Podcasts about qbd

Join host Dion McLeod as he chats with bestselling author Ben Miller about "Diary Of A Puss In Boots", QBD's Children's Book of the Month for May!In this incredible story, Mittens knows a cat of his calibre should be living it up in a castle, and he's determined to make his dream reality.  His master certainly isn't going to be much help, so it's up to Mittens to charm the king and queen, defeat a shapeshifting ogre, and outwit the princess's own cunning kitty. But first things first, he has his eye on a very fetching pair of boots...Purchase your copy of “Diary Of A Puss In Boots” at your local QBD Books store or online today: https://www.qbd.com.au/diary-of-a-puss-in-boots/ben-miller-elisa-paganelli/9781398548473/ Follow along with QBD Books here: QBD Books on Facebook: www.facebook.com/qbdbooks QBD Books on Instagram: www.instagram.com/qbdbooks QBD Books on TikTok: www.tiktok.com/@qbdbooksaustralia

What's the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let's Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.Whether you work in drug development, medical devices, or the space in between, this episode will help you:-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)-See how each system addresses user needs, therapeutic effects, and process control-Apply both systems effectively in combination product developmentTimestamps:00:00 – Intro: Why Compare QbD and Design Controls?01:31 – Philosophical Differences: Process vs. Product Control03:10 – Practical Examples: Drugs vs. Devices05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)15:39 – Final Takeaways: How to Use Both in Combination ProductsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.------------------------ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits

QBD's host Victoria Carthew speaks with broadcaster and author Jane Caro about her latest suspenseful thriller, “Lyrebird”.Twenty years ago, ornithology student Jessica Weston filmed a lyrebird mimicking the dying screams of a woman in the Barrington Tops National Park. Terrified, she took her recordings to the Maitland police to report a murder. Despite support from newly minted detective, Megan Blaxland, no one was reported missing in the area and no body found, so Jessica's claims were mocked and dismissed. Twenty years later, a body is unearthed. Exactly where Jessica said it would be. Jessica and Megan are appalled that the dead woman, whose last moments were heard by only a lyrebird and her killer, has been ignored and forgotten for so long. They both feel they have let the victim down, and are determined to find the killer, whatever it takes. What they do not realise is it is not just their own lives that may be in danger.Purchase “Lyrebird” from your local QBD Books store or online today: https://www.qbd.com.au/lyrebird/jane-caro/9781761471537/ Follow along with QBD Books here: QBD Books on Facebook: www.facebook.com/qbdbooks QBD Books on Instagram: www.instagram.com/qbdbooks QBD Books on TikTok: www.tiktok.com/@qbdbooksaustralia

Join host Victoria Carthew as she chats with author Geoff Parkes about his debut novel, “When the Deep, Dark Bush Swallows You Whole”, which was QBD's Fiction Book of the Month in February 2025.It's January 1983. During his university summer break, Ryan Bradley returns to the remote town of Nashville in New Zealand's rugged King Country. It's a bittersweet trip- he's working long, punishing hours as a woolpresser, he needs to sell his late mother's house, and he's increasingly feeling like an outcast in his childhood town. But mostly he's haunted by memories of Sanna Sovernen, a Finnish backpacker and his secret lover, who worked with him in the shearing shed the summer before - then vanished without trace. Now Sanna's sister Emilia has arrived from Finland, determined to get answers - and as he's the workmate who reported Sanna missing, she wants Ryan's help. Because Emilia knows her sister was not the first female traveller in the area to disappear.Purchase your copy of “When the Deep, Dark Bush Swallows You Whole” at your local QBD Books store or online today: https://www.qbd.com.au/when-the-deep-dark-bush-swallows-you-whole/geoff-parkes/9781761349287/Follow along with QBD Books here: QBD Books on Facebook: www.facebook.com/qbdbooks QBD Books on Instagram: www.instagram.com/qbdbooks QBD Books on TikTok: www.tiktok.com/@qbdbooksaustralia

Join host Victoria Carthew as she chats with Andrea Clarke about her brand-new book "Adapt", which was QBD's Non-Fiction Book of the Month in March 2025.After the global pause in 2020, we returned to a world that feels faster, looser, and less structured – our professional boundaries have been erased, social and cultural norms are shifting rapidly, and at the same time, we're facing profound developments in artificial intelligence. We're facing more change more often, and we're applying a mindset that is simply outdated and no longer fit-for-purpose.In Adapt, work futurist and award-winning author Andrea Clarke offers a fresh perspective. Rather than retreat from change or resist it, Clarke argues that we must engage with it continuously – learning not just how change unfolds, but how we can shape it. With four simple yet powerful principles, she shows how to move from merely reacting to change to anticipating and influencing the future. This book reframes change as a powerful playbook for growth, opportunity, and lasting transformation.Purchase your copy of “Adapt” at your local QBD Books store or online today: https://www.qbd.com.au/product/9781761632433/Follow along with QBD Books here: QBD Books on Facebook: www.facebook.com/qbdbooksQBD Books on Instagram: www.instagram.com/qbdbooksQBD Books on TikTok: www.tiktok.com/@qbdbooksaustralia

QBD's host Victoria Carthew chats with crime thriller fiction author John McMahon about his latest novel, “Head Cases”.Gardner Camden is a puzzle and riddle enthusiast, which makes him the perfect fit for Patterns and Recognitions (PAR) unit of the FBI, a team of five brilliant but misfit agents who are too talented, too extraordinary to fire from the Bureau. When a serial killer starts targeting other serial killers from Gardner's previous cases, and seems to be one step ahead of the FBI at every turn, only the PAR team has a chance of stopping him before it's too late.Purchase your copy of “Head Cases” from your local QBD Books store or online today: https://www.qbd.com.au/head-cases/john-mcmahon/9781460766255/Follow along with QBD Books here: QBD Books on Facebook: www.facebook.com/qbdbooks QBD Books on Instagram: www.instagram.com/qbdbooks QBD Books on TikTok: www.tiktok.com/@qbdbooksaustralia

Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.Key Takeaways:Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring product consistency—a game-changer in the industry's quest for reliability.By adopting a phased approach to process development rooted in QbD, companies can streamline experimentation, minimize resource expenditure, and accelerate time-to-market, amplifying efficiency by up to 40%.Embracing innovation, such as machine learning and digitalization, holds the key to unlocking new horizons in CMC development, paving the way for a future where creativity and regulatory compliance converge seamlessly.Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.Connect with Matthias Müllner:LinkedIn: https://www.linkedin.com/in/matthias-muellnerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Himanshu Gadgil, CEO at Enzene Biosciences. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Himanshu, covering: How a personal tragedy led him from the US to India on a mission to make an impact Shifting from a technical to commercial focus to launch several biosimilars in India and beyond Being at the inception of a big pharma biotech spin-out focused on building a platform of innovation that contributes to society Taking its cost-effective, continuous manufacturing platform from India to the US via a CDMO vertical focused on novel biologics Dr. Himanshu Gadgil serves as the CEO at Enzene Biosciences Ltd. Under his services, Enzene has grown from a start-up biotech to a multi-vertical, multi-site product development and manufacturing service-based biopharmaceutical company. Prior to Enzene, he worked as the Sr. Vice President at Intas Pharmaceutical Ltd. where he was instrumental in turning around the commercial product pipeline by launching several biosimilar products in multiple geographies. During his stint in the US, he led different facets of process and product development at Amgen, spearheading IND, BLA, and Market authorizations of various blockbuster biotech products. At the inception of his career, he joined Waters Corporation, where he pioneered the development of QBD, enabling multi-attribute methodologies for biopharmaceutical characterization. Himanshu holds a Ph.D. in Biochemistry from the University of Tennessee and is a passionate scientific leader and innovator with over 50 publications and patents. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

Are the escalating costs and intricate technical hurdles of cell therapy development causing you stress?Tune into this insightful podcast episode featuring Shin Kawamata, CEO of Cyto-Facto Inc. in Kobe, Japan, who shares his expertise and innovative solutions to these pressing issues in the cell therapy industry.Discover how to streamline your manufacturing processes, reduce costs, and enhance product quality, transforming the way you approach cell therapy development.Key Takeaways:Revolutionize Cell Manufacturing: Shin outlines how Cyto-Facto is pioneering a new business model, merging public sector support with commercial viability. Learn how this shift can accelerate the growth of the cell therapy industry.Leverage QbD in Living Systems: Discover why Quality by Design (QbD) strategies are imperative for cell therapy manufacturing.Scale Up Efficiently: Shin shares valuable insights on the challenges in scaling up cell therapies and the importance of automation, digitalization, and QbD in streamlining manufacturing processes, reducing costs, and enhancing product quality.Join us as we uncover the latest advancements, challenges, and Shin's vision for the future of the cell therapy industry.Connect with Shin:LinkedIn: www.linkedin.com/in/shin-kawamata-84647579Website: www.cytofacto.com/engGet Cell and Gene Therapy Training:Shin Kawamata's offer: The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory: https://www.isctglobal.org/resources/training-programs/workforce-development-in-biomanufacturing401/workforce-development-in-biomanufacturingLearn more about the upcoming Cell and Gene Therapy Training program for the Asia Pacific region: contact David at hello@bruehlmann-consulting.com

This week we speak with passionate wife, mother and grandmother, Robyn Everingham, who has made the commitment to being a ‘Super Alive Centenarian'. She's been researching, exploring and trying out ways to improve her physical and cognitive health with apps and tech. And today we talk about her journey and very personal lessons learned along the way about measuring key health metrics, being curious in her use of health apps; and having a good attitude to her health and longevity. Here's some key points in our conversation. Please note, you can listen to this show as a podcast, but it is also available to watch on Youtube! 3.20  Tell us about your curiosity and your sense of purpose. Robyn talks about her journey to prioritise personal development in every stage of life. 3.51 Life is about squeezing the juice out at every angle according to Robyn4.20 Robyn wants to live to 100. She talks about why she believes she can and what she's doing to achieve this. And we find out WHY Robyn wants this. 5.45 Robyn's three keys to enable her to live to 100 and talks about her passion for fitness and hiking6.00 passion for hiking around the world, and her favourite trails in the US and the UK, including her recent trip to the UK hiking. 7.10 Robyn discusses what led her to wanting to understand longevity better7.20 How she got into riding on Peloton, and the competitiveness and inspirational community she sees on the Peloton app that keeps her hungry. 9.15 Her husband's health scare and atrial fibrillation and how they have led her on a journey to better monitor heart health metrics, and what she's learned personally about it over time. 10.00 What is atrial fibrillation and what has Robyn learned about measuring and monitoring as the partner of someone who suffers it. 11.15 Heart rate variability (HRV) and measurement, what it is and how to measure it in real life and why Robyn monitors that for her own health. 12.25 Her own learnings about HRV and stress and keeping her system in homeostasis. 14.50 Her experience with intermittent fasting. 15.30 Robyn is concerned about strength as she ages. And she tells us what she does regularly to try and prevent a decline in her strength and fitness. She also talks about the differences between hers and her husband's health programs. 17.40 What does Robyn do for cognitive health. She discussed why she chose Lumosity to test out as an app and how she's used it to improve her problem solving skills.  You can read more about this on this article on Robyn's blog Age with Attitude here. 20.00 We discuss how long Robyn has been working on her health and longevity and trying out tech. 20.44 The things she's learned form others and international markets about the use of functional health tech globally, and her real experience of monitoring her own numbers. 21.20 What does Robyn measure regularly? HRV, VO2 Max, Body Composition and what is she learning. 23.25 - Our Fast Five!Important Disclaimer: The information provided in this video/podcast is for educational and entertainment purposes only and should not be considered as medical or financial advice. Viewers are advised to consult with qualified professionals for personalized guidance on medical or financial matters. We do not assume any responsibility for actions taken based on the content of this video. Please seek expert advice from licensed medical practitioners or financial advisors for your specific needs.How to Have an Epic Retirement is now in bookstoresIt's been an exciting week. This week we've sold Amazon Australia out of books! The team at Hachette assure me they'll be back in stock within days though. And in the meantime, you can place your order through Booktopia here or pick up a copy at any major bookseller, including Big W, Collins, QBD, Dymocks, Harry Harthogs and many other stockists which you can see on my website here. Find out more about How to Have an Epic Retirement, the book, here. THIS WEEK'S EPIC RETIREMENT NEWSLETTER - IN CASE YOU MISSED ITLAST SUNDAY'S SYDNEY MORNING HERALD ARTICLECan you afford to retire now? Whether you're coming up to retirement or envisioning it in your distant future, the prospect can be daunting – often due to one issue: money.As we approach the years when retirement is the logical next step, the question on everyone's mind is, “can I afford to retire now?” I'm going to take a deep dive into how we answer that question, as individuals, because the decision is a personal one that requires you to think about and understand the crucial aspects of retirement readiness.Read the whole article here in the Money Section of the Sydney Morning Herald, The Age and The Brisbane Times. Tell me your stories, join our communityI'm super-keen to tell real stories of people living their own epic retirements. If you have a story to tell, please reach out. I'd love to chat. If you haven't already, join our Facebook group to be a part of interesting conversations about retirement, with other pre and post retirees. Media coverage of How to Have an Epic RetirementI've been battling to keep up with the posting of stories that have been in the media in the last week or two about How to Have an Epic Retirement. I have truly been blessed with the most enormous media interest. Many thanks to all the media who have talked about the book. If you'd like to listen to some of the radio shows that have featured the book, or see our appearance on the Today Extra, or read the excerpt that featured in The Sydney Morning Herald and The Age, simply visit our website here. I'll keep adding stories and clips as they come in. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.epicretirement.net

There are many hurdles to streamlined, cost-effective manufacturing of cell and gene therapy products. To help address this, the Alliance for Regenerative Medicine published A-Cell, a case-based guidebook to help drug developers incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs. A-Cell builds on previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene), bringing best practices in CMC to a case study of a CAR-T therapy manufacturing. This is the second of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. This episode covers key questions around conducting a risk assessment and best practices for product and process characterization for cell therapies.

