In this episode of Vistatec Life Sciences - In Focus podcast, Host María Mateos talks with Bre Grignano, a leader who brings her experience from the life sciences, sports, and philanthropic sectors to the forefront of the conversation. As the Associate Director of Business Development at HiRO (Harvest Integrated Research Organization), Bre helps advance clinical research while making an impact through her nonprofit, Greater Than Me, and her work with the Philadelphia Eagles' PR department.

In this episode, Dr. Constanza Kurman Petrozzelli, Senior Manager of US Medical Myeloid at Bristol Myers Squibb (BMS), shared her inspiring career journey in life sciences. With over a decade of experience spanning contract research organizations (CROs) and pharmaceutical companies, Dr. Kurman Petrozzelli is a passionate advocate for patient diversity in clinical trials and advancing health equity.

A Career Inspired by Loss

Dr. Kurman Petrozzelli's path was shaped by a personal loss—her grandfather's death from multiple myeloma. During her final year of high school, this event sparked her interest in medicine and her lifelong dedication to improving patient outcomes. Though initially trained as a physician, she transitioned into the pharmaceutical industry, where she discovered new ways to impact patient care. Now, she focuses on myeloid diseases, addressing educational gaps in the medical community, and advocating for diversity in clinical trials.

Championing Diversity in Clinical Trials

One of Dr. Kurman Petrozzelli's key roles at BMS involves leading initiatives that boost the participation of underrepresented populations in clinical trials. Her work with the Organization for Latino Achievement (OLA) focuses on involving Latino investigators and patients in research. Workshops that bring investigators together have been instrumental in fostering a collaborative environment and promoting diversity in trials. What started with Latino communities has expanded to include other minority groups, such as the Asian population, reflecting broader efforts within the industry.

"We are working towards treatments that represent the real population," Dr. Kurman Petrozzelli said, emphasizing the need to empower investigators and provide tools to engage diverse populations.

Global Perspectives on Clinical Research

Having started her career in Argentina before moving to the U.S., Dr. Kurman Petrozzelli offers a unique global perspective. In the podcast, she compared the resource constraints faced by professionals in Latin America with the more specialized roles and infrastructure available in the U.S.

Advocacy for Women in Science

Dr. Kurman Petrozzelli is a strong advocate for gender equity in science. She believes that women must be better represented both as patients and professionals in clinical trials. Ensuring diverse representation in research benefits everyone by developing treatments tailored to the entire population. Her advocacy also extends to supporting women in the workforce, emphasizing the importance of fostering environments where women feel valued and supported.

Dr. Constanza Kurman Petrozzelli's work at Bristol Myers Squibb exemplifies how passion, creativity, and advocacy can drive progress in the life sciences. Through her leadership in increasing diversity in clinical trials and her commitment to health equity, she is helping shape the future of medical research.

About Life Sciences - In Focus

Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.

About Vistatec

We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com

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LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

Magdalena Daccord, CEO of FH Europe Foundation, leads the organization in advocating for individuals with familial hyperlipidaemias (FH). Under her leadership, FH Europe drives patient support, health policy improvements, and collaborations with European institutions.

Transforming Patient Advocacy

Since joining FH Europe in 2019, Magdalena has expanded the network’s reach and solidified its presence in European public health. A key achievement is relocating FH Europe's legal base to the Netherlands, aligning with its EU project goals.

Raising Awareness for Inherited Lipid Conditions

Magdalena's vision for FH Europe is to improve awareness and care for inherited lipid conditions, which predispose individuals to high cholesterol and heart disease. Although these conditions affect over 4 billion people worldwide, awareness remains low. FH Europe is working to improve health literacy and encourage preventative care, shifting focus from reactive treatments to better health outcomes.

The Work of FH Europe

The FH Europe Foundation advocates for individuals with both common and rare forms of familial hyperlipidemia. Established in 2016 as a charitable organization, it has grown significantly and become a leading voice in European public health. Its move to the Netherlands reflects its ambition to engage in broader EU cardiovascular health projects.

Collaborations and Strategic Partnerships

Collaboration is key to FH Europe's mission. By partnering with patient groups, medical communities, and the life sciences sector, FH Europe ensures its initiatives are science-based and widely supported. The creation of advisory committees and an industry roundtable highlights its commitment to innovative partnerships.

