Episodes
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Today’s guest is Dr Paul Hamilton, Clinical Director of Early Phase Research at Pacific Clinical Research Network (PCRN).
This episode is brought to you by SAPRO Consulting: https://www.saproconsulting.com.au/
New medicines are first studied in animals before they are tested in humans. Animal testing provides an insight into the efficacy, safety and tolerability of the new medicine. But before a new medicine can be tested on their intended patient population, the so-called "First In Human" (FIH) testing needs to take place. This is typically done in Normal Healthy Volunteers (NHVs) - i.e., a group of healthy individuals, not taking any prescription medications. Once the safety and tolerability of a new medicine has been substantiated in NHVs, only then can the medicine be tested in a patient.
These types of trials are Phase 1 and 1b/2a trials, respectively, and are collectively called "Early Phase Trials". Early Phase trials are an exciting part of the clinical trials spectrum, as this is where the "Proof of Concept" is first determined. And, as Dr Paul Hamilton explains, can deliver impressive health improvements if the technology works as expected.
As time progresses, new medicines become more targeted as we enter the era of "precision medicine". The drugs of tomorrow, are being tested today. The argument for participating in a clinical trial as a patient with a disease is compelling as Dr Hamilton explains in this podcast.
In this episode, Dr Hamilton and I discuss:
The importance of Early Phase Clinical TrialsWhy clinical trials need to be seen as a component of a patient's overall healthcare journey Future opportunities and challenges in the Clinical Research/Trials space in New ZealandYou can find out more about Dr Hamilton and Pacific Clinical Research Network (PCRN) here:
Pacific Clinical Research Network
Paul Hamilton - LinkedIn
PCRN - LinkedIn
Timestamps:
00:00 Teaser
00:22 Introduction
01:30 Pivoting from from medicine and clinical research
08:40 Paul's defining moment in clinical trials - Sofosbuvir
12:30 Danicopan
15:50 The future of medicine starts with Early Phase research
21:30 Early Phase vs. Late Phase
23:30 Setting up a new Early Phase research location
29:25 Clinical trials have a responsibility for delivering healthcare
33:00 Designing good early phase studies
37:00 The Future of Clinical Trials in New Zealand
44:25 Advice for getting into clinical research
Dr Paul Hamilton | Clinical Trials are driving the Future of Medicine and Healthcare | Ep 22
innovation #podcast #newzealand #commercialization #clinicalresearchassociate #technologytransfer #biotech #science #choices #country #entrepreneur #products #clinicalresearch #biotech #clinicalpractice #chatgcp #healthcare #clinicaltrials -
Today’s guest is Dr Brian Ward, Founder and CEO of Aroa Biosurgery, an ASX-listed, biotech company with with a ~$200 m AUD market capitalization.
This episode is brought to you by SAPRO Consulting.
Aroa Biosurgery is a New Zealand-based, ASX-listed biotech company that develops and commercializes novel products that promote wound healing and soft-tissue repair. Their proprietary products, developed from tissue taken from the fore-stomach of sheep, provide the body with structural and biological components that provide a head start in the healing process.
Biotech is a hard business. It's expensive, time-consuming and the road to success is fraught with difficulty and complexity and many biotech companies never make it to profitability. Despite this, there are a number of biotech entrepreneurs with such a fire within them that the odds seem to be in their favour.
Dr Ward's and the Aroa Biosurgery story is remarkable. From the idea, to the product, the manufacturing and commercialzation, the various challenges that have arisen have been overcome resulting in a compelling success story that would inspire any current, or aspiring, biotech entrepreneur.
In this episode, Dr Ward and I discuss:
1. The eureka moment that made Brian pivot from clinical practice to entrepreneurial endeavour
2. The science and technology that underpins their novel products
3. Brian's tips for aspiring biotech entrepreneurs - just get started, understand it will not be easy, be prepared for a "game of attrition" and surround your self with people smarter than you.
