The Latest Dose

When Nicole and James Angiolino’s son Joey was diagnosed with the rare disease Hurler’s Syndrome at seven months old, they did everything they could to save his life. They left their eldest son Nicholas, their family, friends, and teaching careers behind and headed to Duke University Hospital in North Carolina to get him the care he needed. James and Nicole remained unwavering in their fight for Joey, living in the hospital to ensure that Joey got every treatment option available. Their motto became Motivation, Perseverance, and Strength (MPS), mirroring the acronym for the medical term Mucopolysaccharidosis, from which Joey suffered. But after a tremendous battle, sadly, Joey passed away on July 16, 2010, at just 15 months old in Nicole’s arms.

Instead of crumbling under the grief of such an immense loss, they vowed to maintain the positivity and strength that Joey demonstrated to them throughout his journey. While it was extremely difficult, they marched on in honor of their son, and decided to help other families going through similar, challenging circumstances.

In episode 23 of The Latest Dose, Nicole and James Angiolino join us to talk about Joey’s Little Angels, the non-profit they founded in honor of Joey’s life and determination. With their last name Angiolino meaning “little angel” in Italian, Joey’s Little Angels’ mission is to provide financial and emotional support to families with children facing rare and difficult diseases.

To date, the non-profit has donated over $100,000 to the Duke Pediatric Bone Marrow Transplant Family Support Program. During the holiday season, Joey’s Little Angels organizes an annual toy drive with the support of volunteers and community leaders. Together, they have gathered 30,000+ toys nationwide for hospitalized children and their siblings. In the past, they’ve made pivotal donations to Duke University Hospital, Children's Hospital of Philadelphia, RWJ New Brunswick, Capital Health, Boston Children's, Rutgers Cancer Institute, St. Christopher's Philadelphia, Cincinnati Children's Hospital, and many more. Their efforts in this space have made a tremendous difference in the lives of families with children undergoing medical treatment.

Anxiety, stress, and exhaustion are on the rise and impacting many of us. With a lot happening in our world that we don’t have much control over, our routines have been disrupted and it’s affecting our overall health and mindset. Combine that with the stress holidays can bring, and you have a recipe for total burnout.

In episode 22, we wanted to cover how and why it’s so important to set healthy boundaries as a means of cultivating optimal health. For example, did you know sleep is the single most effective thing you we can do to re-set our brain and body? And yet, roughly 70 million people in the United States suffer from sleep disorders. Insufficient sleep can cost a nation anywhere from one to almost three percent of their GDP, and in the US, a staggering $411B of lost productivity is also due to not getting enough sleep.

Sit back, relax, and listen as CEO and Founder of the Ardelian Kuzma Group, Aneta Ardelian Kuzma, teaches us tips, tricks, and tools to help us take control of our health and wellness. In this episode, you will learn how to take control of your schedule and implement proactive routines to prevent stress and boost your immune system, create habits that supercharge your self-care journey, increase mindfulness and clarity through meditation, and relieve tension and anxiety by focusing on gratitude.

Men across the globe are dying too young. In the US, three out of four suicides are men, and one in eight (around 10.8 million) will be diagnosed with prostate cancer and testicular cancer, the most common cancers in young men. Our fathers, partners, brothers, and friends are facing a health crisis that isn’t being talked about, and it’s time to speak up.

Since 2003, Movember has empowered over five million people to “challenge the status quo, shake up men’s health research, and transform the way health services reach and support men” for this global men’s movement. Through moustaches grown, connections created, and conversations generated, this charity has funded more than 1,250 men’s health projects in over 20 countries.

In episode 21 of The Latest Dose, Mark Hedstrom, the US executive director of Movember, joins us to talk about how they are tackling the three biggest health issues facing men: mental health and suicide prevention, prostate cancer, and testicular cancer. By giving men the facts and changing behavior for the better, creating services (like True North) that work for men, investing in country and culture-specific health projects, and uniting the brightest minds while listening to the community, Movember is changing the face of men’s health on a daily basis.

By 2030, the Movember aims to reduce the number of men dying prematurely by 25%. You can help them reach this goal by growing a moustache, move for Movember, host a “Mo-ment,” or “Mo your own way” this November.

There’s no question that clinical research is the backbone of healthcare invention, helping to improve the prevention, detection, diagnosis, and treatment of disease. But at the heart of it all you’ll find that patients are the true lifeblood of clinical research, keeping things moving and allowing researchers to save more lives every day.

