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AUTM Insight, V3, #3
February 10, 2021
headshot-2020.jpgBlack History Month Brings Focus to Black Innovations Since USPTO Founding
Kayla N. Meisner, M.Eng.  (she/her)
Licensing & New Ventures Manager
Kentucky Commercialization Ventures
 
As a Black woman working in technology transfer, I look back at the Patent Act of 1790, which created the United States Patent Office (USPTO), and the influence it has had on Black Americans’ influence on innovation. The USPTO was created to promote science and arts. The next two centuries brought significant events in the evolution and regulation of intellectual property rights, and the boom of Black entrepreneurship.
 
Some of the very first patents filed and issued were a vital component of the First Industrial Revolution (1760-1840). These patents focused on ways to make life easier; think of the cotton gin, or improvements to everyday tools, such as refining the process to make gunpowder. Despite the period’s rampant innovation, laws restricted most patent award successes to white men, since women and enslaved persons (Black Americans) were not allowed to own property. In very few instances, Black freemen were granted patents and allowed to practice their innovations. However, more commonly, slave owners exploited and took ownership of inventions made by the enslaved for their own gain.
 
After the abolition of slavery, many Black innovators faced new barriers to gain and protect their intellectual property. Black Americans were still not allowed to obtain formal education, technical skill development, or other resources that would give them the means to pursue intellectual property protection under the law. While the masses continued to fight these systems of oppression, there were notable victories along the way.
 
One such innovator was Henry Boyd, born into slavery in Kentucky in 1802. After purchasing his own freedom in 1826, Boyd invented a corded bed created with wooden rails connected to the headboard and footboard. The “Boyd Bedstead” was so popular that historian Carter G. Woodson profiled his success in the iconic book, The Mis-education of the Negro, noting that Boyd’s business ultimately employed 25 white and Black employees. Mr. Boyd is well known for being one of the earliest Black patent holders. However, unlike Boyd, not all Black innovators tried to obtain patents as a means of protection. Some relied on savvy marketing skills and loyal customers to grow their business.
 
Madam C.J. Walker (formerly Sarah Breedlove) was the pioneer of self-marketing and became one of the most successful entrepreneurs in American history. Her story was recently adapted and can be seen on Netflix staring the award-winning American actress, Octavia Spencer. In the early 1900s, Walker created three products for Black women’s haircare and cosmetics. With the support of her husband, the Madam C. J. Walker Manufacturing Company started selling Madam C. J. Walker's Wonderful Hair Grower in 1906. With her spirit and proof of success, the products were beloved by consumers and the business expanded quickly. At the height of production, the Madame C.J. Walker Company employed over three thousand people, largely Black women who sold Walker’s products door-to-door. Madam C.J. Walker not only was an innovator, but she created an innovation ecosystem that lasted beyond her time.
 
As a Black woman in America some 230 years after the Patent Act, I am excited to be a part of a team working to do the same thing. Kentucky Commercialization Ventures (KCV) is working to create a sustainable, inclusive innovation ecosystem across the Commonwealth of Kentucky. Recently, KCV was recognized by the Small Business Administration in the Lab‐to‐Market Inclusive Innovation Ecosystems Competition. The award recognizes the most impactful organizations, programs, and ideas in the nation that focus on engaging underrepresented communities and promoting their participation in commercialization. Our team, like other change-markers, is working to show that including those who have been historically ‘left-out’ can stimulate a wave of new growth and inspiration in entrepreneurship. Inclusion is the timeliest and readily available fuel for American innovation.
 
I believe technology transfer professionals have a unique vantage point into the crossroads of so many different worlds and communities. In celebration of Black History Month, I ask that we each make strategic efforts to bridge these gaps and aim to build a new legacy of equitable innovation for all.
 
