For UPDATES on this Cardinal Conference and for REGISTRATION, go to

Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Archive for the ‘Drug Discovery Chemistry’ Category

Advancing Drug Development – 12/12/2019, 8:30AM – 8:30PM at The University of Massachusetts Club, One Beacon Street, Boston, MA

Drug Repurposing Hub Library @broadinstitute @MIT @Harvard

Record Innovations in Drug Discovery by Koch Institute @MIT Members and Affiliates

In 2018 Cardiovascular PharmacoTherapy Market: Anti-thrombotic Drug Class Segment will continue to bring in the biggest profit and dominate production

CHI’s Discovery on Target, Sheraton Boston, Sept. 25-28, 2018

Channels for e-Marketing of Biotech Conferences

http://www.discoveryontarget.com/?utm_source=partner

http://www.discoveryontarget.com/programs

What is the Role of the Editor-in-Chief at PharmaceuticalIntelligence.com

The VOICES of Patients, Hospitals CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures … E: Patient-Centered Medicine Book 1)

Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery (Series C Book 2)

The Immune System, Stress Signaling, Infectious Diseases and Therapeutic Implications: VOLUME 2: Infectious Diseases and Therapeutics and VOLUME 3: The … (Series D: BioMedicine & Immunology)

Perspectives on Nitric Oxide in Disease Mechanisms (Biomed e-Books Book 1)

Medical Scientific Discoveries for the 21st Century & Interviews with Scientific Leaders (Series E)

Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics

Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation: The Art of Scientific & Medical Curation

Medical 3D BioPrinting – The Revolution in Medicine Technologies for Patient-centered Medicine: From R&D in Biologics to New Medical Devices (Series E: Patient-Centered Medicine Book 4)

Metabolic Genomics & Pharmaceutics (BioMedicine – Metabolomics, Immunology, Infectious Diseases Book 1)

Cancer Biology and Genomics for Disease Diagnosis (Series C: e-Books on Cancer & Oncology Book 1)

Genomics Orientations for Personalized Medicine (Frontiers in Genomics Research Book 1)

Milestones in Physiology: Discoveries in Medicine, Genomics and Therapeutics (Series E: Patient-Centered Medicine Book 3)

Regenerative and Translational Medicine: The Therapeutic Promise for Cardiovascular Diseases

Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com

Archive for the ‘Drug Discovery Chemistry’ Category

Advancing Drug Development – 12/12/2019, 8:30AM – 8:30PM at The University of Massachusetts Club, One Beacon Street, Boston, MA

Drug Repurposing Hub Library @broadinstitute @MIT @Harvard

Record Innovations in Drug Discovery by Koch Institute @MIT Members and Affiliates

In 2018 Cardiovascular PharmacoTherapy Market: Anti-thrombotic Drug Class Segment will continue to bring in the biggest profit and dominate production

Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Follow Blog via Email

Recent Posts

Archives

Categories

Meta

Advancing Drug Development – 12/12/2019, 8:30AM – 8:30PM at The University of Massachusetts Club, One Beacon Street, Boston, MA

http://advdrug.com/agenda/

Drug Repurposing Hub Library @broadinstitute @MIT @Harvard

The Drug Repurposing Hub: A next-generation drug library and information resource

Drug Repurposing Hub Library @broadinstitute @MIT @Harvard

The Drug Repurposing Hub: a next-generation drug library and information resource

Record Innovations in Drug Discovery by Koch Institute @MIT Members and Affiliates

In Good Company

In 2018 Cardiovascular PharmacoTherapy Market: Anti-thrombotic Drug Class Segment will continue to bring in the biggest profit and dominate production

Who were the top players in cardiovascular disease in 2017?

CHI’s Discovery on Target, Sheraton Boston, Sept. 25-28, 2018

ANNOUNCEMENT

Leaders in Pharmaceutical Business Intelligence (LPBI) Group is a selected CHI Business Partner for Media Communication for this event as well a provider of REAL TIME PRESS COVERAGE for this cardinal event in the domain of Drug Discovery and Drug Delivery.

