Speakers

Jyoti Angal, PhD is the Director of Clinical Research at Avera Research Institute – a team dedicated to improving child health and development through community-based research.

Dr Angal provides compliance and regulatory expertise on all of the center’s studies, including several National Institutes of Health (NIH) research projects such as the:

• Environmental Influences on Child Health Outcomes (ECHO) Study – examination of environmental influences on child health and development
• Safe Sleep Study – initiative to reduce infant mortality in American Indian communities
• Safe Passage Study – investigation of the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS) and stillbirth

As the director, Dr Angal enjoys managing large research projects and incorporating research ethics in order to improve research design. She’s also passionate about using research to improve maternal and child health in communities with health disparities.

Amanda Baer, MBA, has been at Penn for 17+ years and has broad experience in a diverse range of therapeutic areas. She has extensive experience managing phase I—IV clinical trials and leads a highly productive DOM Clinical Trials Unit consisting of research project managers, coordinators, assistants, and regulatory manager. She has served on the Penn IRB as well as on numerous advisory committees and task forces to improve clinical research and human subjects protection. She brings her entrepreneurial spirit to the team and specializes in Research Operations, Strategy, Process Improvement and Mentoring.

Jimmy Bechtel is the Society for Clinical Research Sites’ (SCRS) Vice President, Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Mr Bechtel provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter and operations manager. On the pharma side where he worked in innovation project management, Mr Bechtel utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Mr Bechtel to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Mr Bechtel is in charge of developing and executing the company’s site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. He also manages some of SCRS’s large industry initiatives that are based on innovative concepts and helps oversee the organization’s membership.

Cheryl Bernstein, RN, BSN, CCRC is Director of Clinical Research at the Bernstein Clinical Research Center, LLC, Cincinnati Ohio. During the last 40 years, Cheryl has coordinated multiple Phase II and III multicenter clinical research trials of new investigational products for Asthma, COPD, Allergic Rhinitis, Urticaria, Hereditary Angioedema and for sublingual allergen immunotherapy tablets.  She currently serves as a consumer representative on the FDA advisory panel for new ENT devices.  Cheryl has co-authored 7 research publications. Throughout her career, Cheryl has been a featured speaker for Allied Health continuing medical education programs at multiple annual AAAAI and ACAAI meetings. For her years of service, she received the AAAAI Allied Health Professional Recognition Award in 2013.

Joan Chambers is a senior consultant advising research projects and the Center’s membership programs. She brings more than 30 years of senior management experience — across a variety of strategic and operating roles - in the life sciences industry. Joan serves on a number of boards and committees including US PharmaTimes, Citeline Awards, the Pharmaceutical Business Conference Group, and One Rare. Ms Chambers is an active member of the Drug Information Association (DIA), has published extensively in trade journals, and is a frequent speaker at industry conferences.

Jenn Curry is Head of Patient Engagement Capability at Biogen. In this role, Ms Curry is accountable for driving the capabilities that ensure the patient perspective is incorporated in a manner that optimizes the execution of patient-focused drug development and maximizes the degree of impact on participant enrollment and the participant experience in Biogen’s clinical studies. She is heavily engaged with internal leaders and external partners to support the patient engagement strategies leveraged across Biogen’s portfolio.

Ms Curry entered the field of clinical research as a Research Assistant at Massachusetts General Hospital in 2003 and shifted her focus to industry, specifically patient recruitment, in 2006. Prior to joining Biogen in 2019, she spent 9 years at AES/Acurian Inc., advancing from Project Manager to Director of Operational and Strategic Solutions.

tbd

Maha's, MS, MRA, CCRC, educational background is in Clinical Research Regulatory Affairs, Biotechnology and Life Sciences. At Penn Medicine, our goal is to bring new treatments and innovative approaches to improve patients’ lives.

Ms Dutt’s portfolio at the Office of Clinical Research includes navigating clinical research sites through the complex maze of resources we offer at Penn Medicine. This includes patient recruitment, training requirements, research application implementation and maintenance; and, most importantly facilitating patients and caregivers as they try to find the right trial for their needs.

Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to advance clinical trials with high-quality operational execution and scientific excellence. Rosie’s focus is always on the end users — the patients. Bringing new and, at times, life-saving medications to people in need drives Rosie’s sense of purpose. Rosie is a powerful thought leader at Endo and across the industry, and she is especially proud to mentor the industry’s future leaders and difference makers. Through her work across the industry, she has earned a reputation as a tireless advocate for clinical sites and the patients they serve, believing that they are key to the future of medicine and health. As a breast cancer clinical trial participant, she knows firsthand that her work can positively impact and improve lives.

Patrick Gee, Sr, PhD, JLC, is Founder & Chief Executive Hope Dealer, iAdvocate, Inc. Dr Gee graduated from the American University School of Public Affairs in 2012 with a Doctor of Philosophy in Justice, Law & Criminology. Dr Gee is a former Peritoneal/Hemodialysis patient due to suffering from Diabetic Kidney Disease. He has been a Post-Kidney Transplant Recipient since April 2017. Dr Gee is also a retired Major/Chief of Security from the Virginia Department of Corrections; and currently serves as the Founder & CEHD of iAdvocate, Inc., a non-profit Faith-based Health & Wellness organization. He is also an Ordained Minister at Mountain Movers Ministry in Richmond, VA. As a Patient Representative for the Diabetes Kidney Disease-Collaborative Task Force and an advocate for those living with chronic kidney disease and the morbid conditions that contribute to this disease, such as diabetes, cardiovascular disease, hypertension and obesity, Dr Gee uses his personal experiences to teach, coach, mentor and educate others on how best to manage their outcomes. He also ensures that underserved, undervalued and disenfranchised communities of color have a voice in their quality of life and equitable healthcare access. He also serves as Chair of the Kidney Health Initiative's Patient Family Partnership Council and is on ASN's APOL-1 Kidney Disease Steering Committee.

tbd

Paris Johnson is a highly experienced clinical research professional with over 13 years of dedicated service at AstraZeneca in Site Management and Monitoring. With experience as a US Study Lead in both Biopharma and Oncology, she has a commitment to data-driven delivery with a patient-centric focus. Ms Johnson has played a crucial role in developing, implementing and executing strategies to increase the participation of underrepresented populations in clinical trials, development of Clinical Trial Diversity Action Plans and addressing health disparities within the US. Ms Johnson is a passionate advocate for ensuring that clinical trials reflect the diversity of the populations they aim to serve.

Shafaat Ali Khan, MBBS is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As a Clinical Research Lead in Lilly’s Site and Investigator Engagement organization, Dr Khan spearheads efforts to operationalize and execute highly decentralized clinical trials, driving efficiency and innovation in the field. He also leads multidisciplinary teams at Lilly to closely collaborate with sites and investigators to drive innovation across the drug development lifecycle.

With a strong focus on patient empowerment, Dr Khan is on a mission to enhance patient education and improve access to novel investigational therapies and diagnostics. By leveraging advanced technologies and patient-centric approaches, Mr Khan strives to break down barriers and ensure that more individuals can benefit from cutting-edge treatments.

Dr Khan received a Bachelor of Medicine, Bachelor of Surgery (MBBS) degree from Baqai Medical University and continued on to complete a Postdoctoral Fellowship in Cardiovascular Science Research from Emory University School of Medicine.

tbd

tbd

Carrie Lewis has over 20 years of varied Clinical Research experience. Ms Lewis is currently an Executive Director, Clinical Program Optimization at Endo where she oversees Clinical Operations, Business Operations, eTMF/Inspectional Readiness, Training/Oversight, Medical Affairs Operations, Clinical Supplies, and Data Management. Prior to Endo, Ms Lewis garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO. She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

Matthew Maxwell serves as the Chief Growth Officer at Centricity Research, leading initiatives in patient engagement and growth strategy. With nearly two decades of experience in clinical research, he has focused on developing patient-centric strategies and fostering strategic partnerships to advance healthcare outcomes. His expertise encompasses patient barriers and motivators, recruitment methodology, technology integration with an emphasis on AI, and study simulations, with a particular focus on enhancing clinical trial efficiency through decentralized, patient-centered models. Matt holds a Doctor of Business Administration (DBA) and a Master of Science (MS) in interactive technology.

