Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MA

Archive for the ‘BioSimilars’ Category

Personalized Medicine as Key Area for Future Pharmaceutical Growth

Posted in Alzheimer's Disease, Bio Instrumentation in Experimental Life Sciences Research, Biological Networks, Gene Regulation and Evolution, Biomarkers & Medical Diagnostics, BioSimilars, Cell Biology, Signaling & Cell Circuits, Chemical Genetics, Computational Biology/Systems and Bioinformatics, Disease Biology, Small Molecules in Development of Therapeutic Drugs, FDA Regulatory Affairs, Genome Biology, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, Health Law & Patient Safety, Innovations in Neurophysiology & Neuropsychology, International Global Work in Pharmaceutical, Medical and Population Genetics, Molecular Genetics & Pharmaceutical, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy and Cell Activity, Population Health Management, Genetics & Pharmaceutical, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Scientist: Career considerations, Technology Transfer: Biotech and Pharmaceutical, tagged BRAF, Food and Drug Administration, National Institute for Health and Clinical Excellence, Personalized medicine, Roche, Roche Holding, Severin Schwan, Vemurafenib on September 18, 2012| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

During Investor Day, Roche Highlights Personalized Medicine as Key Area for Future Growth

September 12, 2012

By Turna Ray

As regulators and payors around the world are demanding more evidence that healthcare products improve patient outcomes and save money, Roche this week attempted to reassure investors that its strategy to develop innovative products — with a strong focus on molecularly guided personalized medicines — will place it ahead of competitors.

Through several presentations during an investor day in London, Roche officials highlighted a number of drugs for cancer, neuropsychiatric conditions, and autoimmune diseases for which the company is investigating biomarkers that can help target treatment to specific groups of patients. The company said that more than 60 percent of the compounds in its drug pipeline are currently paired with a companion diagnostic and that it has more than 200 companion diagnostic projects underway across its pharma and diagnostic business groups.

Personalized medicines are not only a major part of Roche’s plan for future growth, but they also represent a way for the company to differentiate its products from competitors. By setting its drugs apart from other me-too treatments in the marketplace, the company is hoping that its products won’t be as heavily affected by the pricing pressures currently plaguing the pharma and biotech sectors.

“Yes, regulators are very stringent. But if I look back at our most recent launches, particularly in the US, if you have true medical innovation, then regulators are very willing to bring those medicines and novel diagnostics to the market,” Roche CEO Severin Schwan said during the investor conference. He highlighted that the US Food and Drug Administration reviewed and approved the BRAF inhibitor Zelboraf for metastatic melanoma and its companion diagnostic in record time and that the recent approval of the HER2-targeted breast cancer drug Perjeta also occurred ahead of schedule (PGx Reporter 8/17/2011 and 6/13/2012).

“Likewise, if you look at the payors, there is cost pressure,” Schwan reflected, but he noted that the “innovative nature” of its portfolio helps it to “negotiate better prices with payors.”

Despite this optimistic forecast, Roche has experienced some pushback from cost-conscious national payors in Europe. For example, in June the UK’s National Institute for Health and Clinical Excellence deemed Zelboraf, which costs more than $82,000 for a seven-month treatment, too pricey. Zelboraf, which Roche launched in the US market last year and in European countries earlier this year, netted the company around $97 million in revenue for the six months ended June 30.

In an effort to battle pushback from national payors, Roche is in discussions with European governments about value-based pricing schemes for several of its products. In this regard, high priced personalized medicine drugs are well suited to these types of arrangements. David Loew, chief marketing officer at Roche, told investors that governments are increasingly developing registries to track how individual patients are doing on various treatments. This information will help governments move from a volume-based pricing model for drugs to paying for them based on the drug’s indication.

He noted that in Germany, for example, Roche has developed a payment scheme where in colorectal cancer, patients pay a certain amount for up to 10 grams of the oncologic Avastin, receive it for free for up to 12 months, and then the scheme repeats. For personalized medicines, such as Herceptin, Perjeta, T-DM1, and Zelboraf, “we will have to think about different ways of pricing those new combinations,” Loew said.

Schwan highlighted that one of the major advantages for Roche in this difficult environment is that it has both drug and diagnostic capabilities in house. This, according to Schwan, enables Roche to have significant internal capabilities in early-phase research, and makes the company attractive for partnerships, as well. Roche currently has more than 70 new molecular entities in clinical development and since 2011 there have been 25 late-stage clinical trials that have yielded positive results. The firm plans to bring three more products into late-stage clinical trials by the end of the year and would like to move 10 products into late-stage development in 2013.

On the diagnostics side, newly hired chief operating officer Roland Diggelmann said that Roche is aiming to grow its presence in the testing market by becoming “the partner of choice” for developing companion assays and collaborating internally with Roche pharma to advance personalized medicine.

“We need to make sure that science translates into great medicines by designing trials that take smart risk into account, that really focus on ensuring that the molecules are being developed in the right diseases; to make sure we have the right dose; to make sure, whenever possible, we have the … companion diagnostic strategies,” Chief Medical Officer Hal Barron said at the meeting. “This whole strategy needs to result in a higher probability of success so that the return on investment is above the cost of capital and an important driver for our business.”

While Roche plans on identifying new product opportunities through a mix of its internal capabilities and external collaborations, growth through large mergers and acquisitions – a strategy that other large pharmaceutical companies have readily utilized to expand product portfolios – doesn’t seem to be a priority at the company. Noting that there may be opportunities for smaller M&A deals, Alan Hippe, chief financial and information technology officer, noted that at Roche, “we are not big fans of big mergers and big M&A.”

Targeting Cancer

A large portion of Roche’s personalized medicine strategy will be directed toward oncology, where the company has allocated 50 percent of its research and development budget.

In June, the FDA approved Perjeta in combination with Herceptin and decetaxel chemotherapy as a treatment for metastatic breast cancer patients whose tumors overexpress the HER2 protein. The agency simultaneously also approved two companion tests that can help doctors discern best responders to the treatment (PGx Reporter 6/13/2012).

Herceptin (trastuzumab), approved in 1998, still comprises a big chunk of Roche’s therapeutics business, contributing 11 percent of the $18.2 billion the firm netted in overall drug sales in the first half of the year. Roche is hoping to preserve earnings from this blockbuster drug — often hailed as the first personalized medicine success story — by combining it with Perjeta and linking it with a derivative of the chemotherapy maytansine, DM1.

Recently, Roche announced data from a late-stage clinical trial called EMILIA that showed that advanced breast cancer patients receiving the antibody drug conjugate trastuzumab emtansine, or T-DM1, lived “significantly” longer than those treated with a combination of Genentech’s Xeloda (capecitabine) and GlaxoSmithKline’s Tykerb (lapatinib). The patients in EMILIA had to have progressed after initial treatment with Herceptin and taxane chemotherapy.

According to Loew, the company is currently conducting a study looking at T-DM1 as a potential option for first-line metastatic breast cancer patients. In addition, Roche is also studying T-DM1 as an adjuvant treatment in early-stage breast cancer patients with residual disease; comparing T-DM1 plus Perjeta against Herceptin plus Perjeta in the adjuvant early-stage breast cancer setting; and looking at T-DM1-based chemotherapy in the neoadjuvant setting.

“So if we are successfully delivering those results, I think the HER2-positive breast cancer space has been completely changed and redefined,” Loew told investors.

At the end of the year, another study, called the Protocol of Herceptin Adjuvant with Reduced Exposure, or PHARE, is slated to report results, and the outcome could have a negative impact on Herceptin sales. PHARE is comparing whether patients given Herceptin for 12 months, which is currently the standard of care in the US, fare better than those given the drug for six months.

Industry observers have projected that Perjeta and T-DM1 could be a sufficient buffer against a scenario in which six months of Herceptin is found to be non-inferior to a year of the drug.

Barron noted that Roche is readily applying the strategy behind antibody-drug conjugates such as T-DM1 – where antibodies to attach to antigens on the surface of cancer cells to localize chemotherapy delivery and reduce adverse reactions – in 25 projects across its portfolio. He added that antibody-drug conjugates offer a promising mechanism for personalizing treatments.

In non-small cell lung cancer, Roche is studying MetMab (onartuzumab) in combination with Tarceva in patients with tumors that overexpress the Met protein. Data from this Phase III trial, called METLUNG, is expected in 2014. Data from a Phase II study looking at MetMab and Tarceva as a second-line NSCLC treatment yielded negative results when all comers were considered. However, the subgroup of patients who over-expressed Met had a “doubling” of progression-free survival and a “pronounced” effect on overall survival compared to the low-Met group.

Roche is also investigating MetMab in metastatic gastric cancer (Phase III), triple-negative breast cancer, (Phase II), metastatic colorectal cancer (Phase II), glioblastoma (Phase II), as well as in combination with Avastin in various cancer indications.

Other Areas of Personalization

Outside of oncology, Roche is exploring biomarker strategies to personalize drugs for Alzheimer’s disease and schizophrenia. Phase I data from a study involving gantenerumab, a IgG1 monoclonal antibody, suggest that the drug could potentially reduce amyloid plaque in Alzheimer’s patients’ brains.

Investigational drugs targeting beta-amyloid, which many researchers believe to be involved in the pathogenesis of Alzheimer’s disease, haven’t fared well in clinical trials. Most recently, Johnson & Johnson/Pfizer’s drug bapineuzumab, which also targeted the β-amyloid protein, failed to benefit Alzheimer’s patients who were non-carriers of APOE4 gene variations.

Wall Street analysts are hoping that Roche’s biomarker-driven strategy for gantenerumab will help it avoid a similar fate. The company is currently conducting a 770-patient trial called Scarlet Road, in which researchers will measure Tau/Aβ levels in study participants’ spinal fluid to identify early onset or prodormal Alzheimer’s patients and treat them with gantenerumab. Roche is developing a companion test to gauge Tau/Aβ levels in trial participants. Results from Scarlet Road are expected in 2015.

Roche subsidiary Genentech is testing another compound, crenezumab, to see if it can prevent Alzheimer’s in a population genetically predisposed to getting the disease. Genentech, in collaboration with Banner Alzheimer’s Institute and the National Institutes of Health, is conducting a Phase II trial investigating crenezumab in the residents of Medellin, Colombia, where people share a common ancestor and have a high prevalence of mutations in the presenelin 1 gene. Those harboring the dominant gene mutation will start to lose their memory in their mid-40s and their cognitive functions will deteriorate by age 50.

