Announcing Honorees for 2018 Founders Dinner

At the 2018 annual Founders Dinner, IPI will be honoring two individuals who have contributed greatly to innovation in the life sciences sector. The dinner will honor Robert Coughlin and also posthumously honor Owen Aurelio.

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As President and CEO of the Massachusetts Biotechnology Council, Bob’s mission is to advance Massachusetts' leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives. Over the last decade, Bob has truly become a champion for patients by ensuring innovative companies have the best environment possible to research, develop, and commercialize breakthrough therapies and cures for people around the world who need and deserve them.

Before joining MassBio, he served as the Undersecretary of Economic Development within Governor Deval Patrick's administration, where he prioritized both healthcare and economic development issues and was a strong advocate for the life sciences industry in Massachusetts. Prior to that, he was elected as State Representative to the 11th Norfolk district for three terms. Bob has also held senior executive positions in the environmental services, capital management and venture capital industries. In addition to his professional responsibilities, Bob is a past board member of the Massachusetts Maritime Academy and Beth Israel Deaconess Hospital, and is currently serving on the board of directors for The Schwartz Center for Compassionate Healthcare and Aridis Pharmaceuticals. He also is a member of the Scientific Advisory Board at Boston Children’s Hospital, and has served as the honorary chairman of the Great Strides Cystic Fibrosis Walk since 1996. In years past, he co-chaired the Children’s Hospital Boston signature event, Champions for Children’s and the Schwartz Center’s Compassionate Healthcare Dinner.

In 2011, the American Diabetes Association honored Bob with their Father of the Year Award. In 2012, the Cystic Fibrosis Foundation honored Bob with the CF Foundation Volunteer Leadership Award and in 2013 he received the Boston Irish Business Award from the Boston Irish Business Association. In 2014, he was awarded for his leadership in Biotechnology by the Massachusetts Society for Medical Research. He received the NTSAD advocate of the year in 2015 and was named to the Boston Business Journal’s Power 50, Top 50 Most Influential Bostonians. In 2016, he was honored with the Boston Biotech CEO Lifetime Achievement Award. His latest honors include the first-ever awarded Governor Paul Cellucci Fatherhood Award from the Children’s Trust and the Breath of Life Award from the Cystic Fibrosis Foundation (2017).

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Owen had a long career in hospital administration, including Washington Hospital, El Camino Hospital, Alameda General Hospital, and most recently Lucile Packard Children’s Hospital, from which he retired as VP of Clinical Services. Prior to his current tenure at Stanford Children's Health, Owen served as Chief Operating Officer both at El Camino Hospital in Mountain View, CA and Washington Hospital in Fremont, CA. After retirement, he remained active on the boards of IPI and the International Society for Pediatric Innovation. He provided leadership and support to IPI as principle representative of Stanford Children’s Health since 2007.  He also served as a U.S. Naval Officer in the Medical Services Corps on the administrative staff at the Naval Regional Medical Center in Portsmouth, Va. Owen was a member of the American College of Healthcare Executives and is a past president of his Rotary Club. 

His positive outlook and steadfastness has been instrumental in building a culture of collaboration amongst our stakeholders. His deep knowledge of hospital operations has been essential in developing the focus for our Catalyst program. As chair of our Board for the last two years, his calm yet forceful presence has helped us navigate our direction. He articulated a vision of how IPI can align itself with other major pediatric coalitions to expand our impact nationally. He leaves a huge gap in this latter area that we will work very hard to fill.

 

RSVP here or email stephen.evangelista@pediatricinnovation.org to buy tickets.

 

IPI Awarded NEPDC Grant for ShapeTape

The Institute for Pediatric Innovation (IPI) is proud to announce that it has been the recipient of a grant from the New England Pediatric Device Consortium (NEPDC) for ShapeTape, a pre-cut therapeutic kinesiology tape used to stabilize the ET tube to reduce the occurrence of unplanned extubations (UEs).

The award will go towards obtaining clinician input and expertise to determine the optimal product shapes and sizes. Additionally, the grant will be used to analyze potential commercial partners.

For more information, check out our press release on PRWeb.

Clinical Innovation Catalyst Program Addresses Pediatric Adverse Drug Events

The Institute for Pediatric Innovation (IPI) is pleased to announce that the 2017-2018 Clinical Innovation Catalyst Program is focusing on Adverse Drug Events (ADEs). 

American Society for Health-System Pharmacists defines an ADE as "any unexpected, unintended, undesired, or excessive response to a drug." This hospital acquired condition can result in prolonging the patient's stay in a healthcare facility, permanent harm, disability and even death. Healthcare providers may be penalized by payors for ADEs, receive negative publicity, and be exposed to litigation. 

ADEs can be especially life threatening for newborns and young children since this population is usually less able to physiologically tolerate a medical error due to their still-developing renal, immune and liver functions. Pediatric ADEs are also problematic because children may not be able to effectively communicate any adverse effects a medication is causing.

