Molecular Health and CENTOGENE Announce an Exclusive Collaboration With the Aim to Transform the Development of Orphan Drugs

Newsroom

All news

CENTOGENE and Molecular Health Announce an Exclusive Collaboration With the Aim to Transform the Development of Orphan Drugs 

 

  • The combination of real-life data sets in rare diseases with innovative big data/artificial intelligence/novel scientific computational knowledge will transform biomedical research, product development, and therapy.
  • Real-life data and Innovative Bioinformatic Algorithms (RIBA project) will enable the creation of a powerful environment to accelerate, de-risk, and improve the development of new orphan drugs for many diseases and disease areas.
  • RIBA develops and offers data-/computing-driven solutions to guide the highest and most precise innovation for a new way of drug development in a modern biopharmaceutical environment.
  • The collaboration will start with Epilepsy as the first indication

Cambridge, MA, USA & Rostock/Berlin, Germany, and Heidelberg, Germany, July 20, 2020 (GLOBE NEWSWIRE) – Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, and Molecular Health, a leading company in the field of data and computing science for precision medicine, announced today that they will collaborate exclusively to initiate the Real-life data and Innovative Bioinformatic Algorithms (RIBA) project – starting with Epilepsy as the first indication. RIBA aims to foster a unique novel precision medicine environment to accelerate, de-risk, and improve the development of new orphan drugs based on the combination of large real-life data sets in rare disease with innovative big data, innovative artificial intelligence, as well as computational algorithms and expertise. Both companies are convinced that this strategy of merging real-life data with a global curated biomedical knowledge, as well as applying artificial intelligence and scientific computing will radically change and transform biomedical research, product development, and therapy. Additionally, it will offer data-/computing-driven solutions to guide the highest and most precise innovation for the new way of drug development in a modern biopharmaceutical environment.

 

Prof. Arndt Rolfs, CENTOGENE Chief Executive Officer, stated, “We are excited about this collaboration. Both companies have been analyzing the potential interaction for an extended period of time and are deeply convinced that now is the right time to start an exclusive cooperation focusing on rare genetic diseases. The complementary expertise and knowledge of both companies will allow us to reduce the time to develop a new orphan drug by combining of real-life data and innovative computational biomedical expertise. CentoMD®, one of the world’s largest rare disease data repositories, allows us to take advantage of the high quality of the real-life data from a global cohort of more than 500,000 consented patients. The extraordinary expertise of Molecular Health will not only speed up the identification of new targets in rare disease, but also allow us to de-risk and accelerate the development of new orphan drugs.

 

“By starting this exciting collaboration between our companies, we are initiating and building a unique novel model of personalized healthcare. The combination of both companies’ data and expertise will ultimately transform modern drug development and therapy. It will allow for the development of better drugs with higher specificity and safety, lower attrition rates in clinical studies, and a faster time to market to help patients with severe diseases worldwide through novel therapies,” said Dr. Friedrich von Bohlen, Molecular Health Chief Executive Officer. “Together with CENTOGENE, Molecular Health´s deep scientific, medical, and computational expertise will lay the fundament for personalized healthcare options in rare diseases to fulfill the promise of precision medicine.”

 

The companies have agreed to start with Epilepsy as the first indication. Financial details were not disclosed.

 

Molecular Health signs up HudsonAlpha Institute for Biotechnology as new US customer for MH Guide

Newsroom

All news

Molecular Health signs up HudsonAlpha Institute for Biotechnology as new US customer for MH Guide

 

Molecular Health signs up HudsonAlpha Institute for Biotechnology as new US customer for MH Guide

 

  • Molecular Health Guide (MH Guide) gains ground in important U.S. market
  • MH Guide easily translates complex genetic data to support intelligent personalized medical decisions

Heidelberg, Germany – May 31, 2019 – Molecular Health (MH), a leading company in the field of data science for precision medicine, today announced that the Company has signed up the HudsonAlpha Institute for Biotechnology (HudsonAlpha) as a new client for MH Guide. HudsonAlpha is a nonprofit institute dedicated to developing and applying scientific advances to health, agriculture, learning, and commercialization.

