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TSUNAMI in HealthCare under the New Name Verily.com

Posted in Big Data, BioIT: BioInformatics, BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics, Biological Networks, Biological Networks, Gene Regulation and Evolution, Biomarkers & Medical Diagnostics, Biomedical Measurement Science, BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Informatics, Cancer Prevention: Research & Programs, Cancer Screening, Frontiers in Cardiology and Cardiovascular Disorders, Gene Regulation, Genetics & Innovations in Treatment, Genetics & Pharmaceutical, Genome Biology, Genomic Testing: Methodology for Diagnosis, Global Partnering & Biotech Investment, HealthCare IT, Immuno-Oncology & Genomics, Innovation in Immunology Diagnostics, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, International Global Work in Pharmaceutical, Investment in Technological Breakthrough, IP Development by LPBI Group Team, IP Development by LPBI Group Team & Other Organizations, Joint Venture - SBH & M3DP: SOP and Arrangements, LPBI Group, e-Scientific Media, DFP, R&D-M3DP, R&D-Drug Discovery, US Patents: SOPs and Team Management on December 14, 2015| Leave a Comment »

TSUNAMI in HealthCare under the New Name Verily.com

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 6/8/2016

The Tricorder project was announced only 3 months after Google entered the life sciences field, according to the report, and came from the same incubator which rolled out the company’s self-driving car and recently cancelled Google Glass.

Verily CEO Andrew Conrad said the scientific basis for the device was proven upon unveiling in 2014, but experts have presented conflicting views on the reality of such a device, STAT Newsreports.

“What (Verily is) really good at is physical measurements — things like temperature, pulse rate, activity level. They are not particularly good at … the chemical and the biological stuff,” Walt toldSTAT news.

Four former Verily employees said the Tricorder “has been seen internally more as a way to generate buzz than as a viable project,” according to the report.

SOURCE

http://www.massdevice.com/googles-star-trek-tricorder-bid-flops/?spMailingID=9031578&spUserID=MTI2MTQxNTczMjM5S0&spJobID=940786327&spReportId=OTQwNzg2MzI3S0

 

UPDATED on 4/16/2016

SOURCE

http://recode.net/2016/04/13/verily-alphabet-profitable/

Verily, Alphabet’s medical business, is profitable, Sergey Brin tells Googlers

Verily | YouTube

SCIENCE

• 
• By Mark Bergen
• @mhbergen
• EMAIL

April 13, 2016, 2:20 PM PDT

Publicly, Alphabet has said very little about its assortment of companies not named Google.

But internally, Alphabet is a little more forthcoming.

As we reported earlier, Nest CEO Tony Fadell appeared before Google’s all-hands meeting two weeks ago to address recent criticism of his company. During that meeting, Google co-founder and Alphabet exec Sergey Brin also defended another company under the holding conglomerate: Verily, the medical tech unit previously called Google Life Sciences.

Lumped together, Alphabet’s moonshots aren’t making money yet — but Verily is, Brin said.

Verily was the target of a scathing article — in Stat, a medical publication from the Boston Globe — scrutinizing its CEO, Andy Conrad. Several former employees told Stat that Verily suffered a talent exodus due to “derisive and impulsive” leadership by Conrad.

Here’s what Brin said in response at Google’s TGIF meeting:

I have seen a smattering of articles. And, you know, it’s actually sad to see sometimes where it appeared that … former employees or soon-to-be former employees talked to the press. But, anyhow, I can tell you what’s going on with these companies, fortunately. So in Verily’s case, despite a handful of examples, their attrition rate is below Google’s and Alphabet’s as a whole. And also, there are articles that have generally said we are blowing a lot of money and so forth. It’s true that, you know, as whole our Other Bets are not yet profitable, but some of them are, including Verily on a cash basis and increasingly so. So we’re pretty excited about these efforts.

Verily makes money through

• partnerships with pharmaceutical companies — such as Novartis, which is licensing and planning to sell Verily’s smart contact lens — and
• medical institutions.

It is one of three units contributing to the Other Bets total revenue ($448 million) in 2015, along with

• Google Fiber and
• Nest.

As we reported earlier, Nest likely brought in around $340 million of that and Fiber pulled close to $100 million, meaning that Verily’s sales were somewhere around $10 million. During the year, all the moonshot units combined reported operating losses of $3.6 billion.

RELATED

SCIENCE

Verily, Google’s Health Gambit, Is Stacked With Scientists. Now It Needs to Build a Business.

By Mark Bergen, Dec 14, 2015, 3:00 AM PST

Note Brin’s stipulation that Verily’s profit comes on a “cash basis.” That probably means that it’s not making profit on the normal basis, meaning when you take into account total sales minus total costs. But “cash positive” suggests they’re booking sales faster than they’re spending money, which is a positive sign. Companies normally report financials accounting for all costs. And that’s how Alphabet will next week, when it shares first-quarter results for Google and the Other Bets — although we almost certainly won’t see figures on Verily’s profitability.

We reached out to Alphabet and Verily reps for more clarity, but didn’t get any.

SOURCE

http://recode.net/2016/04/13/verily-alphabet-profitable/

 

Original Curation dated 12/14/2015

1. Part 1: Verily in Action
2. Part II: Innovations at a Different Scale: GDE Enterprises – A Case in Point of Healthcare in Focus – Work-in-Progress

12/31/2015 – All time

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Part 1: Verily in Action

They write @ https://verily.com/

When Google[x] embarked on a project in 2012 to put computing inside a contact lens — an immensely challenging technical problem with an important application to health — we could not have imagined where it would lead us. As a life sciences team within Google[x], we were able to combine the best of our technology heritage with expertise from across many fields. Now, as an independent company, Verily is focused on using technology to better understand health, as well as prevent, detect, and manage disease.

Andy Conrad, Ph.D.

Chief Executive OfficerFormerly the chief scientific officer of LabCorp, Andy is a cell biologist with a doctorate from UCLA. He has always been passionate about early detection and prevention of disease: Andy co-founded the National Genetics Institute, which developed the first cost-effective test to screen for HIV in blood supply.

Brian Otis, Ph.D.