With patients at the center of clinical trials, it only makes sense that they can (and should) be involved throughout the drug development process. Laws like the 21st Century Cures Act, and programs like the Medicines and Health Products Regulatory Agency (MHRA) pilot expect and encourage the patient perspective to inform product development.

To be clear, having patients contribute to bringing inventions to market is not new. However, it is often much more involved than simply identifying eligible, consenting candidates for a clinical trial.

In episode 20 of The Latest Dose, we discuss the ins + outs of collaborating with patients throughout drug development with two industry experts, Deborah Collyar, founder and president of Patient Advocates in Research (PAIR), and Andy Lawton, director at Risk-Based Approach Ltd. With phrases like patient centricity, patient engagement, and patient empowerment meaning different things to different stakeholders, Deborah and Andy help to breakdown the how and why it’s so critical to involve patients in all aspects of drug development.

Medical devices are an integral part to many procedures and treatments, and last month we started to investigate the vast and innovative world of these types of technologies in a two-part series on The Latest Dose. In part one, our esteemed guests, Dr. Khaudeja Bano, the executive medical director of combination product safety, global patient safety & pediatrics at Amgen; Nada Hanafi, the chief strategy officer at Experien Group; and Shruti Iyer, senior software reliability engineer at Medtronic, took us through the guidance and regulations surrounding medical devices, and highlighted one of the biggest trends in the space, artificial intelligence.

In part two, our guests are back to talk about another significant trend: virtual, augmented, and extended reality in medical devices. These devices are becoming essential in clinical research and healthcare, and are increasingly more innovative with each passing year. They’ll also discuss how to safely and effectively bring these new solutions to patients in a changing clinical world.

From bandaging a sprained ankle and diagnosing HIV/AIDS, to implanting an artificial hip and monitoring your heart, medical devices are an integral part to many medical procedures and treatments.

There is a lot to unpack when it comes to medical devices, so we’ve invited industry leaders Dr. Khaudeja Bano, the executive medical director of combination product safety, R&D strategy & operations, and global patient safety & pediatrics at Amgen; Nada Hanafi, the chief strategy officer at Experien Group; and Shruti Iyer, senior software reliability engineer at Medtronic, to share their thoughts in a two-part series of The latest Dose that will focus both on regulations and trends in medical devices.

In part one of episode 18, we discuss the guidance and regulations surrounding medical devices, and highlight one of the hottest trends in this space, artificial intelligence.

The clinical research ecosystem has undergone an evolution over the past 18 months, and many want it to continue. To help set the industry on a solid path forward, ICH has created guidelines that provide direction on behaviors and actions to take. Recently, a specific set of these guidelines, ICH E6 Revision 3 and E8 Revision 1, have been referred to as being under renovation in response to the way work is done today and in the future.

In this episode, Kathy speaks with Andy Lawton, director at Risk-Based Approach Ltd., Crissy MacDonald, vice president of client delivery at Avoca Group, and Erika Stevens, principal at Recherche Transformation Rapide, about these specific ICH guidelines to learn what is new and improved about the quality by design approach, how this will impact the future of clinical research, and what you need to do to prepare.

Aboard the HMS Salisbury of Britain’s Royal Navy on May 20th, 1747, surgeon James Lind performed what is often considered to be the first randomized clinical trial. Now, every May 20th, International Clinical Trials Day gives us a well-deserved occasion to honor and thank both the professionals and patients who make clinical research possible. It also gives us an opportunity to raise awareness of clinical research and show why it’s critical to the improvement of our health and wellness.

To help us celebrate Clinical Trials Day, we spoke with the Director of Patient Recruitment at Accellacare, ICON’s global clinical research network, Nazneen Qureshi. In this conversation, we discuss the role that volunteers and patients play in clinical research, how to recruit eligible people, and how to spread awareness and gratitude for clinical trial participants.

As a methodology that’s generally been underutilized in the past, the pandemic has brought telemedicine to the forefront as a way for doctors to care for their patients, without them having to come into an office or site. But how exactly is it being used in medicine and clinical research today, and will it still be widely used after the pandemic ends? In this discussion, Kathy speaks with Dr. Thomas Fiel and Everest Group's Nitish Mittal about how telemedicine is being used today, its benefits and challenges, how it impacts diversity in clinical trials, and if they think it will still be widely used post-pandemic.

