Podcasts about worldwide clinical trials

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have several news and insights to cover. Let's dive right in.## Restructuring Efforts at Beam and Top Biopharma ConferencesBiopharmaceutical company Beam is undergoing a restructuring effort, which will lead to the layoff of 100 employees. This move is aimed at prioritizing medicines for sickle cell and alpha-1 antitrypsin deficiency. The company will also trim its plans for other programs.In other news, the top biopharma conferences for 2024 are already being planned, with a few key meetings remaining this year. While these conferences are important for networking and knowledge sharing, let's focus on the developments within the industry itself.## Ultragenyx's Exciting Venture and Worldwide Clinical Trials' Human-Centered ApproachUltragenyx, a biopharmaceutical company, is planning to spin out a new company focused on Alzheimer's gene therapy. The CEO, Emil Kakkis, believes that the findings are too exciting to ignore and describes this venture as "high-risk, high-return." This move highlights the ongoing pursuit of innovative treatments in the biopharma industry.Meanwhile, global clinical trials provider Worldwide Clinical Trials is delivering excellence in the clinical trial experience by offering a human-centered approach that combines cutting-edge science. This approach emphasizes the importance of putting patients first.## Merck's Partnership and Challenges in Biotech IPOsMerck has formed a partnership with Daiichi Sankyo to invest in antibody-drug conjugates (ADCs) for cancer treatment. This partnership solidifies the potential of ADCs in reshaping cancer treatment.On the other hand, fewer biotech companies are going public after a record run. Some companies have seen their shares lose value on the stock exchange, indicating that the public market may be becoming more selective in its support of biotech companies.## Insights in the Medtech Industry and Challenges for Biotech CompaniesMoving on to the medtech industry, Intuitive Surgical's Q3 sales missed estimates due to factors such as robot leasing and decreased demand in China. However, the company's overall procedure growth exceeded market expectations.The CEO of Advamed has warned Congress about potential supply shortages caused by regulations on ethylene oxide (ETO) and per- and polyfluoroalkyl substances (PFAS). This highlights the need for changes to regulatory proposals to ensure a steady supply of medical devices.## Addressing Affordability of Insulin and Telehealth in the Defense SectorGoodRx and Sanofi have partnered to make insulin more affordable. This partnership aims to address the rising cost of insulin, which has led many patients to ration their supply or go without. However, there are still concerns about high drug prices that need to be addressed.Amwell and Leidos have scored a defense contract worth up to $180 million, highlighting the growing role of telehealth in the defense sector. As more healthcare services are being provided remotely, telehealth is playing a crucial role.## Physician Turnover and Healthcare Worker StrikesA study has found that physician turnover is driven by a desire for increased flexibility. This highlights the need for healthcare organizations to prioritize work-life balance and offer more flexible schedules to retain physicians.Over 1,200 nurses in Pittsburgh have authorized a potential strike at Allegheny General Hospital amid ongoing contract negotiations. This is just one example of healthcare worker strikes occurring across the country, driven by concerns over working conditions, staffing levels, and wages.## Challenges in the Biotech Market and Strategies for Combating BurnoutThe biotech market continues to face challenges, with several gene therapy or editing companies laying off employees this year. Additionally, leader

Jason Palasota had always been passionate about improving the quality of clinical research services delivered to patients. He first got his feet wet working on the ground level as a site coordinator for Cetero Research, formerly known as Diabetes and Glandular Research. From there, he began to develop an even deeper respect for the industry and continued to pursue opportunities that would allow him to drive change. After working on the ground level, he was inspired to make an impact and improve the quality of clinical research services delivered to patients. Determined to bring about positive change, Jason worked his way up from proposal development and inside sales roles to external business development positions at Worldwide Clinical Trials, ResearchPoint Global, and IQVIA (formally Quintiles). As Jason gained more experience in this field, he became increasingly aware of significant relationship and communication gaps that existed within the industry. He was determined to bridge these gaps by forming strong partnerships between exceptional clinical research sites and innovative sponsors/CROs. His goal was simple: make a positive difference in people's lives through top-tier healthcare solutions around the world. Clinitiative Health Research was born. This week we discuss the various business development models for sites, why sites might want to consider partnering with a business development vendor, and the incredible significance of relationships in clinical research.  Clinitiative Health Research on Linkedin: https://www.linkedin.com/company/clinitiative/   Clinitiative Health Research on Twitter: https://twitter.com/ClinitiativeHR ,  Clinitiative Health Research on Facebook: https://www.facebook.com/ClinitiativeHealthResearch Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Daniel A. Perez is a rebel in clinical research and passionate advocate for diversity and equity in healthcare. With a servant's heart and desire to lead, he elevates those around him while challenging the industry status quo. In this episode we chat about the state of the industry and what may transform the relationships with investigators and what is necessary to create a successful ecosystem at the site level. We talk about the importance of resources, education and financial compensation, layered in with empathy. A Los Angeles native, Daniel's passion for clinical research materialized over a decade ago, when a new diagnosis forced him to face critical treatment options evolving only as fast as clinical trials allowed. It was during this experience when he recognized his fortune in benefitting from clinical research-fueled medical breakthroughs, as well as the unnecessary dysfunction and inefficiency that existed within this same space. With a newfound desire to make an impact on the traditional clinical trial paradigm, Daniel entered the neurosciences department at Cedars-Sinai Medical Center, where his talent and motivation led to several quick promotions within academia. It was in his expansive role as Clinical Research Manager at Children's Hospital Los Angeles (CHLA) where Daniel fine-tuned his talents across all regulatory, managerial and operational aspects of clinical research. After recognizing the amplified impact possible outside of traditional medical institutions, and experiencing MACRO as a clinical operations consultant, he made the leap and joined MACRO full time. At MACRO, Daniel combined his meticulous operational acumen with his comprehensive research and regulatory expertise to help bring their vision into a tangible reality. Daniel leads by constantly questioning how things have always been done, and continuously evaluating the clinical research process through the lens of the human subjects on which they are based. Daniel cofounded the Coalition for Advancing Research Equity (CARE) and also serves as a founding board member for Clinical Trials in Color, a 501(c)(3) non-profit foundation with a mission to improve health outcomes in communities of color by increasing diversity and access to clinical trials. Daniel is currently the Global Head, Patient Experience, Diversity & Inclusion at Worldwide Clinical Trials.

