Hello everyone! And welcome to the Luko show! In this podcast, I will being doing movie reviews and primarily focused on horror movies. So if you are a horror movie fanatic or just a movie fan, please give me a listen!
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The name caught you, didn’t it? Niggas Drink Wine Too! The Podcast. The collective gets together every Sunday to pour up and vent about life... from our perspective, from our wine glass. A mix of raw, sometimes toxic, most of the time emotional standpoint of 3 black men in a safe space. We cover everything from pop culture, to crying, to getting burned. It’s just that raw, no pun. Luko, Lil Berry and Big Eric are the perfect mix. You’ll surely find somebody to relate to. Straight barbershop ...
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Gido Luko Misiūno tinklalaidė.
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Welcome to P4A Let’s Talk Rare, a monthly podcast highlighting the most important developments in the world of rare diseases orphan drug, cell and gene therapy, hosted by Georgie Rack and Owen Bryant of Partners For Access. To find out more about Partners For Access and our commitment to sustainable orphan drug access for patients with high unmet need, visit partners4access.com
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In the latest episode of Let's Talk Rare, Owen Bryant & Georgie Rack delve into the world of drug development in rare diseases. They are joined by the brilliant Rob Freishtat, president of Uncommon Cures. Rob brings unique insights on who the key stakeholder are in developing drugs and the many ways that we can bring them together in order to impro…
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Brain cancers are notoriously difficult to manage with current treatments offering limited effectiveness. But what if there was a way to change that? Michael Roberts from Adaptin Bio joins Owen Bryant to explore how a pioneering new treatment called BRiTE is driving hope for improved outcomes for patients.…
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Dive into P4A's annual appraisal of the year ahead. In this episode of Let's Talk Rare we examine the most important trends as identified and voted for by the P4A team. Ranging from Donald Trump's tariff impact on EU's ability to price orphan drugs to the change of mindset in HTA bodies to include patient experience data in their decision making ca…
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After3 years in the making, the Joint Clinical Assessment for the EU is in effect. From 12th January 2025 new cancer medicines and advanced therapy medicinal products (ATMPs) will require a JCA across all 27 member states. Join Owen and Georgie, along with guests Darren Callanan and Sam Morrison to discuss the main talking points of the JCA, and wh…
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Innovative Treatments for Cutaneous T-Cell Lymphoma with Leonard Mazur of Citius Pharmaceuticals
26:21
26:21
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26:21Welcome to this month's P4A Let’s Talk Rare podcast episode by Partners4Acess. Today, Georgie and Owen are joined by Leonard Mazur, CEO of Citius Pharmaceuticals, to discuss their innovative therapy, Lymphir, for cutaneous T-cell lymphoma (CTCL). Leonard shares his journey with Citius, from its founding in 2013 to the recent resubmission of Lymphir…
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Amplifying Patient Voices: Wes Michael on Rare Disease Advocacy
23:54
23:54
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23:54In this episode of P4A Let's Talk Rare, hosts Georgie and Owen Bryant from Partners For Access are joined by Wes Michael, founder and president of Rare Patient Voice LLC. Wes shares the organization’s journey from its beginnings as a community project for hemophilia patients to a global platform that connects rare disease patients and caregivers wi…
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Impact of Mergers, Acquisitions, and Patent Expirations on Job Cuts in Pharma and Biotech: Insights from Aurelija Luko and Darren Callanan
27:15
27:15
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27:15Welcome to this month's episode of the P4A Let’s Talk Rare podcast by Partners4Acess. Today, Georgie and Owen are joined by their colleagues Aurelija Luko, the CFO, and Darren Callanan, the Global Digital Lead at Partners4Access. Join them as they discuss the recent job cuts in the pharma and biotech industry and the reasons behind them. Aurelia ex…
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The Role of Patient Experience Data in Drug Development with Pina Haberl and Sam Morrison
34:37
34:37
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34:37Welcome to this month's episode of the P4A Let’s Talk Rare podcast by Partners4Acess. Today, Georgie and Owen are joined by their colleagues Pina Haberl, Senior Director, and Sam Morrison, Executive Director at Partners4Access. Join us as we discuss the crucial role of patient experience data in drug development. The conversation explores the need …
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Welcome to this month's episode of Let’s Talk Rare: The Life Science Podcast brought to you by Partners4Access. Host Georgie records this episode at the World EPA Conference in Amsterdam. She holds a panel discussion with Juliette Sinclair-Spence, Sandrine Ruiz, Neil Grubert, and Seema Sondhi, and together we shared our experiences at the EPA confe…
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Rare Disease Day Special 2024: The Role of Genetic Diagnosis in Rare Conditions with Nick Meade
24:31
24:31
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24:31Welcome to this month's episode of the Let’s Talk Rare: The Life Science Podcast by Partners4Acess. Georgie and Owen are joined by Nick Meade, Head of Policy at Genetic Alliance, to discuss the challenges faced by rare patients in accessing life-saving medicines. Together they explore the EU joint HTA legislation coming into force in January 2025, …
