Clinical Research Coach

Dr Daniel Fox is an advocate for clinical research sites. Living out his purpose driven mission of restoring basic business rights for sites. Dr Fox and I discuss the challenges of underfunded studies, why 70% of physicians who try clinical research never take on another study and the importance of efficiencies and trust in order to elevate the playing field and optimize clinical research. Dr Fox speaks of a collaborative network with unity in the industry and open communication. Truly a visionary, Dr Fox shares about his Good Clinical Business Practices (GCBP) training program and increasing access to clinical research through healthcare integration. 

Dr Daniel Fox is a translational researcher with almost 2 decades of experience in science, quality, and research. He has worked at small biotechs, global pharma, academic institutions, military bases, and clinical research sites.

Dr. Fox dedicates his life to ensuring patients receive new and innovative therapies as quickly, efficiently, and safely as possible. Currently, he focuses on site rights and advocacy to help patients, physicians, and sites access research opportunities as an integrated healthcare solution.

To find out more about Dr Fox:

Check out: https://www.crpaynet.com/

LinkedIn: https://www.linkedin.com/in/daniel-fox-mph-phd-3955b222/

In this episode, Kelsey Brown, Director of Medical Writing at TransPerfect, shares about the importance of plain language and health literacy. Health literacy is the degree in which someone understands text and can take action. Data suggests the lower one's health literacy, the poorer their health outcomes. It's critical that information be provided in a way in which patients can understand and take action. Kelsey shares tips for drafting plain language documents and tools to measure readability. 

We also discuss EU/CTR, the new regulations going into effect in January 2023, and what sponsor companies must do to be compliant.

For further questions and information, you can reach Kelsey at: [email protected]

To find out more about TransPerfect's Medical Writing: https://lifesciences.transperfect.com/medical-writing

To read Kelsey's recent white paper: CLINICAL DATA TRANSPARENCY & PUBLIC DISCLOSURES: OVERCOMING CHALLENGES WITH PROSPECTIVE WRITING https://marketing.transperfect.com/acton/fs/blocks/showLandingPage/a/687/p/p-00d0/t/page/fm/0

Danieska Sandino's experience from CRC to Director of Clinical Operations at a sponsor, gives her the ability to appreciate industry challenges from a broad perspective. In this far reaching episode we discuss how to handle turnover, managing expectations and the need for transparency and collaboration in the industry. Danieska shares practical tips and systems for onboarding staff, negotiating budgets and patient recruitment. We talk about bringing a protocol to life and how to support your team with mission driven goals. 

In this episode, we chat with, Lucy Coassin, Current Health's Senior Director of Pharma Partnerships. Lucy explains how Best Buy's entry into the healthcare sector with Current Health empowers patients and provides greater flexibility utilizing remote patient monitoring technology. We discuss the changing landscape of clinical trials and the need for greater collaboration, commitment and interoperability as we usher in this new age of healthcare. Lucy shares advice for those who wanting to get into the industry, as well as suggestions for getting industry to accept and adopt innovative technology.  

Lucy Coassin is the Senior Director of Pharma Partnerships at Current Health. Previously at Science 37, she is well versed in bringing revolutionary technology to the market. Lucy is a trailblazer, boldly brining transformational technology to the pharma industry. Lucy has an MBA from Stanford and a BS in Chemistry from Duke.   

Daniel A. Perez is a rebel in clinical research and passionate advocate for diversity and equity in healthcare. With a servant's heart and desire to lead, he elevates those around him while challenging the industry status quo. In this episode we chat about the state of the industry and what may transform the relationships with investigators and what is necessary to create a successful ecosystem at the site level. We talk about the importance of resources, education and financial compensation, layered in with empathy.  

A Los Angeles native, Daniel’s passion for clinical research materialized over a decade ago, when a new diagnosis forced him to face critical treatment options evolving only as fast as clinical trials allowed. It was during this experience when he recognized his fortune in benefitting from clinical research-fueled medical breakthroughs, as well as the unnecessary dysfunction and inefficiency that existed within this same space. With a newfound desire to make an impact on the traditional clinical trial paradigm, Daniel entered the neurosciences department at Cedars-Sinai Medical Center, where his talent and motivation led to several quick promotions within academia. It was in his expansive role as Clinical Research Manager at Children’s Hospital Los Angeles (CHLA) where Daniel fine-tuned his talents across all regulatory, managerial and operational aspects of clinical research. After recognizing the amplified impact possible outside of traditional medical institutions, and experiencing MACRO as a clinical operations consultant, he made the leap and joined MACRO full time. At MACRO, Daniel combined his meticulous operational acumen with his comprehensive research and regulatory expertise to help bring their vision into a tangible reality.

Daniel leads by constantly questioning how things have always been done, and continuously evaluating the clinical research process through the lens of the human subjects on which they are based. Daniel cofounded the Coalition for Advancing Research Equity (CARE) and also serves as a founding board member for Clinical Trials in Color, a 501(c)(3) non-profit foundation with a mission to improve health outcomes in communities of color by increasing diversity and access to clinical trials. Daniel is currently the Global Head, Patient Experience, Diversity & Inclusion at Worldwide Clinical Trials. 

In this episode, Steve Wimmer, recounts his experience as a patient in clinical trials. Steve is no newcomer to the clinical trials industry, but in this episode, he shares through the lens of participant, not industry expert. His experience reminds us of the need for clear communication with participants, beginning with the informed consent process, all the way through to sharing study results. We discuss the need to consider the patient journey, and how to consider the safety of a trial. Have you ever participated in a clinical trial? Would you consider participating? Reach out, we'd love to hear your experience. 

When Steve Wimmer isn't participating in clinical trials, you can likely find him out in the real world wearing a Hawaiian shirt. Steve is the Director of Partnerships at 1nHealth, where he helps speed up clinical trials by finding more patients to enroll. 

When Jessica Landsdown's son, Will, was diagnosed with Niemann Pick Type C, she was willing to go anywhere in order to give her son access to a potentially life saving treatment. In this episode, Jessica shares a mother's story of enrolling her son into two expanded access programs for investigational new drugs. Jessica relays her fears of the possibility of losing access to the only possible treatment and the impact that could have on her son. As you listen to this vulnerable conversation, consider how sponsor companies, investigational sites and the entire drug development industry can better serve vulnerable populations.