Oncology Drug Approval - Accelerated

Bridging the gap between biomarkers and In Vitro Companion Diagnostics

Fritz Eibel Appointed to Senior VP and Chief Marketing Officer

PORTLAND, OR — February 9, 2017 — MolecularMD Corp., a molecular diagnostics company that accelerates oncology drug approval by providing custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, has announced the appointment of Frederick (Fritz) Eibel as its new Senior Vice President and Chief Marketing Officer. Mr. Eibel brings almost three decades of broad-based in vitro diagnostics (IVD) and life science experience focused primarily on new and emerging growth opportunities in the precision medicine segment. He most recently served as Senior Vice President of Wren Laboratories and focused on the commercialization of a group of novel gene expression assays designed for the prognosis, monitoring and therapy prediction for patients with neuroendocrine cancer. Mr. Eibel’s additional experience includes leadership roles at Rain Dance Technologies, Sequenom, Life Technologies, Gen Probe and over 23 years in various roles at Roche Diagnostics. He has also served on the MolecularMD Board of Directors for over four years.

“Fritz’s contribution to the Board has been of great value and the company looks forward to further leveraging his experiences and proven strategies for the successful development and commercialization of selling products in today’s Precision Medicine market segment,” said Dan Snyder, President and CEO of MolecularMD . 

Asterand Bioscience and MolecularMD announce a partnership to accelerate targeted therapeutic biomarker validation, optimization, development and commercialization

Partnership facilitates therapeutic biomarker and target validation, assay development and clinical trial management for companion diagnostics and drug development.

PORTLAND, OR, CAMBRIDGE, MA and DETROIT, MI February 15, 2017- Asterand Bioscience, the leader in high quality, well-characterized human tissue and human tissue-based research solutions supporting drug discovery and development, announced today a partnership with MolecularMD to combine MolecularMD’s expertise as a provider of molecular diagnostics products and services with Asterand Bio’s drug target and candidate validation capabilities. MolecularMD is a molecular diagnostics company that develops custom clinical trial assays as well as companion diagnostic products, supporting clinical trial services and commercialization of targeted cancer therapies. The partnership creates an end-to-end workflow for biopharma clients and strengthens the companies’ current offerings in assay development & validation, while creating a global footprint for the efficient delivery of clinical trial sample analyses.

“For over 20 years, Asterand Bioscience’s experienced scientists have worked collaboratively with clients to expedite the highest likelihood for clinical success by providing a variety of pre-clinical research services,” said John Canepa, Chief Financial Officer/Chief Operations Officer. “This agreement brings together MolecularMD’s proven track record in clinical assay development and companion diagnostics with Asterand Bio’s human tissue procurement, characterization and research services to provide a comprehensive approach to meet the needs of pharmaceutical, biotechnology and diagnostic companies from validation of biomarkers and targets to assay development, through regulatory and clinical trials.”

“MolecularMD is uniquely suited to assist biopharma clients with our clinical trial and regulatory expertise,” said Dan Snyder, President/Chief Executive Officer, MolecularMD. “I’m excited that Asterand Bio and MolecularMD have joined forces to provide these unique advantages which will help our broad client base accelerate their pipeline decisions and dramatically improve the efficiency of the clinical trial and commercialization workflow.”

Asterand Bio and MolecularMD will both attend Molecular Med Tri-Con 2017, Feb 19-24 at the Moscone North Convention Center, San Francisco, CA, a meeting bringing together over 3,500 drug discovery and development professionals. More information about the partnership can be found at Asterand Bio’s booth #626. Asterand Bio and MolecularMD will both attend the AACR 2017 meeting, April 1-5 at the Walter E. Washington Convention Center in Washington DC, a meeting that highlights the highest level of cancer science and medicine from institutions all over the world. More information about the partnership can be found at Asterand Bio’s booth #1340 and MolecularMD’s booth #3423.

MolecularMD Enters Into a Collaboration Agreement with Illumina for Drug-Diagnostic Co-development with Biopharma Drug Programs

PORTLAND, OR and CAMBRIDGE, MA – June 27, 2016 – MolecularMD Corporation announced today that it has entered into an agreement with Illumina, Inc. (NASDAQ: ILMN) that establishes a framework for potential collaborations with respect to the development and commercialization of sequencing-based companion diagnostics in support of biopharma drug development program(s). The agreement dovetails MolecularMD’s companion diagnostic development and FDA submission experience with Illumina’s NGS technology.

“This agreement is designed to deliver the combined power of Illumina’s NGS technologies with MolecularMD’s ability to tailor a complete clinical development solution including regulatory planning, IDE validations and centralized testing and data management for global patient enrollment and disease monitoring,” stated Dan Snyder, CEO of MolecularMD.

MolecularMD opened its advanced diagnostic laboratory in Cambridge, MA in 2012 with the objective of providing NGS solutions that support clinical trials of oncology drug programs. MolecularMD has since deployed NGS diagnostics over a broad range of drug targets and indications. The ability to support global trials with centralized testing laboratories while simultaneously obtaining necessary regulatory compliance can allow rapid deployment of Illumina based NGS solutions.

“Our goal is to enable our clients with the latest platforms and proven technologies that solve for the challenges that often arise during drug and diagnostic co-development,” stated Snyder. “The ability to collaborate with Illumina on defined projects will greatly aid our clients to mitigate risks and to accelerate their clinical trial programs.”