Follow us on ALL our Media Communication Channels:

Editor-in-Chief’s Roles and Accomplishments

1 Curation Methodology Development

2 Content Creation and Key Opinion Leader (KOL) Recognition

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

3 Team building: Editors and Expert, Authors, Writers

Our Team

Selection of Journal’s Chief Scientific Officer (CSO) and BioMed e-Series Content Consultant (CC): Series B, C, D, E

4 Book Title Generation and Cover Page Design

5 Style Setting: Instruction manuals for Journal, Articles, Books

6 Annual Workflow Management of Multiple eTOCs – Multi-year Book Publishing Scheduling Plan, 2013 – Present

Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of KitePharma, no approved drug and Canakinumab for Lung Cancer (may be?)

CAR-T Therapies: Product/Molecules/MOA under Development:

Precision Medicine is Costly and not a Rapid manufacturing process

Prediction How Patients will Far Well – Researchers use a big-data approach to find links between different genes and patient survival.

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Adoptive T Cell Therapy

One year ago we published the following:

Novartis’ Canakinumab – NEW Inflammation hypothesis of lung cancer

Advancing Drug Development – 12/12/2019, 8:30AM – 8:30PM at The University of Massachusetts Club, One Beacon Street, Boston, MA

http://advdrug.com/agenda/

Drug Repurposing Hub Library @broadinstitute @MIT @Harvard

The Drug Repurposing Hub: A next-generation drug library and information resource

Drug Repurposing Hub Library @broadinstitute @MIT @Harvard

The Drug Repurposing Hub: a next-generation drug library and information resource

Record Innovations in Drug Discovery by Koch Institute @MIT Members and Affiliates

In Good Company

In 2018 Cardiovascular PharmacoTherapy Market: Anti-thrombotic Drug Class Segment will continue to bring in the biggest profit and dominate production

Who were the top players in cardiovascular disease in 2017?

Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of KitePharma, no approved drug and Canakinumab for Lung Cancer (may be?)

CAR-T Therapies: Product/Molecules/MOA under Development:

Precision Medicine is Costly and not a Rapid manufacturing process

Prediction How Patients will Far Well – Researchers use a big-data approach to find links between different genes and patient survival.

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Adoptive T Cell Therapy

One year ago we published the following:

Novartis’ Canakinumab – NEW Inflammation hypothesis of lung cancer

Posted in Drug Delivery Platform Technology, Drug Development Process, Drug Discovery Chemistry, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical R&D Informatics, Pharmaceutical R&D Investment, Pharmacogenomics, Rapid automation of plasma protein pools on November 4, 2019| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

4th Advancing Drug Development Forum – Making the Impossible Possible – Harnessing Small Molecule Drug Development scheduled to take place December 12th, 2019 at The University of Massachusetts Club, in Boston, Massachusetts from 8:30 AM – 8:30 PM.

Scientists are more than just chipping away and kicking down the barricades to develop complex small molecule products better and faster. Successful companies are spending quality time finding novel and clever approaches and powerful technologies to better support their knowledgeable teams. Often it takes establishing strong partnerships with 1 or more specialized service providers, cleverly combining resources – always striving to raise the bar in order to make life threatening diseases more of a chronic and tolerable disease or eradicated completely.

Hear from key opinion leaders in pharma, biotech, the investment community and innovative service providers on how they are meeting the challenges. Keep in mind, it takes being open-minded, flexible and willing sometimes to redesigning a new formulation that better enhances bioavailability, optimizes drug-delivery profiles, reduces dosing frequency, or improves the patient experience to have the potential to deliver quicker returns on investments than developing a completely new drug.

PROGRAM AGENDA Thursday, December 12, 2019

8:30 AM Registration and Networking Continental Breakfast

9:00 AM Welcome Address and Opening Remarks
Kevin Bittorf, Ph.D., & Shelly Amster

9:15 AM Opening VC Keynote

9:45 AM Bridging the Gap between Experimentation and Implementation
Panel Discussion

10:15 AM Refreshment Break

10:45 AM Cross-Talk Between Clin-Ops and Tech-Ops
Panel Discussion

11:15 AM The Cost of Speed and Value in Drug Development
Panel Discussion

12:00 PM Networking Luncheon

1:00 PM Advances in the Delivery of Therapeutics to the Brain
Academic Keynote
Mansoor M. Amiji, Ph.D., University Distinguished Professor, Professor of Pharmaceutical Sciences & Professor of Chemical Engineering, Northeastern University

