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Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Speakers

  • Robert  Paarlberg, MS, MSc

    Robert Paarlberg, MS, MSc

    • Principal
    • Paarlberg & Associates LLC, United States

    Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory policy and intelligence functions at UCB and Pharmacia (Upjohn). Bob is past Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 35 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs.

  • Suzanne  Carlson, MA

    Suzanne Carlson, MA

    • Consultant
    • ABSD Associates, LLC, United States

    Suzanne Carlson MA, MFA: President and Principal of ABSD Associates LLC, independent medical writing consultant with over a decade of specialization exclusively in clinical trial disclosure and transparency. Suzanne provides strategic advisory and operational expertise tailored to the specific needs of clinical trial sponsors nationwide.

  • Kelly  Coulbourne

    Kelly Coulbourne

    • Associate Director, Clinical Trial Data Registries
    • Allergan, United States

    Kelly is the Associate Director for the Clinical Trial Registries Group at Allergan where she is responsible for global clinical trial registration and results disclosures and compliance to EMA Policy 0070, as well as, providing insight into Allergan’s patient-centricity initiatives. Kelly has recently received her Masters in Regulatory Science from the University of Maryland School of Pharmacy in May 2019.

  • Patrick  Fawcett

    Patrick Fawcett

    • Information Disclosure Administrator
    • Office for ClinicalTrials.gov, University of Pittsburgh, United States

    Patrick holds a BS in Biology from Penn State University. His clinical research work experience includes data monitoring, regulatory affairs and clinical trial disclosure. Patrick contributed to developing the ClinicalTrials.gov reporting program for the NCI-Designated UPMC Hillman Cancer Center. Since April 2017, he has held a newly created position with the University of Pittsburgh, to develop and manage a program of education and compliance monitoring related to ClinicalTrials.gov.

  • Merete  Joergensen, MBA, MSc

    Merete Joergensen, MBA, MSc

    • Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
    • Novo Nordisk A/S, Denmark

    Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk. She is now working as a senior specialist for the area of clinical disclosure. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University.

  • Francine  Lane, MBA

    Francine Lane, MBA

    • Vice President, Global Transparency
    • TrialScope, United States

    Francine Lane is the VP of Global Transparency at TrialScope and the Chair of the DIA Clinical Trial Disclosure Community. In her day job, Francine is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Francine also dedicates her time building relationships with external stakeholders – including sponsors, investigators, regulators, and transparency and patient advocates – to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Prior to her current role, Francine served as Director of Product Management at TrialScope.

  • Deborah E. Collyar

    Deborah E. Collyar

    • President
    • Patient Advocates In Research (PAIR), United States

    Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs, and delivers innovative ways to gather input from thousands of patients. Her work encompasses many diseases, programs and policies at grassroots, national and international levels and emphasizes patient issues throughout development, clinical trials, and health literate communication with providers and patients. She is a speaker, blogger, author, team member, trainer, and faculty at professional workshops.

  • Tabassum "Tab" Y. Hoda

    Tabassum "Tab" Y. Hoda

    • Senior Manager, Clinical Trials Disclosure
    • Amgen, Inc., United States

    Tab Hoda is a Senior Manager at Amgen and manages the Clinical Trials Disclosure. She brings years of industry experience including in data management.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

  • Donna R.  Cryer, JD

    Donna R. Cryer, JD

    • Interim Executive Director
    • People-Centered Research Foundation (PCRF), United States

    Donna R. Cryer, JD, has channeled her personal experience as an IBD and liver transplant patient into professional advocacy as president and chief executive officer of the Global Liver Institute, the innovation and collaboration platform for the liver community. For almost a decade Mrs. Cryer led CryerHealth, a healthcare consulting firm she founded, providing strategic counsel to top biopharmaceutical companies, patient advocacy organizations, and emerging technology firms on patient engagement in health information technology, drug discovery, and clinical decision making. She is a frequent speaker on the topic of patient-centeredness and patient engagement in healthcare transformation.

  • Jennifer  Houser, MS

    Jennifer Houser, MS

    • Senior Manager, Medical Writing
    • Seattle Genetics, Inc., United States

  • Behtash  Bahador, MS

    Behtash Bahador, MS

    • Associate Director, Relationship Management and Development
    • CISCRP, United States

    Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into the process of clinical research, and always keeping the needs of patients, participants and the public at the forefront of his work.

