Thermo Fisher Scientific : Where precision is not just word but a mission

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Thermo Fisher Scientific Inc., one of the world’s top life science company opens it  U.S. Precision Medicine Science Center (PMSC) in Cambridge, Mass.

This facility beholds technologies that addresses collaborators need of  analytical workflows which can generate precise molecular profiles of patients. This data will ultimately complement collaborators quest to treat disease effectively in clinical set-ups.

The centre also houses best in class experts who can help current and potential clients expedite journey from biomarker discovery to assay development. Company intends to achieve this by compressing R&D timelines.

Company Quotes

“For health and science innovators, a bottleneck exists today between the discovery of biomarkers and their widespread use at the point of care,” said Emily Chen, senior director, Thermo Fisher Precision Medicine Science Center. “Our goal at the PMSC is to remove that bottleneck and help scientists and physicians reduce the time it takes to demonstrate clinic validity and utility.”

“Precision medicine needs to be based on high-quality data, and proteomics is central to that,” said PMSC collaborator Jennifer Van Eyk, PhD, Cedars-Sinai Medical Center in Los Angeles. “Our work with the team at the PMSC is helping us accelerate the important journey from discovery to patient care.”

 

This is not first time that company has opened PMSC centre, Thermofisher in past has opened similar centre in China that looks to address same challenges.

This 20 billion dollar sales company has unique blend of services that range from life science research to patient diagnostics, stretching far beyond to laboratory offerings. It is this combination that has positioned the company to forefront of innovation, which is well reflected in its global strategic decisions.  For more updates on Thermo fisher and its peers, follow Pharmed Intel.

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LabCorp does it again; acquires, streamlines and positions Sciformix in its long term strategy

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LabCorp acquires Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices clients. Sciformix will become part of Covance, LabCorp’s drug development business.

Quotes from Company

“This acquisition strengthens our position in the later phases of drug and device development, particularly for post-marketing pharmacovigilance and market access solutions,” said David P. King, chairman and chief executive officer of LabCorp. “The addition of Sciformix’s scientific and technology expertise, combined with its quality-driven processes, will support Covance’s work in transforming drug development through innovation and greater efficiency.”

Asia based Sciformix’s offerings include post-marketing safety and risk management, clinical development support services, regulatory affairs and operations, technology services, and real-world evidence solutions.

Quotes from Company

“The development process does not end once a drug or device is approved,” said Bill Hanlon, Ph.D., group president of Clinical Development and Commercialization Services at Covance. “More than ever, approved treatments must be monitored closely to demonstrate a continued favorable benefit-risk ratio in a much broader population and to safeguard patient safety. Pharmacovigilance solutions address that need. Sciformix’s services and expertise are a compelling addition to Covance’s portfolio. With its scientific knowledge and high-quality delivery, Sciformix is a great fit with our culture and our mission to improve health and improve lives.”

Manish Soman, former president and chief executive officer of Sciformix, said: “Our complementary offerings add depth and breadth to each company’s capabilities, creating an exciting opportunity to offer customers an enhanced range of comprehensive services by a single company.” Ajit Nagral, Sciformix founder and former executive chairman, added: “Sciformix is delighted to become part of the Covance and LabCorp family, bringing new opportunities for our employees as they work to improve healthcare for patients worldwide.”

Terms of the transaction have not been disclosed.

We are all aware of Labcorp’s acquisition appetite, and hence not very surprised by this acquisition. However noteworthy point here is the way Labcorp positions it is acquisition in its long term strategy and view. USD 10 billion dollar company still has enough in its pocket to make more acquisitions of similar sort to continue its in-organic growth. Watch out for this space for more updates on Labcorp and its peers in coming days.

Image and Data Source: Company Website

Alliance with this company positions PPD to a new level in oncology arena

 

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Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), and NeoGenomics Laboratories, Inc., a leading provider of cancer-focused genetic testing services, have entered into an agreement to provide afully integrated global pathology and molecular testing solution to PPD’s current client base.

As part of the deal, NeoGenomics will provide a  range of lab testing services to support PPD® Laboratories’ oncology clinical trial activities globally.

Collaboration’s key focus is centralized pathology review, as well as specialty lab services, including flow cytometry, fluorescence in situ hybridization (FISH),and others.

Duo will also provide its clientele, a comprehensive companion diagnostics offering from biomarker discovery through regulatory approval and commercialization. Talk about the best bundled services in oncology space and this duo surfaces as best in class option.

Below are some of the quotes from company officials:

“NeoGenomics has world-class scientific talent, significant oncology trial experience, and a broad geographic presence that will allow us to further enhance our global laboratory services for oncology trials,” said Christopher Fikry, M.D., executive vice president of PPD Laboratories. “Working with NeoGenomics will enable us to jointly provide a premier global oncology and specialty laboratory solution for our customers.”

“We are pleased to be joining PPD in this important strategic alliance and look forward to collaborating with the many scientific professionals on their team,” said Douglas VanOort, chairman and chief executive officer of NeoGenomics. “Our company is committed to saving lives by improving patient care through communication, accuracy, reliability and efficiency. That commitment aligns closely with PPD’s mission and purpose to help its customers deliver life-changing therapies that improve health.”

So what is in  for buyers:

Oncology is most watched therapeutic segment by leading pharma companies, with quicker need of solution multiple vendor involvement could be tedious task. This deal addresses that issue by bringing in multiple solutions under one roof. Strategic alliance and long term partnership would be key here.