1:30 PM Advancing Drug Delivery and Controlled Release
Panel Discussion

2:00 PM Drowning in DATA

2:30 PM Disruptive AI Technologies Improving Drug Development

3:00 PM Refreshment Break

3:30 PM Small Specialty VS Full Service – What Makes Sense for US?
Panel Discussion

4:00 PM Fireside Chat
Michael Bonney, Executive Chair, Kaleido Biosciences
Heinrich Schlieker, Ph.D., SVP Technical Operations, Sage Therapeutics

5:00 PM – 8:00 PM Networking Social

PROGRAM AGENDA	Thursday, December 12, 2019
8:30 AM		Registration and Networking Continental Breakfast
9:00 AM		Welcome Address and Opening Remarks Kevin Bittorf, Ph.D., & Shelly Amster
9:15 AM		Opening VC Keynote
9:45 AM		Bridging the Gap between Experimentation and Implementation Panel Discussion
10:15 AM		Refreshment Break
10:45 AM		Cross-Talk Between Clin-Ops and Tech-Ops Panel Discussion
11:15 AM		The Cost of Speed and Value in Drug Development Panel Discussion
12:00 PM		Networking Luncheon
1:00 PM		Advances in the Delivery of Therapeutics to the Brain Academic Keynote Mansoor M. Amiji, Ph.D., University Distinguished Professor, Professor of Pharmaceutical Sciences & Professor of Chemical Engineering, Northeastern University
1:30 PM		Advancing Drug Delivery and Controlled Release Panel Discussion
2:00 PM		Drowning in DATA
2:30 PM		Disruptive AI Technologies Improving Drug Development
3:00 PM		Refreshment Break
3:30 PM		Small Specialty VS Full Service – What Makes Sense for US? Panel Discussion
4:00 PM		Fireside Chat Michael Bonney, Executive Chair, Kaleido Biosciences Heinrich Schlieker, Ph.D., SVP Technical Operations, Sage Therapeutics
5:00 PM – 8:00 PM		Networking Social

SOURCE

https://advdrug.com/agenda/

Direct electronic communication with Shelly Amster

Read Full Post »

Posted in Drug Development Process, Drug Discovery Chemistry, drug repurposing, Pharmaceutical Drug Discovery on February 14, 2019| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN and Irina Robu, PhD

CLAIMER: most valuable information for Drug Repurposing is found in the following LPBI Group three Intellectual Property Asset Classes

Our intellectual property “IP” consists of three classes of assets as described in detail within live links in the below, listed article.

First, the Journal, an ongoing journal of curated, current biomedical research;

Second, the books, a collection of 16 volumes of e-books available via Amazon in five specialties of Medicine: Cardiovascular, Genomics, Cancer, Immunology and Precision Medicine; and

Third, real-time curation of biotech and medical conferences yielding an e-Proceedings at the end of the conference in One-click operation.

These three IP asset classes are described in details with live links in

eScientific Publishing a Case in Point: Evolution of Platform Architecture Methodologies and of Intellectual Property Development (Content Creation by Curation) Business Model

https://pharmaceuticalintelligence.com/2019/02/04/escientific-publishing-a-case-in-point-evolution-of-platform-architecture-methodologies-and-of-intellectual-property-development-content-creation-by-curation-business-model/

M Corsello, Steven & A Bittker, Joshua & Liu, Zihan & Gould, Joshua & McCarren, Patrick & E Hirschman, Jodi & E Johnston, Stephen & Vrcic, Anita & Wong, Bang & Khan, Mariya & Asiedu, Jacob & Narayan, Rajiv & C Mader, Christopher & Subramanian, Aravind & R Golub, Todd. (2017). The Drug Repurposing Hub: A next-generation drug library and information resource. Nature Medicine. 23. 405-408. 10.1038/nm.4306.

… Published on January 3, 2018 as DOI: 10.1124/mol.117. Downloaded from additional source, we used data from the Broad repurposing hub ( Corsello et al, 2017), which employed high throughput screening to characterize drug-target interactions of approved drugs, natural products and nutraceuticals along with other entities. Our analysis yielded a list of currently ‘druggable’ GPCRs and the drugs that target them. …