 

MH Guide enables smarter patient care decisions based on deeper and broader biomedical information: Molecular pathologists and human geneticists can interpret genetic data derived from different technologies, such as next-generation sequencing, and create clinical reports that include drug information and variant classifications in minutes – easily, confidently, and accurately. HudsonAlpha plans to use MH Guide to elucidate detailed information on mutations found in patient tumor samples.

 

Dr. Friedrich von Bohlen, Co-founder and CEO of Molecular Health, said: ”Molecular Health is increasing its footprint in the U.S. as we sign on important new clients for our products. We are delighted to welcome HudsonAlpha as a customer and look forward to contributing through MH Guide to the important work they are doing to advance science and healthcare.”

 

About MH Guide
MH Guide, the gold standard in genomic data processing and analysis, is a rich bioinformatics platform, allowing medical professionals to analyze variants in the context of a patient’s cancer disease or predisposition to support identification of the potentially most effective treatments or disease predispositions. Molecular Health integrates private and publicly available databases, peer-reviewed scientific literature, and genome studies to extract salient information categorized by gene variant, disease, indication, cancer pharmacogenetics, and other relevant clinical classifiers. The stringent quality process Molecular Health follows to annotate and create its medical content is what sets MH Guide apart. Clients retain ownership of all data at all stages of the analysis, including the analysis results, which can be provided in a variety of digital formats, and have access to all source evidence for the annotations provided by the system. MH Guide is the first software product approved as an IVD medical device by the EU and is currently eligible for reimbursement in the EU.

Molecular Health appoints Christian Meisel, MD, PhD, as Chief Medical Officer

Newsroom

All news

Molecular Health appoints Christian Meisel, MD, PhD, as Chief Medical Officer

Heidelberg, Germany – Tuesday, May 7, 2019–Molecular Health, a leading company in the field of data science for precision medicine and specializing in the development of products and services leveraging its proprietary biomedicine technology platform Dataome, today announced the appointment ofDr. Christian Meisel as corporate Chief Medical Officer (CMO).

 

Dr. Meiselcomes to Molecular Health with over 25years of experience in the healthcare sector–including clinical practiceand research &development across academia and the biopharmaceutical industry–andmore than 10 years in senior pharma leadership roles. As anMDandPhD with additional qualifications in computer science and extensive experience in precision medicine, Dr. Meisel will be responsible for all clinical aspectsof Molecular Health’sportfolioand development. As a member of the company’s leadership,he will also provide strategicdirection and leadership in the development of Molecular Health.

 

Dr. Friedrich von Bohlen, Co-founder and CEO of Molecular Health, said:”Weare very pleasedto have Dr. Meisel join as our Chief Medical Officer. He not only is anexperiencedphysician but, next to his background in computer science, also brings an extensivetrack record and expertise in precision medicineacross the biopharmaceutical and diagnostics industry. With his broadexperience in molecular diagnostics and drug development,he is a perfect addition to our development and commercial teams and willstrategically enhanceand further sharpen thefocus of our offerings to pharma, physicians, providers, payersand the financial industry. The CMO position is key for our growth strategy, and we are happy to havefound Christianfor this important role at Molecular Health.”

 

Dr. Meisel adds: “I am very much looking forwardto joiningMolecular Health –a company at the forefront of the digital transformation of medicine and R&D –as a member of the executive team. I will bring my first-hand experience and deep knowledge of the demandsof patients and healthcare providers to further improveMolecular Health’s innovative solutions to impact patient care,therapeutic and diagnostic product development,and meet the growing needs of the medical community in the digitalization of healthcare.”

 

Dr. Christian Meisel joins Molecular Health from Roche where heserved for more than 14 years in numerous senior leadership roles, including Global Head Personalized Healthcare Platform, acting Global Head Translational Medicine Oncology, and Global Head Biomarkers and Translational R&D Innovation. Dr. Meisel is board-certified in Internal Medicine and in Clinical Pharmacology, holds an MD from the Technical University of Munich, and a PhD from Charité Berlin, where he also served as associate professor and leader of a bioinformatics research group.

