Archives: Speakers

As Vice President of DCT Study Operations at Care Access, Vanessa Gertsen oversees decentralized trial operations. In addition to decentralized trials, Vanessa specializes in site and patient engagement, digital innovation, and diversity and inclusion in clinical trials. Prior to Care Access, Vanessa served as Head of Patient Recruitment Strategy, Global Clinical Operations at Bristol-Myers Squibb, where she developed and implemented an indication-specific engagement and recruitment plan and also built a high-performing team to support all phases of development across the R&D portfolio. Vanessa honed her patient enrollment skills at Accelerated Enrollment Solutions (formerly Acurian Inc.), where she managed global site relations and enrollment as well as the US field team. She holds a BA in History and Political Science from McDaniel College.

Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization.

In 2011 she co-founded Looms for Lupus when her sister almost lost her life to Immune thrombocytopenia and Lupus; she is alive today because she advocated for herself. Estela has supported her sister and her passion to help others has evolved to “iLOOMinating”, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally.

As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services’ Office of Minority Health and the U.S. Food and Drug Administration’s Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitano’s Mental Health Consortium. Estela is an exceptional community engagement liaison for both English and Spanish speakers.

Mike DeCastro is Head of Sales for Uber Health. In this role, he is responsible for spreading awareness and forging partnerships with payers, healthcare and community organizations across the country to meet the mobility needs of their patients. Prior to joining Uber Health, Mike held commercial leadership roles in digital health at Topcon Healthcare Solutions and GoCheck Kids with over 10 years of experience in medical devices, population health, and value based care.

A Kaizen-certified cross-functional leader with operations experience, I specialize in Global GxP Compliance, Audit Strategy and Execution and FDA BIMO, PAI, MHRA, EMA and Health Canada Inspections. I’ve helped bring life-saving therapies to market while fostering cultures of quality. A trusted change agent and co-creator of quality transformation initiatives, critical thinker, collaborator, embedding a culture of continuous improvement and regulatory excellence across complex, matrixed organizations. My work centers on aligning operational excellence with human impact because behind every system is a story, and behind every story is a life worth protecting. Passionate about Quality allyship, mentorship, learning and reinvesting in community.

I lead with purpose and heart, anchored in authenticity, I cultivate humane spaces where identity is honored and excellence, equity, and empathy co-exist.

My leadership is shaped by resilience, legacy, and the belief that stories bridge connection. Born in Sierra Leone, schooled in the UK, I now live in the US. As a perpetual incomer, I lead with commitment to equity, turning lived experience into systems that uplift.

Fun Facts: I grew up on the beaches of Sierra Leone | Myers-Briggs: INFJ | Sickle-Cell and Newborn Screening Advocate | STEM Mentor | Believer in Kindness

LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/

Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck.  She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry.  She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs.  She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience.

Tara Safakish is a Software Engineer with over 15 years of experience in different roles such as Software Developer, Software Quality Engineer and Quality Computer System Validation specialist in medical device and biotechnology/pharmaceutical industries. She is also a Certified Medical Device Auditor (CMDA) and Six Sigma Green Belt (CSSGB).

She started her career as a software developer and after a few years found her passion in software quality engineering field.  She worked for several medical device and biotechnology companies in North America including, CryoCath, enLabel Global Services, Sciex, Avalanche Biotechnologies. Presently, Tara is the Associate Director, QA Computer System Validation at Ultragenyx Pharmaceutical Inc. where she has worked for over 5 years.

The combination of her education and experience as a software quality engineer involved in all aspects of software development life cycle, including risk management, gives her a unique perspective to identify and assess data integrity risks through its life cycle.