There are many hurdles to streamlined, cost-effective manufacturing of cell and gene therapy products. To help address this, the Alliance for Regenerative Medicine published A-Cell, a case-based guidebook to help drug developers incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs. A-Cell builds on previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene), bringing best practices in CMC to a case study of a CAR-T therapy manufacturing. This is the first of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. The first podcast episode explores quality by design principles and the importance of the quality target product profile.

In this podcast, we talked with Parth Trivedi, Business Development Manager, Pall Corporation, about the importance of implementing a Quality by Design strategy for AAV product manufacturing and specific key steps for successful assessment. We began by talking about the importance of Quality by Design (QbD) in AAV product manufacture and how this pertains to the regulatory landscape. Parth explained that there have been several recent regulatory approvals of gene therapy products, but in 2020 there were also regulatory setbacks. These setbacks mostly involved lack of sufficient data in the chemistry, manufacturing, and controls documentation or CMC. This led Pall to create a framework for QbD assessment and implementation for AAV based products. Parth pointed out that for over a decade the FDA has advocated for a QbD approach in pharmaceutical manufacturing and there is good documentation and regulatory guidance around this approach. QbD is heavily based on prior knowledge and detailed understanding of both the product and the process variables. Most of the industry's experience in QbD has been in traditional drugs and now we need to learn and apply these principles to gene therapy products. Implementing Quality by Design I then asked Parth if he could talk a bit more about what companies should consider before implementing a QbD approach. He said that QbD relies on prior knowledge and detailed understanding of the product and the process, so prior to implementation, it is important to collect and generate information data, analyze it and interpret any process changes that have an impact on the product. Thus, it is important to understand the quality target product profile (QTPP) and define it, focusing on specifications around the safety, purity, and efficacy of the drug product. A Framework for QbD Assessment for AAV Products I then asked Parth if he could discuss a recent white paper that Pall released, “Quality by Design (QbD) for Adeno-Associated Virus (AAV) - A Framework for a QbD Assessment for AAV Products Within the Chemistry Manufacturing and Controls (CMC) Documentation.” I asked him to walk listeners through the four steps that the Pall team identified in creating a risk- and science-based QbD assessment. Identification of CQAs based on QTPP and Risk Assessment Parth explained that in this step it is important to focus on the empirical view, starting with a deep understanding of product knowledge and process knowledge. The product knowledge is where you should focus on the QTPP and the critical quality attributes (CQAs) and the risk associated with it. He went on to say that how we identify CQAs depends on the drug substance or drug product's physical, chemical, biological, and related characteristics, which will eventually impact the quality, purity, activity, efficacy, and safety of the drug. Another important consideration is impurity profiling, there are three categories an impurity can be profiled into - product related impurities, process related impurities and adventitious agents. There are variations in the impurities, especially with upstream vs. the downstream. Specifically focusing on the AVV process on the upstream side, there are different processes that create different impurities, for instance - transfection process vs infection, adherent vs suspension, and mammalian cell vs. insect cell culture types. These parameters and the method of manufacturing will have its own impact on the process related impurities and product related impurities. From there, it is important to know what the target product profile is and what the quality attributes are. Examples of common quality attributes are non-infectious AAVs, empty capsids, aggregated AAVs, and encapsulated host cell DNA. The next step is to ask which of these are critical attributes and this can be determined using a risk assessment guided by the ICH guidelines. Essentially looking at each attribute and assessing the risk assoc...