Last episode (182) we were joined by Dr. Eric Green, the Director of the National Human Genome Research Institute (NHGRI) at the NIH. And we chatted about the recent completion of the human genome. To continue this conversation, I am joined by the co-founders of the Telomere to Telomere Consortium which lead this project!Dr. Karen Miga is an Assistant Professor in Biomolecular Engineering at The University of California, Santa Cruz. She is also the associate director of the UCSC Genomics Institute. The Miga Lab at UCSC focuses on genomic and epigenetic structure within human centromeres and constitutive heterochromatin, which are now emerging to the forefront of genomics. She received a B.S. in biological sciences from the University of Tennessee Knoxville and then went on to get a masters degree in genetics at Case Western Reserve University. Karen received her Ph.D. in genetics and computational biology from Duke University. She was named as “One to Watch” in the 2020 Nature's 10.Dr. Adam Phillippy is a Senior Investigator and Head of the Genome Informatics Section at the National Human Genome Research Institute (NHGRI). His lab develops efficient computational methods for analyzing DNA sequencing data, including tools for genome assembly, alignment, clustering, forensics, and metagenomics. He received a B.S. in computer science from Loyola University Maryland in 2002. He first worked as a bioinformatics engineer at The Institute for Genomic Research (TIGR) and later received a Ph.D. in computer science from the University of Maryland in 2010. After graduate school he led a bioinformatics group at the National Bioforensics Analysis Center before joining NHGRI in 2015. In 2019, he was awarded tenure by the NIH and received the U.S. Presidential Early Career Award for Scientists and Engineers.On This Episode We Discuss:The recent announcement about the completion of the human genome sequenceThe name for this new human reference genome and what the letters stand forHow T2T-CHM13 complements the previous human reference genome, GRCh38Advantages of “long read” over “short read” DNA sequencing technologiesWhy telomeres and centromeres are hard to sequenceValuable information that we can learn from sequencing centromeres and telomeres The future of variant classificationLinking newly sequenced genes to genetic conditions or traits If you're interested in learning more about the newly completed human genome, check out this article and newsletter! Stay up to date with the latest advancements Be sure to follow Dr. Phillippy, Dr. Miga, and National Human Genome Research Institute on Twitter to stay up to date on the latest human genome research news and announcements!Stay tuned for the next new episode of DNA Today on May 13, 2022 where we'll be joined by ​​Khalida Liaquat and Ariana Lichtenstein of Blueprint Genetics to discuss the My Retina Tracker Program! New episodes are released on Fridays. In the meantime, you can binge over 180 other episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “DNA Today”. Episodes since 2021 are also recorded with video which you can watch on our YouTube channel. DNA Today is hosted and produced by Kira Dineen. Our social media lead is Corinne Merlino. Our video lead is Amanda Andreoli. See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, DNApodcast.com. Questions/inquiries can be sent to info@DNApodcast.com. Are you seeking a career with purpose in the healthcare space? We'd recommend checking out Worldwide Clinical Trials, a contract research organization that partners with pharmaceutical and biotechnology companies to advance development of new medicines. Apply your passion at Worldwide where they take an entrepreneurial approach backed by scientific expertise to help bring treatment options to patients. With a global team of 3,000 experts, you will be inspired by bright thinkers, dreamers and doers who innovate and invent for a brighter tomorrow. Perks include unlimited flexible paid time off, limited travel requirements, and the ability to work remotely. Bring your talents and passion and join the team at worldwide.com. (SPONSORED)PerkinElmer Genomics is a global leader in genetic testing focusing on rare diseases, inherited disorders, newborn screening, and hereditary cancer. Testing services support the full continuum of care from preconception and prenatal to neonatal, pediatric, and adult. Testing options include sequencing for targeted genes, multiple genes, the whole exome or genome, and copy number variations. Using a simple saliva or blood sample, PerkinElmer Genomics answers complex genetic questions that can proactively inform patient care and end the diagnostic odyssey for families. Learn more at PerkinElmerGenomics.com. (SPONSORED)Want to become a genetic counselor? Looking for ways to engage with the field and boost your resume for grad school applications? Then you should check out Sarah Lawrence's “Why Genetic Counseling Wednesday Summer Series”! Every Wednesday this June Sarah Lawrence is hosting this series where you can interact through Zoom with genetic counselors from different specialties. It kicks off on June 1st! You can sign up at SLC.edu/DNAtoday to register to level up your resume for applications in the fall. (SPONSORED)

