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Bioprinted liver provides early insight into the role of Kupffer cells in TGF-β1 and methotrexate-induced fibrogenesis

Posted in 3D Plotting Scaffolds, 3D Printing for Medical Application, Bio-MEMS, BioBanking, Bioengineering & reverse engineering design, BioInks, Biological Engineering, Biological Networks, BioPrinting in Regenerative Medicine, CANCER BIOLOGY & Innovations in Cancer Therapy, Cell Biology, Cell Level, Disease Biology, Drug Development using MultiOrgan Chip, Drug Development/Formulation using 3D Printing, Drug Toxicity, MEMS, MicroEngineering Cell-Tissue & Systems, Organoids, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmacologic toxicities, Tissue Engineering and Regenerative Medicine, Tissue Microenvironment, Translational Research, tagged 3-D printed liver tissue, 3D bioprinting, 3D tissue, Amnion Foundation, bioprinting, Brigham & Women's Hospital, drug induced liver injury, ECM, Harvard Medical School, hepatoxicity, Liver Tissue Engineeering, National Institutes of Health (NIH) ’s Common Fund, organova, Tissue engineering, toxicology on April 27, 2019| Leave a Comment »

Curator: Stephen J. Williams, PhD

The Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will hold a workshop on “Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models” on Tuesday, April 9, at the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland. This workshop is the latest in the series, “SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety.”

Human 3D bioprinted tissues represent a valuable in vitro approach for chemical, personal care product, cosmetic, and preclinical toxicity/safety testing. Bioprinting of skin, liver, and kidney is already appearing in toxicity testing applications for chemical exposures and disease modeling. The use of 3D bioprinted tissues and organs may provide future alternative approaches for testing that may more closely resemble and simulate intact human tissues to more accurately predict human responses to chemical and drug exposures.

A synopsis of the schedule and related works from the speakers is given below:

8:40 AM–9:20 AM	Overview and Challenges of Bioprinting Sharon Presnell, Amnion Foundation, Winston-Salem, NC
9:20 AM–10:00 AM	Putting 3D Bioprinting to the Use of Tissue Model Fabrication Y. Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology, Boston, MA
10:00 AM–10:20 AM	Break
10:20 AM–11:00 AM	Uses of Bioprinted Liver Tissue in Drug Development Jean-Louis Klein, GlaxoSmithKline, Collegeville, PA
11:00 AM–11:40 AM	Biofabrication of 3D Tissue Models for Disease Modeling and Chemical Screening Marc Ferrer, National Center for Advancing Translational Sciences, NIH, Rockville, MD

Sharon Presnell, Ph.D. President, Amnion Foundation

Dr. Sharon Presnell was most recently the Chief Scientific Officer at Organovo, Inc., and the President of their wholly-owned subsidiary, Samsara Sciences. She received a Ph.D. in Cell & Molecular Pathology from the Medical College of Virginia and completed her undergraduate degree in biology at NC State. In addition to her most recent roles, Presnell has served as the director of cell biology R&D at Becton Dickinson’s corporate research center in RTP, and as the SVP of R&D at Tengion. Her roles have always involved the commercial and clinical translation of basic research and early development in the cell biology space. She serves on the board of the Coulter Foundation at the University of Virginia and is a member of the College of Life Sciences Foundation Board at NC State. In January 2019, Dr. Presnell will begin a new role as President of the Amnion Foundation, a non-profit organization in Winston-Salem.

A few of her relevant publications:

Integrating Kupffer cells into a 3D bioprinted model of human liver recapitulates fibrotic responses of certain toxicants in a time and context dependent manner. This work establishes that the presence of Kupffer cells or macrophages are important mediators in fibrotic responses to certain hepatotoxins and both should be incorporated into bioprinted human liver models for toxicology testing.

Bioprinted 3D Primary Liver Tissues Allow Assessment of Organ-Level Response to Clinical Drug Induced Toxicity In Vitro

Abstract: Modeling clinically relevant tissue responses using cell models poses a significant challenge for drug development, in particular for drug induced liver injury (DILI). This is mainly because existing liver models lack longevity and tissue-level complexity which limits their utility in predictive toxicology. In this study, we established and characterized novel bioprinted human liver tissue mimetics comprised of patient-derived hepatocytes and non-parenchymal cells in a defined architecture. Scaffold-free assembly of different cell types in an in vivo-relevant architecture allowed for histologic analysis that revealed distinct intercellular hepatocyte junctions, CD31+ endothelial networks, and desmin positive, smooth muscle actin negative quiescent stellates. Unlike what was seen in 2D hepatocyte cultures, the tissues maintained levels of ATP, Albumin as well as expression and drug-induced enzyme activity of Cytochrome P450s over 4 weeks in culture. To assess the ability of the 3D liver cultures to model tissue-level DILI, dose responses of Trovafloxacin, a drug whose hepatotoxic potential could not be assessed by standard pre-clinical models, were compared to the structurally related non-toxic drug Levofloxacin. Trovafloxacin induced significant, dose-dependent toxicity at clinically relevant doses (≤ 4uM). Interestingly, Trovafloxacin toxicity was observed without lipopolysaccharide stimulation and in the absence of resident macrophages in contrast to earlier reports. Together, these results demonstrate that 3D bioprinted liver tissues can both effectively model DILI and distinguish between highly related compounds with differential profile. Thus, the combination of patient-derived primary cells with bioprinting technology here for the first time demonstrates superior performance in terms of mimicking human drug response in a known target organ at the tissue level.

