Moving Medicine Forward (CTI Clinical Trials)

In this episode of #MovingMedicineForward – The Podcast, CTI experts Chad Jones & Eric Clayton discuss challenges in clinical research surrounding Acute Myeloid Leukemia (AML) & Multiple Myeloma (MM). They explore the complexities of designing & conducting clinical trials, the importance of site selection, & how CTI’s expertise enhances trial outcomes. Additionally, they touch on key advancements to watch at the 66th American Society of Hematology Annual Meeting. During the episode, Eric explains how, “These are some of the first times that these therapies are being tried in human participants, & that innovative experimentation is what makes this work so exciting.”

0:22 Challenges in clinical research for Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM), with insights from CTI experts Chad Jones, Sr. Director of Project Management and Oncology Strategy Lead, and Eric Clayton, Clinical Project Manager III. 

0:51 Overview of AML and MM, and why these diseases are particularly difficult to treat. 

1:32 Key challenges in designing and conducting clinical trials for AML and MM. 

3:19 How site selection and management impact trial success, and challenges Contract Research Organizations (CROs) face when recruiting qualified sites. 

5:14 How CTI's expertise supports sponsors and improves trial outcomes. 

6:38 The importance of maintaining proper chain of custody. 

9:53 Key treatments and advancements in hematology to watch at the 66th ASH Annual Meeting. 

10:33 Visit CTI at booth #454 at ASH. 

10:41 Regulatory considerations for treatments and how CTI navigates this process for patients. 

12:31 Collaboration between CROs, pharmaceutical companies, and academic institutions to accelerate research. 

13:12 Unmet needs in AML and MM research and how the industry can address them. 

14:16 Challenges in improving patient outcomes for MM and AML. 

16:22 How CTI mitigates patient retention during clinical trials. 

18:33 Strategies for recruiting critically ill MM and AML patients. 

21:41 CTI is recruiting a Sr. Medical Director in Hematology/Oncology. Apply now: Senior Medical Director - Hematology/Oncology - Level Dependent Upon Experience | Join The CTI Team  

Episode 5 assembles experts in transplantation. Tim Schroeder and Dr. Bill Fitzsimmons join us to discuss how CTI has been a key player in the field of transplantation, current trends, and where the future of transplantation is heading. Dr. Robert Gatson discusses transplantation innovations and his own background in the field. 

In episode 6 of Moving Medicine Forward, we dive into diversity in clinical research with insights from CTI’s CEO Tim Schroeder and Board Member Dr. Bill Fitzsimmons. Hear about Bill's journey into clinical research, the importance of diversity in clinical trials, and strategies to overcome medical mistrust. We also discuss the latest FDA guidance on diversity* and CTI’s initiatives to foster inclusive practices. 

0:29 - Introduction of guests, Tim Schroeder, CEO of CTI, and Bill Fitzsimmons, CTI Board Member.  

2:20 - Bill shares his journey into clinical research and how he became involved with CTI. 

2:45 - Bill's role and responsibilities as a CTI board member. 

3:36 - Defining diversity in clinical research. 

4:10 - The importance of diversity in clinical trials. 

7:15 - Strategies to encourage participation in clinical trials despite medical mistrust. 

12:54 - Reference to Adam Roth’s episode on vaccine trials during COVID-19: Clinical Research Site Spotlight - Vaccine Trials by Moving Medicine Forward (spotify.com) 

13:00 - Challenges in maintaining diversity within clinical trials. 

14:52 - Impact of regulations and strict requirements for diverse populations on the clinical trial process. 

*15:15 - The FDA guidance on diversity in clinical trials mentioned during the episode has since been published. Please note that the episode was recorded prior to its release. 

19:23 - Essential support needed for clinical trial sites to successfully recruit diverse populations. 

20:57 - Role of CROs in supporting sites to recruit diverse populations. 

23:38 - Improving health and research literacy to enhance participation. 

28:56 - CTI’s initiatives to enhance diversity in clinical research. 

In this episode of “Moving Medicine Forward” – The Podcast, Lily McNally and Heidi Shenk from the American Brain Tumor Association (ABTA) share their personal connections to brain tumors and discuss the ABTA’s resources, research initiatives, and community partnerships. They also discuss ABTA’s “Meet Hope Head On” campaign to triple research funding and expand patient outreach. Tune in to learn how the ABTA is advancing brain tumor research and how you can get involved or donate: CTI Cares Employee Fund  

0:23 Meet our guests from the American Brain Tumor Association (ABTA), Lily McNally and Heidi Shenk, who share their personal stories and connection to the organization. 

0:52 Heidi discusses her personal experience with brain tumors and how it led her to become involved with the ABTA. 

3:11 Lily shares her journey and how her family's experience with brain tumors inspired her to contribute to the mission of the ABTA. 

