Most drug developers seek new drug approvals in both the U.S. and Europe as they are two of the largest markets. However, considering both entities have some of the most evolved regulatory guidelines, approvals in the U.S. and Europe are often complicated by different policies, making simultaneous submissions of drug applications to multiple health authorities difficult and inefficient. Steve Sibley, VP of Synchrogenix Regulatory Science at Certara shares his expert opinion on the biggest risks and rewards when pursuing simultaneous drug application submission and talks about the differences and commonalities between the FDA and EMA, and reviews frequent missteps to avoid that can streamline the submission and potential approval success.
INTERVIEWS
New Study Helps People Make Better Informed Decisions About Diet and Healthy Habits
Dr. Christian Razo, MSc, PhD, Postdoctoral Fellow at the Institute for Health Metrics and Evaluation (IHME), discusses the findings of a study published in Nature Medicine (Oct 2022) that aims to clarify the often complex and contradictory health guidance linking certain diets, behaviors, and conditions to illness.
Protara Therapeutics – Tackling the Unmet Need in Bladder Cancer and the company’s investigational cell therapy, TARA-002
Dr. Jathin Bandari, MD, Chief Medical Officer at Protara Therapeutics, a clinical-stage company committed to identifying and advancing transformative therapies for people with cancer and rare diseases, discusses non-muscle invasive bladder cancer (NMIBC) and the company’s investigational cell therapy, TARA-002, that is currently in development for the treatment of NMIBC, which Protara believes can help address the pressing unmet need for the treatment of this form of bladder cancer.
CVS Health – Clinical Trial Services
CVS Health launched Clinical Trial Services (CTS) in mid-2021, with the aim of expanding clinical trial participation in previously underserved demographics, because a CVS retail location is no more than 10 miles from the majority of the American population. Dr. Owen Garrick, MD, Chief Medical Officer at CTS, discusses how the accessibility and flexibility of this decentralized model can address issues of diverse participation in clinical trials.
Attralus’ Pan-Amyloid Removal Therapeutics: A New Possibility for Systemic Amyloidosis
Dr. Jonathan Wall, Co-Founder and Interim Chief Scientific Officer at Attralus discusses the latest developments in systemic amyloidosis research, stemming from its oral and poster presentations at the XVIII International Symposium on Amyloidosis (ISA), alongside updates around its recently initiated Phase 1 trial in its lead therapeutic candidate, AT-02.
Kinnate Biopharma Inc. – Developing Targeted Therapies for Those Battling Cancer
Nima Farzan, CEO of Kinnate Biopharma Inc., a precision oncology company, discusses the company’s investigational targeted cancer therapies which are designed to target validated oncogenic drivers for patients who are not served or severely underserved today, such as patients with solid tumors harboring BRAF and FGFR-driven alterations.
Takeda – Health Equity
Dr. Lauren Powell, M.P.A., Ph.D., Vice President, US Health Equity & Community Wellness at Takeda, a global, values-based, R&D-driven biopharmaceutical leader discusses the importance of improving health outcomes in the most marginalized communities, how Takeda plays a unique role as a collaborator and convener for health equity, and her passion for dismantling the roots of oppression that keep people and communities from wellness.
Climate Change and Otolaryngology – Focus on Climate Health, Sustainability in Healthcare, and Surgeon Advocacy
Dr. Amanda Dilger, MD, ENT surgeon at Mass Eye and Ear discusses climate change and otolaryngology with a focus on climate health, sustainability in healthcare, and surgeon advocacy.
Head and Neck Surgeon Perception of Oral Tongue Depth of Invasion
Dr. Mark Varvares, MD, FACS, Chief of Otolaryngology/Head and Neck Surgery at Mass Eye and Ear talks about his study on Head and Neck Surgeon Perception of Oral Tongue Depth of Invasion that was presented at the 2022 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) annual meeting.
Bristol Myers Squibb – SOTYKTU™ for Treatment of Moderate-to-Severe Plaque Psoriasis
Dr. Jonathan Sadeh, MD, MSc, Senior Vice President of Immunology and Fibrosis Development, Global Drug Development at Bristol Myers Squibb discusses the recent approval of SOTYKTU™ (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. To learn more visit SOTYKTU.com