TSRL, Inc. to Present at Michigan State University on November 11th, 2016

Topic: The TSRL Preclinical Accelerator: Driving Value from Lead to Clinic

Date: Friday, November 11 Time: 9  to 10 a.m.

Place: B448 Life Science Bldg

Who: Elke Lipka, MBA, PhD, President and Andrew Hertig, MBA, Business Development

About TSRL, Inc.: We are a privately-owned pharmaceutical accelerator based in Ann Arbor, Michigan. We provide academic investigators scientific and business resources and access to non-dilutive capital to advance their lead-stage therapeutic compounds to clinical-readiness. Our core competencies include: pharmacokinetics, formulation development, exploratory toxicology, data and project management, regulatory strategy, grant-writing, and business development. Our programs have received over $15 million in grant support over the past ten years and generated ~$20 million in revenues from out-licenses and acquisitions. Currently, we are focused on the development of anti-infective therapeutics for treating severe and multi-drug resistant infectious diseases.

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TSRL, Inc. Client Company Acquired by Allergan

Ann Arbor, Michigan: RetroSense Therapeutics, a privately-held biotechnology company developing novel gene therapies for vision restoration, announced that Allergan plc has acquired all assets related to its lead development program in an all-cash transaction. RetroSense’s RST-001 program employs a photosensitivity gene to restore vision in patients suffering from blindness due to retinitis pigmentosa (RP) and advanced dry age-related macular degeneration. Neither of these conditions have FDA-approved treatments to improve or restore vision.

“There are some great things going on at TSRL,” said former RetroSense CEO Sean Ainsworth. “It was a nice opportunity to work and be co-located with like-minded, driven companies that want to have a positive impact on human health.”

TSRL, Inc. worked with Sean to provide business support and office space for RetroSense as the company expanded operations. Recent milestones for the company included receiving an Orphan Drug Designation for RP in 2014, an IND approval in August 2015 and initiation of a Phase I/IIa clinical trial in March 2016. RetroSense was founded in 2009, securing exclusive, worldwide rights to the optogenetics technology pioneered at Michigan’s Wayne State University and Pennsylvania’s Salus University.

About TSRL, Inc:

TSRL, Inc. is a privately-held, anti-infectives pharmaceutical accelerator focused on the preclinical development of investigator-initiated drug therapy concepts. More information about TSRL, Inc. is available on the company website www.tsrlinc.com or can be requested by contacting Andrew Hertig, Business Development, 734-663-4233 x224, ahertig@tsrlinc.com.

No Bugs, No Interest? How Public Search Queries for "ESKAPE" Pathogens Change Over Time

Introduction

In July 2004, the Infectious Diseases Society of America (IDSA) released a report called "Bad Bugs, No Drugs." This report identified several species of antibiotic-resistant bacteria that were expected to play a lead role in the next global health crisis to come. The authors cited a high prevalence of drug-resistant infections--362,000 in the US in 2002--and lack of new antibiotics in development as warning signs. Twelve years have passed since the report published, and according to the CDC, >2 million people become infected and >23,000 die from drug-resistant infections every year. A 2009 paper by Boucher et al implicated six actors from their pathology, persistence, and presence in US hospitals: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter, Pseudomonas aeruginosa and Enterobacter. They termed them "ESKAPE" pathogens.

Examining search terms on Google sheds light on how the public perceives this threat. But is exposure from reports and other publications sufficient to elicit greater public awareness?

Methodology

First, let's quickly go over our methodology. Some ESKAPE pathogens are represented by their species and others are represented by their genus alone. To see if search interest would vary significantly between genus and species we did a Google Trends search for Staphylococcus aureus, a gram positive bacterium most commonly known for its nosocomial, and deadly, MRSA outbreaks: 

The chart above reveals a change in search intensity between genus vs genus+species, and no big difference between genus vs species. As a result, we chose to use genus+species in future searches. Not to get off track, but it is interesting to note that 1) there was a peak in search interest in October 2007 and 2) an overall slight decline in interest in Staphylococcus since 2004. You might be wondering what caused this spike? It turns out the CDC released a report titled "Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States" on October 17th. A quick search for "MRSA" confirms this, overlapping with one of the first peaks of 'superbug'.

Five killer pathogens...

Second, by using our insight on genus+species we compared the search interest of the five most represented ESKAPE pathogen species, plotted over time since July 2004:

Despite no significant long-term trend, we are immediately drawn to the spike in interest for Pseudomonas aeruginosa, a gram negative pathogen and frequent culprit in respiratory illnesses like ventilator-associated pneumonia and cycstic fibrosis. Two possibilities come to mind: 1) an association with another report or publication or 2) an outbreak that was picked up by the news. Next, we compared this peak with 'cyctic fibrosis' and 'superbug' to see if any overlap existed:

Alas, no clear association was found in these search terms as the impact of Pseudomonas aeruginosa seems unrelated to several uncovered January publications on cystic fibrosis and Pseudomonas. And, as seen above, the public also does yet not associate 'superbug' with Pseudomonas aeruginosa, even if it is multi-drug resistant. So what is causing this peak in Google search terms?

