News & Events

TSRL, Inc. Announces Appointment of President

 Ann Arbor, Michigan, September 11th, 2014: Therapeutic Systems Research Laboratories, (TSRL), Inc. is pleased to announce the appointment of Dr. Elke Lipka as President of TSRL and Member of the Board of Directors. Dr. Lipka succeeds the late Dr. John Hilfinger, who led the company over the past ten years, transitioning its focus from formulation development to prodrug design and delivery. Dr. Lipka, who has served as Vice President of Business Development since 2007, has played a pivotal role in the development of TSRL’s existing assets and the evaluation of new project and growth opportunities. She is an experienced drug development professional with 20 year of experience in the pharmaceutical industry including at Warner-Lambert, Esperion Therapeutics and Pfizer. Dr. Lipka holds a PhD from Goethe University, Frankfurt, Germany and an MBA from the University of Michigan.

TSRL, Inc. is a privately held oral drug delivery specialty firm focused on R&D efforts to enhance the targeted delivery of investigational and marketed therapeutics. More detailed information about TSRL is available on the company website www.tsrlinc.com or can be requested by contacting Dr. Elke Lipka, President, 734 663-4233 x236, elipka@tsrlinc.com.

TSRL Announces Receipt of $4.2 Million in New SBIR Funding

Ann Arbor, Michigan, June 24th, 2014: Therapeutic Systems Research Laboratories, Inc. (TSRL), announced today that the company was awarded two Phase I and one Phase II Small Business Innovation Research (SBIR) grants from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The grants are supporting the preclinical research of the company’s broad-spectrum antiviral prodrug program, as well as the development of an antiviral therapeutic for the treatment of adenovirus infections. TSRL will be receiving up to $4.2 million over the next 3 years through these SBIR grants. In addition, initial manufacturing scale up of a lead candidate and preclinical pharmacology testing has been performed for TSRL by NIAID under the NIAID preclinical services contracts program.

TSRL, Inc. is a privately held oral drug delivery specialty firm focused on R&D efforts to enhance the targeted delivery of investigational and marketed therapeutics. More detailed information about TSRL is available on the company website www.tsrlinc.com or can be requested by contacting Dr. Elke Lipka, Vice President for Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

TSRL, Inc. Announces Agreement with Software Licensee

 Ann Arbor, Michigan, June 12th, 2014: Therapeutic Systems Research Laboratories, (TSRL), Inc. announced today that it has entered into a Termination and Non-Assertion Agreement (the “Agreement”) with Simulations Plus, Inc., a California corporation (“SLP”). Under the terms of the Agreement, SLP and TSRL agreed to terminate the Exclusive Software Licensing Agreement, under which TSRL licensed to SLP Software Technology and Databases in return for royalty payments. SLP will pay TSRL a total consideration of $6 million.

TSRL, Inc. is a privately held oral drug delivery specialty firm focused on R&D efforts to enhance the targeted delivery of investigational and marketed therapeutics. More detailed information about TSRL is available on the company website www.tsrlinc.com or can be requested by contacting Dr. Elke Lipka, Vice President of Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

TSRL, Inc. Engages in CRADA with Walter Reed Army Institute of Research

Ann Arbor, Michigan, November 2012: TSRL, Inc. is a privately-owned specialty pharmaceutical company focused on the discovery and development of orally available antiviral and anticancer therapeutics based on its proprietary prodrug technology.

The company announced today that it entered into a collaborative research and development agreement (CRADA) with the Walter Reed Army Institute of Research. TSRL’s proprietary drug candidates, TSR-087 and TSR-505, have demonstrated significant broad-spectrum antiviral activity in non-clinical studies. The purpose of this Agreement is to conduct additional in vitro studies to further evaluate the activity of these compounds against contemporary, clinically important adenovirus strains.