The five-year study will involve approximately 300 participants, of whom approximately 100 mutation carriers will receive crenezumab and another 100 mutation carriers will receive a placebo. In a third arm, approximately 100 participants who don’t carry the mutations will receive a placebo. Study investigators will begin recruiting patients for this study next year.

In schizophrenia, Roche is exploring bitopertin, a glycine reuptake inhibitor, in six Phase III studies slated for completion next year. Three of these studies are looking at the drug’s ability to control negative symptoms in schizophrenia, while the other three trials are studying the drug’s impact on sub-optimally controlled disease symptoms. “A companion diagnostics assay is in development to validate the hypothesis for an exploratory biomarker predicting response to therapy with bitopertin,” Roche said in a statement.

For lupus, Roche is conducting a proof of concept Phase II trial involving rontalizumab, an anti-interferon-alpha antibody, in which researchers are using a biomarker to identify patients most likely to respond to the drug. Data from this trial will be presented at a medical conference later this year.

Growing Role of Diagnostics

Daniel O’Day, who served as CEO of Roche Molecular Diagnostics until last week when he was appointed chief operating officer of the company’s pharma division, valued the worldwide diagnostics market at $53 billion. “We represent 20 percent of that, or around 10 billion Swiss francs ($11 billion),” he said in his investor day presentation.

While molecular diagnostics promise to be a growing part of Roche’s business in the coming years, these products currently only represent a single-digit percent of Roche’s overall diagnostics business. For the first half of this year, molecular diagnostics comprised around 6 percent of Roche’s diagnostics sales of $5.3 billion.

Roche’s Ventana Medical Systems subsidiary will likely play a large role in advancing Roche’s presence in the companion diagnostics space. This year, Ventana announced it was developing companion tests for a number of drug makers, including Aeterna Zentaris, Syndax Pharmaceuticals, Pfizer, and Bayer (PGx Reporter 1/18/2012).

In addition to these external collaborations, Roche officials highlighted the company’s internal diagnostics capabilities as particularly advantageous for expanding its presence in the personalized medicine space. For example, Roche developed the BRAF companion test for Zelboraf. The company is also developing a companion EGFR-mutation test for its non-small cell lung cancer drug Tarceva in the first-line setting, and a test to gauge so-called “super-responders” to the investigational asthma drug lebrikizumab being developed by Genentech.

In terms of molecular diagnostics, O’Day highlighted a test that gauges the overexpression of the p16 gene in cervical Pap test samples to gauge whether women have precancerous lesions.

Additionally, the FDA this year approved the use of Ventana’s INFORM HER2 Dual ISH DNA Probe cocktail on the BenchMark ULTRA automated slide staining platform, which allows labs to analyze fluorescent in situ hybridization and immunohistochemistry samples in one assay. According to O’Day, this test has been more successful than standard FISH tests in identifying HER2 status in difficult-to-diagnose patients. The company will be publishing data on this test soon, showing that it can “identify about 4 percent more [HER2-postiive patients] than FISH alone.”

When it comes to molecular technologies, Roche, like other pharma and biotech players, appear to be sticking to tried and tested technologies, such as IHC, FISH, and PCR, and reserving whole-genome sequencing for research use. “Today, sequencing is predominantly a research tool. And it’s a very valuable research tool in the future,” O’Day said, estimating that sequencing-based tests will “go into the clinic” in the next half decade.

Turna Ray is the editor of GenomeWeb’s Pharmacogenomics Reporter. She covers pharmacogenomics, personalized medicine, and companion diagnostics. E-mail her here or follow her GenomeWeb Twitter account at @PGxReporter.

Related Stories

• Ventana’s Growing Companion Dx Focus Mirrors Parent Roche’s Investment in Personalized Rx
  January 18, 2012 / Pharmacogenomics Reporter
• Drugmakers’ Commitment to Personalized Rx Growing Despite Barriers, PhRMA CEO Says 
  June 15, 2011 / Pharmacogenomics Reporter
• Genentech Planning Regulatory Filing This Year for New Personalized Rx for Advanced Breast Cancer
  June 6, 2012 / Pharmacogenomics Reporter
• Pfizer, Roche Officials Share Lessons Learned from Rx/Dx Co-development of Xalkori and Zelboraf 
  February 29, 2012 / Pharmacogenomics Reporter
• FDA’s Reorganization of Oncology Office May Be Good for PGx-Guided Drugs
  September 14, 2011 / Pharmacogenomics Reporter

SOURCE

http://www.genomeweb.com/mdx/during-investor-day-roche-highlights-personalized-medicine-key-area-future-growt

 

Share this:

• X
• LinkedIn
• Facebook
• Print
• Email

Like this:

Like Loading…

Read Full Post »

Profits versus R and D: Shifts in the Research Culture – US vs Global Markets

Posted in Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, BioSimilars, Cell Biology, Signaling & Cell Circuits, Chemical Genetics, Computational Biology/Systems and Bioinformatics, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Genome Biology, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, Health Law & Patient Safety, International Global Work in Pharmaceutical, Medical and Population Genetics, Medical Devices R&D Investment, Molecular Genetics & Pharmaceutical, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Population Health Management, Genetics & Pharmaceutical, Proteomics, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Scientist: Career considerations, Stem Cells for Regenerative Medicine, Technology Transfer: Biotech and Pharmaceutical, tagged Biotechnology and Pharmaceuticals, Biotechnology Industry Organization, Milken Institute, University of Toronto Joint Centre for Bioethics on September 7, 2012| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Countries colored in brown rank highly in the Growth Competitiveness Index 2004 – 2005, World Economic Forum. Black circles represent select biotechnology and life sciences clusters.

North AmericaSeattle, USA San Francisco, USA Los Angeles, USA San Diego, USA Saskatoon, Canada *Minneapolis/St. Paul/Rochester USA Austin, USA Toronto, Canada Montreal, Canada Boston, USA New York/New Jersey, USA Philadelphia, USA Baltimore/Washington, DC, USA Research Triangle NC, USA

Central America / South AmericaWest Havana, Cuba Belo Horizonte/Rio de Janeiro, Brazil Sao Paulo, Brazil

United Kingdom / IrelandGlasgow-Edinburgh, Scotland Manchester-Liverpool, England London, England Cambridge-SE England Dublin, Republic of Ireland

Continental EuropeBrussels, Belgium Medicon Valley, Denmark/Sweden Stockholm/Uppsala, Sweden Helsinki, Finland Paris, France Biovalley, France/Germany/Switzerland BioAlps, France/Switzerland Sophia-Antipolis, France BioRhine, Germany BioTech Munich, Germany BioCon Valley, Germany

MideastIsrael

AfricaCapetown, South Africa

AsiaBeijing, China Shanghai, China Shenzhen, China Hong Kong, China Tokyo-Kanto, Japan Kansai, Japan Hokkaido, Japan Taipei, Taiwan Hsinchu, Taiwan Singapore Dengkil, Malaysia New Delhi, India Hyderabad, India Bangalore, India

OceaniaBrisbane, Australia Sydney, Australia Melbourne, Australia Dunedin, New Zealand

Definitions

Biotechnology: Biotechnology is the use of cellular and biomolecular processes to solve problems or make useful products. [Biotechnology Industry Organization – BIO]

Bioscience/Life Science: pharmaceuticals, biotechnology, medical devices, R&D in the life sciences. [Devol et al., 2005]

Clusters: Clusters are a geographically proximate group of interconnected companies and associated institutions in a particular field, including product producers, service providers, suppliers, universities, and trade associations. [Cluster Mapping Project, Institute for Strategy and Competitiveness, Harvard Business School]

* Cited no. 8 for Total Life Sciences Current Impact by Devol (2005) defined as pharmaceutical, biotechnology, medical devices, and R&D in the life sciences. Minneapolis/St. Paul/Rochester is principally a medical device cluster.

References

• Cortright, Joseph and Heike Mayer. “Signs of Life: The Growth of Biotechnology Centers in the U.S.” The Brookings Institution, June 2002. [focuses on biopharmaceuticals]
• Devol,Ross et al. “America’s Biotech and Life Science Clusters: San Diego’s Position and Economic Contributions” The Milken Institute, June 2004.
• Devol,Ross et al. “The Greater Philadelphia Life Sciences Cluster: An Economic and Comparative Assessment” The Milken Institute, June 2005.
• GDIS – Biotechnology Clusters
• “Health Biotechnology Innovation in Developing Countries” Canadian Program on Genomic and Global Health at the University of Toronto Joint Centre for Bioethics, Nature Biotechnology 22 (12s): December 2004.
• OECD: The Bioeconomy to 2030: Designing a Policy Agenda, an Organisation for Economic Co-operation and Development (OECD) Scoping Paper, March 2006.Websites
• BioSpectrum India, Global Bioclusters
• Biotechnology Industry Organization – BIO US
• Canadian Biotechnology Clusters Strategis – Industry Canada
• European Biotechnology Science, 2004.
• Biotech Clusters Department of Trade & Industry, United Kingdom
• BioLondon
• Seebio [South East England]
• BioRegions in Germany
  • BioCon Valley
  • BioTechnikum Greifswald
  • Network LifeScience Bavaria
  • BioRegio STERN
• Biotechnology France
• BioValley [France, Switzerland, Germany]
• Zurich MedNet [Switzerland]
• BioAlps [France, Switzerland]
• Medicon Valley [Denmark-Sweden]
• ScanBalt BioRegion [Scandinavia, Baltic states, Iceland, Poland, North Germany, Northwestern Russia]
• Cape Biotech [South Africa]
• Biotech Japan
• BiotechEast [Taiwan]
• Biopolis Singapore
• BioValley Malaysia
• Bangalore Bio [India]
• Genome Valley [India]
• BioMelbourne Network
• BioFirst [New South Wales, Australia]

Map is a Mercator projection that exaggerates the size of areas far from the equator.

Global biotechnology clusters map published by:

Andersen, Jørn Bang, “Establishment of Nordic Innovation Centres in Asia?” by the Nordic Innovation Centre for the Nordic Council of Ministers, Copenhagen, 2008.

Dimova, Maria, Andres Mitnik, Paula Suarez-Buitron and Marcos Siqueira. “Brazil Biotech Cluster: Minas Gerais” [PDF] Institute for Strategy and Competitiveness, Harvard Business School, Spring 2009.

Encyclopedia of Globalization, Routledge, November 2006.

Hamdouch, Abdelillah and Feng He. “R&D Offshoring and Clustering Dynamics in Pharmaceuticals and Biotechnology: Insights from the Chinese Case,” [PDF] The Spirit of Innovation Forum III, May 14-16, 2007.