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Celebrating 5 Years of P4A: Reflections on Rare Diseases, Cell and Gene Therapies, and Legislation in Europe
53:45
53:45
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53:45Hello and welcome to this special episode of Let’s Talk Rare: The Life Science Podcast as we celebrate 5 years of bringing you the podcast that is now the number one life science podcast across all platforms. We at Partners 4 Access want to thank every single one of our 35,000 subscribers and all the guests who have graced the podcast from the bott…
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Revolutionizing Patient Outcomes: The Power of Digital Health Solutions with RJ Kedziora
28:02
28:02
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28:02In this podcast, Georgie, RJ, and Owen discuss revolutionizing patient outcomes and the power of digital health solutions. RJ, a healthcare industry expert, shares insights on the role of technology in improving patient care and the future of digital health. They also touch on RJ's involvement in triathlons and his passion for running. With a frien…
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The Future of Patient Engagement and the Role of Technology in Healthcare with Iola Forster
23:38
23:38
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23:38Welcome to this month's episode of the Let’s Talk Rare podcast by Partners4Acess. Georgie and Owen are joined by Iola Forster, Head of Publications and Portfolio at Karger Publishers, to discuss the future of patient engagement and the role of technology in healthcare. Together, they cover the future of HCPs (healthcare practitioners) and patient e…
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Navigating the New EU HTA Regulation and Its Impact on ATMP Development
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16:35
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16:35Welcome to this month's episode of the Let’s Talk Rare podcast brought to you by Partners4Acess. Georgie and Owen are joined by Chloe Sheppard and Akshay Kumar to discuss the new EU HTA regulation set to be implemented in 2025. They explore the implications for drug developers of ATMPs, the attractiveness of the EU market, and the importance of pro…
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Alejandro Dorenbaum, CMO of Reneo Pharmaceuticals Discusses Clinical-Stage Therapies
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16:14In this episode we will be talking to Alejandro (Alex) Dorenbaum, M.D., CMO of Reneo Pharmaceuticals. Alex discusses how the company is developing drugs for patients with #rare mitochondrial diseases, a high unmet disease with no current treatments available. Their lead candidate #Mavodelpar has recently completed enrolment for their pivotal STRIDE…
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Interview with Xortx Therapeutics CEO, Dr Allen Davidoff discussing their journey from early development to potential launch
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19:22
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19:22P4A are joined by Xortx Therapeutics' CEO, Dr Allen Davidoff, as he discusses the journey from early development to potential launch for their novel therapy XRX-008 to treat patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Allen discusses the company vision for developing novel therapies for rare progressive kidney disorders, and…
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P4A host a special episode live from World Evidence, Pricing & Access Conference 2023 in Amsterdam. Join Georgie & Owen hosting live from World EPA Conference 2023. We will be bringing you speaker interviews, giving a flavour of the atmosphere and discussing some of the trends & key takeaways that came out of the conference. Max Rex: LinkedIn: http…
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In this episode of Let’s Talk Rare, as we commemorate World Rare Disease Day, Georgie and Owen are joined by Louise Fish and Dan Lewi to discuss all aspects surrounding rare diseases, from key challenges patients face in getting access to life-saving medicines, the clinical trial burden, EU pharmaceutical strategy and more. The topics covered inclu…
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The P4A team have hand-picked trends to look out for in 2023. This episode we are joined by special guest Neil Grubert who will be discussing the topics in further detail, alongside our P4A experts, Shrishti & Jodie. The topics covered are: EU Pharmaceutical Strategy, OMP Legislation, Joint HTA Assessments - cross-country HTA cooperation, Expansion…
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World Orphan Drug Congress Europe 2022 Special
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42:39Did you miss the World Orphan Drug Congress Europe 2022, held in Sitges, Barcelona in November? If you did, don't worry P4A have you covered! This month's special podcast was part recorded live at the conference and part recorded back in London with members of the team that attended! We will be speaking to a few presenters & sponsors to discuss the…
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Winds of change for German Healthcare Market!
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38:42
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38:42Winds of change are howling in Germany, with the draft healthcare bill now approved to stabilise SHI fund finances. What will manufacturers, with innovative orphan drugs and cell and gene therapies, launch strategies be? With the latest decision from Janssen to avoid the German market altogether for x2 Rare Oncology innovative drugs, will this be a…
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Part 2 -Patient Empowerment: Is it a no-brainer?