TSR-087 and TSR-505 have been developed to date through SBIR funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

TSRL, Inc. Reaches a Key Milestone with pre-IND Meeting

Ann Arbor, Michigan, October 2012: TSRL, Inc. is a privately-owned specialty pharmaceutical company focused on the discovery and development of orally available antiviral and anticancer therapeutics based on its proprietary prodrug technology.

The company announced today that it reached agreement with the FDA on its preclinical and clinical development strategy at a pre-IND meeting for TSR-026, an oral prodrug of zanamivir. The product will be developed to follow a 505(b)2 submission pathway. The marketing application will be supported by published literature and the Agency’s prior finding of safety and effectiveness for zanamivir (Relenza®) for treatment of uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 2 days.

This is a key milestone for TSR-026, which has been developed to date through SBIR funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Innovative Research Company Welcomes Congressman John Dingell to its World Headquarter in Ann Arbor, Michigan

Ann Arbor, MI – Today Therapeutic Systems Research Laboratories (TSRL), Inc. welcomed United States Congressman John Dingell to its headquarters to share their work to significantly improve current anti-influenza and antiviral drugs available on the market.  In his remarks to the Congressman, John Hilfinger, President of TSRL, shared how TSRL’s ability to engineer unique drug molecules promises to enhance the performance of a host of drugs. “It’s amazing how many drugs don’t reach their full market potential because they were designed for maximum effect and not for how well they reach their site of action,” said Hilfinger. “TSRL essentially constructs drugs of the right shape and size, which then allows the drugs to be given as a tablet and the body changes them back to original drug to do their work of defeating the ‘bad stuff.’” Chief on TSRL’s list of targets is influenza, the cause of roughly 30,000 deaths in the U.S., and more than one million ambulatory care visits in the U.S. per year, at an estimated cost of $7 billion in lost productivity due to missed days of work.

While TSRL’s products could significantly improve the way we fight viruses and the common flu, the company described the uphill battle that every pioneering drug company faces when getting a product off the ground. “The biggest challenge is to secure funding beyond the early research stage,” said Elke Lipka, Vice President of Business Development. “Before you can attract a large pharmaceutical firm to license your drug for full development and marketing, you have to show that it works in clinical testing.” The typical development cycle for a new drug can last five or more years and require several hundred million dollars in funding. “That’s where government resources and champions such as Congressman Dingell play such a vital role in helping a company like ours,” explained Gordon Amidon, Chairman of TSRL, Inc. “By helping us overcome the hurdles of working with many groups within the federal government, TSRL will be better positioned to access the funding necessary to getting our solutions to clinical proof-of-concept.”

A large percentage of funding for drug discovery comes from the federal government, primarily through the National Institutes of Health (NIH). Federal grants from NIH are known to be extremely competitive, as companies vie for a limited number of opportunities. Furthermore, NIH funding in support of initial clinical studies is even harder to come by. Despite the economic downturn, supporters in Congress such as Dingell have pushed for the provision of stable funding for NIH to enable the fundamental research that will lead to the next big breakthrough and to foster translational research to get promising drugs to the clinic. “We think we’re on to something big,” Hilfinger said. “It takes a lot of work, but we feel it will be worth it in the end.”

When asked about the visit, Congressman Dingell, a strong proponent of Michigan research companies said: “Yesterday I had the opportunity to visit an innovative drug development company, TSRL, located in Ann Arbor, MI. This company has made great strides to develop drug therapies that will improve the way we treat influenza.”  He continued, “TSRL is a strong example of where a federal investment can help kickstart the development of promising new treatments and technologies here at home that can compete with our neighbors abroad. I urge my colleagues in Congress to continue supporting robust funding for NIH, to foster research and drug development, and the FDA so they can continue to approve and ensure the safety and effectiveness of next generation pharmaceuticals.”

ABout TSRL: Therapeutics Systems Research Laboratories (TSRL), Inc. a privately owned oral drug delivery specialty firm located in Ann Arbor, Michigan. Combining customized problem-solving strategies with individually tailored delivery solutions, TSRL helps clients develop valuable oral therapeutic strategies. For more information about TSRL visit www.tsrlinc.com.