… Using a range of ~500 (conservative estimate) to ~700 GPCR-targeted drugs, we estimate that between ~25% and ~36% of approved drugs target GPCRs, with the upper figure the more likely. As additional studies such as the Broad repurposing initiative ( Corsello et al, 2017) characterize GPCR-drug interactions in more detail, we anticipate a growth in this number, as secondary interactions between GPCRs and drugs are defined ( Allen and Roth, 2011). IUPHAR lists more druggable GPCRs than CHEMBL or DRUGBANK but has the smallest number of GPCR-related and overall approved drugs ( Figure 3C shows the number of GPCR-targeted drugs based on target-ligand interactions annotated by either IUPHAR or CHEMBL; of the 476 such drugs listed in one or both sources, only a portion are common to both (50%). …

To date there has not been a systematic effort to identify such opportunities, limited in part by the lack of a comprehensive library of clinical compounds suitable for testing. To address this challenge, we hand-curated a collection of 4,707 compounds, experimentally confirmed their identity, and annotated them with literature-reported targets. The collection includes 3,422 drugs that are marketed around the world or that have been tested in human clinical trials. Compounds were obtained from more than 50 chemical vendors and the purity of each sample was established. We have thus established a blueprint for others to easily assemble such a repurposing library, and we have created an online Drug Repurposing Hub (www.broadinstitute.org/repurposing) containing detailed annotation for each of the compounds.

SOURCE

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5568558/

. Author manuscript; available in PMC 2017 Aug 23.

Published in final edited form as:

Nat Med. 2017 Apr 7; 23(4): 405–408.

doi: 10.1038/nm.4306

PMCID: PMC5568558

NIHMSID: NIHMS893143

PMID: 28388612

Steven M. Corsello,^1,^2,³ Joshua A. Bittker,¹ Zihan Liu,¹ Joshua Gould,¹Patrick McCarren,¹ Jodi E. Hirschman,¹ Stephen E. Johnston,¹ Anita Vrcic,¹Bang Wong,¹ Mariya Khan,¹ Jacob Asiedu,¹ Rajiv Narayan,¹Christopher C. Mader,¹ Aravind Subramanian,¹ and Todd R. Golub^1,^3,^4,^5,^*

SOURCE

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5568558/

Other Resources

Cancer based pharmacogenomics network supported with scientific evidences: from the view of drug repurposing.[BioData Min. 2015]
Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases.[Drug Des Devel Ther. 2013]
The Resource Hub: an innovative e-information service delivery model addressing mental health knowledge management.[Australas Psychiatry. 2009]
A weighted and integrated drug-target interactome: drug repurposing for schizophrenia as a use case.[BMC Syst Biol. 2015]
Drug Repurposing Is a New Opportunity for Developing Drugs against Neuropsychiatric Disorders.[Schizophr Res Treatment. 2016]

Read Full Post »

Posted in BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, CANCER BIOLOGY & Innovations in Cancer Therapy, DNA repair, Drug Delivery Platform Technology, Drug Development Process, Drug Discovery Chemistry, MHC Repertoires for Antigen Prediction, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Discovery on February 6, 2019| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Trovagene announced a new patent for the use of the drug onvansertib in combination with other anti-androgen drugs for the treatment of prostate cancer. Last fall, Trovagene secured exclusive rights to develop combination therapies and clinical biomarkers for prostate cancer based in part on Bridge Project-funded research. Read more.

Lyndra Therapeutics, co-founded by KI member Bob Langer, raised $55 million in its Series B round, with new investors including the Bill and Melinda Gates Foundation and Gilead Sciences. Phase 2 trials for its ultra long-acting drug delivery capsule are expected to begin next year. Read more.

Dragonfly Therapeutics, co-founded by KI director Tyler Jacks, has committed $10 million to launch the first clinical studies of its TriNKETs (Tri-specific, NK cell Engager Therapies) platform for both solid tumor and hematological cancers. Read more.

Following its record-breaking IPO, Moderna Therapeutics (co-founded by KI member Bob Langer) published preclinical data in Science Translational Medicine demonstrating the promise of its mRNA-2752 program in several cancers. Read more.

Dewpoint Therapeutics launched with a $60 million Series A, aims to translate recent insights into biomolecular condensates from the laboratory of co-founder and KI member Rick Young to drug discovery. Read more.

KI member Bob Langer and collaborator Omid Farokhzad co-founded Seer— combining nanotechnology, protein chemistry, and machine learning—to develop liquid biopsy tests for the early detection of cancer and other diseases. Read more.

Epizyme, co-founded by KI member Bob Horvitz, is submitting a New Drug Application to gain accelerated approval of tazemetostat for patients with relapsed or refractory follicular lymphoma. Read more.