On this week's episode of DNA Today we're discussing the past, present, and future of the Human Genome Project and the Telomere to Telomere Consortium with Dr. Eric Green, director of the National Human Genome Research Institute (NHGRI) at the U.S. National Institutes of Health (NIH).The Human Genome Project is an international scientific research project that began in 1990, with the goal of determining the base pairs that make up human DNA, and identifying, mapping, and sequencing all of the genes of the human genome; however, no one chromosome has yet been finished end to end, and hundreds of gaps persist across the genome. The Telomere to Telomere (T2T) Consortium is an open, community-based effort to generate the first complete assembly of a human genome, filling in these unresolved gaps. Our guest today is Dr. Eric Green, the director of the National Human Genome Research Institute (NHGRI) at the U.S. National Institutes of Health (NIH). Throughout his career, Dr. Green has authored and co-authored over 375 scientific publications, a few of which we are chatting about today.As NHGRI director, Dr. Green leads the Institute's research programs and other initiatives. He has played an instrumental leadership role in developing many high-profile efforts relevant to genomics. Dr. Green received his B.S. degree in bacteriology from the University of Wisconsin - Madison in 1981, and his M.D. and Ph.D. degrees from Washington University in 1987. Coincidentally, 1987 was the same year that the word “genomics” was coined. Dr. Green's relationship with the Institute began long before his appointment as director. He served as the Institute's scientific director (2002 - 2009), chief of the NHGRI Genome Technology Branch (1996 - 2009) and founding director of the NIH Intramural Sequencing Center (1997 - 2009). Prior to that, he played an integral role in the Human Genome Project. Throughout his career, Dr. Green has authored and co-authored over 375 scientific publications. Dr. Green is a founding editor of the journal Genome Research (1995 - present) and a series editor of Genome Analysis: A Laboratory Manual (1994 - 1998), both published by Cold Spring Harbor Laboratory Press. He is also co-editor of Annual Review of Genomics and Human Genetics (since 2005).On This Episode We Discuss:Dr. Green's involvement in the Human Genome Project (HGP)The first chromosome to be completely sequencedWhen the human genome sequence was completedThe Telomere to Telomere (T2T) ConsortiumWhat made the last 10% of the human genome difficult to sequenceHow many genomes were studied for the HGPHow the fully complete genome sequence impacts peopleThe NIH's All of Us Reacher ProgramLearn more about the Human Genome Project and what we talked about on this episode at genome.gov. If this episode piqued your interest, check out the articles below to learn about the most recent advancements in the Human Genome Project, and the work of the T2T Consortium. https://www.genome.gov/about-nhgri/Director/genomics-landscape/april-7-2022-the-human-genome-sequence-is-now-completehttps://www.scientificamerican.com/article/completing-the-human-genome-sequence-again/https://www.genome.gov/10000666/1997-news-release-pendred-syndrome-geneBe sure to follow Dr. Green and the National Human Genome Research Institute on Twitter to stay up to date on the latest human genome research news and announcements!Stay tuned for the next new episode of DNA Today on May 6, 2022 where we'll continue discussing the Human Genome Project and the Telomere to Telomere Consortium with Drs. Miga and Philippy. New episodes are released on Fridays. In the meantime, you can binge over 180 other episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “DNA Today”. Episodes since 2021 are also recorded with video which you can watch on our YouTube channel. DNA Today is hosted and produced by Kira Dineen. Our social media lead is Corinne Merlino. Our video lead is Amanda Andreoli. See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, DNApodcast.com. Questions/inquiries can be sent to info@DNApodcast.com. Are you seeking a career with purpose in the healthcare space? We'd recommend checking out Worldwide Clinical Trials, a contract research organization that partners with pharmaceutical and biotechnology companies to advance development of new medicines. Apply your passion at Worldwide where they take an entrepreneurial approach backed by scientific expertise to help bring treatment options to patients. With a global team of 3,000 experts, you will be inspired by bright thinkers, dreamers and doers who innovate and invent for a brighter tomorrow. Perks include unlimited flexible paid time off, limited travel requirements, and the ability to work remotely. Bring your talents and passion and join the team at worldwide.com. (SPONSORED)PerkinElmer Genomics is a global leader in genetic testing focusing on rare diseases, inherited disorders, newborn screening, and hereditary cancer. Testing services support the full continuum of care from preconception and prenatal to neonatal, pediatric, and adult. Testing options include sequencing for targeted genes, multiple genes, the whole exome or genome, and copy number variations. Using a simple saliva or blood sample, PerkinElmer Genomics answers complex genetic questions that can proactively inform patient care and end the diagnostic odyssey for families. Learn more at PerkinElmerGenomics.com. (SPONSORED)The Big Biology podcast dives deep on some of the most provocative and exciting topics in biology today, in a fun and accessible way. In each episode, hosts Art Woods and Marty Martin, biology professors themselves, talk to leading scientists and journalists from around the world about the biggest, most cutting-edge topics in biology. From human consciousness, human origins, new directions in evolutionary theory, to the emergence and spread of zoonotic diseases like COVID-19, and much more! Whether you are a researcher, teacher, student or simply curious about science and biology you'll love the entertaining and deep conversations about biology and the exposure to new research they bring. Learn more at BigBiology.org, and subscribe, rate and review on, Spotify, Apple Podcasts, Google Podcasts, or wherever else you get your podcasts.Are you interested in the rapidly growing field of genetics and want to learn more about clinical genetics, molecular genetics, and laboratory science? Then you should check out the Genetic Assistant Online Training Program at Johns Hopkins University School of Medicine! By taking part in the program, you will be joining both national and international learners with the same passion for genetics. Interact directly with your Johns Hopkins instructors and fellow learners throughout the program. Applications are closing for the summer cohort, and there are spots available for fall 2022. (SPONSORED)

