Mary Short, is a Registered Nurse, a Perinatal Clinical Nurse Specialist, and has a Master of Science in Nursing from Indiana University.  Prior to her tenure at Eli Lilly and Company, Mary served as a staff nurse and Clinical Nurse Specialist at the Neonatal Intensive Care Unit (NICU) of Methodist Hospital of Indiana.  Mary conducted research on positioning and neuromuscular development. Her involvement in National Association of Neonatal Nurses (NANN) included former chair of the International Relations Committee, and former president of the Central Indiana Chapter. She served on the Advances in Neonatal Care Editorial Board and was a co-series editor for Foundations in Neonatal Care. In 1994, Mary received the NANN Robyn Main Excellence in Clinical Practice Award.

Mary’s contributions to pediatric healthcare extend beyond the clinical setting. Throughout her tenure at Eli Lilly and Company, where she retired in 2020, she played a pivotal role in advancing pediatric initiatives. Notably, she spearheaded the establishment of the Pediatric Steering Committee, Pediatric Symposium, Pediatric Excellence Awards, Parent Volunteer Group, and the Pediatric Capabilities Function. Her leadership was instrumental in integrating pediatric requirements and considerations into Lilly’s quality, training, and development systems.  Mary’s expertise in pediatric clinical trials significantly contributed to advancements in pediatric programs of the Biomedicines development area.

Post-retirement, Mary continues to be actively engaged in advocating for children’s unmet medical and drug development needs. She serves as a co-chair for the International Neonatal Consortium Communications Work Group. Mary provides consultation services for pediatric drug development and has interest in promoting multistakeholder engagement to improve the successful completion of pediatric research. She has authored multiple peer-reviewed journal publications.

Dr. Robert M. Ward completed medical school at Johns Hopkins University in 1974 and trained in Pediatrics, Neonatology and Clinical Pharmacology at the University of Minnesota. After serving as assistant professor in Pediatrics and Pharmacology at Pennsylvania State Univ, he moved to the University of Utah in 1985 as Associate Professor of Pediatrics.  He served as Medical Director of the Primary Children’s Hospital NICU from 1989-1997 and was promoted to Professor of Pediatrics in 1995.   

In 1997, he began the Pediatric Pharmacology Division at Utah to study medications in children.  He was PI of the Utah NICHD Pediatric Pharmacology Research Unit Network site from 2004-2010.  In 1997, Dr. Ward became Chair of the AAP Committee on Drugs and consulted in the development of FDAMA, BPCA and PREA, federal legislation to increase the study of drugs in children.  He has consulted with the FDA, NIH, Institute of Medicine, and USP and testified before Congress regarding the need for study and approval of drugs for pediatric patients.  His research interests focused on neonatal and fetal pharmacology through studies of narcotic analgesics, inhaled corticosteroids, neonatal abstinence syndrome, gastrointestinal reflux, and inositol for prevention of ROP.  Dr. Ward lectured frequently nationally and internationally.  He has authored or co-authored over 132 peer-reviewed manuscripts and 29 book chapters.  He retired to emeritus status in 2015, but returned to direct the clinical pharmacology division in 2017-2019.  The University of Utah honored him in 2021 by establishing the Robert M. Ward Endowed Chair in Pediatric Pharmacology. 

Wakako has been a Neonatal Nurse Practitioner (NNP) for 22 years (RN for 33 years). She is an NNP at Pediatrix Neonatology Practice in Nashville, TN. She received MSN in NNP specialty from Vanderbilt University in 2002, and DNP from Northeastern University in 2014. Her commitment to the tiny patients includes clinical practice as NNP, providing education both in the U.S. and abroad, conducting or supporting research, and making contributions to other special causes.

She is an internationally published author both in Textbooks and peer reviewed publication. She is a frequent speaker especially on neonatal topics as well as advance practice content and has served as adjunct faculty at several NP programs abroad including Asia and Africa.

She currently serves as a non-executive board member for the Council of International Neonatal Nurses (COINN) and participates in global health efforts to improve the maternal/infant health. She is an active co-author member for the World Health Organization educational project specific to ‘Sick and Small Newborns’ to inform the clinicians endeavoring in regions where neonatal-specific education is limited.

She also serves on the board of active parent organizations, such as the PreemieWorld Foundation, Inc. and the Books for Healing Partnership, Inc. Family advocates are important in Wakako’s life since she is also a part of a family who experienced a loss of a prematurely born baby leaving a powerful reminder in her mind about prematurity and families’ struggles.

Wakako has represented NANN to the International Neonatal Consortium since its inception in 2015 and worked closely with INC, COINN, Parents Advocates and numerous other stakeholders globally who are involved in the INC’s mission. Many important projects were undertaken since 2015. Wakako considers it a privilege to have been a co-author for numerous publications in the last several years that emerged from the INC projects that NANN supported. Wakako is grateful for NANN’s commitment for INC’s mission and feels honored to be a part of the NANN/INC collaboration on this education project.   

Sandra Sundquist Beauman is a manager of clinical trials operations at the University of New Mexico Health Sciences in Albuquerque, NM where she has been for the last 12 years. In this position, she is responsible for the regulatory and clinical management of neonatal and pediatric trials including assisting with development of protocols and associated documents for successful trial implementation. These trials include many NIH-sponsored trials through the Neonatal Research Network (NRN) and IdeA States Pediatric Clinical Trials Network (ISPCTN). Ms Beauman has a long career of clinical nursing in the Neonatal Intensive Care Unit (NICU) including Level 2 to Level 4 units in various states and holds certification in High-risk Neonatal Care. She began her nursing career with a diploma in 1980 and went on to advance her education through a Master’s in Nursing degree obtained in 1993. Ms Beauman was licensed and practiced as a Neonatal Clinical Nurse Specialist at various hospitals in California prior to her move to New Mexico.

