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2.2) allows for quantitative comparison between evaluation results using different metrics at certain conditions. Fracture criticality, defined as the gradient of critical fluid pressure change to trigger seismicity (pc/h), is proposed as a novel reservoir depth-independent metric of fracture slip susceptibility and used in the probabilistic evaluation. Recently, efforts have been made to combine probabilistic seismic susceptibility evaluation with hydrogeological modelling, which provides a more accurate spatiotemporally varying fluid pressure distribution. The seismotectonic state estimated for each zone is generally consistent with the forecasted susceptibility to seismicity based on statistics of fracture criticality. He holds his BS in Biology from Salisbury University. Data Integrity for Batch Manufacturing Records and Laboratory Software She has a BScH from Queens University, a MSc from the University of Toronto, and is PMP certified from the Project Management Institute. She is well-versed in eCTD construction and harmonization to the guidelines of the FDA and ICH. Mr. Fraser is also an award-winning writer and photographer for Ontario Golf News and Flagstick magazine, two of Canadas leading golf publications. Bull Seismol Soc Am 79:14771495, Dempsey D, Suckale J (2017) Physics-based forecasting of induced seismicity at Groningen gas field, the Netherlands. They trained us effectively and made us feel capable and strong in engaging with the FDA., "Biologics has SMEs who are able to handle my requests., Our consultants feedback was tough, yet effective and the FDA does not question documents she has helped us prepare for submission., communication was easythey responded quickly to the queries we had during the preparation of the IND. 2022). In this respect, the susceptibility to fluid injection-induced seismicity can be evaluated in terms of the fracture slip susceptibility. Dariohas also held senior business intelligence and leadership roles at Scotiabank, Bell before coming to Canada from Peru, Praxair. 9c and 12a) leads to an overall less critical seismotectonic state of off-fault zones (Fig. Van holds an MSW from Wilfred Laurier University specializing in both individual and family counselling. As a Chartered Professional Accountant (CPA), Len obtained his Chartered Accountant (CA) designation with Clarkson Gordon (now Ernst & Young) back in 1985 and also holds the Certified Internal Auditor (CIA) and the Certification in Risk Management Assurance (CRMA) designations. In her role, she leverages Big Data technologies to build out platforms to support an Enterprise Data Lake and Machine Learning use cases. Jason holds a Bachelor of Arts in combined multimedia and theatre & film studies, as well as a Master of Education from Memorial University. With 30 years of experience in the Not For Profit sector, she currently sits on the Board of ART for Cancer Foundation. Considering a friction coefficient of 0.6 for reservoir rocks at Hellisheii (Arnadttir et al. Before joining MLSE Jonathan lead Digital Product Development and Design at the Canadian Broadcasting Corporation (CBC), where he operated at a national level in support of strategic planning across business lines, including News, Sports, TV, and Radio. Today Nancy is working full-time as a Director of Finance and Administration for a manufacturing company in Burlington, Ontario; she volunteers at several non-profit organizations including sitting on the school council for her three children. Dr. Grace has over 30 years CMC experience as a Senior Executive encompassing CMC from analytical development and drug substance/product development, to drug substance and product manufacturing, fill-finish, QC testing and release, packaging and labelling, and supply management and distribution. The framework considers the fluid pressure increase driven by fluid injection operations, the intrinsic variability of fracture criticality, and regional fracture density related to neighbouring fault structures. Fracture criticality obtained for the Hellisheii geothermal site follows the Gaussian distribution within each region, ranging from approximately 0.001bar/km to around 2bar/km (Fig. His CMC experience ranges from pre-clinical/Phase 1-entry programs through Phase 3 registration and licensing programs. Geothermics 63:6273, Fisher MK, Heinze JR, Harris CD et al (2004) Optimizing horizontal completion techniques in the Barnett shale using microseismic fracture mapping. Both indices are suitable to evaluate susceptibility to seismicity induced by a broad range of triggering mechanisms, such as rising fluid pressure (Talwani and Acree 1985; Elsworth et al. Here, the gradient of critical fluid pressure change pc/h is utilised as the fracture slip susceptibility metric. She has over 15 years of diverse and progressive experience in recruitment, program coordination, and job development for a number of non-profit employment services in the greater Toronto community. Geophys Res Lett 48:e2021GL093564, Hjrleifsdttir V, Snbjrnsdttir S, Vogfjord K, et al (2019) Induced earthquakes in the Hellisheidi geothermal field, Iceland. 