Ribon Therapeutics, founded by former KI member Paul Chang, launched with $65 million in a Series B funding round with Victoria Richon, a veteran of Sanofi and Epizyme, at the helm. Ribon focuses on developing PARP7 inhibitors for cancer treatment. Read more.

SOURCE

From: MIT Koch Institute for Integrative Cancer Research <cancersolutions=mit.edu@cmail19.com> on behalf of MIT Koch Institute for Integrative Cancer Research <cancersolutions@mit.edu>

Reply-To: <ki-communications@mit.edu>

Date: Wednesday, February 6, 2019 at 3:15 PM

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

Subject: Lung Microbiome Corrupted in Cancer; Angelika Amon wins 2019 Vilcek Award; Lunch Lines of Inquiry

Read Full Post »

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

Read Full Post »

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

LOGO of LPBI Group

Our Journal has 1,373,977 eReaders on 1/29/2018, for All Time and 7,283 Scientific Comments

http://pharmaceuticalintelligence.com

Aviva’s – +6,430 BIOTECH Followers on LinkedIn

http://www.linkedin.com/in/avivalevari

Aviva is a Member of +60 LinkedIn Groups in Biotech related fields

https://www.linkedin.com/groups/my-groups

LPBI Group’s FaceBook Page

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

https://pharmaceuticalintelligence.com/2016/05/12/preliminary-agenda-available-and-exclusive-discount-to-attend-understanding-crispr-mechanisms-to-applications-symposium-in-boston-september-19-2016

LPBI Group’s Twitter Account

http://twitter.com/pharma_BI

LinkedIn (LI) Group Launcher and Manager of Three LI Groups

Cardiovascular Biotech & Pharma UK & US Networking Group

918 members (1/2018)

Leaders in Pharmaceutical Business Intelligence

342 members (1/2018)

Innovation in Israel

188 members (1/2018)

LPBI Group’s Company’s Page on LinkedIn

https://www.linkedin.com/company/9325543?trk=tyah&trkInfo=clickedVertical%3Acompany%2CclickedEntityId%3A9325543%2Cidx%3A1-1-1%2CtarId%3A1439226813927%2Ctas%3ALeaders%20in%20Pharmaceutica

For PROGRAMS, go to

September 26-27

September 27-28

September 26-27

September 27-28

September 26-27

September 27-28

September 26-27

September 27-28

September 25

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

1,339

Aviva Lev-Ari, PhD, RN

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

Select

Aviva Lev-Ari, PhD, RN 2012pharmaceutical

3,064 Articles

· All (5,288)

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/

· LPBI Group’s Founder: Biography and Bibliographies – Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/founder/

2.2 Digital Presence measured by eViews: Clicks on article by Author Name

Top Authors for all days ending 2018-01-29 (Summarized)

All Time

Author Name		electronic Views
Aviva Lev-Ari, PhD, RN [2012pharmaceutical]		352,153

LPBI Group

1,201

2.3 Digital KOL Parameters

Key Opinion Leader (KOL) – Aviva Lev-Ari, PhD, RN, as Evidenced by

https://pharmaceuticalintelligence.com/2016/07/21/key-opinion-leader-kol-aviva-lev-ari-phd-rn-as-evidenced-by/

L.H. Bernstein, MD, FCAP

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

https://pharmaceuticalintelligence.com/2014/10/16/editorial-publication-of-articles-in-e-books-by-leaders-in-pharmaceutical-business-intelligence-contributions-of-larry-h-bernstein-md-fcap/

As BioMed e-Series Editor–in-Chief, I was responsible for the following functions of product design and product launch

· 16 Title creations for e-Books

· Designed 16 Cover Pages for a 16-Volume e-Books e-Series in BioMed

· Designed Series A eTOCs and approved of all 16 electronic Table of Contents (eTOCs), working in tandem with all the Editors of each volume and all the Author contributors of article contents in the Journal.

· Commissioned Articles by Authors/Curators per Author’s expertise on a daily basis

Below, see Volume Titles and Cover Pages:

13 LIVE results for Kindle Store: “Aviva Lev-Ari”

Oct 16, 2017 | Kindle eBook

by Larry H. Bernstein and Aviva Lev-Ari

$0.00

Subscribers read for free.

