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Start-Up Spotlight: TSRL, Inc.
Posted on January 6th, 2017 by Betsy Davis in Pharma R&D
This week we’re shining our spotlight on Ann Arbor, Michigan-based TSRL, Inc. Drew Hertig, Business Development Manager, explains how TSRL uses its resources to help scientists in academia and industry to develop anti-infective therapeutics.
In brief, what does TSRL do?
TSRL, Inc. is a privately-owned preclinical accelerator based in Ann Arbor, Michigan with a mission to advance promising compounds for treating severe and multi-drug resistant infections. The company partners with investigators from academia and industry to provide scientific and business resources as well as access to non-dilutive capital to help drive their lead-stage compounds into the clinic.
Describe the background of the company and what it aims to achieve.
TSRL was founded by University of Michigan professor Gordon Amidon, an internationally recognized expert in the field of oral drug delivery and biopharmaceutics. The company’s business model originally centered on developing oral drug delivery technologies, then expanding over time to include prodrug strategies for existing drug products. TSRL’s preclinical accelerator model was introduced in 2014 after hearing from collaborators that they were having difficulty finding support for their lead-stage projects. The company decided to focus on infectious diseases as a proof of concept, due to the high unmet medical need of new therapeutics in this space and non-dilutive funding opportunities available.
TSRL helps investigators advance their promising lead candidates to clinical-readiness by providing in-house data-generation capabilities, process management oversight, and business development expertise. Their team of industry veterans has broad experience in molecular biology, biochemistry, analytical chemistry, in vivo animal models, PK/ADME, toxicology, and formulation. Likewise, the company’s collaborations have received over $15 million in SBIR grant support over the last 10 years. A strategic priority for TSRL is developing treatments for multi-drug resistant infectious diseases, including antivirals and antibacterials. The company’s goal is to exit through an out-license or acquisition of one of our partnered assets after an Investigational New Drug (IND) is filed.
Why is TSRL’s work important? What value does it provide?
Preclinical development is complicated, costly, and time-consuming. Many therapeutic assets are struggling to find funding to move past the “Valley of Death,” where substantial investment in in vitro and in vivo studies is necessary to produce the compelling data required to reach the next inflection point. TSRL’s preclinical accelerator was established to give investigators access to a growing number of non-dilutive funding opportunities, especially government-supported research (R21s/R01s) and small business grants (SBIRs/STTRs). The company offers internal scientific and business support, including access to our network of collaborators and consultants, and provides an industry perspective on study design with project management oversight to generate data necessary to be competitive for these grant opportunities.
TSRL will work with the owners of the intellectual property (IP), who are typically research universities and academic medical centers, to put a product plan and commercialization strategy in place. Simultaneously, they put together the materials and the “story” necessary to attract strategic partners and investment groups. In return, the company asks for first right of refusal or an equity consideration upon out-license or establishment of a new company based around the IP, respectively.
Why is this important now?
The anti-infectives field is continuing to experience a resurgence in activity due to the increasing threat of antimicrobial resistance. In March of 2015, the Obama administration released its National Action Plan to Combat Antibiotic-Resistance Bacteria, outlining five years of federal activities to improve the nation’s capacity to prevent and contain antibiotic-resistant disease outbreaks. This plan doubles the FY 2016 Federal budget to $1.2 billion and includes the development of novel antibiotics. In addition to federal grant initiatives through the NIH, CDC, and Department of Defense, Congress signed into law the Generating Antibiotic Incentives Now (GAIN) Act, providing important regulatory benefits for select antibiotics in development. Termed Qualified Infections Disease Products (QIDPs), these antibiotics are eligible to receive Fast-Track and Priority Review, shortening their regulatory pathway, and adding five years of market exclusivity.
This trickles down to greater interest from clinical sponsors and investment groups, resulting in historical highs of capital investment. Moreover, venture funding of US therapeutic companies is trending toward earlier stage programs. 2015 was the first year that preclinical funding surpassed venture funding at all other stages of drug development since records were first kept in 2006. TSRL and its partners combine their relative strengths and develop new drugs that take advantage of the funding climate, ultimately giving providers new weapons in the war against drug-resistant pathogens.
What will the next steps for the company be?
TSRL is actively partnering with investigators – whether they are chemists, microbiologists, or physicians – from academia and industry to provide the support they need in order to advance their promising lead compounds. This past year, the company’s accelerator model is reaching its own inflection point. The company is receiving inquiries from investigators across the United States looking for additional support for their anti-infective projects. In the last funding cycle, TSRL collaborated with investigators from six major research universities and small companies, up from three the prior funding cycle. From these collaborations they plan to spin out two new companies next year, a joint-effort between TSRL and the inventors and their institutions. In the meantime, TSRL will continue to develop relationships with clinical stage companies and investment groups for funding to compliment non-dilutive funding that will allow TSRL to expand operations and grow its portfolio companies.
What TSRL’s Management Has to Say:
“We provide the infrastructure, laboratory, scientific, and business resources necessary to ‘de-risk’ and drive early-stage assets to IND.”
“We’ve had a lot of positive feedback from local and regional investigators and universities who have some data, but need help putting their drug product development strategy together to attract clinical sponsors.”
–Dr. Elke Lipka, President
“I hear a lot of positive feedback from investigators and technology managers as they search for ways to breathe life into their programs. We offer them another route to move their lead-stage compounds through the Valley of Death and reach the clinic.”
–Mr. Drew Hertig, Business Development Manager:
Are you currently looking for partners or investment?
Yes, TSRL is looking for both private and strategic partners to advance its portfolio of antivirals, antibacterials, and prodrugs. A description of the company’s programs can be found on its website at http://www.tsrlinc.com/research-pipeline/.
To get in contact with Drew Hertig, or to follow TSRL:
All opinions shared in this post are the author’s own.
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