Kayla N. Meisner is one of two Licensing and New Ventures Managers for Kentucky Commercialization Ventures (KCV). Her primary responsibilities include outreach and education on matters related to commercialization, along with assessing, managing, and licensing intellectual property developed at KCV Partner Institutions. Kayla obtained her undergraduate Bachelor’s degree and a Master’s in Engineering (M.Eng.) in Bioengineering, with honors, from the University of Louisville. Before joining the KCV team, Kayla spent over four years working in academia-driven commercialization and technology transfer at the University of Louisville. Additionally, Kayla has experience in startups and business development, spending the last year working on contract for Unitonomy, a Kentucky-based startup that makes culture management software.

To learn more:
  1. The Colorblind Patent System and Black Inventors by Shontavia Jackson Johnson
  2. With Patents or Without, Black Inventors Reshaped American Industry by Shontavia Jackson Johnson
  3. “Boyd, Henry,” Notable Kentucky African Americans Database
 
AUTM Insight, V3, #2
January 27, 2021
DWinwood_shdw-(1).jpgAUTM Former President David Winwood on Proposed Bayh-Dole Changes, NPRM​

New regulations proposed – including clarifying march-in rights provision 

In the U.S., the landmark Bayh-Dole Act has served as the bedrock of our profession for 40 years, guiding and instructing how we manage inventions resulting from federally funded research. That this legislation has stood the test of time is not surprising. The results of our collective activities helping to move inventions from the lab to the marketplace are clear, as reported in AUTM’s respected and widely-quoted Annual Licensing Activity Survey. New products and services, new companies, and even new industry sectors and jobs have resulted from the successful implementation of Bayh-Dole. The successes reported by AUTM did not go unnoticed around the world: countries in the Americas, Europe, and Asia have adopted their own versions of Bayh-Dole.

In 2018, the National Institute of Standards and Technology (NIST), the agency responsible for administering the Bayh-Dole Act in the U.S., launched its “Return on Investment (ROI) Initiative,” to improve the uptake of federally funded inventions and innovations into the marketplace by ‘Increasing the Innovation Impacts of Federally Funded R&D.’

After extensive analysis and outreach to stakeholders, NIST issued a Green Paper, “Unleashing American Innovation” in 2019. NIST listed the following objectives: streamlining federal regulations; enabling greater flexibility for public-private partnerships; increasing engagement with private-sector investors; building a more entrepreneurial workforce and improving support for innovation by clarifying the intended purpose of “march-in” rights. AUTM’s posted comments on this Green Paper can be found here.
 
More recently, after additional outreach, NIST released both a legislative package (targeted mainly at technology transfer from the U.S. federal lab system under the Stevenson-Wydler Technology Innovation Act) as well as a regulatory package focusing primarily on Bayh-Dole. The Return on Investment Initiative is a sincere effort by NIST to eliminate some of the challenging portions of both Stevenson-Wydler and Bayh-Dole. Where possible, clauses have been clarified and streamlined as outlined in the Green Paper.

In keeping with NIST’s stated aims, the proposed revisions remove outdated and unnecessary language and reorganize several sections for clarity.  Revisions are proposed in both the legislative and regulatory packages. Among these proposed changes, NIST seeks to:
  • Clarify definitions and applicability of Bayh-Dole to large businesses;
  • Provide additional clarification for processes for march-in, assigning rights to employee inventors, small business considerations, and filing provisional patent applications;
  • Create a new requirement for agencies to annually report statistics about the implementation of Bayh-Dole;
  • Provide additional information about the purpose and use of royalties collected by federal agencies for licensed inventions; and
  • Align exclusive licensing processes with statutory requirements and update appeals processes for licensing activities.
A notable proposal would make clear that the government's march-in authority under Bayh-Dole is not intended as a product pricing control. This issue has long been the subject of fierce debate in the context of drug pricing. Multiple private petitions have been filed over the years, without success, to request that NIH use march-in authority to lower drug prices. With the statement that: ‘March-in rights shall not be exercised exclusively based on the business decisions of the contractor regarding the pricing of commercial goods and services arising from the practical application of the invention’, NIST is seeking to end the controversy.