Challenges in Advocacy

Magdalena acknowledges the challenges of running a non-profit in the public health space, from securing funding to navigating communication barriers. Despite these hurdles, her team is committed to adapting strategies that meet community needs.

Impactful Patient Stories

Magdalena shared stories of lives transformed by FH Europe’s advocacy, such as an eight-year-old boy in Lebanon fighting for access to care. Involving people with lived experiences as ambassadors personalizes their advocacy efforts and strengthens the community.

Looking Ahead: Goals and Initiatives

FH Europe’s future focuses on personalized prevention and precision medicine. Magdalena stresses the importance of robust governance, a clear mission, and securing appropriate projects and funding to ensure long-term impact.

Join the Cause

Magdalena encouraged listeners to get involved by checking cholesterol, sharing awareness, or volunteering. With FH Awareness Day on September 24, now is the perfect time to join the cause. FH Europe is also hosting a logo competition as part of its awareness campaign.

Conclusion

Magdalena's leadership is shaping FH Europe’s critical work in patient advocacy. Their continued efforts promise to make a lasting impact on those affected by inherited lipid conditions. Learn more about their initiatives at FH Europe Foundation.

About Life Sciences - In Focus

Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.

About Vistatec

We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com

Social Media:

LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

In this Life Sciences - In Focus Podcast episode, we catch up with Toban Zolman, the CEO of Kivo, a unified document management system transforming the regulatory landscape in life sciences. With over 20 years of experience developing and validating computerized systems for clinical trials, Toban has an extensive background that bridges regulatory rigor with modern technological innovation.

From Regulatory Pioneer to Digital Transformer

Toban's career began as an early employee at Image Solutions, Inc. (ISI), where he played a pivotal role in pioneering electronic submissions for regulatory processes. His work with ISI led him to collaborate with 47 of the top 50 pharmaceutical companies and consult with over 200 companies across 16 countries. Despite these achievements, Toban felt that the transition from paper to electronic systems, while significant, needed more revolutionary impact.

After ISI's acquisition, Toban ventured into various enterprise SaaS startups, gaining experience in diverse fields such as social cloud and DevOps. However, his passion for life sciences reignited a few years ago when he noticed significant shifts in the industry, driven by technological advancements and a changing market landscape. This realization led to the birth of Kivo, a platform designed to help emerging companies efficiently manage regulatory, clinical, and quality processes in a compliant manner. (Kivo GO is a unified Document Management System that lets your Regulatory, Clinical, & Quality teams get work done together in one efficient, compliant workspace.)

Addressing Market Needs and Technological Shifts

During our conversation, Toban highlighted the increasing role of smaller, venture-backed companies in clinical trials. He noted that companies now conduct 70% of clinical trials without a product on the market. This shift is fueled by a new funding model, with venture capital pouring into life sciences, enabling smaller companies to conduct trials and bring products to market independently.

Toban elaborated on how Kivo addresses these companies' unique needs.

Traditional regulatory processes can be cumbersome and inefficient due to decentralized teams and heavy reliance on contractors.

Innovation and Risk Management in Life Sciences

The discussion centered around the industry's inherent risk aversion, particularly within quality and regulatory teams. Toban acknowledged this cautious approach but emphasized the potential for innovation within safe boundaries. He pointed to the role of AI in drug discovery, where it can dramatically increase the pace of identifying promising compounds without compromising safety.

The Tsunami of Change

Toban predicted a seismic shift in the industry due to AI-driven drug discovery. With substantial investments in AI, the number of promising compounds entering clinical trials is set to explode. This surge will necessitate a paradigm shift in regulatory bodies, CROs, and drug development companies' operations.

About Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division. About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com Social Media: LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

On this insightful episode of the Life Sciences - In Focus podcast, Host María Mateos is joined by Brandon VanArman, a seasoned Software Systems Engineer and contractor at Medtronic, who shares his extensive knowledge and experience in software development for the life sciences and language industry. About Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division. About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com Social Media: LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

In this Life Sciences In-Focus podcast episode, host Karen Tkaczyk sat down with Michelle Lott, the founder and principal of Lean RAQA, to discuss the intricate world of regulatory affairs within the life sciences sector. This conversation not only shed light on Michelle's unique journey into the field but also explored the challenges and nuances of navigating regulatory pathways in the United States and Europe.