To celebrate DNA Day we are joined by Dr. Stephanie Ryan! In this podcast episode, Dr. Ryan discusses science education and communication, especially making science understandable for kids. To keep the celebrations going we will be co-hosting a virtual event on DNA Day itself, Monday, April 25th at 6pmET! During this special DNA Day event we will do a live DNA experiment with Dr. Stephanie Ryan. You can follow along at home to do the experiment with us! You can register for the event here.Stephanie Ryan, Ph.D. is a chemist, boy mom, and a social media influencer who enjoys using her background in academia to create educational products and content, helping young kids learn through play about the fascinating world around them. Over the years, Dr. Ryan has taught science to all age groups, both in and out of the classroom, helping toddlers learn about their world and college students define theirs. She is an active member of the chemistry education community and is currently a committee member of the International Activities Committee for the Division of Chemical Education. Ryan earned her Ph.D. in the Learning Sciences and her M.S. in Analytical Chemistry from the University of Illinois at Chicago. She earned her B.S. in Chemistry from Saint Mary's College.On This Episode We Discuss:Thoughts on correcting kids if they have an incorrect understanding What to do if kids ask questions that we don't know how to answerRecommended resources for parents/caregivers to foster scientific curiosity in their children from a young ageThe recommended age kids should start learning about STEM conceptsThe inspiration behind Dr. Ryan's book, “Lets Learn About Chemistry”Advice for being a science communicator, especially on social media Want a free copy of “Lets Learn About Chemistry”? Head over to our social media to enter our giveaway! Search “DNA Today” on Twitter, Instagram, and Facebook. For great learning activities in the sciences, book recommendations, and more, follow Dr. Ryan on Instagram and visit her website letslearnaboutscience.com. Also don't forget to mark your calendar for Monday, April 25th. It's DNA Day! At 6pmET we will be co-hosting a virtual event with Dr. Ryan. She will be our guide for doing these at-home DNA experiments together! Register here.Stay tuned for the next new episode of DNA Today on April 29, 2022, where we'll be discussing the completion of the human genome with Dr. Eric Green, Director of the National Human Genome Research Institute (NHGRI) at the National Institutes of Health (NIH)! New episodes are released on Fridays. In the meantime, you can binge over 180 other episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “DNA Today”. Episodes since 2021 are also recorded with video on our YouTube channel. DNA Today is hosted and produced by Kira Dineen. Our social media lead is Corinne Merlino. Our video lead is Amanda Andreoli. See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, DNApodcast.com. Questions/inquiries can be sent to info@DNApodcast.com. Are you seeking a career with purpose in the healthcare space? We'd recommend checking out Worldwide Clinical Trials, a contract research organization that partners with pharmaceutical and biotechnology companies to advance development of new medicines. Apply your passion at Worldwide where they take an entrepreneurial approach backed by scientific expertise to help bring treatment options to patients. With a global team of 3,000 experts, you will be inspired by bright thinkers, dreamers and doers who innovate and invent for a brighter tomorrow. Perks include unlimited flexible paid time off, limited travel requirements, and the ability to work remotely. Bring your talents and passion and join the team at worldwide.com. (SPONSORED)PerkinElmer Genomics is a global leader in genetic testing focusing on rare diseases, inherited disorders, newborn screening, and hereditary cancer. Testing services support the full continuum of care from preconception and prenatal to neonatal, pediatric, and adult. Testing options include sequencing for targeted genes, multiple genes, the whole exome or genome, and copy number variations. Using a simple saliva or blood sample, PerkinElmer Genomics answers complex genetic questions that can proactively inform patient care and end the diagnostic odyssey for families. Learn more at PerkinElmerGenomics.com. (SPONSORED)If you enjoy DNA Today, especially Episode 139 with Dani Shapiro who discovered she was donor conceived, then you'll also enjoy more shocking discoveries from DNA testing in a new podcast I love, BioHacked: Family Secrets. It's a brand new podcast all about hidden ancestry, medicine, and technology. The show follows the children of anonymous sperm and egg donors — some with dozens or hundreds of half-siblings — who accidentally learn the truth because of commercial DNA kits like 23andMe. The podcast drops some bombshells...and shows how new technology is unraveling the deep, dark secrets of the baby business. Along with scandalous personal stories, BioHacked: Family Secrets also reveals unexpected ethical, scientific, and political questions. It's a vital listen for anyone who loves wild stories about science, tech, and history...or even just messy family drama. You can find BioHacked: Family Secrets...wherever you're listening right now. New episodes drop every Wednesday.The Big Biology podcast dives deep on some of the most provocative and exciting topics in biology today, in a fun and accessible way. In each episode, hosts Art Woods and Marty Martin, biology professors themselves, talk to leading scientists and journalists from around the world about the biggest, most cutting-edge topics in biology. From human consciousness, human origins, new directions in evolutionary theory, to the emergence and spread of zoonotic diseases like COVID-19, and much more! Whether you are a researcher, teacher, student or simply curious about science and biology you'll love the entertaining and deep conversations about biology and the exposure to new research they bring. Learn more at BigBiology.org, and subscribe, rate and review on, Spotify, Apple Podcasts, Google Podcasts, or wherever else you get your podcasts.