Read for Free

$49.00^$ 49 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

May 13, 2017 | Kindle eBook

by Larry H. Bernstein and Demet Sag

$0.00

Subscribers read for free.

Read for Free

$100.00^$ 100 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Sep 4, 2017 | Kindle eBook

by Larry H. Bernstein and Aviva Lev-Ari

$0.00

Subscribers read for free.

Read for Free

$115.00^$ 115 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Jun 20, 2013 | Kindle eBook

by Margaret Baker PhD and Tilda Barliya PhD

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

5 out of 5 stars 6

Sold by: Amazon Digital Services LLC

Dec 9, 2017 | Kindle eBook

by Larry H. Bernstein and Aviva Lev-Ari

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Nov 28, 2015 | Kindle eBook

by Justin D. Pearlman MD ME PhD MA FACC and Stephen J. Williams PhD

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Nov 29, 2015 | Kindle eBook

by Larry H. Bernstein MD FCAP and Aviva Lev-Ari PhD RN

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Dec 30, 2017 | Kindle eBook

by Larry H. Bernstein and Irina Robu

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Jul 21, 2015 | Kindle eBook

by Larry H. Bernstein MD FCAP and Prabodah Kandala PhD

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

5 out of 5 stars 1

Sold by: Amazon Digital Services LLC

Aug 10, 2015 | Kindle eBook

by Larry H Bernstein MD FCAP and Prabodh Kumar Kandala PhD

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Nov 22, 2015 | Kindle eBook

by Sudipta Saha PhD and Ritu Saxena PhD

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Dec 26, 2015 | Kindle eBook

by Larry H. Bernstein MD FACP and Aviva Lev-Ari PhD RN

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

Dec 26, 2015 | Kindle eBook

by Justin D. Pearlman MD ME PhD MA FACC and Ritu Saxena PhD

$0.00

Subscribers read for free.

Read for Free

$75.00^$ 75 ⁰⁰ to buy Kindle Edition

Get it TODAY, Jan 29

Sold by: Amazon Digital Services LLC

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	???

Read Full Post »

Posted in Drug Delivery Platform Technology, Drug Development Process, Drug Discovery Chemistry, Patient-centered Medicine, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Informatics, Pharmaceutical R&D Investment, Pharmacogenomics, Value-based Drug Pricing on August 31, 2017| Leave a Comment »

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 9/1/2017:

This Pioneering $475,000 Cancer Drug Comes With A Money-Back Guarantee

Novartis defends the eye-popping price of its pioneering gene therapy with arguments about its $1 billion expenditure—and novel “value-based” pricing.

https://www.fastcompany.com/40461214/how-novartis-is-defending-the-record-475000-price-of-its-pioneering-gene-therapy-cancer-drug-car-t-kymriah

On 8/30/2017 we wrote:

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/08/30/fda-has-approved-the-worlds-first-car-t-therapy-novartis-for-kymriah-tisagenlecleucel-and-gileads-12-billion-buy-of-kite-pharma-no-approved-drug-and-canakinumab-for-lung-cancer-may-be/

The Price for the Treatment was published on 8/31/2017, a Value-based Pricing Payment Model of a $475,000 per patient charge for the responding patients after ONE month of treatment. Novartis says it takes an average of 22 days to create the therapy, from the time a patient’s cells are removed to when they are infused back into the patient. Kymriah will initially be available at 20 U.S. hospitals within a month, Novartis says. Eventually, 32 total sites will offer the therapy.

CAR-T gained national attention three years ago when Carl June, a researcher at the University of Pennsylvania, used to put a young girl’s acute lymphoblastic leukemia. Genetically altering the girl’s immune cells had made her deathly ill, but June had used a Roche drug, Actemra, to treat the side effects. She lived, and the results were published in The New England Journal of Medicine. Novartis bought the rights to the Penn treatment for just $20 million up front.

Pharma Buying the right to use from an Academic Institution is a known route to leap frog the R&D lengthy process of Drug discovery.

“I’ve told the team that resources are not an issue. Speed is the issue,” says Novartis’ Chief Executive Joseph Jimenez, told Forbes in a cover story about the work then.

The FDA calls this CAR-T therapy treatment, made by Novartis, the “first gene therapy” in the U.S. The therapy is designed to treat an often-lethal type of blood and bone marrow cancer that affects children and young adults. The FDA defines gene therapy as a medicine that “introduces genetic material into a person’s DNA to replace faulty or missing genetic material” to treat a disease or medical condition. This is the first such therapy to be available in the U.S., according to the FDA.

