The Center for Pediatric Clinical Development

Dr. Mark Sorrentino has 20 years of experience in the pharmaceutical and biotech industries. Prior to joining PRA, Dr. Sorrentino spent five years as the global chair and founder of the pediatric practice area at a leading CRO, overseeing all aspects of strategy and pediatric clinical development, as well as the global therapeutic head of critical care. An active medical team member of Team Rubicon, Dr. Sorrentino sits on a variety of advisory boards, including Maryland Responds, and also serves on the board of directors for the CMR Institute, and two Enpr-EMA Working Groups.

He also sits on the advisory board of Curesearch for Children’s Cancer, which has a goal of providing knowledge about pediatric research related to cancer and to fund young researchers in their quest to develop new therapies. Dr. Sorrentino is a founding member of the AAP Council on Children and Disasters, which looks for ways to ensure that the medical community, families, caregivers, and children are prepared for natural and manmade disasters.

What inspires you to work in pediatric clinical research?

“The ability to influence policies and design clinical trials for our most vulnerable, and often neglected, populations continues to be my motivation and inspiration. After spending many years in clinical practice, first as a pediatric critical care nurse and subsequently as a pediatric critical care physician, it was astounding that the vast majority of our therapeutics (over 90% of those used in the PICU) had no labelled indication in children, and many had never undergone any type of randomized trial in this medically fragile population. I decided to change my focus and set out to make a difference in the lives of many by working toward a day where the drugs and biologics used in children have been studied for safety and efficacy in those children.”

Dr. Dehlinger-Kremer’s expertise spans more than 30 years in the research industry, including 29 years of experience in regulatory, medical affairs, and pediatric leadership. Prior to joining PRA, she served in several executive leadership roles at global CROs, and has experience in global drug development in more than 40 countries. She has contributed hands-on to the global development of numerous products, including medicines for children and drugs for orphan diseases and biosimilars. Her vision and leadership extend to service with a number of professional organizations – she is an observer member of the Coordinating Group of the European Network of Pediatric Research (Enpr-EMA) at the European Medicines Agency, chair of the Pediatric Working Group and also President of the European CRO Federation (EUCROF), serves as the chair of European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party, and is active in the International Children’s Advisory Network (iCAN). In 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE’s 100 Most Inspiring People in Life Sciences.

What inspires you to work in pediatric research?

"I’ve always felt a bond with children and their playful, inspiring, sincere, and trusting spirit. Working in pediatric clinical research provides the opportunity to contribute to the development of better medicines for children who really need them and deserve them. There’s nothing more rewarding than helping families find an appropriate clinical trial or identifying the best center for their child’s condition."

Jo joined PRA in 2012 in the Global Regulatory Affairs group, working as a global regulatory lead on global clinical trials, including a number of pediatric trials. She has been working in the CRO industry for the past 19 years, starting in pre-clinical development and moving into Global Regulatory Affairs in 2004. She also spent 18 months as the Investigator Contracts Manager, dealing with site contracts and budgets.

At PRA, Jo is continuing to develop her interest in pediatric drug development. She has a strong interest in Informed Consent and Assent content, which she expanded on by joining the European Network of Pediatric Research at the European Medicines Agency (EnprEMA) Working Group, which is tasked with developing improved pediatric information sheets and assent documents.

She holds a BSc (Hons) in Anatomy and a Law degree and Diploma in Law.

What inspires you to work in pediatric clinical research?

"My goal is to improve treatment options available for children by thinking outside the standard pathways to help make clinical trials more patient friendly and participation more accessible. I also believe we have a duty to make clinical trials more understandable through the development and use of appropriate patient materials that focus on the patient needs. This, in turn, will help everyone bring more treatment options to market for children."

Missy brings to PRA 26 years of experience as a certified pediatric nurse practitioner, working the first 18 years in primary care with pediatric patients and the last 17 years until December 2019 at Children’s MN, which provided the largest hematology oncology care in her five state region. Missy cared for patients throughout their journey from diagnosis to end of therapy and follow up and sometimes end of life. Nurse practitioners at Missy’s site cared for these patients in all settings including outpatient, inpatient and urgent care. Missy remains dedicated to the specific patient population by maintaining a nationally recognized certification in the field of pediatric hematology oncology.

