Xtalks Life Science Podcast

In this episode, Ayesha spoke with Jordyn Playne, President of the Métis Nation of Ontario Youth Council, a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level.

Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention. Jordyn has a Master’s degree in social work and licenses/certifications in cognitive behavioral therapy.

To mark Cancer Prevention Action Week, which took place during the third week of February, Jordyn also shared a personal story to help raise awareness about the importance of cancer prevention, particularly among Indigenous communities like the Métis.

Cancer is a significant concern among Métis people, including women, as they face higher cancer rates than the non-Indigenous population. Jordyn describes herself as a cancer “previvor,” as she took preventative action to reduce her risk of breast cancer.

Tune into the episode to learn more about Jordyn’s story and her work in helping to improve health awareness and health outcomes among Métis youth and the greater Métis Nation.

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In this episode, Ayesha spoke with H. B. Pierre Simon Jr., MBA, Vice President, Global Head of Marketing, Sight Sciences, about the evolving field of eye care. Sight Sciences is focused on developing and commercializing innovative solutions for eye diseases like glaucoma and dry eye disease to transform care and improve patients’ lives.

Among some of Sight Sciences devices and technologies include the OMNI® Surgical System, a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The company’s other notable product is the TearCare® System, which has FDA clearance for localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), the leading cause of dry eye disease.

Pierre has been in the eye care industry for almost two decades. Prior to Sight Sciences, he was at Alcon for 15 years in roles with increasing responsibility, including Senior Product Manager, Global Franchise. Pierre is also a life influencer and two-time best-selling author. His latest book is entitled ‘Down Thru Love,’ a story about the journey of a young man born with Down syndrome.

In the episode, Pierre discusses some important considerations in the development of innovative new treatments for eye conditions like glaucoma and dry eye, such as working with patients and doctors and having an awareness of both current and future needs. Hear more about Pierre’s work at Sight Sciences and also as an author and speaker.

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In this episode, Ayesha talked about Rare Disease Day 2024, a global movement held on the last day of February each year that focuses on raising awareness about rare diseases including their impact on patients’ lives. This year, Rare Disease Day falls on February 29, the rarest day in a leap year, making it even more special.

Ayesha spoke about how the Rare Disease Day campaign helps increase awareness about rare diseases, promotes research and development, supports advocacy for policies supporting patients and their families and brings together a global rare disease community.

Advancements in rare disease research are leading to innovative new treatments for various rare conditions, including genetic disorders, which make up just over 70 percent of all rare diseases.

Hear more about new rare disease drugs approved by the FDA in the past couple of years. Also hear about some of the latest trends in rare disease research, including innovative trial designs, patient-centric approaches, the use of cutting-edge technologies like AI and international collaborations.

Read the full articles here:

Rare Disease Day 2024: Highlighting Statistics and Patient Stories
New Rare Disease Drugs and Research Advancements

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This episode features an interview with Amir Reichman, CEO of Scinai Immunotherapeutics, a biopharma company focused on developing, manufacturing and commercializing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases.

Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therapies for various illnesses. These NanoAbs are being tailored to treat conditions with significant unmet medical requirements and promising market prospects, including psoriasis and asthma.

Prior to being appointed as Scinai’s CEO in 2021, Mr. Reichman recently held the position of Head of Global Vaccines Engineering Core Technologies and Asset Management at the GSK Vaccines headquarters in Belgium. Before that, he was the Senior Director of the Global GSK Vaccines Supply Chain. He became part of GSK in 2015 following its acquisition of Novartis Vaccines, where he had various leadership positions with growing responsibilities within the Global Vaccines Supply Chain Management team, based in Holly Springs, NC, USA.

Tune into the episode to hear more about the development of new, cutting-edge inflammation and immunology therapies. Mr. Reichman also shares insights into the most significant trends currently shaping the inflammation and immunology sector.

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This episode features an interview with Yang Liu, PhD, founder, chairman, CEO and chief scientific officer; and Abid Ansari, MBA, chief financial officer at OncoC4, a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer. This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4.

OncoC4 is a spinout of OncoImmune, which was acquired by Merck in December 2020. OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications.

Dr. Liu is recognized internationally for his research on immune recognition of cancer and activation of lymphocytes. He has received several academic and research awards including the Snyder Award for Cancer Research in 2015, and was elected to the rank of fellow at the American Association for Advancement of Science (AAAS) in 2004 for his pioneering contribution to innate immunity, T cell costimulation and cancer immunology. Prior to serving full-time as OncoC4’s CEO, Dr. Liu was a faculty member at multiple academic institutions, including New York University and the Ohio State University.

Abid Ansari is a finance executive with a more 20-year track record in the life sciences industry encompassing corporate finance, fundraising, business development and investor relations experiences for public and private life science companies. Previously, he served as CFO of Artios, a UK-based DNA damage response company where he led the company’s $153 million Series C fundraising. Earlier in his career, Abid held positions at GlaxoSmithKline (GSK) in deal finance and portfolio management.