Two gene therapies for rare, inherited diseases have already been approved in Europe.

To further evaluate the long-term safety, Novartis is also required to conduct a post-marketing observational study involving patients treated with Kymriah.

The FDA granted Kymriah Priority Review and Breakthrough Therapy designations. The Kymriah application was reviewed using a coordinated, cross-agency approach. The clinical review was coordinated by the FDA’s Oncology Center of Excellence, while CBER conducted all other aspects of review and made the final product approval determination.

The FDA granted approval of Kymriah to Novartis Pharmaceuticals Corp. The FDA granted the expanded approval of Actemra to Genentech Inc.

FDA commissioner Scott Gottlieb in a statement.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,”

“Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials.”

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm

The Protocol

A patient’s T cells are extracted and cryogenically frozen so that they can be transported to Novartis’s manufacturing center in New Jersey. There, the cells are genetically altered to have a new gene that codes for a protein—called a chimeric antigen receptor, or CAR. This protein directs the T cells to target and kill leukemia cells with a specific antigen on their surface. The genetically modified cells are then infused back into the patient.

In a clinical trial of 63 children and young adults with a type of acute lymphoblastic leukemia, 83 percent of patients that received the CAR-T therapy had their cancers go into remission within three months. At six months, 89 percent of patients who received the therapy were still living, and at 12 months, 79 percent had survived.

https://www.technologyreview.com/s/608771/the-fda-has-approved-the-first-gene-therapy-for-cancer/?utm_campaign=add_this&utm_source=email&utm_medium=post

Similar CAR-T treatments were being developed at other institutions including
Memorial Sloan-Kettering Cancer Center,
Seattle Children’s Hospital, and
The National Cancer Institute.
The Memorial and Seattle work was spun off into a startup called Juno Therapeutics, which has fallen behind. Juno Therapeutics ended a CAR-T study earlier this year after patients died from cerebral edema, or swelling in the brain.
The NCI work became the basis for the product being developed by Kite Pharma. Kite Pharma, which is awaiting FDA approval for its CAR-T therapy to treat a form of blood cancer in adults, was this week bought out by Gilead in a deal worth $11.9 billion.

On Cambridge Healthtech Institute’s 4th Annual Adoptive T Cell Therapy, Delivering CAR, TCR, and TIL from Research to Reality, August 29 – 30, 2017 | Sheraton Boston | Boston, MA

TUESDAY, AUGUST 29 – I covered in Real Time the talk on Juno Therapeutics: Building Better T Cell Therapies: The Power of Molecular Profiling by Mark Bonyhadi, Ph.D., Head, Research and Academic Affairs, Juno Therapeutics

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/

All of the CAR-T products are expensive to make, and must be manufactured on an individual basis for each new patient from the patient’s own T-cells, a type of white blood cells, a process that takes weeks.

How quickly companies can speed up manufacturing.

Kymriah will be manufactured at a facility in Morris Plains, N.J.

CAR-T technology, which has so far been used only in patients with blood cancers that have not been cured by other treatments, can be used earlier in the disease or for solid tumors: Breast, Prostate, Melanomas.

https://www.forbes.com/sites/matthewherper/2017/08/30/fda-approves-novartis-treatment-that-alters-patients-cells-to-fight-cancer/#2aecb25b4400

https://www.technologyreview.com/s/608666/a-cancer-atlas-to-predict-how-patients-will-fare/?set=

Modeling the cancer transcriptome

Recent initiatives such as The Cancer Genome Atlas have mapped the genome-wide effect of individual genes on tumor growth. By unraveling genomic alterations in tumors, molecular subtypes of cancers have been identified, which is improving patient diagnostics and treatment. Uhlen et al. developed a computer-based modeling approach to examine different cancer types in nearly 8000 patients. They provide an open-access resource for exploring how the expression of specific genes influences patient survival in 17 different types of cancer. More than 900,000 patient survival profiles are available, including for tumors of colon, prostate, lung, and breast origin. This interactive data set can also be used to generate personalized patient models to predict how metabolic changes can influence tumor growth.

Read Full Post »

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

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

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

Read Full Post »

Older Posts »

BioMed e-Series