Chief Technical OfficerBrian’s team focuses on end-to-end innovation ranging from integrated circuits to biocompatible materials to sensors. He joined Google[x] as founder of the smart contact lens project and now leads our efforts across all hardware and device projects, including wearables, implanted devices, and technology like Liftware.

Jessica Mega, M.D., MPH

Chief Medical OfficerJessica leads the clinical strategy and research team at Verily. She is a board-certified cardiologist who trained and practiced at Massachusetts General Hospital and Brigham and Women’s Hospital. As a faculty member at Harvard Medical School and a senior investigator with the TIMI Study Group, Jessica directed large, international trials evaluating novel cardiovascular therapies.

Linus Upson

Head of EngineeringA long-time Google software engineer, Linus has been a team lead in developing products that now help billions of people worldwide find the information they need on the Internet, including Chrome and Chrome OS. He now oversees our engineering teams.

Tom Stanis

Head of SoftwareTom spent nine years working on core Google products before joining Google[x] in 2014 to work on the Baseline Study. He now leads all our Software projects, including the development of machine learning algorithms for applications ranging from robotic-assisted surgery to diabetes management.

Vikram (Vik) Bajaj, Ph.D.

Chief Scientific OfficerVik’s broad research interests in industry and as a former academic principal investigator have included structural and systems biology, molecular imaging, nanoscience, and bioinformatics. Vik now leads the Science team in research directions related to our mission.

What are the Dimensions of the Tsumani in Healthcare?

• prevention,
• detection,
• management of disease

 

Hardware

• contact lens with an embedded glucose sensor for measuring the glucose in human tears.

Software

• multiple sclerosis, for example, combines wearable sensors with traditional clinical tests
• signals that could lead to new knowledge about the disease and why it progresses differently among individuals.

Clinical

• Constituencies industry, hospitals, government, academic centers, medical societies, and patient advocacy groups
• The Baseline Study is one of these dedicated efforts, a multi-year initiative that aims to identify the traits of a healthy human by closely observing the transition to disease.

Science

• Understand processes that lead to conditions like cancer, heart disease, and diabetes
• computational systems biology platforms and life sciences tools
• bio-molecular nanotechnology for precision diagnostics and therapeutic delivery
• advanced imaging methods for applications ranging from early diagnosis to surgical robotics.

 

FOLLOW the LEADER of Parish in the Tsunami

 

Google[x] searches for ways to boost cancer immunotherapy | Science/AAAS | News

http://news.sciencemag.org/math/2015/01/googlex-searches-ways-boost-cancer-immunotherapy

 

Google Life Sciences and American Heart Association commit $50M to study heart disease | VentureBeat

http://venturebeat.com/2015/11/08/google-life-sciences-and-american-heart-association-commit-50m-to-study-heart-disease/

 

Google Life Sciences Division Is Now Called… Verily?

http://gizmodo.com/google-life-sciences-division-is-now-called-verily-1746729894

 

WIRED: Google’s Verily Is Spinning Off ‘Verb,’ a Secretive Robot-Surgery Startup

Alphabet’s Verily, née Google Life Sciences, has announced its first spinoff, a brand new robot-assisted surgery company.

http://www.wired.com/2015/12/googles-verily-is-spinning-off-verb-a-secretive-robot-surgery-startup/

 

Google Life Sciences Rebrands as Verily under Alphabet – Fortune

Vik Bajaj, CSO

http://fortune.com/2015/12/08/google-alphabet-verily/

Verily, I Swear, Google Life Sciences debuts a New Name

By CHARLES PILLER  DECEMBER 7, 2015

http://www.statnews.com/2015/12/07/verily-google-life-sciences-name/

 

Alphabet’s Life Sciences Business Has a New Name: Verily

CONOR DOUGHERTY DECEMBER 7, 2015 8:22 PM

http://bits.blogs.nytimes.com/2015/12/07/alphabets-life-sciences-business-has-a-new-name-verily/?_r=0 

Why biomedical superstars are signing on with Google Tech firm’s ambitious goals and abundant resources attract life scientists.

Erika Check Hayden 21 October 2015

http://www.nature.com/news/why-biomedical-superstars-are-signing-on-with-google-1.18600

 

GOOGLE LIFE SCIENCES MAKES DIABETES ITS FIRST BIG TARGET

• AUTHOR: KLINT FINLEY.KLINT FINLEY BUSINESS

• DATE OF PUBLICATION: 08.31.15.08.31.15

• TIME OF PUBLICATION: 6:01 PM.6:01 PM

http://www.wired.com/2015/08/google-life-sciences-makes-diabetes-first-big-target/

 

GOOGLE WON THE INTERNET. NOW IT WANTS TO CURE DISEASES

• AUTHOR: DAVEY ALBA.DAVEY ALBA BUSINESS

• DATE OF PUBLICATION: 08.19.15.08.19.15

• TIME OF PUBLICATION: 7:00 AM.7:00 AM

http://www.wired.com/2015/08/google-won-internet-now-wants-cure-diseases/

 

Google Reveals Health-Tracking Wristband

Caroline Chen and Brian Womack

June 23, 2015 — 9:30 AM EDT

http://www.bloomberg.com/news/articles/2015-06-23/google-developing-health-tracking-wristband-for-health-research

 

Google Moves to the Operating Room in Robotics Deal With J&J

ALISTAIR BARR and JOSEPH WALKER

http://blogs.wsj.com/digits/2015/03/27/google-moves-to-the-operating-room-in-robotics-deal-with-jj/

 

Google, Biogen Seek Reasons for Advance of Multiple Sclerosis

Caroline Chen

January 27, 2015 — 9:00 AM EST

http://www.bloomberg.com/news/articles/2015-01-27/google-biogen-seek-reasons-for-advance-of-multiple-sclerosis

 

Google’s Newest Search: Cancer Cells

Google X Team Hopes to Develop Nanoparticles to Provide Early Detection of Cancer, Other Diseases

ALISTAIR BARR and RON WINSLOW

Updated Oct. 29, 2014 11:17 a.m. ET

http://www.wsj.com/articles/google-designing-nanoparticles-to-patrol-human-body-for-disease-1414515602

 