You can find out more about Brian Ward and Aroabiosurgery here:
LinkedIn - Dr Brian Ward
LinkedIn - Aroa Biosurgery
Aroa Biosurgery Website -
Missing episodes?
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Today’s guest is Madhu Vyas, Theranostics Site Leader at Mercy Radiology, and Programme Lead at Unitec.
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
Nuclear Medicine, Molecular Imaging and Radiochemistry sound like terms pulled straight from a science fiction novel. Yet the use of radioactive materials for the purposes of diagnosing and treating disease - collectively referred to as theranostics (therapy + diagnostics) - are commonly place and an exciting field of discovery and development.
But with so many different radioactive materials to choose from, each with their own characteristics, how do researchers and physicians choose the right one? And how is the radiation targeted to the desired organ or diseased tissue without damaging normal tissue?
In this episode, Madhu and I discuss:
1. The origins of nuclear medicine, molecular imaging and "theranostics"
2. How radioactive material is targeted to different tissues within a patient for the purposes of either diagnosis or therapy
3. What we can expect for the future of an area of medicine that is now hitting it's stride
Madhu Vyas' passion for this field is palpable. When not working as the Theranostics Site Leader at Mercy Radiology, he is teaching the next generation of Medical Imaging technicians and also completing a PhD. Clearly, Madhu has discovered a way to wring more than 24 hours out of a single day!
You can find out more about Madhu, Mercy Radiology & Unitec:
https://www.linkedin.com/in/150880/
https://www.linkedin.com/company/mercy-radiology/ https://radiology.co.nz/ https://www.linkedin.com/school/unitecnz/
https://www.unitec.ac.nz/
#newzealand #radiochemistry #radiation #radiationtherapy #theranostics #nuclear #nuclearimaging #molecularimaging #theranos #innovation #podcast #commercialization #science #entrepreneurship #innovation -
Today’s guest is Will Charles, the Executive Director of Investment at UniServices.
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
UUniversities are a great place to get higher education, but they're also places where new ideas, concepts and technologies first take root. But how do new ideas make their way from the academic setting to the commercial setting?
UniServices is wholly owned by the University of Auckland and is a not-for-profit, stand-alone company that provides support to researchers by helping them secure the funding and connections that can help them make a positive impact.
Will Charles (great surname) has built an amazing career over time, tacking on new skills to make him a force in the world of commercialization of science and ensuring that University Intellectual Property simply doesn't gather dust on a shelf.
In this episode, Will and I discuss:
What Technology Transfer isHow UniServices supports acadmics and entrepreneurs alike3. Will's recommendations for budding entrepreneurs - top tip: Get in early, make mistakes in a low-risk environment (i.e., while at university).You can find out more about Will and UniServices here:
https://www.linkedin.com/in/will-charles-b4005a5/ https://www.uniservices.co.nz/ https://www.linkedin.com/company/auckland-uniservices-limited/
#newzealand #technologytransfer #innovation #podcast #commercialization #science #entrepreneurship #innovation -
Today’s guest is Dr Rohit Katial, a Research Physician involved in Early Phase Clinical Trials in New Zealand.
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
Unfortunately, in New Zealand our access to modern medicines is well behind our OECD peers, and it typically takes 10 years before a new medicine is funded by Pharmac after being approved by Medsafe. Thus, Clinical Research is starting to do more and more of the heavy lifting to fill the gap between need and access.
An interesting component of ClinicalResearch is Early Phase trials - which range from firstinhuman trials, to the initial studies in patients i.e., single ascending dose or multiple-ascending dose studies, aptly shortened to SAD or MAD trials.
New Zealand is increasingly becoming an attractive place to conduct Early Phase research, by virtue of our diverse & young population, less onerous regulatory requirements and skilled workforce.
Despite this, early phase ClinicalResearch is not an obvious career choice for those studying or participating in medicine. This is a challenge that will need to be addressed if we are to make the most of the opportunity that is before us.