The next step towards the implementation of the proposed changes to the (regulatory) Bayh-Dole portion of the NIST report provides an opportunity for input from interested parties via the ‘Notice of Proposed Rule Making (NPRM)’ mechanism; NIST is requesting comments about 37 CFR parts 401 and 404 of the Bayh-Dole regulations, the sections generally of most interest to AUTM members.

AUTM will respond to the NPRM and post its comments in advance of the April 5, 2021, deadline.

I strongly encourage you to have your institution respond to this NPRM and participate in this important process that will help guide the next 40 years (or more!) of successful implementation of the Bayh-Dole Act.

David Winwood, PhD, RTTP, has experience in academia and the private sector, including basic research, business development, company formation, licensing, and management of university intellectual property.  Following postdoctoral work in medicinal chemistry, Winwood worked in three drug delivery & development startup companies before starting his university technology transfer career in 1996. He served on the AUTM Board for five consecutive years, first as VP for Advocacy, before he was elected President. He also served on the Board and Executive Committee of the Council on Governmental Relations (COGR), where he chaired the Contracts & Intellectual Property Committee. He currently serves as Executive Director of LSU’s Innovation Park and the Louisiana Business & Technology Center in Baton Rouge, LA. 

 
AUTM Insight, V2, #27
December 30, 2020
AUTM’s Chair Marc Sedam Reflects on the Year that Was​
Dear Members:
I won’t be the first or the last person to wish an enthusiastic “good riddance” to 2020. We all know that this was a year like no other, both for the unfathomable toll it has taken on the world but also for the speed at which solutions were brought forward. Many of those solutions were facilitated by you and your colleagues around the world placing tech transfer squarely on the front page of the world’s newspapers, even if the story never used the phrase. I said to many people in early March that if science could go from the early signals of an emerging threat to an approved vaccine (with a pandemic in between) within a year it would be humankind’s singular achievement. And as of today it not only happened once but twice!

AUTM will emerge from the pandemic, like all of us, fundamentally changed. I’m proud to say that we did more than survive. We were able to re-establish a solid and sustainable financial position through careful management of costs. Since COVID flipped our tried and true business model of in-person education and networking on its head, we focused heavily on asynchronous learning opportunities and actually saw improved engagement and participation by Members across the globe. We tried more and different professional development offerings. And we’re committed to bringing you the most engaging online meeting of your lives for the 2021 Annual Meeting. Since this wasn’t enough change, the Board also voted to support AUTM CEO Steve Susalka's plan to convert AUTM from an organization reliant on a third-party management company to one where all employees work directly for AUTM. The idea had been discussed for some time but making this change now allows us to be more nimble, responsive, and adaptable to changing times. Hopefully you didn’t even notice.

There are always multiple ways to respond to a crisis. I’m proud to say AUTM chose to “turn into the spin” and regained a great deal of the momentum from early 2020. The COVID-19 Licensing Guidelines were signed by over 90 institutions around the world. We’re increasingly asked to comment on proposed changes to legislation before they occur and offer suggestions on ideas that could improve research commercialization. Finally, our commitment to equity, diversity and inclusion across programming has led to important changes in accessibility and representation; not the least of which was AUTM’s most diverse slate of elected Directors in history including the first elected Director from an HBCU—both an important milestone but the next of many future steps towards an inclusive profession and technology transfer ecosystem.

It was not the year I imagined for my term as Chair but, in reflection, it might just be more rewarding. AUTM has an excellent and committed staff, exciting new programming, and expanded relevance. Most importantly it has you. We’re here to support you as the innovations you work with lead us out of the pandemic and into a better tomorrow.

On behalf of the Board and the staff of AUTM, thank you for all that you do. Be safe and be well.