  • Sudipta  Chakraborty, PhD

    Sudipta Chakraborty, PhD

    • Senior Medical Writer
    • PRA Health Sciences, United States

    Sudipta Chakraborty is a Senior Medical Writer at PRA Health Sciences. After earning her PhD in neuroscience from Vanderbilt University, Sudipta joined the medical writing space with the desire to help the public better understand the complexities of science and medicine. Collectively, Sudipta has over 10 years of biomedical communication, with her current specialization in plain language summaries of clinical study results. This has included supporting the operationalization of plain language summaries for sponsors, as well as advising sponsors on plain language best practices and regulatory requirements. Sudipta has also trained and managed other writers in the areas of plain language summary development and management.

  • Michelle  Detry, PhD

    Michelle Detry, PhD

    • Director, Adaptive Trial Execution & Senior Statistical Scientist
    • Berry Consultants, United States

    Michelle Detry, PhD, is the Director of Adaptive Trial Execution and a Senior Statistical Scientist for Berry Consultants. Dr. Detry’s expertise is in the implementation of adaptive clinical trials, including platform trials. As part of her role in implementing Berry Consultant’s trial designs she is a member of numerous statistical analysis committees that conduct the interim analyses. In addition, she has expertise in clinical trial design, reporting for Data Monitoring Committees, and also serves on Data Monitoring Committees.

  • Michelle  Hellstern, BSN

    Michelle Hellstern, BSN

    • Manager, Clinical Trial Disclosure & Transparency
    • CSL Behring, United States

  • Georgina  Humphreys, PhD, MSc

    Georgina Humphreys, PhD, MSc

    • Clinical Data Sharing Manager
    • Wellcome Trust, United Kingdom

    Georgina is committed to maximising the benefits from research data and has experience in clinical trials, both in UK academic institutions, and in the field in East Africa. She completed an MSc at the London School of Tropical Medicine and Hygiene and a PhD at University of Glasgow. She then spent 12 months as a postdoctoral researcher in Tanzania, before moving back to the UK and joining the University of Oxford where she worked for 6 years on individual patient data meta analyses. Georgina joined Wellcome in December 2018 and currently leads work on clinical trial transparency and data sharing.

  • Anthony  Keyes, MBA, PMP

    Anthony Keyes, MBA, PMP

    • Program Manager, Clinical Research Projects
    • Johns Hopkins University, United States

    Anthony Keyes, MBA, PMP is the Program Manager, Clinical Research Projects at Johns Hopkins University, Institute for Clinical and Translational Research. As a certified Project Management Professional he has successfully completed several several large-scale research projects. He founded and directs the Johns Hopkins ClinicalTrials.gov Program and Co-chairs the national Clinical Trial Registration and Results Reporting Taskforce. Anthony has over 15 years of experience in many aspects of clinical trial coordination and management. He received his MBA in healthcare management from Johns Hopkins University Carey Business School and a Bachelor's in biology from the University of Maryland, College Park.

  • Noemi  Manent

    Noemi Manent

    • Scientific Administrator, Compliance and Inspection
    • European Medicines Agency, European Union, United Kingdom

    Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is involved in the coordination of EMA Good Clinical Practice (GCP) and pharmacovigilance inspections. She also has a major role in the update of the European Clinical Trial Database (EudraCT) to integrate clinical trial results data to the already established protocol related data and allow for sponsors to publish clinical trial results on the European Clinical Trial Register (www.euclinicaltrialsregister.eu). Currently, she is involved with the implementation of the clinical trial Regulation No. 536/2014 and particularly with the EU portal and database.

  • Patrick  McNeilly, PhD

    Patrick McNeilly, PhD

    • Senior Health Policy Analyst, Office of Special Medical Programs, OC
    • FDA, United States

    Dr. McNeilly is a Senior Health Policy Analyst with the FDA’s Office of Good Clinical Practice. He is involved in a variety of policy issues related to human subject protections and good clinical practice. He joined FDA in May 2011 with FDA’s Center for Drug Evaluation and Research overseeing compliance programs related to IRBs and RDRCs. Prior to working at FDA, he was the Human Protections Administrator for the Agency for Healthcare Research and Quality. He has also served as a Compliance Oversight Coordinator for the HHS/Office for Human Research Protections. He is a registered pharmacist and trained at the Rutgers University, College of Pharmacy and received his doctoral degree in medicinal chemistry from the University of Maryland.

