Life Sciences 360

Weronika discusses the importance of integrating software with other systems for success and touches on various challenges such as data integration, user needs, and documentation practices. She highlights the evolving role of AI and software in healthcare, emphasizing patient-centered solutions and the importance of continuous learning in the Med-Tech industry.  Harsh and Weronika focus on softwar...

Heather talks about the role of art in quality and documentation, challenges with document control methods, and her experience writing an article for Quality Magazine. She shares advice for entering the life sciences industry and the role of mentors in career development. Harsh and Heather also address the importance of mental health for leaders, the positive outcomes of supporting mental health,...

Episode 034: Harsh Thakkar (@ harshvthakkar ) interviews Kimberly Wallbank (@ kimberlywallbank ), the Principal Consultant at Quality Systems Services, LLC. Kimberly addresses the evolution of quality and regulatory practices, particularly the increased focus on risk assessment. She discusses the challenges companies face with compliance and the need for a cross-functional approach, as well as the...

Episode 033: Harsh Thakkar (@ harshvthakkar ) interviews Chijindu E. O. (@ chijindu-authorceco ), the Founder & Creative Director of Ceco Creations. Chijindu shares his journey in the field of science and art, starting with creating cartoons and animations to inspire and educate people, noting that visual appeal and creativity can make scientific content more interesting and enjoyable.  He emp...

Episode 032: Harsh Thakkar (@ harshvthakkar ) interviews Elizabeth Smalley (@ elizabeth-smalley-product-leader ), the Director of Product Management, Data and Analytics at Aris Global.  Elizabeth discusses proactive safety signal detection in the context of drug development and the challenges faced in this space. She highlights the importance of utilizing real-world data and changing the methods o...

Episode 031: Harsh Thakkar (@ harshvthakkar ) interviews Penelope Przekop (@ penelopeprzekop ), the CEO at PDC Pharma Strategy and author of the book 'Five Star Career.' Penelope discusses her background in the pharmaceutical industry and the importance of quality management. She provides practical advice on collaboration, continuous learning, and finding fulfillment in one's career...

Episode 030: Harsh Thakkar (@ harshvthakkar ) interviews Ivan Perez Chamorro (@ ivan-perez-chamorro ) the CEO and Founder of MedBoard. Ivan shares the inspiration behind starting MedBoard. He recognized the need for a platform that provides access to trusted information in the life sciences industry. He describes how AI is integrated into MedBoard to assist users in making decisions and automating...

Episode 029: Harsh Thakkar (@ harshvthakkar ) interviews Bethany Corbin (@ bethanycorbin ), the Co-Founder of FEMInnovation and Managing Partner at Women's Health Innovation Consulting. Bethany shares her journey, going from law studies to founding FEM Innovation, focusing on improving reproductive health for women. She talks about the challenges women's health companies face, like adver...

Episode 028: Harsh Thakkar ( @harshvthakkar ) interviews Dr. Cortney Warren ( @drcortney ), a Clinical Psychologist and the Founder and Owner of Choose Honesty LLC. Dr. Cortney emphasizes the need for mindfulness regarding our technology usage and its effects on our mental health. She also delves into the importance of being truthful about our struggles to better our relationships and mental healt...

Episode 027: Harsh Thakkar ( @harshvthakkar ) interviews Niyati Patel ( @niyatipatel ), the Director of Quality Engineering at Getinge (Maquet Cardiovascular) and a Sr. Regulatory/ Quality Consultant at Compliance Insight, Inc. Niyati breaks down the complexities of quality management systems, compliance, and regulations in the industry. She discusses the unique challenges companies face, especial...

Episode 026: Harsh Thakkar ( @harshvthakkar ) interviews John McKay ( @johnlmckay ), President, Chief Operating, Quality & Regulatory Affairs Officer at Q1 Associates LLC. John emphasizes the critical role of quality plans in ensuring error prevention and maintaining top-notch quality in the life sciences industry. The conversation takes a global perspective as he shares his extensive experien...

Episode 025: Harsh Thakkar ( @harshvthakkar ) interviews Kamya Elawadhi ( @kamya_elawadhi ), SVP of Platform and Corporate Strategy at Doceree. Kamya shares her wealth of experience in healthcare advertising and innovation, bridging the challenges and opportunities of navigating regulatory environments and leading in the healthcare advertising industry. Throughout the conversation, she offers insi...

Episode 024: Harsh Thakkar ( @harshvthakkar ) engages in a riveting discussion with RJ Kedziora ( @RJKedziora ), Co-Founder / Partner and Solutions Architect Estenda Solutions, Inc. In this episode, RJ uncovers the ins and outs of blending clinical information with imaging data, especially for patients with chronic conditions like diabetes and hypertension. RJ also dives into how data management h...