In this episode, Dr Rohit Katial and I discuss:
1. His journey from mainstream medicine to early phase clinical research
2. the core skillset that is needed to be proficient as an early phase clinical trials investigator
3. Some of the exciting trials Rohit has been a part of....hint: gene editing
You can find out more about Rohit and New Zealand Clinical Research here: https://www.linkedin.com/in/rohit-katial/ https://www.linkedin.com/company/nzcr-christchurch/ https://www.nzcr.co.nz/
#newzealand #clinicalresearch #innovation #podcast #clinicalresearchassociate #principalinvestigator #clinicaltrials #CRISPr #geneediting -
Today’s guest is Shamubeel Eaqub, and economist, author and commentator.
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
In this episode Shamubeel and I discuss New Zealands productivity has not kept up with our OECD peers. Reasons for this include some things we cannot change, such as the fundamental realities of our small population and remote location at the bottom of the South Pacific, but also things we can, including policy settings, institutions, incentives, long-termism, and culture.
Some very impressive companies have been built in New Zealand by some truly great minds, yet it would seem that the success of these companies has not been due to the settings, but rather in spite of them.
https://open.spotify.com/episode/2zKFT444A8FhtpnWlJx2Ci?si=6d1621a6b10e41ba
You can find out more about Shamubeel here:
https://www.linkedin.com/in/eaqub/
#newzealand #incentives #innovation #country #commercialization #government #economy #productivity #universities #biotech #risk #shorttermism #choices #geography -
Today’s guest is Natalia Lopez, the Co-Founder and Chief Operations Officer of Kitea Health.
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
In our first episode of 2024, we are picking up where we left of in 2023 with another guest from Kitea Health - this time with Chief Operations Officer Natalia Lopez.
We talk about Natalia's journey from the automotive industry to Medical technology, the importance of developing meaningful skills to bridge the gap between the science "bench-top" and the patient, and dive a little deeper into the technology that underpins Kitea's novel deveice of the monitoring of Physiological Pressure.
This was a very inspiring discussion, and we're looking forward to the day where Kitea's vision for proactive healthcare is a reality.
You can find out more about Natalia Lopez and Kitea Health here:
https://www.linkedin.com/in/natalia-lopez-a34457147/
https://www.linkedin.com/company/kitea-health/
https://www.kiteahealth.com/
#research #clinicalresearch #clinicalresearchassociate #healthcare #research #pharmaceuticals #podcast #podcasts #medicine #medicalresearch -
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
Today’s guest is Dr Simon Malpas, the Co-founder and CEO of Kitea Health.
Simon is a distinguished New Zealand scientist and entrepreneur, and has co-founded three successful medical device & life science companies from his research, including Kitea Health, a Start up company transforming healthcare for people living with chronic conditions via the monitoring of physiological pressure.
In this episode we discuss:
How Kitea’s technology can help us graduate from a Reactive to a Proactive model of healthcare for chronic conditionsKitea’s plans to address the unmet clinical need in patients with hydrocephalusKitea’s commercialization journey to date, including their upcoming first in human clinical trial, slated for 2024.This was a super interesting discussion, with plenty of insights for budding life science entrepreneurs, and for someone with a passion for clinical research I will be watching their progress closely over the 2024.
You can find out more about Simon Malpas and Kitea Health here: https://www.linkedin.com/in/simon-malpas-65052268/ https://www.linkedin.com/company/kitea-health/
https://www.kiteahealth.com/
research #clinicalresearch #clinicalresearchassociate #healthcare #research #pharmaceuticals #podcast #podcasts #medicine #medicalresearch Subscribe for free on Spotify - https://open.spotify.com/show/3Vet6Hn8XFMhprr2LrY3XS
Get in touch in the comments below or head to: https://www.instagram.com/chat_gcppodcast/ -
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
Dr Chris Wynne is the Chief Scientific Officer at New Zealand Clinical Research (NZCR). Chris has had a career of giant proportions in Clinical Research, and has been involved in a wide range of trials, including the early trials that laid the groundwork for the function cure of Hepatits C, down to the Pharmacokinetic studies for Juul - the infamous flagship vaping product of the late 2010s.