Missy and her team were extremely dedicated to the impact and improved outcomes that trials offered to patients. The hospital recognized their efforts, realizing that patients were likely to have better outcomes when enrolled on an oncology trial. As a result, the hospital’s executive leadership approved staff to care for newly diagnosed young adults into their twenties for inpatient and outpatient needs throughout therapy. In the best interest of the adult patients, a collaborative arrangement was made with the adult internist/family medicine team from the nearby adult hospital to collaboratively care for the unique needs of this special patient population.

What inspires you to work in pediatric clinical research?

"I’m inspired by better outcomes. It’s something I’ve lived for the last 17 years—making diagnoses, searching for available trials, and following families and protocols every step of the way. My number one priority was making sure families knew that the trial was there to help support appropriate care and direct treatment toward the identified outcome. It was crucial to work in alignment with the patient and family and be cognizant that whatever we did was for the patient and not ‘to’ them and to have ongoing dialogue regarding that frequently."

Kirsten provides PRA with over 20 years of experience in the industry, having held operations and leadership positions at Duke Clinical Research Institute, Neeman Medical International, and PPD, where she spent many years leading global teams in the conduct of protocol and site feasibility, strategic site partnerships, as well as clinical trial management system administration. She is a fierce advocate for children’s healthcare and rights in both her professional and personal life, being involved in the International Children’s Advisory Network (iCAN) as both an External Advisory Board Member and Parent Council Chair.

What inspires you to work in pediatric research?

"I’m driven to educate more people to the fact that treatments given to pediatric patients have only been tested in about 30% of cases, which is unacceptable. I can also relate to the uncertainty of an unknown prognosis and the challenges of a life-threatening, chronic disease, because my family has faced them as well. I gain inspiration from both my work and daily life, with the goal of improving young lives however I can."

Heather brings to PRA the sincere, genuine compassion that comes from personally caring for patients. She is a registered nurse that began her nursing career caring for patients suffering with neurocognitive disorders. It was during this time she realized more than ever the depth and passion she had advocating for patients and families and helping them navigate a new disease process and being a voice for and with them. She began her career in research as a cardiovascular research nurse, then became a lead clinical research coordinator before finding her home with the CPCD. She generously gives her personal time and professional expertise to organizations including the University of Nevada Reno IRB Scientific Committee, Donor Network West, Northern Nevada Children’s Cancer Foundation, Washoe County Medical Reserve Corp, and St. Baldrick’s Foundation.

What inspires you to work in pediatric clinical research?

"I’m inspired by young patients and their families who will do whatever it takes to regain health or find treatments. This alone stirs a desire to provide viable treatment options that limit secondary illnesses or adverse effects in children. There are limited approved treatment options designed for children; my role with the CPCD and the changes we are incorporating into clinical trial design equates to children having safe, clinically approved treatment options."

Harris’ near 40-year career includes experience in academia teaching pharmacology and conducting cardiorespiratory assessments on patients, as well as in preclinical, clinical development, and development operations within the biopharmaceutical industry. He’s been involved in pediatric trials since 1999 and helped support the formation of PRA’s pediatric working group. Since 2017, Harris has served as Executive Director of Medical & Scientific Affairs and Vice-Chair of the Center for Pediatric Clinical Development. He has a BSc in Pharmacology, a Master’s in Medical Law & Ethics, and PhDs in both Medicine and Law. Outside of PRA, Harris is a lecturer for a British Faculty of Pharmaceutical Medicine course and continues to publish book chapters and articles on a variety of clinical research topics, including pediatric assent/dissent, GDPR, consent in vulnerable populations, and post-trial access to drugs.

What inspires you to work in pediatric clinical research?

"I believe in doing things right the first time—and on time—to reduce the consequences and impact of manageable conditions in children by quickly reaching the correct decisions regarding new drugs. My background helps me ensure that PRA supports our clients in the proper conduct of pediatric trials of new medicines."

After many years in the financial industry, Jami’s career path changed when he joined PRA and entered the clinical research field 14 years ago. The majority of Jami’s time at PRA has been dedicated to feasibility efforts. This has allowed her to see and become a part of significant changes in the clinical trial landscape. Jami is thrilled to bring her experience to the Center for Pediatric Clinical Development and apply it to supporting the relationships being built with pediatric centers through PRA’s Pediatric Site Network.

What inspires you to work in pediatric clinical research?

"Pediatric research supports vulnerable populations that often cannot speak for themselves. I want to be part of something that ensures safe trials for this vulnerable population."