 

About Molecular Health

Molecular Health is a data science-focused artificial intelligencecomputing company enabling and improving decision making in precision medicine for healthcare organizations.The company offerings are based on the capture, curation, integration, and analysis of large biomedical and drug data sets andcombining them with novel artificial intelligence and machine learning (AI/ML) technologies.For more than a decade, the company has been developingDataome, a unique high-quality curated, interoperable system that combines clinico-molecular and drug data with proprietary analytical processes.Dataome –stand alone or in combination with customer data –enables the unlocking of actionable intelligence at the molecular level toa)improve diagnosis and therapy decisions by physicians and patients;b) enrich and support better drug discovery, drug development, trial optimization, drug differentiation and positioning for pharma and healthcare organizations;andc) more accurately predict the likelihood of success and likelihood of approval of drug candidates in clinical development for better trial prioritization and resource and investment allocation.For more information,visit www.molecularhealth.com.

 

Molecular Health GmbH
Thomas König
Head of Marketing
thomas.koenig@molecularhealth.com

 

Media Relations
MC Services AG
Katja Arnold, Eva Bauer, Laurie Doyle
molecularhealth@mc-services.eu
+49-89-210 2280

Molecular Health ’s MH Guide shortlisted for the German Digital Health Award 2019

Newsroom

All news

Molecular Health ’s MH Guide shortlisted for the German Digital Health Award 2019

• Molecular Health Guide (MH Guide) shortlisted forthe German Digital Health Award 2019
• Novartis and Sandoz/Hexal nominate seven out of 119 submissions
• MH Guide enables evidence-based cancer therapy decisions for physicians, patients and health insurers

 

Heidelberg, Germany–Monday, February 18, 2019–Molecular Health (MH), a leading company in the field of data science for precision medicine and specializing in the development of products and
services leveraging its proprietary biomedicine technology platform Dataome, has been shortlisted for the German Digital Health Award 2019. As Novartis Pharma and Sandoz Germany/Hexal announced earlier, MH Guide is one of only seven entriesselected from a total of 119 submissions. The German Digital Health Award is given to sustainable digital solutions to improve healthcare in Germany. The
2nd annual awards ceremony will take place in Berlin on March 20, 2019.

 

Dr. Friedrich von Bohlen, Co-founder and CEO of Molecular Health, said: ”We are delighted to be shortlisted for the German Digital Health Award 2019 and by the recognition this means for our work. At Molecular Health, we are constantly seeking smart solutions to address the challenges in cancer healthcare. Nine renowned experts have been appointed to the jury by Novartis, and their
nomination reinforces that we are following a future-oriented and sound path.”

 

With MH Guide, physicians in their everyday cancer practice can make an evidence-based therapy decision that takes into account the individual patient’s tumor characteristics. Utilizing MH’s
proprietary technology platform Dataome, MH Guide generates a summary of potentially effective medications, potentially ineffective medications, and medications that may pose a higher risk of adverse reactions or be predictive for an increased risk of cancer progression. MH Guide is the first software product approved as an IVD medical device by the EU and is currently eligible for reimbursement.

 

About Molecular Health
Molecular Health is a data science-focused artificial intelligence computing company enabling and improving decision making in precision medicine for healthcare organizations.The company offerings are based on the capture, curation, integration, and analysis of large biomedical and drug data sets and combining them with novel artificial intelligence and machine learning (AI/ML) technologies. For more than a decade, the company has been developing Dataome, a unique high-quality curated, interoperable system that combines clinico-molecular and drug data with proprietary analytical processes.Dataome – stand alone or in combination with customer data – enables the unlocking of actionable intelligence at the molecular level to a) improve diagnosis and therapy decisions by physicians and patients; b) enrich and support better drug discovery, drug development, trial optimization, drug differentiation and positioning for pharma and healthcare organizations; and c) more accurately predict the likelihood of success and likelihood of approval of drug candidates in clinical development for better trial prioritization and resource and investment allocation.
For more information,visit www.molecularhealth.com.