  • Andre  Molgat, PhD

    Andre Molgat, PhD

    • Senior Regulatory Affairs Advisor, Resource Management and Operations Directorat
    • Health Canada, Canada

    André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

  • Chris  Pfitzer, MA

    Chris Pfitzer, MA

    • Transparency Operations Lead
    • UCB Biosciences, United States

    Christopher Pfitzer is the Transparency Operations Lead at UCB BioSciences in Raleigh, North Carolina but today he is representing the TransCelerate Clinical Research Access Initiative. Chris earned his Master’s degree from NC State University and a Bachelor’s degree from the University of Alabama at Birmingham. Prior to joining UCB, Chris worked extensively with healthcare and nonprofit organizations supporting policy and communications activities.

  • Liz  Roberts, MSc

    Liz Roberts, MSc

    • Global Public Policy Lead, External Engagement Practice
    • UCB Inc., United States

    Liz is Senior Director and Global Public Policy Lead at UCB where she is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform clinical trial transparency and responsible data sharing. She also leads other public policy priorities with a focus on producing sustainable value for people living with severe diseases. Liz led the TransCelerate Clinical Data Transparency Data Anonymization sub-team and co-leads the PhUSE Data Transparency workstream. She is also the UCB representative on the PhRMA Clinical Trials Data Transparency work group. Prior to her role in Data Transparency, Liz has more than 20 years’ experience working as a biostatistician, and has an MSc in Applied Statistics.

  • Patty  Spears

    Patty Spears

    • Research Patient Advocate
    • University of North Carolina At Chapel Hill, United States

    Ms. Spears is a 20-year breast cancer survivor and cancer research advocate. Ms. Spears has extensive clinical trial advocacy experience serving as an advocate on the Translational Breast Cancer Research Consortium (TBCRC) and the NCI Breast Cancer Steering Committee (BCSC). She is also Associate Group Chair for Advocacy of the Alliance for Clinical Trials in Oncology (NCTN) as well as Chair of the Alliance Patient Advocate Committee. She is a member of NCI Core Correlative Science Committee (CCSC) and an FDA Patient Representative. She is also an advocate research grant reviewer ASCO (YIA). Ms. Spears is currently working as a scientific research manager and patient advocate at UNC Chapel Hill.

  • Raina  Agarwal, MPharm

    Raina Agarwal, MPharm

    • Senior Manager
    • Kinapse, A Syneos Health Company, United States

  • Michael A. DiMaio, JD

    Michael A. DiMaio, JD

    • JD, Associate
    • Ropes & Gray LLP, United States

    Michael DiMaio is an associate in the corporate department at Ropes & Gray, working primarily in the health care group. He advises health care providers, pharmaceutical and medical device manufacturers, contract research organizations, and other health care organizations regarding a broad range of transactional, regulatory, compliance, and privacy issues.

  • Julie G. Holtzople

    Julie G. Holtzople

    • Clinical Trial Transparency Operations Director
    • AstraZeneca, United States

    Prior to joining AstraZeneca’s Clinical Trial Transparency Office, Julie worked as a Management Consultant and IT Program Delivery Manager. Today Julie is focused on the end to end implementation of new policies, regulations, tools and the general best practices as they emerge in Clinical Trial Transparency. Julie has been particularly focused on the global implementation of the Data and Document Anonymization, as well as Lay Summaries over the past 3 years.

  • Pamela  Miller

    Pamela Miller

    • Special Projects
    • New England Journal of Medicine, United States

    Pamela Miller has been with the editorial office of the New England Journal of Medicine for over 20 years, currently serving as Assistant to the Editor. Prior to that she was the General Manager of Margun and GunMar Music and has been a grants administrator at various Boston Hospitals. In her role at the NEJM she manages large projects, including implementing online peer review, overseeing the publication’s 200th Anniversary and digitizing the journal archive. She also implements policy for the editorial office, most recently the ICMJE's requirements around data sharing statements.