A Spoon That Shakes To Counteract Hand Tremors

Updated May 14, 201411:43 AM ET

INA JAFFE

http://www.npr.org/sections/health-shots/2014/05/13/310399325/a-spoon-that-shakes-to-counteract-hand-tremors

 

Google’s New Moonshot Project: the Human Body

Baseline Study to Try to Create Picture From the Project’s Findings

ALISTAIR BARR

Updated July 27, 2014 7:24 p.m. ET

http://www.wsj.com/articles/google-to-collect-data-to-define-healthy-human-1406246214

 

Novartis Joins With Google to Develop Contact Lens That Monitors Blood Sugar

MARK SCOTT JULY 15, 2014

http://www.nytimes.com/2014/07/16/business/international/novartis-joins-with-google-to-develop-contact-lens-to-monitor-blood-sugar.html

 

Google[x] searches for ways to boost cancer immunotherapy

Jon Cohen

15 January 2015 6:25 am

http://news.sciencemag.org/math/2015/01/googlex-searches-ways-boost-cancer-immunotherapy

 

SOURCE

https://verily.com/

Part II: Innovations at a Different Scale: GDE Enterprises

A Case in Point of Healthcare in Focus –

Work-in-Progress

 

 

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Biomarker Development

Posted in Artificial Intelligence - Breakthroughs in Theories and Technologies, Big Data, Biochemical pathways, BioIT: BioInformatics, BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics, Biomarkers & Medical Diagnostics, Cancer Informatics, Clinical & Translational, Clinical Diagnostics, Clinical Genomics, Computational Biology/Systems and Bioinformatics, Curation, Diagnostics and Lab Tests, Digital HealthCare – biotech & internet joint ventures, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Electronic Health Record, Enzymes and isoenzymes, Epigenetics and Cardiovascular Risks, Genetics & Innovations in Treatment, Genetics & Pharmaceutical, Genome Biology, Genomic Testing: Methodology for Diagnosis, Image Processing/Computing, Innovations, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Intelligent Information Systems, International Global Work in Pharmaceutical, Medical and Population Genetics, Metabolism, Microbiologial genetics, Microbiology, Micronutrients, Molecular Genetics & Pharmaceutical, Nutrigenomics, Nutrition and Phytochemistry, Personal Health Applications: Tech Innovations serves HealhCare, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical Discovery, tagged biomarkers, Institute of Medicine, NBDA, Personalized medicine on November 16, 2015| Leave a Comment »

Biomarker Development

Curator: Larry H. Bernstein, MD, FCAP

 

 

NBDA’s Biomarker R&D Modules

http://nbdabiomarkers.org/

“collaboratively creating the NBDA Standards* required for end-to-end, evidence – based biomarker development to advance precision (personalized) medicine”

http://nbdabiomarkers.org/sites/all/themes/nbda/images/nbda_logo.jpg

http://nbdabiomarkers.org/about/what-we-do/pipeline-overview/assay-development

 

Successful biomarkers should move systematically and seamlessly through specific R&D “modules” – from early discovery to clinical validation. NBDA’s end-to-end systems approach is based on working with experts from all affected multi-sector stakeholder communities to build an in-depth understanding of the existing barriers in each of these “modules” to support decision making at each juncture.  Following extensive “due diligence” the NBDA works with all stakeholders to assemble and/or create the enabling standards (guidelines, best practices, SOPs) needed to support clinically relevant and robust biomarker development.

Mission: Collaboratively creating the NBDA Standards* required for end-to-end, evidence – based biomarker development to advance precision (personalized) medicine.
NBDA Standards include but are not limited to: “official existing standards”, guidelines, principles, standard operating procedures (SOP), and best practices.

https://vimeo.com/83266065

 

“The NBDA’s vision is not to just relegate the current biomarker development processes to history, but also to serve as a working example of what convergence of purpose, scientific knowledge and collaboration can accomplish.”

NBDA Workshop VII – “COLLABORATIVELY BUILDING A FOUNDATION FOR FDA BIOMARKER QUALIFICATION”
NBDA Workshop VII   December 14-15, 2015   Washington Court Hotel, Washington, DC

The upcoming meeting was preceded by an NBDA workshop held on December 1-2, 2014, “The Promising but Elusive Surrogate Endpoint:  What Will It Take?” where we explored in-depth with FDA leadership and experts in the field the current status and future vison for achieving success in surrogate endpoint development.  Through panels and workgroups, the attendees extended their efforts to pursue the FDA’s biomarker qualification pathway through the creation of sequential contexts of use models to support qualification of drug development tools – and ultimately surrogate endpoints.

Although the biomarker (drug development tools) qualification pathway (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentTools…) represents an opportunity to increase the value of predictive biomarkers, animal models, and clinical outcomes across the drug (and biologics) development continuum, there are myriad challenges.  In that regard, the lack of evidentiary standards to support contexts of use-specific biomarkers emerged from the prior NBDA workshop as the major barrier to achieving the promise of biomarker qualification.  It also became clear that overall, the communities do not understand the biomarker qualification process; nor do they fully appreciate that it is up to the stakeholders in the field (academia, non-profit foundations, pharmaceutical and biotechnology companies, and patient advocate organizations) to develop these evidentiary standards.

This NBDA workshop will feature a unique approach to address these problems.  Over the past two years, the NBDA has worked with experts in selected disease areas to develop specific case studies that feature a systematic approach to identifying the evidentiary standards needed for sequential contexts of use for specific biomarkers to drive biomarker qualification.   These constructs, and accompanying whitepapers are now the focus of collaborative discussions with FDA experts.

The upcoming meeting will feature in-depth panel discussions of 3-4 of these cases, including the case leader, additional technical contributors, and a number of FDA experts.  Each of the panels will analyze their respective case for strengths and weaknesses – including suggestions for making the biomarker qualification path for the specific biomarker more transparent and efficient. In addition, the discussions will highlight the problem of poor reproducibility of biomarker discovery results, and its impact on the qualification process.

