FDA Approval of LYNPARZA® in US for HRR gene-mutated mCRPC

Dr. Josefa Briceno, M.D., Medical Head for the DNA Damage Response Franchise in US Medical Affairs at AstraZeneca discusses the recent FDA approval of LYNPARZA® (olaparib) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.  Approval was based on results from the Phase III PROfound trial, which were published in the “New England Journal of Medicine”.

Read More

FDA Approval of Enspryng™ For Neuromyelitis Optica Spectrum Disorder (NMOSD)

Dr. Geoffrey Eubank, M.D., Medical Director of the Mid Ohio MS Center at OhioHealth Neurological Physicians, discusses 2 Phase lll clinical trials of Enspryng™ (satralizumab-mwge) that demonstrated robust efficacy and safety profiles for the treatment of adults living with anti-aquaporin-4 (AQP4) antibody-positive NMOSD, a rare disabling neurological disorder often misdiagnosed as multiple sclerosis.  Enspryng represents significant therapeutic progress for the NMOSD community, offering the only FDA-approved injectable treatment option that can be self-administered every four weeks by a person living with NMOSD or a caregiver following training from a healthcare provider. 

Read More

Aegis Life’s Investigational DNA Vaccine

Dr. John Lewis, Ph.D., CEO of Aegis Life, Inc., a spinout of Entos Pharmaceuticals, discusses the company’s goal of developing a novel DNA vaccine using its proprietary gene delivery technology, Fusogenix, in the fight against COVID-19.  The flexibility of Fusogenix may enable Aegis Life’s investigational DNA vaccine to target and deliver simultaneously the Spike (S) protein and the Nucleocapsid (N) protein intracellularly. This approach may maximize the potential of inducing a potent, durable, and balanced T cell response against COVID-19, in addition to having a strong neutralizing antibody response.

Read More

The Age of Precision Medicine

Glen de Vries, co-CEO and co-founder of Medidata, the most-used platform for clinical trials around the world, shares insights from his new book coming out on September 14, 2020, titled “The Patient Equation: The Precision Medicine Revolution in the Age of COVID-19 and Beyond”.

Read More

Adarza Biosystems – ZIVA™ Platform

Bryan Witherbee, CEO of Adarza Biosystems discusses ZIVA™, a label-free protein detection platform that can accurately test 100s of protein from a single drop of blood in a time and cost-efficient manner. While the initial launch of ZIVA was focused on biomarker detection in cancer, they have changed direction to assist in vaccine development and immunosurveillance following COVID-19 and they are now applying this technology in the quantification of SARS-CoV-2/COVID-19 antibodies and other upper respiratory pathogens.

Read More

Active Living Awareness Initiative – A Clinician Perspective

Dr. Kendra Grubb, surgical director of the Emory Structural Heart and Valve Center in Atlanta discusses data from a national survey released by patient advocacy group Heart-Valve-Surgery.com and supported by Medtronic, of more than 3400 heart valve patients and caregivers about managing heart valve disease and how a return to “active living” is key in their treatment decision.  The findings from the survey were the impetus for the “Active Living” Initiative.

Read More

Lineage Cell Therapeutics – Cell Therapy Programs

Brian Culley, CEO of Lineage Cell Therapeutics, a clinical-stage biotechnology company, discusses the three cell therapy programs they currently have in clinical trials: OpRegen – a cell replacement therapy for the treatment of advanced dry age-related macular degeneration (dry AMD), OPC1 – a cell replacement therapy for the treatment of acute spinal cord injuries, and VAC2 – an allogeneic cancer immunotherapy for patients with non-small cell lung cancer (NSCLC). 

Read More