Definiens and MolecularMD Announce Partnership to Combine IHC Assays with Advanced Digital Pathology and Data Mining

Partnership Provides State-of-the-Art Patient Stratification Using Quantitative Tissue Assays For
Clinical Development and Diagnostics

Munich, Germany – June 2, 2016 – Definiens, the pioneer in Tissue Phenomics solutions for
diagnostics development and commercialization, today announced a partnership agreement
with MolecularMD to combine MolecularMD’s expertise in specialty diagnostic assays with
Definiens’ quantitative tissue read-outs. MolecularMD is a molecular diagnostics company that
develops custom companion diagnostic products and supports clinical trial services for targeted
cancer therapies.

“Definiens’ technology already empowers smarter tissue-based diagnostics,” said Merrilyn
Datta, chief commercial officer, Definiens. “This agreement brings together MolecularMD’s
proven track record in clinical assay development and companion diagnostics with Definiens’
unparalleled image analysis platform to provide the confidence of an integrated solution in
stratifying patients.”

The new partnership between the two diagnostics companies provides custom solutions that
meet data and regulatory requirements for both biopharmaceutical clients and academic
medical center oncology programs, including advanced solutions with assays, image analysis
and data mining, combined with deep scientific, regulatory and pathology support.

“MolecularMD is uniquely suited to assist biopharmaceutical clients and academic medical
centers with our clinical trial and regulatory expertise,” said Dan Snyder, president and chief
executive officer, MolecularMD. “I’m thrilled that Definiens and MolecularMD have joined
forces to provide these unique advantages, accelerating pipeline decisions and dramatically
improving patient stratification from the pre-clinical phase.”

MolecularMD has obtained CE Marking of a Diagnostic Assay Developed for a Daiichi Sankyo, Inc. Phase II Clinical Trial

PORTLAND, OR and CAMBRIDGE, MA – April 25, 2016 – MolecularMD Corp., a molecular diagnostics company that accelerates oncology drug development by providing custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, has partnered with Daiichi Sankyo, Inc. on their work in developing oncology compounds. In collaboration with Daiichi Sankyo, MolecularMD has validated a clinical trial assay that will be used to enrich the patient population for a Phase II clinical trial which is commencing in Europe. MolecularMD has completed the CE registration with the European authorities to ensure future access as an assay, which is to be used for patient selection into the trial.

“Identifying the precise subset of patients who may respond to our compound helps to fully assess its potential efficacy and safety profile,” said Antoine Yver, MD, MSc, Executive VP and Global Head, Oncology R&D, Daiichi Sankyo.

“MolecularMD is entirely focused on accelerating development  of precision oncology medicines. Our work with Daiichi Sankyo demonstrates our ability to support a wide spectrum of clinical and regulatory strategies, stated Dan Snyder, CEO of MolecularMD. “We have a long standing and successful collaboration with their team”. The arrangement with Daiichi Sankyo represents just one of MolecularMD’s Master Service Agreements among the top 25 prominent BioPharma companies in the Industry.  

More Articles...

  1. MolecularMD Announces Presentations at Upcoming AACR-NCI-EORTC International Conference
  2. MolecularMD Receives New York State Approval for Next Generation Sequencing Test to Support Clinical Trial Enrollment
  3. MolecularMD Announces Presentations at Upcoming American Association for Cancer Research Annual Meeting
  4. MolecularMD Receives ISO Certification for Design, Development and Production of Molecular Diagnostic Products
  5. MolecularMD Cambridge Laboratory Receives CAP Accreditation with Focus on NGS Panels for Clinical Trial Enrollment and NGS Liquid Biopsy Testing
  6. MolecularMD Develops Notch1 Next Generation Sequencing Test to Support Clinical Development for OncoMed's anti-Notch1 antibody, OMP-52M51
  7. MolecularMD to Adopt Oncomine Cancer Research Panel with Ion Torrent Next-Generation Sequencing Platform
  8. MolecularMD Receives CLIA Certification for its Second Next Generation Sequencing Laboratory
  9. MolecularMD Launches NanoString Platform for Multiplexed Digital Evaluation of Gene Expression and Copy Number Variation in Clinical Specimens
  10. MolecularMD to Develop Highly Sensitive Companion Diagnostic Test to Support CML Treatment Free Remission Clinical Trial
  11. MolecularMD Announces Presentations at Upcoming American Society of Hematology Annual Meeting
  12. MolecularMD Announces Presentations at Four Upcoming Scientific Conferences
  13. Personal Genome Diagnostics and MolecularMD Collaborate to Provide Advanced Genomic Testing Services to Cancer Drug Developers
  14. MolecularMD Announces Presentations at Upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
  15. MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy
  16. MolecularMD Corp. Offers Testing Services for Determining LKB1 Mutation and Expression Status
  17. MolecularMD Announces Launch of Next Generation Sequencing Services for Oncology Drug Development
  18. MolecularMD Corp. Obtains Exclusive License to LKB1 Uses in Non-Small Cell Lung Cancer
  19. MolecularMD and Ventana Medical Systems, Inc. reach Collaborative Research Agreement: Limits of detection and sensitivity for PTEN gene using in-situ hybridization and immunohistochemistry methods
  20. MolecularMD Announces Next Generation Sequencing Presentation at Upcoming American Society of Hematology Annual Meeting

Watch the short video below to learn more about how MolecularMD develops and commercializes specialty molecular diagnostics for oncology applications.