Tune into the episode to hear more about the development of new, cutting-edge cancer treatments, including current challenges in oncology and immunotherapies. Also hear about OncoC4’s collaborations including a co-development commercialization partnership with BioNTech on its lead product and a collaboration with Merck.

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This episode features an interview with Carlos Doti, MD, Vice President, US Medical Affairs Oncology, AstraZeneca, about new breast cancer treatments.

Dr. Doti is a hematologist by training and is passionate about developing treatments that have a real impact for people living with cancer across every aspect of their disease. Dr. Doti has worked in industry for the last 14 years, including seven years at AstraZeneca in various roles, and in small markets like Argentina as well as larger global markets. Since 2022, Dr. Doti has been focusing on the US market in hematology and oncology, working in breast, lung, GI and gynecological cancers among others.

Dr. Doti has previously served in medical affairs roles at Novo Nordisk A/S and Pfizer. His work is supported by more than 70 congress presentations and several peer-reviewed publications. He has also served as an investigator in more than 25 clinical trials in hemostasis, onco-hematology and infectious disease.

Recently, AstraZeneca won approval for the company’s AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN). The approval of Truqap was the first-in-class approval for AstraZeneca.

Tune into the episode to hear more about the milestone approval of the new combination breast cancer treatment, which has been a much-needed treatment option for the nearly 50 percent of patients with advanced HR-positive breast cancer who have PIK3CA and AKT1 mutations or PTEN alterations, and experience resistance to first-line treatments such as endocrine therapies and CDK 4/6 inhibitors.

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This episode features an interview with Punit Dhillon, Chairman & CEO of Skye Bioscience, a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development.

Punit brings two decades of experience as a leader and investor within the life sciences sector. During the interview, he shared his journey leading up to his role at Skye Bioscience and how his previous experiences have shaped his vision for the company.

During the interview, Punit discussed Skye Bioscience’s mission and therapeutic approach. The company is aiming to unlock the medicinal possibilities of the endocannabinoid system for addressing diseases that lack adequate treatments for patients globally.

At the end of the interview, Punit shared some advice for those looking to venture into the biotech and pharmaceutical industry.

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In this episode, Ayesha talked about some of the trends in the life sciences to watch out for in 2024. From the increasing integration of artificial intelligence (AI) and machine learning (ML) tools in drug development to medically accurate health wearables, hear about the trends and innovations that will be shaping the life sciences this year.

Ayesha spoke to industry experts and innovators in the pharmaceutical, biotechnology and medical device spaces to learn more about these trends and more. Hear about the latest technologies and approaches that will help drive innovations in drug discovery, clinical research and medical device design this year.

Read the full article here:

Life Science Trends to Look Out for in 2024

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This episode features an interview with Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics, a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging.

Ben is an engineer by training and prior to joining Monogram, he served as the Director of Business Development at Pro-Dex, an OEM manufacturer of Orthopedic Robotic End-Effectors. At Pro-Dex, Ben was responsible for the development, management and launch of a proprietary product solution, helping to negate a distribution agreement with a major strategic partner.

Monogram is working to develop tailored orthopedic solutions that can help reduce complications associated with orthopedic procedures such as knee replacement surgery. In this episode, hear about Monogram Orthopedics’ customized implants, which facilitate minimal processing and coordination time for orthopedic joint replacements, and how the company is going up against big industry names like Stryker and its market-leading Mako robot as well as Zimmer Biomet.

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This episode features an interview with Adam Kaplin, MD, PhD, Cofounder, President and Chief Scientific Officer at MIRA Pharmaceuticals, a preclinical-stage pharmaceutical company focused on the development and commercialization of new molecular synthetic cannabinoid analogs for the treatment of anxiety and cognitive decline typically associated with early-stage dementia.

Dr. Kaplin is a neuropsychiatrist whose research focuses on the investigation of the biological basis of immune-mediated depression and cognitive impairment by using multiple sclerosis as the model. Dr. Kaplin transitioned into industry by joining MIRA Pharmaceuticals to help lead drug development in the space.

Prior to joining MIRA Pharmaceuticals, Dr. Kaplin served in a number of positions at Johns Hopkins University, including Principal Neuro-Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis Center of Excellence, among others. He also served as Co-Founder of numerous healthcare related startups, including, from 2018 to present, REWARD Pathways, a company devoted to addiction treatment focused on a combined eHealth and medicine approach.

Dr. Kaplin’s original research has been published over 70 times in peer-reviewed publications in key areas in neuroscience and immunology, with a particular focus on the intersection of neurology and psychiatry.