Recently, Covance announced that they are transforming to a fully decentralized CRO – an exciting step in the life sciences industry. In this episode, Kathy speaks with Covance’s Director of Decentralized Trials, Jane Myles, and Vice President and Head of Decentralized Trials, Bola Oyegunwa, about how they’re driving the implementation of decentralized trials globally, and what they think the core tenants are that the industry should abide by when executing decentralized trials.

Clinical Trial Transformation Initiative (CTTI) announced on January 25, 2021, a new vision for clinical trial ecosystem and beyond, called Transforming Trials 2030. The pandemic has changed the way we perform clinical research, and many constituents have implemented new and efficient solutions, systems, and processes to conduct trials. CTTI members believe this passion and experience will help shape a future of smarter, faster research. In this episode, Kathy speaks with Dr. Pamela (Pam) Tenaerts, executive director at CTTI, about CTTI’s vision for the future of clinical research, Transforming Trials 2030.

The pandemic has created a lot of disruption in clinical trials, but not all of it has been negative. From accelerating the adoption of decentralized trials and speeding up the delivery of vaccines, to telemedicine and mHealth playing bigger roles in patients’ lives, opportunities have emerged to help us rediscover and recalibrate the way we perform clinical research. Many believe we can’t go back to the old way of doing things – so who’s leading the charge?

In this episode, we define what a movement is, learn how to be the “Dancing Man,” and discuss why the #NoGoingBack mission is so critical to preserving the progress we’ve made in clinical research. To talk about why this is so important, we've brought on two leaders of the #NoGoingBack movement, Maimah Karmo and Craig Lipset, to share what it means to them.

Research shows that animals can improve the mental, physical, and emotional wellbeing of their human companions. From this strong bond comes the concept of therapy animals, or in this case, therapy dogs.

But what is a therapy dog, and how are they being used today?

In this episode, Kathy speaks with Children's Hospital Los Angeles and the Alliance of Therapy Dogs about their therapy dog programs, what it takes to become a volunteer, how dog therapy works, and more.

What is the role of innovation in clinical trials and why is it important? In this episode, Kathy speaks with Craig Serra, who works in clinical technology and innovation at Novartis, about different types of innovation and how they're used in the pharma industry.

Every year, the brightest minds in pharmaceuticals and clinical innovation put on their best black-tie attire for the life science industry’s biggest event, the Prix Galien. In this episode, you’ll learn about the history of the Prix Galien Awards, why it is considered the “Nobel Prize” for pharmaceutical research and development, and find out the new additions to its program from its chair and co-chair, Bruno Cohen and Dr. Michael Rosenblatt.

The pandemic heavily disrupted clinical trials, pushing us to rethink how we conduct clinical research. In this episode, Kathy invites Casey Orvin, SVP of pharmaceutics relationships at StudyKIK and honorary president of SCRS to talk about the future of decentralized trials and remote visits from the patient and site perspective.

In episode seven of The Latest Dose, our host Kathy Vandebelt invites two of Oracle’s safety experts, Vice President of Safety Product Strategy, Bruce Palsulich, and Senior Director of Safety Strategy, Michael Braun-Boghos, to explore areas in pharmacovigilance where AI, automation, and touchless case processing are having a significant and positive impact on managing patient safety.

In this episode, host Kathy Vandebelt discusses how to get comfortable with the use of mobile technologies in clinical trials with our guest, Jennifer GoldSack. Jen serves as the Executive Director of the Digital Medicine Society (DiMe). She was also an Olympic athlete, and ties in her experience in the Olympics with the topic at hand – biometric monitoring.

In this episode, our host Kathy Vandebelt brings back Greater Gift and PopUp Star Founder, Jennifer Byrne, to talk this time specifically about the importance of giving back to clinical trial participants. In this interview, Jennifer dives into what Greater Gift is, her motivation for founding it, why it’s important, and what they do to thank participants and other clinical research stakeholders.

For Clinical Trials Day, we want to shine a light on the patients and people who bring awareness to clinical research. To do this, Kathy Vandebelt interviews two industry veterans, Greater Gift and PopUp Star Founder Jennifer Bryne, and Oracle Health Sciences’ Senior VP and General Manager Steve Rosenberg, about their personal experiences with clinical research, the history of Clinical Trials Day, what PopUp Star is, and how it's bringing awareness to clinical research.