Happy New Year,
Marc
AUTM Insight, V2, #27
December 30, 2020
The Value of New TT Professionals
By Maithili Shroff, Isabel Ramos, Eleftheria Ledaki, and Anji Miller
The importance of technology transfer (TT) has never been more prevalent than in recent times; from bringing life-saving medical interventions during a global health crisis to constantly providing solutions to areas of patient need. Given the importance of the technology transfer office (TTO) and the crucial role it plays in supporting the onward development and commercialisation of early academic research, one would imagine that there would be specific routes and requirements to entering the profession. However, as anyone considering a transition into a TT role will confirm, no such direct pathway exists, and TT fellowships and other training opportunities are scarce.

As a new fellow, the true value and potential of programmes, like the LifeArc AUTM fellowship is not fully realised until you have faced your first interview. Each element of the carefully curated programme complemented each other - from the educational materials (e.g. AUTM webinars) and attendance at TT conferences to discussions equipping us with tools to surpass the daily hurdles that a new TT entrant faces. In addition, this fellowship provided valuable insights from expert mentors who helped guide our career path by sharing their own professional experiences. It was enlightening to discover the diversity of technical backgrounds, routes into the profession and the wider TT community’s enthusiasm to engage and support new entrants in the field. These networking opportunities gave us the confidence to comfortably converse with those that are in the sector, from our first interview to presentations at conferences.

Being part of the new stream of TT professionals, we felt it was important to address the challenges we are facing and highlight the path and support that has impacted our careers so far. We are qualified, adaptable, hungry for practical experience and we are here! We are more useful than you might think. The innovative TT sector benefits by having a fresh breeze of motivated people with new ideas and a new perspective. Although the recruitment of TT interns is slowly increasing, TT fellowships or other types of training to support early-stage TT professionals are rare and this is the gap that the LifeArc AUTM fellowship is successfully addressing.

TT Fellows are a key addition to any knowledge exchange function. We are handpicked for our technical skills, motivation, passion, creativity, and the ability to envision science in the real world. By the end of the fellowship programme we are freshly equipped with the theory of TT and therefore we can hit the ground running. Innovation is all about sharing expertise, knowledge, and inspiring people and this is what we need from the TT community. Our request to technology transfer offices and divisions is for new TT hires to be encouraged to get involved in challenging projects as early as possible, support and promote continuous training, and finally, empower us to work independently. Every year, a new crop of fellows are nurtured into promising TT professionals of tomorrow. All we need is an opportunity to shine, with the right support. Looking at the career progression of the LifeArc AUTM fellowship alumni, the impact of the programme is evident. See for yourself here.

Inspire us and let us in, we promise you will not be disappointed.

The LifeArc AUTM Technology Transfer is a training programme designed to help scientists transition from the laboratory to become technology transfer professionals. Details of the programme can be found here.

Maithili Shroff, PhD, cRTTP, Licensing Associate, UNHInnovation, The University of New Hampshire
Eleftheria Ledaki, MSc, cRTTP, Commercialisation Manager, Queen Mary Innovation Ltd., Queen Mary University of London
Isabel Ramos, PhD, Innovation Manager, Digital Health, Siemens Healthineers

Anji Miller MSc, PhD, CLP, RTTP is a Senior Business Manager for LifeArc and leads the LifeArc AUTM Fellowship in collaboration with AUTM. If you would like to hear more, contact Anji at [email protected].

About LifeArc
LifeArc is a self-funded medical research charity. Our mission is to advance translation of early science into health care treatments or diagnostics that can be taken through to full development and made available to patients. We have been doing this for more than 25 years and our work has resulted in a diagnostic for antibiotic resistance and four licensed medicines.
 
We have our own drug discovery and diagnostics development facilities, supported by experts in technology transfer and intellectual property who also provide services to other organisations.
 
