Artificially intelligent tools are revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry. As the drug discovery and preclinical stages speed up and potentially produce more drugs to test in the clinical trial phase, how do clinical researchers prepare and …

Artificial intelligence (AI) is one of the most discussed technologies across all industries. Life science professionals working in the pharmaceutical industry strive to improve people’s lives tackling incredibly complex diseases. Drug development is often perceived as slow. As the pharma industry looks to improve the drug development process AI pr…

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. President Biden has reignited the Cancer Moonshot initiative and set a new national goal: “if we work together, we can cut the death rate from cancer by at least 50% over the next 25 years and improve the experience of people and their families living wit…

The US cancer death rate has fallen by 33% since 1991 with an estimated 3.8 million deaths averted. This is attributed to “good progress” improvements in cancer treatment, decreases in smoking, and increases in early detection. A recent rise in advanced cancer cases reported is believed to be an outcome of the COVID-19 pandemic which delayed screen…

The success or failure of clinical trials is dependent in large part on the engagement of the principal investigator (PI). PIs play an important role in trial selection, site activation, and study execution. This includes but is not limited to, the development and implementation of a strategy to maximize enrollment, optimize data quality, and ensur…

Researchers use controls to help them understand what effect a new therapy or drug might have on a particular condition. Clinical research practice favors placebo controls over usual-care controls. Sometimes a person can have a response, positive or negative, to the placebo control. These responses are known as the "placebo effect and nocebo effect…

Clinical research professionals across all types of research organizations often struggled with implementing process improvements and the adoption of digital tools. When external factors (such as pandemic disruptions) force transformational process changes, the adoption of digital tools follows. At that point, the value of the new solutions suddenl…

Clinical research can make all the difference when it comes to saving people’s lives or improving their quality of life. In this episode, Mathias Eichler-Mertens, Managing Director of Accenture Life Sciences R&D Europe, and Henry McNamara SVP and GM of Oracle Health Sciences, will discuss what can be done to boost innovation and productivity in the…

The digital health ecosystem has helped create an infrastructure that supports the transformation of the organization-centered care model into a patient-centered care model. Various reports highlight the staggering investments and the market growth in digital health technologies supporting this change. In this episode of the Latest Dose, Naomi Frie…

Monitoring safety of biological products, drugs, and devices in healthcare is a priority for inventors, prescribers, regulatory authorities and of course patients. Safety data are collected and analyzed throughout product development and assessed prior to approval for commercial use. In this episode, Dr. Joseph (Joe) Tonning medical and pharmaceuti…

"First, do no harm" is a popular saying amongst those involved in the healthcare, medicine, or bioethics field, and is a basic principle taught in health-related courses. To faithfully follow this principle, a health professional should help their patients by recommending tests or treatments for which the potential benefits outweigh the risks of ha…

On receiving news of a health concern there is an immediate thirst for knowledge to understand the condition, the care, and treatment options available. As a healthcare professional assesses the health status of a person, it may be decided that prescribing a therapeutic drug is the best course of action. These treatments are assigned systematically…

Patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Participation in clinical research requires informed consent. The importance of informed consent cannot be overstated – participants must completely understand all that is involved in a clinic…

Access to relevant and trustworthy data to make accurate and timely healthcare decisions is critical. Cohesive industry collaboration is key to removing barriers to data access and increasing adoption of sensors in health science. In this episode, Jennifer Goldsack, Chief Executive Officer of non-profit Digital Medicine Society (DiMe) discusses a m…

Clinical research is the study of health and illness in people. It’s about putting people – the participants and volunteers – at the center of finding out if a new treatment is safe and effective. What clinical research and clinical research participation means is often discussed and frequently shared. In this episode, Ken Getz, Executive Director …

International Clinical Trials Day, celebrated each year on May 20th, commemorates the day that James Lind began the first randomized clinical trial in 1747. It also provides an opportunity to recognize and thank everyone involved in clinical research. In this episode, Bruce Hellman, Co-founder and Chief Patient Officer at uMotif offers a practical …

The use of mobile devices, social media, wearables, and other biosensors continues to expand year on year. The curation and analyses of health-related data is accelerating, and these data provide the potential to answer questions previously thought infeasible. When a researcher is seeking answers to a health question, when is it appropriate to use …

The European Union (EU) has been on a path to harmonize the clinical trial process and requirements since 2004 starting with the Directive. The next step came 10 years later, in 2014, with the Clinical Trial Regulation (CTR). This year, as of January 31, the Clinical Trials Information System (CTIS) went live and supports the flow of information be…

There are more than seven thousand rare diseases in the world – 95% of which have no known treatment. The term rare diseases is a cruel misnomer – in fact they aren’t that rare, and importantly, the definition of what constitutes a rare disease differs by country. To raise awareness, Rare Disease Day is recognized on the last day of February annual…

Life sciences organizations face intense pressure to speed clinical trials while boosting operational efficiencies to battle the rising costs of drug development. So what does the future of clinical trials look like? In this episode, Dr. Avi Kulkarni, senior vice president of research and development at Cognizant, and Henry McNamara, senior vice pr…

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 a…

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 co…

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 sp…

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 pat…

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 safet…

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 combinat…

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 …

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 a…

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 en…

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 decentral…

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 member…

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 perfor…

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 …

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.توسط oraclehealthsciences

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 …

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 positiv…

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 m…

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 parti…

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 clin…

Kathy Vandebelt speaks with Joe Kim, Eli Lilly & Company’s Sr. Advisor, Digital Health Office, and host of Lilly’s podcast Elixir Factor, which explores the factors that inspire bold advances in science. He aims to improve the capabilities for one of humankind's biggest social issues - the development of new medicine. Hear Joe’s opinions on approac…

In this episode, Host Kathy Vandebelt discusses decentralized trials with Dylan Rosser, Executive Director of Global Development Operations at Amgen. Dylan brings to light the various virtual components that are used and can be stitched together in a trial. He also talks about the importance of the patient in clinical research, and highlights the b…

In this episode, Oracle Health Sciences Global Head of Innovation, Kathy Vandebelt, speak with Allergan's Director of Global Study Start Up and Essential Documents, Lorena Gomez, about TransCelerate and her role since the beginning. Tune in to hear her opinions about industry initiatives, insights into the Shared Investigator Platform program, and …