Congressman John Dingell (center) poses with TSRL President John Hilfinger to his left, and TSRL Chairman Gordon Amidon and TSRL Vice President of Business Development Elke Lipka to his right.

 

TMC news:  August 22, 2011

Drug Development Firm TSRL Slides into Biotech Business

(BioWorld Today by Catherine Shaffer, Contributing Writer) TSRL Inc. is not a new company by any stretch of the imagination. It has been a going concern since 1986, when it was founded as a spinout from the University of Michigan.

For the first 10 or 15 years of its existence in Ann Arbor, Mich., it focused on formulations, particularly controlled release. But within the past few years, it has been building a new biotechnology business with an active pipeline of drugs based on its prodrug technology.

TSRL, whose name stands for Therapeutic Systems Research Laboratory, experienced two successful exit events in 1998, when it out-licensed one of its formulation technologies and an absorption simulation module that  is now part of the GastroPlus software package.

“Those revenues from prior exits were a constant stream over the past decade,” Elke Lipka, TSRL Vice President of Business Development, told BioWorld Today. It also produced revenue through contracting and consulting work.

Around 2000, the company began to move into development of its own pharmaceutical products. It now has a pipeline of preclinical compounds in the areas of influenza and inflammatory bowel disease, supported in large part by Small Business Innovation Research (SBIR) grants.

TSRL’s prodrug and carrier technologies address poor intestinal permeability of drugs. The technology makes use of intestinal transporters to increase absorption. It was a natural evolution of the company to develop some compounds internally based on that technology.

A number of broadly successful drugs are limited by low bioavailablity, including bisphosphonates, neuraminidase inhibitors, antiviral nucleosides, ACE inhibitors and some cancer drugs. That creates market opportunity for TSRL to apply its prodrug technology to compounds that have already been shown to be successful and have proven commercial track records.

Additionally, prodrug technology enables oral dosing for compounds that have been administered only by inhalation or injection.

As one of its first programs, TSRL has applied its technology to influenza therapeutics. It created a new drug by linking a prodrug construct to the drug molecule. The prodrug enables transport into the cells of the GI tract through nutrient transporters and then is cleaved off, releasing the drug, once it reaches the bloodstream or at its target site.

In December 2010, the National Institute of Allergy and Infectious Diseases awarded a grant of up to $2.6 million over three years to TSRL to support its influenza prodrug program, including lead candidates TSR-026 (zanamivir), as well as TSR-462 (guadino OC), a drug abandoned by Gilead Sciences Inc. for low bioavailability.

These compounds are designed to be highly potent against Tamiflu (oseltamivir)-resistant strains of influenza. TSR-026 is a prodrug of Relenza (zanamivir).

Relenza is administered by inhalation, and is not recommended for use in patients with underlying airway diseases such as asthma – a group that is at high risk of complicaitons from the flu. That means the accessible market segment for Relenza is limited to a smaller subset of all possible patients who could benefit from it.

TSRL’s calculations for prodrug adaptations have come up favorable for Vistide (cidofovir), Fosamax (alendronate) and Zometa (zolendronate).

TSRL has established in vitro potency and in vivo efficacy for TSR-026 against a number of current virus strains through National Institutes of Health contract laboratories, has completed initial pharmacokinetic studies in mice and hopes to file an investigational new drug application next year.

TSR-462 is the current back-up candidate to TSR-026.

The firm is interested in partnering with a larger company for development of its influenza therapeutics.

It also is working on TSR-243 (cidofovir) for human cytomegalovirus under an SBIR grant and TSR-272 (vidarabine) for smallpox, for which it is seeking a research collaboration for joint lead development.

Lipka said the company additionally has a discovery program for candidates in inflammatory bowel disease. “We are working on a candidate that’s a repurposed formulation of an ACE inhibitor,” Lipka said.

Drugs in that class are marketed as infusion products or oral prodrugs for hypertension and have been shown to be effective in reducing inflammation in irritable bowel syndrome.