 

Related News:
https://www.novartis.de/news/media-releases/shortlist-mit-sieben-projekten-fuer-den-digitalen-gesundheitspreis-von-novartis
https://www.novartis.de/aktuelles/digitaler-gesundheitspreis

 

Molecular Health GmbH
Thomas König
Head of Marketing
thomas.koenig@molecularhealth.com

 

Media Relations
MC Services AG
Katja Arnold, Eva Bauer, Laurie Doyle
molecularhealth@mc-services.eu
+49-89-210 2280

Molecular Health Licenses its Proprietary Predictive Analytics to DATEN CAPITAL

Newsroom

All news

Molecular Health Licenses its Proprietary Predictive Analytics to DATEN CAPITAL

• Molecular Health Predict enables highly accurate estimates of clinical trial success probabilities 
• Exclusive license for the financial industry granted to DATEN CAPITAL  
• Molecular Health to receive an annual license fee and success-based payments  

 

Heidelberg, Germany and Boston, MA — Monday, January 7, 2019 — Molecular Health, a leading company in the field of data science for precision medicine and specializing in the development of products and services leveraging its proprietary biomedicine technology platform Dataome®, is pleased to announce that it has granted an exclusive license for Molecular Health Predict (MH Predict) to DATEN CAPITAL LLP (DATEN), for its use in the financial industry. MH Predict was developed by Molecular Health to calculate the likelihood of success of drug clinical trials, and DATEN is a private limited liability partnership founded to commercialize data-science, AI-driven approaches to investing. Molecular Health will receive an annual license fee as well as success-based payments from DATEN. Friedrich von Bohlen, PhD, Cofounder & CEO of Molecular Health GmbH, said: “We are very excited to announce this exclusive license for the financial industry with DATEN CAPITAL. Understanding and effectively predicting the likelihood of success of clinical trials is critical to achieving better efficiencies and savings in drug R&D – which today still represents billions of dollars of annual losses due to trial attrition for both pharmaceutical companies and investors. We believe that MH Predict will drive a true paradigm shift in drug development, resource and investment allocations and ultimately patient outcomes. We look forward to launching this product also to the pharmaceutical industry in early 2019.” “I came to know Friedrich von Bohlen and Molecular Health during my time in investment banking at Goldman Sachs. After learning more about the company, and assessing its technology, I became increasingly convinced of the potential for Molecular Health to transform the drug development industry. Our mission when founding DATEN CAPITAL was to build a data-science, AI-driven approach to allocating capital. This is why we are particularly excited to have obtained an exclusive license to apply MH Predict to the financial markets. Our aim, and our belief, is that we will help enable the biopharmaceutical industry to deliver new drugs to the market in a much better, faster and cheaper way,” said Amit R. Karna, CFA, Managing Partner at DATEN CAPITAL LLP.  

 

About MH Predict  

MH Predict is an artificial intelligence (AI) based product that predicts the likelihood of success of a clinical trial to achieve its endpoints. Models are designed and validated based on a range of public and proprietary data sources, including Dataome®, a proprietary database custom built by Molecular Health over 10 years and with over €150m of invested capital.  

 

About Molecular Health  

Molecular Health is a data science-focused artificial intelligence computing company enabling and improving decision making in precision medicine for healthcare organizations. The company offerings are based on the capture, curation, integration, and analysis of large biomedical and drug data sets and combining them with novel artificial intelligence and machine learning (AI/ML) technologies. For more than a decade, the company has been developing Dataome®, a unique high-quality curated, interoperable system that combines clinico-molecular and drug data with proprietary analytical processes. Dataome® – stand alone or in combination with customer data – enables the unlocking of actionable intelligence at the molecular level to a) improve diagnosis and therapy decisions by physicians and patients; b) enrich and support better drug discovery, drug development, trial optimization, drug differentiation and positioning for pharma and healthcare organizations; and c) more accurately predict the likelihood of success and likelihood of approval of drug candidates in clinical development for better trial prioritization and resource and investment allocation. For more information, visit www.molecularhealth.com. 

 

About DATEN CAPITAL

DATEN CAPITAL LLP (DATEN) is a private limited liability partnership incorporated in England and Wales (registered no: OC424550). The firm was founded in 2018 with a mission to apply data-science, AI-driven solutions to the financial markets. DATEN plans to initially focus on the biotech sector, primarily in the US and Europe. The Managing Partner for DATEN is Amit R. Karna, CFA, a former investment banker who spent ten years in the healthcare team at Goldman, Sachs & Co., based initially in New York before transferring to London. DATEN CAPITAL LLP is backed by leading investors and individuals in the healthcare and technology sectors. For more information, visit www.datencapital.com

 

Molecular Health Predict (MH Predict)
Blanca Baez
Global Head of Pharma & Biotech
 