2021). Ramy is in his first year of teaching Design Thinking, but has previous teaching experience at the Universities of Waterloo and Toronto. Vans past clinical work experience also included forensic assessment services, childrens mental health treatment, clinical supervision, and over 10 years of experience working as a Probation Officer in both community and custodial settings. 2004; Zhao et al. 2021). Throughout her career, Kathryn has worked with hundreds of companies. Whilst induced seismicity went through a quiescence period during 16 May15 July (Fig. He earned his Bachelor of Science at the University of Toronto, double majoring in Psychology and Crime & Deviance where he also studied two years of Chemical Engineering. She has worked in the international development field for ten years in Canada, the United States, Kenya, India, Pakistan, and Tajikistan. The forecasted seismically active regions extend from the ground surface to below 3km depth, but are characterised by the inverted cone shape. He has worked with well over 7000 attendees and takes pride in adjusting his approach to the needs of each individual. He has dealt with areas of strategic development, internal audit, financial reporting, budgeting and forecasting across a variety of industries including: Healthcare, Financial Services, Technology, and Manufacturing. Mr. Crist joined Biologics Consulting in 2018 with 7 years of experience as a biomedical engineer and lead reviewer at the FDA in the Office of Device Evaluation (ODE), Division of Surgical Devices (DSD), where he evaluated a wide variety of device and submission types. Jason Lamb is an education-technology specialist living in Hamilton, Ontario. Pedram Habibi has a BSc in Physics, a Bachelor of Applied Science in Computer and Communication Networking and a Masters of Engineering in Electrical and Computer Engineering. Pedram has many years of experience as an IT consultant and network administrator. J Geophys Res Solid Earth 120:50825103, Seithel R, Gaucher E, Mueller B et al (2019) Probability of fault reactivation in the Bavarian Molasse Basin. 333-267951 He is a Chartered Professional Accountant (CPA), a Professional Engineer (P.Eng), a Certified Management Consultant (CMC), and a Project Management Professional (PMP). Deepti Patki began working in the field of clinical research in 2009 after receiving her Masters in Clinical Research Management from the University of North Texas Health Science Center, USA. Figure4 presents field recorded operational time series and monitored seismicity for geothermal fluid injection into the five re-injection wells during the first half-year period at Hsmli area. There are also local extensions of the contour boundary around the faults, resulting from larger elevated fluid pressure changes due to the higher permeability of faults. in Psychology from McMaster University; a B.Sc. He has proposed relative efficacy theory identifying issues with the current generation of blood substitutes limiting efficacy compared to standard of care, packed red blood cells. She authored Module 3 submissions for two BLAs and developed responses to FDA Information Requests. Heather received her BA and BEd from the University of Western Ontario in London. She is a member of the Canadian Marketing Association. Figures10 and 11 present the forecasted likelihood of seismicity occurrence within each gridblock for four subsequent half-year injection periods at 1km reservoir depth and within the 3D model domain, respectively. She comes with both a patient and sponsor centric understanding of clinical research and has had the opportunity to lead data analysis and research design of dozens of research projects simultaneously. An energetic, results-oriented consultant, Diana takes great pride in influencing the human side of business. Outside of the office, Rouzbeh enjoys hiking, reading, and sampling overpriced craft beers! Jonathan is recognized for his engaging teaching style. He is also a founder of the organization and one of its original directors. Allyson Conrad is an experienced, enthusiastic and dedicated instructor with