If you have been in the industry for a while, you'll maybe remember all the excitement around using gesture technology to control screens. That was followed by the letdown of how crappy and feeble these gesture-driven touchless working examples turned out to be. Like just about everything, the technology and the ideas have got a lot better, and there is a lot of renewed discussion about how camera sensors, AI and related technologies can change up how consumers both interact ... and transact. Ultraleap is steadily developing a product that lets consumers interact with and experience digital displays using sensors and, when it makes sense, haptic feedback. The company was formed in 2019 when Ultrahaptics acquired Leap Motion, and the blended entity now operates out of both Silicon Valley and Bristol, England. Leap Motion was known for a little USB device and a lot of code that could interpret hand gestures in front of a screen as commands, while Ultrahaptics used ultrasound to project tactile sensations directly onto a user's hands, so you could feel a response and control that isn't really there. Or something like that. It's complicated stuff. I had an interesting chat with Saurabh Gupta, who is charged with developing and driving a product aimed at the digital OOH ad market, one of many Ultraleap is chasing. We got into a bunch of things - from how the tech works, to why brands and venues would opt for touchless, when touchscreens are so commonplace, as is hand sanitizer. TRANSCRIPT Hey, Saurabh, thank you for joining me. Let's get this out of the way. What is an Ultraleap and how did it come about?  Saurabh Gupta: Hey, Dave, nice to be here. Thank you for having me. Ultraleap is a technology company and our mission is to deliver solutions that remove the boundaries between physical and digital worlds. We have two main technologies. We have a computer vision-based hand tracking and gesture recognition technology that we acquired and on the other side of the equation, we have made a haptic technology using ultrasound. The whole premise of how we came about was we started out as a haptics company and that's what our founder and CEO, Tom Carter, built when he was in college, and it was a breakthrough idea for us to be able to deliver the sense of touch in mid air using ultrasound was how we started, and to be able to project haptic sensations in mid-air, one of the key components of that was, you need to understand where the hands are in space and for that we were using computer vision technology by Leap Motion to track and locate user's hands in space, and we had an opportunity to make an acquisition, and some of your listeners may already know about Leap Motion. Leap Motion has been a pioneer in gesture based hand tracking technology since 2010. They've got 10 plus years of pedigree in really refining gesture based hand tracking models. So we had an opportunity to purchase them and make an acquisition in 2019, we completed the acquisition and rebranded ourselves to Ultraleap. So that's how we started. As stated in our mission, it's all about focusing on user experience for the use cases of how users are interacting with their environment, and that environment could be a sort of a 2D screen in certain applications, the application that we'll probably talk about today, but also other aspects of augmented reality and virtual reality, which are on the horizon and our emerging technologies that are gaining more ground. So that's the central approach. How can we enhance the interactivity that users have with a physical environment, through an input and an output technology offerings with gesture as input and haptics being the output?  The whole gesture thing through the years has been kind of an interesting journey, so to speak. I can remember some of the early iterations of Microsoft Kinect gesture, sensors, and display companies and solutions providers doing demos showing, you can control a screen by waving your hand, lifting it up and down and this and that, and I thought this is not going to go anywhere. It's just too complicated. There's too much of a learning curve and everything else.  Now, the idea as it's evolved and like all technology got a lot better is, it's more intuitive, but it's still something of a challenge, right? There's still a bit of a curve because we're now conditioned to touching screens. Saurabh Gupta: Yeah, you're right. One of the key aspects here is that gesture has been around. There's been research that goes back to the early 90s, if not in the 80s, but computer vision technology in general has come a long way. The deep learning models that are powering our hand tracking technology today are a lot more sophisticated. They are more robust, they are more adaptable and they are able to train based on a lot of real world inputs. So what that really means is that since the computing power and the technology behind recognizing gestures has improved, a lot of that has manifested itself in a more approachable user experience, and I completely accept the fact that there is a gap and we've got 10 plus years of learned behavior of using a touchscreen. We use a touchscreen everyday, carry it in our pockets, but you also have to understand that when touch screens became prevelant, there was the type keyboard before that.  So the point that I'm making here with this is that we are pushing the envelope on new technologies and a new paradigm of interactivity. Yes, there is a learning curve, but those are the things that we are actually actively solving for: The gesture tracking technology should be so refined that it is inclusive and is able to perform in any environment, and I think we've made some really good steps towards that. You may have heard of our recent announcement of our latest hand tracking offering called Gemini. The fundamental thing with Gemini is that it's based on years and years of research and analysis on making the computer vision, deep learning models, that power that platform to be as robust, to be low latency, high yield in terms of productivity and really high initialization, which means as part of the user experience, when you walk up to an interface, you expect to use it right away. We know we can do that with touch screens, but if you put this technology complementary to an interface, what we are solving for at Ultraleap is: when somebody walks up to a screen and they put up their hand to start to interact, the computer vision technologies should instantly recognize that there's a person who is looking to interact. That's number one, and I think with Gemini, with the deep model work that we've done, we've made some good progress there. Number two, which is once the technology recognizes that a person wants to interact, now can we make it more intuitive for the person to be as or more productive than she would be with a touchscreen interface? And that's where I think we've made more progress. I will say that we need to make more progress there, but some of the things that we've done, Dave. We have a distance call to interact, which is a video tutorial attraction loop that serves as an education piece. And I'll give you a stat. We ran a really large public pilot in the Pacific Northwest at an airport, and the use case there was immigration check-in, so people coming off the plane, before they go talk to a border security agent, some people to fill out their information on a kiosk. So we outfitted some kiosks with our gesture based technology and the rest were the controls, which were all touchscreen based and over multiple weeks we ran this study with active consumers who actually had very little to no prior experience using gestures and we did this AB test where we measured the gesture adoption rate on the kiosks without a call interact, before a call to interact and after a call to interact, and it increased the gesture adoption rate by 30%, which means that it certainly is helping people to understand how to use the interface. The second stat that came from it, that at the end of the pilot, we were almost at 65% gesture adoption rate, which means almost more than 6 out of 10 people who use that interface used gesture as the dominant interface for input control, and the third piece of this was how long did it take for them to finish their session? We measured that using the gesture based interaction, the time was slightly higher than for the control group that was using a touchscreen, but it wasn't much, it was only 10% higher. Now one can look at that stat and say in a transactional setting where you know, it's going to take you 30 seconds to order a burger, adding an extra second can be a problem, but at the same time, those stats are encouraging for us to think about when we look at that as the baseline to improve from.  So if I'm listening to this and I'm trying to wrap my head around what's going on here, this is not a gesture where you're standing 3 feet away from a screen and doing the Tom cruise Minority Report thing, where you're waving your arm and doing this and that is, can you describe it? Because you're basically doing touch-like interactions and the ultrasonic jets or blasts of air or whatever are giving you the feedback to guide you, right?  Saurabh Gupta: So we've got two avenues that we have going at this from. One is for the self service type offering, so you think of check-in kiosks or ordering kiosks at restaurants or even digital wayfinding, digital directories. We are solving for those primarily led at least in the first phase led by our gesture tracking technology. So gesture being the input modality, complimentary to touch. So, what we do is we build a touch-free application, which is a ready to use application that is available today on Windows based media players or systems to convert existing touch screen-based user interfaces to gesture, but what we've done is we've made the transition a lot more intuitive and easier because what we've done is we've replicated and done a lot of research on this and replicated interaction methods or gestures you would call it. I hate to use gestures as a word, because it gets tagged with weird hand poses and things like that, people pinching and all of that. For us, it's all about how we can replicate the same usage that a typical average consumer will have when she interacts with a touch screen based interface. So we came up with this an interaction method that we call Airpush which is basically, to explain it to your listeners, it's all about using your finger and moving towards an interactive element on screen. But what happens is the button gets pressed even before you approach them based on your forward motion or interaction. Now, the smart math behind all of this is that not only do we track motion, but we also track velocity, which means that for people who are aggressive in terms of their button pressing, which means they do short jabs, we can cater for those or people who are more careful in their approach as they move towards the screen, the system is adaptable to cater to all types of interaction types, and we track all the fingers so you can use multiple fingers too or different fingers as well. So these are some of the things that we've included in our application. So that's one side. The second side is all about interactive advertising, immersion and that's where I think we use our haptic technology more, to engage and involve the user in the interactive experience that they're going to. So for self service and more transactional type use cases, we're using primarily our hand gesture technology. And for immersive experiential marketing, or even the digital out-of-home advertising type of use cases, we are leading without haptic based technology.   And you're involved on the digita, out-of-home side, right? That's part of your charge?  Saurabh Gupta: That's correct. So I lead Ultraleap's out-of-home business. So in the out-of-home business, we have both self service retail, and digital out-of-home advertising businesses that we focus on. David:. So how would that manifest itself in terms of, I am at a train station or I'm out somewhere and there's a digital out-of-home display and I go up and interact with it and you're saying it's a more robust and rich experience than just boinking away at a touchscreen. What's going on? What would be a good example of that? Saurabh Gupta: So a good example of digital out of home activations is that we've partnered with CEN (Cinema Entertainment Network) where we've augmented some of their interactive in cinema displays that are being sold from a programmatic perspective. Now the interactive piece is still being worked into the programmatic side of things, but that's one example of an interactive experience in a place based setting. The other example is experiential marketing activations that we've done with Skoda in retail malls and also an activation that we did with Lego for Westfield. So these are some of the experiences that we've launched and released with our haptics technology and on the self service side we've been working with a lot of providers in the space you may have heard of.  Our recent pilot concluded with PepsiCo where we are bringing in or trialing gestures for their ordering kiosks for their food and beverage partners. So these are some of the things that are going on on both sides in the business. David:. So for the Lego one or the Scoda one, what would a consumer experience?  Saurabh Gupta: So these are all interactive experiences. So for Lego, it was about building a Lego together. So basically using our haptic technology which obviously contains gestures as the input, moving Lego blocks and making an object that was being displayed on a really large LED screen at one of the retail outlets and in London, so a user would walk up, they would use their hands in front of our haptic device to control the pieces on the screen and then join them together and make a Lego out of it and while they're doing that, they're getting the sensation of the tactile sensation of joining the pieces and that all adds up to a really immersive, engaging experience within a digital out of home setting.  So you get the sensation that you're snapping Lego pieces together?  Saurabh Gupta: Yeah, snapping pieces together, controlling so you get the agency of control, and it's one of those sensations that gives you a very high memorability factor. I don't know whether you track the news. This was in 2019. We did actually a really extensive activation with Warner Brothers in LA, and what we did was at one of the cinemas down there for Warner Brothers' three upcoming movies, Shazam, The Curse of La Llorona, and Detective Pikachu, we added interactive movie posters using haptics in the cinema lobby, and this would complement the digital poster network that was already existing at that location, and over the course of the activation, which was around six weeks long, we had almost 150,000 people that went through the cinema and we actually did in partnership with QBD, we did a lot of analytics around what the. performance was of an interactive movie poster experience within a digital out-of-home setting and got some really great stats.  We measured a conversion rate between an interactive experience versus a static digital signage experience. The conversion rate was almost 2x, 33% increase in dwell time, like people were spending more time in front of an interactive sign versus a static sign. Attention span was significantly higher at 75%, 42% lift in brand favorability. So these are really interesting stats that gave us the confidence that haptic technology combined with gesture based interface has a lot of value in providing and delivering memorable experiences that people remember. And that's the whole point with advertising, right? That's the whole point. You want to present experiences that provide a positive association of your branded message with your target consumer, and we feel that our technology allows that connection to be made  One of the assumptions/expectations that happened when the pandemic broke out was that this was the end of touchscreens, nobody's ever going to want to touch the screen again, the interactivity was dead and I made a lot of those assumptions myself and turns out the opposite has happened. The touch screen manufacturers have had a couple of pretty good years and the idea is that with a touchscreen, you can wipe it down and clean your hands and do all that stuff. But you're at a far greater risk standing four feet away from somebody across a counter, ordering a burger or a ticket or whatever it may be.  So when you're speaking with solutions providers, end user customers and so on are you getting the question of, “Why do I need to be touchless?” Saurabh Gupta: Yeah, it's a fair point, Dave, and let me clarify that. Look, from our perspective, we are focusing on building the right technology and building the right solutions that elevate the user experience. Hygiene surely is part of that equation, but I accept your points that there are far greater risks for germ transmission than shared surfaces, I totally accept that, and yes, there is a TCO argument, the total cost of ownership argument that has to be made here also.  The point that I will make here is that we fundamentally believe and being a scale-up organization that is focusing on new technology, we have to believe that we are pushing the technology envelope where what we are focusing on is elevating the user experience from what the current model provides. So yes, there will be some use cases where we are not a good fit, but contactless as a category or touchless as a category, maybe the pandemic catalyzed it, maybe it expedited things, but that category in itself is growing significantly.  A couple of stats here, right? The contactless payment as a category itself, 88% of all retail transactions in 2020 were contactless, that's a pretty big number And assuming that retail is a $25 trillion dollar market. That's a huge chunk.  But that's about speed and convenience though, right? Saurabh Gupta: Totally. But all I'm saying is contactless as a category is preferable from a user perspective. Now, gesture based interactivity as a part of that user flow, we fundamentally believe that gesture based interactivity plays a part in the overall user journey. So let me give you an example.  Some of the retailers that we are talking to are thinking about new and interesting ways to remove levels of friction from a user's in-store experience. So there are multiple technologies that are being trialed at the moment. You may have heard of Amazon's just walk out stores as an example. You don't even have to take out your wallet and that is completely based on computer vision, as an example, but there are other retailers who are looking to use technology to better recognize who their loyal customers are. So think of how we used to all have loyalty cards for Costco or any other retailer.  They're removing that friction to say, when you walk through the door, you've done your shopping and you're at the payment powder, we can recognize who you are. And if we recognize who you are, we can give you an offer at the last mile, and in that scenario, they are integrating gestures as part of the completely contactless flow. This is where I think we are gaining some traction. There is a product that we are a part of that hasn't been announced yet. I can't go into details specifically on who it is and when it's going to be released. But we are part of a computer vision based fully automated checkout system that uses gesture as the last mile for confirmation and things of that nature. That's where we are gaining traction. Overall point here is that we are focusing on really showcasing and delivering value on how you can do certain things in a more natural and intuitive way. So think of digital wayfinding at malls, right? You have these giant screens that are traditionally touchscreens, right? When you think of that experience, it has a lot of friction in it, because first of all, you can't use touch as effectively on a large screen because you can't swipe from left to right to turn a map as an example. We fundamentally believe that the product could be better with gesture. You can gesture to zoom in, zoom out, rotate a map, and find your direction to a store. Those kinds of things can be augmented. That experience can be augmented with adding just a capability as opposed to using a touchscreen based interface. So those are the high value use cases that we are focusing on.  So it's not really a case where you're saying, you don't need to touch screen overlay anymore for whatever you're doing, Mr. Client, you just use this instead. It's tuned to a particular use case and an application scenario, as opposed to this is better than a touch overlay? Saurabh Gupta: I think that is a mission that we are driving towards, which is, we know that there is potentially a usability gap between gesture in terms of its evolution than touchscreen. We are looking to bridge that gap and get to a point where we can show more productivity using gesture.  And the point is that with our technology, and this is something that you referenced a second ago, you can turn any screen into a touchscreen. So you don't necessarily need a touchscreen and then you can convert it to gesture. You can convert any LCD screen to an interactive screen. So there is some deep argument there as well. What's the kit, like what are you adding? Saurabh Gupta: Just a camera and a USB cable, and some software. And if you're using haptics feedback, how does that work? Saurabh Gupta: So haptics is a commercially off the shelf product. So it's another accessory that gets added to the screen. However, that contains the camera in it so you don't need an additional camera. That also connects to external power and a USB back to the media player.  So as long as you've got a USB on the media player, you're good, and right now your platform is Windows based. Do you have Android or Linux?  Saurabh Gupta: Good question, Dave. So right now we are Windows based, but we know it's of strategic importance for us to enable support on additional platforms. So we are starting to do some work on that front. You'll hear some updates from us early next year on at least the hand tracking side of things being available on more platforms than just Windows.  How does economics work? I suspect you get this question around, “All right. If I added a touch overlay to a display, it's going to cost me X. If I use this instead, it's going to cost me Y.  Is it at that kind of parity or is one a lot more than the other?  Saurabh Gupta: It depends on screen size, Dave, to be honest. So the higher in screen size you go, the wider the gap is. I would say that for a 21 or 23 inch screen and up, the economics are in our favor for a comparable system. And are you constrained by size? I think of all the LED video walls that are now going into retail and public spaces and so on, and those aren't touch enabled. You really wouldn't want to do that, and in the great majority of cases with this, in theory, you could turn a potentially fragile, please don't touch surface like that into an interactive surface, but are you constrained to only doing things like a 55 inch canvas or something? Saurabh Gupta: This will require a little bit of technical explanation. The Lego example that I talked about was targeted on, I would say a large outdoor LED screen. So the concept here is that if you want one-to-one interactivity.  So what do I mean by one-to-one interactivity? One-to-one interactivity is that basically when in our interface, when the user approaches the screen, there is an onscreen cursor that shows up, and that on screen cursor is what is the control point for the user. Now one-to-one interactivity for us to achieve that where the cursor is at the same height or there's no parallax between where the finger is and where the cursor is, for that you have to be connected to or at the screen, and when you are connected to the screen, based on our current camera technology, we can control up to a 42 inch screen for one-to-one interactivity, but we've also been doing exams showing examples where if you connect the sensor to slightly in front of the display, then you can cover a wider area and we've been able to showcase examples of our technology being used on up to a 75 inch LCD screen in portrait mode.  So then any larger than that, the scale gets a little wonky, right? Cause you've got a person standing in front of a very large display and it just starts to get a little weird. Saurabh Gupta: Yeah. It's like putting a large TV in a small living room. So you need to be slightly further away because then it gets too overwhelming, and for that, we have worked with certain partners and they've done some really interesting work like this company called IDUM, they built a pedestal and so that pedestal encloses our tracking device, and that can be placed several feet from a large immersive canvas, like a LED wall, as an example, in a museum type activation, and people can walk by and then they can control the whole screen with that pedestal slightly further away from the screen. So it's like a Crestron controller or something except for a big LED display!  Saurabh Gupta: Exactly. It's like a trackpad in front of the screen, but slightly further away.  Gotcha. All right. Time flew by, man. We're already deep into this. You were telling me before we hit record that your company will be at NRF and you may also have people wandering around IEC but if people want to know more about your company, they go to ultraleap.com?  Saurabh Gupta: That's correct. Ultraleap.com, we have all the information there and David, it was great to talk to you and thank you for the opportunity.   

Visionary entrepreneur Bart Van Acker founded pharma and biotech knowledge hub and consultancy company QbD as a one-man venture in 2011. A decade later, QbD boasts almost 400 employees with a presence in 7 countries across two continents. Bart is one of those forward thinkers and serial entrepreneurs that never falter in their ambition, and his business enthusiasm is infectious. In the pilot episode of our new podcast, Science Boosters, Bart shares his impressive rise to the top in a conversation with Filip Heitbrink, CEO of Scilife; from bioengineer to Flemish Young Entrepreneur of 2019, to board director, to co-founding and investing into multiple companies in the life sciences space and spurring the stellar growth curve of QbD. He's eager to help other startup entrepreneurs in the sector, and we're thrilled to listen to his guidance and personal experiences on Science Boosters.