Find out more about our work on www.lifearc.org
AUTM Insight, V2, #21
October 7, 2020
Introducing TenU, a New International Tech Transfer Collaboration
By Dr. Ananay Aguilar
Policy Advisor, TenU

TenU is the minimalist name for an ambitious transatlantic effort that brings together ten leading university technology transfer offices to leverage their combined knowledge on how best to use cutting edge research outcomes to tackle global challenges. TenU’s members are Cambridge (UK), Columbia University (USA), Edinburgh (UK), Imperial College London (UK), Leuven (Belgium), Manchester (UK), MIT (USA), Stanford (USA), Oxford (UK), and University College London (UK).
 
TenU was formed to 1) capture experiences and insight of leading technology transfer offices and 2) share these with UK and US Higher Education communities and governments in order to increase the societal impact of research.

Capturing experiences and insights: the impact of TTOs in times of COVID-19
One key area that TenU will address over the next few months is metrics. Like many in the technology transfer community, TenU members agree that easily tracked data, such as the number of patents issued, licenses signed, spin-outs launched, and income generated do not deliver the full picture.
 
Although useful in some ways, quantitative measures fail to capture the real impact TTOs have on society. The response of university TTOs to the COVID-19 crisis provide many examples of this. For instance, members of TenU created non-exclusive, royalty-free licenses for improved types of face protection to be used by healthcare workers (see Columbia Covid-19 Face Shields, MIT Covid-19 Face Shields and My Mask Movement). Columbia Technology Ventures organized the manufacturing, promotion, and distribution of face shields, and, within a week, had scaled up production to 50,000 per day in order to deliver their first order of 1.5 million shields to New York City hospitals.
 
Other TenU members have supported spin-outs that have provided the basis for rapid testing technologies (see Diagnostics for the Real World, OSCAR, and Oxford Nanopore), are creating licensing partnerships to develop therapeutic solutions for COVID-19 (see Manchester Antiviral Polymers, UCL-Ventura, and Aligos/KU Leuven), and have helped raise millions in funding to develop vaccines (see Imperial and Oxford).
 
Many of the COVID-19 related agreements executed by university technology transfer offices are time-limited, royalty-free, and non-exclusive. In keeping with usual practice, publication of results is key to sharing outcomes to find solutions to prevent, treat, and contain the COVID-19 virus. Technology transfer offices have also enhanced the profile of their available technologies and intellectual property which may be applicable in the COVID-19 space, with initiatives such as UCLB’s E-Lucid platform.
 
Universities generally, and technology transfer offices specifically, have taken on varied and multiple roles to address the pandemic. Each of their initiatives have been rapidly deployed while retaining high standards in a period of significant disruption. TenU provides a platform to share such experiences and collectively demonstrate the enormous impact of University technology transfer.
 
Sharing experiences and insights: introducing the “TenU hosts” series
TenU is organizing a series of events entitled “TenU hosts.” Initially an invitation-only series, the series will eventually be open to the public.
 
The first of the TenU hosts series was on economic recovery and how technology transfer offices can contribute to this effort supported by policies such as the US Endless Frontier Acts bill and the UK Research and Development Roadmap. Guest speakers included Walter Copan (US Under Secretary of Commerce for Standards and Technology and Director of NIST), David Sweeney (Executive Chair, Research England), and representatives from TenU’s membership. TenU was delighted to welcome high-level policy officials and Higher Education representatives from both the US and the UK.
 
A second event is likely to be on ecosystems and place, drawing on TenU’s expertise and that of its partner Policy Evidence Unit for University Commercialisation and Innovation (UCI), recently launched at Cambridge’s Institute for Manufacturing (IfM).
 
As TenU moves forward, the most pressing priority will be to talk to the US and UK Higher Education communities, funders, and governments to find out how TenU can leverage its reputation and international network to increase the societal impact of research. We count on the HE community for support.
 