Joanne Monaghan, RN, CCRC, is a highly experienced healthcare professional with a passion for patient care and clinical research. With a career spanning over two decades, she has established herself as a dedicated and knowledgeable registered nurse since 1993. Ms Monaghan’s expertise and commitment to delivering exceptional care has made a significant impact on the lives of countless patients.

In 2005, Ms Monaghan transitioned her career into the field of clinical research, assuming the role of a clinical research coordinator. With her strong clinical background and meticulous attention to detail, she quickly excelled in managing complex research studies and ensuring compliance with regulatory requirements. Ms Monaghan’s in-depth understanding of study protocols, data collection, and participant recruitment has contributed to the successful execution of hundreds of clinical trials.

Since 2021, Ms Monaghan has taken on the role of Site Director at Boston Clinical Trials, a prestigious research institution renowned for its groundbreaking contributions to medical advancements. As Site Director, she oversees the coordination and management of multiple research projects, working closely with interdisciplinary teams to ensure the smooth operation of clinical trials. Ms Monaghan’s leadership skills, problem-solving abilities, and effective communication have played a crucial role in fostering a collaborative and efficient research environment.

Beyond her professional accomplishments, Ms Monaghan remains dedicated to ongoing education and professional development. She actively participates in workshops, conferences, and seminars to stay abreast of the latest advancements in clinical research and nursing practices.

In her spare time, Ms Monaghan enjoys giving back to the community through volunteer work, spending time with her family and her 6 year old German shepherd.

With over 25 years of experience in the clinical research industry, Suzy Montanye has dedicated 19 years as a Site Director at a private research clinic, where she successfully oversaw the completion of more than 150 clinical trials across 50 indications. Currently, she serves as a Site Relationship Manager, where she supports both seasoned and novice sites in navigating the complexities of running clinical trials. My role involves close collaboration with site teams and sponsor clinical teams to ensure that the site’s perspective is integrated into every aspect of the trial, fostering smoother and more effective study execution.

tbd

Terry Oehler, DPM has been practicing podiatry in the Denver metro area more than 25 years. Dr Oehler recently developed Colorado Clinical Research chasing his passion for clinical research.  He has more than 27 years of experience in practicing podiatry and surgery.  He graduated from Iowa State University with a BS in Biology with emphasis in pre-med and Des Moines University with a Doctorate in Podiatric Medicine before completing a 2 year surgical residency program.

tbd

Currently, as the Head of Patient & Site Engagement Capabilities, Tracey leads a team that is responsible for the development the global solutions and processes supporting all aspects patient and site engagement including the use of decentralized technologies in trials. She started her career in consulting working for Coopers & Lybrand / PricewaterhouseCoopers on projects across a broad cross-section of pharmaceutical clients. Prior to her current role at Boehringer she has worked across Medicine leading the business activities for global systems implementations, in IT heading support for Regulatory Submissions Management, and in Biostatistics & Data Science as the Digital Trials team lead. Her career to date has taken her from the UK to US, Germany and back to the US. Typically, she is responsible for strategy development, leadership, project management, process harmonization, innovation, and organizational change management. She has a Bachelor of Science (Hons) in Technology & Business Studies (Production Engineering and Economics) from Strathclyde University, and an MBA Information Management from Robert Gordon University (Scotland, UK). She is Project Management Professional (PMP) and Certified Scrum Master (CSM). 

With over 25 years of experience in the biopharmaceutical and contract research organization (CRO) industry, Samir Shah is a pharmaceutical executive with documented expertise in developing new verticals and platforms in the clinical development sector of pharmaceutical services. Mr. Shah’s most notable achievement has been the pioneering, developing and maturing a new outsourcing paradigm (Functional Service Provider Model) for large and midsize bio-pharmaceutical organizations to prosecute their clinical development portfolio. This new paradigm now represents a multi-billion dollars of annual R&D spend. Mr. Shah’s expertise and focus is supporting biopharmaceutical organizations with evaluating core/critical/non-core competencies, workforce optimization models, and unlocking outsourcing optimization value in clinical development. In addition, he is well-versed in complex integrations creating sustainable and nimble organizations, M&A activities for scale and new offerings, and innovative enterprise deal development and maturation. This new paradigm now represents multi-billion dollars of annual R&D spend.