This week, Stacey is joined by FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them.   Resources from this episode: Pharmaceutical Quality for the 21st-century report Quality Management Maturity Pilot Program as announced by the FDA   About Our Guests: CDR Lyle Canida CDR Lyle Canida is a PHS officer with 11 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA, he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing post-market safety programs for drugs, foods, cosmetics, and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other strategic initiatives. Jennifer Maguire, Ph.D. Dr. Jennifer Maguire is the Deputy Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including QbR, QbD, ICH Q12, Site Selection Model, Quality Metrics, and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a Ph.D. in Industrial and Physical Pharmacy from Purdue University. Nandini Rakala, Ph.D. Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master's degree in Applied Mathematics and Computing from Manipal University, India; and a bachelor's degree in Mathematics Honors from the Sri Sathya Sai Institute of Higher Learning, India. During her past 2.5 years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ pilot programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of PQS-CAPA effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on several occasions at various conference seminars, and she is a recipient of numerous prestigious awards. In her personal free time, Nandini enjoys volunteering in community service activities, serving as a judge, playing tennis, writing, reading articles, and biographies. Alex Viehmann Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance.  The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment.  Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control.  He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions.  Since joining OQS in 2015, Alex has guided the development of OPQ's Quality Metrics program, CDER/ORA's New Inspection Protocol Project (NIPP), and OQS's analytics and modeling program.  He is also actively engaged in implementing Pharmaceutical Quality System (PQS) assessments in support of Established Conditions and the Site Engagement Program (SEP).  He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management. Alex received his bachelor's degree in economics from the University of Maryland at College Park.  Carla Lundi Carla J. Lundi has been with the FDA as a Consumer Safety Officer since 2002, working initially with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016 she transferred to CDER's Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug product and manufacturing site quality-related signals for mitigation of urgent quality issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal and external customers; collaborating with business partners to determine data to be collected from sites through onsite inspections or other innovative approaches; and drug training collaboration and development. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Perspectives Podcast - Tony Nash[00:00:00] Hey, everyone. Welcome to this episode of  Perspectives. It's such a pleasure to join you. And I want to thank you for being with us. I really appreciate you. I got interviewed the other day and I got to brag about our view is, and I think you're fantastic. So it's great that you're here today. We have a very special guest, especially if you're Australian centric.So his name is Tony Nash. You may know him as the man who co-founded Booktopia. It is a very large online book seller here in Australia. It's massive. It's where I do my business, which I didn't get to tell Tony in the interview, but Tony is just a great guy. He's a real pragmatist. You're going to enjoy.He's very down to earth approach and nature. When it comes to building such a successful business, it is the world's largest online and offline book retailer. In the world, which is quite the achievement. I think it's fantastic because obviously everybody's minds go to Amazon, but Amazon's focus as Tony reveals is an inbox now.So they've [00:01:00] carved out this phenomenal niche themselves with some entrepreneurial thinking, pragmatism seeing gaps in the market and just figuring out obsessing about what the customers want. He created the business with his brother, Simon and friend, Steve. And they're starting budget on Google ads was $10 a day.They deliberately did not make a profit until 2016. They started in 2004 did not make any profit to two 16. We talk about that in the interview, and that was deliberate because what they wanted to do was to keep funding the growth that was required to take care of their customer demands. It turns over in exists.I think it's over $200 million a year. Now it's been listed in the AFI Bow's fast hundred, eight times the only company ever to achieve this feat from 2009 to 2017, it's been voted bookstore of the year. They've moved into publishing as well. We didn't get to talk about that as much as I'd liked, but that's a really interesting new niche they're carving out for themselves.It has [00:02:00] won the New South Wales Telstra Business  of the Year the Australian Telstra Business Award People's  choice Award we were a finalist in that. I remember that. They've been a finalist seven times in the Telstra business awards and they are state, it stated that Australian authors and titles are a key focus for this company.And you'll hear that come through. When we talk with him, they completed an IPO in 2020 during the first year. Did you believe he'd ever say this the first year of this global pandemic and our response to it? They did an IPO. So initial public offering, they went public and their capital raised successfully.They did an 11 week launch from decision to IPO, which I think is fantastic. They hold nearly 200,000 books in stock, ready to ship. They sell an item every 4.8 seconds. Their warehouses in excess of 10,000 square meters. Their main rival apparently is Amazon. Even though Amazon is in Australia, Booktopia is just doing gangbusters, going from strength to [00:03:00] strength.We talk about teams, culture. We talk about what it takes to build a business very much this theme of pragmatism and keeping your head and focusing on the customer and figuring out where the sale is going to be made because everything else up until then is talk and with no further talk from him.Here is Tony Nash. So you've been going now, you began in 2004. How would you say if you were to describe right now, how you got here? Rather than telling me what you did. How did you get here to be in this position where you are now with Booktopia mostly, for me, it feels like one thing led to another. So I'm very horizon point driven.That means that I have a clear picture of where I want to get to. And I may not necessarily know that that's. How to get there, but by having that horizon point to me it's more like a mountain range beyond the mountain range that I can see in the [00:04:00] distance and going, right. We've got to get to X and at the moment we're turning over 200 million.So therefore, what have I got to do to get to 300 million? But before that, of course it was getting from 100 to 200, from 20 to a hundred and so on and so forth. So if you work your way back then that's that's quite often when I think about the driving force, it's like, if someone said to me, come on, let's, let's get on a boat and go for a trip.And, and, and where do you want to go? And I say, look, let's go east. Well, we can end up in Alaska. We could end up in Antarctica and you got, what can you be a bit more specific? And it's like, well, New Zealand, north or south island and north, so Wellington or Auckland, Oakland, Ryan and I were in Oakland.Well, you know, the where the marina is, where we're going to where they had the America's cup, that's where we're going. And all of a sudden everything gets clear. And, and that to me is a lot about having that destination that then creates a level of [00:05:00] thinking, which gets you into action. Okay. So you start with the end in mind, which is what anybody who's an entrepreneur who's successful and not successful starts with that's.I imagine that's part of it, but there must be more to the soup because. It's not as simple as just set the intention and the horizon line cause a new horizon line keeps presented itself and that horizon line is always further away and to get to their new horizon line, the challenge is always unique because the once you've conquered one horizon line, you've conquered those challenges.The next horizon line is completely different. Challenges are required for you to overcome. Can you talk about that? Yep. So where the Where the engine sits in terms of how we fire up and what we do comes from asking one question every day, what do our customers want? So even though there's an end point in mind, it's still coming from the point of what do they want, because that will determine what we do to get where we need to get to, to the horizon point.So that's how it feels to me. In [00:06:00] terms of, I guess, if you were to use the New Zealand metaphor, it's kind of like, oh, we're going to go in a cruiser or you're going to go on a sailing boat. Are we, how are we going to get there? And, and so that, that would be the next unpicking of the, you know, taking the layers of the onion away.There are many, many other things though that make up the. You know, who who's on your crew what sort of roles do you need to have or the other we can't afford to have passengers. So who's doing what that comes, that comes into play. If I think about it I've never really used it in this kind of metaphor before, but that makes sense to me.How are we funding it? So are we, do we want to have more month left at the end of the money or do we want to have more money left at the end of the month? We focused more on cashflow statements in the beginning that we did in profit and loss. There was a very clear growth strategies that I had in mind in terms of, in terms of getting, you know, I didn't want to overgrow.I didn't want to under, but I didn't want to grow too quickly. So it's slow down there. So it's talking about capital raising [00:07:00] or not capital raising. How did you decide what your sweet spot was for over or under growing? How did you, was it an intuition? Did you have numbers to base it on? How did you go?Yeah, kind of felt to me, like by growing at around 25 to 30% a year was was a, a stretch that was manageable. But not exhaustive. And so, and what I liked about that, it wasn't lumpy. So every year people were used to beat in the distribution center and customer service, sales, marketing, whoever, like, they just knew that we were growing at a very steady, right.And I found that to be really helpful in terms of people getting used to, if we were jumped, like. 80% one year with the pandemic, which some companies would have. And then it's only 10% the next year. Overall over two years, you've increased by about 40% a year, 35% a year. But for us having that steady growth all the time, Pru proved that we could bring on [00:08:00] people that we could fulfill the orders that we were getting, that we can manage our cashflow, that we weren't spiraling out of control.That's how it felt for me. And I imagine if you had overreach, you would have been in danger of not getting the capital funding you needed to bail you out of the overreach. So it wasn't as simple as finding the sweet spot, really the business relied on it because you were profit net, nothing for how many years.That was extraordinary. Part of the story. Yeah, that was, that was intentional. So to me it was about pushing, putting back into the business, everything that we were accumulating. So having started the business off a $10 note back in. 2004. We we had another business at a time and when I say we I've been in business with my brother and my sister and my brother-in-law and we had another business, internet marketing.So we were doing consulting work and Booktopia was a little side project for me that got bigger and bigger. So it was about, it was just about getting old that And the beautiful thing for us, of course, it customers paid upfront. [00:09:00] So they, they transacted, they gave us their money. We then hustled as hard as we could.And then our suppliers, mostly in the book industry is, is that it's 30 days end of month. So in some instances we may have sold the book on the first, second, third, fourth of the month. We didn't have to pay that for, you know, almost 60 days later. So there was an aspect of using our customer's money. They were our investors, they, they handed over their money and we, we worked hard to hire more people hold more stock, write more software, buy more automation.Yeah. But there were times when we when we moved, when we change facilities, we invested in automation and our suppliers were, were stretched to we, we were late in paying them. We had to continue selling more books to then eventually pay them. And, and then we got to the next level and we finally were able to.Kind of get some clean air again. And once we'd done through that light not make money for that was until 2016 and that was incredible, but that was on par. [00:10:00] So it was on purpose. It was on purpose. And what happened was we tried to IPO in 2016 we had got to 80 million in revenue and we we went through the whole journey and it was basically like going down to Bondai beach and Sydney on a mid winter's day to try and sell ice greens with a southerly coming in from the Antarctic.And it was eight degrees because temple and Webster were trading at 15 cents. Then now at $10, a Kogan had flatline over the six months since they had listed SurfStitch was going off. The market red bubble had gone backwards. And so it was there. And then the, the week that we were trying to firm up the price and do our management roadshow, Amazon announced they were coming to Australia and the fund managers all said, well, they're going to annihilate you.So we're not interested. And, and we had to go away and do go from 80 million to 200 million in the meantime. And so Amazon didn't annihilate, but the one thing I took away from. From that particular process, was that okay. Growth has been great and, and putting all the money [00:11:00] back in has been terrific, but I think we now need to become a little bit more sustainable and, and focus on revenue and profit.And, and so we, we started to focus on profit and build that up as well. So that then type it out our growth. So we didn't put as much money back in, but we had we still had high double digit growth. We just didn't have as much, but we were then is no one gave us money. If we couldn't raise money ever, ever, ever, ever.Then we still had our own business too, and we were still funding it then. So they put us in a stronger position and that's why we, we shifted. And I shifted from being a revenue based business. And in the early days of the internet, people really didn't care about profit. They just wanted to know that you were growing.Yes. But it'd be, I, it was clear to me that especially talking to fund managers, they wanted to know that if they put the money in it, wasn't, it wasn't only going to be potentially capital growth, but it was also going to be dividends as well. In long-term yeah. When you're talking about sustainability, you talk about in terms of the needs to be the cashflow and the [00:12:00] profit.Isn't sustainability though. Also about stabilizing your supply chains and stabilizing distribution in Australia. Tell me about it. So you had to not invest as much money back in your business, as you had to stabilize a sustainable distribution network. How did you do both? How did you do all of that?Nope. The way that most people do that is they, they understand their supply chain model and where they can get their product from and how that works. And then they start to order and and build up a level of capacity that Takes into consideration the slowness of whoever whoever's supplying you.So in our case the, the algorithms that we write to, to order the stock that we needed for the. 150,000 titles that we had in stock was to make sure that yeah, we would buy them out and have zero for a little while, but then it was coming back in now algorithms, cause we've got the funding is to hold as much as we can.So we, our low tide is well above the zero [00:13:00] point. And so then you do that. What I'm doing now though, is which is more exciting for me having moved from online retailing about four or five years ago, we got into distribution. Now the publishers are appointing us as their Australian distributor. So we go to ourselves, but we also sell to Amazon and Dimmick's and QBD and all the little indie bookstores, whether they buy from us, buy from us.So we've actually, we've actually addressed that supply chain by saying, Hey. We can hold your books. We can actually sell more if you keep less. And of course for Booktopia we get better discounts because we are the distributor now. And so that's one of the areas. Okay. Thank you. And, and then also we are we're talking to printers, like for example there, there are printers, there's a legal publisher here in Australia.They print in Sydney, their warehouses in Canberra, which is three and a half hour drive away. So they drive all the stock and all the product down to Canberra, put it in the warehouse. Some PR obviously gets sold in Canberra, but it's mostly in Sydney and [00:14:00] Melbourne. So then it all comes back to Sydney, into Melbourne, right?What the hell? Like my company is making money out of that. And there's yeah, there's even at the last semester we were very big on academic books and one of the PhD students ordered a book from us, which John Wiley is the publisher. So we ordered it from Wiley. It's a. PhD books are not many are needed.So it was print on demand. It was printed in Singapore, which is the PID partner. They then ship it to Queensland. Where there John Wiley shed is their distribution center is they then freight it down to us and Sydney and we sent it to the customer. What the hell, how much it's all going to the freight companies?So my goal over the next 10 years is really to address that Leia historically in the book industry. Cause it's been going for 570 years and certainly for the last several decades, it's very siloed. So the printers did the printing and the publishers did the publishing. The distributors held the books, the authors write, then the literary agents represented them and so forth.It's very, very silent and I'm looking [00:15:00] at it addressing that without investment in logistics and publishing which we've also stabbed in the last couple of years. And and, and just kind of see if we can remove some of that and have that profitability. Sit with us, give more to the author.And, and hopefully make the price very compelling to the customer. What you're also doing is taking over proud of the market. That's never been addressed. You're doing something you're making a unique offering that hasn't been available to authors until now. Yeah. And one of the reasons for that is The lucky thing for me is I'm not really a reader.I actually do. I listen to audio books. I listened to a lot of audio books, but to sit down or because I have ADHD is that I I don't, I was never much of a Raider. So I came into the book industry as, as an outsider, looking at it from a very different perspectives. They had a very, like, this is the way it always was the way it always is.We're looking across the valley of, of publishing in the book, industry gain, look at our valley and I'm going well, [00:16:00] I'm in a helicopter looking from up here. Or I went over to the other side of the valley, or I sat down through the river through the middle of it and I got a different perspective. And so from my view, I just didn't see it the way that they saw it.And I just saw other opportunities within that. One of the things that you saw was a belief in a business model. I'm going to say it. Perhaps Amazon may have been on your mind in a couple of those meetings. How did you know to keep going? When this monolith had decimated the U S book market and the publishing industry around the world, how did you, I want to know your thinking.Cause it's more than a punch that you've done. This is well, in the beginning though, the thing was, is that Booktopia was started with no light bulb moment or insight, or there's a gap in the market. It was just a side project, $10 a day. We used another company to manage our site and fulfill our orders because they had done it for one of our internet marketing clients, Angus and Robertson.So they built the site for you as well, the first ever ordering. [00:17:00] Yeah, they, we got through our internet marketing consulting business. We got Angus and Robertson. One of Australia's oldest bookstores, their website to the top of Google as a project. And they use this company in Sydney to manage their site and fulfill their orders.And this company managed 80 bookstores websites. So my brother who had done that project set up a meeting and Christmas of 2003 pitched the idea of, of of us. Being introduced to their other clients and getting them all to the top of Google so they can make more money. And the owner of that company said not interested.I said, you're not interested in making more money. I said, seriously. And he goes, he goes, no, we build websites. We manage you. We've got this platform that we can, we can get a bookstore website up and running within 10 minutes, 10 minutes. There's a million books on there. And if you sell anything, we pay a commission.I said, well, that sounds interesting. Yeah. And he goes, yeah, I know, but no internet, only businesses have made anything out of it's all been off the back of a traditional bookstore. So I went away from that meeting. I [00:18:00] said to my brother, he said, what? Wouldn't mind giving that book thing a bit of a guy.Cause I could see there was very little cost from outside other than driving traffic and, and getting a commission. And, and so I kind of went away from that, came up with the name, Booktopia registered the business and sure enough, this company got the Booktopia website up and running within 10 minutes with a million books on there.And my brother handled the finances, said. You can stop Booktopia it's gotta be outside of hours. Cause we're doing all this consulting work. And I said, sure. Yeah. So you was selling your time for money as a consultant, not even. Visualizing the vision of what God's hope you could become. No, we had no idea my brother, right.My brother read the sales plan. You'll you'll sell one book for the first three months and then it'll go to two and then it'll go, right. This is awesome. This is awesome. And my brother finances gave me a budget of $10 per day to start. What did you spend the $10 on? I've been dying to ask you that question.Google ad words. I was a Google ads, Google ads, but I didn't [00:19:00] go for search terms like books or bookshop or, or or, you know, those kinds of generic terms. I went for authors and titles and sent them deep into the site because they had already used Google to do a search. So I sent them to where those books were and it took me three days to sell my first book.And that was the total sales for the day one book. At the end of the month, I had done $2,000, but by the fourth month, I was up to 30,000 a month by the end of the year, a hundred thousand dollars a month by the end of two years, $200,000 a month. So We kept publishing distribution back then they, so that, that company that managed our site amazing, they took care of it all for a commission.That's all right. Yeah. Well, they, we got a commission for generating a sale, so it was a white label system. They had 80 odd stores that they were managing and they, they did Angus and Robertson, Collins books bunch of other independent bookstores. And, you know, we were one of them and then we quickly became one of their largest and it was once we got to [00:20:00] around 2 million in revenue we could see that there was something going on here.And I went through the Australian booksellers association annual conference in 2006, and we were still doing the internet marketing. We were still using this other company. And I came back from that and I said to the family, these guys have no idea what's going on. We got to go out and do this ourselves.And because of my background before internet marketing I was, I. Sorry. I was a recruitment consultant for the competing industry. And before that I was a computer programmer and my brother-in-law was an IBM software engineer. And so we had the confidence to build our own site, which we did. And in 2007 beginning of 2007, three is after we had started Booktopia.We parted ways with the other company when it moved into a small warehouse in Sydney, 500 square meters, next door, a brothel. And not that we knew that when we moved in, we had found out later and then bought some shelves on eBay. Hi, hi to warehouse manager rang the publishers and we said, it's assets.Booktopia, we're [00:21:00] turning over 2 million a year. Never heard of you. Because all our orders have been going through this other company. So we've got basic terms, basic discounts, and we still did our consulting work. So it wasn't until two years later that we could finally say, all right, Booktopia is turning over.I think it was around 7 million. So we could stop doing the recruitment or the internet marketing. So we could focus on the, the Booktopia business. What were the publishers saying to discuss, to offer you such lousy terms? When you clearly, the volume you were moving was bigger than any one bookstore or brand in Australia, we were only doing 2 million, so there was nothing there.In fact, I remember getting a letter from PSM, the education publishers to say, as you're an online retailer and have no overheads, your discount will be 10%. Now at that stage, I think we had about 10 people working in the business. I looked around at our warehouse and our shows and our people. What do you mean no overheads?I just think that it's some sort of smoke happens by magic. And so [00:22:00] it took quite a while. It took I would say another five or six years for them to really get their head around what was going on. And they started to shift because it was a very archaic industry where you know, where they they controlled everything.And, and so w once we got to 30 or 40 million in revenue, we were starting to you might've negotiated a little differently, probably. Yeah. I just got some discounts, improved terms improved once we, of course, you know, paid our bills and, and, and put more volume. Yeah. What was it like signing that first contract on the first warehouse, still working in your other job that wasn't too scary?It was $1,500 a month. Yeah, I think so. It was not much more than what we're paying for an office in, in north Sydney. But it was. We didn't hold any stock in the beginning. So we literally took orders from customers. And we would order it from the supplier would come in, you know, a few weeks later, five weeks later, eight weeks later, and people were [00:23:00] bitching and complaining saying, you don't like you guys suck.I should have bought from Amazon. And it was about a year after we had gone out on our own. So almost four years of being in the business, there's one book had been selling really well at because the author had been on Oprah and it was the wife of Jerry Seinfeld, Jessica Seinfeld and, and America had sold out of its 300,000 copies and HarperCollins in Australia had 200 copies left.So I said to my brother and brother-in-law, we shouldn't buy all of them then no one left, but except us. So we did, and it arrived into our warehouse. And imagine what keen to a bookshop where there's only like one book on the shelf or that yeah, that's how a bookshop looked at that time. So, so when this order, when an audit would come through the site, we just pick it, pack it and ship it.And the feedback from everyone was, wow. What great service you guys are really quick. And I, I said to the others, you know, to kill a Mockingbird is sold every single month for 50 years. Why, why are we ordering it in? And what else is there? How to win friends and influence people, power positive thinking, thinking very rich Harry Potter, Dr.Zeus. So a little warehouse that was supposed to be more of a cross-docking kind of thing [00:24:00] really started to fill up. And then after a couple of years, by 2009, we had to move out of there to, to 2000 square meters. And we thought, well, this will last us five years, the five years that ran out of space after two years.And then we take another 2000 square meters. And at this stage it's all manual handling of every book. Yeah. Yeah. Except we had, we bought one packing machine that in the middle and someone would have the one in, just put it through and we'll come out with a package wrapped around. And it was in 2014, seven, seven years ago when we moved to 10,000 square meters.And that was a pretty big league. We were turning over 40 million. And we moved here. And that was where we invested initially 5 million in automation and then, which was conveyed as in more packing things. And then, and then over the next few years we invested another 5 million in, in automation to improve our capabilities.And then that got us to around 150 million in revenue by the beginning of 20 [00:25:00] 2020. And that's when we did our first raise, how, how did you come to the decision to do the crowdfunding? Can you talk a little bit about that? I think our listeners would be really interesting interest in how Boulder moved.That was to even consider it. Was it over a glass of red that you came to that decision when you're on MBMA how did you crowd go to crowdfund? Talk about that. So what happened was when the IPI didn't happen and we had when you do an IPO, there was there's a lot of costs involved and we accumulated those costs and then we never raised the money to pay our first costs.What I recommend to the listeners, if they are looking at it is definitely. Accumulate the money for the capital raise rather than trying use it out of the proceeds of your business, because that really stretched us. We had a couple of million dollars in costs that needed to be paid down and that put pressure on our suppliers, which meant that we were putting, being put on stock because we couldn't pay them.We had to sell so more and it was a very tricky period to navigate and our way through to get that's not how you want to do an IPO. Yes. Well we [00:26:00] didn't have much 80 million in turnover, so we didn't have many other options, but yeah, that was our learning, our lessons and learnings on that period. So then once that didn't happen, we didn't look at a trade sale.So we, we engaged a company from Seattle to go around the world and talk to companies who might be interested in buying us because we were on track to under a million in revenue. We got no interest there, so then, okay. That's that was done. And then we the business was continuing to grow and I felt well, you know, one of the reasons why we wanted to IPO in the first place is that our customers are our hugest fans.They've been our investors all the way through buying books from us. And that's why we wanted to list. So I knew some guys who did had the crowdfunding platform and I reached out to them and I said, look, how about we do raise some capital through you guys. And so we we had some conversations and we said, we already had a prospectus that could be used reused to go to market with.And, and so we, we did that and we were going to be able to raise a few million dollars out of that. [00:27:00] And the reason why we didn't was because we also did a road show with a guy who has a company called wholesale investor. And we went to Sydney, Brisbane, and Singapore presenting ourselves to to invest at the investor community.So this was alongside the crowd funding and through those. Those events I did end up at the top of the Sheraton at 11:30 PM, edging my way to the back of the room. Cause it was so noisy standing next to this guy who we get into a conversation and he came out to Booktopia gave him a tour, told him where we were at and he goes, I think I know a guy who might be able to help you out raise some capital.Yeah. And then this guy, mark Peyton from ifs G capital came out. We really liked each other. He came into the business three to four days a week working inside. And that's the one thing I feel at that time, it felt like the problem or the reason why we weren't getting any any results in terms of raising capital is we didn't come from the capital markets and other companies who had been [00:28:00] succeeding, had someone there.Either an investor or a CEO or something who had come from the capital markets and can talk the talk of the, of that part of the world. And so, so he came on and there was things that were missing in terms of some of the modeling that we had within our books. That's helpful, more profits. So we've made some changes to some of the things that we've been doing in terms of postage and so forth, and made sure that we upped our profits slightly.And then within six months we had completed an $8 million raise. And then we also added to that $12 million of some senior debt that we had had for, we ended up having for about 11 months until the IPO, and that enabled us to, to invest in the automation that we needed to get to the next level. So that was, that was how come the crowdfunding came into play.I still won. 10 11. I wanted to have our customers own a piece of booklet. Exactly. I love that. It's a really inspiring message. How was it received by your customers? [00:29:00] W well pissed off in the end because we, we closed it off and and, and went through the traditional because we were going to raise a lot more money, which is what the business actually needed rather than, you