(c) 2011 Thomson BioWorld, All Rights Reserved

National Day of Sharing, Tuesday, June 21, 2011

Ann Arbor, Michigan, June 21, 2011: TSRL, Inc. will be closed today, so that theTSRL Team can volunteer at Dawn Farm.

TSRL, Inc. is Excited to Announce Four New Members to Our Scientific Advisory Board

Ann Arbor, Michigan, June 15, 2011: TSRL, Inc. is a privately-owned specialty pharmaceutical company focused on the discovery and development of orally available antiviral therapeutics based on its proprietary transporter-targeted drug delivery technology.  The company today announced the addition of four new members to its Scientific Advisory Board.

“Each one of these highly accomplished individuals will bring a unique insight to our antiviral prodrug projects and guide us as we build our portfolio,” said John Hilfinger, President of TSRL.

John C. Drach, PhD, Professor Emeritus, active in the Department of Biologic and Materials Sciences at the University of Michigan School of Dentistry.  He is also Professor Emeritus of Medicinal Chemistry in the College of Pharmacy.  Drach has been involved in antiviral drug research since 1969 when he was a Research Scientist at Parke-Davis and Company.  His current research interests are the design, discovery, metabolism, and mode of action of antiviral agents, with specific focus on cytomegalovirus.

Chris McGuigan, PhD, Professor of Medicinal Chemistry at Welsh School of Pharmacy, Cardiff University, UK, is a world-renowned expert in drug design, synthesis and evaluation, particularly for antivirals.  Two agents designed and prepared in his lab are now in human clinical trials, McGuigan’s research breadth paired with his entrepreneurial spirit to rapidly advance preclinical chemicals to viable drug condidate status ready for clinical evaluation make him an invaluable advisor to all of TSRL’s preclinical prodrug discovery and development efforts.

Arnold Monto, MD, Professor of Epidemiology, Thomas Francis, Jr. Collegiate Professor of Public Health, University of Michigan, is a veteran in influenza vaccine and therapeutics development and was involved with the development of Tamiflu®, Relenza® and Flumist®.  The major focus of his work has been the epidemiology, prevention and treatment of acute infections in the individual and the community.  Monto has worked extensively with national and international organizations on issues related to pandemic preparedness and was a member of the WHO Influenza Pandemic Task Force.

Anne Moscona, MD, Weill Cornell Medical Center, Cornell University, is Attending Pediatrician at New York-Presbyterian Hospital/Weill Cornell medical Center, Professor of Pediatrics and of Microbiology and Immunology, Vice Chair for Research and Chief of Infectious Diseases in Pediatrics at Weill Cornell Medical Center.  Renowned for her research in parainfluenza virus, Dr. Moscona is active in explorations of structure-activity relationships between viral targets and antiviral therapeutics with an emphasis on understanding the mechanism of emergence of resistant virus strains.

For additional information contact Dr. Elke Lipka, Vice President of Business Development, 734-663-4233 x 236, elipka@tsrlinc.com

TSRL to present at Michigan Growth Capital Symposium

Ann Arbor, Michigan May 9th, 2011:  Therapeutic Systems Research Laboratories, Inc. (TSRL, Inc.) will be presenting at the 30th Annual Michigan Growth Capital Symposium in Ypsilanti on May 11th.  Dr. Elke Lipka will introduce TSRL’s new oral therapeutic prodrug for the treatment and prevention of influenza.

For additional information contact Dr. Elke Lipka, Vice President of Business Development, (734) 663-4233 x 236, elipka@tsrlinc.com

TSRL announces TSRL Researchers invited to NIAID/NIH Antiviral Workshop

Ann Arbor, Michigan.  March 11, 2011:  Therapeutic Systems Research Laboratories, Inc. (TSRL, Inc.) announces the invitation of Drs. Hilfinger and Lipka to the NIAID 2011 Influenza Antiviral Research Pipeline Workshop. The workshop is scheduled for March 23 & 24 at NIH in Bethesda, MD. The workshop is hosted by the Division of Microbiology and Infectious Diseases, NIAID/NIH. Participants will examine the state-of-the-art and the broad range of therapeutics development efforts currently underway worldwide.  The hope is to share several new approaches and strategies for influenza prophylaxis and treatment, and for investigators to share with NIAID issues and uncertainties affecting the antiviral development community.

