Casey Orvin has a long and exemplary career history in pharmaceutical research services. Most recently, he was serving as the Senior VP of Pharmaceutical Relationships at StudyKik, a full-service patient recruitment and retention technology company. Mr Orvin is also serving as the Honorary President of the Society for Clinical Research Sites (SCRS), a global organization representing nearly 10,000 clinical research sites in 47 countries within the pharmaceutical industry. Mr Orvin began his career leading a large pharmaceutical research site network, Research Solutions. In 2007, he was recruited to join Clinical Research Advantage/Radiant as Executive Vice President of Business Development and successfully led a network of over 75 research sites conducting clinical trials for pharmaceuticals, vaccines, and medical devices. Under Mr Orvin’s leadership, several crucial partnerships were formed with major pharmaceutical companies which fueled the company’s rapid growth both geographically and within the medical community. Mr Orvin facilitated the acquisition of two competitors, securing the company’s spot as what was at the time the largest clinical research site network in the US. In 2015, Casey and the executive team at Radiant merged with Synexus, a division of PPD. With Mr Orvin’s guidance, Synexus continued to expand to 215 global clinical sites in 4 continents and over 15 countries. Mr Orvin is passionate about representing the site voice within the industry while ensuring every research patient’s journey is a positive one. As a thought leader in the industry, Mr Orvin is regularly invited to be a keynote speaker and panelist and is often quoted by the leading publications covering the clinical research landscape. In 2020, he was recognized in PharmaVoice as one of the 100 Most Inspiring People in the industry. Mr Orvin currently leads the commercial team for Alcanza, a large owned and integrated network of research sites dedicated to reducing barriers to clinical research with sites located in underrepresented patient populations across the US and Puerto Rico.

Debbie Profit, PhD, began her career at Otsuka over two decades ago in Clinical Operations and has since held progressive leadership roles in R&D, as the Vice President of Otsuka Information Technology (R&D, Enterprise and Commercial) and now as the VP of Clinical Management and Applied Innovation. Dr Profit has played a key leadership role in driving novel solutions and real time data visualization of clinical trial data into Otsuka’s day to day processes. Dr Profit leads collaborations to disrupt clinical research by partnering with the likes of Verily, Amazon and Spenser Health to truly democratize clinical trials. She also contributed significantly to the clinical operations and development of digital medicine (“Abilify MYCITE”) to successful FDA submission and subsequent approval in November 2017. She possesses undergraduate degrees in both nursing and psychology, a Master of Science in Regulatory Affairs – Drugs, Biologics and Medical Device and earned her Doctorate in Leadership Studies – with a concentration in Innovation and Creativity.

Krista Russell is a clinical researcher and digital health scientist, eager to bring digital capabilities to solve complex challenges. She is passionate about improving health outcomes for patients through the adoption of the right technology solutions.

Ms Russell is Head of the Digital Health Solutions team at Takeda. Her team is partnering with teams to take on fundamental challenges to further Takeda’s vision of streamlining Digital, Data and Technology in clinical trials. Prior to Takeda, Krista developed, validated, and managed business and clinical technology tools.

Ms Russell’s passion for technology began with her career in the United States Navy. Her career passion for the use of high-quality, safe technology for patient care began while working with Veterans at high risk for suicide. She has worked extensively with patients and sites to implement and validate new technology solutions over the past two decades. She is a certified clinical research coordinator and clinical project manager, having spent over a decade conducting and managing hundreds of clinical trials before transitioning to sponsor work. Ms Russell holds a BS in Health Information Management from Saint Louis University and an MS in Health Informatics from Liberty University.

Michelle Shogren is the CEO of Innovate in What You Do! LLC. Most recently, she was the Senior Director of Innovation in Pharma R&D at Bayer. She has over 20 years of experience in Clinical Research across many different roles. Ms Shogren began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in: Clinical Operations; Training and Quality; and now in Business Excellence and Innovation. Ms Shogren has also participated as a patient in 2 clinical trials and experienced trials through the role of a caregiver for both parents while they were in clinical trials. This experience allows her to consider the firsthand viewpoint of a patient, caregiver, site, CRO and sponsor when looking at innovative opportunities. Ms Shogren ’s greatest passion is customer focused innovation and responding to the voice of the patients and sites.

Ren Shogren has 10 years of experience in marketing, training, innovation, development, sales, digital marketing, and proficiency. She is currently focused on supporting innovation with the use of user voice and innovation methodology as the Creative Director for Innovate In What You Do, LLC. In addition, Ren is also the CEO and founder of her own small business, Wired On A Whim where she makes handmade jewelry, candles, and home décor.

Dr Janet Woodcock began her long and distinguished FDA career in 1986 with the agency’s Center for Biologics Evaluation and Research (CBER) as Director of the Division of Biological Investigational New Drugs. She also served as CBER’s Acting Deputy Director, and later as Director of the Office of Therapeutics Research and Review.

In 1994, Dr Woodcock was named Director of the FDA’s Center for Drug Evaluation and Research (CDER), overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking drug initiatives.  She has also served in other leadership roles at the FDA, including as Deputy Commissioner and Chief Medical Officer.