know, three to 5 million.But they, they loved it. And those that were going to invest More than most people that were investing 5,000 and more we're invited to be on the priority offer for the IPO. Yeah. And that, that would have been great. The head away to have P feel part of the story that was unfolding. I'm interested that when you went looking around the world, there were no potential buyers.Was that because you feel you were under in terms of what those potential investors may have been looking for, what weren't they seeing that this is a stable, sustainable replicable completely. It can only scale up because all you're doing is supplying to customers, not consulting clients. So the scalability is obvious.What was the gap? That's a tricky one to [00:30:00] answer. Cause there's two types. There's obviously private equity firms who have got a specific mandate and they'll, they'll be looking at businesses in a very. Two dimensional way going, okay, where are they geographically, geographically? Are they based? What's what vertical or sector are they in?And a variety of other things and being Australian and growth, they care about growth trajectories, tremendously. They're going to show how they can make the money in five years. Yeah. The Australia was not part of their geographical mandate or, you know, what, what they were looking for for those that were in publishing.Because we're e-commerce and because of the value that we, and Amazon and others at LaSeon and so many other businesses that are out there based on it's a very different valuation than a publisher or a traditional business is based on. So they, they struggled to get their head around the multiples.So the multiples are higher. Yeah. Yeah, because not according to them though, no [00:31:00] traditional businesses there was there was little appetite there, so it just, I mean, interestingly for me after the IPO didn't happen because many reasons, but one was because Amazon was announced that we're coming to Australia.So I reached out to the Amazon through that process. And personally, directly, I reached out to the Amazon M and a team and I said, are, you know, here we are, we're turning over a hundred million a you interested in. I said we only buy businesses that we don't care what revenue you're doing. We don't care how much profit you make.They just have to be aligned to our three to five year goals. And I said, well, where Australia's biggest online book retailer, you guys sell books with turning over a hundred million and we're on track to get a 200 million. And you're saying that we're not aligned to your three to five year goals. I said, To myself, not to them.Thank you for that insight information. I will take that away and on. That was really helpful because we were seeing that Amazon was moving away from books and have been doing that globally. And [00:32:00] even though they're still the biggest book retailer, the publishers and the evidence was there, that they actually were moving more into a tech company rather than a supply chain and logistics fulfillment business.That was a very inspirational conversation to have had. So that's led you to decide then and there to do IPO again, or what was your thinking that time just to, were you always going to keep it in the family? What led you to decide to IPO again? Was that a turning point moment or what was the turning point for you?For us, it was always about how do we get money off the table? So we build a business and my brother is always, he's two years younger than me. I'm the CEO and have been he was, once we got past 50 million, it was big enough. He was happy to still leave it at 50 million revenue, pay a dividend lovely business.Thank you very much, but that's not what our, it, he may say. That's not what I wanted, but it's actually not what our customers were wanting from us. And to be fair. And yeah. And when you say that, can you just slow down? So I assume you mean by that you had to [00:33:00] provide a bigger range and faster. Is that what you mean by what our customers wanted?No, it's just that more people were transitioning online and therefore more people were coming to us. What do you do say we don't want you to buy from us. We, you need to stay at 50 million. No, they, they continued to To want to transact with us. And that's what was fundamentally, we kept doing what we were doing.More people were moving online. We were, and we did it well. So, so Simon, my brother, he, he was ready to retire, which he did just before the IPO. But part of that whole that whole journey, that goal was to how do we get money off the table? How do we convert the value of the business? So the family can know, can be set for, you know, how many generations who knows.We knew that we had done the hard work. There were many ways to, would have been happy to sell it to someone if the price was right. But that, that wasn't the way it worked out. So when we did the capital raise at the beginning of 2020, which is quite funny because I'm assuming one who is the founder and chairman of champ [00:34:00] benches and He was it wasn't through champ.It wasn't through private equity is to resign personal investment and a consortium of people who came in with him to make the $8 million investment. Six weeks later, the pandemic hit. And I remember meeting out with him and looking at his very grave and grey face going, what have I just done? I've just put what was money into a company.And we're being hit with a global restructure and, and it turned out to be one of the best investments that he's been the best investment. He made that. If you're online and you must've known it at the time, I'm going to throw that credit to you. Everyone has to go home. They have to have things to do.Now. That's not in the moment. In those days. When I, when I reflect on it, there was no guarantees who knew with the postal service stay open with, would we be able to deliver, how, how devastating was it? How, how did it, was it transmittable by, by a book? All these things, [00:35:00] there was still a lot of dust had to settle.Got it. So but things very quickly, we worked out that we were on the right track and sales kicked in excuse me. So, so what happened was we we were never planning to IPO. In that year we were going to wait a whole year because the investment that we had that they had made in us was to, to, for us to.Increase our capacity by adding more automation. We want it to go from our capacity of 30,000 books in and out per day to 60,000 out per day and an hour. That, that was a project that we'd been working on for some time and why we did the raise and that wasn't going to go live until the end of the year.So pandemic hit and we didn't have that in place. So we wanted to we wanted to get that deployed, get it optimized, and then be able to say to the market look how much profitability we have now. Look at the scale, look at everything else and, and have, have the runs on the board, but everything was very [00:36:00] uncertain and.E-commerce had moved from the wings to send a stage theater had been darkened and the spotlight was on e-commerce and we decided in August let's do it. And basically we did an 11 week IPO. Yeah, it was bloody quick. And that helped actually it helped so well because we could nothing was as long as a piece of string, everything goes, no, no, don't worry about that.We'll just, you know, just do this, do this. And so we stripped a lot of a way decisions were made quicker. And we, we were fortunate to a degree because we tried to IPO four years before and we still have that Pathfinder, which is the pre prospectus document we have We had, we had appointed out chairman four years before and we, he and I liked each other and he stayed on for those four years as our unlisted chair of Booktopia.So he'd been to our monthly board meetings. He had heard us discuss everything. I'm assuming Wong had joined us as a board member [00:37:00] already at the beginning of the year and had met with me already. Well, before that, as we discuss the plans for the business and he was on as a director. So, so there was already quite a bit of.Knowledge about our business quite often, when you try to IPO, which is what happened last time, you're appointing your, your non-executive directors. They're going into the due diligence process and the DDC meetings which is due to the due diligence committee meetings with the lawyers and with the accountants and so forth, doing all of the due diligence to then get their head around what your business is.They have a cultural match or a philosophical match about how to, how to do it. Exactly. So you had, so your feeling is, and your perception is it was successful this time around partly because you had the right people around you who already up to speed with how you were doing it. No, because it was like going down the Bondai beach on a mid day.So ice creams, right. We were oversubscribed four or five times. The value survey on the valuation of the business is [00:38:00] 300 in 15 million. And when we started probably four or five months before, it was probably more like 200 million. So e-commerce was e-commerce was really hot and we had the product and to be fair, even though a businesses value today at around 350 360 million, we're very similar in size to temple and Webster who have got a market cap of 1 billion.We've got a, we're much bigger than Adobe beauty and their market cap is in the mid 400. So we, we knew we had a very, very good business. And, and so what we've been able to do is get some money off the table. Like we had planned the school that the family still owns at this stage, I think over 40%, 45% of the companies, which is, which is Terrific.And we were able to sell down and, and and bought some and great institutional funds onto the register and very passionate about a business we're in for the long term and also the retail customers as well, who are now. So we, we did accomplish, it was very helpful to have the pandemic [00:39:00] accelerate.E-commerce exactly. What was the biggest challenge you've faced in your first 10 years when you had made a conscious decision not to make profit? It was 12 years. What was the mental challenge? Not the physical challenge of making sure you had enough money and money, but what was the biggest challenge you faced for you?I never feel like I haven't like them. The question I get asked often as, you know, what keeps you up at night? Nothing. I hit the bed, I got to sleep. So I'm I don't feel like that. It's this, you make it sound like it's it's you know, it was a big burden or that it was heavy or that it was like, oh my God, I, you know, I don't know how I'm going to do this, but we did it.It's it's never been like that. I don't think that way, I think, okay, this is what you've thrown at me out of left field. Never expected it. Okay. How are we going to deal with this? Because we will, and, and that's, that's one of the attributes that I have, I think, [00:40:00] I think so, which is quite helpful. I think maybe the things that I don't, and this is the way that I explain it when I do my keynotes to entrepreneurs and, and hopefully anyone can get this you know, through this, just through talking about it, is that Yeah, I've got a, I've got a good friend of mine.She's she's in credible talent, but she rides the highs. Like she, she has a great month or like win an award and like, she's just not there. Right. And then something doesn't work out and it's just like, blah, she's just bitching, incompliance. Right. And then she's up again. And she said, you know, I get exhausted just watching her go along this journey of like a roller coaster.Like we, we list on the, on the ASX. So we win the Telstra business award of the year or whatever. It's like, I, yeah. That's how I celebrate very little, you know, a fist pump and we're on track. And then when something doesn't work out, so the distance that I travel, right. Modulator is very flat. It's very modulator.[00:41:00] Very rolling. Rolling Hills. Yeah. And so I'm not, I'm a peaks in the valleys. And I think for me that, that. Solid being solid and, and not being. And actually she and I caught up only the last couple of weeks because I told her exactly what I what I tell people in, in I gave her that and she goes, you know, I've, I listened to that and I I've stopped myself sometimes and going, I don't need to get that pissed off or agitated or aggravated.And she, even, she, she heard me, she listened. So that was but I that's the way that I do it. And I think anyone that is in business, particularly as a business owner you get stuff thrown at you out of left field that you do not expect. The government will contact you. The regulations will change.The ASX will have a view. Yeah. In our, in our warehouse, the first time we moved in here, we moved in mid winter. It was called, of course it's a warehouse, but then it hit summer and it was 42 degrees in the warehouse. And then everyone struggled and it got to winter and everyone was fine. And then it was coming around to summer and they [00:42:00] were going to complain to fair work and it was okay, what do we have to do?Well, we're going to have to strengthen the stress into the ceiling and we've got to put these big jet engines. Two of them that are going to cost $600,000 and that'll keep it at 28 degrees and get all the hot air out. Okay. That's what we've got to do. You didn't expect it was an extra cost, but that's what you do.And you, you, you just keep pushing through that. That's that's that's what it is to be in business. You've got to say, bring it on. You also gotta be pragmatic. So the biggest challenge I faced, so you didn't really face my, my biggest challenge when I built my business in the first 10 years was my inability to trust others.As much as I trusted myself, I could do everything better all the time. And that was my biggest thing to get over. It's just that I know best. So therefore I should do best or interfere and just learning how, when to let go when it's not abdication, but delegation, which taught me systems. That was my biggest challenge.And is the only way we go. We're nothing like you. We do [00:43:00] over eight, we do eight figures, but to get to my first eight fears, I had to overcome my own BS about what others could do around me and how to build a team and what culture means. Yeah. That's interesting. So I do talk about that in my keynotes about Shlomo.So he, he also had an online bookstore and Booktopia, and his company started a similar time and we were turning over about, I don't know, five, $7 million. And I keep in touch and I called him. I said, man, how you going? And he goes, all tidy, terrible. I said, what's the matter? And he goes, well, I've had 18 angina or texts in the last three months.Wow. You're kidding mate. What's why. And he goes, well, you know, my wife and I were working 18 hours a day, six days a week. And and I said, how many people have you got working there? Cause he was turning over 2 million and we had, I don't know, maybe 12, 14 people. And he goes, oh, and there's my wife and I, and two casuals.You're joking. He goes, why don't you hire more people? [00:44:00] He goes, well, they just never do it as good as us. I said exactly, but at least they're doing part of it and they're taking it away. So if it's at 80 or 90% or 70%, but that's more because I'd come from a recruitment background. And I 14 years in recruitment, I understood hiring people.I understood what it took to bring people on board and let people go and so forth. So it was, it's been very much part of me as bringing people on and empowering them to, to give them the opportunity to grow with the business. So that was not one of the things that that I had to, that I, I had to NGO or challenge like you, you had to do.But I will share one thing with you, which I think has been really valuable to me when I was a recruitment consultant. I had contractors it contractors working for me and. I had 15 of them. And I went and did this course with Robert Kiyosaki, the guy that wrote rich dad, poor dad, about seven years before you wrote that book in the course called money in you, I did that.Or you did that. Okay, [00:45:00] great. You know what I'm talking about? 1992. And, and what happened was it was actually, I went in there because it said money, but in the end it was more about you. You probably have the same experience. And so, so I came back from that course, having had some great insights about myself, because the problem I had with my recruiting was that I got to 15 and then.I would drop back down to 11 contracts and then I came back up to 15 and then I dropped back down to 10 to eight and it just, I was stuck at this invisible ceiling. And then I had some breakthrough realizations about myself that I realized how I was self sabotaging or my thinking was not this certain.Right. And I went from 15 to 30 contractors in three months. Yeah. And then I got stuck there and I'd got back down to 24, 25 that got to 30 and then down to 20. So then I went back and did another one of these courses called creating wealth. And I had another breakthrough and I got to 45 contractors and I'd get back then.[00:46:00] And I was stuck at 45 and then I did business school for entrepreneurs in Hawaii in 93. And then I had more breakthroughs. And then I ended up with about 110 contractors working for me. Now, the reason why I share that story with you in particular for entrepreneurs, because I talk about, and I make up, I make up the scenario.And if you can hear me out, imagine if you owned them as Alrighty. I actually. Was presenting to a group of jewelers. My friend is in the jewelry business and I S I said that, you know, imagine you're in a Maserati and they all looked around the room. Yeah,well, that was quite a, that was not the normal reaction, but imagine you're in a Maserati and Maserati being an Italian sports car, quite often, it needs to end up in the workshop. And, and this particular day, there it is. You've got to drop it off and a mechanic needs to work on it. He gives you the loan and the loan is a 15 year old to Dorothy it.And you've got this very important meeting that you need to get to. And it's [00:47:00] in double bay or it's in Toorak if you're in Melbourne. All right. And you've got to get to this meeting and, and you, you get there and when you arrive there, It's a little restaurant cafe that you're meeting this new, big client that you're going to pitch to.And, and you think, well, I'll just pack in the back straight and I'll walk around and there's no parking spots and the light is light. And if you do not get there on time, right? It's a reflection on the opportunities, but there's only one spot available in front of the cafe restaurant. So you pack 15 year old two-door theater in front of the restaurant and you get out and you look at the client and they're looking at you and you're looking at the car and they're looking at the car and you're going, I mess it, rati.This is not, this is not my car. It's not, this is not who I am. Right. You got to get out of that car as you is not. About the car, right? You are not your car. You are not your wife. You are not your husband or boyfriend or girlfriend. You are not your kids. You're not your kids' academic results or their [00:48:00] sporting results.You are not your footie team. Even though one of my best mates thinks he's the Richmond tigers. He is not the Richmond tight, the Richmond tigers. And, and with Booktopia. Right. I am not. Booktopia. OPR is listed it's Booktopia that was listed when it wins the Telstra business awards. It's Booktopia. And I remember when I started it and I was walking through the apartment and pass the room where I was doing my work in, and I stopped all of a sudden in front of the door because I felt this boom, boom, boom.I felt the baby. Like I could feel the hopper business. I remember when it crowed. I remember when it took it to the steps. I remember when we went to daycare for the first day, I remember when it went to primary school and high school and went to university and went out on its own. And because I see it as a separate organism and I'm thinking all the time, what does it need?What does it need right now? Who does it need to have in its team? What funding does it need? What nourishment does it need? What [00:49:00] space does it need? Right. I am not. I have not overlaid my own ego and my own belief systems about myself onto my company, which is for me. I honestly, I can honestly say to your listeners that one of the reasons why Booktopia has had for from 2008 to 2000, 20, 30% plus company, and you guys, right.And its revenue is because of that is because I have not identified myself as the business. It's its own organism, it's its own thing. And I I'm sure that that's how Jeff Bezos and others think about their business. It's unencumbered is enabled to, to flourish, overturn a core because if it, if it was me and I had to overlay my own ego on it maybe we'd be at 60 or 70 million because that's all I could.You know, imagine of myself, it's been a very interesting aspect to the growth and the success of the business. Have you made mistakes with hiring with someone has brought their ego or their own [00:50:00] insecurity into it and tried to move it in a different direction or a bad direction or a self-serving direction?Not that because I'm, maybe I'm waiting. Maybe I'm just way too dominant in terms of my vision. I do empower people to get on with it. They, if they know what they need to do, and I'm not saying I'm, I'm not micromanaging. I think people who've worked here will attest to that. So this is what we need to do.Go away and make it manifest it, make it happen. So they have a lot of scope there, but I, I don't feel like I've been. Now that we have a board there's that aspect in terms of being listed, of course, non-executive, they can have their inputs, but I think one of the reasons that's the beauty of the Booktopia business versus say an adore beauty is that you know adore beauty, Kate has stepped back new CEO.She's very talented actually to kneel. But it's a, it was an IPO led it was a private equity led IPO. They already own quadrant owned 60% of the business. That's not the situation here, so people are investing in [00:51:00] Booktopia and see Booktopia because of the vision that I am the executive have not necessarily that it's transitioned more towards, towards you know, a, an investor led business.So You know, Jeff Bezos owns 10% of Amazon. That means 90% is owned by everyone else. It's still quite a large number, 180 billion us in, in personal wealth. But it's yeah, it's, it's I think that's one of the things, so I don't, I didn't experience that. And I, I understand the question that you asked, but I've never felt like I've been.Railroad I've certainly made mistakes. I've certainly learnt from certain things where I've been able to pivot and change and, and go, yeah. Okay. That didn't work. So let's, let's move on and let's do this. I'm sure you get a lot of questions about your mistakes. I'm generally pretty interested to know what are you most pleased about in terms of strategic thinking?People will say you only learn from your mistakes. You don't learn from your successes. That is not true. I've learned stacks from when I'd make a good strategic decision, and I'm going to keep doing [00:52:00] that. Where did your strategy really serve for you to get to where you are now? As you look back in hindsight, you can think, ah, I see now why that really contributed.It's asking that one question over and over. What do our customers through through asking that and exploring that and be curious, curious around it, holding stock, investing in automation all the things that we've done to, to. Complish that has, has led us to here. So I think that that has been one of the the most insightful and valuable things that we were able to hold onto as a, as a, a guide along the journey people ask me, is they all the time, the same thing, actually oddly enough I give them the tour of the facility.So they see all the automation and the robots and the automatic packing machines, conveyors, you know, hundreds and hundreds of thousands of books everywhere. It's like, they go crazy. And as we were walking back towards the office, they say, oh, you must be so proud how proud you must be. And I say, [00:53:00] I say to me, I said to them, this is pride to me.Imagine yourself in a pitch black room where you can't even see the hand in front of your face, that you. You know, when you take a step forward that you're on track or off track, simply by the way that your foot strikes the ground. Nah, that doesn't feel right. That that's where I'm going to be. That is pride to me.So it's very, very internal. It's very internal. It's a very, yeah. Internal sense of knowing they say that in the money in you, I remember that flip chat that height was on track only 3% of the time and 97% on you know, correcting and re and reconnecting back to be on track. So it's a bit like that.So yeah, I'm the successes to me in terms of some of the things that have come that have come through is, is like, is that knowing that you're on track? Knowing that that, and that, that you're not, you're not there yet. Like one of the thing with the IPO people asking me, oh, you must be, you must feel fantastic.It must be [00:54:00] great to list. And like I could tell by the way they were asking, it's like, this is kind of feels like you finally made it. And I said at the ASX, in my, in a speech to the people that were there, I said, I said, here it is. This is the way it feels to me. It's like being on the tour, de France you're on the 10th stage.And the IPO is the 40 kilometer go banner, where you've got still 40 Ks to get to the top of the mountain to finish the stage. And after that, you got an another 11 more stages before you get to the sharps Elisa. When you get to drink champagne with your mates, go 20 kilometers an hour and, and make it to the finish line.I said I said, this is just assigned to say, you're on track and you want that in your revision mirror really quick, because it's focused on whatever you got to do next. And that that's how that the IPO and many of the other things that we've accomplished as well, Telstra business awards, so forth, I'm sensing from you.And I'm sure it's coming through to our viewers. You ha you've become more of you through this process. And not [00:55:00] less of you. I see a lot of business owners have success. I would call a successful or a business that's in the public eye and they seem to magnify aspects of themselves that perhaps they wouldn't be pleased with.As they look back, I have a sense that you're pleased with. As you look back of you becoming more review in the aspects of you that you like about yourself. It's I would, I would put more of that down to marriage. Nice. Yeah. You know, my wife and I have been together for almost 10 years. My son is 18, so yeah.I never got married, but I I'm a father and and my ex works in the business. My wife was married before, I've got a 15 year old stepdaughter and, and I, I would say that re you've got a lot of hope and you've got a lot of you know, imagination about why you want to marry that person and be in that relationship.But I can assure you it is at times you do not feel like you're going to be married the next day. And that [00:56:00] divorce lawyers are going to be, I going to be cold in, but you talk it through and you love each other and you keep discovering, you know, how you're, how you're connected and you know, what's not working for you and why what's going on for you.And it's it's businesses. Life is like that. It's, it's a, it's a, an emotional. Marriage of, of, of achiever accomplishing something together and, and that it's easy to bail out and go, you know, I'm pulling the rip cord and I'll see you back down on the ground. You know, I'm out of this one, it's going to crash and burn or you're in it for the longterm.So, so I have no there's no guarantees that cath Catherine and I are going to be together. We just are in it every day. And Y that's how businesses is as well. It's like, you've got, you've got, you're dealing with issues and you're being, you're being asked to step up and learn and challenge yourself.And, [00:57:00] and and that that's, you know, that you're either, you're either invested in your own personal yeah, that's what I'm sensing in. You, you either are invest in becoming the best of you and you bring that and business requires that. So does marriage. You've got to want to bring your best to it for the best of it to flourish, or it's not going to be the best.It's going to be some facsimile that just can't sustain. That's right. Add on top of that parenting, would you even take you at a whole nother level? But I think, I think for me that even one of my best mates product from when I went to high school, he goes, Tony, I know you from, I know you from high school Chatswood high school, just a typical, you know, public school.And he goes, how the hell did you end up here? Like what? I know that kid. Right. It's impossible to think that you're the guy, but it's just that personal mission that voyage of discovery to find out more and ask those questions and to go deeper and [00:58:00] understand yourself and unpack. I liked, I liked to do personal development workshops.I did many of them just with Robert. I did tons of different ones to me now being in businesses like a personal development workshop, being in a marriage and being a parent is like a personal development workshop to act like it's not it's to let down the other team, you'll let down your business. You let down your wife or your husband, you let down your kids.If you don't see this moment as an opportunity for ourselves to grow, cause then we put it on them and it's up to them to change it's up to them to do bad, or it's up to them to stop it rather than saying, what can I own in this? That's what I got from my personal development. How much of this can I look within rather than.I can easily point don't get me wrong, but how much can I look within myself? If there was an entrepreneur starting out today, what would you be talking with them or mentoring that mentoring them about other than the basics and getting the fundamentals in play? Most of the time when I meet entrepreneurs what's missing [00:59:00] is that the point of cash?Where is someone going to hand over the money to that's something. And I'll share with you a story. When I was at business school with Robert Kiyosaki in 1993, I The course of 16 days, it was incredible. You at 7:00 AM and you're running team, you finished at 2:00 AM and your marketing teams. He flew people in a crisis, many different subjects all through the, through the 16 days.I learned so much and it was three years before I started my own company. But during, on one of the days as a, just as a process, as a, as a challenge at the break, he sent us out and said, what I want you to do is I want you to go out there. And we were in Hawaii on the big island of Hawaii, and I want you to go out there and sell.And if you got a dollar bill in your pocket, just take it out. That was 150 in the course, just go around and sell it. And if you, for the point of integrity of the process, if you could be the, the one being sold to, if you feel like you want that, then you got to hand over your dollar. And I went out and I was in recruitment.So I went out hard and strong. Like we've got the [01:00:00] best business, we've got the biggest, we advertise more in marketing than anyone else, Ellison in the newspapers. And we, we attract more candidates and so on and so forth. And I was just saying all these. You know, it was really intense. And I came, I came back in after that, I had not made one back test as a really hopeless, you know, I'm the best salesman in my company that that really sucks.And so I walked back into the room and the course goes on the next break. He does the same thing. I changed my tactic and I, I'm more loving, you know, I listened, we listened to our candidates. We, we understand what they need. We talk to our clients really looking for what they want. And we, we do, it's like a matchmaking service and people were much kinder in the feedback this time around tenure.I really love what you're saying, but no, I don't think so. I went back into the room and go that price that's really sucks. I hate that prices I'm in the best salesman in my company. And so of course goes on. Then we take the next break [01:01:00] and I do something completely different. I sit in the corner with my arms folded and my legs crossed and I said, well, you can go and get stuffed.Right. That didn't work either. Can't believe it. Yeah. While I was sitting there and got into myself, you know what? I just, this is not right. What am I not thinking? What am I doing here? That's this is, I've got, something's got to change. And while I'm sitting there, I realized, oh my God, two years ago, I remember I did that.That remedial massage course, I can go out and offer a massage. So the next break, I offered three minute massages for a dollar. I made four backs. And seriously, when you ask that question, in terms of entrepreneurs, it's about really understanding where the Kashi is. So when, when we had our before our internet marketing business, we had a chat software company and the.com crash.And we were not, no one was interested in putting chat software in the website. We couldn't pay ourselves a salary. My son had just been born. My [01:02:00] brother and brother-in-law his families. They, I mean, they did, they couldn't earn any money. My parents were giving us a bit of money to make it through. And I was speaking to a web designer asking them.How do you, how do you get to the top of Google? Like if we were at the top of Google for the software that we had, which was chat software for the internet, how do you get to the top of Google as someone does a search? Cause they'd been goin

