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 experience working with regulatory agencies in the US, Europe, and Asia, highlighting the importance of adapting to different regulatory requirements.

Throughout the podcast, Harsh and John share their wisdom on various aspects of the life sciences industry, including communication, technology's evolving role, and intriguing predictions for the future. John also delves into his personal journey, sharing helpful tips on adapting to new work environments, a journey that took him from the East Coast to the West Coast. He encourages listeners to embrace new experiences, maintain an open mind, and focus on continual improvement, emphasizing that these principles are keys to success.

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Links:

*Q1 Associates LLC
*Would you rather watch the video episode? Subscribe to full-length videos on our YouTube channel.

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Show Notes:

(7:45) Adapting to new countries for work. 

(11:19) International travel and work culture differences. 

(16:46) Cultural differences in work environments. 

(22:52) Regulatory research and agency priorities. 

(27:39) Leadership, communication, and global work experiences. 

For transcripts, check out the podcast website - www.lifesciencespod.com

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 insights on navigating healthcare regulations, digital nomadism, and innovation in a tightly regulated field based on her personal journey.

Harsh and Kamya discuss the realities and potential of the digital nomad trend in healthcare. They offer a comprehensive view of how remote work impacts business operations, team management, and industry advancements. In this ever-evolving field, they also explore tactics and strategies to remain competitive and relevant.
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Links:

*Doceree Website
*Would you rather watch the video episode? Subscribe to full-length videos on our YouTube channel.

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Show Notes:

(4:03) Data challenges in healthcare marketing. 

(7:54) Regulations and innovation in the healthcare industry. 

(16:00) Remote work, digital nomadism, and emerging trends in healthcare marketing. 

(22:04) Marketing trends and personal growth through reading. 

For transcripts, check out the podcast website - www.lifesciencespod.com

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 has evolved and the exciting opportunities AI brings to healthcare. 

Harsh and RJ also explore the regulatory landscape surrounding AI in healthcare, discussing the EU and FDA's risk-based approach towards medical devices and AI applications. They emphasize the importance of transparency, data governance, and addressing biases in AI training datasets to ensure the technology serves a diverse population effectively.

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Links:

*Estenda Solutions, Inc. Website
*Upcoming HLTH Conference in Las Vegas
*Would you rather watch the video episode? Subscribe to full-length videos on our YouTube channel.

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Show Notes:

(5:45) Using AI in healthcare with examples from Joslin Diabetes Center. 

(10:47) AI in healthcare, data quality, and regulations. 

(15:59) AI in healthcare, data bias, and integration.

(24:31) Digital health data analysis and expertise needed.

(29:19) AI security challenges and solutions.

For transcripts, check out the podcast website - www.lifesciencespod.com

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 discussions to achieve consensus.

Harsh and Naveen delve into the dynamics of risk management within the medical device industry and explore the balance between compliance and courage-driven patient focus. They highlight the importance of streamlined documentation and suggest using diverse perspectives to resolve differences in risk assessment among teams.

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Links:

* Let's Talk Risk! Newsletter
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(1:32) Why does risk management become so difficult for people?

(6:41) Qualifying for the Boston Marathon Analogy.

(12:32) Understanding the documentation requirements.

(17:53) Assessing risk appetite of people involved in risk assessment.

(22:24) Practical tips on how to manage the conversations.

(24:59) Managing risk with new technology and regulations.

(29:41) Risk management and human error.

(34:47) How do you get started creating courses?

For transcripts, check out the podcast website - www.lifesciencespod.com

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 sciences industry and the need for intuitive software to facilitate this transition.

Harsh and Andy also discuss the importance of finding an internal champion when pitching a product, highlighting the critical role of building relationships with key stakeholders within an organization.

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Links:

* Bits In Bio
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(6:31) Paper vs. Electronic QMS implementation.

(11:16) Finding an internal champion.

(19:49) What is a no-code app?

(23:48) How Andy scrapped the idea of building the app.

(29:30) Validate in 4.0 working group.

(35:31) What if part 11 doesn't exist?

For transcripts, check out the podcast website - www.lifesciencespod.com

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 understanding medical device regulations, and the challenges he faces in consulting.

Harsh and Monir discuss the importance of staying up-to-date with medical device regulations and the challenges that come with consulting in the life sciences industry. Harsh and Monir also discuss the importance of building a personal brand and give tips on leveraging social media to grow a business.

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Links:

* Easy Medical Device
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(7:29) How to be an online marketer. 

(15:25) What Monir loves about being a consultant.

(19:34) How to use LinkedIn to help your clients. 

(24:50) Advice on medical device classifications.

(29:41) How do you track and share information with your audience?

(34:49) The importance of content marketing.

(37:56) Advice for people just starting out in the industry.

For transcripts, check out the podcast website - www.lifesciencespod.com

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 promotional materials are compliant with FDA and FTC regulations.

Harsh and Darshan discuss various topics such as the use of AI in education and legal work as well as the challenges and risks associated with using AI-generated content in legal documents and journalism.

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Links:

* DarshanTalks
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(6:18) AI is not a good writing tool.

(8:49) The problem with lawyers and judges using ChatGPT.

(14:04) The difference between label and labeling.

(18:43) The difference between a drug and a food product.

(21:53) Dealing with regulatory inspections and the FDA.

(26:56) Responding appropriately to the FDA.

(29:47) Dealing with inspections and compliance.

For transcripts, check out the podcast website - www.lifesciencespod.com

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, as well as challenges related to incorporating AI technology and the importance of data governance

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Links:

* Continuous Validation
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(3:28) The concept of continuous validation. 

(7:12) What happens if you already work on the platform?

(11:32) The production pipeline for Vmware.

(15:00) Manual vs. AI. 

(19:27) Log analysis and audit trails.

(25:59) Man vs. Machines

(30:48) Data Governance and audits.

For transcripts, check out the podcast website - www.lifesciencespod.com

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 need to take a comprehensive view of the system, rather than solely focusing on human error.

Harsh, Amy, and Cliff stress the importance of building fluency in the vocabulary and concepts of human and organizational performance in order to enable the adoption of new practices and processes within an organization. The podcast also touches on practical examples from their careers and the challenges of writing their book, Do Quality Differently.

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Links:

* Do Quality Differently website and blog
* Get your copy of the book on Amazon
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(3:09) The process of writing the book.

(8:09) How can companies ask better questions around human performance?

(12:27) Understanding the black and blue line. 

(17:24) Building the necessary fluency to enable adoption. 

(20:08) The integration of human and organizational performance into the book.

(26:23) Batch losses and how to prevent them.

(30:22) One-line mission of "Do Quality Differently".

For transcripts, check out the podcast website - www.lifesciencespod.com

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 and Vivek also discuss the role of AI in healthcare, the challenges of regulating AI in medical devices, and how companies can go about validating AI-based software as medical devices. They also touch on the potential for AI to generate outlines for regulatory submissions.

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Links:

* MedPaLM
* FDA draft guidance on predetermined change control plan
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.

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Show Notes:

(3:05) What are the regulations around AI?

(8:59) Clinical research and clinical trials.

(14:15) Regulatory Intelligence and regulatory submissions.

(17:42) Can AI be used to write regulatory submissions?

(22:55) The importance of humans in the loop in healthcare.

(32:21) Will AI take your job? 

For transcripts, check out the podcast website - www.lifesciencespod.com