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PODCAST

The Life Science Rundown

The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.

science life sciences

All Episodes

00:41:35

Quality Metrics that Matter with Kimberly Wallbank

The Life Science Rundown ·

2024/08/19

The FDA Group's Nick Capman sits down with quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences industry.Discussion points include: Quality vs. Quantity in Metrics: Kimberly emphasizes the importance of focusing on meaningful metrics rather than simply tracking throughput. Aligning Metrics with Business Goals: Kimberly discusses how to connect quality metrics to financial impacts and overall

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00:30:35

Applying AI in the Life Sciences with MasterControl's...

The Life Science Rundown ·

2024/07/15

The FDA Group's Nick Capman sits down with Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry.Discussion points include: AI Applications in Life Sciences: Matt outlines the broad spectrum of AI applications, from early-stage drug discovery to post-market analysis of customer feedback and adverse events. Risk-Based Approach to AI: Matt emphasizes the importance of applying a risk-based approach to AI

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00:32:55

Navigating Challenges in Raw Material and Finished...

The Life Science Rundown ·

2024/07/03

The FDA Group's Nick Capman sits down with Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufacturers.They discuss the critical challenges and solutions for storage in the life sciences industry, particularly for manufacturers experiencing rapid growth. Discussion points include: Understanding Storage Challenges: Eric explains the common storage issues that arise as life science manufacturers

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00:55:00

Building and Leading Effective Quality Assurance...

The Life Science Rundown ·

2024/06/20

The FDA Group's ⁠Nick Capman⁠ sits down with ⁠Aaron Snyder⁠, the Vice President of Quality Assurance at Allotex, where he oversees the development and implementation of quality systems for medical devices and pharmaceuticals.They discuss the critical elements of building and leading a successful QA team in the life sciences industry. Discussion points include: Recognizing the Need for Change: Aaron explains how to identify early signs of strain in the quality system and the importance of

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00:50:33

The Pharma Startup Playbook: Advice from the Field...

The Life Science Rundown ·

2024/06/18

The FDA Group's Nick Capman sits down with Tagg McGurrin, who most recently served as the President and Chief Business Officer (COO/CFO) at Neumentum, Inc., where he led corporate strategy, capital markets, corporate financing, accounting, legal, investor relations, and business development. They discuss the critical elements of planning, governance, and capital access necessary to build a strong foundation for a pharmaceutical startup in today’s economic environment. Discussion points

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00:28:37

Navigating FDA Regulations for SaMD AI and Machine...

The Life Science Rundown ·

2024/05/15

The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the dental diagnostic market.Discussion points include: The Regulatory Landscape for AI in Dental Diagnostics: Adam

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00:18:36

Crafting Quality Systems for Each Phase of Drug...

The Life Science Rundown ·

2024/04/30

The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing. With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of

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00:47:25

Leading Through Transition: Strategic Insights from...

The Life Science Rundown ·

2024/04/01

The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director). They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transition, such as layoffs or department closures. Discussion points include: » Stephen's transition due

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00:44:47

Real Talk on Remote Leadership with Nick Klingensmith

The Life Science Rundown ·

2024/03/29

The FDA Group's Nick Capman sits down with Nick Klingensmith, a four-time cancer survivor, motivational speaker, and mindset coach. They discuss the challenges of remote work, especially the disconnect between leadership, management, and frontline employees, and how it affects company culture and employee engagement.Key points discussed include: Klingensmith's journey from sales in the telecom and logistics industries to becoming a motivational speaker and coach, emphasizing resilience

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00:27:36

Audit and FDA Inspection Readiness Best Practices...

The Life Science Rundown ·

2024/02/19

The FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries.Discussion points include: The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner. The complexities and confusion surrounding QMS integration

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00:17:04

Mastering the TMF: Ensuring GCP Compliance and...

The Life Science Rundown ·

2024/02/05

The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance. Discussion points include: The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance. The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for

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00:40:15

The Startup's Guide to Setting Up Cell Therapy...

The Life Science Rundown ·

2024/01/18

The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups. Discussion points include: » Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials. » Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time. » The

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00:53:38

A Blueprint for Quality Culture with Vincent Cafiso

The Life Science Rundown ·

2023/12/19

The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise. Discussion points include: » The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of

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00:52:14

An FDA Inspection Survival Guide with Jonathan Wacks

The Life Science Rundown ·

2023/12/14

The FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections. Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic assemblies, and supply chain management. Discussion points include: » The importance of a robust QMS and

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00:21:26

Clinical Data Standards in Focus: SDTM Compliance...

The Life Science Rundown ·

2023/12/12

The FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes. Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new technologies for clinical trials. Discussion points include: » The transition from manual processes to

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01:08:52

The Link Between Quality Culture and QA Communication...

The Life Science Rundown ·

2023/11/15

The FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs. Discussion points include: » The crucial role of a Quality culture, especially in biopharma and clinical settings. David

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00:45:56

Mastering Medical Device Supplier Management with...

The Life Science Rundown ·

2023/11/09

The FDA Group’s CEO, Nick Capman, sits down with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of supplier management in the medical device industry. Discussion points include: » Paul's journey from a supplier quality engineer to Vice President of Quality and his experience across various company sizes in the medical device sector. » The critical importance of supplier management in the medical device industry, highlighting the necessity for clear

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00:37:30

Recent FDA Enforcement Trends with George Toscano

The Life Science Rundown ·

2023/11/03

The FDA Group’s CEO, Nick Capman, sits down with George Toscano, President & CEO of Toscano Consulting Group, to explore recent FDA enforcement trends and the nuances of the FDA inspection process, especially in light of the COVID-19 pandemic's impact on the industry. Discussion points include: » George's extensive background in the pharmaceutical, biologics, and medical device industries, highlighting his transition from an analytical development chemist to a consultant specializing in

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00:53:40

Growing Your Career in RA/QA with Jessica Smith...

The Life Science Rundown ·

2023/11/01

The FDA Group’s CEO, Nick Capman, sits down with Jessica Smith Beaver, PhD, President & CEO of Verinetics, to explore various career trajectories within the quality and regulatory space in the life science industry, the advantages and challenges of different paths, and the crucial role of personal reflection in career development. Discussion points include: » Dr. Beaver's journey from a pharmacist to a contributing scientist in the pharmaceutical industry, and her eventual transition into

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00:39:26

Drug Delivery System Innovation and Leadership with...

The Life Science Rundown ·

2023/10/20

The FDA Group’s CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field. Discussion points include: » Dr. Knowles's transition from a physician

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64 results

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