TSRL, Inc. announces NIH – NIAID Phase II SBIR Grant Award

Ann Arbor, Michigan, February 2, 2011: Therapeutic Systems Research Laboratories, (TSRL), Inc. announces the award of a Phase II SBIR grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). TSRL will receive up to $2.6 million over the next 3 years, further supporting the development of the company’s oral influenza prodrug program. In addition, TSRL will be accessing NIAID’s preclinical services for the initial scale up of their lead candidates, TSR-026 and TSR-462. The company is planning on using these funds in addition to funds from the therapeutic tax credit grants received at the end of 2010 to advance their lead influenza therapeutics candidate to IND.

For additional information contact Dr. Elke Lipka, Vice President of Business Development, 734 663-4233 x 236, elipka@tsrlinc.com

TSRL, Inc. Awarded Four Therapeutic Discovery Tax Credit Grants

Ann Arbor, Michigan, November 11, 2010: Therapeutic Systems Research Laboratories, (TSRL), Inc. announced today receipt of four grants Therapeutic Discovery Tax Credit Program totaling $573,095. The grants were awarded against investments TSRL made in the development of oral prodrugs for influenza, human cytomegalovirus (CMV) and smallpox infections, development of novel local therapeutics for the treatment of IBD and an absorption enhancing technology.

TSRL will use these funds to advance their lead influenza therapeutics candidate to IND.

For additional information contact Dr. Elke Lipka, Vice President of Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

http://concentratemedia.com/innovationnews/tsrlannarbor0127.aspx

Ann Arbor, Michigan, November 5th, 2010:  Therapeutic Systems Research Laboratories, (TSRL), Inc, will present at the 8th Annual MidAmerica Healthcare Venture Forum, November 10-11, 2010

TSRL will introduce its oral prodrug program for the treatment and prevention of influenza at the Biotechnology and Pharmaceutical Showcase on Wednesday.

For additional information contact Dr. Elke Lipka, Vice President of Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

Ann Arbor, Michigan, October 25th, 2010: Therapeutic Systems Research Laboratories, (TSRL), Inc. will present at the MichBio 2010 Expo, October 26-27th.

TSRL will introduce its oral prodrug program for the treatment and prevention of influenza at the Emerging Bioscience Showcase session on Tuesday.  In addition, there will be a poster presentation on development of oral HPMPC and HPMPA prodrugs for treatment of human cytomegalovirus (CMV) infections.

For additional information contact Dr. Elke Lipka, Vice President of Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

TSRL announced their new Director of Laboratory Services

Ann Arbor, Michigan, October 6, 2010: Therapeutic Systems Research Laboratories, (TSRL), Inc. announced today the promotion of Mrs. Dawn Reyna to Director of Laboratory Services.

In this role, Mrs. Reyna will be leading TSRL’s laboratory research efforts focusing on preclinical ADME and early stage drug delivery evaluations. She has more than 10 years of research and Quality Assurance expertise and was instrumental in establishing TSRL’s GLP compliance. She holds a B.S. in Biology from Western Michigan University. She is a registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) who began her career in a CRO environment at MPI Research in 1997. Prior to joining TSRL, she held a number of quality assurance and management positions of increasing responsibility at MPI Research and Pfizer.  Mrs. Reyna demonstrates the ability to deliver high-quality products that ensure the integrity of the results and meet the customer’s needs.

