Biopharmaceutical Section Webinar Series: Don't go it alone: Benefits of joining our community of statisticians in small biotechnology companies
Panelists:
- Liang Fang, Nuvation Bio
- Mohamed Hamdani, Larimar Therapeutics
- Alan Hartford, Clene Nanomedicine
- Sharon C. Murray, BioCryst
Moderator: Alan Y. Chiang, Lyell Immunopharma
Date and Time: December 1 2023, 11.00am – 12.00 pm Eastern Time
Registration link: www.eventbrite.com/e/753502274587?aff=oddtdtcreator
Abstract:
With the rapid growth of biotechnology in the last half century, new drug discovery and development have now reached an inflection point where hundreds of emerging small biotech are evolving into the clinical development stage. These companies employ a growing number of statisticians. While the majority of statisticians in the pharmaceutical industry are employed by big pharma, we are seeing an increasing number taking the leap into the small biotech world. The purpose of this panel-discussion is to connect statisticians who either work for or want to work for a small biotech company so that they can share strategies, experiences, and ideas.
There are several challenges and opportunities when working in a small biotech. For example, there may be only one or a few statisticians/programmers working at the company, which means that there is heavy reliance on CROs for statistics and programming work. Consultants may be required for advice or to review documents. On the other hand, the statistician will have many opportunities for growth while making an impact on advancing human health through innovation. They will need to wear many hats, perhaps working on multiple phases of clinical trials, preparing for audits, answering analyst questions related to statistics, developing departmental SOP's, participating in regulatory discussions and/or advisory committee meetings, and overseeing outsourcing. Resources are limited and forming a strategy is key. Part of that strategy involves determining the level of CRO oversight, selecting preferred vendors, deciding what work to do in-house vs. outsourcing, acquiring statistical software, and liaising with other departments as the company grows. The strategy will need to be revisited on a regular basis as the company evolves.
The panel discussion will focus on four key questions:
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What are the main challenges one needs to overcome in interdisciplinary collaboration?
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How has the application of statistics played a key role in innovation, decision making, and clinical advances in a small biotech company?
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How could members benefit from being part of the ASA community for statisticians working in small biotech companies?