Loh, Melvyn Wei Ming, “Riding the Biotechnology Wave: A Mixed-Methods Analysis of Malaysia’s emerging Biotechnology industry” [PDF] Victoria University of Wellington, New Zealand, 2009.

Murray, Fiona and Helen Hsi, “Knowledge Workers in Biotechnology: Occupational Structures, Careers & Skill Demands” [PDF] MIT Sloan School of Management, September 2007.

Rinaldi, Andrea. “More than the sum of their parts? Clustering is becoming more prevalent in the biosciences, despite concerns over the sustainability and economic effectiveness of science parks and hubs,”EMBO reports, February 2006 [PDF]

Royer, Susanne, “Crossing-borders: International Clusters: An analysis of Medicon Valley based on Value-Adding Web “ [PDF] University of Flensburg, July 8, 2007.

Salerno, Reynolds. “International Biological Threat Reduction at Sandia,” Sandia National Laboratory, July 31, 2006 [PDF]

Source:

http://biotech.about.com/gi/o.htm?zi=1/XJ&zTi=1&sdn=biotech&cdn=b2b&tm=7&f=00&tt=3&bt=1&bts=1&zu=http%3A//mbbnet.umn.edu/scmap/biotechmap.html

The 26th annual issue of Beyond borders, E&Y annual report on the global biotechnology industry.

Our analysis of trends across the leading centers of biotech activity reveals both signs of hope and causes for concern. The financial performance of publicly traded companies is more robust than at any time since the onset of the global financial crisis, with the industry returning to double-digit revenue growth.

Companies that had made drastic cuts in R&D spending in the aftermath of the crisis are now making substantial increases in their pipeline development efforts.

But even as things are heading back to normal on the financial performance front, the financing situation remains mired in the “new normal” we have been describing for the last few years. While the biotech industry raised more capital in 2011 than at any time since the genomics bubble of 2000, this increase was driven entirely by large debt financings by the industry’s commercial leaders.

The money flowing to the vast majority of smaller firms, including pre-commercial, R&D-phase companies — a measure we refer to as “innovation capital” — has remained flat for the last several years.

As such, the question we have posed for the last two years is more relevant than ever: how can biotech innovation be sustained during a time of serious resource constraints?

These are timely topics, and we look forward to exploring them with you.

Take a closer look at our findings and point of view:

• Holistic open learning networks -Holistic open learning networks (HOLNets) could make R&D shades more efficient by harnessing the power of big data to develop real-time insights.Even as biotech adjusts to its new normal, health care is moving to an outcomes-based ecosystem characterized by new incentives, new technologies and big data.

  HOLNets could reinvent R&D by pooling data, creating standards and engaging regulators and patients.

  Now, more than ever, this approach is feasible because it is in the self interest of the entities that would need to be part of it.

• Financial performance heads back to normal -The aggregate financial performance of publicly traded biotechnology companies in the four established clusters — the United States, Europe, Canada and Australia — showed encouraging signs of recovery and stabilization.Growth in established biotechnology centers, 2010-11 (US$b)
  

  Source: Ernst & Young and company financial statement data.
  Numbers may appear inconsistent because of rounding.

  The acquisition of three large US companies — Genzyme Corp., Cephalon and Talecris Biotherapeutics —by non-biotech buyers made a significant dent in the industry’s 2011 performance.

  To get a sense of the organic “apples-to-apples” growth of the industry, we have therefore calculated normalized growth rates that remove these three firms from the 2010 numbers.

  After adjusting for these large acquisitions, the industry’s revenue growth rate returned to double-digit territory for the first time since the global financial crisis. R&D grew by 9% in 2011, after being slashed in 2009 and growing by a modest 2% in 2010.

  US biotechnology at a glance, 2010-11 (US$b)

  Source: Ernst & Young and company financial statement data.
  Numbers may appear inconsistent because of rounding.

  As always, since the US accounts for a large majority of the industry’s revenues, the US story is very similar to the global one.

  After normalizing for the acquisitions of Genzyme, Cephalon and Talecris , the US industry’s revenues increased by 12%, outpacing the 10% growth rate seen in 2010 and 2009 (adjusted for the Genentech acquisition).

  Source:

  http://www.ey.com/GL/en/Industries/Life-Sciences/Beyond-borders—global-biotechnology-report-2012_Financial-performance-heads-back-to-normal

  ---

• Financing remains stuck in the “new normal”
• Big pharma stayed away from M&A deals -Given the critical role that big pharma could play in supporting the biotech innovation ecosystem and the fact that the expected exit for most venture investors is an acquisition, this lack of activity is unsettling.With big pharma in the midst of crossing the long-awaited patent cliff, many expected a more pronounced upsurge in transactions — particularly for targets with product revenue or very late-stage product candidates.

  However, only Sanofi’s acquisition of Genzyme (which really played out in 2010 but did not get finally negotiated and closed until 2011) entered the ranks of the year’s 10 largest deals. Even more noteworthy, big pharma was the buyer in only 7 of the year’s 57 M&A transactions.

  US and European M&As, 2006-11

  Source: Ernst & Young, Capital IQ, MedTRACK and company news.
  Chart excludes transactions where deal terms were not publicly disclosed.

  Meanwhile, the number of strategic alliances declined for the second straight year, and the potential “biobucks” value of these deals hit a six-year low.

  US and European strategic alliances based on up-front payments, 2006-11

  

  
  

  ---

Source:

http://www.ey.com/GL/en/Industries/Life-Sciences/Beyond-borders—global-biotechnology-report-2012-Big-pharma-stayed-away-from-MandA-deals

http://www.ey.com/GL/en/Industries/Life-Sciences/Beyond-borders—global-biotechnology-report-2012

Resizing the Global Contract R&D Services Market

 A new study revises estimates of the market

By Kenneth Getz, Mary Jo Lamberti, Adam Mathias, Stella Stergiopoulos, Tufts CSDD

Published May 30, 2012

      

Related Features

• ADCs and Outsourcing
• CMC and Regulatory Affairs
• Shared Supplier Audits
• Clinical Materials for Asthma and COPD Studies

Pharmaceutical, biotechnology and medical device company managers serving every R&D function — from discovery and manufacturing through post-approval clinical trials — are keenly aware today of the integral role that outsourcing plays in supplementing capacity and expertise. Demand for outsourced services has increased sharply as drug and device development sponsors have downsized and consolidated infrastructure in response to a sharp global economic downturn, poor short-term revenue growth prospects and costly and inefficient operating conditions. In addition, startups and small companies actively leverage contract service providers to gain access to expertise and skills not available internally.Contract service organizations have proliferated across a wide spectrum of R&D services areas. A 2011 analysis by Tufts Center for the Study of Drug Development (Tufts CSDD) found a nearly four-fold increase in the number of contract research organizations (CROs) in the U.S. alone during the past decade: Whereas an estimated 800 contract service providers operated in the U.S. in 2000, more than 3,100 did so at the end of 2011. (Data on the proliferation of contract R&D service providers in Europe and in other regions around the world are not available.) In another study, Tufts CSDD found that in 2010, CRO-employed professionals were more than doubling the capacity of the global drug development enterprise — the first time in history when CROs were providing more head count in support of R&D activity than were pharma and biopharma companies.

Despite this dramatic proliferation during the last 10 years, however, little information exists that characterizes the size and characteristics of the overall global outsourcing landscape. Coverage of CRO markets and usage practices by peer-review and trade journals has largely focused on individual service areas aligned with either each publisher’s readership or the author’s primary area of expertise. Contract lead identification and optimization services markets and practices, for example, tend to be covered in publications reaching discovery scientists. Similarly, the contract formulation services area is typically discussed in publications catering to professionals in chemistry, manufacturing and controls. Some directories (e.g., Contract Pharma (www.contractpharma.com/csd), PharmaCircle (www.pharmacircle.com)) profile companies across contract R&D service areas. These directories do not publish macro-analyses of the global aggregate R&D outsourcing market.

Capital market analysts and industry observers have also largely focused on characterizing only the most mature R&D outsourcing markets: contract clinical and preclinical research services. These markets have historically had the highest prevalence of large, publicly-traded companies making it relatively easy to monitor performance, assess transactions and evaluate corporate strategies. Goldman Sachs, UBS, Fairmount Partners, Jefferies and William Blair are among the many financial services firms that support transactions and cover developments in the global outsourcing marketplace. Published reports from these organizations typically only cover and estimate the size of the clinical and preclinical markets — a fraction of the total contract services marketplace. Industry professionals and analysts tend to use these estimates as proxy measures for total market size when they grossly underestimate the size of the overall outsourcing market.

Two recent reports stand out as noteworthy attempts to size the overall CRO market and affirm the growing interest in this aggregate market metric: the Harris Williams & Company 2008 Market Monitor report and the 2011 BCC Research Report. The former report focused on the larger healthcare and life sciences arena but estimated — using a top-down approach — the size of the contract clinical, preclinical, manufacturing, clinical laboratory and sales markets. Harris Williams, a private investment banking firm, estimated that the total market for these specific service areas in 2008 reached approximately $75 billion. The later BCC Research report sized the overall 2011 global outsourcing market at $217.9 billion. This top-down analysis included not only contract service providers supporting prescription drugs, but also over-the-counter and nutraceuticals products.

As demand for — and the adoption of — contract research services has grown there is a greater need for more accurate and comprehensive measures of the size and structure of the overall landscape. Better metrics assist companies and analysts in assessing the financial health, trends, structure, operating conditions and maturity of the overall market for contract research services. Sponsor companies can also use these metrics for strategic planning purposes and to forecast the impact of new management practices on the landscape. More accurate metrics enable analysts to monitor consolidation, diversification and divestiture activities. And more accurate descriptive statistics on the landscape assist CRO companies in developing, implementing and evaluating strategic initiatives.

In late 2010, Tufts CSDD began a new study using a rigorous, bottom-up approach to independently size the U.S. market for all contract R&D services. The goal of the study was to perform a carefully designed, methodical and systematic market-sizing study using actual data wherever possible. It is our hope that this initial but definitive quantitative assessment will serve as a basis for sizing contract service providers in Europe and in the rest of the world, and that it will better inform discussion, analysis and understanding of the global outsourcing landscape.