Molecular Health GmbH
Thomas König
Head of Marketing
 
Media Relations
MC Services AG
Katja Arnold, Eva Bauer, Laurie Doyle
+49 – 89 – 210 2280
 

Molecular Health to attend key conferences in 3rd quarter 2018

Newsroom

All news

Molecular Health to attend key conferences in 3rd quarter 2018

Heidelberg, Germany and Boston, USA – July 3, 2018 – Molecular Health (MH), a leading biomedical company that is transforming molecular data into clinically actionable information for efficient and safer
cancer treatment options based on its proprietary Dataome® technology platform, announced that the company is going to attend several industry and scientific conferences in the third quarter 2018.

July 

The 16th Annual Meeting of Japanese Society of Medical Oncology JSMO, July 19 – 21, 2018 – Kobe International Conference Center, Japan. Attendance: 3 posters and 1 oral presentation 
– MH BRCA – Confident BRCA1/2 variant classification: using ACMG and public data for systematic molecular profiling
– Intelligent treatment decision support combining variant interpretation and phenotype analytics can transform healthcare
– Comprehensive treatment decision support of more than 1,000 patients by the medical device Molecular Health Guide®
– Evidence-based software for NGS in pancreatic cancer: first results from the PePaCaKa study   

August 

The 9th Annual Cancer Genomics Consortium CGC Meeting, August 6 – 8, 2018 – Nashville, TN, USA. Attendance: Molecular Health booth.   

September 

Molekularpathologie-Symposium, September 5-9, Gera, Germany. Attendance: lecture from Dr. Stephan Brock CTO of Molecular Health.  
Heidelberger Myelomtage, September 21 – 23, 2018 – Im Neuenheimer Feld 410, 69120 Heidelberg, Germany. Attendance: Molecular Health booth.  
ISPOR Asia Pacific 2018, September 8 – 11, 2018 – Kei Plaza Hotel, Tokyo, Japan. Attendance: Poster presentation. 
– MH EFFECT® – A novel technology for the molecular analyses of Real-world outcomes/adverse event data. 

Molecular Health launches Molecular Health Guide 3.0, providing improved support for precision medicine

Newsroom

All news

Molecular Health launches Molecular Health Guide 3.0, providing improved support for precision medicine

New features for intuitive biomarker classification and improved usability 

Heidelberg, Germany and Boston, USA – June 1, 2018 – Molecular Health (MH), a leading company in the field of precision medicine, specialized in the development of products and services leveraging their proprietary Dataome® technology platform, has launched Version 3.0 of Molecular Health Guide® (MH Guide), a comprehensive software solution for precision medicine. MH Guide compares patient-specific molecular information with biomedical knowledge to deliver an interactive, editable, medical report that supports treating physicians in evaluating the range of therapy options identified for the unique genomic profile of the patient. MH Guide is registered as an in vitro diagnostic device in the EU.

 

Physicians need to understand and interpret numerous biomarkers to assess their significance and make a reliable statement on the suitability of a specific cancer therapy. MH Guide identifies clinically significant variants from panel or whole exome analyses and provides physician-approved variant interpretations describing their clinical significance in the context of the patient’s disease. Physicians use this expert-curated knowledge on each variant and follow clickable references to the peer-reviewed sources as a basis for their clinical reports.

 

Version 3.0 comes with an improved AMP guideline-compliant biomarker classification scheme and supports HGVS variant nomenclature.  MH Guide 3.0 users can now incorporate results from other important diagnostic tests in their reports, such as protein expression, mutational burden, and microsatellite instability. Customizable gene filters mean physicians can streamline the workflow to focus on standard panels for genes of interest. Variant details from standard sources recommended by variant classification guidelines are now shown in MH Guide, in addition to the physician-approved variant interpretations, to support the physician in assessing the clinical significance of a variant. The MH Order portal provides order management tools for seamless communication between labs, hospitals, and Molecular Health.

 

“MH Guide 3.0 marks a further milestone in cancer treatment based on the genetic variants in a tumor. It gives the treating oncologist a fast and comprehensive overview of treatment recommendations,” said Dr. Rudolf Caspary, CIO of Molecular Health. “We can help to significantly facilitate and improve the daily clinical routine of the treating physicians, while delivering well-informed therapy decisions. Ultimately, this benefits patients – and the entire healthcare system.”

