Xtalks Life Science Podcast – Details, episodes & analysis

In this episode, Ayesha spoke with Joshua Cohen and Justin Klee, co-CEOs and co-founders of Amylyx Pharmaceuticals, a company developing therapeutics for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).

Josh and Justin co-founded Amylyx Pharmaceuticals in 2013. Josh co-invented the oral, fixed-dose combination AMX0035 (known commercially as Albrioza in Canada and Relyvrio in the US), which is being explored for the potential treatment of neurodegenerative diseases. With a background in biomedical engineering, Josh is passionate about improving outcomes where there is a significant unmet need by pursuing research into novel drug candidates for ALS and other neurodegenerative diseases.

Justin previously conducted research in neural systems in the Moore lab at Brown University and in neurophysiology and Alzheimer’s disease under Dr. Rudolph Tanzi, founding member of Amylyx’ Scientific Advisory Board, at Harvard Medical School to explore new approaches to treating relentlessly progressive neurodegenerative diseases.

In 2020, Josh and Justin were named to Business Insider’s 30 Under 40 in Healthcare list and PM360’s ELITE in the Drug Researchers and Developers category among the many other awards they have won throughout their careers thus far.

Josh and Justin have overseen the growth of Amylyx from its start as a concept dreamed up in a dorm room at Brown University to a global, commercial stage and publicly traded pharmaceutical company hundreds of employees and headquarters in the US, Canada and the Netherlands to support Amylyx’s global operations.

Josh and Justin led the global regulatory approvals of AMX0035 for the treatment of ALS in Canada and the US. In April, Amylyx decided to remove the drug from the US and Canadian markets based on data from a confirmatory trial.

Tune into the episode to learn more about Amylyx’s plans for AMX0035, which include investigations in progressive supranuclear palsy (PSP) and Wolfram syndrome.

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In this episode, Ayesha spoke with Howard McLeod, PharmD, Director of the Center for Precision Medicine and Functional Genomics, Professor of Pharmacy and Medicine at Utah Tech University and Precision Medicine Advisor at the Geriatric Oncology Consortium; and Sharmeen Roy, PharmD, Chief Strategy and Science Officer at DoseMe, which is the world’s first and largest Bayesian dosing platform designed for clinical practice.

Precision dosing, also known as personalized dosing, aims to tailor drug dosages to the individual characteristics of each patient to achieve optimal therapeutic outcomes while minimizing adverse effects. It leverages various patient-specific factors, including genetics, age, weight, organ function and even lifestyle, to determine the most appropriate dosage for each individual. 

Dr. McLeod is an internationally recognized expert in precision medicine, who has made novel contributions at the discovery, translation, implementation and policy levels. Dr. McLeod received his Doctorate in Pharmacy from the Philadelphia College of Pharmacy and Science and completed his Post-Doctoral Training at St Jude Children’s Research Hospital and the University of Glasgow. 

Dr. Roy is passionate about leveraging technology to amplify the impact of the pharmacist. Her career spans pediatric clinical pharmacy, clinical research and pharmacogenomics with leadership roles at University of Chicago Medical Center and PipelineRx. She received her Doctor of Pharmacy degree from the University of Illinois at Chicago, is a Board-Certified Pharmacotherapy Specialist and completed a Pediatric Specialty Pharmacotherapy Residency at Texas Children’s Hospital.

Tune into the episode to learn more about the current landscape of precision dosing, including the latest technologies and tools designed to help optimize drug dosages.

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In this episode, Ayesha spoke with Margaret Froh, President of the Métis Nation of Ontario (MNO). Margaret is also a lawyer by training.    The Métis are a distinct Indigenous people recognized in s.35 of Canada’s Constitution. Métis communities have their own shared customs, traditions and collective identities that are rooted in kinship, their special aboriginal relationship to the land and a distinctive Indigenous culture and way of life that persists to the present day.    Cancer is a significant concern among Métis people in Ontario and across the Métis Nation Homeland, including women, as they experience higher cancer rates and lower cancer screening uptake than the non-Indigenous population.    Cancer Prevention Action Week, which took place during the third week of February, focuses on supporting and empowering people to make changes to their lifestyle and promoting routine cancer screening to reduce the risk of preventable cancers.    To help uncover and address cancer disparities among the Métis, Margaret has helped lead Métis-specific health research in collaboration with organizations like Ontario Health (formerly Cancer Care Ontario) and the Sunnybrook Research Institute.    Margaret is also a recent breast cancer survivor and by sharing her personal cancer story, is helping raise awareness about the importance of routine cancer screening among the Métis.    Tune into the episode to learn about the disproportionate impact of cancer on Métis communities and how Margaret’s leadership at the MNO is helping to drive changes to help improve cancer screening rates and better health outcomes.    For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/   Follow Us on Social Media

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This episode features an interview with Georgia Institute of Technology researcher Dr. Woon-Hong Yeo who has helped lead a team of researchers to develop a novel vascular monitoring system based on a specially designed smart stent. Hear about how the implantable smart stent system offers real-time and continuous monitoring of metrics like blood pressure and blood flow, as well as Dr. Yeo’s personal motivation for creating the vascular monitoring system to help people monitor their cardiac health. Dr. Yeo is a Woodruff Faculty Fellow; Associate Professor in Mechanical Engineering and Biomedical Engineering; and the Director of the Center for Human-Centric Interfaces and Engineering at Georgia Tech.