About the Host

Karen Tkaczyk

Director of Sales for the Vistatec Life Sciences Division. Karen is an accomplished chemist and translator with extensive experience in the drug, medical device, and chemical industries. MChem in Chemistry with French from the University of Manchester, UK, and a PhD in Chemistry from the University of Cambridge, UK.

About Life Sciences - In Focus

Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple and Google podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.

About Vistatec Life Sciences

The Vistatec dedicated Life Sciences Division understands the importance of specialized workflows and expertise to deliver solutions for leading organizations worldwide.

Our clients benefit from accurate and high-quality solutions, with industry-leading expertise demonstrated across a portfolio that includes medical devices, health care software, clinical trials, biotechnology, mental health, pharmaceuticals, and pure and applied science.

Find out more: https://vistatec.com/life-sciences-division

In this Vistatec Life Sciences - In Focus Podcast episode, we hosted Eliana R. Burke, the Global Head of Client Engagement and Marketing at GreenLight Clinical. Eliana brought her professional prowess into the limelight. She shared her deeply personal and inspirational journey as a cancer survivor, melding professional dedication and personal resilience into a narrative that's both empowering and enlightening.

About the Hosts

Karen Tkaczyk

Director of Sales for the Vistatec Life Sciences Division. Karen is an accomplished chemist and translator with extensive experience in the drug, medical device, and chemical industries. MChem in Chemistry with French from the University of Manchester, UK, and a PhD in Chemistry from the University of Cambridge, UK.

María Mateos

An experienced professional in the pharmaceutical, clinical, and medical devices fields. María is no stranger to global life sciences topics and developing strategic alliances. María was honored with the “Most Valuable Player” award for her outstanding dedication and contributions to her profession.

Teresa Lawless

Teresa brings a wealth of industry experience as a host, including Life Sciences. Teresa is an alumnus of the National University of Ireland, Galway, majoring in Arts, English, Sociology, and Politics.

About Life Sciences - In Focus

Discussions with inspiring people from the world of Life Sciences.

About Vistatec Life Sciences

The Vistatec dedicated Life Sciences Division understands the importance of specialized workflows and expertise to deliver solutions for leading organizations worldwide.

Our clients benefit from accurate and high-quality solutions, with industry-leading expertise demonstrated across a portfolio that includes medical devices, health care software, clinical trials, biotechnology, mental health, pharmaceuticals, and pure and applied science.

Find out more: https://vistatec.com/life-sciences-division

In Episode 1 of the Life Sciences - In Focus podcast, we welcome Aman Khera, Vice President of Regulatory Science, Strategy, and Innovation at Worldwide Clinical Trials. Khera is a force of innovation and an advocate for diversity and patient inclusion in clinical research. Her journey from a curious student in the UK to a leading executive in the clinical research organization space is a testament to her passion, resilience, and dedication to improving healthcare.

About the Hosts

Karen Tkaczyk

Director of Sales for the Vistatec Life Sciences Division. Karen is an accomplished chemist and translator with extensive experience in the drug, medical device, and chemical industries. MChem in Chemistry with French from the University of Manchester, UK, and a PhD in Chemistry from the University of Cambridge, UK.

María Mateos

An experienced professional in the pharmaceutical, clinical, and medical devices fields. María is no stranger to global life sciences topics and developing strategic alliances. María was honored with the “Most Valuable Player” award for her outstanding dedication and contributions to her profession.

Teresa Lawless

Teresa brings a wealth of industry experience as a host, including Life Sciences. Teresa is an alumnus of the National University of Ireland, Galway, majoring in Arts, English, Sociology, and Politics.

About Life Sciences - In Focus

Discussions with inspiring people from the world of Life Sciences.

About Vistatec Life Sciences

The Vistatec dedicated Life Sciences Division understands the importance of specialized workflows and expertise to deliver solutions for leading organizations worldwide.

Our clients benefit from accurate and high-quality solutions, with industry-leading expertise demonstrated across a portfolio that includes medical devices, health care software, clinical trials, biotechnology, mental health, pharmaceuticals, and pure and applied science.

Find out more: https://vistatec.com/life-sciences-division