A great interview with Dr. Presnell and the 3D Models 2017 Symposium is located here:

Please click here for Web based and PDF version of interview

Some highlights of the interview include

Exciting advances in field showing we can model complex tissue-level disease-state phenotypes that develop in response to chronic long term injury or exposure
Sees the field developing a means to converge both the biology and physiology of tissues, namely modeling the connectivity between tissues such as fluid flow
Future work will need to be dedicated to develop comprehensive analytics for 3D tissue analysis. As she states “we are very conditioned to get information in a simple way from biochemical readouts in two dimension, monocellular systems” however how we address the complexity of various cellular responses in a 3D multicellular environment will be pertinent.
Additional challenges include the scalability of such systems and making such system accessible in a larger way

Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology

Dr. Zhang currently holds an Assistant Professor position at Harvard Medical School and is an Associate Bioengineer at Brigham and Women’s Hospital. His research interests include organ-on-a-chip, 3D bioprinting, biomaterials, regenerative engineering, biomedical imaging, biosensing, nanomedicine, and developmental biology. His scientific contributions have been recognized by >40 international, national, and regional awards. He has been invited to deliver >70 lectures worldwide, and has served as reviewer for >400 manuscripts for >30 journals. He is serving as Editor-in-Chief for Microphysiological Systems, and Associate Editor for Bio-Design and Manufacturing. He is also on Editorial Board of Bioprinting, Heliyon, BMC Materials, and Essays in Biochemistry, and on Advisory Panel of Nanotechnology.

Some relevant references from Dr. Zhang

Multi-tissue interactions in an integrated three-tissue organ-on-a-chip platform.

Skardal A, Murphy SV, Devarasetty M, Mead I, Kang HW, Seol YJ, Shrike Zhang Y, Shin SR, Zhao L, Aleman J, Hall AR, Shupe TD, Kleensang A, Dokmeci MR, Jin Lee S, Jackson JD, Yoo JJ, Hartung T, Khademhosseini A, Soker S, Bishop CE, Atala A.

Sci Rep. 2017 Aug 18;7(1):8837. doi: 10.1038/s41598-017-08879-x.

Reconstruction of Large-scale Defects with a Novel Hybrid Scaffold Made from Poly(L-lactic acid)/Nanohydroxyapatite/Alendronate-loaded Chitosan Microsphere: in vitro and in vivo Studies.

Wu H, Lei P, Liu G, Shrike Zhang Y, Yang J, Zhang L, Xie J, Niu W, Liu H, Ruan J, Hu Y, Zhang C.

Sci Rep. 2017 Mar 23;7(1):359. doi: 10.1038/s41598-017-00506-z.

A liver-on-a-chip platform with bioprinted hepatic spheroids.

Bhise NS, Manoharan V, Massa S, Tamayol A, Ghaderi M, Miscuglio M, Lang Q, Shrike Zhang Y, Shin SR, Calzone G, Annabi N, Shupe TD, Bishop CE, Atala A, Dokmeci MR, Khademhosseini A.

Biofabrication. 2016 Jan 12;8(1):014101. doi: 10.1088/1758-5090/8/1/014101.

Marc Ferrer, National Center for Advancing Translational Sciences, NIH

Marc Ferrer is a team leader in the NCATS Chemical Genomics Center, which was part of the National Human Genome Research Institute when Ferrer began working there in 2010. He has extensive experience in drug discovery, both in the pharmaceutical industry and academic research. Before joining NIH, he was director of assay development and screening at Merck Research Laboratories. For 10 years at Merck, Ferrer led the development of assays for high-throughput screening of small molecules and small interfering RNA (siRNA) to support programs for lead and target identification across all disease areas.

At NCATS, Ferrer leads the implementation of probe development programs, discovery of drug combinations and development of innovative assay paradigms for more effective drug discovery. He advises collaborators on strategies for discovering small molecule therapeutics, including assays for screening and lead identification and optimization. Ferrer has experience implementing high-throughput screens for a broad range of disease areas with a wide array of assay technologies. He has led and managed highly productive teams by setting clear research strategies and goals and by establishing effective collaborations between scientists from diverse disciplines within industry, academia and technology providers.

Ferrer has a Ph.D. in biological chemistry from the University of Minnesota, Twin Cities, and completed postdoctoral training at Harvard University’s Department of Molecular and Cellular Biology. He received a B.Sc. degree in organic chemistry from the University of Barcelona in Spain.

Some relevant references for Dr. Ferrer

Fully 3D Bioprinted Skin Equivalent Constructs with Validated Morphology and Barrier Function.

Derr K, Zou J, Luo K, Song MJ, Sittampalam GS, Zhou C, Michael S, Ferrer M, Derr P.

Tissue Eng Part C Methods. 2019 Apr 22. doi: 10.1089/ten.TEC.2018.0318. [Epub ahead of print]

Determination of the Elasticity Modulus of 3D-Printed Octet-Truss Structures for Use in Porous Prosthesis Implants.

Bagheri A, Buj-Corral I, Ferrer M, Pastor MM, Roure F.

Materials (Basel). 2018 Nov 29;11(12). pii: E2420. doi: 10.3390/ma11122420.

Mutation Profiles in Glioblastoma 3D Oncospheres Modulate Drug Efficacy.

Wilson KM, Mathews-Griner LA, Williamson T, Guha R, Chen L, Shinn P, McKnight C, Michael S, Klumpp-Thomas C, Binder ZA, Ferrer M, Gallia GL, Thomas CJ, Riggins GJ.

SLAS Technol. 2019 Feb;24(1):28-40. doi: 10.1177/2472630318803749. Epub 2018 Oct 5.

A high-throughput imaging and nuclear segmentation analysis protocol for cleared 3D culture models.

Boutin ME, Voss TC, Titus SA, Cruz-Gutierrez K, Michael S, Ferrer M.

Sci Rep. 2018 Jul 24;8(1):11135. doi: 10.1038/s41598-018-29169-0.

A High-Throughput Screening Model of the Tumor Microenvironment for Ovarian Cancer Cell Growth.

Lal-Nag M, McGee L, Guha R, Lengyel E, Kenny HA, Ferrer M.

SLAS Discov. 2017 Jun;22(5):494-506. doi: 10.1177/2472555216687082. Epub 2017 Jan 31.