Episode 023: Harsh Thakkar ( @harshvthakkar ) interviews Naveen Agarwal ( @naveenagarwal ), the Principal and Founder of Creative Analytics Solutions, LLC. Naveen highlights the importance of aligning risk management with innovation and patient well-being, contrasting it with compliance-focused approaches. He also addresses evaluating team risk appetite through diverse perspectives and facilitated...

Episode 022: Harsh Thakkar ( @harshvthakkar ) interviews Andy Robinson ( @andyrobinson2 ), Founder & CEO at GxPaaS. Andy discusses the importance of customer discovery when creating a new product and shares his experience with creating a questionnaire to gain feedback from potential customers. He also talks about the challenges of transitioning from paper to electronic systems in the life scie...

Episode 021: Harsh Thakkar ( @harshvthakkar ) interviews Monir El Azzouzi ( @melazzouzi ), Founder & CEO at Easy Medical Device. Monir emphasizes the importance of following people in the medical device industry, learning as much as possible, and providing the right vocabulary and language to build self-confidence. Monir also shares his favorite LinkedIn creators, the importance of understandi...

Episode 020: Harsh Thakkar ( @harshvthakkar ) interviews Darshan Kulkarni ( @darshankulkarni ), Regulatory and Compliance Attorney at The Kulkarni Law Firm. Darshan talks about the importance of understanding how to use AI properly. He also discusses his work in advertising compliance, which involves ensuring that companies meet the labeling requirements for their products and that their promotion...

Episode 019: Harsh Thakkar ( @harshvthakkar ) interviews Nagesh Nama ( @nageshnama ), the Chief Executive Officer at xLM. Nagesh shares his perspective on continuous validation and emphasizes the unique capabilities of his platform, which includes the generation of digitally signed PDF reports. Harsh and Nagesh discuss xLM's platform and its approach to software validation and test automation...

Episode 018: Harsh Thakkar ( @harshvthakkar ) interviews Amy Wilson ( @amydwilson ) and Cliff Berry ( @cliffordberry ), co-authors of the book Do Quality Differently, a playbook for creating more success in biopharma (or any) manufacturing. Amy Wilson and Cliff Berry explore the concepts of the black line and blue line, underscoring the importance of distinguishing between them. They highlight the...

Episode 017: Harsh Thakkar ( @harshvthakkar ) interviews Vivek Thakkar ( @vivekbthakkar ), the Senior Digital Health Consultant at Biologics Consulting Vivek emphasizes the importance of validating AI-based software in clinical settings to ensure safety and efficacy. He also discusses the challenges of continuous improvement in algorithms and the need for a predetermined change control plan. Harsh...

Episode 016: Harsh Thakkar ( @harshvthakkar ) interviews Dharti Pancholi ( @dhartipancholi ), the Founder and Chief Executive Officer at Omni Consulting Services Dharti discusses her journey in starting her own consulting firm, her experience in both consulting and user-side companies, and her thoughts on recruitment and AI technology. Harsh and Dharti also discuss the importance of finding the ri...

Episode 015: Harsh Thakkar ( @harshvthakkar ) interviews Greg Hutchins ( @greghutchins ), the Founder of Quality + Engineering and Founder & Director of Certified Enterprise Risk Manager® (CERM) Academy. Greg Hutchins provides examples of unintended bias in AI systems and the challenge of monitoring and managing AI systems to ensure that they are fair, equitable, and transparent. Harsh and Gre...

Episode 014: Harsh Thakkar ( @harshvthakkar ) interviews Giovanni Lauricella ( @giovannilauricella ), the Co-Founder & Managing Partner at Lifeblood Capital and Board Member & Investor at Vivifi Medical. Giovanni emphasizes the need for entrepreneurs to understand their audience and to have a viable product that solves a problem. He also stresses the importance of being a good storyteller...

Episode 013: Harsh Thakkar ( @harshvthakkar ) interviews Marcus Emne ( @marcusemne ), the Chief Executive Officer at Hoodin . Marcus explains how Hoodin's platform helps users gather specific data by monitoring keywords, regulations, and standards from selected sources. He also mentions the importance of AI in the industry and how it can help professionals be more efficient and get more infor...

Episode 012: Harsh Thakkar ( @harshvthakkar ) interviews Aaron Snyder ( @aaron-snyder-mscgmp ), the Head of Quality at Fresenius Kabi and a lead faculty and trainer for FDA and industry professionals at AAMI. Aaron touches on the challenges of making regulatory training engaging and interesting, and the importance of understanding the difference between quality and compliance. Harsh and Aaron disc...