Dr. Ananay Aguilar is Policy Advisor for TenU. She has been an international strategic industry consultant and is a former research fellow at the University of Cambridge, specializing in copyright policy. If you would like to hear more about TenU, contact Ananay at [email protected].
AUTM Insight, V2, #15
July 15, 2020
Why Work In Tech Transfer? The Pandemic Has Illustrated Why People Do
By Kirsten Leute
Partner, University Relations
Osage University Partners

It’s hard to work, write, or think about anything without the context of COVID-19 these days. Living at the intersection of academic institutions and new ventures, I have daily insights into the plethora of programming at universities intended to advance scientific discoveries and see them translated into practice, especially through the activities of the technology transfer offices.

Working as a staff member at an academic institution does not tend to be glamorous. Hierarchy is an inherent trait of a university, and staff typically are not in the upper echelons of the pyramid. Those who do make it to a director level are often subject to the whims of the changes in the administration. One of the first questions I was asked by my colleagues when I started working at OUP was “Why is there so much turnover in technology transfer offices at universities?”

The fact of the matter is that people often change jobs in tech transfer, at least in the United States, although I have seen it in other countries as well. Thousands of people work in the industry across the world. Most of the tech transfer officers I know are working hard for minimal personal financial reward, although they do feel pride in the work they do. They do not share in the upside of the deals they negotiate. They don’t receive large yearly salary increases (and in times like these, there are no salary increases or in some cases there are even furloughs at the academic institutions). Service awards or recognition otherwise by their academic colleagues is rare. The upsides of jobs in industry become alluring.

Given the downsides I noted, the question has become even more relevant during the pandemic — why work in tech transfer? Because you are helping life-saving inventions cross one of the thresholds from labs to patients. Because you have a community that cares about what they do, cares for each other, cares that they make a positive impact. As a professional in the area, you learn about and shepherd along the best innovations scientists are creating — what may be the next industrial robot, the next search algorithm, the next pancreatic cancer diagnostic test, the next COVID-19 vaccine. Each day, you work with passionate individuals whose main goal is to see their baby grow up and do something that makes a difference, whether it transforms the lives of a small population, impacts the globe, or advances our exploration of the universe. The pervasive mindset is “How can I help make a solution a reality?”

One need only look at the many examples from universities to see how this community performs and cares, as highlighted in this PBS NewsHour article in April. Universities stepped up to the plate early in the pandemic to design and mass produce personal protective equipment (see designs and efforts from Columbia, NYU, UMass and Temple, just to cite a few) and the tech transfer offices shepherded many of these solutions to reality, making their way to medical professionals. To help ensure any solutions did not run afoul of legal complications, the tech transfer offices developed simple license guidelines. Since the early days of the pandemic, the technology transfer offices have received numerous invention disclosures from researchers eager to help. There are many examples of new tests, treatments, and vaccines to address the pandemic from these academic institutions (potential UNC Chapel Hill therapy, MIT diagnostic, University of Wisconsin-Madison vaccine and Oxford vaccine).

The tech transfer professional’s can-do attitude isn’t a mindset for just this pandemic. For those who stay in this business, this is perennial behavior. While we may enter technology transfer for a variety of reasons, the caring, get-things-done community is one of the reasons the long termers stay. So I’d like to give a huge shout-outs to these shepherds of technology — thank you for the long hours, for tackling new territories, for the general make-it-happen mindset that we know you always have, but is especially shining through right now.
AUTM Insight, V2, Issue #12
June 3, 2020
USPTO Launches “Patents 4 Partnerships” IP Marketplace Platform
By Andrei Iancu
Director of the United States Patent and Trademark Office 
 
Innovation empowers, improves, inspires, and will lead us out of the current crisis and beyond. It is intellectual property that incentivizes and protects innovation and drives the American economy.