Riassunto Spreaker Puntata n° 142PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano Lagravinese.In questa puntata parliamo di:Amgen, MSD, Vaccino Covid-19, CAR-T, AbmonoclonaliAziende: Amgen, Acceleron Pharma, Gilead, IQVIA, Worldwide Clinical Trials, PPD Nuove terapie: Vaccino.Patologie: Covid-19.Lavoro: CRA Line Manager, In-House CRA, CRA II Home-based.Il mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su:www.telegram.me/pharmapillswww.facebook.com/pharmapills/

Lynn Ledwith, CMO of Ansys, Inc. the most renowned and best simulation software company, previously EVP of Global Strategic Marketing at Worldwide Clinical Trials, and before that working her way up the corporate marketing ladder with prominent companies such as such as Unisys, H-P, Siemens and SunGard. Lynn also earned an MBA from St. Josephs University and an undergrad degree from Bloomsburg University of Pennsylvania.

Album 2 Track 26 – Lynn Ledwith, CMO of Ansys, Inc. the most renowned and best simulation software company, previously EVP of Global Strategic Marketing at Worldwide Clinical Trials,  and before that working her way up the corporate marketing ladder with prominent companies such as such as Unisys, H-P, Siemens and SunGard.  Lynn also earned an MBA from St. Josephs University and an undergrad degree from Bloomsburg University of Pennsylvania.PLEASE NOTE- THIS TRACK RECORDED PRIOR TO US PRESIDENTIAL ELECTION.Hey Brand Nerds! We have a B2B Marketing powerhouse in our virtual house today!!  Truth be told, Lynn is a client of our consulting company who we have been trying to get onto the show for our audience's great benefit, so enjoy!  Oh and lots to learn including these highlights:   Competitive spirit, take it to work and use to your advantage If you are not failing, you are not pushing the envelope enough “Don't let perfection get in the way of progress” (from the great Howard Moskowitz) Iterate, iterate, iterate! 70/20/10 Rule Finding the tech personalization and privacy balance DRIP  B2B vs. B2C Marketing  #lynnledwith #marketing #branding #ansys #b2b #b2bmarketing #b2cmarketing