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In this episode, Ayesha and the editorial team spoke with Dr. Samantha Dale Strasser, chief scientific officer and co-founder of biotech start-up Pepper Bio. The company is working to develop therapeutics in the areas of oncology, neurodegenerative disease and inflammatory conditions using a ‘transomics’ drug discovery approach. This involves the integrated analysis of several layers of biological data, including genomic, proteomic, transcriptomic and phosphoproteomic data using novel transomics technologies involving lab methods and AI approaches. Hear more about Pepper Bio as well as Dr. Strasser’s journey from academia to the biotech industry.

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In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP). With the approval, Eli Lilly will be giving Novo Nordisk’s blockbuster diabetes injection Ozempic some tough competition. Hear about the projected sales of Mounjaro, data from studies that led to its approval and its impact from a patient perspective.

Ayesha also talked about the current monkeypox outbreak as clusters of cases continue to be reported in countries in Europe and North America. The US recently reported its first case of monkeypox, and all cases so far are linked to international travel. Learn more about monkeypox and how health authorities are asking people not to panic as most cases are mild and treatable. Also hear about how Britain is offering the smallpox vaccine to healthcare workers to help prevent infection from the monkeypox virus.

Read the full articles here: 

Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod

Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

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In this episode, Ayesha discussed a new study that evaluated a text messaging program designed to improve medication adherence and lifestyle factors among heart attack survivors. While the program did not lead to improvements in medication adherence, it did have a positive impact on lifestyle factors like diet. Hear more about the study and the importance of managing heart attack risk factors like hypertension and diabetes. This is especially relevant on World Hypertension Day (May 17) and May Measurement Month, which bring awareness to the importance of accurately measuring blood pressure.

Ayesha also talked about the FDA’s decision to place stricter restrictions on the use of Janssen/Johnson & Johnson’s COVID-19 vaccine given continuing concerns of the rare but serious side effect of blood clots. Hear about why the FDA revised the vaccine’s authorization, and why the FDA maintains that the vaccine’s benefits outweigh any known or potential risks.

Read the full articles here: 

How Heart Attack Survivors Can Improve Lifestyle Factors with a Text Messaging Program

FDA Puts Further Restrictions on Use of Janssen/Johnson & Johnson COVID-19 Vaccine

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In this episode, Ayesha discussed Bristol Myers Squibb’s new heart drug Camzyos (mavacamten), which has received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The drug is the first to target the pathophysiology of obstructive HCM and may be Bristol Myers’ next blockbuster cardiac drug. Hear more about the company’s looming patent cliff for some of its drugs as well as the company’s risk evaluation program for Camzyos given some of its safety concerns.

Ayesha also talked about a new ovarian cancer blood test developed by researchers at the University of Manchester that may help diagnose the disease quicker and more accurately, especially in younger women. The test includes a newer ovarian cancer biomarker that when used in combination with CA-125, the biomarker currently used to monitor and screen for ovarian cancer in some cases, could improve its diagnostic value. Learn more about the test and about the importance of women’s health advocacy in the early detection of diseases like ovarian cancer.

Read the full articles here: 

Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer

Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug

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In this episode, Ayesha discussed the FDA approval of Mycovia Pharmaceuticals’ Vivjoa (oteseconazole) as the first approved treatment for recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection. The drug is indicated for women who permanently lack reproductive potential or are postmenopausal. The editorial team discussed the significant unmet need for this condition and how although many women’s health issues are now given greater spotlight, there still need to be more conversations around them. The episode marked World Maternal Mental Health Day and was sponsored by Elligo Health Research.

The editorial team also talked about the latest results of Eli Lilly’s investigational obesity drug tirzepatide, which demonstrated it could reduce body weight by an average of 20 percent in individuals without diabetes. Tirzepatide is a GLP-1 receptor agonist, a class of drugs designed to treat diabetes but at higher doses, can help with weight loss. Hear more about the drug and the obesity drug market, which is projected to grow to $5.42 billion in 2025.

Read the full articles here: 

Oteseconazole (Vivjoa) Becomes First FDA-Approved Drug for Recurrent Yeast Infection

Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial

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In this episode, Ayesha talked about World Immunization Week, which is celebrated during the last week of April every year. The theme of this year’s World Immunization Week is “Long Life For All,” which aims to communicate the importance of vaccines for a healthy and fulfilling life by protecting yourself and your loved ones against deadly diseases. Immunization programs were impacted by the COVID-19 pandemic but find out how immunization rates have been on the decline, particularly in developing countries, which have led to the resurgence of diseases like polio and measles.

The editorial team also discussed a new COVID-19 breathalyzer test that recently received emergency use authorization (EUA) from the US Food and Drug Administration (FDA). The mobile rapid test generates results in just three minutes from a sample of exhaled air. Hear more about how the test in the podcast, including how it works and about its high degree of sensitivity and specificity that edges out rapid antigen tests.

Read the full articles here: 

World Immunization Week 2022: Long Life For All

First COVID-19 Breath Test Gets FDA Authorization

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