Retaining Diverse Patient Groups in Clinical Trials through Patient Experience Data

Maimah Karmo is the Founder/CEO of the Tigerlily Foundation (Tigerlily)and a twelve-year survivor of breast cancer. On February 28, 2006, at 4:45 p.m., Maimah was diagnosed with Stage 2 breast cancer. She had no family history and was32-years old. While undergoing her second round of chemotherapy, she launched an organization to educate, empower, advocate for and support young women affected by breast cancer. Tigerlily provides breast health, educational, empowerment wellness and transformational programs to young women. After working with Congresswoman Debbie Wasserman Schultz to develop the Breast Cancer Education and Awareness RequiresLearning Young (EARLY) Act, in October 2011, Maimah was appointed to theFederal Advisory Committee on Breast Cancer in Young Women, a committee established by the Affordable Care Act, on which she works to develop initiatives to increase knowledge of breast health and breast cancer, for women under the age of 45 and those at heightened risk for developing the disease. She is a speaker and media personality, regularly called upon to speak on Capitol Hill and other venues,as a health, advocacy and empowerment expert. In 2015, Maimah advocated withMembers of Congress to ensure that young women had access to breast screening. Tigerlily Foundation flew young women to Washington, D.C. to meet with 74 members of Congress. The visit resulted in doubling theHouse and Senate support for the Protecting Access to Lifesaving Screening(PALS) legislation. The bill was signed into law within a month, protecting the lives and rights of millions of women. Maimah has worked with the Centers for Disease Control (CDC) to launch national campaigns and has served as an Ambassador for National Women’s HealthWeek, an initiative of the Office of Women’s Health. Tigerlily Foundation has launched national and global health initiatives focused on ending disparities, through the #InclusionPledge, partnering with global stakeholders, with a call to action to recognize health disparities as a social justice issue; and working to end disparities for black women in our lifetime.Maimah has appeared in several nations publications. She has also been featured on Fox 5, ABC 7, CBS, the Oprah Winfrey Show, OWN, Good Morning America, theToday Show. Most dear to Maimah’s heart is her 17-year old daughter,Noelle. Maimah earned her BA in Communications from George Mason University and an MBA from the University of Maryland UniversityCollege. In 2010, Maimah published Fearless:Awakening to my Life’s Purpose Through Breast Cancer. Visit www.tigerlilyfoundation to learn more.

Craig Lipset leads at the forefront of innovation in clinical research and medicine development. Mr Lipset is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. He was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Mr Lipset designed and launched multiple industry firsts — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants. He currently serves on the Board of Directors for the Decentralized Trials & Research Alliance (Co-Chair), Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. He is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.Mr Lipset has received the red jacket ‘hall of fame’ recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who’s Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.

As CEO, Carlos Orantes provides leadership and strategic direction for site network. With over 30 years of experience within the life sciences industry, his career has included executive leadership, operational management, LEAN Six Sigma process improvement, as well as systems and technology deployment. Most recently, Mr Orantes served as Executive Director, Site Operations for Accelerated Enrollment Solutions, a business of PPD and ThermoFisher Scientific. There, he led the site operations for the Americas site operations in support of the company’s vast global clinical trial network. Prior to joining PPD, Mr Orantes served as Chief Executive Officer of Amplify Clinical and Accel Research Sites, where he developed the business strategy to effectively compete in Phase II-III clinical research involving multi-therapeutic trials and specialty vaccines. He also led activities related to both companies’ asset purchase by private equity. Earlier career positions included 20 years of operational, quality assurance, process improvement and laboratory management roles of increasing responsibility at Covance, now part of LabCorp. Mr Orantes earned a Master of Business Administration degree from Old Dominion University, and a Bachelor of Science degree in biology from George Washington University. He is a certified Lean Six Sigma Black Belt from Six Sigma Academy.

Jodie Huddleston is the Senior Managing Director and Head of Clinical Solutions for Life Sciences at Press Ganey with 30 years of experience leading clinical trial operations in the CRO, academic medical, community hospital, and vendor support services spaces. Over the past ten years, Jodie has been primarily focused on strategy and operations for decentralized clinical trial solutions with a focus on patient-centric innovation and direct-to-patient services.  Jodie has extensive experience in building and growing innovative offerings and disruptive models in Life Sciences. Prior to joining Press Ganey, she held leadership roles at Worldwide Clinical Trials, ICON, IQVIA, Lightship and CVS Health. Earlier in her career, Jodie worked in academia leading clinical trial operations at University Hospitals of Cleveland, Case Western Reserve University and Children’s Hospital in Colorado. She also built out a new Site Network model for the Center for Clinical Trials at Catholic Health Initiatives where she served as National Director.  Additionally, Jodie was Principal of her own consulting firm for many years and was contracted by several well-known start-up companies to assist them in building and implementation of innovative clinical trial solutions.