WCG Talks Trials

"What impact does a remote clinical team operating model have on clinical trial performance?" That’s one of the hot topics from Ken Getz’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. He describes several projects that the Tufts Center for the Study of Drug Development (Tufts CSDD) is currently working on; ones that will provide robust...

Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. This makes her an ideal person to co-chair an indus...

Pharmaceutical executive Peter A. DiBiaso, MHA, a triathlete who has successfully completed the grueling Ironman, learned at age 49 he had early-onset Parkinson’s disease. He shares his experiences—and triumphs—in this episode. What started as a small tremor in his right hand and a stiffness in his right ankle ended up changing his life.  It was a blow, but he knew what to do: The diagnosis brough...

In this episode, host Linda Sullivan, MBA, Executive Director of WCG's Metric Champion Consortium (MCC) chats with Laurie Halloran, founder of the Halloran Consulting Group, about how she developed an on-demand drug development team that can fill in gaps in the clinical trial process for life science companies, whether these involve regulatory strategy or execution, or quality, clinical, or m...

To fully engage Chicago’s medically underserved Chinese and other Asian communities and to help them address their own health issues, Dr. Hong Liu’s Midwest Asian Health Association reaches out in Mandarin, Cantonese and other languages—and does so in culturally appropriate ways. The result is better access to healthcare for many low-income, often new-immigrant minorities who experience certain he...

In this episode, Roslyn Daniels, the founder and president of Black Health Matters, talks about how her organization educates and motivates African-American communities about taking care of one’s own health. Seeing her own grandparents die too soon and recognizing that, in many communities,  people are forced to choose between rent and healthcare, she realized that “access means nothing unless you...

Our guest this episode, patient advocate Dorelia Rivera, improves access to healthcare services and clinical trials for the underrepresented, including her own Hispanic community. Her advocacy ranges from community volunteer work, to jobs for a state health and human services department, a payor, and a rare disease drug company. She advocates on Capitol Hill and served on the National Institutes o...

“Our research population should match our community population.” That’s one of the takeaways from Christopher Gantz’s interview with WCG President of Patient Advocacy Steve Smith. He describes several programs that help connect researchers with minority communities to increase engagement and access enrollment in clinical trials. Gantz is senior director of the Regional Liaison Office at the Sidney...

In this episode, we learn about CISCRP’s AWARE for All campaign, which builds awareness of, creates access to and encourages participation in clinical trials. Ellyn Getz, Associate Director of Development and Community Engagement at CISCRP, The Center for Information and Study on Clinical Research Participation, discusses AWARE for All . CISCRP's flagship grassroots campaign works with divers...

Independent expert committees provide essential validation of clinical data. Without their insights, sponsors risk missed signals, conflicts of interest and costly delays. But establishing a successful expert committee can be tricky. It requires the right combination of people, process and technology. In this three-part podcast, Lakshmi Sundar, head of business transformation at WCG ACI Clinical,...

In this episode, Dolly Niles, executive director of QUEST Research Institute, talks about the role of small research sites and the value of community outreach. QUEST, a multi-specialty independent research site in metro Detroit, has conducted more than 350 phase 1-4 trials since it was established in 1996. Niles talks about the role of agile smaller sites during the height of the COVID-19 pandemic...

In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network--a “peaceable kingdom,” as he calls it. Millions of patients representing 3,500 diseases--including many rare ones --come to Inspire.com for online community discussions focused on their own particular disease. The...

Drug policy has transformed to bring transformative improvement to the way rare diseases are developed resulting in more FDA approved treatments. This transformation came about because of collaboration across stakeholders: patient advocates, the FDA, Congress, drug developers, researchers, and legal specialists.  Profound change came in the mid 1980’s when AIDS activists, Rare Disease Activists, a...

In this episode, Brian Loew, founder and CEO of online patient portal Inspire, talks about the value to patients and caregivers of providing a safe and trustworthy online social network: a “peaceable kingdom,” as he calls it. Millions of patients representing 3,500 diseases—including many rare ones—come to Inspire.com for online community discussions focused on their own particular disease. The pl...

