services, MaRS Discovery District The clinical trial process has evolved over the years to address increasingly stringent regulatory and functional requirements to demonstrate product efficacy and safety. In doing so, it is becoming increasingly expensive. If this trend is not reversed, the current trial process may ultimately become economically non-viable. Meanwhile, we have seen digital technologies introduce disruptive innovation to many industrial sectors, although to date they have had little impact on clinical trials. However, despite the conservative and regulated nature of the trial process, technological disruption is likely inevitable, although the timing of this disruption is not clear. Meanwhile, digital technologies have already provided incremental benefits to all aspects of trial management from patient recruitment, to data collection and analysis. The Future of Clinical Research Terri Hinkley, RN, BScN, MBA, CCRC, Deputy Executive Director, ACRP Synopsis to follow

Welcome to the annual clinical research conference presented by the Canadian Chapter of the Association of Clinical Research Professionals (ACRP). W e are delighted that you have decided to participate in this full-day educational event and trust that you will find it to be a worthwhile, fulfilling and rewarding experience.

Please take the time to read the information below, and if we can assist in any way, please let us know.

Best wishes,

Liana Di Marco, Co-President, ACRP Canadian Chapter

Jovana Vojnovic, Co-President, ACRP Canadian Chapter

INFORMATION & FAQs Presentations Your information pack includes the latest program for you to refer to during the event. In an effort to be environmentally responsible, electronic copies of the conference material will be available to paid registrants prior to the event, subject to speakers’ permission.

ACRP Continuing Education Unit (CEU) Contact Hour Application 6 .25 contact hours have been applied for through ACRP and are free for all attendees. Membership is not required for online registration/application for contact hours. To receive contact hours: go to your “My Tests, Evaluations, and Certificates” (TEC) record on the ACRP website (http://www.acrpnet.org/) and complete the evaluation within 30 days following the event (13MAY2016 – 11JUN2016). You MUST sign the conference attendance sheet to prove participation.

The CEUs provided by the Association of Clinical Research Professionals (ACRP) can be used to meet the certification maintenance requirement. Once CEU units are approved for this event, the events page will be updated with exact number of credits approved. Please check for updates at: http://www.acrpnet.org/GetInfoFor/InternationalChapters/Canada/UpcomingChapterEvents.aspx

Personal effects Please ensure that you keep your personal belongings with you at all times. We regret that we cannot be held responsible for any loss or damage to your belongings. Delegates are responsible for their own insurance, including but not limited to travel insurance, personal effects, baggage loss/damage and any personal insurance/personal injury.

Sponsors We would like to thank our sponsors for their generous support, which has made this conference possible.

Speaker Opportunities If you are interested in becoming a guest Speaker for our upcoming events and conferences, please send an email to ACRP: canadianchapter@acrpnet.org

Membership Information For more information about ACRP, and to enquire about membership or volunteering opportunities, please feel free to visit our website, or speak to a Chapter Executive member during the conference.

Association of Clinical Research Professionals (ACRP) at www.acrpnet.org

REGISTRATION INFORMATION

Conference seating is limited. Please register early to avoid disappointment. Registration Deadline: Wednesday, May 6, 2016.

http://www.acrpnet.org/GetInfoFor/InternationalChapters/Canada.aspx

Registration is done through Eventbrite (automatic link on registration form). Registration will not be accepted without receipt of correct payment.

Conference Registration Fee Conference fee includes: all sessions, continental breakfast, lunch, coffee breaks, and parking. In an effort to be environmentally responsible, electronic copies of conference materials will only be available to paid registrants prior to the event.

ACRP Canadian Chapter Member Not an ACRP Canadian C hapter Member

$210.00** $245.00***

** Registrants must be paid-up Global and Canadian Chapter members in good standing at the time of registration to receive the ACRP chapter member conference rate.

*** Not an ACRP Canadian Chapter member? Visit the ACRP website at www.acrpnet.org to join the Canadian Chapter. Please note that you MUST be a Global member before you can join the Chapter. *** Not an ACRP Global member? Visit the ACRP website at www.acrpnet.org to become a Global member, then join the Canadian Chapter. Please note that you MUST be a Global member before you can join the Chapter.

Prices are in Canadian Currency. The ACRP Canadian Chapter Executive Committee reserves the right to cancel or postpone the event due to circumstances beyond its control. In the event of cancellation, all registrants will be notified before the event and receive a full registration fee refund.

The organizers are not responsible for any other costs incurred by registrants.

Cancellation Policy — Cancellations must be received no later than May 6, 2016 for a full refund. A $75 administrative fee will apply to ALL cancellation requests received after May 6, 2016. NO REFUNDS will be issued for "No-Show" registrants. Substitutions are allowed (see below).

Substitutions/Replacements — If you are unable to attend for any reason, you may transfer your registration to another individual. The registrant must provide a request and a completed form for the person replacing them. The replacement registrant must meet the above qualifications to receive any applicable discount. Please send all cancellation or substitution requests or enquiries to: canadianchapter@acrpnet.org

HOTEL ACCOMODATIONS

Toronto Airport West Hotel 5444 Dixie Road

Mississauga, ON L4W 2L2 (905) 624-1144

Room Rate: A conference rate is available for Conference Participants at $129.00 night + applicable taxes (single or double occupancy). Rate is applicable for “Standard Rooms”. Other rooms are available for different rates; please ask at the time of making your reservation.