4:33 Heidi and Lily talk about how their families became involved with the ABTA and its supportive community. 

7:21 Learn about the various resources the ABTA offers to patients and families, and how these services have personally benefited Heidi and Lily. For help, call the ABTA Care Line: 800-886-ABTA(2282). 

11:36 Heidi and Lily explain ABTA’s partnerships with marathons, including Cincinnati’s Flying Pig, and how local events support their mission. 

13:47 Discover how physicians, alumni, and others can contribute to the ABTA’s efforts, including its annual national conference. [Learn more about the Alumni Research Network (AARN): ABTA Alumni Research Network - Learn More or Donate Today!]  

15:43 The ABTA’s 5-year campaign, Meet Hope Head On, aims to triple research funding, double patient outreach, and increase federal funding for oncology research. [Link to donate: CTI Cares Employee Fund]  

17:15 Discover how the ABTA partners with clinical research organizations like CTI to help patients access clinical trials and advance treatment options. [Link to Clinical Trial Finder: Home | ClinicalTrials.gov] 

19:45 In August 2024, the FDA approved a new treatment for low-grade glioblastomas. [Get the latest information on this treatment: VORANIGO® (vorasidenib) | For Grade 2 IDH-Mutant Glioma] 

In this episode of “Moving Medicine Forward” – The Podcast, Christine Eby, Director of Clinical Project Management & Therapeutic Strategy Lead at CTI, Anna Sowa, Chief Mission Officer at CurePDE, Curtis R. Coughlin II, PhD, MS, MBE, Associate Professor, Department of Pediatrics and Center for Bioethics and Humanities, and Kristy McCay, mom of a two-year-old living with pyridoxine-dependent epilepsy (PDE), join together to discuss the ongoing efforts to raise awareness and provide support for those affected by this rare condition. They share insights on the challenges of PDE diagnosis, the importance of newborn screening, and the role of gene editing in treatment. The conversation also explores CurePDE’s advocacy work, its partnerships with organizations like CTI, and the significance of community and patient education in advancing their mission.  

0:36 – Introduction of podcast guests: Christine Eby (CTI), Anna Sowa (CurePDE), Dr. Curtis Coughlin II, PhD, MS, MBE, and Kristy McCay (mom of a child with PDE). 

1:20 – Overview of CurePDE, a family advocacy organization focused on raising awareness and support for pyridoxine-dependent epilepsy (PDE). 

2:29 – Dr. Curtis introduces himself and discusses his involvement with PDE research and the impact of CurePDE’s work in the field. 

3:45 – Explanation of PDE from a medical perspective, including common symptoms and challenges faced by patients. 

6:40 – Kristy McCay shares her personal journey with her child's PDE diagnosis and the ongoing experience. 

7:59 – Kristy reflects on navigating her child’s diagnosis and the challenges of managing a postpartum experience with a new diagnosis. 

10:42 – The medical community’s awareness of PDE, including key insights into best practices for diagnosis and treatment. 

12:34 – Progress made in advocating for the inclusion of PDE in newborn screening programs. 

15:34 – Discussion on a federally recommended panel for states to consider adding to their newborn screening protocols. 

16:59 – Lessons other advocacy groups can learn from CurePDE’s work and the importance of understanding each group’s unique journey. 

22:06 – How CurePDE is collaborating with organizations like CTI to advance gene editing technology for PDE treatment. 

28:06 – Family feedback on gene editing treatments and how families have embraced these new options. 

30:44 – The role of organizations like CTI in supporting advocacy groups to further their missions. 

36:23 – The significance of community building and patient education in successful advocacy efforts. 

41:24 – Activities and support offered to families involved with CurePDE. 

43:04 – Advice for other advocacy groups looking to gain recognition and connect with doctors and patients. 

44:54 – CurePDE’s fundraising initiatives, where families work together to raise money for the cause. 

50:05 – Long-term goals and vision for the future of CurePDE. 

In this special 25th-anniversary episode of "Moving Medicine Forward" - The Podcast, we're excited to welcome Tim Schroeder, Chief Executive Officer of CTI, Lynn Fallon, CTI Board Member and former President, and Kevin Schwarz, Chief Operating Officer of CTI. They share insights into CTI’s founding vision and its evolution over the past quarter-century. Tim and Kevin also discuss how CTI has driven innovation and contributed to the growth of the clinical research industry, highlighting key milestones such as their involvement in over 200 drug approvals. Join us as we celebrate this milestone and explore CTI's journey!  

CTI Clinical Trial and Consulting Services presents Moving Medicine Forward, a podcast centered on advancements in healthcare and elevating individual’s stories and expertise. CTI, a global Contract Research organization with associates in 60 countries, has contributed to 10,000+ projects, 200+ drug and device approvals, and 300+ pharmaceutical and emerging biotechnology partners. Our group of innovative thinkers work to change the lives of chronically and critically ill patients.