In today’s episode you can expect to learn:
What makes NZ a great place to do Clinical ResearchWhy the language of Clinical Research, and science more broadly, doesn’t translate well into marketingChris’s hopes for the future of Clinical Research in NZ and abroadMuch much more...Always great to speak with Captains of Industry, and Chris fits that description all too well. We need to capture the hearts and minds of more talented individuals to create products that will serve our populations in the future.
You can find out more about Dr Wynne and NZCR Here:
https://www.linkedin.com/in/chris-wynne-b0414241/
https://www.linkedin.com/company/nzcr-christchurch/
https://www.nzcr.co.nz/
#research #clinicalresearch #clinicalresearchassociate #healthcare #research #pharmaceuticals #podcast #podcasts #medicine #medicalresearch -
This episode is brought to you by SAPRO Consulting PTY Ltd https://www.saproconsulting.com.au/
Courtney Rowse is the Clinical Operations Manager for MSD (ANZ). Clinical Research is one of those industries where most people get into it by accident. There are no consistent pathways into the industry, in fact if you were to sample 100 people, the only consistency would be inconsistency.
Join us for Episode 11 where you can expect to learn:
Why New Zealand is a great place to conduct Clinical ResearchWhy working at the site-level and Sponsor-level are not so differentThe "WHY" behind Courtney’s passion for the industry- and much, much more…I really enjoyed this conversation with Courtney, we may be biased, but we both agree that Clinical Research is a great industry to be a part of. Every now and then we need a good reminder that everything we do is centered on the patients we serve.
You can find out more about Courtney and MSD here:
https://www.linkedin.com/in/courtney-rowse-7592a21a7/
https://www.linkedin.com/company/msd-australia/
#research #clinicalresearch #clinicalresearchassociate #healthcare #research #pharmaceuticals #podcast #podcasts #medicine #medicalresearch -
Kieran Jina is Partner at Pacific Channel, a Venture Capital firm focusing on start-up companies using breakthrough science and advanced engineering to seucure the future of Health, Environment and Food, aka "Deep Tech". Their second Fund "Pacific Channel Fund II" is the largest fund of its type and sector in New Zealand.
Venture Capital has a certain mystique to it. What does a Venture Capitalist do, where do they get their money from and how to they choose the companies they invest in,....and importantly.... do you have to wear Patagonia?
Join us in Episode 10 where Kieran and I discuss
why Venture Capital is pivotal for a functioning startup ecosystemthe similarities between capital raising for a VC fund, and the capital-raising that is done by startup founderswhat makes a good venture capitalisthow to get started in Venture Capital........and much much more.You can find out more about Kieran, Pacific Channel and Upstream here: https://www.linkedin.com/in/kieran-jina-63202752/
https://www.linkedin.com/company/pacific-channel-limited/ https://www.linkedin.com/company/upstreammedicaltechnologiesltd/
#venturecapital #investment #medtech #medical device #research #clinicaltrials #clinicalresearch #podcast #podcasts #medicine #healthcare #medicalresearch #venturecapital #startup #startups #entrepreneur #entrepreneurship -
Dr Diana Siew is the Strategic Partnerships Lead for the Bioengineering Institute and the Co-Founder of the Consortium for Medical Device Technologies (CMDT).
Twelve years ago, there was not much in the way high-value Medical Research commercialization - publicly-funded research was sitting idle, and international companies were bypassing New Zealand in favor of other countries. Dr Siew has been pivotal in growing New Zealand's capacity in Research Commercialization, particularly in the realm of Medical Technologies (MedTech).
Join us in Episode 9 where Diana and I discuss why the CMDT was started, the importance of screening-out bad ideas early, how the ABI/CDMT achieve high rates of success, opportunities for the next 12 years....and much much more.