With the anticipated adoption of ICH-E8-R1 this summer, there's going to be even more attention on patient voice and engagement and critical-to-quality factors. MCC's Quality by Design (QbD) - Risk Based Quality Management (RBQM) – Quality Improvement community of practice group is has already developed practical tools to help optimize quality by design. These are some of the key topics discussed in Keith Dorricott's interview with Linda Sullivan, MBA, Executive Director of WCG's Metric Champion Consortium. Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates the MCC QbD-RBQM- Quality Improvement Group.  The Cost of Poor Quality Estimator Tool enable users to estimate the financial impact of quality problems that arise during study conduct, notes Dorricott.  Other tools developed by MCC members in the quality by design area, note Sullivan and Dorricott, include the protocol development quality scoring tool and the protocol operational complexity scoring tool, which support the process of identifying potential quality problems during protocol development. Both  tools include consideration of the patient perspective, and the protocol operational complexity scoring tool calculates a patient burden measurement as well, adds Sullivan. MCC members will be reviewing the tools over the next few months to determine what updates will be needed to align with ICH-E8-R1, she notes. Finally, Sullivan says, MCC will be launching a Patient Diversity community of practice group this month to provide a place for members to consider how to assess the impact of patient engagement programs and to ensure that the “voice of the patient” is incorporated into QbD tool updates. For more on this topic, check out the MCC website,  https://metricschampion.org. And while you're there, check out the upcoming MCC Virtual Summit,, www.mcc-summit.com