Exploring Drug Dosing Regimens In Vitro Using Real-Time 3D Spheroid Tumor Growth Assays.

Lal-Nag M, McGee L, Titus SA, Brimacombe K, Michael S, Sittampalam G, Ferrer M.

SLAS Discov. 2017 Jun;22(5):537-546. doi: 10.1177/2472555217698818. Epub 2017 Mar 15.

RNAi High-Throughput Screening of Single- and Multi-Cell-Type Tumor Spheroids: A Comprehensive Analysis in Two and Three Dimensions.

Fu J, Fernandez D, Ferrer M, Titus SA, Buehler E, Lal-Nag MA.

SLAS Discov. 2017 Jun;22(5):525-536. doi: 10.1177/2472555217696796. Epub 2017 Mar 9.

Posted in Pharmaceutical Analytics on March 26, 2019| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

The Boston Chapter of the American Statistical Association (BCASA) invites you all to attend the Third Boston Pharmaceutical Symposium on May 3, 2019 at Pfizer, Building 2, Kendall Sq., Cambridge MA.

As an annual event, the Boston Pharmaceutical Symposium provides a unique venue for sharing statistical applications and research in the biotech-pharma industry, and building connections among all colleagues of the Greater Boston area engaged in the industry statistical practice. We welcome the participation from industry statisticians, academia researchers, as well as university students and any professionals who are interested in pharmaceutical statistical topics.

Third Boston Pharmaceutical Symposium will be a full-day event, featuring a series of invited talks, a poster session, and networking opportunities.

Public transportation and parking: The closest T-stop is the Kendall MIT station on the Red line. Parking is available for a fee of $38 for the day at the garage on-site. Please see Pfizer Event Information for more information on parking garages.

Confirmed Speakers

Craig Mallinckrodt, Distinguished Biostatistician, Biogen
Neal Thomas, Senior Director, Pfizer
Chunlei Ke, Senior Director, Biogen
Ying Yuan, Professor, Department of Biostatistics, University of Texas, MD Anderson Cancer Center
Satrajit Roychoudhury, Senior Director, Pfizer
Matthias Kormaksson, Senior Principal Statistical Consultant, Novartis
Laurence Colin, Director, Novartis

Submit a Poster Abstract

Please consider participating in Third Boston Pharmaceutical Symposium by submitting an abstract to the poster session.

Participants who are interested to have a poster presentation are encouraged to submit an abstract to the poster session. Abstracts need to be submitted by Friday, April 12 to Dr. Olga Vitek via o.vitek@northeastern.edu. Abstracts on topics related to pharmaceutical statistics may include, but are not limited to, adaptive designs, platform trials, umbrella designs, mater protocols, use of machine learning in clinical trials, dose response, wearable devices, analysis of pediatrics studies, etc.

Registration:

All participants in the symposium should register by Friday, April 26. (Late registration may be possible for a higher fee if the event does not sell out.) The registration fee covers a light breakfast, lunch, afternoon snacks, and symposium materials. The registration fee is $165 for industry professionals. Members of the Boston Chapter (BCASA) receive a discounted registration fee at $135. Thanks to support from Cytel, we are able to reduce the registration fees for participants from academic and nonprofit institutions to encourage broader participation. The fees are $60 for a non-BCASA member and $30 for a BCASA member if a participant is from academic or a nonprofit institution and registers with an academic/nonprofit system email address. To register, please go to https://bcasa2019pharma.eventbrite.com

Scientific Committee:

Olga Vitek, Northeastern University (chair)
Weidong Zhang, Pfizer (host)
Wenting Cheng, Biogen
Tim Clough, Novartis
Hrishikesh Kulkarni, Cytel
Andrew Lewandowski, Novartis
Jameson Luks, Cytel
Huyuan Yang, Alnylam Pharmaceuticals

Please contact Dr. Olga Vitek via o.vitek@northeastern.edu for general inquiries.

Acknowledgements: We thank our colleagues at Pfizer for hosting this event. Financial support from Cytel is also gratefully acknowledged.

SOURCE

From: Tom Lane <tlane@mathworks.com>

Date: Tuesday, March 26, 2019 at 4:46 PM

To: Tom Lane <tlane@mathworks.com>

Subject: [BCASA] Third Boston Pharmaceutical Symposium, May 3 in Cambridge

Mathias Baedeker, Michael Ringel & Ulrik Schulze

Posted in Biochemical pathways, Enzymes and isoenzymes, Metabolomics, Neurodegenerative Diseases, Neurological Diseases, Parkinson's disease dyskinesia levodopa, Pharmacodynamics and Pharmacokinetics, Pharmacologic toxicities, tyrosine decarboxylases on January 23, 2019| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Decarboxylase enzymes can convert levodopa into dopamine. In contrast to levodopa, dopamine cannot cross the blood-brain barrier, so patients are also given a decarboxylase inhibitor. “But the levels of levodopa that will reach the brain vary strongly among Parkinson’s disease patients.

The bacterial tyrosine decarboxylase enzyme, which normally converts tyrosine into tyramine, but was found to also convert levodopa into dopamine. “We then determined that the source of this decarboxylase was Enterococcus bacteria.” The researchers also showed that the conversion of levodopa was not inhibited by a high concentration of the amino acid tyrosine, the main substrate of the bacterial tyrosine decarboxylase enzyme.

Carbidopa is over 10,000 times more potent in inhibiting the human decarboxylase,

the higher abundance of bacterial enzyme in the small intestines of rats reduced levels of levodopa in the bloodstream,

positive correlation between disease duration and levels of bacterial tyrosine decarboxylase.

Some Parkinson’s disease patients develop an overgrowth of small intestinal bacteria including Enterococci due to frequent uptake of proton pump inhibitors, which they use to treat gastrointestinal symptoms associated with the disease.