 

 

Novartis like always, leads in yet another innovative model : Clinical trials


Novartis could be tagged as one of those companies that look to do things differently. It taps into new platforms and technologies to pave way for new practices , and one such example of company’s move is its alliance with Thread research.

Team of both companies have developed an app namely “Focalview”, which aims at collecting real time data from 150,000 users.

The data also referred to as eDROS ( electronic device recorded outcome measurements),  would help ophthalmic researchers gain more real time insights from patients who are positioned away from trial sites.

This is not first time that Novartis is exploring waters of remote patient clinical trials , it had earlier inked deal with Science 37 on similar lines.

These series of strategic activities from Novartis just go about highlighting company’s chase of paving new ways in clinical trial arena. And, we would be not be surprised if Novartis masters this pilot engagement and puts this practice for global operations.

SO analysis

Strengths: Being forerunner in all novel practices , having diversified portfolio of business, just puts Novartis at position of strength in comparison to its peers. Thread research on other hand is placed in business that is yet to explore its potential. Needless to say clinical trials away from site or remote patient monitoring is the future that healthcare industry beholds.

Opportunities

Opportunities that this engagement would bring in for Novartis are enormous. While the application is currently been tagged to Ophthalmic therapy, going forward scope of therapeutic coverage can definitely hold huge bargain for both the parties involved.

CRO market facts, figures and deductions

According to recent report from GVR, CRO SERVICES market is likely to touch USD 45.2 billion in year 2022. The market is dominated by handful of vendors namely IQVIA, Labcorp, ICON, Parexel and PPD. IQVIA leads this trail by accounting for 12.4 percentage of market share.

According to recent article from Outsourcingpharma which discusses  CRO market nuances, and markets consolidation over the course of time, it would not be surprising to witness these players consolidate further. Given the fact that top 7-10 players in this industry accounts for close to 60% of market share.

Some of the other specifics that report from GVR highlights is 

  1. US leading the chart from both supply and demand side (CRO services).
  2. When it comes to segmentation of CRO service types , Drug discovery accounts for major share of  33%. 
  3. At therapeutic level it’s oncology that accounts of largest share of 25%.

The important essence of the report is its estimate of growth rate for CRO services. It is analyzed to be 12% , which is higher than yesteryear’s 10% . Now the question to be asked is,

  1.  Is it from increased outsourcing from Biopharmaceutical companies? 
  2.  Is the uptick on the grounds of  sponsors increased outsourcing addiction because of availability of bundled services from CRO behemoths?
  3.  Or is it because small CROs have garnered expertise in niche therapeutic areas, which in turn triggered increased outsourcing by small sponsors? 

Good thing is CRO is embracing the wave of time, innovation and regulatory- which is very much visible by new models that likes of IQVIA, Labcorp and others are offering.

Icon-Intel deal is start of something really remarkable


Icon recently signed a deal with Intel where former will use latter’s Artificial intelligence portal for remote patient clinical trials.

Deal is considered one of the major milestone for CRO fraternity as it involves  analytical platform that links data from multiple sensors and wearables, analyse collected data & provide real time insights to end users.

Icon’s appetite for embracing innovation has always been on high note, this is very much acknowledged by numerous proof of concept studies that company has carried out in recent past.

This one though seems like match made in heaven – where best in class unite together to address issues pertaining to clinical trial management.

AI & machine learning are no longer fancy words having vivid description and application, it is now a hard-core reality touching new heights in every sector you can think off. Healthcare though has been late embracer of this innovation,  it is trying to run really fast to make up for the lag.

Company that is taking clinical trial methodology to new heights : Science 37

Science 37, which recently was in buzz for its deal with Novartis has some what of a unique offering when it comes to clinical trials.

Company has inked a deal with Novartis for 10 new clinical trials involving usage of its new operating model meta site, which is based on its mobile research platform NORA.

Company under the leadership of Belinda Tan had closed cumulative funding amount of USD 66 million in year 2016 & 2017. Early round of investments that Science 37 closed in 2015 involved dRx capital, joint investment venture of Novartis.

Science 37 has also been able to impress other pharmaceutical behemoths such as Otsuka Pharmaceuticals, this goes about highlighting potential that Science 37 carries with its amazing service portfolio.

Medical device and Drugs trial converge, so does Pharma and Medtech CROs

The statement above is on grounds of recent uptick that clinical research industry is witnessing on supply front. Couple of days back we had published CSSI Lifescience’s launch of fully integrated medical device CRO, and now CiToxLAB acquiring AccelLAB.

The trend of acquisitions is justifiable, as Healthcare industry embraces convergence of medical devices and drugs. Combination products are buzz words of healthcare industry and no CRO; big or small are leaving any stone un-turned to address booming client need.

Looking to reduce timeline of your quest to launch medical devices? Looking to get this done at right price? Watch out for this fully integrated medical device CRO

We are referring CSSi Lifescience’s recently launched medical device CRO. The fully integrated medical device CRO is here impact timelines of regulatory clearance and increase profitability of medtech OEMs, both big and small.

Claims of the company are backed by 250+ filed 510K submissions. CSSi Lifescience provides end to end services and beyond, it assists medical device OEMs in design development, testing, clinical studies and reimbursement.

About Company:

CSSi LifeSciences™ Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. CSSi LifeSciences™ Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with knowledge that goes beyond published guidance, documents and initiatives. CSSi LifeSciences™ Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability.

Specialties

Medical Device Commercialization, Clinical study planning and design, Global Regulatory filing and Representation, Preclinical and clinical studies, Quality Management Systems, CRO, Medical Devices