 

Health Care in the Digital Age

Mobile, big data, the Internet of Things and social media are leading a revolution that is transforming opportunities in health care and research. Extraordinary advancements in mobile technology and connectivity have provided the foundation needed to dramatically change the way health care is practiced today and research is done tomorrow. While we are still in the early innings of using mobile technology in the delivery of health care, evidence supporting its potential to impact the delivery of better health care, lower costs and improve patient outcomes is apparent. Mobile technology for health care, or mHealth, can empower doctors to more effectively engage their patients and provide secure information on demand, anytime and anywhere. Patients demand safety, speed and security from their providers. What are the technologies that are allowing this transformation to take place?

 

https://youtu.be/WeXEa2cL3oA    Monday, April 27, 2015  Milken Institute

Moderator

---

Michael Milken, Chairman, Milken Institute

 

Speakers

---

Anna Barker, Fellow, FasterCures, a Center of the Milken Institute; Professor and Director, Transformative Healthcare Networks, and Co-Director, Complex Adaptive Systems Network, Arizona State University

Atul Butte, Director, Institute of Computational Health Sciences, University of California, San Francisco

John Chen, Executive Chairman and CEO, BlackBerry

Victor Dzau, President, Institute of Medicine, National Academy of Sciences; Chancellor Emeritus, Duke University

Patrick Soon-Shiong, Chairman and CEO, NantWorks, LLC

 

Mobile, big data, the Internet of Things and social media are leading a revolution that is transforming opportunities in health care and research. Extraordinary advancements in mobile technology and connectivity have provided the foundation needed to dramatically change the way health care is practiced today and research is done tomorrow. While we are still in the early innings of using mobile technology in the delivery of health care, evidence supporting its potential to impact the delivery of better health care, lower costs and improve patient outcomes is apparent. Mobile technology for health care, or mHealth, can empower doctors to more effectively engage their patients and provide secure information on demand, anytime and anywhere. Patients demand safety, speed and security from their providers. What are the technologies that are allowing this transformation to take place?

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blocking copper transport in cancer cells

Posted in Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Chemical Biology and its relations to Metabolic Disease, Clinical & Translational, Curation, Disease Biology, Small Molecules in Development of Therapeutic Drugs, FDA, Gastroenterology, Gene Regulation, Innovations, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, International Global Work in Pharmaceutical, Investment in Technological Breakthrough, Liver & Digestive Diseases Research, Metabolism, Metabolomics, Patents, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, tagged anticancer agent, binding to chaperone, copper transport, liver on November 11, 2015| Leave a Comment »

blocking copper transport in cancer cells

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

DC_AC50, selective way of blocking copper transport in cancer cells

http://newdrugapprovals.org/2015/11/11/dc_ac50-selective-way-of-blocking-copper-transport-in-cancer-cells/

Dr. Melvin Crasto, World Drug Tracker

Jing Chen of Emory University School of Medicine, Hualiang Jiang of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, Chuan He of the University of Chicago, and coworkers have now developed a selective way of blocking copper transport in cancer cells (Nat. Chem. 2015, DOI: 10.1038/nchem.2381). By screening a database of 200,000 druglike small molecules, the researchers discovered a promising compound, DC_AC50, for cancer treatment. They zeroed in on the compound by testing how well database hits inhibited a protein-protein interaction leading to copper transport and reduced proliferation of cancer cells.

 

DC_AC50

3-amino-N-(2-bromo-4,6-difluorophenyl)-6,7-dihydro-5H- cyclopenta [b] thieno [3,2-e] pyridine-2-carboxamide

licensed DC_AC50 to Suring Therapeutics, in Suzhou, China

INNOVATORS  Jing Chen of Emory University School of Medicine, Hualiang Jiang of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, Chuan He of the University of Chicago, and coworkers

 

http://www.nature.com/nchem/journal/vaop/ncurrent/images/nchem.2381-f1.jpg

 

COPPER TRANSPORT

Chaperone proteins (green) transfer copper ions to copper-dependent proteins (lilac) via ligand exchange between two cysteines (-SH groups) on each protein. DC_AC50 binds the chaperone and inhibits this interaction.

Credit: Nat. Chem.

Inhibition of human copper trafficking by a small molecule significantly attenuates cancer cell proliferation

Jing Wang, Cheng Luo, Changliang Shan, Qiancheng You, Junyan Lu, Shannon Elf, Yu Zhou, Yi Wen, Jan L. Vinkenborg, Jun Fan, et al.

Nature Chemistry, (2015)   http://dx.doi.org:/10.1038/nchem.2381

Jing Chen of Emory University School of Medicine, Hualiang Jiang of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences,Chuan He of the University of Chicago, and coworkers have now developed a selective way of blocking copper transport in cancer cells (Nat. Chem. 2015, DOI: 10.1038/nchem.2381). By screening a database of 200,000 druglike small molecules, the researchers discovered a promising compound, DC_AC50, for cancer treatment. They zeroed in on the compound by testing how well database hits inhibited a protein-protein interaction leading to copper transport and reduced proliferation of cancer cells.

http://cen.acs.org/content/cen/articles/93/web/2015/11/Agent-Fight-Cancer-Inhibiting-Copper/_jcr_content/articlebody/subpar/articlemedia_0.img.jpg/1447092911801.jpg

 

Scientists had already found a molecule, tetrathiomolybdate, that interferes with copper trafficking and have tested it in clinical trials against cancer. But tetrathiomolybdate is a copper chelator: It inhibits copper transport in cells by nonselectively sequestering copper ions. Sometimes, the chelator snags too much copper, inhibiting essential copper-based processes in normal cells and causing side effects.

In contrast, DC_AC50 works by inhibiting interactions between proteins in the copper-trafficking pathway: It prevents chaperone proteins, called Atox1 and CCS, from passing copper ions to enzymes that use them to run vital cellular processes. Cancer cells are heavy users of Atox1 and CCS, so DC_AC50 affects cancer cells selectively.

The team has licensed DC_AC50 to Suring Therapeutics, in Suzhou, China, for developing anticancer therapies. The group also plans to further tweak DC_AC50 to develop more-potent versions.