In this week's episode we take a sneak peak at Madonna King's newest (soon-to-be-released) book Ten-ager. Available from the 27th January from Booktopia, Dymocks, QBD and all good book stores.The book looks into what we all are starting to see firsthand in everyday life, which is, teenage-hood is starting a lot earlier than it used to. And we're now starting to see the characteristics of teenage development is actually starting as early as the age of 10.Madonna saw this and, and has utilised this as the basis for this outstanding book. I was lucky enough to nab access to a secret early copy and I can tell you it is such a well-executed and research body of work. In this week's special episode we covered:Her personal confidence & its influences when she was a teenagerWhat surprised her when undertaking the research to write Ten-agerThe importance of letting your daughter have and express opinionsHer thoughts on the impact standardised testing has on confidenceParents' expectations about their daughter's resilience and gritUpsetting discoveries about 10 year old girls in Australia todayThe importance of communication between parents and daughters... and so much more!About Madonna KingMadonna King is one of Australia's most accomplished journalists, having won awards for her ABC Mornings current affairs program.She is the author of ten books, including the bestselling Being 14 which was ABIA shortlisted for non-fiction book of the year, and Fathers and Daughters.She has interviewed five prime ministers, at least a dozen premiers, some of Australia's leading chief executives and the full range of sportsmen and entertainers - and possibly most exciting - over 1000 10 and 14 year old girls, their parents and educators!Also the biographer of Australian of the Year Professor Ian Frazer and former treasurer Joe Hockey, Madonna lives in Brisbane with her husband and two teenage daughters.