Altogether, these factors result in a vicious circle leading to an increased levodopa/decarboxylase inhibitor dosage requirement in a subset of patients.El Aidy concludes that

the presence of the bacterial tyrosine decarboxylase enzyme can explain why some patients need more frequent dosages of levodopa to treat their motor fluctuations. “This is considered to be a problem for Parkinson’s disease patients, because a higher dose will result in dyskinesia, one of the major side effects of levodopa treatment.“

SOURCE

https://www.rdmag.com/news/2019/01/how-gut-bacteria-affect-treatment-parkinsons-disease?type=cta&et_cid=6585419&et_rid=461755519&linkid=Mobius_Link

Article | OPEN | Published: 18 January 2019

Gut bacterial tyrosine decarboxylases restrict levels of levodopa in the treatment of Parkinson’s disease

Sebastiaan P. van Kessel,

Alexandra K. Frye,

Ahmed O. El-Gendy,

Maria Castejon,

Ali Keshavarzian,

Gertjan van Dijk &

Sahar El Aidy

Nature Communications volume 10, Article number: 310 (2019) | Download Citation

Abstract

Human gut microbiota senses its environment and responds by releasing metabolites, some of which are key regulators of human health and disease. In this study, we characterize gut-associated bacteria in their ability to decarboxylate levodopa to dopamine via tyrosine decarboxylases. Bacterial tyrosine decarboxylases efficiently convert levodopa to dopamine, even in the presence of tyrosine, a competitive substrate, or inhibitors of human decarboxylase. In situ levels of levodopa are compromised by high abundance of gut bacterial tyrosine decarboxylase in patients with Parkinson’s disease. Finally, the higher relative abundance of bacterial tyrosine decarboxylases at the site of levodopa absorption, proximal small intestine, had a significant impact on levels of levodopa in the plasma of rats. Our results highlight the role of microbial metabolism in drug availability, and specifically, that abundance of bacterial tyrosine decarboxylase in the proximal small intestine can explain the increased dosage regimen of levodopa treatment in Parkinson’s disease patients.

Posted in Drug Development Process, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Pharmaceutical Analytics, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment on January 16, 2019| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

BIOBUSINESS BRIEFS

15 JANUARY 2019

In 2018, the FDA approved an all-time record of 62 new therapeutic drugs (NTDs; see Fig. 1 for the definition and the difference compared with new molecular entities). This is consistent with the increase we predicted last year (Nat. Rev. Drug Discov. 17, 87; 2018) and the overall resurgence of R&D in the last 5 years, with an average of 51 approvals per year in this period even with a low count in 2016. This is substantially more than the average of 31 approvals per year in the period 2000–2013 (Fig. 1).

Fig. 1 | **FDA approvals of new therapeutic drugs and aggregate projected peak global annual sales: 2000–2018.** We analysed 2018 FDA approvals of new therapeutic drugs (NTDs), defined as new molecular entities approved by the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), but with two adjustments: first, **we excluded diagnostic imaging agents; and second, we included combination products with at least one new molecular entity as an active ingredient.** The analysis is based exclusively on approvals by the FDA and the year in which the first indication approval took place. All peak sales values were obtained from EvaluatePharma and were inflation-adjusted to 2018 using standard global GDP-based inflators sourced from the Economist Intelligence Unit. To arrive at peak sales for each NTD, we reviewed both historical actual sales as well as the full range of forecast sales that are available from EvaluatePharma and selected the highest value. Sources: EvaluatePharma, FDA and Boston Consulting Group analysis.

**SOURCE**

https://www.nature.com/articles/d41573-019-00004-z

Posted in Drug Development Process, Drug Discovery Chemistry, Pharmaceutical Analytics, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Value-based Drug Pricing on February 27, 2018| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

By GlobalData Healthcare

http://pharmaceuticalintelligence.com

Posted in Conference Coverage with Social Media, Drug Delivery Platform Technology, Drug Development Process, Drug Discovery Chemistry, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Informatics, Pharmaceutical R&D Investment, Pharmacodynamics and Pharmacokinetics, Pharmacogenomics, Pharmacologic toxicities on February 21, 2018| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Dr. Aviva Lev-Ari, PhD, RN, Editor-in-Chief, PharmaceuticalIntelligence.com will be in attendance covering this event for the Press using Social Media via 12 Channels

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Leadership we provide on curation of scientific findings in the eScientific publishing for Medical Education contents.

In Section 1, the Leadership we provide on curation of scientific findings in the eScientific publishing for Medical Education contents is demonstrated by a subset of several outstanding curations with high electronic Viewer volume. Each article included presents unique content contribution to Medical Clinical Education.

· These articles are extracted from the list of all Journal articles with >1,000 eReaders, 4/28/2012 to 1/29/2018.

Article Title, # of electronic Viewers, Author(s) Name

Is the Warburg Effect the Cause or the Effect of Cancer: A 21st Century View?

16,114

Larry H. Bernstein, MD, FCAP

Do Novel Anticoagulants Affect the PT/INR? The Cases of XARELTO (rivaroxaban) and PRADAXA (dabigatran)		11,606	Vivek Lal, MBBS, MD, FCIR, Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN
Clinical Indications for Use of Inhaled Nitric Oxide (iNO) in the Adult Patient Market: Clinical Outcomes after Use, Therapy Demand and Cost of Care		5,865	Aviva Lev-Ari, PhD, RN
Peroxisome proliferator-activated receptor (PPAR-gamma) Receptors Activation: PPARγ transrepression for Angiogenesis in Cardiovascular Disease and PPARγ transactivation for Treatment of Diabetes	1,919			Aviva Lev-Ari, PhD, RN

Bystolic’s generic Nebivolol – Positive Effect on circulating Endothelial Progenitor Cells Endogenous Augmentation

1,059

Aviva Lev-Ari, PhD, RN

Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes

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Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?	1,472		Aviva Lev-Ari, PhD, RN
Treatment of Refractory Hypertension via Percutaneous Renal Denervation	1,085		Aviva Lev-Ari, PhD, RN