Thomas O’Halloran of Northwestern University, who has studied tetrathiomolybdate, comments that “the challenge in drug design is hitting one of these copper-dependent processes without messing with housekeeping functions that normal cells depend upon. DC_AC50 appears to block the function of copper metallochaperone proteins without interacting directly with their cargo, copper ions. As the first member of a new class of inhibitors, it provides a new way to interrogate the physiology of copper trafficking disorders and possibly intervene.”

PATENT

http://www.google.com/patents/WO2014116859A1?cl=en

 

COMPD IS LC-1 COMPD 50

 

NMR and mass spectral data: LC-1 (Compound 50)- 3-amino-N-(2-bromo-4,6-difluorophenyl)-6,7-dihydro-5H- cyclopenta [b] thieno [3,2-e] pyridine-2-carboxamide

1H NMR (CDCI3, 400 MHz) δ 9.15 (s, 1H), 7.61 (s, 1H), 7.13(m, 1H), 6.60 (m, 1H), 6.27 (s, 2H), 3.20 (t, 2H), 2.98 (t, 2H), 2.39 (m, 2H); ESI-MS (EI) m/z 422 (M⁺)

 

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Phase I/II Hepato-specific Glucokinase Activator

Posted in Cell Biology, Chemical Biology and its relations to Metabolic Disease, Clinical & Translational, Curation, Diabetes Mellitus, Diagnostics and Lab Tests, Disease Biology, Endocrine Diseases, Enzymes and isoenzymes, Epigenetics and Cardiovascular Risks, FDA, Gastroenterology, Gene Regulation, Genomic Testing: Methodology for Diagnosis, Innovations, Intellectual Property, International Global Work in Pharmaceutical, Kinase, Metabolism, Metabolomics, Nutrition, Origins of Cardiovascular Disease, Patents, Personal Health Applications: Tech Innovations serves HealhCare, Pharmaceutical Analytics, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, tagged glucokinase activator, glucokinase inhibitor, liver specificity, pharmaceutical innovation, T2DM on November 10, 2015| Leave a Comment »

Phase I/II Hepato-specific Glucokinase Activator

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Advinus Therapeutics announced that it has successfully completed a 14-day POC study in 60 Type II diabetic patients on its lead molecule, GKM-001, a glucokinase activator. The results of the trial show effective glucose lowering across all doses tested without any incidence of hypoglycemia or any other clinically relevant adverse events.

GKM-001 is differentiated from most other GK molecules that are in development, or have been discontinued, due to its novel liver selective mechanism of action.

GKM-001 belongs to a novel class of molecules for treatment of type II diabetes. It is an activator of Glucokinase (GK), a glucose-sensing enzyme found mainly in the liver and pancreas. Being liver selective, GKM-001 mostly activates GK in the liver and not in pancreas, which is its key differentiation from most competitor molecules that activate GK in pancreas as well.

GKM 001 in pipeline for Diabetes by Advinus by DR ANTHONY MELVIN CRASTO Ph.D

https://newdrugapprovals.files.wordpress.com/2015/11/ad-1.jpg

GKM 001

Advinus Therapeutics Private L,

A glucokinase activator for treatment of type II diabetes, currently in PI. Advinus is actively exploring partnership options to expedite further development and WW marketing of GKM-001.

Company	Advinus Therapeutics Ltd.
Description	Activator of glucokinase (GCK; GK)
Molecular Target	Glucokinase (GCK) (GK)
Mechanism of Action	Glucokinase activator
Therapeutic Modality	Small molecule

Latest Stage of Development	Phase I/II
Standard Indication	Diabetes
Indication Details	Treat Type II diabetes

PATENT

https://www.google.co.in/patents/WO2009047798A2?cl=en

Example Cl : (-)-{5-ChIoro-2-[2-(4-cyclopropanesulfonylphenyI)-2-(2,4- difluorophenoxy)acetylamino]thiazol-4-yl}-acetic acid, ethyl ester
¹H NMR(400 MHz, CDCl₃): δ 1.06-1.08 (m, 2H), 1.30 (t, J=7.2 Hz, 3H), 1.33-1.38 (m, 2H), 2.42-2.50 (m, IH), 3.73 (d, J=2 Hz, 2H), 4.22 (q, J=7.2 Hz ,2H), 5.75 (s, IH), 6.76- 6.77 (m, IH), 6.83-6.86 (m, IH), 6.90-6.98 (m, IH), 7.73 (d, J=8.4 Hz, 2H), 7.96 (d, J=8.4 Hz, 2H), 9.96 (bs, IH). MS (EI) m/z: 571.1 and 573.1 (M+ 1; for ³⁵Cl and ³⁷Cl respectively).

Examples C2 and C3 were prepared in analogues manner of example (Cl) from the appropriate chiral intermediate:

Example Dl : (+)-{5-Chloro-2-[2-(4-cyclopropanesulfonylphenyl)-2-(2,4- difluorophenoxy)acetylamino]thiazol-4-yl}acetic acid, ethyl ester

Advinus’ GK-activator Achieves Early POC for Diabetes

November 29 2011

Partnership Dialog Actively Underway

Advinus Therapeutics, a research-based pharmaceutical company founded by globally experienced industry executives and promoted by the TATA Group, announced that it has successfully completed a 14-day POC study in 60 Type II diabetic patients on its lead molecule, GKM-001, a glucokinase activator. The results of the trial show effective glucose lowering across all doses tested without any incidence of hypoglycemia or any other clinically relevant adverse events.

The clinical trials on GKM-001 validate the company’s pre-clinical hypothesis that a liver selective Glucokinase activator would not cause hypoglycemia (very low blood sugar), while showing robust efficacy.

“GKM-001 is differentiated from most other GK molecules that are in development, or have been discontinued, due to its novel liver selective mechanism of action. GKM-001 has a prolonged pharmacological effect and a half-life that should support a once a day dosing as both mono and combination therapy.” said Dr. Rashmi Barbhaiya, MD & CEO, Advinus Therapeutics. He added that Advinus is actively exploring partnership options to expedite further development and global marketing of GKM-001.

