Sponsored by: California Institute for Regenerative Medicine (CIRM)
Session ends: August 23, 2013 @ 3PM EST
Answers by: Neil Littman, Business Development Officer, CIRM
Ask our Expert about navigating funding and grant writing, partnering with organizations, and the regulatory process.
There are an increasing number of promising new stem cell therapy applications in research and development. When these potential therapies show promise, the challenge of moving these therapies from concept to commercialization can be a daunting and confusing task. Important steps need to be followed for success including finding funding, creating effective partnerships with organizations and fostering a positive regulatory process, including IND submission. If you have questions about the best way to move your product idea forward , then please join us for a special Ask the Expert session “Moving your Cell Therapy from Concept to Product.
Hosting this week’s session is Neil Littman, the Business Development Officer at the California Institute for Regenerative Medicine (CIRM): Mr. Littman is responsible for facilitating opportunities for outside investment in stem cell research in California for both CIRM-funded and non CIRM-funded programs by biopharmaceutical strategic partners, equity investors, and disease foundations.
Questions & Answers
I do not think there is one answer to this question – there are a variety of factors that will determine if a product is ultimately successful in the market including its positioning (i.e. what market segment or sub-segment you are targeting), competition, reimbursement, pricing as well as a host of other factors. Beyond the […]» Read MoreThis is typically what investors refer to as “positioning” and is the crux of a good pitch. The key items to discern are how is your technology/product different from the competition? Is your technology entirely novel, or does it built upon and improve what is already on the market? What sets you apart from the […]» Read MoreDeciding when and if to “spin-out” a company from an academic lab largely depends on the ability to secure the intellectual property (IP) rights from the academic institution, the ability to finance the new entity, and the ability to properly manage the new entity in order to drive the technology forward towards commercialization. The first […]» Read MoreThe single best recommendation I have for a successful IND submission is to make sure that you have communicated with the FDA throughout the development process. This can be accomplished by communicating with the agency via a pre-pre-IND meeting, which is an informal discussion focused primarily on preclinical issues (and always handled by teleconference). The […]» Read MoreOften times a strategic partnership is a great way to advance your technology or product candidate. There are many forms of strategic relationships, ranging from collaborations where the strategic partner is very hands-on and involved in the development (often committing in-kind services), to others where the partner may simply help fund the development based on […]» Read MoreThere are a multitude of opportunities to interact with the FDA during the product development cycle that should be taken advantage of, with the earliest interactions beginning at the “pre-pre-IND stage”. Pre-pre IND interactions are informal discussion, focused primarily on preclinical issues. These interactions are always handled by teleconference and there is no set time […]» Read MoreThe answer to this question is unequivocally the latter strategy – it is imperative that you start as early as possible using cGMP (current good manufacturing practice) that may be scaled-up and scaled-out as your process moves through clinical development. While having dispersant manufacturing areas at various hospitals may be suitable for phase 1 studies […]» Read MoreAbout CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity […]» Read MoreThere are a variety of funding sources available for small start-up companies that have generated proof of concept (POC) data, as well as for those companies that have yet to do so and are seeking funds to establish POC. The available sources of financing at this stage in a company’s life cycle will generally include […]» Read More