For more information, check out our press release on PRWeb.

Study of practices for obtaining assent of pediatric patients in clinical trials just published

The Institute for Pediatric Innovation (IPI) announces that the Journal of Therapeutic Innovation & Regulatory Science has just published the results of a study on practices for obtaining the assent of pediatric patients who are asked to participate in clinical trials.

This study, entitled “Industry and Patient Perspectives on Child Participation in Clinical Trials,” is a result of a collaboration among IPI, biopharmaceutical companies Pfizer and Shire and healthcare communications firm The Medicine Group. Coauthors on the study are Irmgard Eichler, Stephanie Gilstein, Donald Lombardi, Philip Sjostedt, Liza Squires, Charles Thompson and Mark Turner.

The issue of obtaining assent of pediatric patients has long been seen as a challenge in the medical world, especially since the introduction of new regulations in the early 2000s. Although children cannot generally provide legal informed consent until they reach adulthood, they need to be given age-appropriate information and asked to agree to participate in clinical trials.

The study focused on determining how varying stakeholders dealt with ambiguities inherent in the assent requirements and the differences observed among patients from a range of ages and populations, cultures, clinical trial types and regulatory environments.

Launched in 2014, the study centered around digital surveys offered both in the United States and internationally. The first survey polled children, parents and/or caregivers while the second was aimed at clinical trial professionals on their organizations’ experiences and policies regarding pediatric assent.

Forty-five respondents completed the child and parent/caregiver survey. Fifty-seven individuals completed the industry survey. Survey respondents offered their experiences of clinical trials and challenges they encountered to secure assent. Common obstacles included language barriers, cultural issues, disease severity and child maturity.

Respondents also surfaced potential solutions. Both children and parents/caregivers called for visual aids that would clearly explain the procedure while retaining a child’s attention. The study reports that standardized practices and tools would help pediatric patients make well-informed decisions about their participation in clinical trials. Such tools would establish a baseline standard for the assent process.

The results of the surveys indicate that a shift in handling management of child assent can provide relief for parents and children in a hospital setting.

If you are interested in reading the article, visit the online journal.

Participants in IPI’s Catalyst Program Develop Solutions for Unplanned Extubations in Babies and Children

 2017 Participants at Shriners Hospitals for Children

2017 Participants at Shriners Hospitals for Children

This year, participants in the Institute for Pediatric Innovation’s (IPI) Clinical Innovation Catalyst program focused on finding product improvements that could reduce the occurrence of unplanned extubations (UEs).

Pediatric patients have tubes placed in their throats when they need help breathing or to provide medication. Sometimes, patient movement can cause unplanned UEs which is when these tubes become dislodged or removed, resulting in situations that can prolong treatment or even become life threatening. In addition to additional treatment time and potential airway trauma, these conditions can add an average of 6.5 days to a hospital stay and up to $37,000 per case in pediatrics.

IPI’s Catalyst program, a professional education experience and training program for nurses and allied health professionals, addresses hospital acquired conditions to improve safety and outcome. Innovation concepts are developed based upon these clinicians’ vast experience, education, practice and input from patients, families and other caregivers to generate new devices and technology for pediatric hospitals. Each year, IPI’s member hospitals choose a new hospital acquired condition on which to focus.

Selected participants from member hospitals— Shriners Hospital for Children Northern California, Stanford Children’s Health, Texas Children’s Hospital and University Hospitals Rainbow Babies & Children’s Hospital—participate in four workshops each focused on a different aspect of the innovation process. Workshop topics include problem identification, content development, concept refinement/selection and business planning. At the conclusion of the four workshops, participants deliver fully developed product concepts.

During this year’s cycle, the team of three respiratory therapists, two nurses and one parent developed three product concepts: ShapeTape, HoldET and Flo-Frame to reduce the outcome of UEs.  

The first product concept presented was ShapeTape, a precut therapeutic kinesiology tape used to stabilize the ET tube. This durable tape, adapted from other healthcare uses, is specially precut to adapt to a baby’s face and withstands patient movement and adverse environments. Participants assessed the business opportunity, noting its lower cost against competitors and potential to decrease UEs by 20%.

HoldET reinvents an existing ETT holder by adding adjustable straps to securely fit pediatric patients. The product will decrease UEs by an estimated 10%.

The final product concept, Flo-Frame, included improved fixation of the tubes to the patients, a re-invention of current tube holder design, and system to more easily move with the patient. It is estimated that the device will decrease UEs by as much as 10%.  

IPI is currently seeking commercialization partners to continue ongoing product development and commercialization of these concepts.

 “This program enables bedside providers to make smart, significant and most of all, useful changes to well-known healthcare problems,” said Catalyst participant Jennifer Michals.

The final product concepts highlight participant dedication to finding effective solutions to the many challenges encountered in pediatric hospitals.