many yearsof experience teaching both overseas and in Canada. Drug Development and Licensing Strategy: Optimizing and streamlining clinical development programs through use of tools such as adaptive clinical trial designs; Shortening the critical path to market by optimizing regulatory development strategies through the use of tools such as surrogate endpoints. Dr. Carmen Dima is a professor with teaching responsibilities in the Accounting and International Trade Programs at diploma, undergraduate and post-graduate levels. In the analytical arena, Christinas areas of expertise have included analytical method development and validation, development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity. Moreover, she supervises and mentors student-teachers in developing their abilities as educators in order to help them obtain their TESL certification. from the University of Toronto. In this role, she also gained experience assembling and validating eCTD submissions for Australia, New Zealand, Saudi Arabia, and Switzerland. To ensure the reservoir behaviour to be realistically represented, the reservoir model constructed would incorporate known geological structures and be calibrated through historically matching field injection pressure time series over the injection period according to field injection rates. To learn more, visit www.modernatx.com. on product development plans. Konrad holds a MBA from the University of Liverpool. from the University of Toronto. McMaster Continuing Education is located at One James North (OJN) in Hamilton, Ontario, Canada. Mr. Adcock is currently a director of AbacusNext. (2021) inferred three preferential fluid flow paths corresponding to three major NNE-SSW trending faults in the geological model. She has over 15 years of accounting experience which includes teaching in the post-secondary sector, working in Public Accounting, and the private sector. Yelena has experience with original applications as well as application maintenance (amendments and supplements). Clinical trials hold the key to the development of new treatments and therapies for the prevention, diagnosis and treatment of diseases and disorders. She has been in adult education for 38 years and continues to teach at various other schools in Southern Ontario. She has completed a Master of Arts in Political Science and has also completed a Health Law Certificate from Osgoode Hall Law School. During his time in service he served 1 combat tour to Iraq, and 1 combat tour to Afghanistan. To account for uncertainties intrinsic to the fracture slip process, the fracture slip susceptibility index used for probabilistic evaluation of induced seismicity needs to meet the following requirements: (1) critical value to trigger fracture slippage is independent of reservoir depth, and (2) statistics of the critical value reflects uncertainties in both tectonic stress gradients and fracture frictional properties. Paul Chipperton is the CEO of CanFocus Technologies Inc. and the Managing Director of EiGR Consulting. As an industry physician, Dr. Thorntons most recent positions were Chief Medical Officer and Chief Development Officer at biotechnology companies developing cutting edge products, primarily in the oncology setting. She has masters degree (M.Arch) in sustainable design with extensive experience and expertise in sustainable architecture. Prior to PAREXEL, Shannon worked for Arivis producing eCTD submissions in accordance with FDA requirements, and was the primary contributor to the publishing of original IND applications and master files. In addition, Golda provided project management, timelines, and planning to achieve strategic targeted clinical and financial goals. She holds a B.A.A from Ryerson University, and B.Ed from Niagara University and AQ Qualification from Queens University for Communication Technology. Kris previously worked for Advarra Consulting as Director of Business Development for nine years and assisted over seventy-five clients with repeated GXP engagement support. Previously she has worked as a Manager of Access and Privacy where she was responsible for managing the daily operations of the hospitals privacy program. Cole Gately is a part-time instructor at McMaster University and Mohawk College, and is a faculty member at Hamiltons Neighbourhood Leadership Institute. Bull Earthq Eng 17:44754493, Hainzl S, Fischer T, Dahm T (2012) Seismicity-based estimation of the driving fluid pressure in the case of swarm activity in Western Bohemia. Frost has over 13 years experience in adult higher education and over 20 years experience in business communications. He also has over 30 professional