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28:25
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28:25P4A’s 2 part -Patient Empowerment podcast series has been released. Our incredible panel of experts Laurence Woollard, Neil Bertelsen & Sophie Schmitz are back with us to carry on the discussion in part 2 on true patient empowerment and really looking at the WHY’s! Why should drug manufacturers involve & listen to and involve the patients. What are…
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Part 1 Patient Empowerment; Why involving patients from early drug development through to launch is a no-brainer!
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31:08
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31:08This month we have a special 2-part series focused on Patient Empowerment, with special guests Laurence Woollard, On the Pulse, Neil Bertelsen, Independent Consultant & Sophie Schmitz, Managing Partner at P4A. This podcast is a MUST to listen too if you are a company looking to successfully develop and commercialize an orphan drug or ATMP The first…
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What makes P4A an award winning consultancy?
15:03
15:03
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15:03This month we have put together a slightly different episode with a twist. Georgie & Owen will take you behind the scenes at P4A and discuss 'What makes P4A an award-winning global market access consultancy?' Why we do what we do every day, and what it means to each and every member of staff. Pride, Passion & Partnership are the core values at P4A,…
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Special Episode with EUCOPE-Part 2 with Alexander Natz
28:57
28:57
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28:57In this episode Chloe & Alexander will be starting the discussion with an overview of EU HTA regulation, looking at the harmonization debate and how this came about. We then discuss JCA evaluation methodology (e.g. comparator selection, acceptability of clinical evidence), the potential new role of individual country agencies and how the joint HTA …
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Special series with Eucope: Part 1 featuring Victor Maertens
24:51
24:51
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24:51Part 1 featuring Victor Maertens, Government Affairs Manager at EUCOPE In this episode Victor and Aparna will be focusing on Advanced Therapy Medicinal Products (ATMPs). We will start by looking at the main challenges for manufacturers in the ATMP approval process and what is required from an HTA perspective. We then discuss EUCOPE’s position paper…
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China market access: obstacle or opportunity for orphan drug, cell and gene therapy manufacturers?
10:27
10:27
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10:27In 2020 China’s pharmaceutical market passed an important milestone, a Deloitte report cited that China was expected to grow its pharmaceutical market volume by 2020 to $220 billion (USD) becoming the second largest market behind the US. The commercial potential is huge, so what do we know about the orphan drug (OD) potential in China? Fisentzos St…
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Should the Middle East be a priority launch market for orphan drug manufacturers?
12:34
12:34
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12:34Over the last few years, the Middle East has piqued the interest of orphan drug manufacturers, and some have prioritised launching in this region before European markets. Akshay Kumar and Lavni Varyani discuss what is driving this behaviour, the orphan drug infrastructure within the region, and opportunities, barriers, and key considerations for ma…
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Rare Disease Day Special featuring Janet Bloor and Nick Meade - February 2022
28:47
28:47
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28:47For this Rare Disease Day episode, Janet and Nick discuss a range of topics associated with the rare disease community and patient advocacy. They address new-born screening, patient registries, the UK rare disease framework, the NICE methods review and much more! Presenter: Georgie Rack, Communication Executive Contributors: Janet Bloor, CEO of Duc…
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P4A Insights: Trends to look out for in 2022
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10:32
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10:32Lots of anticipated changes are expected in the orphan drug, cell and gene therapy space and 2022 is going to be an exciting year. Listen to our latest podcast on the top trends in drug development, HTA and pricing from Akshay Kumar and Andrea Bernardini to help you navigate the year ahead. Presenter: Georgie Rack Speakers: Akshay Kumar & Andrea Be…
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Special episode - Bluebird Bio: What went wrong? -December 2021:
17:15
17:15
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17:15Sophie Schmitz and Joanna Fernandes discuss bluebird bio’s innovative gene therapy Zynteglo and its withdrawal from the European market. Sophie and Joanna will be looking at the fall of Zynteglo from two sides: from a company perspective and from the perspective of the EU environment. Presenter: Georgie Rack, Communication Executive Contributors: S…
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Special episode featuring James Mackay - November 2021
23:59
23:59
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23:59This episode featuring James Mackay, President & CEO of Aristea Therapeutics. James provides insights on his experience with setting up a biotech and challenges associated, industry climate on spin off opportunities, Aristea’s pipeline, collaborations and US PRMA reforms. Presenter: Aparna Krishnan Contributors: James Mackay, President & CEO of Ari…
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In this episode P4A’s Richard Wang and Adama Anozie discuss Hospital Exemption (HE) which is an emerging access pathway for Advanced Therapy Medicinal Products (ATMPs). Main topics of discussion include the benefits and potential downsides associated with this pathway, the EU regulations involving HE and recent events in Italy, Spain and France, as…
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In this episode P4A’s Senior Client Relationship Director, Bruce Chin discusses his experiences from the in person World Orphan Drug Congress USA 2021. Topics of discussion included travel and safety precautions due to COVID, Bruce’s favourite sessions, key learnings from the sessions, and much more! Presenter: Georgie Rack Contributor: Bruce Chin …
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In this episode Akshay Kumar and Richard Wang discuss how through innovative technology, decentralised clinical trials came to the limelight, facilitating remote access and ensuring continued operation of clinical trials. In addition, we discuss the future of decentralised clinical trials in a post-COVID world, its implications and demands within t…
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In this episode, the P4A team take a deep dive into the Brazilian pharmaceutical market and discuss its potential for access to orphan drugs, cell and gene therapies. The overall Latin American pharma market is forecast to grow by 9% per year through to year 2028. However, major markets in this region such as Brazil have some major barriers to acce…
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Its almost six months since President Joe Biden came to office but the role of the head of the country's key drug regulator, the US Food and Drug Administration (USFDA) is yet to be filled. In this episode, the P4A discusses the absence of a USFDA commissioner and its impact. Also, we understand the significance of recent remarks of the Center for …
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Man look this might be our last episode Jamaal ain’t want to be here fawreel, Berry in URL, Eric happy we don’t like that, Luko bought all this podcast equipment for no reason, and Bud was like this podcast shit dead WE GOT WINE THO!!!