On this episode of “Moving Medicine Forward” - The Podcast, we delve into groundbreaking research with Dr. Richard Curry, Medical Director at CTI. Dr. Curry offers an in-depth look at the ongoing Bexion BXQ350 study, shedding light on the significant advancements and the journey of the trials over recent months. This innovative therapy holds promise for revolutionizing cancer treatment, and Dr. Curry's insights provide a glimpse into the future of medical science. 

In the episode's second segment, we're joined by therapeutic leads Chad Jones and Katie Westerkamp, who bring their expertise in hematology and oncology research to the forefront. They discuss the cutting-edge approaches being explored in their fields, emphasizing the importance of innovative therapies in battling cancer. Chad and Katie share their experiences from clinical trials, offering listeners a rare peek into the challenges and triumphs of oncology research. 

Listeners will leave this episode with a deeper understanding of the complexities of cancer research, the importance of ongoing clinical trials, and the collaborative effort required to move medicine forward. This episode not only informs but also inspires, showcasing the tireless work of individuals like Dr. Curry, Chad, and Katie, who are at the forefront of transforming patient care through scientific discovery. 

[1:05] Dive into the origins of the pivotal Bexion BXQ350 study: Discover the compelling history and purpose behind its inception, providing hope and new directions in cancer research. 

[2:25] The pivotal moment neuropathy became a focus: Learn how this challenging condition spurred the initiation of a crucial trial, aiming to bring relief to many. 

[2:56] Explaining neuropathy: An introduction to neuropathy is followed by the announcement of an innovative clinical study aimed at finding effective treatments. 

[4:38] The ongoing search for a cure: A candid discussion on the current state of neuropathy treatment and the relentless pursuit of a cure. 

[5:23] The collaboration that could change the future: Discover how CTI and Bexion joined forces, marking a significant milestone in the journey towards groundbreaking therapies. 

[6:08] From inception to impact: A chronological exploration of the trial's evolution, showcasing the milestones achieved through years of dedicated research. 

[7:28] Breaking new ground with a Phase I trial: An in-depth explanation of the trial's expansion, illustrating the critical steps forward in the fight against cancer. 

[9:04] The expansive network driving the study: An overview of the numerous sites involved in the study, highlighting the collaborative effort across the globe. 

[9:29] A focused approach: Insight into why the trial is uniquely dedicated to cancer patients, underscoring the targeted efforts to combat the disease. 

[14:06] The science behind BXQ350: Delve into the structure and mechanism of the drug, understanding its potential to make a significant impact in cancer treatment. 

[16:18] The critical role of cancer research: Reflect on why pursuing oncology research is not just important but imperative for medical advancement. 

[17:58] Dr. Curry's journey to oncology: Discover the inspiring path Dr. Richard Curry took to become a leading figure in oncology research and his vision for the future.  

 
[20:07] Embarking on a New Perspective: The episode transitions, bringing into focus Chad Jones and Katie Westerkamp, who offer a fresh perspective on the relentless pursuit of breakthroughs in cancer treatment. 

[20:31] Facing the Challenges Head-On: Delve into the unique obstacles encountered in hematology and oncology research.

[21:28] Accelerating Treatment Delivery: Learn how research sites become pivotal in fast-tracking treatments to patients.

[21:59] Integrating Diverse Therapeutic Approaches: Unpack the roles of cell therapy and small molecule research within the trials.

In this episode of "Moving Medicine Forward" – The Podcast, Jill Black, Validation IT Principal Auditor at CTI, shares the deeply personal story of her daughter, Emma, and their journey navigating this rare disease. She offers valuable insights into the challenges and impact of Rett Syndrome, while discussing her work at CTI and how being part of an organization focused on rare diseases fuels her hope and purpose. Jill reflects on her experience speaking at the 2024 Rett Syndrome National Summit, supported by NORD, and highlights the critical role of connecting with other parents and advocates. Tune in as Jill explores the exciting progress in Rett Syndrome research, including the FDA-approved drug and the work of pharmaceutical companies aiming to find a cure.  

1:19 – Jill shares the powerful story of her daughter, Emma, and her journey with Rett Syndrome, including key insights into the condition and its impact. 

6:10 – Jill discusses her role at CTI and how working with an organization that focuses on rare diseases has given her a sense of hope and purpose in making a real difference. 

6:33 – Reflecting on her experience speaking at the 2024 Rett Syndrome National Summit, Jill talks about how NORD supported her attendance, enabling her to connect with other parents and advocates in the Rett Syndrome community. 

7:50 – After 25 years of research, one FDA-approved drug is available for Rett Syndrome. Jill explains how 20 pharmaceutical companies are currently working to find a cure and the progress being made. 