certifications and diplomas including Professional Engineer (PE), Engineering Leadership Programs (ELP), Manufacturing Management Programs (MMP), Project Management (PM), Certified Energy Manager (CEM), Energy Systems Auditor (ISO 50001), Lean Six Sigma Greenbelt (GB), Blackbelt (BB), Master Blackbelt (MBB), Sustainability Management, Occupation Health & Safety (OSH), Global Procurement, Supply Chain Management (SCM), Operations Management (OM), Total Quality Control (TQC), Product Development Management (PDM), Quality Management System (QMS), Manufacturing Materials & Processes (MMP), Certified Professional Facilitator (CPF), New Product Introduction (NPI), Organizational Change Management (OCM), Professional Negotiation Management (PNM), Products Commercialization program among others. During October 2020April 2021, most induced seismicity is observed to fall within regions with an elevated fluid pressure in excess of 0.2bar, in comparison with Fig. For several years, Pauline served as Principal Consultant to Celladon Corporation and was responsible for the nonclinical development of a gene therapy program for congestive heart failure, working in conjunction with FDA on developing guidance documents for industry. Steve Fletcher has been an Occupational Health and Safety Professional for the past 24 years. She additionally has worked with vaccines and with peptide based therapies. She is also accredited as an Ontario Certified English Language Teacher (OCELT) and has an International Certificate in Teaching English as an Additional Language (ICTEAL). As an Executive Director in Biologics Process & Product Development at Bristol-Myers Squibb, Dr. Grace lead Phase 3 CMC bioanalytical development and validations for Orencia (abatacept) and Orencia SC, Nulojix (belatacept), and Yervoy (ipilimumab), as well as Phase 2 bioanalytical development for Opdivo (nivolumab). Induced seismicity is a longstanding concern in geothermal production, where energy-depleted geothermal fluids are re-injected into the subsurface and circulate in the reservoir system. She has been an instructor with McMaster since 2012. He has extensive facilitation experience teaching software applications and training at Fanshawe, Brock, Michener Institute, and in the corporate setting. Munaza thoroughly enjoys teaching, and strives to create a culture of learning within the virtual classroom, where students are encouraged to take risks in the discussion, feel confident starting conversations, and therefore drive their own instruction. communication, project management, statistics, strategy, information technology, finance, quality management, reliability, Lean Six Sigma, law, marketing, risk management) for corporations, colleges and universities. Andrew holds an MBA from the Queens School of Business. He also led the de novo establishment of an internal cGMP facility for Phase 1 manufacture of patient-specific IO vaccines. In a subsequent role at MSKCC, Chris led the establishment of a new testing facility for GLP-compliant nonclinical studies which included the design of laboratory and animal facilities, installation and validation of new equipment, authoring of SOPs, and training of personnel for GLP compliance. At McMaster she has taught Risk Management courses and facilitated corporate training workshops since 2000. PSHA has been applied to develop earthquake-triggering probability maps in many areas, though its utilisation has constantly been debated and questioned (e.g., Mulargia et al. Her experiences include small and large molecules (including vaccines) in various therapeutic indications, including Oncology, Pain Management, HIV, CNS, CVS, Rare Diseases, Endocrine, Womens Healthcare & Fertility products. Dr. Baylor joined Biologics Consulting after 20 years with the Food and Drug Administration (FDA), most recently as the director of the Office of Vaccines Research and Review (OVRR). For more than ten years, Scott Parker has taken his brand of creativity and used it successfully in a number of courses across Ontario. MS, Biotechnology & Regulatory Affairs, Johns Hopkins University, Baltimore, MD (2007), BS, Biotechnology, James Madison Universitys College of Integrated Science and Technology, Harrisonburg, VA (2001), Regulatory Affairs Certification (RAC) (2010). The authors (Cao et al. She is an educational consultant with more than 10 years of experience as an educator, and has worked with colleges, school boards, and both private and public organizations in developing courses, delivering workshops and teaching in many modes, including face-to-face, blended and online formats. 