INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Speed vs Safety: How Regulators Are Sizing Up Evidence Today

  n drug development, there is always pressure to move quickly, and with today’s push to develop treatments and vaccines for COVID, those pressures are exacerbated. In this webinar, the speakers will ground their predictions for the future in the historic response of regulatory bodies to epidemics, then explore recent shifts in the regulatory environment in response to COVID and the resulting new efficiencies in drug development.

• Beware of Underestimating The Value Of A Pre-NDA Meeting

  Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of a well-organized NDA that fits the expectations of agency reviewers.

• CRO Of Choice For Cell And Gene Therapies

  Nothing is standard about study design, trial conduct, or regulatory process in this specialized area. Our scientific team of experts are adept at strategy and execution across the clinical development journey. Whatever the study’s unique considerations – patients, products, process, follow-up, regulatory – Veristat can successfully get you through it.

• Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?

  Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

• Navigating Regulatory And Development Milestones

  The biotherapeutics market is evolving, and emerging companies are advancing cutting-edge therapies to keep pace with innovation. The potential for life-changing, curative solutions where limited options exist makes this an exciting time to be in biotech. Although patient focus is constant, regulatory concerns and investment capital needs evolve as biopharma startups move their products from development to approval. This article addresses how early-stage biotherapeutic companies can avoid common pitfalls and access support as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

• Gap Analysis Fundamentals To Maintain Forward Progress

  Gap analysis—defined as the process of reviewing all the available information for a candidate product to assess current development status, identify potential gaps in information, and the subsequent steps required to develop a strategy to fill those gaps a fundamental and ongoing exercise. In a recent The Business Of Biotech podcast Dr. Valenzuela,  CEO at Andes Biotechnologies, was joined on the podcast by Cristian Hernández-Cuevas, COO at Andes. Their collective reflections and advice on gap analysis execution provides real-world guidance for the leaders of emerging biopharma organizations.

• CMC Considerations For First In-Human Studies

  As you gear up for your first-in-human studies, your CMC (chemistry, manufacturing, and controls) and medical affairs leaders will come together to play principal—and interdependent—roles in the success of those initiatives.  On a recent episode of The Business of Biotech podcast, Dr. Perez, Chief Medical Officer and Dr. Ihle, VP of CMC and Quality at Bolt Biotherapeutics, Inc. shared their collective advice for emerging biotech leaders who are new to first-in-human studies. Here’s a sample of what they shared.

• The Relationship Between GMP And CMC - And The Team That Ties It Together

  While GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching CMC (chemistry, manufacturing, and controls) strategy.

• The Data Quality & Master Files Challenge For FDA Submissions

  From its beginnings in 2016, Celularity Inc.’s Dr. Robert Hariri knew his company would face a particularly acute challenge with the FDA. The company’s therapeutic approach—the development of medicine from allogeneic placental-derived cells—is entirely dependent on its ability to do something that had never been done before: accomplish the at-scale harvest and preservation of healthy, postpartum fetal stem cells from maternity wards far-and-wide.

• Particle Size Analysis Overview

  This paper reviews different analytical techniques for particle size analysis, including types of distributions, laboratory versus online systems, and sample result comparisons. It is intended to help those new to particle size analysis understand each technique’s various strengths and weaknesses in order to select the proper technique for their samples.