In this podcast, Thomas Farrington, founder of the Prostate Health Network , speaks with WCG President of Patient Advocacy Steve Smith. Mr. Farrington discusses his experience with the healthcare system, coupled with his own research on prostate cancer, which led him to become a vocal advocate for prostate cancer patients and survivors. His advocacy spans a wide range of approaches from educationa...

In this episode, former Assistant FDA Commissioner Jonca Bull, MD , discusses racial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials. Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current crisis has simply magnified existing disparities. A...

This episode takes on a topic from recent headlines--namely, the racial disparity in COVID-19 cases and deaths. Edith P. Mitchell, MD, MACP, FCPP, shares her insights on the causes of these health disparities and how they relate to the coronavirus. Contributing factors include less access to testing, lack of insurance and paid time off, underlying health conditions, and the spread of misinformatio...

In this COVID-19 focused episode, Dr. David Fajgenbaum chats with President of WCG Patient Advocacy, Steve Smith, to talk about his journey as a medical researcher and patient of a rare disease and about the pandemic facing our daily lives. Known for his best-selling book, Chasing My Cure: Turning Hope Into Action, Dr. Fajgenbaum shares best practices for how everyone facing this crisis can get th...

In this episode, WCG’s President of Patient Advocacy, Steve Smith, talks with Dr. Charlotte Owens, MD, FACOG, Medical Director at AbbVie Pharmaceuticals, who works in the general medicine therapeutic area with a focus on women’s health. As a physician, Dr. Owens describes her passion for pursuing a career that’s truly helpful for others and her desire to educate women on how to bring healthy child...

In this episode, WCG’s President of Patient Advocacy, Steve Smith, interviews Dr. Jonathan Seltzer, MD, Chief Scientific Officer at WCG, expert on data safety monitoring boards, biomarkers, biostatistics, and clinical endpoints. During their conversation, Steve and Dr. Seltzer discuss how biomarkers are appropriate for the use of trials, especially when clinical data is tough to get. Part of this...

In this episode, Dr. Janet Wittes, Founder and President of WCG Statistics Collaborative sits down with WCG’s President of Patient Advocacy, Steve Smith. Their conversation focuses on the importance of reliability and efficiency in clinical trials, and how biostatisticians work closely with clinicians and patients to help ensure clear results from trials. Moreover, they dive into how biomarkers ca...

In this episode, Steve Smith, WCG President of Patient Advocacy sits down with Julia Jenkins of the EveryLife Foundation to discuss the impact her organization has on giving patients a voice to legislators on Capitol Hill. Julia shares how patient communities can advocate for public policy changes, improve the FDA-regulatory approval process, and educate on the effectiveness of different trial des...

In this episode, WCG’s President of Patient Advocacy, Steve Smith, interviews Dr. Jeffrey Cooper, MD, MMM, Vice President of Process & Strategic Improvement at WCG, expert in the conduct of clinical trials, and Parkinson’s patient himself. During their conversation, Steve and Dr. Cooper highlight the strides clinical research has made for many therapeutic areas and the promise research has for...

In this episode, WCG’s President of Patient Advocacy, Steve Smith, sits down with Sarah Zentack, a Certified Genetic Counselor at InformedDNA and Leslie Urdaneta, Family Support Coordinator at the National MPS Society. Their discussion highlights the importance of genetic counseling and the intelligence patients can gain to better understand their treatment options, ensure they’re receiving the co...

In this episode, Mark Dant, Founder of the Ryan Foundation speaks with Steve Smith, WCG’s President of Patient Advocacy. Their conversation highlights the importance of Patient Advocacy Groups – and the resources they bring to individuals diagnosed with a disease – as well as the great promise clinical trials bring to patients. Mark shares a personal story of his son, Ryan, who was diagnosed with...