  • Catina  O'Leary, PhD

    Catina O'Leary, PhD

    • President and CEO
    • Health Literacy Media (HLM), United States

    Catina O’Leary, PhD, LMSW, is President and CEO of Health Literacy Media (HLM), a nonprofit health communications company located in downtown Saint Louis, Missouri. HLM provides training for health care providers in clear verbal and written health communication; plain language writing; health education and marketing documents to increase accessibility to community members; health literate clinical trial materials and summaries; and deep engagement with communities on their selected health topics. Before joining HLM, O’Leary served on the faculty at Washington University School of Medicine. O’Leary currently serves as a member of the National Academy of Sciences, Engineering and Medicine Roundtable on Health Literacy.

  • Oladayo  Oyelola, PhD

    Oladayo Oyelola, PhD

    • Director, Clinical Trial Information Disclosure
    • Daiichi Sankyo, Inc., United States

    Dr. Oladayo Oyelola is Director, Clinical Trial Information Disclosure (CTID) at Daiichi Sankyo, Inc. He is in charge of corporate CTID and data sharing strategy and operations including training, process improvements and trial disclosure regulatory policy intelligence. He holds a PhD in Clinical Chemistry and certification of the American Society for Clinical Pathologists (ASCP). He has over 30 years’ experience in clinical and pharmaceutical R&D activities. He is a member of the ASCP and DIA.

  • Thomas  Wicks, MBA

    Thomas Wicks, MBA

    • Chief Strategy Officer
    • Trialscope, United States

    Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling, and submissions management. Thomas has been a been focused on trial transparency since 2007.

  • Diane Lehman Wilson, JD, MA

    Diane Lehman Wilson, JD, MA

    • Regulatory Affairs Manager
    • University of Michigan Medical School Office of Regulatory Affairs, United States

    Diane Lehman Wilson has worked in the Office of Regulatory Affairs at the University of Michigan Medical School for nearly a decade. She covers a range of regulatory matters supporting research faculty including clinical trials disclosure, human subjects protection, and FDA inspections of clinical trials. Her earlier career included legal and educational positions, teaching in contexts ranging from pre-school Science, a decade of teaching middle school human rights, English, and History in Detroit, to Continuing Legal Education in areas related to Medicare and Medicaid. She has presented to national audiences on clinical trial disclosure obligations as well as the Clostridium Difficile risks of antibiotics.

  • Deborah A. Zarin, DrMed, MD

    Deborah A. Zarin, DrMed, MD

    • Faculty, Harvard Medical Center; Program Director
    • MRCT Center, United States

    Deborah A. Zarin, M.D. was the Director of ClinicalTrials.gov between 2005 and 2018. In that capacity, she oversaw the world’s largest clinical trials registry, as well as the development and implementation of the first public database for summary clinical trial results. She also played a major role in the development and implementation of regulations under FDAAA (42 CFR Part 11) and the NIH trial reporting policy. Dr Zarin’s recent research has been on the quality of trial reporting, as well as issues in the design and analysis of clinical trials. Dr. Zarin has recently joined the MRCT Center as Program Director, Advancing the Clinical Trials Enterprise, and Member of Faculty, Harvard Medical School.

  • Matthias  Zerm, PhD

    Matthias Zerm, PhD

    • Lead Expert, Clinical Trial Disclosure and R&D Processes
    • Merz Pharmaceuticals GmbH, Germany

    Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Pharmaceuticals located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions, training and education, as well as process development. He is also involved in a wide range of organizational and process-related projects at Merz. He is a biologist by training and has >15 years of global experience in the clinical research arena.