Room Bookings: Registrants can contact the reservation department at 905-624-1144 or 1-800-737-3211. Please quote “ACRP” at the time of booking to get the conference rate. Rooms are blocked off until April 11, 2016. Please reserve your hotel accommodations and travel after receipt of Confirmation of Registration.

Transportation from and to Airport: The Toronto Airport West offers complimentary shuttle service to and from Lester B. Pearson International Airport. Details about the shuttle service can be found here: http://www.torontoairportwesthotel.com/

Parking: Parking is included for conference attendees so please do not pay for parking outside. Please register your license plate (Hotel guests - at the Hotel front desk / Registrants at the Conference Desk).

Driving Directions: Please go to the Toronto Airport West hotel website (above link) to get driving directions from your location.

SPEAKER BIOGRAPHIES

Patricia Jones, ART, RAC (CAN/US/EU), Director, Clinical Quality and Compliance, Therapeutic Products Inc. Pat is a Medical Laboratory Technologist with more than 40 years of experience in the health-care and pharmaceutical/biologics manufacturing and consulting industries, including over 25 years in Quality and Compliance. She is currently employed at Therapeutic Products, Inc. (TPIreg), as the Senior Director, Clinical Quality and Compliance. Pat worked at CanReg, Inc. (now known as MAPI), from 1999 to 2008, most recently as Associate Director, Compliance, Clinical Services, then from 2008 to early 2014, as an independent Quality and Compliance consultant. Pat’s primary focus is compliance auditing, training, and project management in the areas of GLP, GCP, GMP, ISO (medical devices) and related Quality Systems. Pat is a member of the Regulatory Affairs Professionals Society (RAPS), and holds certifications in Canadian, US, and European Regulatory Affairs. Pat is Past President of the Canadian Chapter of the Association of Clinical Research Professionals (ACRP), past Member of the ACRP Global Membership and ACRP Global Professional Development Committees. She is a member of the Clinical Research Association of Canada (CRAC), and the Canadian Association of Professionals in Regulatory Affairs (CAPRA). Pat is a regular speaker at meetings and conferences for ACRP, other professional organizations, and health-care companies and institutions.

Liana Di Marco, BSc, CCRP, CCRT, Project Manager, EXCITE, MaRS Discovery District Liana is a Certified Clinical Research Professional and Trainer with 11 years experience in corporate medical device, academia and laboratory/medical clinic settings. Throughout her career, Liana has worked with many global partners on the strategic development and implementation of pre- and post-market clinical studies incorporating health economic and outcomes research. She completed the post-graduate Clinical Research program at Humber Institute for Technology & Advanced Learning and was invited back as faculty to teach the Medical Devices in Clinical Research course. She has been a member of Association of Clinical Research Professionals (ACRP) since 2008 and is thrilled to volunteer as President of the Canadian Chapter of ACRP for her second term.

Jovana Vojnovic, MSc, Project manager, HealthDiary Inc. Jovana is currently a project manager at HealthDiary Inc., a leading technology partner for implementation of customized software solutions encompassing electronic data capture (EDC) and electronic Patient Reported Outcomes (ePROs). She works closely with clients including pharma, CROs and academic institutions to understand their specific data collection and study monitoring needs in order to ensure smooth transition to an electronic research platform. Ms. Vojnovic holds a M.Sc. Degree in Cardiovascular Physiology from York University and also has experience working as a teaching assistant, laboratory coordinator, research assistant, and speaking at scientific conferences.

instructor duties for the Michener Institute’s Clinical Research Associate Program, was program administrator for Seneca College's clinical research certificate program; and was a founding member of the Canadian Association for Independent Clinical Research. Terri is also an adjunct instructor in the Clinical Research and Leadership graduate program at George Washington University in Washington, DC. Terri graduated from Centennial College’s Diploma Nursing program in 1986, after which she gained experience in Medicine, ICU and Emergency. She completed her BScN in 2000 and her MBA in 2005.

David Chapin, CEO Forma Life Science Marketing For nearly 30 years, David has provided strategic and tactical marketing expertise in the pre-clinical and clinical research, drug development, medical device and life science sectors. He has a keen understanding of scientific and medical concepts and a proven ability to translate them in ways that improve sales and marketing alignment, and that can be applied to communications of all types, including lead generation campaigns, content marketing and other thought leadership initiatives, websites, video, brochures, and more. David presents to diverse audiences – from C-Suite executives, to researchers, to other technically sophisticated directors and managers – about the challenges of marketing in the life

sciences. His recent engagements include presentations about creating high-performance marketing for the North Carolina Center of Innovation, Virginia Bio, Charlottesville Business Innovation Council (VA), and MAGI East 2015 Clinical Research Conference. He has also taught and lectured at the Business / Innovation / Growth Council in Charlotte, NC, and several universities and colleges including the College of Design at North Carolina State University, the Kenan-Flagler Business School at the University of North Carolina at Chapel Hill, UNC-Charlotte, East Carolina University, and Peace College. He was invited to speak at the South Carolina Arts Commission’s first biennial, state-wide design arts conference entitled ‘Good Design is Good Business.”