Therapeutic Systems Research Laboratories (TSRL), Inc. is a privately held oral drug delivery specialty firm. TSRL is focused on R&D efforts to enhance the oral absorption of investigational and marketed compounds currently not suitable for this most convenient route of drug administration. TSRL provides preclinical development research services in early formulation development, PK/ADME and BCS biowaiver data packages. More detailed information about TSRL is available at the company website www.tsrlinc.com or by contacting Dr. Elke Lipka, Vice President of Business Development, 734 663-4233 x236, elipka@tsrlinc.com

TSRL, Inc., announces expansion of laboratories

Ann Arbor, MI (October 7, 2009) Therapeutic Systems Research Laboratories, Inc.  In line with the continued growth of TSRL’s contract research, we recently expanded our current facilities at Avis Farms, which now total 7,000 sq.ft., 4,800 of which is laboratory space.

Therapeutic Systems Research Laboratories (TSRL), Inc. (www.tsrlinc.com) is a privately held oral drug delivery specialty firm. TSRL is focused on R&D efforts to enhance the oral absorption of investigational and marketed compounds currently not suitable for this most convenient route of drug administration. TSRL provides preclinical development research services in early formulation development, PK/ADME and BCS biowaiver data packages. More detailed information about TSRL is available by contacting Dr. Elke Lipka, Vice President for Business Development, 734 663-4233 x236, elipka@tsrlinc.com.

 

TSRL announces the formation of its Scientific Advisory Board

Ann Arbor, MI (April 13, 2009) – Therapeutic Systems Laboratory (TSRL, Inc.), a biopharmaceutical company developing oral drug delivery solutions for poorly absorbed drug candidates, welcomes Drs Andreas Bommarius, Shan Lu, and Blake Roessler, to their Scientific Advisory Board (SAB).

Dr. Bommarius’ area of expertise is in biomolecular engineering, especially biocatalysis, bioprocessing, and protein stability. Dr. Bommarius joined the Georgia Tech faculty in 2000 after an industrial career of more than 10 years with the Degussa Company in specialty chemicals where he headed the Biocatalysis laboratory and pilot plant. At Georgia Tech, he is a faculty member of both the School of Chemical and Biomolecular Engineering and the School of Chemistry and Biochemistry. Andy brings a strong formulation manufacturing perspective to TSRL’s research and will advise us on scale-up and manufacturing issues of our product candidates.

Dr. Shan Lu is a researcher and clinician at the University of Massachusetts’s Medical School. Shan focuses on translational research in vaccine development both for civilian and biodefense related targets. With his extensive experience in developing clinical development trial protocols, he was able to move a candidate human HIV vaccine from early preclinical stage to human testing within 3.5 years. Shan is a pioneer in DNA vaccine delivery and has worked on a wide range of anti-infective vaccine and drug candidates. In addition, Shan founded Antibody Science, Inc., a start-up firm focused on novel antibody development. Shan’s clinical perspective in antiviral drug development paired with his unique knowledge of the biodefense space will help shape TSRL’s development strategies.

Dr. Blake Roessler is Associate Professor of Internal Medicine in the Division of Rheumatology at the University of Michigan Medical School. Dr. Roessler leads active basic and clinical research programs and continues as a practicing clinician. He currently directs the Viral Vector Core, the Process Development Core and the Human Applications Laboratory Core. Dr. Roessler has a long-standing research interest in nucleic acid delivery technologies and is co-inventor of the BAC technologies. Blake’s broad clinical and gene therapy background make him an ideal advisor to TSRL’s continued strategic interest in peptide and biologics delivery.

Therapeutic Systems Research Laboratories (TSRL), Inc. is a privately held oral drug delivery specialty firm focused on R&D efforts to enhance the oral absorption of investigational and marketed compounds currently not suitable for this most convenient route of drug administration. TSRL is applying its technologies towards the discovery and development of oral therapies for infectious diseases, osteoporosis and gastrointestinal disorders. More detailed information about TSRL is available at the company website www.tsrlinc.com or by contacting Dr. Elke Lipka, Vice President for Business Development, 734 663-4233 x236, elipka@tsrlinc.com

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