GUESS WHAT?!?! The Nasty Woman Club has started a BOOK CLUB. On the first Sunday of every month myself Demi Lynch and contributor Ellie Stamelos will be reviewing and discussing a book that looks at issues and topics in the world of intersectional feminism. To kick off this series we decided to deep dive into Glennon Doyle's latest memoir - UNTAMED.To read Ellie Stamelos' written review on UNTAMED head to TNWC website - thenastywomanclub.comSeptember's book of the month is EGGSHELL SKULL by BRI LEE. It's available at Booktopia, Amazon and QBD. Ellie and Demi will be reviewing the book on the podcast on the first Sunday of October.Feel free to message The Nasty Woman Club Instagram and Facebook pages with your thoughts on Eggshell Skull - we'd love to include others' thoughts on the book in the future episode.The Nasty Woman Podcast is hosted and produced by Demi Lynch.For more stories on intersectional feminism and women empowerment head to thenastywomanclub.comMake sure to also join The Nasty Woman Club Facebook groups 'The Catch Up' and 'Unfiltered.' If you wish to support this podcast and The Nasty Woman Club platform head to paypal.me/thenastywomanclub See acast.com/privacy for privacy and opt-out information.

Ross has recently completed his PhD at the Manchester Institute of Biotechnology. Ross has worked on modern tools for fine-tuned regulation of gene expression in bacteria, with a focus on applying statistical modelling techniques and QbD and Design of Experiments to rapidly engineer and optimise genetic toolkits. Ross is currently working at the University of Manchester as a postdoctoral research associate in the lab of Dr. Neil Dixon, but will shortly be starting a new position at Syngenta as an Automation Scientist. In this episode we're talking with Ross about his work, Design of Experiments, Computer-Aided Biology, the impact of the coronavirus pandemic and more. Referenced Links Survey and CAB website: https://www.computeraidedbiology.com/cab-survey https://www.computeraidedbiology.com Paper explaining why we need DoE: https://pubmed.ncbi.nlm.nih.gov/26505134 Synthace articles on DoE: https://synthace.com/blog/2020/6/4/heres-why-you-should-stop-doing-science-like-you-were-taught-in-high-school-part-1 https://synthace.com/blog/2020/6/29/heres-why-you-should-stop-doing-science-like-you-were-taught-in-high-school-part-2

Ross has recently completed his PhD at the Manchester Institute of Biotechnology. Ross has worked on modern tools for fine-tuned regulation of gene expression in bacteria, with a focus on applying statistical modelling techniques and QbD and Design of Experiments to rapidly engineer and optimise genetic toolkits. Ross is currently working at the University of Manchester as a postdoctoral research associate in the lab of Dr. Neil Dixon, but will shortly be starting a new position at Syngenta as an Automation Scientist. In this episode we’re talking with Ross about his work, Design of Experiments, Computer-Aided Biology, the impact of the coronavirus pandemic and more.Referenced LinksSurvey and CAB website:https://www.computeraidedbiology.com/cab-surveyhttps://www.computeraidedbiology.comPaper explaining why we need DoE:https://pubmed.ncbi.nlm.nih.gov/26505134Synthace articles on DoE:https://synthace.com/blog/2020/6/4/heres-why-you-should-stop-doing-science-like-you-were-taught-in-high-school-part-1https://synthace.com/blog/2020/6/29/heres-why-you-should-stop-doing-science-like-you-were-taught-in-high-school-part-2

Is survival cannibalism illegal? After the crew of the Mignonette turn to the custom of the sea, they find themselves embroiled in a landmark 19th Century court case. The status of maritime cannibalism in British law will never be the same again. TRANSCRIPT https://castinglotspod.home.blog/2019/12/12/8-sea-part-v-the-mignonette/ CREDITS Written, hosted and produced by Alix Penn and Carmella Lowkis. Theme music by Daniel Wackett. Find him on Twitter @ds_wack and Soundcloud as Daniel Wackett. Logo by Riley. Find her on Twitter and Instagram @tallestfriend. Casting Lots is part of the Morbid Audio Podcast Network. Network sting by Mikaela Moody. Find her on Bandcamp as mikaelamoody1. BIBLIOGRAPHY Australian Town and Country Journal (Sydney, NSW : 1870 – 1907). (1884). ‘The wreck of the Mignonette’, Australian Town and Country Journal (Sydney, NSW : 1870 – 1907), 15 November. Available at: https://trove.nla.gov.au/newspaper/article/71020081/5045099# Hanson, N. (1999). ‘The custom of the sea’, Independent, 6 October. Available at: https://search.proquest.com/docview/311526455 Hibbard, A. (2019). ‘Cannibalism and the late-Victorian adventure novel: The Queen v. Dudley and Stephens’, English Literature in Transition, 1880-1920, 62(3), pp. 305-327. Available at: https://muse.jhu.edu/article/721841/summary Kidd-Hewitt, D. (2017). ‘Homicide By Natural Necessity: The Mignonette Tragedy’, David Kidd-Hewitt, 6 November. Available at: https://davidkiddhewitt.wordpress.com/2017/11/06/homicide-by-natural-necessity-the-mignonette-tragedy/ Moreton, C. (1996). ‘He wanted some adventure on the high seas. His shipmates ate him’, Independent, 28 July. Available at: https://www.independent.co.uk/news/uk/home-news/he-wanted-some-adventure-on-the-high-seas-his-shipmates-ate-him-1330828.html. The Queen v. Dudley and Stephens. (1884). 14 QBD 273 DC. Available at: http://www.bailii.org/ew/cases/EWHC/QB/1884/2.html

Welcome to Episode 3: Nautical! Today we talked about: vegans & cannibals, horses & turtles, and (of course) Richard & Parker.| James: R v Dudley and Stephens 14 QBD 273 DC | Henry: “Graveyard of the Atlantic: Shipwrecks of the North Carolina Coast” by David Stick | Gabe: “The Ashley Book of Knots” by Clifford W. Ashley & “The Shipping News” by Annie Proulx Our intro/outro music is "Listen to the Radio" by JHS Pedals

In Episode 6, Dr. Phil Nethercote discusses the factors that led to the beginnings of MLCM and QbD in 2004; his early days at GSK and the implementation of MLCM; and how Method Lifecycle Management might evolve.

In our second episode, we examine a method lifecycle management approach in monitoring method performance and applying MLCM to address real world issues like nitrosamines (ni-tros-a-mine) in Valsartan.

Welcome to the 22nd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin has a depth of experience in pharmaceutical development and implementing methodologies founded in Quality by Design (QbD). He is a Chemical Engineer and got his PhD in Chemical Engineering from Rutgers University. He has been spending the past 12 years in the inhalation part of life sciences and pharmaceutical development. He has gotten involved in the area of QbD in the last 4-5 years to try and understand how they can better their development on their products at Experic, where he serves as Director of Pharmaceutical Development and Manufacturing Services.   Today they are going to be discussing Quality by Design — a really important and hot topic in pharmaceuticals! In the past decade, there has been rapid adoption of QbD on the pharmaceutical side of the life sciences industry. So tune in to learn all about what QbD is, what the overall process looks like, the phases and approach of a formalized QbD process from a pharmaceutical development perspective, the relationship between QbD and experimental design, how QbD can help design an effective product development plan, and much more.   Key Takeaways: [:14] About today’s episode. [1:49] About today’s featured guest, Justin Lacombe. [2:08] Justin introduces himself and gives some background about his career. [4:05] Justin explains what QbD is and what the overall process looks like. He then goes a bit deeper, explaining the phases and approach of a formalized QbD process from a pharmaceutical development perspective. [9:01] Justin explains the relationship between QbD and experimental design, and how this all ties into controlled strategy for manufacturing. [15:18] Justin outlines how critical quality attributes and QbD can help design an effective product development plan. [20:41] Why is QbD so critical for tech transfer? [23:23] Mandy highlights the benefits of QbD. [25:35] Thanks for listening to this week’s episode! If you have any questions for Mandy you can contact her at . If you have any questions for this week’s guest, Justin Lacombe, you can contact him on his LinkedIn page, linked below.   Mentioned in this Episode: Justin Lacombe (LinkedIn) Quality by Design (QbD) Tech Transfer Mandy.Podcast@Solabs.com

In our first episode, host Greg Martin of Complectors Consulting talks with Dr. Phil Borman of GSK about the advantages and influences of  method lifecycle management including analytical quality by design, risk assessment tools, ICH guidances, and opportunities to kick off the approach in your organization.

Barrister Chris talks about Strict Liability and how it even applied to a 15 year old defendant in R v G (2005). We also touch upon the offence of selling alcohol to minors. Further on R v G [2008] UKHL 37 Further reading on Strict Liability could include; Cundy v Le Cocq (1884) 13 QBD 207, Alphacell v Woodward [1972] AC 824, Warner v MPC [1969] 2AC 256 Alongside the detailed case studies, in these shorter “Brief Notes” episodes, Chris will tell us what being a barrister is really like, as well as explaining the court system, legal tactics and even answering any questions listeners may have.  Mondeo Law is written and produced by Alex Boardman and Chris Kehoe, and was developed with Ant McGinley (@antmanlovesyou) Brief notes theme music is Funk Down by MK2, and appears under creative commons 3.0 license, Follow us on social media @mondeolaw on Twitter and Instagram.

A bonus flashback podcast that takes a fresh look at Carlill v Carbolic Smokeball Co. [1892] EWCA Civ 1, [1893] 1 QBD 484. Examines unilateral offers and the elements of a contract under UK law.