9:00 – Jill shares ways listeners can get involved and support families living with Rett Syndrome.  

In this episode we delve into the world of regulatory interactions, strategy, & operations with two industry leaders: Dr. Monica Rodriguez, Executive Director of Model-Informed Development, & Christine Norman-Tiner, Executive Director of Global Regulatory & Scientific Affairs. They share their invaluable expertise on: 

• Developing effective regulatory strategies for clinical trials  

• Navigating challenges in global regulatory communications  

• The influence of model-informed development on regulatory practices  

Explore how emerging technologies, patient-centric trials, & real-world evidence are transforming the biotech landscape.

In this episode of “Moving Medicine Forward” – The Podcast, Mike Vieth, CTI Board Member and partner at E Gateway Capital, and Tim Schroeder, CTI CEO and Chairman, explore key topics in clinical trial funding. They discuss the role of venture capital in overcoming funding challenges, balancing high-risk investments, and supporting clinical research beyond financial backing. They also dive into how data analytics and AI are shaping investment decisions and the importance of CROs in connecting venture capital with small biotech companies. Tune in for insights on how venture capital influences clinical research and the future landscape in 2025. 

In this episode of "Moving Medicine Forward" - The Podcast, Greg Ruf, Founder & Executive Director of the DCM Foundation, and Bret Marshall, Senior Director of Business Development & Client Management at CTI, discuss the vital role of patient advocacy groups and the partnership between CTI and the DCM Foundation. Greg shares his journey in founding the DCM Foundation, and they explore key projects, achievements, and strategies for patient education and sponsor engagement. Tune in to learn how collaboration can enhance clinical research and advance patient advocacy. 

0:24 Introduction of guests Greg Ruf and Bret Marshall. 

1:06 Explanation of patient advocacy groups. 

2:30 Overview of CTI and DCM Foundation partnership. 

3:22 Greg’s journey in founding the DCM Foundation. 

4:41 CTI's criteria for selecting advocacy group partners. 

6:30 Highlights of joint projects and initiatives with DCM Foundation. 

8:33 Key achievements of the DCM Foundation. 

13:28 Methods used by the DCM Foundation to educate patients. 

18:20 Ways for listeners to contribute. 

23:16 Discussion on the timing of genetic testing. 

25:40 Strategies to engage sponsors with advocacy groups. 

28:36 How the DCM Foundation connects with patients. 

34:42 Advice for enhancing collaboration between CROs, pharma, and advocacy groups. 

Today on Moving medicine forward we have a great discussion with Adam Roth, Vice President, Research Site Services at CTI. In this conversation we take a deep dive into how our Clinical Research Center in Cincinnati OH supports clinical research. We focus on the work the site has done on Vaccine trials including how the site supported the Covid-19 Vaccine trials during the pandemic.

Episode 4 assembles various CTI experts to discuss Cell and Gene Therapy. In episode 4, Bret Marshall, joins us to discuss CTI’s involvement in Cardiac Cell and Gene trials, our impact, and goals, as well as the current industry trends and advocacy groups. Jaclyn Guillory discussed the groundbreaking advancements in targeted therapies for KRAS mutations. Later in the episode, Michael Schmidt and Nicole Sparshott joined to discuss cell product chain of custody. Concluding with Joana Lancastre’s discussion on feasibility in cell and gene therapy.  

Today for our very first episode We will be talking with Christine Eby director of clinical project management and the Therapeutic lead for Rare Disease here at CTI. She will be sharing her son’s patient Journey as her family navigates his Type 1 diabetes Diagnosis. 

In this episode of "Moving Medicine Forward" – The Podcast, Dr. Monica Shah, Chief Medical Officer at CTI, discusses her journey into clinical research and her transition into her new role. Dr. Shah shares her immediate priorities and goals as CMO, her leadership style, and her approach to fostering collaboration within CTI. She also expresses her enthusiasm for the upcoming ARM Cell & Gene Meeting on the Mesa, highlighting the key topics and discussions she anticipates. Tune in to gain insights into Dr. Shah’s vision for her role at CTI and learn about her personal interests outside of work. 

0:25 Meet Today’s Guest: Dr. Monica Shah, Chief Medical Officer at CTI. 

0:30 Dr. Shah delves into her background and her journey into the field of clinical research. 

6:50 Dr. Shah outlines her immediate priorities and goals as the new CMO. 

8:05 Dr. Shah’s leadership style and how she plans to foster collaboration at CTI. 

8:55 Dr. Shah shares her excitement about the upcoming ARM Cell & Gene Meeting on the Mesa. 

10:20 Insights into the key topics and discussions Dr. Shah anticipates at the Meeting on the Mesa. 

12:48 Dr. Shah reveals what she’s most excited about in joining the CTI team. 

13:24 Learn about Dr. Shah’s interests and passions outside of her professional life.