In this episode, hear about drug development for conditions like dementia, cognitive decline and anxiety, and how MIRA Pharmaceuticals’ synthetic cannabinoid-based drug candidate could serve as a significant treatment advancement for these conditions.

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This episode features an interview with vaccine scientists and executives from Vaccines Global Clinical Development at Merck, Dr. Heather Platt, MD, Distinguished Scientist and Pneumococcal Vaccine Lead; and Dr. Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head.

Over the past ten years, Dr. Platt has worked across both infectious disease and vaccines products in both early- and late-stage clinical research. In her current role at Merck, she leads the product development team for V116, an investigational pneumococcal conjugate vaccine. Dr. Platt completed her training in Internal Medicine at Rutgers/Robert Wood Johnson Medical School, and Infectious Diseases Fellowship at New York Presbyterian/Columbia University Medical Center.

Dr. Buchwald applies her experience in public health and basic science research to expand Merck’s pneumococcal vaccine franchise and the development of next generation adult and pediatric pneumococcal conjugate vaccines. Since 2017, Dr. Buchwald has focused on pneumococcal disease prevention in various roles at Merck. Dr. Buchwald received her MD and Dr. med degree from the Freie University in Berlin, Germany, and completed her Internal Medicine residency and Infectious Diseases fellowship at New York University. She continues to see patients at Johns Hopkins University.

Merck recently announced results from STRIDE-3, a Phase III trial evaluating the immunogenicity, tolerability and safety of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, which is specifically designed for the protection of adults against pneumococcal infection.

In this episode, hear more about V116, pneumococcal infection, Merck’s vaccine development program and the company’s approach to addressing the specific needs of different populations, including infants and children, adults and at-risk subgroups.

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This episode features an interview with Fady Boctor, MBA, President and Chief Commercial Officer at Petros Pharmaceuticals, a Men’s Health pharmaceutical company that aims to develop complementary therapeutics designed for a man’s journey. The company focuses on therapeutics that promote medication adherence, tolerability and preservation of male organic function.

Fady has over 20 years of experience in the pharmaceutical industry, and has worked for companies such as Novartis, Forest Pharmaceuticals, Auxilium Pharmaceuticals, Endo Pharmaceuticals and Adapt Pharmaceuticals (Emergent Biosolutions).

In the episode, Fady discussed Petros Pharma’s lead ED therapeutic and its potential to be transitioned to OTC status. He also discussed the overarching challenges in men’s health today and how Petros is positioned to tackle them.

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This episode features an interview with Wa'el Hashad, CEO of Longeveron.

Hashad discussed Longeveron’s mission and the therapeutic areas the company is investigating. He discussed the mechanism of action of the company’s lead program, Lomecel-B.

Lomecel-B is an “allogeneic” (donor-derived) cell therapy product. Lomecel-B is a cellular therapy currently under clinical investigation as a potential treatment for various aging-related chronic diseases and life-threatening conditions. These studies are conducted under the approval of the FDA’s Investigational New Drug (IND) Applications.

Lomecel-B is under clinical investigation for pediatric hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and aging frailty.

Longeveron is based in Miami, Florida, with its corporate headquarters and manufacturing operations situated in the Converge Miami Building.

Hashad also shared the next steps for Longeveron’s programs.

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This episode features an interview with Attorney Temitope (Tope) Leyimu, a toxic exposure attorney at Motley Rice  who is leading a lawsuit over hair relaxing products that contain harmful chemicals.
 
Hair relaxing products are used for straightening/smoothening hair and many contain harmful formaldehyde, formaldehyde-releasing and other toxic chemicals. The FDA recently issued a recommendation for the recall of chemical hair relaxers containing harmful chemicals. While the agency has initiated its rule-making process, a ban hasn’t been implemented yet.

The products, which have historically been targeted primarily at black and brown women of African descent, have drawn major concern due to their links with reproductive-related cancers such as ovarian, cervical and uterine cancer. An October 2022 study by the National Institutes of Health, revealed that women using chemical straighteners face a 150 percent increased risk of uterine cancer.

Attorneys leading the hair relaxer lawsuit including Leyimu say the FDA proposal is a significant step in advancing public health for women, particularly black and brown women, who are disproportionately impacted by many of these products that are alleged to be harmful.

Tune into the episode to learn more about the litigation, including the historic racialized marketing of harmful hair relaxing products to women of African descent in the US.

If you or anyone you know may have been affected by these products, you can complete the webform to contact Motley Rice if you would like to talk to someone about the lawsuit.

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This episode features an interview with Dr. Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP).

The company presented details about the trial at the Neuro2023 PSP and CBD International Research Symposium that took place in London last month in October. The ORION study will evaluate the safety, efficacy, and tolerability of AMX0035 in PSP patients. The drug was approved by the FDA last year for the treatment of ALS.