Joe Linnen is a Partner of The Jordan Company. He is also a member of the firm's Executive Committee. Joe joined TJC in 1993. He focuses all of his time on sourcing, originating and evaluating transactions on behalf of TJC. ​He serves on the board of directors of Worldwide Clinical Trials and CFS Brands. Joe is Chairman Emeritus of the La Lumiere School Board of Trustees and he was Co-Chairman of its Courageous Vision Capital Campaign. Joe was a founding Director of the Oz Park Baseball Association in Chicago. Joe holds a BS degree in Business Administration with concentration in Finance from the University of Notre Dame.     00000468 00000465 000052FA 000052FA 000CEF53 000CEF53 00007DAE 00007F07 000032D0 000032D0

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Azienda: Gsk, Tesaro, Takeda, Shire, Merck, FDA, Novimmune, IQVIA, Worldwide Clinical Trials, PPD.Persone: Hal Barron (Gsk), Gloria Dalla Costa (Ospedale San Raffaele di Milano), Donatella Mattia (Irccs Fondazione Santa Lucia di Roma).Nuove terapie: niraparib, emapalumab.Patologie: tumore ovarico, sclerosi multipla, linfoistiocitosi emofagocitica primaria.Lavoro: Clinica Research Associate.Il mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Azienda: Gsk, Tesaro, Takeda, Shire, Merck, FDA, Novimmune, IQVIA, Worldwide Clinical Trials, PPD.Persone: Hal Barron (Gsk), Gloria Dalla Costa (Ospedale San Raffaele di Milano), Donatella Mattia (Irccs Fondazione Santa Lucia di Roma).Nuove terapie: niraparib, emapalumab.Patologie: tumore ovarico, sclerosi multipla, linfoistiocitosi emofagocitica primaria.Lavoro: Clinica Research Associate.Il mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: Sanofi, MSD, Recordati, Mylan, Natural Point, IQVIA, Abbvie, Galapagos, Gilead, Worldwide Clinical Trials, Takeda.Persone: Daniela Poggio (Sanofi), Nicoletta Luppi (MSD), Andrea Recordati (Recordati), Sergio Liberatore (IQVIA), Ilaria Ciancaleoni Bartoli (Osservatorio Malattie Rare), Fabio Cartabellotta (Ospedale Buccheri La Ferla), Raffaella Giavazzi (Istituto Mario Negri), Ariela Benigni (Istituto Mario Negri).Nuove terapie: GLPG2737.Patologie: fibrosi cistica, HCV, malattie neurologiche.Lavoro: Site Qualification Manager, CRA, Medical Science Liason.Il mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: Sanofi, MSD, Recordati, Mylan, Natural Point, IQVIA, Abbvie, Galapagos, Gilead, Worldwide Clinical Trials, Takeda.Persone: Daniela Poggio (Sanofi), Nicoletta Luppi (MSD), Andrea Recordati (Recordati), Sergio Liberatore (IQVIA), Ilaria Ciancaleoni Bartoli (Osservatorio Malattie Rare), Fabio Cartabellotta (Ospedale Buccheri La Ferla), Raffaella Giavazzi (Istituto Mario Negri), Ariela Benigni (Istituto Mario Negri).Nuove terapie: GLPG2737.Patologie: fibrosi cistica, HCV, malattie neurologiche.Lavoro: Site Qualification Manager, CRA, Medical Science Liason.Il mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/

Meghann Howland, Vice President, Therapeutic Strategy Lead, Oncology, at Worldwide Clinical Trials, discusses the challenges of managing an early phase oncology clinical trial, and how the right contract research organization (CRO) can be a valuable asset.

The scientific, medical, and operational experts at Worldwide Clinical Trials’ have been leading Alzheimer’s disease research since the advent of cholinesterase inhibitors as a cognitive therapeutic in the late 1970s. It’s been a long road on the way to finding a cure for Alzheimer’s disease and related dementias. And we’re not about to give up … Continue reading Alzheimer’s Disease: We’re Not About to Give Up Now →

Laurie Witherwax is the Vice President of Project Management at Worldwide Clinical Trials, which provides drug development services from Early Phase and Bioanalytical Sciences, through Phase II, III and IV. In this episode, Laurie discusses the role of CROs (clinical research organizations). Laurie was the Program Director for global Phase III cardiovascular trials encompassing 38 countries across 620 sites, including 3,400 patients, and other trials involving complex and rare diseases. Her responsibilities have spanned the full duration of studies, from start-up to project close-out and review. Learn more about pulmonary hypertension trials at www.phaware.global/clinicaltrials. Never miss an episode with the phaware® podcast app. Follow us @phaware on Facebook, Twitter, Instagram, YouTube & Linkedin Engage for a cure: www.phaware.global/donate #phaware #phawareMD