Methods
Tufts CSDD focused on the U.S. market for this initial study due to the labor-intensive nature of analyzing a large, fragmented market predominantly made up of small, privately held organizations and independent consultants. Tufts CSDD developed detailed definitions of primary contract service markets, and compiled a list — to the best of its ability — of all known contract service providers in each respective market within high concentration metropolitan and industrial areas. A total of 15 major geographic clusters, defined by Metropolitan Statistical Area (MSA), were identified and analyzed. These clusters capture approximately 75% of the list of contract service companies operating in the US. Contract service companies operating within these 15 geographic regions likely capture an even larger proportion of total U.S. outsourced services revenue as these companies include all the major, widely-recognized players. Data on more than 4,500 companies — some of them divisions or branches of diversified players — were analyzed.

Market Segment Definitions: The five primary market segments evaluated correspond with primary R&D and manufacturing processes: Applied Research, Non-Clinical Research, Clinical Research, Chemistry Manufacturing and Controls (CMC) and Staffing-Consulting-Management (Other) services. This ‘Other’ segment includes a wide variety of small, independent companies as well as large providers offering contract professional staffing, supply chain management, import/ export and distribution services as well as business development support. Specific main service category and common sub-category service areas within each of the primary market segments are characterized in Figure 1. (Main Categories and Sub-Categories are not mutually exclusive.)

Figure 1: Service Area Map

Service Provider Identification: Tufts CSDD used seven published, commercially available print and online directories of contract service providers to identify individual contract R&D services companies:

• Applied Clinical Trials 2010 Directory & Buyers Guide
• Contract Pharma2010/2011 Contract Services Directory
• Fierce Marketplace 2010/2011 Directory for Contract Manufacturing
• Hoovers.com Biotechnology Services Directory
• The Pharmaceutical Outsourcing^TM 2011 Company Focus and Industry Reference Guide (Volume 11, Issue 6, October 2010)
• The PharmaCircle Database 2010/2011
• ReferenceUSA.com (SIC Code 591207; “Pharmaceutical Consultants”) as of December 2010

Top Areas of Geographic Concentration: From these directories, company names and addresses were captured. Each company’s main address zip code was organized according to the U.S. Office of Management and Budget (OMB)’s definition of Metropolitan Statistical Areas (MSA). This approach was used in order to systematically identify and analyze areas of highest geographic concentration. The OMB’s definition of the MSA is “one or more adjacent counties or county equivalents that have at least one urban core area of at least 50,000 population, plus adjacent territory that has a high degree of social and economic integration with the core as measured by commuting ties.” The largest 15 geographic areas, defined by MSAs, containing contract service providers are:

• New York/Northern New Jersey (i.e., New York-Northern New Jersey-Long Island)
• Greater Boston (i.e., Boston-Worcester-Lawrence)
• Delaware Valley (i.e., Philadelphia-Wilmington-Atlantic City)
• Los Angeles (i.e., Los Angeles-Riverside-Orange County)
• The Washington DC Area
• San Francisco Bay (i.e., San Francisco-Oakland-Freemont)
• San Diego (i.e., San Diego-Carlsbad-San Marcos)
• Durham NC (i.e., Durham-Chapel Hill)
• Greater Chicago (i.e., Chicago-Joliet-Naperville)
• Greater Baltimore (i.e., Baltimore-Towson)
• Raleigh NC (i.e., Raleigh-Cary)
• Minneapolis (i.e., Minneapolis-St. Paul-Bloomington)
• Kansas City Area
• San Jose (i.e., San Jose-Sunnyvale-Santa Clara)
• Houston (i.e., Houston-Sugar Land-Baytown)

Figure 2 provides a visual representation of the 15 highest concentration areas of contract R&D services providers in the United States. These concentrated areas of contract service providers are in close proximity to geographic areas where pharmaceutical, biotechnology and manufacturing sectors in the US originated.

Figure 2: High Concentration Geographic Areas

Contract Service Company Types: Tufts CSDD organized companies along the following lines to assist with its evaluation of overall market and service segment characteristics:

• Pure-play companies: companies offering only one service area main-category. Examples of pure-play companies include: Abpro Corporation, cGMP Validation LLC. and Profacgen.
• Mid-sized companies: companies with two to five service area main-categories. Examples include: Accugenix Inc., Beckloff Associates Inc., QS Pharma and the Zitter Group.
• Conglomerate companies: companies with six or more service areas main-categories. Examples include: Aptuit (multiple sites); Covance (multiple Sites); PPD (multiple sites) and Quest Diagnostics (multiple sites)

(Service areas are defined in Figure 1.)

Tufts CSDD used company websites to determine branch and satellite office locations. If a company did not have a website, it was removed from the analysis. If the website did not specify which site performed which service, it was assumed that all locations offered the same number of services.

For publicly traded companies, Tufts CSDD used published company reports — annual reports, 10Ks, trade journal and newspaper articles — for operating information, revenue figures, locations and employee size. For privately held companies, Tufts CSDD used Hoovers.com.

Actual revenues and employee data were used whenever possible. In those cases where actual data were not available, financial and employee data were imputed using benchmark metrics derived from actual data:

• Pure-play companies: assigned average revenue and employee values based on actual data from other pure-play companies.
• Mid-sized companies: derived revenue and employee values based on actual data from companies of equal size and diversity.
• Conglomerate companies: derived revenue and employee values based on actual data from companies of equal size and diversity.
• Public companies: If service area-specific revenue and employee data was not reported, values were distributed equally across service areas.

Results
In total, 3,244 unique contract R&D service companies actively operating in the U.S. were identified and analyzed. These companies generated an estimated $32.9 to $39.5 billion in contract R&D services revenue with the largest share coming from the CMC and Non-Clinical market segments — 29%, and 21% respectively. The U.S. Clinical Research Services segment — which includes regulatory services — generated approximately $6.5 billion. Chart 1 shows the relative U.S. market share of each contract R&D service segment.

In the aggregate, companies operating in the overall U.S. contract R&D services market employ approximately 154,000 people and were founded more than 17 years ago. The typical company is privately-held, generates $10 million ($US) in revenue annually and is operating in 1.4 service areas.

The CMC and Non-Clinical Research segments have the largest number of companies providing services as shown in Chart 2. An estimated 1,274 companies in the U.S. offered CMC services in 2011, and 1,205 companies in the U.S. offered Non-Clinical Research Services. The Clinical Research segment had 643 active companies in the U.S. providing services in 2011.

The majority — 69% — of contract R&D service providers overall are privately held companies. CMC and Non-Clinical Research services segments have the highest concentration of publicly traded companies at 47% and 52% respectively. Approximately 17% of all companies providing Clinical Research Services are public. Chart 3 depicts the proportion of public to private companies in each major U.S. contract R&D services market segment.

Applied Research Services and Other Services U.S. market segments are the least mature and most productive segments, as reflected in Table 1 and Table 2. Companies in the Applied Research Services segment are the youngest, the most likely to be privately held, and the smallest. As a more nascent segment, revenue per employee in the Applied Research Services segment is one of the highest, at $267,000. The Other Services segment is also relatively young, with a high concentration of privately held companies. Revenue per employee in this segment is higher than any other U.S. market segment, at $284,000.

Individual companies in the Clinical Research Services and Other Services segments generate more revenue per company and have relatively higher levels of employee productivity. The CMC and Non-Clinical Research Services segments are the most mature, with the highest proportion of publicly-traded companies, the highest average number of employees and the lowest relative employee productivity.

Discussion
This initial Tufts CSDD study sizes the overall U.S. contract R&D services using a systematic bottom-up approach based on actual company data whenever possible and imputed data based on benchmarked actuals. The overall U.S. market for the 15 highest concentration geographic areas — as defined by MSA — is estimated at between $32.5 and $39.5 billion. Assuming that these geographic areas represent 75% of the total U.S. market, and that the U.S. market contributes 50% of contract services worldwide, Tufts CSDD estimates that the total global market for all contract services supporting prescription drug R&D is $90 billion to $105 billion. The total global market for contract R&D services therefore is more than five times larger than commonly cited figures.

Adjusting the service areas to adhere to traditional market definitions established by the investment banking community, the Tufts CSDD figures for the Clinical Research and Preclinical Research markets are consistent with those published by financial analysts (see Table 3).

It is highly likely that the overall market and individual segment sizes are larger than the conservative estimates presented in this paper. Tufts CSDD acknowledges the limitations of usingHoovers.com to characterize the high proportion of privately held companies, as Hoovers tends to present ultra-conservative figures. In addition, there are some limitations to using imputed data within service area revenues, as there is a tendency to inflate the smallest company revenue. However, using our estimates combined with actual data from public and some private companies helps to mitigate this limitation to some degree.

The major market segment definitions and service areas that comprise them are a useful approach to organizing contract services companies and it may provide a valuable framework for future analyses. The Tufts CSDD study finds that all of the market segments are accommodating very large and highly diversified publicly traded companies and many small, specialty companies. CMC and Non-Clinical Research segments are the most mature with the oldest relative companies, the highest proportion publicly traded, and the lowest levels of employee productivity (e.g., revenue per employee). Segment maturity is a function of historical receptivity by pharmaceutical, biotechnology and medical device companies to outsource high fixed cost, manufacturing and labor-intensive activities that are deemed non-core. Relative to the other segments, the Clinical Research Services segment is one of the most productive with the highest proportion of privately held companies.

The Other Services segment remains too diverse, making it difficult to characterize this segment adequately. In the future, Tufts CSDD will look to refine the definition of this segment to ensure that it is a more homogeneous group of companies.

At the present time, Tufts CSDD is analyzing contract services company data by geographic cluster to better understand the economic impact of each market segment locally. In addition, Tufts CSDD plans to apply this more robust methodology to sizing the overall contract services market in Europe and in other major global regions.

Drug and device innovation is evolving and re-inventing itself continually. As R&D costs rise, operating and regulatory complexity increases, and mergers, acquisitions and consolidation continue, the use of contract service providers as integral and integrated sourcing providers will similarly continue to grow. It is our hope that the analysis and results contained in this article will play a role in improving future assessments of the size and structure of the outsourcing landscape.

---

Kenneth Getz, MBA, is Senior Research Fellow and Assistant Professor at Tufts Center for the Study of Drug Development. He can be reached at kenneth.getz@tufts.edu. Mary Jo Lamberti, Ph.D., is Senior Project Manager at Tufts CSDD. Stella Stergiopoulos is project manager, Tufts CSDD.  Adam Mathias is Research Analyst, Tufts CSDD. This project was funded by an unrestricted grant from the Kansas Bioscience Authority (KBA).