 

Prof. Dr. Matthias Löhr, Professor of Gastroenterology at the Karolinska Institutet in Stockholm, commented “As longstanding users of MH Guide we are especially impressed by the quality of the results and their clear presentation in version 3.0 of MH Guide. This makes MH Guide easy to use and easy to integrate in our daily routine. We can focus on the essentials – making informed decisions on the best therapy available and the best care for each individual patient.” 

 

About Molecular Health
Molecular Health(MH)is a computational biomedicine company focused on the capture, curation, integration, and analysis of large data sets in the field of biomedicine and medical products and combining them with novel artificial intelligence and machine learning (AI/ML) technologies to enable precision medicine. Overmore than a decade, the company has developed Dataome®, a unique, high-quality curated, interoperable system that combines clinico-molecular drug data and analytical processes. Dataome, in combination with novel AI/ML technologies, creates a totally new approach for prognostic and predictive in silico science that can guide some of the most promising yet most challenging domains of precision medicine.

 

For more information,

visit www.molecularhealth.com

Carla Mertens
Molecular Health GmbH
Carla.mertens@molecularhealth.com
HGVS, Human Genome Variation Society; AMP, Association for Molecular Pathology

Molecular Health to pursue drug repurposing in tuberculosis treatment and perinatal complications

Newsroom

All news

Molecular Health to pursue drug repurposing in tuberculosis treatment and perinatal complications

Molecular Health receives grant from Bill & Melinda Gates Foundation

Heidelberg, Germany/Boston, MA, May 16, 2018. Molecular Health announces it was awarded a grant from the Bill & Melinda Gates Foundation. Through the program enabled by the grant, Molecular Health (MH)will leverage computational biomedicine technology and domain expertise captured in MH core assets, Dataome® knowledgebase and MH Effect™ software, to help find shorter, more effective and better‐tolerated treatment regimens for TB, and to explore ways to address perinatal complications in developing countries.

 

Dataome® is MH’s biomedicine knowledgebase with comprehensive, current and curated clinico-molecular data and information on targets, molecules, diseases, variants, pathways, drugs and outcomes and will be utilized to identify treatment improvement opportunities in these two areas of unmet need, deriving novel insights on drug outcomes from other areas, such as immuno-oncology. MH Effect™ will allow MH experts to tap onto millions of patient records on drug outcomes to efficiently draw and test treatment hypotheses.

 

Blanca Baez, Global Head of Pharma & Biotech at Molecular Health, expressed: “Our value proposition to drug discovery and drug development is to employ highly specialized in silico research and machine learning techniques to speedily generate, prove and disprove hypotheses for novel, repurposed or combined drug treatments to improve efficacy and safety in specific patient profiles. We do this through clinico-molecular analytics on drug target, mode of action and disease pathways. This grant allows us to continue delivering on this promise.”

 

About Molecular Health
Molecular Health, a computational biomedicine company, is focused on capturing, curating, integrating, and analyzing biomedical data and knowledge to enable precision medicine. For over a decade, the company has built and developed Dataome®, a unique highly-curated and interconnected reference system that includes clinical, molecular and drug data. Dataome® enables integration and referencing of further drug outcomes data, including electronic medical records and clinical trial data. These are used to run clinico-molecular analyses to elucidate and predict outcomes in specific patient profiles and
inform the discovery and development of more effective and safer therapies. MH Effect™ is one of the software applications MH has packaged to enable advanced clinico-molecular analytics on drug outcomes. Most recently, Dataome® enabled the development of a new AI algorithm that predicts likelihood of success and approval of clinical trials and drug development programs, MH Predictive Engine.

 

https://www.molecularhealth.com

Contact Molecular Health

Blanca Baez
Global Head of Business Development – Pharma & Biotech
blanca.baez@molecularhealth.com

Molecular Health starts market entry and product distribution in Arab countries

Newsroom

All news

Molecular Health starts market entry and product distribution in Arab countries

As it gains a foothold in international markets, Molecular Health will be demonstrating its latest product developments at the Arab Health Exhibition and Congress in Dubai, U.A.E. (29 January – 01 February 2018). 