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Aviva Lev-Ari, PhD, RN 2012pharmaceutical

3,064 Articles

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avivalev-ari@alum.berkeley.edu

Administrator

3064

2.1 Volume of Articles in the Journal and in the 16 Volume-BioMed e-Series

1. Volume of Articles in the Journal since Journal inception on 4/28/2012:

· Total articles by ALL authors in Journal Archive on 1/29/2018 = 5,288

· ALL articles/posts Authored, Curated, Reported by Aviva Lev-Ari, PhD, RN = 3,064

2. Volume of Articles in the 16 Volume-BioMed e-Series

· Editorial & Publication of Articles in e-Books by Leaders in Pharmaceutical Business Intelligence: Contributions of Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/10/16/editorial-publication-of-articles-in-e-books-by-leaders-in-pharmaceutical-business-intelligence-contributions-of-aviva-lev-ari-phd-rn/

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Editorial & Publication of Articles in e-Books by Leaders in Pharmaceutical Business Intelligence: Contributions of Larry H Bernstein, MD, FCAP

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As BioMed e-Series Editor–in-Chief, Aviva Lev-Ari, PhD, RN was responsible for

· All the documentation (Instruction manuals) on Style setting, and for

· Training all team members

· Journal Articles Format

· Journal Comment Exchange Format

· e-Books Production Process:

1. Volume creation from Journal’s Article Archive,

2. Format Translation from HTML to .mobi for Kindle devices,

3. Proof reading process,

4. Title release,

5. Book electronic Upload to Amazon.com Cloud.

6. Connection of all articles and e-Books to Social Media, Ping back generation by mentioning other related articles published in the Journal

Lastly, 6, below

Title	Date of Publication	Number of Pages
Perspectives on Nitric Oxide in Disease Mechanisms	6/21/2013	895
Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation	11/30/2015	11039 KB
Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics	11/29/2015	12333 KB
Regenerative and Translational Medicine: The Therapeutics Promise for Cardiovascular Diseases	12/26/2015	11668 KB
Genomics Orientations for Personalized Medicine	11/23/2015	11724 KB
Cancer Biology & Genomics for Disease Diagnosis	8/11/2015	13744 KB
Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery	5/18/2017	5408 pages
Metabolic Genomics and Pharmaceutics	7/21/2015	13927 KB
The Immune System, Stress Signaling, Infectious Diseases and Therapeutic Implications	9/4/2017	3747 pages
The VOICES of Patients, Hospitals CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures	10/16/2017	826 pages
Medical Scientific Discoveries for the 21st Century & Interviews with Scientific Leaders	12/9/2017	2862 pages
Milestones in Physiology: Discoveries in Medicine, Genomics and Therapeutics	12/27/2015	11125 KB
Medical 3D BioPrinting – The Revolution in Medicine, Technologies for Patient-centered Medicine: From R&D in Biologics to New Medical Devices	12/30/2017	1005 pages
Pharmacological Agents in Treatment of Cardiovascular Disease	Work-in-Progress, Expected Publishing date in 2018	???
Interventional Cardiology and Cardiac Surgery for Disease Diagnosis and Guidance of Treatment	Work-in-Progress, Expected Publishing date in 2018	???

https://www.biopharmadive.com/news/gilead-kite-car-t-christi-shaw-dealmaking/568767/

Posted in CANCER BIOLOGY & Innovations in Cancer Therapy, CAR-T, Drug Development Process, Drug Discovery Chemistry, Immuno-Oncology & Genomics, Immunotherapy, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmacogenomics on August 30, 2017| Leave a Comment »

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 12/10/2019

For an ‘acquisitive’ Gilead, 2020 will be key test for CAR-T plans

Success for Kite, which O’Day made an independent unit, is critical for Gilead. Not only did the California biotech invest a large sum to buy the CAR-T specialist, it’s the most notable bet made on a future outside of drugs for HIV and hepatitis C.

Sentiment on Wall Street has begun to turn against the wisdom of Gilead’s choice, doubting CAR-T will live up to the promise envisioned by O’Day’s predecessors. One analyst went so far as to include the acquisition among the five most value-destroying biopharma deals of the past decade.

Commercially, sales of Yescarta have grown to $334 million through the first nine months of the year, up from $183 million during the same period last year. Still, marketing CAR-T has proved challenging, with hurdles in reimbursement and in-hospital administration particularly acute.

The coming year could prove consequential in shifting Kite’s trajectory higher.

Within the next few weeks, Gilead will ask regulators to approve its second CAR-T cell therapy, a variation of its currently cleared leukemia and lymphoma treatment Yescarta that’s manufactured differently.

A new site in Europe coming online next year could substantially cut times down for Yescarta delivery there, Shaw said. (Globally, Novartis appears better positioned, with sites in Switzerland and France as well as partnerships in China, Japan and Australia.)

Automation of what’s now a mostly manual process will play an important role in CAR-T’s future too, according to Shaw.

“If we get our autologous cell therapy automated very well, you could imagine one day it could be at point of care,” she said. “We don’t want to be disrupted by someone else doing that.”

Disruption could also come in the form of allogeneic cell therapies, which are constructed using donor T cells rather than autologous treatments that use a patient’s own. Numerous clinical hurdles have made that approach more difficult but companies like Allogene — founded by former Kite executives — are moving ahead.

SOURCE

UPDATED on 5/3/2019

Gilead Sciences tapped new CEO Daniel O’Day in part because of his cancer expertise. But he’s not planning to lead the company’s oncology ramp-up alone.

The Roche veteran intends to bring on a CEO for Gilead’s Kite unit, responsible for key CAR-T drug Yescarta. The new chief will report to O’Day and operate Kite as a separate business unit, JPMorgan analyst Cory Kasimov wrote in a Thursday note to clients.