...and a Brazilian supermodel?

We focused in on the peak to pinpoint its maximum as if we were examining a LC/MS readout. Comparing the peak on January 24th 2009 to the term 'outbreak' we found no association between the two: 

We did, however, find something unexpected. We searched Pseudomonas aeruginosa on the peak date of January 24th and came across news articles on 20-year old Brazilian model Mariana Bridi da Costa, a Miss World 2008 finalist who was battling septic shock from this "little known" disease. What started out as a urinary tract infection got progressively worse, to the point where both her feet and hands had to be amputated from tissue necrosis caused by sepsis. After a short battle, Miss Da Costa passed away on the 24th. The world knew about it.

What does it all mean?

Although search terms for Pseudomonas aeruginosa eventually decreased over time, awareness was elevated for several months after the story was published. The public was searching more for this pathogen on one day than all ESKAPE pathogens combined, even more so than on March 8th, 2012 when the IDSA released its report promoting antimicrobial stewardship before the House Committee on Energy and Commerce Subcommittee on Health.

Understandably, technical searches such as genus+species are more difficult search terms than 'superbug' or 'MRSA.' However, we don't know which search terms will become popular until the story gets picked up. Government and policy-minded agencies can multiply the impact of news events by promoting simple search terms in conjunction with peak search terms from their counterparts. ESKAPE was an attempt to do this, but unfortunately its awareness is still limited. It is important for policy makers to use the same keywords to promote a unified message to the public. This, in turn, will directly impact how the public perceives the threat to come.

For more information on drug-resistant bacteria please visit: http://www.idsociety.org/Index.aspx

Find your own trends on Google Trends: https://www.google.com/trends/explore

TSRL, Inc. to Present at the 29th International Conference on Antiviral Research

Ann Arbor, Michigan, March 3rd, 2016: TSRL Inc., a preclinical accelerator developing novel anti-infective therapeutics in areas of high unmet medical need, is presenting at the 29th International Conference on Antiviral Research (ICAR) April 17th - 21st at the Hilton La Jolla Torrey Pines hotel in La Jolla, CA.

Dr. Steven King will present on a "Genetically Optimized Banana Lectin for the Treatment of Influenza," and Dr. Eric Simon will present on an analytical method for characterization of BL-84, a genetically optimized therapeutic banana lectin. Furthermore, Dr. Shyamala Ganesan will present on the in vitro potency of nucleoside phosphonate analogues and Dr. Simon will present an LC-MS assay for measuring intracellular concentrations of USC-505, a nuceleoside phosphonate analogue.

Our collaborators Dr. William (Bill) Wold and Dr. Jennifer Moffat will present on the in vivo efficacy of nucleoside analogues in Syrian hamster and mice, respectively. Dr. Wold will present on the protection of immunocompromised Syrian hamsters against type 5 and 6 adenovirus and Dr. Moffat will present on the protection of mice against VZV, otherwise known as herpes zoster or shingles.

Abstracts are available here:

Genetically Optimized Banana Lectin for the Treatment of Influenza

Analytical Method Development for the Structural Characterization of BL-84, a Genetically Engineered, Recombinant Banana Lectin with Potent Antiviral Activity and Reduced Mitogenicity

Improved In Vitro Potency of Nucleoside Phosphonate Analogs against Different
Adenovirus Serotypes Using an Oral Prodrug Approach

Development of an LC-MS/MS Assay for Measurement of the Intracellular Concentrations of USC-505 (a Prodrug of Cidofovir) and its Metabolites

USC-087 and USC-505 Protect Immunosuppressed Syrian Hamsters against Lethal Intravenous Challenge with Human Type 5 and 6 Adenoviruses

Tyrosine Ester Prodrug of Cidofovir is Effective Against VZV in Mice

About TSRL, Inc:

TSRL, Inc. is a privately-held, anti-infectives pharmaceutical accelerator focused on the preclinical development of investigator-initiated drug therapy concepts. More information about TSRL, Inc. is available on the company website www.tsrlinc.com or can be requested by contacting Andrew Hertig, Business Development, 734-663-4233 x224, ahertig@tsrlinc.com.