PSP is a rare, progressive, adult-onset neurological disorder that affects body movements, walking and balance, eye movement, swallowing, and speech. There are currently no approved medicines to treat PSP.

Hear more about the details of the trial, which is set to begin in December this year.

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In this episode, Ayesha talked about the FDA’s acceptance of AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. While FluMist has been in the market since 2003, AstraZeneca is now seeking FDA authorization for a self-administered option of the vaccine. By offering a more accessible and flexible self-administered option, the company and experts in the field hope it will help increase uptake of the flu vaccine, especially as flu vaccinations have been on the decline in recent years.

Ayesha and the editorial team also talked about a new ad from GSK Canada that features Wayne Gretzky, as well as a younger, AI-generated Gretzky, raising awareness about RSV vaccination among older adults. The ad features young Gretzky reminding his older self to get his RSV vaccine as older adults are at a greater risk of developing complications from RSV infection. Hear more about the ad featuring the Canadian hockey icon.

Read the full articles here:

FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration
GSK Canada’s New RSV Vaccine Ad Features Wayne Gretzky, Young and Old

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Visit clinicaledge.xtalks.com/issue1 to dive into the first issue of Xtalks Clinical Edge magazine and be a part of the conversation shaping the next era of clinical trials. Xtalks Clinical Edge — "where innovation meets expertise!"

This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine.

Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device. Dr. Brown is co-chair of the Aesthetics Pharmaceutical Governance Board at AbbVie and is the co-founder of the Science of Aging. She was honored as a 2023 Healthcare Business Women’s (HBA) Luminary. Prior to joining industry, Dr. Manson Brown was trained to be a Plastic Surgeon and is a board-certified surgeon (MRCS).

Dr. Manson Brown spoke about the innovations in the medical aesthetics space, including breast reconstruction for breast cancer patients. She spoke about clinical trials in the space, including Allergan Aesthetics' commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.

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This episode features an interview with Dr. Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.

It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms, which include hot flashes and night sweats, associated with menopause.

Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies. It also included safety data over a period of 52 weeks from three randomized Phase III studies (SKYLIGHT 1, 2 and 4).

It is estimated that around 60 to 80 percent of women experience vasomotor symptoms during or after the menopausal transition. They can have a significant impact on daily activities and overall quality of life.

Tune into the episode to hear from Dr. Neal-Perry about vasomotor symptoms associated with menopause and the new trial data for fezolinetant.

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In this episode, Ayesha talked about a lawsuit that Johnson & Johnson and IBM are facing over a data breach that occurred at Janssen’s CarePath, Johnson & Johnson’s patient assistance program, the portal for which is run by IBM. The lawsuit was filed with the federal court in the Southern District of New York by a Florida resident who claims the companies failed to adequately protect patients’ personal identity and health information as per the Health Insurance Portability and Accountability Act. Hear more about the data breach and the risk and repercussions of cyberattacks in pharma and healthcare.

Ayesha also talked about a new contactless, at home sleep monitoring device that measures vital signs which received clearance from the FDA. The device, developed by Zürich-based med tech startup Sleepiz AG and called Sleepiz One+, offers short- and long-term monitoring of heart rate and respiration during sleep to provide insights into a patient’s physiological status. The company says the device helps monitor disease progression or remission and also helps in the diagnosis of sleep disorders such as sleep apnea. Hear more about the device in this episode.

Read the full articles here:

Johnson & Johnson and IBM Hit with Class Action Lawsuit Over Patient Data Breach

Sleepiz’s At Home Sleep Monitoring Device Wins FDA Clearance

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This episode features an interview with Dr. Paul Rennert, co-founder, CEO and CSO of Aleta Biotherapeutics, an immuno-oncology company focused on multi-antigen targeting solutions designed to enhance the action of CAR T cell therapies in B cell lymphoma, B cell leukemia and multiple myeloma, as well as non-B cell cancers such as acute myeloid leukemia (AML) and solid tumors such as breast cancer, gastric cancer and pediatric brain tumors.

Dr. Rennert spoke to Xtalks about CAR T cell engagers that Aleta is developing for both B-cell and non-B cell cancers. The company was recently granted clinical trial authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its investigational biologic CAR T-Cell engager ALETA-001. It will be evaluated in a Phase 1/2 clinical trial for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T-cell therapy. 

Dr. Paul Rennert is a noted research scientist and biotechnology executive with extensive strategic and leadership experience. After launching successful new biotech companies from 2012 to 2016, he co-founded Aleta Biotherapeutics. Dr. Rennet’s ability to work broadly across the industry grew from his outstanding early career at Repligen and Biogen, highlighted by multiple successful drug-development campaigns, over 50 patents filed and granted, and approximately 100 peer-reviewed publications.

Tune into the episode to hear more about Dr. Rennert’s work in advancing CAR T cell therapies in oncology.

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