RELATED: Gilead, looking for cancer sales, swipes Roche pharma chief Daniel O’Day for CEO post

Gilead acquired Kite in 2017 for $12 billion as its hepatitis C revenues, once its bread and butter, crashed. But so far, both Yescarta and Novartis’ rival CAR-T player, Kymriah, have struggled, thanks to a mix of reimbursement and manufacturing challenges.

Kite underperformed expectations once again in the first quarter, with Yescarta’s $96 million in sales for the period checking in below Wall Street consensus of $105 million.

O’Day doesn’t expect to see that trend continue, though. On Gilead’s earnings conference call, he “proclaimed his confidence in cell therapy, noting that it was a critical element of the company’s long term strategy,” Kasimov wrote.

Getting Gilead’s commercial business in order is just one of O’Days three main priorities as he settles into the CEO role, though. After taking the reins March 1, he decided to zero in on strengthening Gilead’s pipeline, in part through M&A. And he’ll also be making organizational tweaks to “ensure the right people are in the right place,” as Kasimov put it.

Gilead is “continuing to scan the entirety” of the M&A landscape and “acknowledges they will continue to ‘look at late stage pipeline,’” while keeping an eye on the company’s areas of expertise—oncology, HIV and hepatitis B and nonalcoholic steatohepatitis, Jefferies analyst Michael Yee wrote to his own clients. And the Big Biotech will be “accelerating internal” candidates in addition to adding bolt-on buys.

RELATED: Gilead executives predict patience—and some deal scouting—from new CEO Daniel O’Day

Unsurprisingly, analysts trained their attention on the call to O’Day’s strategy comments, and “there were literally minimal to no questions about financials,” Yee noted. But that doesn’t mean Gilead turned in a bad quarter. On the contrary, the first quarter was “fairly clean,” he wrote, with revenues of $5.28 billion meeting expectations and earnings per share of $1.76 topping forecasts by 15 cents.

New HIV hotshot Biktarvy stole the show on the revenue side, blowing the $648 million consensus prediction out of the water with $793 million in quarterly sales.

In the quarter, “about 80% of Biktarvy revenue came from switches with 25% from dolutegravir-containing regimens in the U.S.,” Kasimov wrote, referencing key combinations from Gilead’s HIV archrival, GlaxoSmithKline.

SOURCE

https://www.fiercepharma.com/pharma/new-gilead-chief-plots-kite-ceo-hire-pipeline-m-a-and-organizational-tweaks?mkt_tok=eyJpIjoiTTJRM1pUY3pZMkUwWmpkayIsInQiOiJwZTgzWVMwcjhlWUR4Z2RCc1VyalU4ck9GMWh1UUIzamZYbUJGclFhTjZibG1aN05Db0VQRVorWTI2UjdlM1ozcjhIKzVhTzJTVlwvbzlnVFwvRE1uMmpkYnUybXdnbnNrRWxpSTV4UWtyTkJHRWNpVjl6cW5BWGtBemxGM3VoNnh4In0%3D&mrkid=993697

UPDATED on 9/7/2017

Here’s the inside account of Gilead’s 11-week sprint to its $12B Kite buyout – ENDPOINTS NEWS

UPDATED on 8/31/2017

Gilead-Kite: A New Transformative Deal For Biotech, AUG 30, 2017

Gilead has made a big bet on new technology in Kite’s immunotherapy platforms and has reduced the number of credible large players in the space.

With a reputation for intense diligence and dynamism in its business development efforts, Gilead’s management team will only bolster the immunotherapy field as it prepares to face off with Novartis, its immediate competitor, and enters squarely in the province of Merck and Bristol Myers Squibb, two of the leaders in immuno-oncology.

Gilead has reinvented the transformative transaction for the sector.

https://www.forbes.com/sites/stephenbrozak/2017/08/30/gilead-kite-a-new-transformative-deal-and-maybe-the-new-future-of-healthcare-deals/#fc64fca65d49

I attended this week the Cambridge Healthtech Institute’s 4th Annual

Delivering CAR, TCR, and TIL from Research to Reality
August 29 – 30, 2017 | Sheraton Boston | Boston, MA

The following talks on 8/29/2017 presented the frontier of CAR-T Therapies and Technologies from lab to bed side:

Building Better T Cell Therapies: The Power of Molecular Profiling

Mark Bonyhadi, Ph.D., Head, Research and Academic Affairs, Juno Therapeutics

Tricked-Out Cars, the Next Generation of CAR T Cells

Richard Morgan, Ph.D., Vice President, Immunotherapy, Bluebird Bio

The Generation of Lentiviral Vector-Modified CAR-T Cells Using an Automated Process

Boro Dropulic, Ph.D., General Manager and CSO, Lentigen Technology, Inc.

I covered this event in Real Time for the Press

LIVE – 8/29 – CHI’s Oncolytic Virus Immunotherapy and ADOPTIVE CELL THERAPY, August 28-29, 2017 Sheraton Boston Hotel | Boston, MA

https://pharmaceuticalintelligence.com/2017/08/29/live-829-chis-oncolytic-virus-immunotherapy-and-adoptive-cell-therapy-august-28-29-2017-sheraton-boston-hotel-boston-ma/

What does this mean for Immunotherapy? FDA put a temporary hold on Juno’s JCAR015, Three Death of Celebral Edema in CAR-T Clinical Trial and Kite Pharma announced Phase II portion of its CAR-T ZUMA-1 trial

https://pharmaceuticalintelligence.com/2016/07/09/what-does-this-mean-for-immunotherapy-fda-put-a-temporary-hold-on-jcar015-three-death-of-celebral-edema-in-car-t-clinical-trial-and-kite-pharma-announced-phase-ii-portion-of-its-car-t-zuma-1-trial/

Lydia Ramsey reported on Aug. 28, 2017 that Gilead just handed a revolutionary kind of cancer treatment a $12 billion endorsement.