With the onset of the COVID-19 public health emergency last year, Dr Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. 

Dr Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021. 

Dr Woodcock has received numerous honors during her distinguished public health career, including: a Lifetime Achievement Award in 2015 from the Institute for Safe Medication Practices; the Ellen V Sigal Advocacy Leadership Award in 2016 from Friends of Cancer Research; the Florence Kelley Consumer Leadership Award in 2017 from the National Consumers League; the 2019 Biotechnology Heritage Award from the Biotechnology Innovation Organization and Science History Institute; and the 2020 Lifetime Achievement Award from NORD.  She is also an avid and accomplished gardener.

TBA

Karen Travers joined Halloran in order to be part of such an enthusiastic group of life science professionals. Her work is meaningful to her because having dealt with various family members with chronic disease she realized what a difference this work makes in the lives of patients and their families. Before Halloran, she worked at Quvium, a medical device company working on a wearable cough monitor and Vertex Pharmaceuticals implementing a variety of different technologies. She also spent time at Oracle Life Sciences and Parexel. She would like to be known as Halloran’s go to person for leveraging technology in unique and complex business settings so head to her with any questions you have when faced with a complex or just plain interesting problem and new technology or an interesting way to use and existing solution could help!

Edward Triebell is the Executive Director, Product Development of Digital Health, at MRN and is responsible for the launch of new products and services in the digital health and data centric operating environment of clinical trials. His career has focused on the forefront of disruptive innovations in the telecommunications, semiconductor, SaaS/PaaS software platforms, mobile/cellular data networks and the healthcare industry for over 30 years. His career started in designing engineering and then migrated into significant roles in project engineering, program management, global sales, product marketing, and strategic business development for enterprises focused on digital technology innovation. Within the healthcare industry, Mr Triebell has been involved with strategic programs that included the creation of a private satellite-based telemedicine platform for the Mayo Clinic network of hospitals to accomplish remote diagnosis and surgical treatments with high resolution imaging/videos, RFID solutions for patient tracking within Emergency Departments as well as audited tracking of patient biological samples, outsourcing radiological contouring services for cancer treatments using a joint-venture with a leading cancer hospital in China, and pivoting an Internet of Things (IoT) software platform into a leading ePRO (electronic Patient-Reported Outcomes) platform. Mr Triebell’s educational background includes a Bachelor of Science degree and Master’s degree coursework in Electrical Engineering, graduate coursework for his Master’s degree in Business Administration and completion of an Executive Management program at the Aresty Institute of Executive Education at the Wharton School, University of Pennsylvania.

Dr Debra Weinstein’s involvement in clinical research began in 2002 when she became involved as both a sub-investigator and principal investigator with Visions Clinical Research. In 2007, she founded her own clinical research company, ZASA Clinical Research which has had great success in all aspects of Internal Medicine research. In 2009, Dr Weinstein co-founded and became the managing member of Orthopedic Research Institute, a company specializing in rheumatologic, orthopedic, podiatric and pain management studies. In 2011, she became one of the founding members of Atlantic Clinical Research Collaborative (ACRC). ACRC operated as multi-disciplinary research company with broad capabilities. Dr Weinstein currently devotes all of her time to clinical research. Over the last 21 years, Dr Weinstein has served as an investigator on over 260 clinical studies. Dr Weinstein joined the team at Science 37 in October of 2017. She is currently serving as Vice President of Internal Medicine at Science 37.

Amy West is a senior healthcare executive with over 25 years focused on disrupting markets by championing digital transformation and commercial innovation strategies that drive positive patient experiences and outcomes.

In her current role leading US Digital Transformation and Innovation for Novo Nordisk, Ms West is a change agent to drive exploration and market validation of disruptive innovation throughout the enterprise. She leads a team of industry pioneers to identify customer pain points, market trends, and emerging health tech opportunities focused on improving patient experiences and outcomes that will also benefit the broader healthcare stakeholder ecosystem.

An industry-leading marketer, Ms West is a frequent speaker and has been recognized with awards including MM&M Top 40 Healthcare Transformer, PM 360 Elite Leader of the Future and Trailblazer, and DTC Perspectives Top 25 Marketer of the Year. She is an adjunct faculty member, Women’s Health Tech advisor, and Breakthrough Alliance Advisory Board member to the Columbia School of Business HITLAB and a MATTER Advisory Board member and Community Mentor, a global healthcare innovation start-up community.

Dr Tina Kennelly received her undergraduate degree from Clemson University in 2005 and graduated from the University of South Carolina school of medicine in 2009. She then did her internship, residency and chief residency at the Medical University of South Carolina in Charleston. In 2013 she moved to Charlotte and joined Mecklenburg Medical Group as an Internist. In 2018 she became a founding partner of Tryon Medical Partners which serves over 150,000 patients in the greater Charlotte area. She then became the Director of Research for TMP where she has served as the Principal Investigator for numerous research projects including the Moderna COVE study as well as the Janssen ENSEMBLE study.