INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Are You Ready To Engage With Health Canada?

  Meetings with regulators are yours to direct. It’s up to you to get the most out of them. This resource addresses engagements with Health Canada however the key takeaways can also be helpful for your interactions with other global regulators.

• Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus

  In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.

• How MilliporeSigma Handles Quality Inspection Readiness

  While quality management is a major priority across the life sciences industries, it takes specific precedence in viral gene therapy. Heather Burnell, Head of Quality at MilliporeSigma’s viral vector manufacturing facility in Carlsbad, CA, highlights how quality management is embedded in the MilliporeSigma culture.

• When And How To Engage With Your Regulator

  Whether you are developing a therapeutic or an enabling technology, you know that ambiguity can be one of the biggest hurdles to overcome in early development and can slow down or even stall decision making. One way to reduce ambiguity, and therefore risk, is to consult with regulators on your planned development activities. This blog post will provide insights into effectively engaging with regulators so that you can move your development program forward.

• Is It Time To Leave The Biotech Incubator?

  By the traditional definition, incubators are warm, safe places that nourish and protect their inhabitants and give fledglings a start that optimizes their chances of survival. They’re also, by design, a bit too confining for growth-oriented entities to occupy for long. Multi-time emerging biopharma leader Kavitha Iyer-Rodrigues, founder of Zumutor Biologics, Inc. offers experience-based insight into maximizing the value of incubation time, and knowing when it’s time to spread your wings and step out of the nest.

• Building An All-Star Biotech Team

  Building your biotech team isn’t easy, but it’s central to your value. In fact, Roivant Sciences founder and CEO Vivek Ramaswamy believes people are the most important ingredient for launching a biopharma company. Here he shares more about why finesse, not formula, should drive your hiring decisions.

• Finding Biotech Funding In Volatile Times

  Dr. Ben Zeskind, CEO of Immuneering, founded the biotech in 2008 as the global economy suffered the beating that would come to pass as the Great Recession. This blog highlights Dr. Zeskind's insight into how the fund-seeking exercise changes in challenging economies, and presents his strategies for addressing those changes.

• Pitching Your Biotech To Investors

  Early-stage biopharmas find themselves in an increasingly crowded field of companies seeking capital, and the noisier the crowd gets, the harder it is to differentiate your science, your people, and your value proposition. Unless you’re extremely lucky or the spouse or offspring of a billionaire, successfully producing investor dollars from the story of your science, people, and value proposition is going to require a pitch deck and tireless energy to present it. Multi-time biotech founder Leslie Williams has been down this road more than once, and she’s got plenty of candid advice on building a pitch deck and preparing for the pitching process.

• Linking Biotech Value Creation And The Exit Strategy

  Dr. Francois Nader has taken multiple biotechs from non-factor to multi-billion-dollar exits. Here, Dr. Nader discuss the business side of biopharma, and more specifically, why it's important for emerging biopharma leaders to launch with the end in mind and what that means in the contexts of building company valuation and maximizing the exit.

• The Business Of Biotech

  Multi-time biotech founder, board member, and advisor Allan Shaw has a lot of insight to offer the emerging biotech community. In this wide-ranging interview, he shares some of his best advice on organizational structure, funding opportunities, onboarding talent, timing your next big move, and a whole lot more.