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: EMA, Boehringer Ingelheim, Farmindustria, AIFA, Aridis Pharmaceuticals, Pfizer, Merk, Loxo Oncology, Intercept Pharma, GSK, MSD, Novartis, Worldwide Clinical Trials. Persone: Riccardo Palmisano (Assobiotec), Massimo Scaccabarozzi (Farmindustria), Monica Iurlaro (Boehringer Ingelheim), Beatrice Lorenzin (Ministro della Salute), Stefano Vella (AIFA).Nuove terapie: pseudouridimicina, AR-301, Trumenba, pembrolizumab, larotrectinib, acido obeticolico, idarucizumab, terapia genica con cellule staminali, vaccino anti-HPV, fingolimod.Patologie: polmonite, cancro, cirrosi biliare primitiva, terapia anticoagulante, Ada-Scid, sclerosi multipla.Ogni mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/Hai un dispositivo Apple? Seguici e abbonati al podcast tramite la app iPod http://nelfarmaceutico.link/pharma-apple

PharmaPills - Pillole dal farmaceutico: Novità, Curiosità e Lavoro dal mondo del farmaceutico. A cura di Stefano LagravineseIn questa puntata parliamo di:Aziende: EMA, Boehringer Ingelheim, Farmindustria, AIFA, Aridis Pharmaceuticals, Pfizer, Merk, Loxo Oncology, Intercept Pharma, GSK, MSD, Novartis, Worldwide Clinical Trials. Persone: Riccardo Palmisano (Assobiotec), Massimo Scaccabarozzi (Farmindustria), Monica Iurlaro (Boehringer Ingelheim), Beatrice Lorenzin (Ministro della Salute), Stefano Vella (AIFA).Nuove terapie: pseudouridimicina, AR-301, Trumenba, pembrolizumab, larotrectinib, acido obeticolico, idarucizumab, terapia genica con cellule staminali, vaccino anti-HPV, fingolimod.Patologie: polmonite, cancro, cirrosi biliare primitiva, terapia anticoagulante, Ada-Scid, sclerosi multipla.Ogni mercoledì alle h 12.00 su Spreaker.com e iTunes.Seguici su: www.telegram.me/pharmapillswww.facebook.com/pharmapills/Hai un dispositivo Apple? Seguici e abbonati al podcast tramite la app iPod http://nelfarmaceutico.link/pharma-apple