For Gilead, which is known for its HIV and hepatitis C medications, this is an entirely new area of cancer development.

“The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients,” Gilead CEO John Milligan said in a news release. “We are greatly impressed with the Kite team and what they have accomplished, and share their belief that cell therapy will be the cornerstone of treating cancer.”

In July, a Food and Drug Administration panel voted in favor of approving one of these treatments made by Novartis. One of the panelists called it “most exciting thing I’ve seen in my lifetime.” The FDA is expected to decide whether to approve that therapy, a treatment for pediatric acute lymphoblastic lymphoblastic leukemia, by October.

Gilead won’t have to wait long to see if the FDA will approve Kite’s leading cell therapy, which is called axicabtagene ciloleucel or axi-cel. In November, Kite is expected to get an answer from the FDA regarding its CAR-T treatment for a type of blood cancer called aggressive B-cell non-Hodgkin lymphoma. In data Kite released in February, the company found that out of 101 patients, 36% had a complete response to the treatment after six months.

The one-time treatments won’t come cheap. While companies might price the drug based on how well it works, axi-cel’s price tag could still be $325,000. Analysts expect the therapy to generate $1.7 billion in sales by 2022.

While its axi-cel program is the farthest along, Kite’s also working on another CAR-T cell therapy that’s in clinical trials to treat multiple myeloma, another form of blood cancer. The company’s also working on cell therapies to treat solid tumors that are still in early clinical trials.

On August 30, 2017, John Carroll writes:

[A]pproval marks a major shift in oncology, with a truly revolutionary approach to treating cancer.

The FDA has approved the world’s first CAR-T therapy, giving a green light to Novartis for Kymriah (tisagenlecleucel) in what regulators themselves describe as an historic event.

The accelerated approval — about a month ahead of the PDUFA date — came through for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia

Novartis, the leader in the field, which will set the price on this therapy and likely those to come. Novartis’ investigators registered a game-changing 83% remission rate in its pivotal study.

CAR-T, though, is also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome with some patients dying from brain swelling in separate studies from the Novartis drug.

Regulators noted that they will require special training for anyone involved in delivering this therapy, while expanding the approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years of age or older. “In clinical trials in patients treated with CAR-T cells,” the FDA reported, “69% of patients had complete resolution of CRS within two weeks following one or two doses of Actemra.”

Said Joseph Jimenez, CEO of Novartis:

“Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need. With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care.”

This approval marks a major shift in oncology, with a truly revolutionary approach to treating cancer. That hasn’t escaped the notice of big players and small, with a host of developers looking to do much better, more safely, with new drugs in the pipeline.

SOURCE

From: “John Carroll [Endpoints News]” <john@endpointsnews.com>

Reply-To: <john@endpointsnews.com>

Date: Wednesday, August 30, 2017 at 11:27 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: BREAKING: FDA ushers in a new era in cancer treatment with ‘historic’ CAR-T approval for Novartis

When researchers looked at the safety profile of canakinumab, they found something amazing — a major reduction in the risk of fatal cancers. This was driven by an effect of the highest dose of the drug to prevent lung cancer. The 300 mg dose reduced the occurrence of lung cancer by 67% and death from lung cancer by 77%. It was Viagra all over again.

SOURCE

Is Canakinumab the Next Viagra?

In this Revolution and Revelation, Milton Packer explains how safety data can sometimes trump a primary endpoint

by Milton PackerAugust 30, 2017

https://www.medpagetoday.com/Blogs/RevolutionandRevelation/67605

https://www.genengnews.com/a-lists/top-10-best-selling-cancer-drugs-of-2018/

Posted in Cancer and Current Therapeutics, Pharmaceutical Analytics, Pharmaceutical Industry Competitive Intelligence, tagged AbbVie AMGen AstraZeneca BMS Bristol-Myers Squibb cancer CHMP FDA GSK Janssen Keytruda Merck multiple myelomanew drugs nivolumab Novartis oncology Opdivo Pfizer Roche on January 3, 2017| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 8/29/2020

The top 10-selling cancer drugs generated a combined $63.58 billion in sales in 2018, up 17.5% from $54.126 billion in 2017. Seven of this year’s top 10 showed year-over-year increases in sales, of which six enjoyed double-digit gains.

Ranking #15 through #11 among cancer best-sellers are Takeda/Johnson & Johnson’s Velcade^® (bortezomib); Incyte/Novartis’ Jakafi^®/Jakavi^® (ruxolitinib); Genentech (Roche)’s Perjeta (pertuzumab); Merck & Co.’s Gardasil/Gardasil 9; and J&J’s Zytiga^® (abiraterone acetate). The treatments generated between $2.274 billion and $3.498 billion last year.

10. Xtandi^® (enzalutamide)

Astellas Pharma and Pfizer

Type of Drug: Androgen receptor inhibitor
2018 Sales: $3.624 billion (¥327.8 billion [$2.925 billion Astellas + $0.699 billion Pfizer)
2017 Sales: $3.116 billion (¥282.8 billion [$2.526 billion Astellas + $0.590 billion Pfizer)
% Change: 16.3%

9. Ibrance^® (palbociclib)

Pfizer

Type of Drug: Kinase inhibitor
2018 Sales: $4.118 billion ¹
2017 Sales: $3.126 billion ¹
% Change: 31.7%

8. Neulasta/Peglasta (pegfilgrastim)

Amgen and Kyowa Hakko Kirin

Type of Drug: Leukocyte growth factor
2018 Sales: $4.684 billion ($4.475 billion Amgen + $0.209 billion [¥23.1 billion] Kyowa Hakko Kirin)
2017 Sales: $4.716 billion ($4.534 billion Amgen + $0.182 billion [¥20.1 billion] Kyowa Hakko Kirin)
% Change: -0.7%

7. Imbruvica^® (ibrutinib)

Pharmacyclics (AbbVie) and Johnson & Johnson (J&J)