Source:

http://www.contractpharma.com/issues/2012-06/view_features/resizing-the-global-contract-rd-services-market/

US cities lose jobs and revenues as big

pharma companies close R&D facilities

By Tony Favro, USA Editor*

9 April 2012: 

In 2007, Pfizer, the pharmaceutical company, closed its research and development facility in Ann Arbor, Michigan, displacing 2100 workers. In 2009, the University of Michigan purchased the vacant site and expected to create two to three thousand jobs over ten years. At the time of the sale, Ann Arbor Mayor John Hieftje expressed mixed emotions. On the one hand, he said in a statement, “If the University of Michigan is able to greatly expand life sciences research in Ann Arbor it will have far-reaching long-term economic benefits for the whole region.” On the other hand, Mayor Hieftje told Crains’ Detroit Business newspaper, “[The deal] has troubling aspects for local government”. Hieftje was referring to the $14 million in local taxes paid by Pfizer, which will not continue since the University of Michigan is a tax-exempt organization.

• Profits versus R&D
• The Government steps in
• Shift in research culture
• Bigger government

The Ann Arbor story is not unique. According to the US Bureau of Labor Statistics, the pharmaceutical industry shed 35,000 in the United States in 2010, the most recent year for which complete data are available. Cities throughout the US were burdened by plant closures. Ann Arbor was luckier than most cities. The University of Michigan employed about 1,700 workers at the former Pfizer site at the end of 2011. These workers are doing much of the research formerly done by Pfizer — and this gets to the heart of the matter. Big pharma companies are abandoning basic drug research, leaving the federal government and universities to pick up the slack.

Profits versus R&D
According to the August 2011 issue of the journal Nature Reviews Drug Discovery, the decline of prescription drug research and development R&D is the result of 15 years of continuous industry consolidations and the drive by drug manufacturers to maximize profits.

Since 2000, for example, Pfizer has acquired three major drug makers, Warner-Lambert, Pharmacia, and Wyeth, closing research centers with each acquisition. “These [closed] sites housed thousands of scientists, and many major drugs were discovered there,” the journal notes. “The same pattern has been observed after most of the mergers and acquisitions by other major pharmaceutical companies during the past decade.”

Profit is another reason big pharma companies are abandoning basic research. Over the past couple of decades, big drug firms competed to produce blockbuster drugs that yielded huge payoffs. Drugs such as Merck’s Vioxx and Pfizer’s Lipitor generate several billion dollars in annual sales and reap big profits for their makers. The fierce competition leads to costly duplication of work with as many as 20 companies vying to be the first to come out with the next blockbuster drug. The stakes for drug companies become higher as patents expire for popular and profitable drugs and revenue streams dry up.

The potentially enormous profits of a breakthrough discovery, however, are proving too elusive to offset the heavy upfront costs of basic research and development, an estimated 10 to 20 per cent of total expenditures. As a researcher told the Rochester Business Journal, “The days of the blockbuster drug are over”.

Businesses survive by making money for their shareholders, and when part of a business can no longer reliably generate profits — in this case, basic drug research — the unprofitable part is understandably jettisoned.

This makes good business sense, but poor public policy. People need pharmaceuticals — in many instances, it’s a question of life or death — and so the federal government has had to fill the void left by drug companies’ retreat from basic and early-stage research.

The government steps in
Over the past few years, the federal National Institutes of Health has invested hundreds of millions of dollars to build a drug-discovery infrastructure. Most of the federal expenditures have been used to establish a network of 60 “clinical translational centers” at research universities. These centers are changing the direction of pharmaceutical research and creating new opportunities for public-private collaborations.

In essence, the emerging drug-development model in the USA has big pharmaceutical firms coming in at a later stage to market and distribute drugs that have been discovered and tested by university researchers and small, private biotech companies.

The emerging model promises to greatly expand opportunities for universities to earn royalties from pharmaceutical companies. The federal funding for “translational” research also incentivizes entrepreneurship at universities. Universities that develop and hold patents are expected to translate that knowledge into jobs, not only by contracting with big pharma but also by incubating and spinning-off small, private drug-development companies. In the federal model, big drug makers will strike licensing deals directly with universities or with small companies, primarily university spin-offs. One potential benefit of the new model is that entire categories of drugs previously ignored by big pharma because of their low-profitability may now be brought to market.

Shift in research culture
Federal monies are helping build a research infrastructure at the university level to bring basic discoveries to market as well as catalyze broader economic growth. This requires a culture shift at both universities and businesses. Traditionally, a scientific advance by a university professor might end as a research paper read by a few colleagues in the same field. In the clinical translational model supported by the National Institutes of Health, scientists must collaborate with colleagues in different fields — the chemist with the engineer and sociologist and marketing professor, for example. Drug companies also have to discuss their research and results with academics and with their counterparts at different drug firms. They can no longer label such information as proprietary and keep it to themselves.

Bigger government
Critics of big government should take note: when businesses contract, government often has to expand to protect citizens. Businesses may create jobs, but they will also pass their costs to taxpayers when they can. Large drug companies consider delivering a return to shareholders their first duty, and therefore cut R&D that drains short-term profits. But short-term business sense may threaten public health and even the profitability of corporations since, over the long-term, a less-healthy labor pool could drive up the cost of doing business.

And sometimes government requirements and mandates, such as the clinical translational research model, can spark economic growth. According to Dr. Karl Kieburtz of the University of Rochester, one of the first universities to be funded by the National Institutes of Health, “We are looking at many things, surgical devices and other things, not just drugs.” The University of Rochester, which purchased a building that Wyeth vacated for research, has already spun-off 30 companies. As multinational pharmaceutical companies unload more of their marginally-profitable but publicly-indispensible activities, the public and nonprofit sectors will have to fill the gap.

The effect on US city governments is uneven. Cities will lose jobs and property tax revenues when pharmaceutical companies close their R&D facilities. Cities fortunate enough to have a university with a translational research center should eventually recover their losses and more.

*Tony Favro also maintains the blog Planning and Investing in Cities.

Source:

http://www.citymayors.com/economics/usa_big_pharma_cities.html#Anchor-Profits-49575

Share this:

• X
• LinkedIn
• Facebook
• Print
• Email

Like this:

Like Loading…

Read Full Post »

« Newer Posts - Older Posts »

• Follow Blog via Email

  Enter your email address to follow this blog and receive notifications of new posts by email.

  Email Address

  Follow

  Join 2,041 other subscribers

• Recent Posts

  • FDA Moves Forward With Its Guidance Framework for Rare Disease Trials: 2026 August 3, 2026
  • Artificial Intelligence TRANSFORMS Medicine, Biotech and Healthcare, How? August 3, 2026
  • In Memoriam: Nobel Laureate J. Michael Bishop for discovery of Retroviral Oncogenes July 31, 2026
  • Companies Actively Engaging Artificial Intellegence for Drug Design: 2026 July 31, 2026
  • AI-Native Drug Discovery Landscape 2026 – How LPBI Group Differentiates in the New Era of Foundation Models July 19, 2026
  • In Memoriam: In Remembrance of Cancer Researchers who passed in 2026 July 13, 2026
  • Urgent Request for Action on Proposed Rule Affecting Federal Funding Grant Review July 7, 2026
  • 2026 Tang Prize in Biopharmaceutical Science Awarded to Three Pioneers of Cellular Immunotherapy Revolutionizing Treatments for Blood Cancers and Solid Tumors July 5, 2026
  • Protected: KOL on Competitive Dynamics: LPBI Group’s Founder’s Radar Screens on AI-in-Health, Life Sciences & BioPharma June 15, 2026
  • Tumor Infiltrating Lymphocytes (TIL) as a first of kind FDA approved immunotherapy for cancer June 12, 2026

• Archives

  Archives Select Month August 2026  (2) July 2026  (6) June 2026  (4) May 2026  (1) January 2026  (10) December 2025  (8) November 2025  (8) October 2025  (12) September 2025  (2) July 2025  (4) June 2025  (8) May 2025  (4) April 2025  (2) March 2025  (1) February 2025  (2) January 2025  (3) December 2024  (1) November 2024  (5) October 2024  (7) September 2024  (7) August 2024  (1) June 2024  (1) May 2024  (2) April 2024  (2) January 2024  (1) November 2023  (1) October 2023  (3) September 2023  (3) August 2023  (2) July 2023  (2) June 2023  (7) May 2023  (4) April 2023  (2) March 2023  (5) February 2023  (2) January 2023  (3) December 2022  (2) October 2022  (6) September 2022  (2) August 2022  (1) July 2022  (3) June 2022  (3) May 2022  (8) April 2022  (10) March 2022  (7) February 2022  (7) January 2022  (3) December 2021  (3) November 2021  (4) October 2021  (11) September 2021  (5) August 2021  (8) July 2021  (21) June 2021  (8) May 2021  (10) April 2021  (8) March 2021  (15) February 2021  (17) January 2021  (20) December 2020  (10) November 2020  (12) October 2020  (26) September 2020  (17) August 2020  (22) July 2020  (27) June 2020  (33) May 2020  (26) April 2020  (42) March 2020  (22) February 2020  (11) January 2020  (7) December 2019  (20) November 2019  (13) October 2019  (11) September 2019  (3) August 2019  (8) July 2019  (25) June 2019  (47) May 2019  (40) April 2019  (27) March 2019  (29) February 2019  (17) January 2019  (50) December 2018  (14) November 2018  (17) October 2018  (18) September 2018  (17) August 2018  (8) July 2018  (20) June 2018  (22) May 2018  (17) April 2018  (12) March 2018  (20) February 2018  (26) January 2018  (16) December 2017  (6) November 2017  (20) October 2017  (13) September 2017  (16) August 2017  (16) July 2017  (19) June 2017  (20) May 2017  (32) April 2017  (21) March 2017  (10) February 2017  (24) January 2017  (21) December 2016  (43) November 2016  (8) October 2016  (40) September 2016  (67) August 2016  (59) July 2016  (75) June 2016  (37) May 2016  (95) April 2016  (152) March 2016  (175) February 2016  (196) January 2016  (139) December 2015  (90) November 2015  (287) October 2015  (237) September 2015  (115) August 2015  (96) July 2015  (63) June 2015  (44) May 2015  (53) April 2015  (76) March 2015  (95) February 2015  (83) January 2015  (75) December 2014  (75) November 2014  (88) October 2014  (135) September 2014  (117) August 2014  (88) July 2014  (88) June 2014  (109) May 2014  (60) April 2014  (85) March 2014  (58) February 2014  (72) January 2014  (107) December 2013  (104) November 2013  (136) October 2013  (62) September 2013  (32) August 2013  (46) July 2013  (74) June 2013  (110) May 2013  (112) April 2013  (86) March 2013  (92) February 2013  (63) January 2013  (63) December 2012  (46) November 2012  (71) October 2012  (84) September 2012  (82) August 2012  (122) July 2012  (59) June 2012  (34) May 2012  (46) April 2012  (2)

