Overview
In this webinar, ICON will provide insights on the pediatric regulatory requirements and study approaches for the development of new medicines, with a particular focus on oncology drug development. This webinar will also seek to address some of the challenges encountered and provide recommendations to overcome these.
This webinar will be hosted by KoNECT.
| Speakers: |
Dr Mark Sorrentino & Dr Martine Dehlinger-Kremer |
| Time: | 09:00-10:00 AM |
| Subject name: | The Utility and Benefits of Adding Adolescents to an Adult Programs |
|
Speakers: |
Missy Hansen |
| Time: | 10:00-11:00 AM |
| Subject name: | RACE for Children Act Prompts more pediatric clinical trials for oncology drug developers |
Registration details
Cost: 15,000 KRW
Registrations open: March 27 - April 14 2023
Speakers
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Mark Sorrentino
Mark has over 20 years of experience doing drug development in the biotechnology and pharmaceutical industry, having worked at Medimmune, Biosynexus, ADMA Biologics and PPD prior to joining ICON.
He has a clinical background in Pediatric Critical Care and spent 15 years in academic medicine at Children’s National Medical Center in Washington D.C.
Dr. Sorrentino founded the pediatric practice area at PPD and both the Center for Pediatric Clinical Development and Center for Vaccines and Emerging Infectious Diseases at ICON.
Mark continues to work with clients, especially in the biotech sector, to understand at an early stage how they can incorporate children and adolescents into their development programs in order to satisfy regulatory requirements and to reduce the number and cost of their overall CDP.
He has an interest in critical care, infectious diseases (with an expertise in RSV), transplant medicine, and pediatric device development.
Dr. Sorrentino sits on the board of two non-profits in the life sciences industry and volunteers extensively with Team Rubicon, the Ventura Country Medical Reserve Corp, and the Ventura County Emergency Veterinary Rescue Team.
Dr. Dehlinger-Kremer’s expertise spans more than 30 years in the research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior to joining ICON, 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 to the global development of numerous products, including medicines for children, drugs for orphan diseases and biosimilars.
Her vision and leadership extend to service with a number of professional organisations – 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 chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party and Board Member of the association, 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.
Dr. Dehlinger-Kremer earned a Doctorate in Sciences from the J. W. Goethe University in Francfort on the Main, Germany; a Diploma of Advanced Study in Neurophysiology from the University Louis-Pasteur, Strasbourg, France; and a Master of Sciences degree from University Moulin de la Housse in Reims, France.
Missy Hansen
MSN, CPNP, joined ICON in 2019 as a pediatric strategy liaison. Her focus at ICON is to consider the patient and family journey when considering and enrolling on a study and to support internal and external teams throughout ICON’s involvement with the study. Ms. Hansen has 25+ years of experience as a pediatric nurse practitioner, including 17+ years in pediatric haematology/oncology at Children’s Minnesota, the largest hematology/oncology service line the region, providing care for infants through young adults diagnosed with haematologic and/or oncology conditions and is certified in paediatric haematology/oncology nursing (CPHON). Ms Hansen gained expertise working in inpatient, outpatient, and urgent care settings. Ms Hansen also works with the Children’s Oncology Group—the largest consortium with the most open paediatric studies around the world as well as other consortia that conduct trials for paediatric to young adult patients.
Audiences
This webinar will be useful for pharma and biotech professionals working in drug development.