 

Heidelberg, Germany – January 05, 2018. Molecular Health, pioneer in data- and analytics-driven precision medicine expands its efforts to establish collaborations in the Arabic precision-medicine scene.  

 

In cooperation with strategic partners, which include some of the world’s most renown laboratories, universities, and organizations, Molecular Health starts to bring its technology (Dataome®) and products also to Arabian countries. 

 

“Strategic partnerships and collaborations are essential for us to grow, as our regional partners enable us to efficiently bring our products to market,” says Friedrich von Bohlen, Chief Executive Officer, speaking of Molecular Health Guide® (MH Guide).  

 

MH Guide is a treatment decision-support product for physicians, hospitals and diagnostic laboratories. It is registered as in-vitro diagnostic medical device (IVD) in Europe and is CE-compliant with European regulations. MH Guide includes all steps of the clinical genomics workflow in oncology, from raw sequencing data to generating an interactive, editable medical report. It is the first product of its kind in Germany to be reimbursed by public health insurances. 

 

In future, precise and individual approaches in oncological therapy will play an even more important role in diagnosing and treating patients. As tumors become increasingly better genetically characterized and understood, patients very likely will benefit from such highly targeted approaches prior to treatment. 

 

To learn more about Molecular Health or experience an MH Guide demo, visit us at our booth in Dubai, UAE, at the International Convention and Exhibition Centre, German pavilion, stand number Z3.H12. 

MEDIA CONTACT 

Thomas Koenig 
thomas.koenig@molecularhealth.com 
(+49) 6221 43851-2280 

 

Visit: www.molecularhealth.com/us/patients-us  

 

ABOUT MOLECULAR HEALTH 

Molecular Health is a computational biomedicine company focused on big-data curation, integration and analytics to enable precision medicine. The company has developed Dataome®: the most effective, quality-curated, interoperable technology system comprising a large set of databases and analytics that allow the integration and referencing of clinico-molecular drug and disease data to generate novel and actionable insights on drug outcomes for stakeholders across the healthcare ecosystem. These include physicians, hospitals and research networks, commercial labs, regulators and Pharma companies. MH Guide®, a genome-guided oncology treatment decision software, holds an ISO 13485 certification and is the only tool of its kind registered as in vitro diagnostics device in Europe. Molecular Health scientific and commercial teams are based in Heidelberg, Germany and Boston, MA in the US. 

 

The company is financed by Dievini Hopp BioTech, an investment vehicle of former SAP CEO and founder Dietmar Hopp. 

Molecular Health and FDA Extend Software Collaboration to Drug Safety Prediction

Newsroom

All news

Molecular Health and FDA Extend Software Collaboration to Drug Safety Prediction

Cambridge, MA – November 16, 2017 –Molecular Health, Inc (MH), a company marketing computational biomedicine tools to support healthcare decisions with clinical and molecular data, and the FDA’s Center for Drug Evaluation and Research (CDER) have extended for an additional 5 years, their research collaboration to jointly address one of the biggest challenges in drug development: the prediction of drug safety. In recent years, nearly 30% of new drugs failed in Phase II and III clinical studies1 and 270 marketed drugs have been withdrawn worldwide for safety reasons2. To tackle this issue, MH has developed its Molecular Health Effect® (MH Effect) technology, a leading-edge software solution for the comprehensive clinical and molecular assessment of drug action and adverse events. 

 

Under the initial research collaboration agreement (RCA) executed in January 2012, FDA used the MH Effect to molecularly analyze adverse events data. During the first five years of collaboration, MH Effect was used to evaluate the potential mechanisms of emerging safety issues. Under the new RCA, the FDA will continue to assess the ability of MH Effect to predict adverse events and safety label changes. The results of the collaboration will be incorporated into MH’s technology to jointly advance computational capabilities for drug development. 

 

“After our successful research collaboration with the FDA for the past 5 years, we are excited about the decision to extend our collaboration,” said Dr. Friedrich von Bohlen, CEO of Molecular Health. ” This decision underlines the unique value proposition of MH Effect for predicting and characterizing drug adverse events that patients are or can be exposed to. With MH Effect and our other products and technologies creating novel insights from data we will continue to help improve the development of novel medicines, with benefits for patients and the entire healthcare industry.” 

 

1https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847363/ 

2http://cheminfo.charite.de/withdrawn/