How to Partner with the Frederick National Lab and National Cancer Institute

Maggie Scully, who works in the Partnership Development Office at the Frederick National
Laboratory
, loves her job for lots of reasons. But among the top reasons is the collaborations
her team helps facilitate between FNL and researchers in academia, industry, and other
organizations.

Whether it’s a major pharmaceutical company or a one-person start-up, Scully says the
collaborations are about FNL’s core mission: getting effective biomedical solutions that improve
human health.

Scully shared the value of working with FNL and the National Cancer Institute during a panel at
the 2021 NCI and FNL Technology Showcase on Wednesday, Sept. 1. Steve Ferguson, NIH
Office of Technology Transfer, moderated the discussion.

How Partnerships are Beneficial

FNL is a Federally Funded Research and Development Center. The objective of the national lab is to quickly respond to the most urgent challenges and high-priority goals in biomedical science. FNL is home to several scientific initiatives that bring together experts from the FNL, NIH and the broader research community. FNL is operated by Leidos Biomedical Research for the NCI.

Both the FNL and NCI look for partnerships that can aid their mission while providing their
partners’ resources and expertise.

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“These partnerships, for example, can help start-up biotech companies looking to develop a
novel cancer therapeutic fill a gap from discovery to development,” Scully said ahead of the
panel. “We may be better equipped at modeling cancer progression to test the drug’s
effectiveness, as an example. So we can fill a big niche for a resource-strapped start-up
company with a unique technology.”

“Why should the commercial or business sector work with NCI? It’s frankly because we need
each other,” said James Hodge, Chief Director of the Laboratory of Tumor Immunology and
Biology. “We’re a transitional research lab and we want to make things that go into patients, but
I can tell you, we’re not going to vial it, we’re not going to label it, we’re not going to sell it.”

Hodge sees the relationship between NCI and FNL and their partners as symbiotic because
they’re both benefitting.

“If we can help a company get FDA approval, then we will do that,” he said. “We need the
business community and the business community needs a deep bench of scientists working on
the problem that they’re interested in.”

However, NCI and FNL are not Contract Research Organizations (CROs); instead, they are
collaborative partners. They can publish their findings and contribute to technology
development.

“This is a very unique relationship that can be beneficial to everyone, but most importantly to the
patients,” said Helen Sabzevari, president and CEO of Precigen. Sabzevari spent several years
at NIH in the early 2000s before starting her own company, so she has been on both ends of
the table.

The Logistics

Connecting with the Frederick National Laboratory and National Cancer Institute is often
organic. Hodge gave the example of seeing a researcher’s work at a conference and talking to
them about potentially collaborating. Before NCI or FNL strikes an official partnership with their prospective collaborator, the two entities might exchange data and information, said Michael Pollack, Unit Supervisor of the NCI Technology Transfer Center. These exchanges will often include non-disclosure agreements (NDAs) or material transfer agreements. Later, if NCI wants to formalize a partnership with a company, the parties might sign a CRADA or a Cooperative Research and Development Agreement. In the FNL case, it is a contractor-led CRADA (cCRADA).

“This is like dating. You’re going to date before you get married,” Hodge explained. “A CRADA
is getting married. It’s serious, there’s a lot of paperwork, and it’s hard to get out of.”

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It can take up to a year to get a CRADA finalized, Hodge said. But the material transfer
agreements and NDAs mean that preliminary research and work can start before the CRADA’s
finalization. Not all partnerships will require a CRADA. Part of Scully’s job in the Partnership Development Office is to evaluate projects and collaborations to determine how to move forward. First, Scully and her team have to decide if the project fits the mission of the lab and if there is mutual interest to undertake a collaboration.

“We can help identify relevant FNL investigators and enable discussion to develop a
collaborative project,” she said. “There are a few questions that we look at, one: does it fit our
mission and scientific interest of FNL investigators, two: are there appropriate resources to do
the work, and three: what agreement type is most appropriate.”

Not every partnership will work out. Hodge encouraged companies not to wait for their funding
to fall through to contact NCI and not to treat the NCI like a CRO. But when partnerships do
work out, they can help both the company and NCI achieve their goal of getting the right
treatments to patients.

“Working on a unique problem — a unique cancer therapeutic agent, for example — definitely
improves our capabilities and our expertise,” Scully said. “So, it’s really a win-win-win.”

For partnering with NCI questions, please contact Michael Salgaller at
michael.salgaller@nih.gov.

For partnering with FNL, please reach out to FNL’s Partnership Development Office at
PDO@nih.gov or to Vladimir Popov, PDO Director at vladimir.popov@nih.gov.

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