In April, I had the honor to participate in the 2018 Annual INC Neonatal Scientific Workshop in Bethesda, MD. INC stands for the International Neonatal Consortium, and it’s a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates. INC is a branch of the Critical Path Institute (C-Path), which is an independent, nonprofit organization dedicated to bringing together experts from regulatory agencies, industry, and academia to collaborate and improve the medical product development process.
The goal of this year’s workshop was to have the attendees consider the role for ‘Real-World Evidence’ on medical product development for neonates, examine the regulatory implications of nutritional influences on outcomes of preterm birth, discuss the standardization of safety approaches for neonatal trials, and review the progress of INC workgroups.
My workgroup, the Communications Workgroup, has been working on the development of parallel multi-stakeholder survey to identify communication practices in NICUs in regards to neonatal research and research practice.
As a Co-Chairs of INC’s Communication Workgroup, we were tasked with fine tuning our multi-stakeholder NICU survey so that it will be ready to send out to all stakeholder groups in the late spring. Dr. Christina Bucci-Rechtweg (the other Co-Chair) and I, along with the rest of our workgroup, had been working for months on this survey so that we would be able to add the final touches and make the last necessary modifications by the end of the workshop. Our workgroup hosted an open session and we were able to address all comments and thoughts before our session ended.
The other members of the Communications Workgroup are:
- Sandra Beauman – Consultant
- Wakako Eklund – NANN
- Yamile Jackson – Nurture By Design
- Carole Kenner – COINN
- Mehali Patel – Bliss
- Mary Short – Eli Lilly
- Nicole Thiele – EFCNI
- Mark Turner – University of Liverpool
- Scott Winiecki – US Food and Drug Administration
And I think we’ve convinced Keira Sorrells (PPA President) and Cristal Grogan (NICU Helping Hands) to join our group, too!
I was also invited to participate in the Standardizing Safety Approaches for Neonatal Clinical Trials Panel Session. Here I was able to share the NICU parent perspective, as far as how clinical trial safety is handled in the NICU and in the planning and execution of clinical studies in the NICU. I must applaud INC for making such efforts to include the NICU parent’s perspective in all areas of their work. They recognize how important the parent voice is and they are very much willing to listen to it. In fact, many members of the Preemie Parent Alliance were in attendance at this year’s INC Conference!
There were many other workgroup face-to-face meetings and presentations given throughout the conference. The workgroup meetings included the Hemodynamic Adaptation Workgroup Meeting, the Bronchopulmonary Dysplasia Workgroup Meeting, and the Clinical Pharmacology Workgroup Meeting. The presentations included Applying Innovative Approaches to Developing Neonatal Therapeutics, Real World Evidence to Inform Regulatory Decision-Making on Neonatal Medicinal Products, Standardizing Safety Approaches for Neonatal Clinical Trials (of which I was part of), and Regulatory Implications of Nutritional Influences on Outcomes of Preterm Birth.
Don’t be fooled into thinking that it was all business! We did have some time to mingle and chat with old friends and make some new friends as well. There were several coffee breaks during the conference and there was even a dinner at a restaurant called Pinstripes so that we could eat and talk with other meeting participants and maybe even brainstorm ways to collaborate on future projects.
Overall, it was a very productive conference and I am proud to have contributed in the ways that I did. This is one of the ways that I can give back to the community that developed the procedures and medications that saved by daughter’s life after her micro preemie birth at just 23 weeks gestation. I will always do whatever I can to further advance neonatal care.
INC is led by several people of whom I have been honored to work with over the last 18 months, since I joined the group. They include Ron Portman (Executive Director, Pediatric Therapeutic Area, Novartis), Dr. Jon Davis (Professor of Pediatrics, Tufts University), and Dr. Mark Turner (Senior Lecturer in Neonatology, University of Liverpool). The members of C-Path, who oversee INC, are Laura Butte, Alicia West and Lynn Hudson. Each and every one of these individuals works tirelessly to ensure that all of the INC’s goals are met and that the future is brighter for the next generation of premature babies.
Many of the photos (at least the beautiful professional looking ones!) were taken by Communications Workgroup member/NANN member, Wakako Eklund.
You can learn more about the work that INC does by clicking HERE.
Thanks for taking the time to read my writing and please share with any interested parents or health care providers who are looking to advocate in the maternal or neonatal health space, and as always- please check back to www.speakingformomsandbabies.com to stay aware 🙂