On this weeks show, Accelerating precision medicine for cancer patients, Avivagen partners with NRC to tackle antibiotic resistance in humans, and Knight buys in on an Israeli biotech, We have all this and more on this week’s Biotechnology Focus Radio Show Podcast. Welcome to another episode of Biotechnology Focus Podcast. I’m your host Shawn Lawrence, here to give you a rundown of this week’s top stories on the Canadian biotech scene, Story Montreal’s Knight Therapeutics-a specialty pharma company reports it is taking a small stake in an Israeli-based company, Protalix BioTherapeutics, through the acquisition of 6,200,000 common shares of the company at an average price of US$0.57 per share. With the purchase, Knight now owns approximately five per cent of the outstanding common shares of Protalix. The shares were purchased by Abir Therapeutics Ltd., Knight’s wholly-owned Israeli headquartered subsidiary, which owns 28.3 per cent of Medison Pharma (Medison), Israel’s third largest pharmaceutical company ranked by revenues. It is anticipated that Medison will provide selected services to Abir in order to launch innovative pharmaceuticals in Israel.  Protalix, a publicly traded biopharmaceutical company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. FDA. Story In VICTORIA, BC, Aurinia Pharmaceuticals Inc. reports it has selected Worldwide Clinical Trials as its Clinical Research Organization (CRO) for the company’s AURORA Phase 3 study of volcosporin for the treatment of active lupus nephritis (LN). Voclosporin, an investigational drug, is calcineurin inhibitor and immunosuppressant. According to the company, by inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing.  Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). With the selection of Worldwide, Aurinia will now proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients. The primary endpoint as in the Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Therefore, secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN. Story On the business front, Mississauga’s Aralez Pharmaceuticals announced last week that it is opening new offices in Dublin, Ireland. The company, which focuses on cardiovascular, pain and other specialty areas, says it plans to add more highly skilled jobs in Dublin by the end of 2017, and use these offices as a launching pad for expansion into the broader European Union market. The Dublin offices are Aralez's first permanent business premises outside of North America.   Story New findings published in Nature are highlighting the potential of a new messenger RNA vaccine to protect against Zika virus. Acuitas Therapeutics Inc., a private biotechnology company based in Vancouver published the data demonstrating that single low dose immunization with a messenger RNA delivered in an Acuitas LNP carrier has the potential to protect against infection by Zika virus. The company is developing a lipid nanoparticle (LNP) delivery technology for the messenger RNA (mRNA).  In the Nature paper, Acuitas Therapeutics scientists and academic researchers including Dr. Drew Weissman, a professor of Infectious Diseases in the Perelman School of Medicine at the University of Pennsylvania showed that single low-dose immunization with mRNA-LNP encoding the pre-membrane and envelope (prM-E) glycoproteins of a Zika virus strain responsible for the 2013 outbreak elicited potent, durable and protective neutralizing antibody responses in animals. The company in collaboration with Dr. Weissman say they hope to further advance this exciting new therapeutic modality. Story In Ottawa, ON, Avivagen Inc., a life sciences company commercializing products intended to replace the antibiotics added to livestock feeds, with the help of the National Research Council of Canada (NRC) has launched a new project to establish proof-of-concept for a first human health application of its OxC-beta™ Technology. The technology is derived from Avivagen discoveries about carotenoids, compounds that give certain fruits and vegetables their bright colors and is a non-antibiotic means of maintaining optimal health and growth. OxC-beta™ Livestock is a proprietary product shown to be effective and economic in replacing the antibiotics commonly added to livestock feeds.  Specifically, the project will evaluate the efficacy of OxC-beta™ Technology (“OxC-beta”) in an established research model of an infectious disease of humans. Work will be conducted by NRC experts at its facilities based upon a jointly developed protocol and is expected to be completed in 2017. Dr. James (Jamie) Nickerson, Avivagen’s director of product validation, commented on the project and its objectives, saying the company is pleased to be working with NRC. He adds that OxC-beta has demonstrated safety and effectiveness across more than a dozen livestock trials and those results suggest it could also prove to be important to human health and well-being. Neither the NRC or Avivagen have disclosed the specific disease target at this time, in the hopes of ensuring the patentability of this potential new application for OxC-beta™ technology. What is known is that the disease target is one of the top 18 urgent, serious or concerning drug-resistance threats listed by the United States Centers for Disease Control (the “CDC”). Story Vancouver’s Aequus Pharmaceuticals has landed $100,000 in funding from the National Research Council of Canada Industrial Research Assistance Program to support the ongoing Proof of Concept clinical study of its lead product candidate, AQS1301, a once-weekly transdermal aripiprazole patch. Aripiprazole is an atypical antipsychotic and the active ingredient in Abilify®, a leading medication in the US used for the treatment of a number of psychiatric disorders including bipolar I disorder, schizophrenia, major depressive disorder and irritability associated with autistic disorder. Aripiprazole is currently available in once-daily oral tablets and a once-monthly injectable form, however, medication adherence continues to be a significant challenge for patients. In terms of the clinical study, Aequus anticipates results of this repeat dose, 28-day study in the first quarter of 2017. The results will be used to inform the final design of the patch to be advanced into the regulatory phase of its clinical trials. Aequus expects to confirm its regulatory development plan in a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) in the second half of 2017. Story In Toronto, Trillium Therapeutics Inc, a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, has initiated dosing in its second Phase 1 clinical trial with TTI-621 in patients with relapsed or refractory percutaneously-accessible solid tumors and mycosis fungoides. Trillium is developing TTI-621 as a novel checkpoint inhibitor of the innate immune system, and the drug is currently being evaluated in an ongoing 10-cohort Phase 1b study in patients with relapsed or refractory hematologic malignancies. The two-part clinical trial is designed as a multi-center, open-label Phase 1a/1b trial, with TTI-621 being evaluated as a single-agent in patients. The escalation phase will include single or multiple doses of TTI-621 delivered by intratumoral injections, which will be followed by an expansion phase during which one or more selected dose levels of TTI-621 will be tested. Story Wrapping things up this week, in a national first,t he Terry Fox Research Institute and two leading cancer centres in Canada -- the Princess Margaret Cancer Centre in Toronto and the BC Cancer Agency in Vancouver – are partnering on an innovative pilot project to accelerate precision medicine for their cancer patients. The initiative comes at a time when other developed countries are investing heavily in strategies to improve survival from cancer through precision medicine and increased collaboration. The pilot will provide much-needed evidence on how best to roll out a broader vision for data sharing and collaborative translational and clinical research to enable precision medicine for cancer patients.  The pilot is the first phase for developing and implementing a national program that will link high-performing comprehensive cancer research centres, hospitals and universities and their clinical and laboratory programs across Canada through the Terry Fox Designated Canadian Comprehensive Cancer Centres Network. Through the pilot project, each organization will provide complementary analyses of specimens (e.g. tumour biopsies and blood samples), identify and determine ways to harmonize their research processes, set up an IT infrastructure for data sharing, and develop resources required to conduct multi-centre precision medicine clinical trials.  The initial focus will be on colorectal, ovarian, and prostate cancers, with the goal of improving the health outcomes of patients through treatment by precision medicine. Each organization is contributing $4 million over the next two years for a $12-million total investment that will see multidisciplinary teams focus on four specific research thrusts that are institutional priorities: genomics, immunotherapy, molecular imaging and data sharing. That concludes another episode of the Biotechnology Focus Podcast. If you like our show, let us know via a twitter, you can We’re also always looking for your feedback, story ideas and suggestions so we’d love to hear from you.  You can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca . For all of us here at Biotechnology Focus, thanks for listening.