• Categories

  Categories Select Category 3D Printing for Medical Application  (239)    3D Plotting Scaffolds  (44)    BioInks  (34)       Biopolymer Blend Open Porous  (18)       Dental Applications  (10)    BioPrinting in Regenerative Medicine  (77)       Cell Level  (16)       MicroEngineering Cell-Tissue & Systems  (31)       Tissue Engineering  (37)    Cardiovascular and Vascular Systems  (30)       Artificial Vascular Structures  (9)       Cardiovascular Tissue  (8)    Drug Development using MultiOrgan Chip  (11)    Drug Development/Formulation using 3D Printing  (10)    MEMS  (16)       Bio-MEMS  (12)    Organ-on-a-Chip  (11)    Programmable Sensors (Carbon Nano Tubes)  (5) 3rd Party IP: Drug DIscovery  (1) 4D Printing and Meta Materials  (10) Academic Publishing  (223)    Key Opinion Leaders in eScientific Publishing – Interviews with  (8) Advanced Drug Manufacturing Technology  (96)    Antimalarial Preparation  (8)    Autologous Cell Therapy  (14)    Automated Cell Processing  (13) Allergy and Infectious Diseases  (12) Alzheimer’s Disease  (163)    Etiology  (77)    Medical Device Therapies for Altzheimer’s Disease  (15)    Pharmacotherapy and Cell Activity  (51) Anticancer Resistance  (31) Art Exhibits on the Human Condition  (1) Art Inspires Science  (4) Article Type  (2)    Authored  (1)    Curated  (2)    Scientific report  (1) Artificial Heart  (2) Artificial Intelligence – General  (239)    An executive’s guide to AI  (11)    Artificial Intelligence – Breakthroughs in Theories and Technologies  (119)    Artificial Intelligence Applications in Health Care  (130)       Artificial Intelligence in CANCER  (42)       Artificial Intelligence in Health Care – Tools & Innovations  (77)    Artificial Intelligence in Medicine – Application for Diagnosis  (72)       Artificial intelligence applications for cardiology  (33)          AI-assisted Cardiac MRI  (10)       Artificial Intelligence in Psychiatry  (7)       Deep Learning in Pathology  (19)    Artificial Intelligence in Medicine – Applications in Therapeutics  (71)    ChatGPT, GPT-4  (7)       ChatGPT at LPBI Group  (3)       ChatGPT in Academic Education  (3)    Machine Learning  (73)       Deep Learning  (26)       Natural Language Processing (NLP)  (45)    Machine learning in predicting type 2 diabetes  (6) Auditory and vision  (13) Autism Spectrum Disorders  (10) Autoimmune Inflammatory DIseases  (24)    Crohn’s disease  (5)    Tolerance-inducing Autoimmune Disease Therapeutics  (6)    Ulcerative Colitis  (3) Autophagosome  (4) Bacterial Resistance  (25) Behavior  (26) Behavioral Genetics  (21) Big Data  (88)    Intelligent Information Systems  (51) Bio Instrumentation in Experimental Life Sciences Research  (368)    Analytical Instruments Industry  (5)    Microfuidics  (8) Bio-Ethics  (16) BioBanking  (36) Biodegradable Drug-eluting Material  (8) Bioengineering & reverse engineering design  (43) BioIT: BioInformatics  (147) BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics  (135)    Advanced Computing Platform  (32)       Blockchain Transactions System  (6)          Platform for Content Monetization embedded Content Promotion  (1)    Pancreatic adenocarcinoma classifier  (4)    Simulation Modeling in NGS  (5) Biological Engineering  (43) Biological Networks  (193) Biological Networks, Gene Regulation and Evolution  (479)    Virology  (10) Biomarkers & Medical Diagnostics  (571)    VOC – Volatile Organic Compounds as BioMarkers  (2) Biomedical Measurement Science  (173) BioSimilars  (112) BioTechnology – Venture Creation  (133)    Foundations for supporting Science and Education  (14)    Philanthropy to Academic Institution  (3) BioTechnology – Venture Creation, Venture Capital  (110)    Seeking Talent  (3) BiVAD  (1) Blindness  (6) Bone Disease and Musculoskeletal Disease  (82) Brain Basis of Emotion  (5) Business Career Consideration  (1) Ca2+ triggered activation  (61) Calcium  (21) Calcium Signaling  (71) Calmodulin Kinase and Contraction  (36) Cancer – General  (186) Cancer and Current Therapeutics  (412)    interventional oncology  (49)       Breast Cancer – impalpable breast lesions  (20)       Prostate Cancer: Monitoring vs Treatment  (9) CANCER BIOLOGY & Innovations in Cancer Therapy  (1,127)    Anaerobic Glycolysis  (51)    Cachexia  (18)    Cancer Genomics  (85)       Circulating Tumor Cells (CTC)  (27)          Liquid Biopsy Chip detects an array of metastatic cancer cell markers in blood  (17)             mRNA  (6)          MagSifter chip  (1)       KRAS Mutation  (9)       Li-fraumeni syndrome.  (4)       TP53 – Germline mutations  (9)    cancer metabolism  (28)    Funding Opportunities for Cancer Research  (13)    Genomic Expression  (150)    Glioblastoma  (7)    Hexokinase  (14)    Loss of function gene  (18)    Metabolic Immuno-Oncology  (21)    Metastasis Process  (15)    Methylation  (33)    Microbiome and Responses to Cancer Therapy  (10)    Monoclonal Immunotherapy  (29)    mtDNA  (13)    Oxidative phosphorylation  (56)    Pancreatic cancer  (10)    Pyruvate Kinase  (27)    The NCI Formulary  (1)    tumor microenvironment  (16)    Warburg effect  (50) Cancer Informatics  (104) Cancer Prevention: Research & Programs  (132) Cancer Screening  (108) Cancer Vaccines: Targeting Cancer Genes for Immunotherapy  (30)    Engineering Enhanced Cancer Vaccines  (3) cancer-general  (7) Cardiac and Cardiovascular Surgical Procedures  (328)    Aortic Valve: TAVR, TAVI vs Open Heart Surgery  (91)       Prosthesis-Patient Mismatch (PPM) in TAVI vs SAVR  (2)       TAVI vs Open Heart Surgery  (6)       Transcatheter Aortic Valve Replacement via the Transcarotid Access  (3)       Transcaval TAVR Procedure  (3)       Valve-in-Valve Procedure  (5)    Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias  (18)    BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy  (1)    CABG  (47)    Cancer Surgery of the Heart  (10)    Cardiovascular Fluid Management: algorithms  (1)    Heart Transplant  (16)    Heart-Lung Transplant  (11)    Implantation  (3)    Left Main Coronary Artery Disease (LMCAD)  (3)    Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart  (22)    Mitral Valve: Repair and Replacement  (64)       TMVR – Transcatheter Mitral Valve Repair  (5)    PCI  (108)       Bioresorbable Vascular Scaffold (BVS)  (4)       Invasive FFR for PCI  (2)       Multivessel PCI FFR Guidance  (1)       Robotic-assisted percutaneous coronary intervention  (2)       Stent Retriever in endovascular thrombectomy  (3)    Peripheral Arterial Disease & Peripheral Vascular Surgery  (65)       Abdominal Aorta  (20)       Carotid Artery  (15)       Limb ischemia  (4)       Thoracic Aorta  (16)    Pulmonary Valve Replacement and Repair  (3)    Renal Denervation  (20)    Replacement  (1)    Robotically assisted Cardiothoracic Surgery  (2)    Tricuspid Valve Repair  (7)    Vena Caval Filters: Device for Prevention of Pulmonary Embolism and Thrombosis  (2) Cardiovascular Pharmacogenomics  (171) Cargo  (3) Cell Biology  (323) Cell Biology, Signaling & Cell Circuits  (672)    Apoptosis  (17)    Autophagy-Modulating Proteins  (6)    “Antibody–enzyme conjugates”  (6)    Cell Processing System in Cell Therapy Process Development  (27)    Endoplasmic reticulum  (3)    Enzymatic mechanism underlying the synthesis of adenosine triphosphate (ATP)  (3)    Ubiquitin  (11) Cerebrovascular and Neurodegenerative Diseases  (123)    Stroke  (9) Chemical Biology and its relations to Metabolic Disease  (464)    #BIGAxisSummit  (1)    Gut Microbiome and Obesity  (8) Chemical Genetics  (350) Child and Adolescent Psychiatry  (13) Childhood cancer  (17) Childhood malnutrition  (3) children  (4) Circulating Progenitor Cells  (27)    Bone marrow derived cells  (17)    Endothelial cells  (7)    Umbilical cord cells  (6) Clinical & Translational  (239) Clinical Diagnostics  (220)    Mass automation of plasma proteins  (13) Clinical Genomics  (144) Coagulation Therapy and Internal Bleeding  (83) Cognition  (47) Commercialization  (20) Components and IRB related issues  (4) Computational Biology/Systems and Bioinformatics  (470)    Computational Histopathology  (3)    Meta-analysis of transcriptome data  (10) Conference Coverage with Social Media  (494)    MassBio  (3) coronavirus  (18) COVID-19  (20) CRISPR/Cas9 & Gene Editing  (192)    CRISPR alternative for editing genes without cutting  (14)       CAST – Alternative to CRISPR/Cas9  (3)       Transposon-encoded CRISPR–Cas systems direct RNA-guided DNA integration  (4)    CRISPR applied to Human Germ Line  (13)       Gene Editing Impact on Longevity  (6) CT  (20) Cytokines  (21) Cytoskeleton  (85) Developmental biology  (107) Diabetes Mellitus  (146)    Artificial Pancreas for Type 2 Diabetes  (4)    Artificial Pancreas for Type1 Diabetes  (8)    Gestational diabetes  (5) Diagnostic Immunology  (61) Diagnostics and Lab Tests  (128)    Liquid Biopsy: Circulating Tumor Cells in Urine and Blood  (9) Digital HealthCare – biotech & internet joint ventures  (47) Disease Biology  (334) Disease Biology, Small Molecules in Development of Therapeutic Drugs  (488) DNA repair  (73)    Apoptosis  (13)    Autophagy  (13)    Cell death pathways  (19)    Proteolysis  (8)    Proteosome  (8) Drug Delivery Platform Technology  (159)    Drug Carrier Design  (21)       Medication Remote Compliance Monitoring  (3)    Exosomes: Natural Carriers for siRNA Delivery  (9) Drug Toxicity  (74) Ecosystems & Industrial Concentration in the Medical Device Sector  (172)    Cardiac & Vascular Repair Tools Subsegment  (128)    Exec Compensation in the Cardiac & Vascular Repair Tools Subsegment  (14)    Massachusetts Niche Suppliers and National Leaders  (20) Electronic Health Record  (10) Embryology  (24) Empathy  (6) Endocrine Diseases  (60) Enzyme Induction  (46)    ion-transporting enzyme  (2)    K + -ATPase.  (1)    Na +  (2) Epigenetics and Environmental Factors  (35) Ethics and Leadership  (10) Executive Compensation – Big Pharma  (3) Fat soluble vitamins  (4) FDA  (72) FDA Regulatory Affairs  (359)    FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning – GCP, GLP, ISO 14155  (52)    ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics  (30) Fetal Ultrasound  (2) Fiction and medicine  (5) Frontiers in Cardiology and Cardiovascular Disorders  (929)    Acute Myocardial Infarction  (63)       Cardiogenic Shock  (5)    Anemia in CVD Patients  (6)    Cardio-Oncology  (4)    Cardiomyopathy  (57)    Cardiovascular Research  (187)       Myocardial metabolism, Myocardial ischemia, myocardial perfusion, Myocardial adenine nucleotide metabolism  (64)       Pre-Clinical Animal Model Development  (23)    Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH)  (20)    Cost of Inpatient Stay for Cardiovascular Diagnosis for Admission  (1)    Electrophysiology  (111)       Ablation Procedure vs Drug Therapy  (2)       Arrhythmia Detection with Machine Learning Algorithms  (7)       Cardiotoxic Risks of Immune Checkpoint Inhibitors  (1)       Genomic Analysis of EKG Electrophysiology Genomics  (3)       implantable cardioverter defibrillator (ICD) and External Defibrillation  (1)       implantable pacemaker  (2)       Rare heart rhythm disorders and Long QT syndrome (LQTS)  (7)    Epigenetics and Cardiovascular Risks  (57)    Heart Failure (HF)  (51)       Acute coronary syndrome  (7)       congestive heart failure  (19)       Hypertensive Disorders of Pregnancy  (1)    Medical Devices R&D and Inventions  (212)       Assist Devices: LV  (3)       RV  (1)       Stents & Tools  (90)       Valves & Tools  (67)    Origins of Cardiovascular Disease  (422)       Atherogenic Processes & Pathology  (180)       Congenital Heart Disease  (34)          Genetic Mutations in Congenital Heart Disease  (4)       inflammation independent of lipid levels  (13)       Systemic Inflammatory Diseases as CVD Risk  (12)    Pharmacotherapy of Cardiovascular Disease  (356)       HTN  (176)       HTN in Youth  (8)       Resident-cell-based  (43)       Subarachnoid Hemorrhage (SAH)  (1)       Transthyretin amyloid cardiomyopathy (ATTR-CM)  (1)    Spontaneous Coronary Artery Dissection (SCAD)  (6)    Stroke  (15)       endovascular thrombectomy  (6)    Vascular Diseases  (21)       mesenteric ischemia  (3) Future Pandemics Inform-graphics  (1) Gastroenterology  (38) Gene Regulation  (233) Gene Regulation and Evolution  (137) Genetics & Innovations in Treatment  (176) Genetics & Pharmaceutical  (204) Genome Biology  (967)    Exosomes  (25)    Gene Therapy & Gene Editing Development  (42)    mRNA Therapeutics  (20)    Mutagenesis  (27)    Single Cell Genomics  (25)    Single-cell sequencing  (20)    Variation in human protein-coding regions  (35) Genomic Endocrinology  (42) Genomic Testing: Methodology for Diagnosis  (416) Genomics Pharmacy  (40) Global Market of Medical Devices Technology  (3) Global Medical Publishers by Country  (3) Global Partnering & Biotech Investment  (48) GLP  (4) Glycobiology: Biopharmaceutical Production  (16) Glycobiology: Biopharmaceutical Production, Pharmacodynamics and Pharmacokinetics  (28) Health Care System by Country  (58)    AI Models in Healthcare  (12)    Centers for Medicare & Medicaid Services  (8)    Health in Israel  (2)    India  (1)    United States  (27)       Hospital-based Medical Innovations  (10)       Medical Recertification and Maintenance of Certification (MOC)  (1) Health Economics and Outcomes Research  (384)    Women Health  (18)       Heart and Brain Disease in Women  (3) Health Law & Patient Safety  (165)    and Bioethics  (14)    Biotechnology  (12)    Health Law Policy  (13) HealthCare IT  (139) Healthcare Reform  (118)    Accountable Care Organizations  (26)    Affordable Care Act  (29)       Repair  (1)       Repeal ACA  (1)       Replace  (1)    Federal Budget Appropriations  (27)    Healthcare costs and reimbursement  (59)    Indigent Nutrition  (14)    Medicare and Medicaid  (20)    Prescription Drugs Costs  (21)    Skilled Nursing Facilities  (6)    Technology Capital Expenses  (15)    Uninsured and Underinsured  (20) Hematology  (100)    Acute lymphocytic leukemia  (18)    Acute myelocytic leukemia  (21)    Hematopoiesis  (48)    Lymphoma  (21) History and physical exam  (6) Human aging  (27) Human Immune System in Health and in Disease  (246) Human Sensation and Cellular Transduction: Physiology and Therapeutics  (21) Image Processing/Computing  (41) Imaging-based Cancer Patient Management  (116) Immuno-Oncology & Genomics  (133)    mRNA platform in Drug DIscovery  (6) Immunodiagnostics  (141)    Cancer-Immune Interactions  (31)    CNS-Immune Interface  (5)    Neuronal Circuits  (4) Immunology  (123)    Adaptive Immune Response to Biomaterials and Tissue Repair  (13)    Antibody Responses Predict Antigen Exposure  (17)    Cytokine Receptor Structure  (8)    Human Antibody Response  (18)    Human Circulating Antibody Repertoire  (11)    Human Naive B Cell Repertoire  (8)    MHC Repertoires for Antigen Prediction  (8)    Protection Against Autoimmune Disease  (11)    Synthetic Immunology: Hacking Immune Cells  (15) Immunotherapy  (136)    CAR-T  (16)    combination immunotherapies.  (15)    Efficacy of Anti-Tumor T Cells  (15)    Engineering Better T Cells  (10)    Immune Engineering  (18)    Immune Modulatory  (16)    Integrin-targeted Combination Immunotherapy  (6)    Modulating Macrophages in Cancer Immunotherapy  (17)    NK Cell-Based Cancer Immunotherapy  (20)    Synergistic Innate and Adaptive Immunotherapy  (14) Income Disparity  (2) Infectious Disease & New Antibiotic Targets  (162)    Antibiotic resistance  (7)    Viral diseases  (37)       Myocarditis  (1) Infectious Disease Immunodiagnostics  (58)    Virology – Vector-borne DIsease  (17) Inflammasome  (29)    Anti-tumor necrosis factor drugs (TNF inhibitors)  (3) Innovation in Immunology Diagnostics  (111)    Universal Immune Cell Therapies (uICT)  (11) Innovations  (186)    R&D Expenditure  (8) Innovations in Neurophysiology & Neuropsychology  (145)    Age and Life Expectancy  (3)    autism spectrum disorder  (1)    Circadian Rhythm and Sleep  (6)    hNPCs  (1)    Nervous System Function  (2)    Relapsing Multiple Sclerosis  (1) Intellectual Property  (85)    Disputes and Settlements  (9)    IP Valuation Models – Pricing Intangible Assets  (7)    Patent Law in Biotech  (12) Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough  (121) International Global Work in Pharmaceutical  (191) Interventional Oncology: Radiofrequency Ablation, Transarterial Chemoembolization, Microwave Ablation and Irreversible Electroporation (IRE)  (12) Interviews with Scientific Leaders  (319)    Albany Medical Center Prize in Medicine and Biomedical Research  (3)    Annual Breakthrough Prize  (4)    Annual Lewis S. Rosenstiel Award  (2)    Awards in Cardiology and Cardiovascular Medicine  (6)    CEOs of Biotech Companies  (3)    Gerald D Aurbach Award for Outstanding Translational Research  (2)    Interviews with Key Opinion Leaders (KOLs)  (11)    James Prize in Science and Technology Integration  (2)    Jessie Stevenson Kovalenko Medal – Medical Sciences  (2)    Lemelson-MIT Prize  (2)    Life Sciences Breakthrough Prize  (6)    Mosteller Statistician of the Year Award  (2)    Mourning the Loss of a Scientific Leader  (6)    National Academy of Sciences AWARDS  (4)    Nobel Prize Winners  (30)    Noble Prize (Not Nobel Prize)  (2)    Paul Marks Prize for Cancer Research  (2)    Russ Prize recognizes bioengineering achievements worldwide  (2)    The Dan David Prize  (6)    Warren Alpert Foundation Prize Recipients  (4)    Wolf Prize  (2)    Wolf Prize in Medicine  (2)    women in science  (5) Investment in Technological Breakthrough  (60) Ionic Transporters Na+  (25) IP Development by LPBI Group Team  (14) IP Development by LPBI Group Team & Other Organizations  (8) ISO 14155  (3) Joint Venture – SBH & M3DP: SOP and Arrangements  (1) Justice & Law  (1) K  (15) Lab-on-a-chip  (2) Landscape  (1) Lasers and photonics  (18)    Midrange IR spectroscopy  (1) Law and Medicine Conflicts  (15) Leadership, Power, Social Interlocking Connections  (13) Lipid metabolism  (109)    Fatty acids  (38)    Lipids  (38)    PCSK9 Inhibitor Therapy  (19) Lipidomics  (11) Liposome  (4) Liver & Digestive Diseases Research  (122) LPBI Group, e-Scientific Media, DFP, R&D-M3DP, R&D-Drug Discovery, US Patents: SOPs and Team Management  (143)    Award Nominations  (5)    BioMed e-Books e-Series by LPBI Group  (9)    Feedback from Investors: LPBI Portfolio of Five Businesses  (2)    LPBI Group Founder – Aviva Lev-Ari  (27)    PhD  (1)    RN  (1) LPBI Management  (23) Massachusetts Academy of Sciences (MAS)    (2) Materials Science & Engineering  (37)    Organic BioElectronics  (2) Math  (13)    Great Discoveries  (7) Mechanical Assist Devices: LVAD  (4) Medical and Population Genetics  (193) Medical Devices R&D Investment  (242)    21st Century Cures Act  (2)    CE Mark & Global Regulatory Affairs: process management and strategic planning – GCP  (14)    Rhythm management device hardware: dual-chamber pacemakers  (1)       Systolic HTN  (1) Medical Imaging Technology  (59) Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound  (164)    Circumferential-Intravascular-Radioluminescence-Photoacoustic-Imaging (CIRPI)  (3)    Echocardiography  (3)    MRI  (18)    Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT  (6)    Ultra Sound  (10) Melatonin & Circadian Regulation  (9) memory loss  (1) Metabolism  (239)    Biochemical pathways  (144)       Enzymes and isoenzymes  (73)          Dehydrogenase  (16)          Kinase  (28)          Phosphatase  (9)          Phosphorylase  (22)          tyrosine decarboxylases  (3)    Inosine nucleotides  (9)    Leloir pathway  (6)    microbiome  (7)    Pentose monophosphate shunt  (14)    Pyridine nucleotides  (28)       Pyridine nucleotide transhydrogenase  (7) Metabolomics  (321) Methods  (37) Mg++  (10) Microbiologial genetics  (36) Microbiology  (68)    Virology  (14) Micronutrients  (16) Microvesicle  (7) Microwave Ablation and Irreversible Electroporation (IRE)  (1) Mobile Healthcare  (5) Molecular Genetics & Pharmaceutical  (377)    Organoids  (3) Monoclonal antibody therapy  (14) Mutant Gene Expression  (42) Myocardial adenine nucleotide metabolism  (6) Myocardial Ischemia  (26) Myocardial Metabolism  (36) Na-K transport  (40) Na-K-ATPase  (27) Nanotechnology for Drug Delivery  (99) Nephrology  (46) Nephrology & Regenerative medicine  (9) Neurodegenerative Diseases  (89)    hNPCs  (3)    MS  (5) Neurohumoral Transmission  (68)    Ca2+ triggered activation  (21)    Calmodulin  (13)    Parkinson’s disease dyskinesia levodopa  (3)    PKC  (13)    Synaptic vesicle  (20) Neurological Diseases  (121) Neuroscience  (126) Next Generation Sequencing (NGS)  (27)    Nanopore sequencing  (1) NIH Common Fund  (1) Nitric Oxide in Health and Disease  (136) Nuclear Medicine  (11) Nutrigenomics  (68) Nutrition  (195)    Nutritional Supplements: Atherogenesis, lipid metabolism  (50) Nutrition and Phytochemistry  (62)    Minerals in Medicine  (4)    Plant extract  (22) Nutrition Disorders  (31) Nutritional Supplements: Atherogenesis  (31) Obesity  (19) Oligonucleotide Therapeutics & Delivery  (7) Oncolytic virus & OncoViro-Therapy  (23)    Synthetic Virology  (1) Organ-on-a-Chip & 3D Printing in Life Sciences  (7) Pain: Etiology, Genetics & Innovations in Treatment  (24) Parasitology  (5)    Malaria  (4)    Tropical diseases  (1) Patents  (35) Patient Experience  (66)    Art therapy  (1)    Hospital reputation  (7)    Humor  (1)    Music therapy  (2)    Pain Alleviation  (7)    Patient Outlook  (28)    Reputation of Interventionist  (4)    Support Staff  (13)    Supportive therapies  (6)       laughfter  (1)    Surgical Procedure  (9) Patient Experience: Personal Memories of Invasive Medical Intervantion  (30) Patient’s Voice: Personal Experience with Invasive Medical Procedures  (18) Perioperative Statins at Noncardiac Surgery  (2) Personal Health Applications: Tech Innovations serves HealhCare  (43) Personalized and Precision Medicine & Genomic Research  (739)    Longevity  (3)    New Drug Approval  (6)    Patient-centered Medicine  (39)       cell-based therapy  (9)       stem cell biology and patient-specific  (7)    Personalized Medicine Coalition  (10)    Precision Cancer Medicine  (33) Phagophore  (2) Pharmaceutical Analytics  (261)    Pharmacologic toxicities  (62) Pharmaceutical Discovery  (111)    Rapid automation of plasma protein pools  (18) Pharmaceutical Drug Discovery  (206)    Drug Development Process  (61)       Drug Discovery Chemistry  (33)    drug repurposing  (11) Pharmaceutical Industry Competitive Intelligence  (346)    Pharmacovigilance  (7)    Value-based Drug Pricing  (8) Pharmaceutical R&D Informatics  (45) Pharmaceutical R&D Investment  (301) Pharmacodynamics and Pharmacokinetics  (24) Pharmacogenomics  (161) Photography Collection  (1) Physics  (12) Placenta  (7) Population genetics  (27) Population Health Management  (205)    Evolution of Biology Through Culture  (14)    U.S. Employment-to-Population Ratio  (8) Population Health Management, Genetics & Pharmaceutical  (643)    COVID-19  (157)       Biomarkers: Inflammation  (37)       Cancer Researchers Fighting COVID-19  (14)       COVID-19 effects on Human Heart  (15)       COVID-19: Pandemic Surgery Guidance  (19)       Economic Impact of Coronavirus Pandemic  (41)       number of asymptomatic infections  (27)       Treatment Protocols for COVID-19  (62)    SARS-CoV-2  (141)       Coronavirus Gene Expression  (66)          SARS-CoV-2 circulating variants   (14)          SARS-CoV-2 Viral Variants  (19)       Glycosylation and its Role in SARS-CoV-2 Viral Pathogenesis  (2)       Immune-Mediation (independent immunopathology: lung and reticuloendothelial system)  (30)       Mechanisms of infection by SARS-CoV-2  (21)       SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus  (35)          SARS-COV2 Hijacking the Complement and Coagulation Systems  (19)       Seasonality & Environmental Factors in Resurgence  (26)       Serology tests for coronavirus antibodies  (44)       T-cell response to SARS-CoV-2 infection  (14)       Vaccinology  (51)          Mechanism of Thrombosis with AZ & J&J COVID-19 Vaccines  (5)       Virtual Drug Molecule Screening targeting SAR-CoV-2 proteins  (8)    Virus Infective Acute Respiratory Syndrome: SARS-CoV  (92) Population Health Management, Nutrition and Phytochemistry  (162) Preimplantation Genetic Diagnosis and Reproductive Genomics  (13) Protein-energy malnutrition  (12) Proteomics  (367)    Amino acids  (54)    Proteins  (138) Pulmonary diseases  (16)    Lung and pulmonology  (15) Pulmonary pathology  (8) Radio Frequency (RF)-based Surgical Solutions  (2) REAL TIME Conference Coverage Twitter’s Hashtags and Handles per Presentation/session  (50) Regenerative Biology and Medicine  (92) Regulated Clinical Trials: Design, Methods, Components and IRB related issues  (265) Reproductive Andrology, Embryology, Genomic Endocrinology, Preimplantation Genetic Diagnosis and Reproductive Genomics  (113) Reproductive Biology & Bio Instrumentation  (78) RNA Biology  (81)    RNA interference (RNAi) therapeutic  (4) RNA Biology, Cancer and Therapeutics  (64) RVAD  (1) SBIR, SBA, NIH, NSF  (3) Schizophrenia  (16) Scientific & Biotech Conferences: Press Coverage  (182) Scientific Publishing  (609)    Curation  (585)       Curation methodology  (40)       De novo synthesis  (16)       Dialectic  (17)       Discovery process  (72)       Evolutionary cognition  (52)       Experimental validation  (91)       Explanatory  (91)       Historical relevance  (71)       Technology Advance Assessment of  (69)       Theoretic convergence  (27)    Open Access Journals  (37) Scientist: Career considerations  (198)    Big Data & Analytics  (17)    Data Science  (13)    Women in Life Sciences  (12) Scoop.it  (19) Sensors & Analytics  (18) Sepsis  (2) Severe Autism  (3) Signaling  (102)    Phosphorylation  (43)    S-nitrosylation  (13)    Ubiquitinylation  (34) Signaling & Cell Circuits  (130) single cell sequencing  (3) Small Molecules in Development of Therapeutic Drugs  (71) Social Development  (15) Specialized 3D BioPrinters (Cornea  (1) Statistical Methods for Research Evaluation  (137) Stem Cells for Regenerative Medicine  (177)    Cardiac muscle regeneration  (19)    Competition in regenerative stem cell science  (18)    Human neural progenitor cells  (8)    Skeletal muscle regeneration  (9) STORM  (2) Stress Disorders  (19) Substance Abuse  (4) Systemic Inflammatory Response Related Disorders  (161)    Inflammatory Pathophysiology  (9) Technology Transfer: Biotech and Pharmaceutical  (354) therapeutics  (3) Tissue Engineering and Regenerative Medicine  (22) Tissue Microenvironment  (5) Transarterial Chemoembolization  (2) Transcriptomics  (47) Transformative Technologies in Healthcare  (23) Translational Science  (230)    Best evidence  (52)    Bias measurement tools  (2)    Evidence-based decision-making  (29)    Inferential analysis  (25)    Intra-rater error  (1)    Quality Assurance  (8)    Random Error  (2)    Systematic Error (Bias)  (6)    Total error  (2)    Translational Effectiveness  (49)    Translational Research  (92) Trends in Global Economy  (6) Uncategorized  (1,019) Unfolded Protein Response (UPR)  (6) US and Global Economy: Trends and Findings  (9) Venture Capital  (47)    Income Geographic Distribution  (3)    Institutional Capital Raised by Female Founders  (6) virology  (10) Vision  (7) Voices of Patients and Healthcare Providers  (22) Water Transporters  (8) Wearable Tech + Digital Health  (5) Anemia  (22) Neutropenia  (8) Neutrophilia  (9) Platelet count disorder  (9) Folate and B12  (7) Iron deficiency  (5) Myelodysplasia  (13) Myelofibrosis  (10)

• Meta

  • Log in
  • Entries feed
  • Comments feed
  • WordPress.org

• • 2012pharmaceutical
  • sjwilliamspa