FIERCE BIOTECH VIRTUAL SERIES
How to Grow: Insights from Fierce 15 Alumni
October 5-7, 2020 Virtual Event
The annual Fierce 15 list highlights companies on the leading edge of biopharma R&D — and on the cusp of big leaps forward in the lives of their companies. Here, they share their insights for advancing a young biotech, from early breakthroughs and financing, to clinical trials and partnering.
Monday, October 5
VC, M&A and IPO: The Funding Game and Investor Strategy
In recent years, venture capital funding rounds have commonly run into 9 digits, and ambitious biotechs often rack up several before selling or going public. Winning that VC backing is a journey young companies must learn to navigate, and the investor commitment is just the start of a relationship that comes with its own challenges and protocols. And when it comes time to launch an IPO or make a sale, biotech execs must sell their ideas and accomplishments to a wide world of investors and potential partners.
In this session, we’ll hear lessons from companies that successfully made their way from startup to market or M&A—obstacles overcome, make-or-break points on the timeline, and the unwritten rules to follow along the way.
Tuesday, October 6
Strategies to Avoid Enrollment Delays
Completing enrollment is typically one of the most critical milestones in a clinical trial. Enrollment delays impact the study budget, site resources, and downstream timelines. Therefore, it is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible. Defining risk mitigation strategies and setting quality tolerance limits allows the study team to quickly identify when a strategy must be implemented to keep enrollment on track. In this webinar, we will discuss how we have used a risk-based quality management system to document enrollment risks and creative solutions we have implemented.
Overcoming Challenges in Midstage Trials, from Clinic to Supply
Today’s phase 2 trials, pivotal or otherwise, face the usual challenges of site selection and setup, patient recruitment and retention, regulatory hurdles, clinical supply, data management and follow-through. But today’s trial sponsors must also contend with a set of unprecedented operational circumstances presented by the coronavirus pandemic.
Those circumstances have halted some trials in their tracks, but others chugged ahead by deploying new technologies and processes. And even if drugmakers pulled back in some areas, they stepped up elsewhere—namely by joining the race for COVID-19 therapeutics and vaccines, where phase 2 data are more closely watched than ever.
In this session, we’ll discuss how trials in COVID-19 and beyond are adapting to constantly changing circumstances to keep important drug and vaccine research on track.
Wednesday, October 7
Partnering in Phase 3: The Big Leap to Big Trials
The last mile of drug development lies on an entirely different plane. It’s bigger, more expensive, more complicated—and the stakes couldn’t be higher. With the biotech world flush with funding, many companies can draw on their own resources to run pivotal trials, but money isn’t all that’s required. Expertise, infrastructure and relationships all matter, too.
Hence the late-stage partnership, whether with a bigger drugmaker or contractors that can fill in the blanks. Which to choose? Our conversation will address that question and lay out advice for companies seeking those all-important partners: how to find them, how to woo them, how to get to an agreement and how to work with them after the papers are signed.