GKM-001 belongs to a novel class of molecules for treatment of type II diabetes. It is an activator of Glucokinase (GK), a glucose-sensing enzyme found mainly in the liver and pancreas. Being liver selective, GKM-001 mostly activates GK in the liver and not in pancreas, which is its key differentiation from most competitor molecules that activate GK in pancreas as well. The resulting increase in insulin secretion creates a potential for hypoglycemia-a risk GKM-001 is designed to avoid. Advinus has the composition of matter patent on GKM-001 for all major markets globally. Both the Single Ascending Dose data, in healthy and type II diabetics, and the Multiple Ascending Dose Study in Type II diabetics has shown that the molecule shows effective glucose lowering in a dose dependent manner and has excellent safety and tolerability profile over a 40-fold dose range. The pharmacokinetic properties of the molecule support once a day dosing. GKM-001 has the potential to be “First-in-Class” drug to address this large, growing and yet poorly addressed market.

Advinus also has identified a clinical candidate as a back-up to GKM-001, which is structurally different. In its portfolio, the company has a growing pipeline for COPD, sickle cell disease, inflammatory bowel disease, type 2 diabetes, acute and chronic pain and rheumatoid arthritis in various stages of late discovery and pre-clinical development.

Advinus Therapeutics team discovers novel molecule for treatment of diabetes

• The first glucokinase modulator discovered and developed in India 
• A new concept for the management of diabetes for patients, globally 
• 100 per cent ‘made in India’ molecule for the treatment of diabetes 
• IND approved by DGCI, Phase I clinical trial shows excellent safety and tolerance profiles with efficacy

Bangalore: Advinus Therapeutics (Advinus), the research-based pharmaceutical company founded by leading global pharmaceutical executives and promoted by the Tata group, today, announced the discovery of a novel molecule for the treatment of type II diabetes — GKM-001.The molecule is an activator of glucokinase; an enzyme that regulates glucose balance and insulin secretion in the body.

GKM-001 is a completely indigenously developed molecule and the initial clinical trials have shown excellent results for both safety and efficacy.

“Considering past failures of other companies on this target, our discovery programme primarily focused on identifying a molecule that would be efficacious without causing hypoglycaemia; a side effect associated with most compounds developed for this target.

“Recently completed Phase I data indicate that Advinus’ GKM–001 is a liver selective molecule that has overcome the biggest clinical challenge of hypoglycaemia. GKM-001 is differentiated from most other GK molecules in development due to this novel mechanism of action,” said Dr Rashmi Barbhaiya, MD and CEO, Advinus Therapeutics.

He further added, “We are very proud that GKM-001 is 100 per cent Indian. Advinus’s discovery team in Pune discovered the molecule and entire preclinical development was carried out at our centre in Bangalore. The Investigational New Drug (IND) application was filed with the DGCI for approval to initiate clinical trials in India within 34 months of initiation of the discovery programme. Subsequent to the approval of the IND, we have completed the Phase I Single Ascending Dose study in India within two months.”

GKM-001 is a novel molecule for the treatment of type II diabetes. It is the first glucokinase modulator discovered and developed in India and has potential to be both first or best in class. The success in discovering GKM-001 is attributed to the science-driven efforts in Advinus laboratories and ‘breaking the conventional mold’ for selection of a drug candidate. Advinus has ‘composition of matter’ patent on the molecule for all major markets globally. Glucokinase as a class of target is considered to be novel as currently there is no product in the market or in late clinical trials. The strategy for early clinical development revolved around assessing safety (particularly hypoglycaemia) and early assessment of therapeutic activity (glucose lowering and other biomarkers) in type II diabetics. The Phase I data, in both healthy and type II diabetics, shows excellent safety and tolerability over a 40-fold dose range and desirable pharmacokinetic properties consistent with ‘once a day’ dosing. The next wave of clinical studies planned continues on this strategy of early testing in type II diabetics.

Right behind the lead candidate GKM-001, Advinus has a rich pipeline of back up compounds on the same target. These include several structurally different compounds with diverse potency, unique pharmacology and tissue selectivity. Having discovered the molecule with early indication of wide safety margins, desired efficacy and pharmacokinetic profiles, the company now seeks to out-licence GKM-001 and its discovery portfolio.

Liver Selective Glucokinase Activation for Treating Type 2 Diabetes: Translation fromMouse to Man

Kasim A. Mookhtiar, , Debnath Bhuniya, Siddhartha De, Anita Chugh, Jayasagar

Gundu, Venkata Palle, Dhananjay Umrani, Nimish Vachharajani, Vikram

Ramanathan and Rashmi H. Barbhaiya

Advinus Therapeutics Ltd, Hinjewadi, Pune – 411057, and Peenya Industrial Area,

Bangalore – 560058, India

REFERENCES

http://www.asiabiotech.com/publication/apbn/14/english/preserved-docs/1410/0043_0043.pdf

http://www.thepharmatimes.in/index.php/news/general/national/268-advinus-gk-activator-achieves-early-poc-for-diabetes

 http://ctri.nic.in/clinicaltrials/pmaindet2.php?trialid=2869

patent

wo 2008104994

wo 2008 149382

wo 2009047798

WO2008104994A2*

25 Feb 2008

4 Sep 2008

Advinus Therapeutics Private L

2,2,2-tri-substituted acetamide derivatives as glucokinase activators, their process and pharmaceutical application

///////GKM 001, pipeline, Diabetes, Advinus, type II diabetes, glucokinase modulator, Rashmi Barbhaiya

DR ANTHONY MELVIN CRASTO Ph.D | November 10, 2015 at 12:55 pm | Tags: Advinus,DIABETES, GKM 001, glucokinase modulator, pipeline, Rashmi Barbhaiya, type II diabetes | Categories: Uncategorized | URL: http://wp.me/p38LX5-44G

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Transparency in Clinical Trials

Posted in BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics, Clinical & Translational, Computational Biology/Systems and Bioinformatics, Curation, Diagnostics and Lab Tests, Digital HealthCare – biotech & internet joint ventures, Disease Biology, FDA Regulatory Affairs, Global Partnering & Biotech Investment, International Global Work in Pharmaceutical, Molecular Genetics & Pharmaceutical, tagged Clinical Trials, Transparency on November 9, 2015| Leave a Comment »

Transparency in Clinical Trials

Curator: Larry H. Bernstein, MD, FCAP

 

 

Does Pharma Really Want Transparency In Clinical Trials?

Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @outsourcedpharm
http://www.clinicalleader.com/doc/does-pharma-really-want-transparency-in-clinical-trials-0001

 

My recent article on transparency in clinical trials, featuring Dr. Brad Thompson, CEO of Oncolytics, solicited a good number of comments and emails from readers. While most readers agree that more transparency would be good for patients and the industry, there seems to be a lot of disagreement over how it can be achieved, and if it can actually be achieved at all.

To recap, Thompson believes we still have a long way to go, and questioned whether true transparency would ever be achieved. His primary argument noted researchers who want to be published will not put much focus on neutral or negative trials, and even the press releases put out by sponsors include a limited amount of information.

One reader that works for a CRO made the following comment: “Dr. Thompson from Oncolytics made some very interesting comments about investigators holding back information. An investigator will enter patient data into an EDC system that is then verified by monitors. And that is just one of a number of sites. These investigators will generally know when a drug is working and when it is not. As a CRO, I often saw statistical outputs on blinded studies where you could see where the data was trending. Even data guys can tell if a drug is working by the data results and improvements in patients.”

If physicians and researchers are able to see clear results even when the data is still in the process of being collected, then what is the problem with being more transparent? One possible explanation is that once physicians know a drug will not work, they will no longer continue to place patients at risk by having them participate in the trial. This could be done for purely ethical reasons.

But there may also be reluctance to greater transparency on the part of the pharma company. “No drug company truly wants transparency because it leaves the results and outcomes more open to interpretation, mainly by Kaiser, Blue Cross and other groups,” noted another reader.  “Pharma companies could cost themselves a lot of money in sales if they do not have the time to target and position.”

Investors Are A Consideration

There is still another consideration at play. If a study is not going well, would it be to the benefit of the executives of a company to share those results? Let’s play devil’s advocate for a moment and assume you are the CEO of a biotech company. You’re making $500,000 a year with good benefits. You have several investors who have dumped millions of dollars into your company and your product. The study is targeted for four years, but within the first year you see results that indicate your drug is not going to produce the intended results.

“In that scenario, how prone would you be to ending the trial, saving the investors their remaining money, and losing your job?” notes one reader. “Are companies prone or pressured to locate new targets for therapy or identifying reasons to extend the trials, sometimes for a few years or longer?”

All of us have heard discussions about the possibility of electronic medical records (EMRs) someday replacing electronic data capture (EDC). According to one email I received, this will never happen because of the physician issue mentioned above. After all, if patient results were posted in the EMR and every doctor on the network has access to the information, everyone would know if I drug was not having the desired effect. As soon as that happens, promises of riches being delivered to investors will fall by the wayside, and executives will be out of jobs.

“Within big pharma, this is called job preservation,” noted another reader. “If funding for the trial is cut, I am out of a job. At the same time, trial results are not getting any better for patients. Years ago about one in three trials resulted in a successful outcome. Then it went to one in four. Today that success rate is around 15 percent with R&D commitment at about 12% (down from approximately 28%). It appears that the industry is run by money and managed by guys who know how to play the system.  If patients are the primary concern, the industry would target physicians who have the right patients, get enrollment done faster, and quickly identify if the product works as advertised.”

Limit Procedures And Additional Fields

Going back to Thompson’s comments, the problem is not always investigators wanting to get published. One reader noted oftentimes it is the in-house pharma and biotech doctors as well as researchers in academia who are anxious to get their names into publications. “Unfortunately, these are often the same people who include numerous unnecessary procedures in protocols. They will also ask for additional data fields to be included in EDC systems after study launch, which can delay database activity for two months. The reason is they see a hint of something and decide they want to dig deeper, even if the activity has nothing to do with the study results and the overall goal of the trial.”

The obvious fix to this would be executive leadership and study teams standing up and challenging the reason for inclusion of the additional data fields, which cost the industry both time and money. A large number of procedures should be challenged as well, especially if they are not standard of care.

“If a researcher sees a hint of something that seems to be interesting but has nothing to do with the study, they should engage one of the thought leaders to conduct an IIR program to see if the hypothesis is valid,” notes the reader. “They can do this while keeping the clinical program on track to closure without delay, and still appease their interests.”

Clearly, there are no easy solutions. Many pharma companies are certainly making a concerted effort to put the patient first, and I believe those efforts are sincere. But there is no question they must also be focused on funding and trial results – the industry has gone from one focused on a patient to one driven by investors, and that trend is unfortunate. Physicians and researchers will always have their own goals and aspirations, and placing additional burdens upon them could have the unintended consequence of driving them away from trial participation – poor sponsor/CRO pay practices and poorly written/detailed protocols have already moved many physician practices away from clinical trial participation. Coming up with a solution will likely involve bringing together all stakeholders for a more in-depth discussion on the topic, which unfortunately I don’t see happening anytime soon.

 

Transparency In Clinical Trials: Will It Ever Be Achieved?
Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @outsourcedpharm

 

A lot has been made recently about transparency in clinical trials. In the EU a new regulation is about to address the issue, and CISCRPrecently sent a petition letter to the FDA asking it to pass a similar regulation in this country. The petition, signed by hundreds of patients, hopes to make trials results more accessible to patients.

It’s also not hard to understand why a patient participating in a trial would want to know the results of the study, and whether or not they received the active drug or a placebo. But while changes might help companies with patient recruitment and retention issues, will true trial transparency ever be possible?

Dr. Brad Thompson, CEO of biotech firm Oncolytics, believes we still have a very long way to go, and that perhaps pharma companies are not the ones that should be blamed. “I think a lot of people, patients especially, believe that companies are the roadblock in keeping the results of clinical studies from becoming public,” he says. “But personally, I believe it is a much wider issue than that, especially when it comes to finding out the results of unsuccessful trials.”

For example, Thompson looks at clinical investigators. He notes many of these individuals would like for their academic careers to progress. For these folks, the reporting of trial results, especially those that are negative or neutral, does nothing to advance their goals. It is not a deliberate action to conceal information, but the lack of an incentive to do so can often result in delays, provided the results are reported at all.