 

TSRL, Inc. to Present at the 2015 AAPS Annual Meeting and Exposition

Ann Arbor, Michigan, Sept 15th, 2015: TSRL Inc., a preclinical accelerator developing novel anti-infective therapeutics in areas of high unmet medical need, is presenting at the 2015 AAPS Annual Meeting and Exposition, October 25-29, at the Orange County Convention Center in Orlando Florida.

Dawn Reyna, Sr. Director of Laboratory Services, will be presenting on the "Pharmacokinetics of Potent HPMPA and HPMPC Tyrosinamide Prodrugs with Broad Spectrum Antiviral Activity" and Deanna Mudie, on behalf of the University of Michigan College of Pharmacy, will be presenting on the "Influence of Fluid Shear Rate on the Dissolution Rate of Poorly Soluble Drug Particles; Implications for In Vivo Predictive In Vitro Dissolution Methodologies and Mechanistic Computational Modeling".

Abstracts are available here:

Pharmacokinetics of Potent HPMPA and HPMPC Tyrosinamide Prodrugs with Broad Spectrum Antiviral Activity

Influence of Fluid Shear Rate on the Dissolution Rate of Poorly Soluble Drug Particles

About TSRL, Inc.

TSRL, Inc. is a privately-held anti-infectives drug development firm and accelerator focused on R&D efforts to optimize effectiveness and safety of investigational and marketed therapeutics. More information about TSRL, Inc. 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, Inc. Presents at the Cutting Edge/Drug Discovery & Development in Michigan Symposium

Ann Arbor, Michigan, Sept 15th, 2015: TSRL Inc., a preclinical accelerator developing novel anti-infective therapeutics in areas of high unmet medical need, has presented on various topics at the Cutting Edge/Drug Discovery & Development in Michigan Symposium September 9th and 10th.

Eric Simon, PhD presented on the "Development of an LC-MS Assay for Measurement of of Intracellular Concentrations of Cidofovir Prodrug USC-505 and its Metabolites". Shyamala Ganesan, PhD presented on "Improved Intracellular Concentrations of Cidofovir Diphosphate Using an Oral Prodrug Approach". Andrew Hertig, MBA, presented on "The Preclinical Accelerator: A New Model for Drug Development".

Presentations are available for viewing here:

LC-MS Method for Measuring Cidofovir Prodrugs Poster

Intracellular Conversion of Cidofovir Prodrugs Poster

Preclinical Accelerator Model for Drug Development Poster

About TSRL, Inc.

TSRL, Inc. is a privately-held anti-infectives drug development firm and accelerator focused on R&D efforts to optimize effectiveness and safety of investigational and marketed therapeutics. More information about TSRL, Inc. 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.

Having Fun and Helping the Local Community

Ann Arbor, Michigan, June 26th, 2015Members of our team at TSRL, Inc. visited the Foundations Preschool of Washtenaw County (http://www.foundations-preschool.org/) last Friday for our annual Day of Caring. The weather couldn't have been better as we were put to work scrubbing floors, ripping out weeds, and staining decks. One of our team members even got a bee sting. They are okay--with the help of an onion to reduce the swelling--and the hard work was worth it for everybody. We were able to make our community preschool a cleaner, happier place for the at-risk children who need a place to learn and grow.

Looking forward to next time!

Learn more about United Way/Day of Caring: http://www.wuway.org/node/778

About Foundations Preschool:

Foundations Preschool prepares children from low income families for future academic and social success while providing their parents opportunities for professional, personal and parental growth.

We Accomplish This By Providing:

  • A focus on the needs of low-income families
  • Tuition subsidies based on household income
  • A researched-based curriculum and teaching methods
  • Professional and educated staff
  • Opportunities to strengthen parenting skills through monthly workshops and a true parent/school team approach
  • Speech/language/social work assessments and intervention services
  • On-site dental screenings and varnishes
  • Vision and auditory screenings
  • Free breakfast, lunch and afternoon snack

TSRL, Inc Presents at the 28th International Conference on Antiviral Research

Ann Arbor, Michigan, May 14th, 2015: TSRL Inc., a pharmaceutical company developing novel anti-infective therapeutics in areas of high unmet medical need, is pleased to announce that Elke Lipka, PhD, MBA, has presented at the 28th International Conference on Antiviral Research (ICAR) in Rome, Italy. The presentation, entitled "Potent Broad Spectrum Anti-DNA Viral Activity for HPMPA and HPMPC Tyrosinamide Prodrugs", reports on the broad spectrum antiviral activity of acyclic nucleoside phosphonates (ANPs) as useful agents in the treatment of many DNA virus infections.

The full poster presentation can be accessed here.

About TSRL, Inc.

TSRL, Inc. is a privately-held anti-infectives drug development firm and accelerator focused on R&D efforts to optimize effectiveness and safety of investigational and marketed therapeutics. More information about TSRL, Inc. 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, 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.