Currently, researchers are working tirelessly toward new solutions during this unprecedented challenge of the global pandemic. Inventions developed into commercial products and services will ultimately improve health and save lives. On May 4, 2020, the US Patent and Trademark Office launched the “Patents 4 Partnerships” IP marketplace platform to help bring such inventions to market. This new platform will facilitate the voluntary licensing of a wide range of patented technologies that can be used in the fight against COVID-19, including, for example, personal protective equipment, ventilators, disinfectants, and treatments. 
The platform provides companies and entrepreneurs access to COVID-19-related patents and published patent applications that are available for licensing. It can be easily searched by keywords, patent or patent application publication numbers, inventor names, and other criteria.

Search results include links to the full text of US patents and published patent applications. Each listing includes contact information for licensing opportunities or links to external websites where such information can be found. Once potential licensees select a technology of interest, they can contact the IP owner to share information and explore opportunities for contracts and agreements. From face shields to treatments and vaccines, the Patents 4 Partnerships platform includes available patented IP that can help save lives.

At launch, its contents have been drawn from a variety of public sources, including the USPTO, the Federal Laboratory Consortium for Technology Transfer (FLC Business), the AUTM Innovation Marketplace (AIM), universities, and a number of federal agencies, including the National Institutes of Health, the Department of Energy, the National Aeronautics and Space Administration, the Food and Drug Administration, the Centers for Disease Control and Prevention, the Department of Defense, and the Department of Veterans Affairs databases. Individuals, universities, companies and other entities with COVID-19-related patents and published patent applications available for licensing can add these to the Patents 4 Partnerships platform by completing a form provided on the website.

Patents and published patent applications included in the Patents 4 Partnerships platform have not been endorsed by the US government as effective in fighting the COVID-19 pandemic, but we hope the platform will be useful in linking potential business partners and research collaborators.

Whether you’re contributing your technologies through AIM or Patents 4 Partnerships, or hopefully both, we can help end this global pandemic by working together to develop and produce innovative and effective solutions. As we continue into a new era of collaboration, we must invent the new technologies needed to rebuild our economy and prepare for any future crises.
Patents 4 Partnerships IP Marketplace Platform  
AUTM Insight, V2, Issue #5
February 26, 2020

Bridging the “Valley of Death”
By Lili Portilla, MPA; Krishna Balakrishnan, PhD, MBA; Sury Vepa, PhD, JD; and Ami Gadhia, JD, LL.M., CLP, members of NCATS Office of Strategic Alliances
 
Bridging the “Valley of Death” is a significant challenge in technology development and commercialization efforts. Therapeutics face a long timeline before they reach market and their benefits are realized by patients. Universities and academic centers are a tremendous source for promising early-stage research and innovation. However, they also encounter most difficulties in translating early discoveries into useful products. The National Center for Advancing Translational Sciences (NCATS) was formed within the National Institutes of Health (NIH) in 2011 to help “to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.”
 
Here, we briefly describe a successful NCATS collaboration with Brigham Women’s Hospital/Massachusetts General Hospital (BWH/MGH), and Keros Therapeutics involving a NCATS “de-risking” resource program, Therapeutics for Rare and Neglected Diseases (TRND), which supports the pre-clinical discovery and development of candidate therapeutics, with the goal of enabling IND applications.
See: https://ncats.nih.gov/about/center/org/dpi
 
MGH/BWH scientists identified a target and potential compounds to treat fibrodysplasia ossificans progressive (FOP) an ultra-rare condition (about 800 known cases worldwide) with no cure. MGH/BWH had relevant IP on the disease. MGH/BWH entered into a TRND collaboration by executing a Cooperative Research and Development Agreement (CRADA). Under this collaboration, NCATS conducted lead optimization, preclinical studies, and de-risked the compound profile. The collaborative effort resulted in new jointly owned IP. NCATS executed an inter-institutional agreement with Partners Healthcare Innovation (the innovation management arm of MGH/BWH) which gave Partners Healthcare Innovation the lead for managing the jointly developed CRADA IP. Partners Healthcare Innovation out-licensed background IP and joint CRADA IP to Keros Therapeutics, Inc., a start-up. The CRADA was amended to include Keros as a collaborator and to provide for the flow of future CRADA IP. Initial funding enabled the team to further optimize the lead compound and complete the IND enabling studies. The success of this collaborative effort resulted in Keros receiving $23 million in Series B Funding for further clinical development.
See: https://innovation.partners.org/ and https://kerostx.com/our-science/