Laura Fabbri is a Biologist with a PhD in Clinical Pharmacology (University of Bologna and Milan; Italy).  She has been working in Chiesi Pharmaceutical (Corporate R&D) for 20 years, at Global Clinical Development department; for the first 4 years as Neurology and Psychiatry Clinical Area Manager and then up to April 2021 she was the of Head of Neonatology Clinical Unit. She is currently covering the role of Head of Real-World Evidence (RWE).

Previously Laura worked at GlaxoSmithKline for 14 years, engaged in clinical product developments at local level (Verona; Italy) and at corporate level for 1 year (Greenford; UK).

She has large experience in the coordination and management of different clinical team groups to deliver clinical projects on phase I-IV drugs, nationally and worldwide, in writing clinical development plans and single clinical protocols, study reports and manuscripts for national and international journals; furthermore, always collaborates in writing the clinical sections of Pediatric Investigational Plans and other documents for EMA or FDA or other Agencies.

Laura has consolidated relationships with worldwide neurologists and neonatologists, because of reciprocal faith and friendship due to the long- lasting collaboration; she is member of the International Neonatal Consortium (INC), committed to organizational plans processes, improvement, and global standardization in neonatology research. In the last 2 years, she is building the unit of RWE in Chiesi for the first time, and creating the connections with networks / registries /agencies and most proper internal and external groups for regulatory and post- approval RWE activities. With this role, she has also become member of EFPIA Integrated evidence generation and use working group and of Duke Margolis RWE group.

Gina Calarco Smith is a scientific director at the Critical Path Institute, a non-profit organization acting as a neutral entity to build private public partnerships with regulators to address unmet needs in drug development. Ms. Smith sits within the Pediatrics Program and contributes to the work of the International Neonatal Consortium (INC). Prior to joining C-Path Ms. Smith was at LabCorp Drug Development as a Senior Director of Strategy & Planning within the rare diseases, advanced therapies, and pediatrics team (RAPT). In this role she planned strategies and responded to risks or issues that arose within pediatric and complex rare disease clinical trial work. Gina received her nursing degree in 2001 and is a pediatric registered nurse, earning her master’s in public health in 2010 from the University of Kansas. Nearly her entire career has been focused within pediatrics beginning as a neonatal ICU nurse and moving into study coordination of infectious diseases and vaccine research at Children’s Mercy Hospital in Kansas City, project management of Phase I - IV pediatric clinical trials at a global clinical research organization (CRO), strategy and planning for complex and rare indication pediatric clinical trials, and now as a scientific director of pediatrics at C-Path

After studying and practicing veterinary medicine in the Caribbean as well as the mid-West and mid-Atlantic states for 12 years, Dr. Milne attended The John Hopkins University MPH program. Upon graduation he pursued a career in Public Health at the NJ State Department of Health addressing the impacts of pesticides on children. He later attended law school at the University of New Hampshire and after passing his Law Bar exam accepted a job at the Tufts Center for the Study of Drug Development located in Boston at the Medical School. His initial research project was to evaluate the impacts of new laws being proposed to incentivize the development of pediatric labeling and formulations of drugs previously applicable only for use in adults. He spent 20 years in this area of research and advocacy as well as assuming several administrative positions along the way from Associate Director to Director of Research until retiring from Tufts in 2019. Currently, he has just completed several fictional novels based on his encounters with the exotic flora and fauna of the island of Hispaniola in the Caribbean

Dr. Thomas F. Miller is Vice President & Global Head, Acute, Chronic and Pediatric Disease Nucleus in Bayer’s Pharmaceutical Division, a role he assumed earlier this year. He joined Bayer in 2017 to create and effectuate their Pediatric Clinical Development function. In total, Dr. Miller’s career in the life science industry spans more than 28 years, with a primary focus on the development of therapeutics, medical devices and combination products for pediatric and rare disease patients. Prior to joining Bayer, Dr. Miller served in the capacity of Chief Executive Officer of Therabron Therapeutics, Inc. with oversight of all operational functions for the company (R&D, manufacturing, quality, regulatory affairs, etc.). While at Therabron, he oversaw their clinical program through Phase 2 completion for their lead molecule (orphan pediatric disease) and secured both the Rare Pediatric Disease and Fast Track designations for this program. Prior to Therabron, Dr. Miller served in the capacity of Chief Operating Officer of Discovery Laboratories, Inc. During his tenure, the company successfully secured marketing authorization for their first approved therapeutic, successfully registered their first medical device and advanced multiple rare disease pipeline programs into the clinic. Earlier, Dr. Miller served in operational roles of increasing responsibility at Pfizer, Novartis, BASF Pharma, and Johnson & Johnson. He received his doctorate from the Temple University School of Medicine, his MBA from Fairleigh Dickenson University and his bachelor’s degree from Fairfield University. Dr. Miller has authored several peer-reviewed publications, given numerous presentations at scientific symposia and is an inventor with an issued and licensed patent in the field of pediatric respiratory drug delivery