You can find out more about Diana, the ABI and CMDT:
https://www.linkedin.com/in/diana-siew-05139310/
https://www.linkedin.com/company/auckland-bioengineering-institute/
https://www.cmdt.org.nz/ -
Hanie Yee is the COO of Alimetry, a New Zealand-based MedTech company developing a device for the non-invasive diagnosis of gastric disorders; as well as the Investment Committee Chair for the Return on Science MedTech and Surgery Investment Committee.
Hanie began her career in Clinical Research and worked with some of the big names in the industry including Genetech and Takeda, before moving to Fisher & Paykel, the most valuable company on New Zealand's stock exchange. After catching the entrepreneurship bug by way of an MBA, Hanie jumped aboard the start up company Alimetry, and has since contributed to what is one of New Zealand's most visible success stories in the MedTech sector. With her considerable experience, passion and expertise, Hanie is also fostering the next generation of MedTech entrepreneurs via her role as the Investment Committee Chair for the Return on Science MedTech and Surgery Committee.
Join us in Episode 8 where Hanie and I discuss what inspired her to jump ship from the "Oil Tanker" that was her previous role to the "JetSki that is Alimetry, her philosophy when it comes to building a team to execute a vision, why New Zealand could become the Silicon Valley of MedTech world....and much much more.
You can find out more about Hanie, Alimetry and Return on Science here: https://www.linkedin.com/in/haniey/
https://www.linkedin.com/company/alimetry-ltd/
https://www.alimetry.com/ https://www.returnonscience.co.nz/
#medicine #surgery #surgeon #medical device #resarch #clinicaltrials #clinicalresearch #podcast #podcasts #medicine #healthcare #medicalresearch #venturecapital #startup #startups #entrepreneur #entrepreneurship -
Julie Jones is the Founder and CEO of BioValeo, a New Zealand-based Contract Research Organization (CRO) providing services to companies developing Precision or Personalized Medicine Interventions.
As medicine progresses, treatments are becoming more specific and tailored to the individual patient. Rather than bundling patients according to a high-level disease category, next generation treatments offer targeted interventions based on their specific disease characteristics - via their genetic or other biomarkers, for example. With this increased "Precision" or "Personalization", comes additional complexity, cost and regulatory scrutiny.
oin us in Episode 7 where Julie and I discuss how Precision or Personalized Medicine trial differ from the "status quo" and why a bespoke CRO is needed to support these trials; the long-term healthcare and economic benefits of developing the supporting infrastructure for Precision/Personalized medicine trials; the exciting developments happening in this space in New Zealand....and much much more.
You can find out more about Julie and BioValeo here:
https://www.linkedin.com/in/julie-jones-64198215/
https://www.linkedin.com/company/biovaleo-limited/
https://www.biovaleo.com/
#medicine #precisionmedicine #personalizedmedicine #research #clinicaltrials #clinicalresearch #podcast #podcasts #medicine #healthcare #medicalresearch #venturecapital #startup #startups #entrepreneur #entrepreneurship -
Prof Greg O'Grady is a Professor of Surgery and the CEO of Alimetry, a New Zealand-based MedTech company developing a device for the non-invasive diagnosis of gastric disorders, such as neuromuscular dysfunction, Gut-brain disorder, Gastric Outlet Disease, to name a few.
Greg's career is truly impressive, and with each rung he has climbed, the scale of the impact he can effect has increased. As a doctor & surgeon, he had the ability to improve the lives of one patient at a time. As a Researcher involved in the development of new techniques or procedures, he could improve the lives of more patients as those improvements were passed on to to other physicians & surgeons. As a Professor, he contributed to the education of the next generation of physicians, who would in turn improve the lives of their patients. But as the an Entrepreneur and CEO responsible for the development of a new medical technology that could improve the lives of as much as 10% of population, the scale of potential impact is unparalleled. It is the ultimate manifestation of the Hippocratic Oath of doing the most good, with the least harm.
Join us in Episode 6 where Greg and I discuss what drove his career pivot from surgeon and surgical/medical research to commercialization, the scale of the problems that Alimetry's device is attempting to solve, why the Healthcare System has a so-called "immune-system" against the adoption of new technologies....and why this is a good thing...and much much more.
