156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc.


On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the challenges posed by longer-acting drugs, higher viscosities, and large injection volumes. Laxman also discusses his transition from large corporations to startups and the multifaceted nature of scaling up projects. 00:00 Introduction to the Combinate Podcast 00:56 Understanding the Intersection of Medical and Pharmaceutical Industries 02:56 Challenges in Medical Devices and Pharmaceuticals 03:22 Governance and Risk Management in Healthcare 08:13 Transitioning from Big Pharma to Startups 15:46 Trends in Injection Delivery Systems 28:38 Challenges in Home Administration and Sustainability 31:07 Scaling Up in the Pharmaceutical Industry 32:47 Conclusion and Contact Information


Laxman Halleppanavar is currently the Head of Portfolio Strategy and Management at Credence MedSystems, leading the Injectable Device Portfolio Strategy and Management team for internal and external customer endeavors. Previously, Mr Halleppanavar was the Director - PharmSci Technical Team Lead at Pfizer. He came to Pfizer upon its acquisition of Hospira where Mr Halleppanavar was responsible for combination product development from early-stage development to manufacturing scale up leading to commercial launch. Prior to Pfizer, Mr Halleppanavar was the Program Manager at GE Healthcare responsible for development, manufacturing, and commercialization of multiple medical device/patient monitoring platforms namely, patient worn devices, blood pressure cuffs, bedside monitoring devices, networked central & remote monitoring stations.

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Avsnitt(247)

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances a...

3 Juni 11min

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.The core question behind ICH Q12 is simple: once a ...

27 Maj 10min

239 - ICH Q11 in 6 Minutes

239 - ICH Q11 in 6 Minutes

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with...

20 Maj 6min

238 - 6 Audit Strategies Every Auditor Should Know

238 - 6 Audit Strategies Every Auditor Should Know

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...

13 Maj 10min

237 - ICH Q10: The Pharmaceutical Quality System

237 - ICH Q10: The Pharmaceutical Quality System

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style...

6 Maj 8min

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...

29 Apr 12min

235 - ICH Q8: How Pharmaceutical Development Actually Works

235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines...

22 Apr 10min

234 - ICH Q7: The GMP Framework for API Manufacturing

234 - ICH Q7: The GMP Framework for API Manufacturing

In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read ...

15 Apr 13min

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