  • Brendan  Barnes

    Brendan Barnes

    • Director, Data Protection & IP
    • EFPIA, Belgium

    Brendan Barnes joined EFPIA in 2002 to work on the alignment of national laws in new member states during the enlargement of 2004. Subsequently, he has been involved in EFPIA’s work on multilateral trade and intellectual property issues, including the EU’s legislation on product diversion and compulsory licensing and on issues relating to access to medicines. More recently, he has been involved in the development of new business models in the areas of neglected disease and infection and is now mainly focused on data governance issues. He previously worked in the pharmaceutical industry for 11 years, in a range of roles including Finance, Strategic Planning and Public Affairs,

  • Till  Bruckner, PhD

    Till Bruckner, PhD

    • Founder
    • TranspariMED, United Kingdom

    Till Bruckner is the founder of TranspariMED, a UK-based initiative that works to end evidence distortion in medicine worldwide. TranspariMED has driven improvements in the posting of clinical trial summary results by combining research with coalition building, advocacy and media outreach, with a particular focus on non-profit trial sponsors. Notably, TranspariMED has been a central participant in the UK House of Commons enquiry into unreported clinical trials and its aftermath. Prior to setting up TranspariMED, Till Bruckner worked for the AllTrials campaign and Transparency International.

  • Niem-Tzu Rebecca  Chen, MEd, MS

    Niem-Tzu Rebecca Chen, MEd, MS

    • Human Subjects Protection Senior Analyst
    • Rutgers, The State University of New Jersey, United States

  • Cathal  Gallagher

    Cathal Gallagher

    • Senior Life Science Consultant
    • d-wise, United Kingdom

    Cathal is a Senior Life Sciences Consultant with d-Wise. He provides product leadership for d-Wise's market-leading data de-identification solution, Blur. He collaborates with customers on product improvements and provides industry thought leadership through papers, presentations, webinars, and blogs. He is also the stream chair at Phuse for Trends and Technologies and is part of an industry-wide working group for data anonymisation. His expertise includes Data Transparency, reusable code, SDTM & ADaM Templates, Clinical Data Integration and Base SAS.

  • Rebecca  Williams, PharmD, MPH

    Rebecca Williams, PharmD, MPH

    • Acting Director, ClinicalTrials.gov, NCBI
    • National Library of Medicine, NIH, United States

    Rebecca Williams, PharmD, MPH, is Acting Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. She moved into this role after serving as the Assistant Director for over a decade. She is responsible for technical, scientific, policy, regulatory and outreach activities related to the operation of ClinicalTrials.gov, an international registry and results database of clinical research. Her research interests relate to improving the quality of reporting of clinical research. Her prior experience was in the area of prescription drug advertising and promotion at FDA and then as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins University.

  • Rebecca  Li, PhD

    Rebecca Li, PhD

    • Senior Advisor, MRCT Center; Executive Director
    • Vivli Center for Global Clinical Research Data, United States

    Rebecca Li, PhD, is the Executive Director of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over 5 years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. She completed a Fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.

  • Lucy  Mosquera

    Lucy Mosquera

    • Lead Statistician
    • Replica Analytics, Canada

  • Olivia  Shopshear, MS

    Olivia Shopshear, MS

    • Senior Director, Science and Regulatory Advocacy
    • Pharmaceutical Research and Manufacturers of America (PhRMA), United States

    Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical product development to commercial tech transfer to global supply chain management. She currently leads PhRMA’s quality and manufacturing and data transparency advocacy programs.

  • Veera  Thota

    Veera Thota

    • MMS Holdings, United States

  • Anne K. Walsh, JD

    Anne K. Walsh, JD

    • Director
    • Hyman, Phelps & McNamara , United States

    With more than 21 years of experience in private practice and government, Ms. Walsh helps pharmaceutical and medical device companies comply with, and defend against, FDA regulation. She regularly counsels clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls. She has specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and has investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General.

  • Pooja  Phogat, PhD

    Pooja Phogat, PhD

    • VP, Head of Development Operations
    • Kinapse, A Syneos Health Company, India

  • Nirpal  Virdee, MSc

    Nirpal Virdee, MSc

    • Global Head of Transparency & Disclosure
    • Synchrogenix, United Kingdom

    Nirpal Singh Virdee is the Director of Client Services, Technology at Synchrogenix, a Certara company. Nirpal is accountable for business development, client management and consulting for their technology enabled services. Nirpal provides industry insight, market trends and service line alignment when Synchrogenix look to invest, plan and implement new technologies. This includes the adoption of open APIs, real time data, and machine learning within our regulatory services. Nirpal comes with over 21 years of Life Sciences experience. He has an MSc from Brunel University in London. He is considered an industry thought leader, having globally presented at conferences. He has sat on industry advisory panels and publishes articles and Podcasts