• Author of Making the Complex Compelling: Creating High Performance Marketing in the Life Sciences, published by Rockbench Press in 2014

• Named Best Life Science Consultant in Triangle Business Journal’s inaugural 2013 Life Sciences Awards • Published in Life Science Leader, Impact, and PharmaExec magazines and MedAd News • Named inventor on more than 40 medical device and instrumentation patents in the U.S. and ex-US

Terri Hinkley, RN, BScN, MBA, CCRC, Deputy Executive Director, ACRP Terri is the Deputy Executive Director at the Association of Clinical Research Professionals (ACRP) with responsibility for all programs and publications. Terri joined ACRP in September of 2013 after 18 years in the clinical research industry. Formerly the director of clinical operations at Helix BioPharma Corp. in Aurora, Ontario, Canada, for which she successfully implemented a clinical operations program, Terri more recently put her experience in translating strategy into operations to use as an independent clinical research consultant and as a program coordinator for the clinical research curriculum at Seneca College. She also has worked in leadership positions for Anapharm Inc., Apotex Inc., and Biovail Corp. International; held longstanding Emergency Department duties with the Rouge Valley Health System and

Amr Sharaf, Research Compliance and Education Specialist, Applied Health Research Centre, St. Michael’s Hospital Amr completed his undergraduate degree in biochemistry at the University of Toronto before attending Humber College in the Clinical Research Post-Graduate Program. He began his career as a Quality Assurance Assistant at the Ottawa Hospital Research Institute (OHRI) before being hired full time as the Institutes Internal Research Monitor. During his time in Ottawa Amr helped develop and implement the Internal Monitoring Program for OHRI-Sponsored, Health Canada regulated clinical trials, and worked closely with the Network of Networks (N2) in developing online training courses such as the Health Canada Division 5 course, Transportation of Dangerous Goods course, and GCP Refresher course. As a Research Compliance and Education Specialist with the Applied Health Research Centre (AHRC) at St. Michael’s Hospital, Amr continues to work closely with N2 while operating in both a research QA/QC role and educational trainer role within the institute.

Jerry Legierski, BCom, President & CEO, HealthDiary Inc. Mr. Legierski holds a B.Com. Degree from Ryerson University in Information Technology Management as well as a diploma in Business Marketing from Humber College. As president of HealthDiary, he has collaborated on numerous clinical studies by providing customized technology solutions incorporating Electronic Data Capture (EDC) and electronic Patient Reported Outcomes (ePRO). Mr. Legierski has 15 years of experience working in the technology industry designing and implementing complete data collection and management systems for real time quantitative and qualitative data collection using portable devices. He has worked with organizations within academic, government and clinical environments such as Glaxo Smith Kline, AstraZeneca, Chiesi Pharmaceutici, McMaster University, The LUNG Association, Mental Health Commission of Canada and many more. Through involvement in large national and multinational studies, Mr. Legierski has experience spanning a broad range of therapeutic areas, notably Asthma, COPD, mental health, child health and urology.

Jack Corman, BSc, BEd, Principal, JHC Consultants Jack Corman is a former senior biopharma industry executive, starting in sales in 1972, progressing to General Management responsibility, with Canadian and multinational pharmaceutical/biological, medical devices, branded generics, health services and Canadian junior public health care companies. He also served as a consultant on health care product and services advertising and promotion, marketing, manufacturing, regulatory affairs and governmental relations/market access, either in his time as an employee or as a consultant for a variety of clients. In 1993, he founded, and was President/CEO of, IRB Services (IRBS), Canada’s largest, and most respected and only AAHRPP accredited Canadian independent IRB/REB. In addition to Canadian ethics committees in Aurora and Montreal, IRBS also operated a successful IRB in Boca Raton, FL, reviewing hundreds of US clinical research projects over the years. He sold IRBS in 2014, staying on until his departure in February 2015. Since leaving IRBS early in 2015, he has re-established his consulting practice, while maintaining his volunteer activities with CAICR, ACRP, and CCTAM in particular.

Martin Sumner-Smith, PhD, Senior Advisor, Health Venture Services, MaRS Discovery District Martin Sumner-Smith, PhD, is a senior advisor with MaRS Health Venture Services. Originally trained as a molecular biologist, he worked in the biotechnology industry, and later in bioinformatics and enterprise software, holding research management, marketing, communications, public relations, business development and licensing roles. As an entrepreneur, Martin has founded several startup companies. He brings a biological scientist’s perspective to the analysis of the complex value networks that operate within and between organizations, and that increasingly depend on digital media and other emerging technologies. You can connect with Martin through his blog (Digital for Health), Twitter (@MartinSS) or LinkedIn (ca.linkedin.com/in/martinss/).