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In this month's episode, the P4A team take a deep dive into the impact of Brexit on the UK's market access landscape. Four months after leaving the European Union, the UK's attractiveness as a key destination for commercialisation of new drugs is being tested. In order to improve its credentials, the UK is exploring a slew of measures that could po…
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Welcome everyone! This is just a very brief description of my new show and basically how it is going to be running and working. Very excited to start this podcast and to share my thoughts and feelings on all sorts of movies
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In this episode I will be giving my review for the newest edition to the DCEU, The Snyder Cut. I will be giving my thoughts on the movie and where this leaves us in the DC universe
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The world of orphan drugs is at the cusp of a transformation in the post COVID era. In this episode, the team discuss the impact of the pandemic on value demonstration of orphan drugs. In order to be successful, manufacturers of precision medicine will need to focus on carving out a niche for their drugs and support health systems to find the right…
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In this episode, the P4A team discussed the impact of cost-containment measures in Germany, the European Commission's recent move to revise legislation on orphan medicinal products and potential legislative reforms in the US under the new Biden administration. Presenter: Jens Leutloff Contributors: Chloe Sheppard, Max Rex Producer: Aparna Krishnan…
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Rare Disease Day special episode: Reclaiming the rare disease patient’s voice
36:55
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36:55In this Rare Disease Day special episode, we focus on the impact of COVID -19 on rare disease patients. Some of the key challenges for patients during this pandemic include disruption in their access to treatments, struggle to continue participation in clinical trials, lack of access to vital equipment such as PPE (Personal Protective Equipment) an…
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In this episode, the P4A team review all the key events of the year 2020 in the orphan drug, cell and gene therapy world. The emergence of COVID-19 pandemic has caused disruption but also opportunities for the biotech industry. From change in regulations, new stakeholder collaborations to impact of Brexit and US drug pricing reforms, a full round u…
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We back back back! *Jamaican horns*! We get to it on this one! Lil Berry, Luko and Eric brings the heat! We start off with Berry beating Covid. MEEK MILL vs DJ AKADEMIKS on CLUBHOUSE? Logan Paul vs Floyd and are the Paul Brothers that big of a pull on the Internet? Also w jump into the question... what is white culture. Enjoy this one. Til next tim…
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EP 12 “It's Two Gay Niggas Fighting"
1:08:27
1:08:27
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1:08:27We bike! Another one... This Lil Berry and I’m not making a drawn out description cuz I got some pussy over here. Be blessed. #NDWT
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EP 11 “Felt Like I Was Gettin Tested For Covid”
1:46:56
1:46:56
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1:46:56We bike!!!! This episode we bring in a guest! Our brother Que. The podcast ends up becoming a therapy session because once again Luko gets cheated on, Que got 17 girlfriends he don’t know what to do with and Berry just living his best life off E&J! Once again we let the drank flow and talk about our lives. We also randomly talk about who are the wo…
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Special episode: Gene Therapy access from a specialty pharmacy perspective
20:50
20:50
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20:50This episode discusses patient access to AveXis' gene therapy Zolgensma from Orsini Healthcare, US based specialty pharmacy's perspective. The senior team at Orsini provide insight on their experience of Zolgensma access including key manufacturer criteria, payer landscape along with challenges and lessons learnt. Presenter: Aparna Krishnan Contrib…
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Ummmmm all I can say about this one is... it get deep. During these trying times, we have that conversation. #BlackLivesMatter. RIP BIG FLOYD! Enjoy.
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