Type of Drug: Kinase inhibitor
2018 Sales: $6.205 billion ($3.590 billion Pharmacyclics [AbbVie] + $2.615 billion J&J)
2017 Sales: $4.466 billion ($2.573 billion Pharmacyclics [AbbVie] + $1.893 billion J&J)
% Change: 38.9%

6. Rituxan^®/MabThera (rituximab)

Genentech (Roche) and Biogen ²

Type of Drug: CD20-directed cytolytic antibody
2018 Sales: $6.750 billion [CHF 6.752 billion] ²
2017 Sales: $7.298 billion [CHF 7.300 billion] ²
% Change: -7.5%

5. Avastin

Roche

Type of Drug: Vascular endothelial growth factor–directed antibody
2018 Sales: $6.822 billion (CHF 6.849 billion)
2017 Sales: $6.662 billion (CHF 6.688 billion)
% Change: 2.4%

4. Herceptin

Roche (Genentech)

Type of Drug: HER2/neu receptor antagonist
2018 Sales: $6.951 billion (CHF 6.982 billion)
2017 Sales: $6.983 billion (CHF 7.014 billion)
% Change: -0.5%

3. Keytruda

Merck & Co.

Type of Drug: Programmed death receptor-1 (PD-1)-blocking antibody
2018 Sales: $7.171 billion
2017 Sales: $3.809 billion
% Change: 88.3%

2. Opdivo

Bristol-Myers Squibb (BMS) and Ono Pharmaceutical

Type of Drug: Programmed death receptor-1 (PD-1) blocking antibody
2018 Sales: $7.570 billion ($6.735 billion BMS + $835 million [¥92.5 billion] Ono)
2017 Sales: $5.763 billion ($4.948 billion BMS + $815 million [¥90.2 billion] Ono)
% Change: 31.4%

1. Revlimid

Celgene

Type of Drug: Thalidomide analogue
2018 Sales: $9.685 billion
2017 Sales: $8.187 billion
% Change: 18.3%

References
1. Despite the year-over-year sales increase, Pfizer said international Ibrance revenues were negatively impacted by a one-time price adjustment to full-year 2017 revenues related to finalizing reimbursement agreements in certain developed Europe markets
2. Biogen receives a share of U.S. pre-tax profits on sales of Rituxan, which is marketed by Genentech (Roche). Sales figures do not include U.S. pre-tax profits generated by Biogen, since the company only discloses those profits combined with profits from Gazyva^® (obinutuzumab), and does not break out each product separately. Biogen reported combined Rituxan-Gazyva pre-tax profits of $1.432 billion for 2018, and $1.316 billion for 2017.

SOURCE

UPDATED on 1/17/2017

All told, by 2022, the top 15 cancer drugs are expected to collectively make almost $90 billion in sales. To put that in perspective, that represents about one-fourth of the entire U.S. pharma market in 2014, according to QuintilesIMS data. It’s also bigger than pharma’s haul in Japan or China that year.

It will likely be no revelation that three drugs among the top six on our list—provided courtesy of EvaluatePharma and Chempetitive—come from the highly touted PD-1/PD-L1 or checkpoint inhibitor class.

The top 15 best-selling cancer drugs in 2022

http://www.fiercepharma.com/special-report/special-report-top-15-best-selling-cancer-drugs-2022?utm_medium=nl&utm_source=internal&mrkid=993697&mkt_tok=eyJpIjoiWW1aa1kyRmpaV1poTlRZMiIsInQiOiJkSEU3WFdzNHd4cnhmc2NQN0tSUjNVbEY4NDQyUUdHZ29NY2cwWEM1OHRxRmdWWHowVDY5eDMxWkdhZ1ZucHAxTjk5ZmJRWERKT2V4UExCUFd3U25vTkdQWk9ZQWVPQkszUVlVeUFjTjVqcXJJVDB1a1ZDWmNJZ0U4UHhEQUhHdiJ9

Top Oncology Medicines

Projected Sales in 2020

Revlimid (Celgene)

Generic Name: Lenalidomide

$10,110 Million

Imbruvica (AbbVie/J&J)

Generic Name: Ibrutinib

$8,213 Million

Avastin (Roche)

Generic Name: Bevacizumab

$ 6,733 Million

Opdivo (BMS)

Generic Name: Nivolumab

$ 6,201 Million

Xtandi (Medivation & Astellas)

Generic Name: Enzalutamide

$5,700 Million

Rituxan (Roche)

Generic Name: Rituximab

$5,407 Million

Ibrance (Pfizer)

Generic Name: Palbociclib

$4,722 Million

Perjeta (Roche)

Generic Name: Pertuzumab

$4,669 Million

Herceptin (Roche)

Generic Name: Trastuzumab

$4,573 Million

Keytruda (Merck)

Generic Name: Pembrolizumab

$3,560 Million

SOURCE

https://igeahub.com/2016/04/01/worlds-top-ten-cancer-drugs-by-2020/

Posted on 1 April 2016 by Luca Dezzani

A 2016 statistical report from Statista (www.statista.com) has displayed the projected top 10 oncology drugs worldwide by 2020. The drugs are ranked by revenue. The list is expected to be headed by Revlimid, a cancer drug manufactured by U.S.-based company Celgene, forecasted to manufacture five of the leading six cancer drugs by 2020.

SOURCE

https://igeahub.com/2016/04/01/worlds-top-ten-cancer-drugs-by-2020/

Igea gives professionals, patients and investors interested in pharmaceuticals, biotechnology, healthcare technology, diagnostics and medical devices the most relevant, actionable news, information and analysis available anywhere. Our goal is to provide expert insights, analysis and information from industry leaders with a deep understanding of life sciences, medicine and healthcare. Created and curated by Luca Dezzani, MD, Global Medical Director at Novartis Oncology*, Igea offers an insider’s view on the most important developments in life sciences, healthcare technology, digital health and more.