You can find out more about Greg and Alimetry here:
https://www.linkedin.com/in/greg-o-grady-b9520353/
https://www.linkedin.com/company/alimetry-ltd/
https://www.alimetry.com/
#medicine #surgery #surgeon #medical device #research #clinicaltrials #clinicalresearch #podcast #podcasts #medicine #healthcare #medicalresearch #venturecapital #startup #startups #entrepreneur #entrepreneurship #hippocrates -
Dr Ed Watson is the CEO of Aotearoa Clinical Trials, a network of hospital based clinical trial sites with over 20 years experience in clinical trials in Aotearoa - New Zealand.
While it is well understood that Clinical Research plays a crucial role in advancing medical knowledge, and developing new therapies, we need to also recognize that it also contributes to the reduction of Health Inequities by providing access to next generation interventions before they hit the market.
In an era where public health budgets are tightly constrained and the costs of modern technologies is ever-increasing, Clinical Trials need to be viewed as a vital component of the wider Healthcare System.
Join us in Episode 5 where Ed and I discuss these topics and more.
You can find out more about Ed and Aotearoa Clinical Trials here: https://www.linkedin.com/in/edwardwatsonnz/ https://www.aotearoatrials.nz/ https://www.linkedin.com/company/aotearoa-clinical-trials/
#medicine #pharmaceuticals #resarch #clinicaltrials #clinicalresearch ##podcast #podcasts #medicine #healthcare #biotech #biotechnology #medicalresearch -
Kris Vette is the Founder and CEO of Genecrypt, a platofmr providing end-to-end encryption of genomic data.
As technology advances, we can expect genetic data to be used more frequently in both research and clinical settings. The promise of Precision medicine is we could use our unique genetic fingerprints inform healthcare decisions, and thus get the most out of our health, whether it be treatment, prevention or longevity.
As more people have their DNA sequenced, it is critical that this information is kept secure. We are all aware of the importance of protecting our personal information - you wouldn’t share your home address or bank account details with the public for example. By virtue of its unique fingerprint, genetic data is the pinnacle of personal information - it is unique to that individual, and it is also enduring - i.e. it doesn’t change.
Join us in Episode 4 where Kris and and I discuss the importance of genetic data in the future of medicine, how genetic data could be used, by both benevolent and malevolent parties, the value of having vast genetic "data lakes" that are accessible by multiple research entities, and some of the challenges that need to be overcome by founders developing medical technologies for the future.
You can find out more about Kris here:
https://www.linkedin.com/in/kris-vette-b8416620/
https://genecrypt.io/
#medicine #pharmaceuticals #resarch #pharma #neuroscience #podcast #podcasts #neurodegenerative #healthcare #biotech #biotechnology #medicalresearch #genomics #genetics -
Dr Malvindar Singh-Bains' is a Research Fellow at the University of Auckland Centre for Brain Research, and her work is contributing to a paradigm shift in the way we investigate Neurodegenerative disease and design future treatments.
One of Malvindar's areas of research is Huntington's Disease (HD), a neurodegenerative disease characterized by the accumulation of a mutated version of the aptly-named protein, Huntingtin. Traditionally, the accumulation of Huntingtin has been thought of as the molecular mechanism by which Huntington manifests. New evidence suggests that this is only the tip of the iceberg.
Join us in Episode 2 where Malvindar and I discuss why Huntington's Disease is a model disorder for other neurodegenerative diseases; why there are many different types of mutant Huntingtin protein, ' and why science is yet to identify the "bad guy" variant or variants; and why Malvindar is confident that we will have a breakthrough in treatment of HD in our lifetimes.
You can find out more about Malvindar and here research here:
https://www.linkedin.com/in/malvindar-singh-bains-49801a226/ https://www.auckland.ac.nz/en/fmhs/research/cbr.html https://www.hdyo.co.nz/ - Show more