333-267951 Histograms of both variables follow Gaussian distribution with the similar shape and spread. As a Medical Officer in the FDA CBER Division of Clinical Trial Design and Analysis, Dr. Thorntons focus was on biologics therapeutics, mostly in oncology, infectious disease and inflammatory disease settings. Her leadership in, and trailblazing contributions to, the mortgage industry led to her recognition as the 2021 Canadian Mortgage Awards Woman of Distinction recipient as well as her selection as a 2019 CMP Women of Influence. Connect with us through our Contact Us form. Nanda has co-authored numerous scientific publications and is frequently an invited speaker at Industry Meetings. Ankit holds a Bachelor of Commerce and MBA degrees(earned from state university in India). Whether it be schedule, budget and risk planning or leading a team of project managers, he has experiences classroom attendees are sure to benefit from. She has led teams for national and global organizations that have contributed to HRs plans to align and help achieve corporate objectives. He also did several postdoc research in academic institutes such as Korean Astronomical and Space Institute, National Astronomical Observatory of Japan, Canadian Institute for Theoretical Astrophysics. In: Proceedings of International Geothermal Workshop IGW2004 Heat and light from the heart of the earth. This includes substance-based disorders, such as cannabis or alcohol use disorders, non-substance-based disorders, including gambling disorder, as well as other disorders characterized by problems with impulse control, such as binge eating disorder. Issued March 30, 2021 62 Whittemore Avenue Cambridge, MA 02140 (617) 876-1400 www.gcpat.com Manufacturing Plants: Bedford Park, IL Evanston, IL Mt. John Nashid has over ten years of experience in teaching, health care and consulting sectors. Glenn Mills has spent most of his professional career in retail running big-box operations, including most recently as general manager of Sport Chek in Toronto. Melissa Singh is a Senior Manager of Data Science at TD Bank in Toronto. Geology 44:991994, Weir RM, Eaton DW, Eyre TS, Lawton DC (2022) Integrated interpretation: defining risk corridors by combining 3-D seismic interpretation with induced seismicity hypocenters. Keith Keindel is the executive director of the Canadian Golf Industry Association (CGIA). Dr. McEwan works with clients/sponsors to provide regulatory strategy and to assist in FDA meetings on behalf of clients for combination (drug-drug, drug-device, biologics-device) products at CBER, CDER and CDRH divisions. He began his professional career in pharmaceutical development where he held senior leadership positions in Product Development, Clinical Affairs, and Regulatory Affairs for Sanofi-Pasteur Inc. and Schering Corporation. View Joseph H.s profile on LinkedIn, the worlds largest professional community. Based on As Vice President of Technical Operations & Manufacturing at Advaxis Inc., Dr. Grace led a rapid Phase 3 analytical and process development program, followed by validation and technical transfer to an EU CDMO for the MAA registration submission for an IO vaccine product. He has also completed his doctorate degree which focused on responsibility centre management and collaboration. She holds a Bachelor of Health Administration (Post Diploma) from Athabasca University and an Associate Degree in Health Record Administration from Douglas College, New Westminster, BC. (2018) forecasted the likelihood of damage inducing earthquakes in both space and time using a hybrid physical-statistical model, which involved the evaluation of pore pressure change by a regional hydrogeologic model, and analysis of spatial variability of the seismogenic state. Janice Locke is the owner of Janice Locke Business and Financial Consulting. She has mentored many graduate students on how to start a career in clinical research and is passionate about teaching professional skills and simulating real-world experiences. She is a member of the College of Social Workers and Social Service Workers, the Ontario Association of Social Workers, and Canadian Addiction Counsellors Certification Federation. He has taught both online and in-class accounting courses at McMaster since 2009. Considering that the fracture criticality is statistically distributed, the probability can be expressed as (Shapiro 2015): where f(C) is the probability density function (PDF) of the fracture criticality C(r) at any spatial location r. Given the observed range for the fracture criticality (Cmin~Cmax), the seismic occurrence probability would be 0 when p/h
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