“If you are conducting a trial at 50 or 60 locations, it doesn’t take too many of them not reporting information to significantly slow down the ability of a sponsor to report on what is going on with the study,” notes Thompson. “And the more time that goes by, the more people will lose interest in doing so. Add to that the fact that there are no journals or annual meetings that are focused on reporting negative results. This is due to space and time limitations. If there are 100 speaking opportunities at the ASCO show in June, those spots will be given to people reporting exciting new results in cancer therapies. There is no time for, nor interest in, anyone reporting on therapies that didn’t work.”

From the standpoint of a public sponsor company, they will typically report negative trial results, but that will generally be via a press release, where there is very little detail. It’s also unlikely that a patient participating in a trial will be on the company’s PR distribution list. As a result, there is an entire system set up with no positive incentives to go into more detail about trials that did not go as planned.  That in itself is unfortunate, since we often learn as much from things that don’t work as we do from things that do.

“In many ways, knowing what didn’t work, or what caused a safety problem, can be more important than knowing what did work and knowing there were no safety problems,” adds Thompson. “Knowing of negative results will allow you to improve your own trials and continue to work to try and find something that does work. I think this is a bigger issue than people realize and it is not something that will be easy to address.”

All Requirements Fall On Sponsors

Of course in this entire daisy-chain of events, there is only one party involved that has a legal obligation to disclose positive or negative information on the trial. That is the sponsor company, which by law is required to disclose information about the trial. Failure to report something could result in a criminal offense. If an investigator doesn’t disclose something, they do not face the same negative repercussions.

“If you talk to an attorney from any sponsor company, they will tell you how important it is to disclose, disclose, disclose,” says Thompson. “They fully understand the importance of doing that. The situation might be slightly different in privately-held companies, because public companies have an obligation to their investors. But even then they have a duty of disclosure under the investment terms. More often than not the investors are sitting on your board of directors and would be privy to the information anyway.”

On a positive note, Thompson is quick to note that most companies, investigators, and researchers he knows want to disclose as much as they possibly can.  There are just a number of soft reasons that might end up keeping them from getting into more detail than they do. For example, there is generally the same amount of content going into a press release regardless of whether or not the trial was successful. He notes no one on the planet is going to put out a 30-page press release covering the detail of a clinical study, whether it was good or bad.

For that reason, most of the press releases that go out are seldom more than two pages, with just a few sentences on the results and the safety aspects. While that will meet the disclosure standards, it certainly does not disclose much detail to the investigators or others who wish to know the details.

“When you look closely at this situation, what you see is a system that is almost accidentally set up to inhibit full disclosure,” states Thompson. “The industry might feel it is good to publish negative results, but where would we publish them? Who is going to pay for it? Who is going to read it? It’s a difficult issue. You can try to induce people to do things, but if an investigator has a failed study, his academic career will not be helped by spending the weeks it would take to write a paper to be published. Especially if they can spend that time writing a paper on a study that did work. There is not a conspiracy of silence. It is just natural for people to want to focus on things that will help them out with their careers.”

More Information Benefits Patients

There are other reasons for reporting as much information as possible. Patients appreciate the information, but from the sponsor perspective, more information might mean coming up with better versions of existing medicines. Thompson likes to use bone marrow studies as an example of how more information can be helpful to patients. When physicians first started using radiation to kill off bone marrow for certain types of leukemia patients, that marrow had to be replaced. It was discovered that bone marrow transferred from people who did not match the patient’s tissue type caused them to perform better…but only for a period of time. After that, the patients began to die quicker. Still, researches published the complete findings.

“They could have reported that non-matching bone marrow works really well for six months and left it at that,” says Thompson. “But they opted to include the downside of the study as well. That led physicians to decide it would be used for emergency use only until a better match could be found. That knowledge ended up making these transplants better for the patients and better for the industry. I think in that case we were lucky that there was a positive effect to report along with the negative. If there was only the negative effect, I don’t know that it would have ever been published.”

Is There A Fix?

I wish I could report that there is an easy fix to this transparency issue. Unfortunately, there is not. According to Thompson, there are not a couple of adjustments that can be made to correct the problem.  After all, you cannot force a researcher to publish an article on a failed study if they have more important needs to attend to. You can’t force a company to produce or publish a 30-page press release or, if they did, force anyone to read it. Unfortunately, that is a reality of the industry.

“We need to come up with a mechanism where the end result is of benefit to the industry, such as people having access to needed information and disseminating it without the process being burdensome,” notes Thompson. “I honestly don’t know how you do that.”

There are so many pieces to this problem…the sponsor companies, the FDA, the investigators, the research sites. It is difficult to fix a problem when the players involved in it are so varied. Still, if this is an issue that is too complicated to tackle with all players at once, perhaps the best approach would be to take it one step at a time. If we put sponsors, patients, and investigators in a room together, all would likely be clamoring for the same end result.

“We would not see pockets of stakeholders fighting this,” adds Thompson. “A solution to this transparency problem would make everyone better off. It’s frustrating because everyone knows this is an issue, and that we have to do better. People who are a lot smarter than I am have spent time on this and were not able to come up with an answer.  But the fact that this is a complicated issue doesn’t mean we should throw our hands in the air and give up. Eventually we will have to produce a solution.”

 

Taking The “Risk” Out Of Risk-Based Monitoring

http://www.clinicalleader.com/doc/taking-the-risk-out-of-risk-based-monitoring-0002

The clinical trial landscape is continually evolving and with it, efforts in the improvement of participant safety and data integrity. CROs are beginning to transition from on-site monitoring, with 100% point-to-point source data verification, toward a risk-based monitoring (RBM) approach that utilizes source data review and more centralized monitoring techniques better adapted for mitigating risk.

While RBM has gained considerable attention in recent years, reluctance still remains around the approach—from uncertainty arising from the use of “risk” employed in its name to sponsors being wary of potential implications on data quality and regulatory inspection outcomes.

Despite these concerns, there is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% source data verification to ensure subject protection, data integrity, and overall study quality.

 

Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial

http://www.clinicalleader.com/doc/improve-the-inclusion-exclusion-criteria-for-your-next-clinical-trial-0001

 

 

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