Success of this multiparty collaboration illustrates that in areas such as rare diseases, where the Valley of Death is a reality for early stage discoveries, especially those from universities and academic institutes, and where investment into research and development is still lagging; programs such as NCATS TRND can fill the gaps. Further, highly focused and goal driven multiparty collaborations between government laboratories, universities and for-profit entities can bring novel, safe and effective treatments to more patients more quickly.  
 
Learn more at the AUTM 2020 Annual Meeting:
Tuesday, 8:30 - 9:45 a.m., Harbor D, 2nd Level
4D - Why and How to Collaborate with Federal Laboratories to Advance Your Pursuits
Federal labs in the United States are a unique resource for the private sector to support technology and innovation advancement. In fact, more than $43 billion (or more than one third of the Federal R&D budget) funds R&D and engineering at the nation’s more than 300 labs! In this session, we will focus on the resources available to you and strategies on how to get access to the labs. You may not know, but it is the policy of the federal government to ensure that the private sector has access to, and full use of, the results the labs’ work. This means you can license lab innovation, collaborate with lab SMEs, have access to technical data and special facilities and more.
Moderator: John Dement, Federal Lab Consortium for Tech Transfer
AUTM Insight, V2, Issue #1
January 2, 2020
University of Alaska Fairbanks: Making Good on TTO-Fed Lab Collaborations. Your Institution Can Too

By Mark Billingsley
UAF IP and Contracts Director
 
As AUTM and the Federal Laboratory Consortium kick off a new partnership, opening the door for exciting opportunities for tech transfer professionals on both sides of the academic and government aisles, the University of Alaska Fairbanks (UAF) can be looked upon as one of many existing, successful collaborations between tech transfer offices and federal labs.
 
In 2018, UAF partnered with the Department of Energy’s (DOE) National Laboratories to develop and commercialize arctic innovations. UAF, located just 200 miles from the Arctic Circle, is, no surprise, an international leader in arctic research. Recently, UAF has grown its relationship with the DOE to the great benefit of its tech transfer operations, research, and scholarship. Alaska National Lab Day 2018 symbolized the labs’ commitment to Alaska, and brought together key stakeholders to produce, among other opportunities, the Arctic Innovator Program and Alaska Manufacturer’s Pilot Project.
 
What are they? The Arctic Innovator Program supports researchers and entrepreneurs with technology solutions to uniquely arctic challenges. Innovators spend part of their time at a national lab developing their technology. They spend the balance of their time in Alaska refining their value proposition through customer discovery and testing their solutions through small-scale implementation. This brings new innovators to Alaska, provides solutions to arctic challenges, and creates new economic opportunities in the state. Click here for more information.
 
Meanwhile, it is through the Alaska Manufacturer’s Pilot Project that national labs are contributing resources to move technologies with relevance in the Arctic closer to commercial viability. The Project’s first partner is UAF spin-off company Aquagga, which uses supercritical water and advanced additive manufacturing to develop wet-waste treatment solutions for industrial effluents.
 
UAF is working on these and other programs directly with the national labs as well as through the Oak Ridge Institute for Science and Education, or ORISE.
 
AT UAF, we’re seeing positive returns from working with the national labs, and it’s a mutually beneficial relationship. We’re bringing them new ideas, and they’re moving our technologies closer to commercial viability.
 
Many academic institutions around the US work with federal labs, but most do not build that kind of relationship through their tech transfer offices. As UAF is demonstrating, this is a missed opportunity for universities, the federal labs, and the general public that benefits so greatly from our research innovations.
 
For more information, reach out to me via email at [email protected].