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Archive for January, 2023

Press Release for Five Bilingual BioMed e-Series in English and in Spanish

Posted in LPBI Group, e-Scientific Media, DFP, R&D-M3DP, R&D-Drug Discovery, US Patents: SOPs and Team Management on January 29, 2023| Leave a Comment »

Press Release for Five Bilingual BioMed e-Series in English and in Spanish

 

Version #1: English-language

Authors: Marcus W. Feldman with edits by Aviva Lev-Ari, PhD, RN

Leaders in Pharmaceutical Business Intelligence (LPBI) Group announces the publication of its two Kindle Editions on Amazon.com – its English Text Edition and its Spanish Audio Edition. The Spanish translation was performed by Montero Language Services, Madrid, Spain.

Eighteen volumes in the English Edition and 19 volumes in the Spanish Edition including 2,728 articles by biomedical professionals are available.

https://lnkd.in/ekWGNqA

The electronic books are collections of curated articles in biomedical science. The electronic Tables of Contents (eTOCs) of each volume was designed by a senior editor with expertise in the subjects covered in that volume. The curations use as sources published research findings in peer-reviewed scientific journals together with expert added interpretations.

The e-books are designed to make the latest research in the Five Bilingual BioMed e-Series – 37 volumes accessible to practicing health care professionals. These five e-Series cover the following medical specialties: cardiovascular diseases and therapies, genomics, cancer etiology and oncological therapies, immunology, and patient-centered precision medicine.

The material in these volumes can greatly enhance medical education and provide a resource for continued updating and education for health care professionals. In addition to the 37 e-books, LPBI has published more than 6,000 articles in its online scientific journal “PharmaceuticalIntelligence.com”, which has received 2.2 million views since its launch in 4/2012, Top articles had more than 15,000 views.

The authors of the curations are a team of eminent biomedical scholars assembled and led by Dr. Aviva Lev-Ari, Ph.D., R.N., Editor-in-Chief of the BioMed e-Series and the Journal, and LPBI Group’s founder.  Dr. Lev-Ari also contributed to many articles in these collections.

As LPBI Group’s leader, Dr. Aviva Lev-Ari, served as an invited Press/Media professional in +70 Global conferences, which she covered in-person in real-time and produced e-Proceedings and Tweet collections cited in many journal and book articles. Dr. Lev-Ari remarked that she was “gratified that the English language e-books had received more than 140,000 page-downloads. This is a strong indication that our work has been successful”. The Spanish Edition, offered at a 25% discount, will reach healthcare professionals in 22 Spanish speaking counties.

[345 words]

Version #2: Spanish-language

Nota de prensa

Leaders in Pharmaceutical Business Intelligence (LPBI) Group anuncia la publicación de sus dos ediciones en formato Kindle en Amazon.com: la edición de texto en inglés y la edición de audio en español. La traducción al español fue realizada por Montero Language Services, Madrid, España.

Están disponibles 18 volúmenes en la edición en inglés y 19 volúmenes en la edición en español, que incluyen 2 728 artículos elaborados por profesionales biomédicos.

https://lnkd.in/ekWGNqA

Los libros en formato electrónico son colecciones de artículos seleccionados sobre biomedicina. El índice de contenido electrónico (IDCe) de cada volumen ha sido diseñado por un editor con experiencia en los temas tratados en ese volumen. Las selecciones utilizan como fuentes los resultados de investigaciones publicadas en revistas científicas revisadas por expertos, junto con interpretaciones añadidas por expertos.

Los libros electrónicos están diseñados para dar a conocer las últimas investigaciones recogidas en las cinco series de libros electrónicos bilingües BioMed, con un total de 37 volúmenes a los profesionales sanitarios en ejercicio. Estas cinco series de libros electrónicos abarcan las siguientes especialidades médicas: enfermedades cardiovasculares y su tratamiento, genómica, etiología del cáncer y tratamientos oncológicos, inmunología, y medicina de precisión centrada en el paciente.

El material contenido en estos volúmenes puede enriquecer enormemente la educación médica y aportar un recurso para la actualización y formación continua de los profesionales sanitarios. Además de los 37 libros electrónicos, LPBI ha publicado más de 6 000 artículos en su revista científica en línea «PharmaceuticalIntelligence.com», que cuenta con más de 2,2 millones de visitas desde su lanzamiento en abril de 2012. Los artículos más importantes han tenido más de 15 000 visitas.

Los autores de las selecciones forman parte de un equipo de eminentes académicos reunidos y dirigidos por la Dra. Aviva Lev-Ari, PhD., RN., redactora jefe de la serie de libros electrónicos BioMed y fundadora de LPBI Group.  La Dra. Lev-Ari también colaboró en muchos artículos de estas colecciones.

Como líder de LPBI Group, la Dra. Aviva Lev-Ari ha participado como profesional de prensa y medios de comunicación en más de 70 conferencias mundiales, que ha cubierto en persona en tiempo real y ha elaborado actas electrónicas y colecciones de tweets citadas en numerosos artículos de revistas y libros. La Dra. Lev-Ari afirmó: «Estoy satisfecha con que los libros electrónicos en inglés hayan recibido más de 140 000 descargas. Esto es un claro indicio de que nuestro trabajo ha sido un éxito». La edición en español, que se ofrece con un 25 % de descuento, llegará a los profesionales sanitarios de 22 países de habla hispana.

 

Version #3: English-language with additional details

Curators: Aviva Lev-Ari, PhD, RN and Stephen J. Williams, PhD

Leaders in Pharmaceutical Business Intelligence (LPBI) Group would like to announce the completion of the Translation in the Spanish-language of their’s Five Series of BioMedical E-Books, containing 18 Volumes total in the English-language. Translation was performed by Montero Language Services, Madrid, Spain.

Five Bilingual BioMed e-Series – 37 volumes

  • English-language Edition:  18 volumes in 17 books, and
  • Spanish-language Edition (EDICIÓN EN ESPAÑOL): 19 volumes in 19 books

All the details on book structure and content in the Spanish-language Edition is found in

https://pharmaceuticalintelligence.com/audio-english-spanish-biomed-e-series/

All the details on book structure and content in the English-language Edition is found in

https://pharmaceuticalintelligence.com/biomed-e-books/

All the 37 e-Books on Amazon.com are found in

https://lnkd.in/ekWGNqA

 

URLs for the Spanish-language Edition by e-Series:

 

Serie A: Enfermedades cardiovasculares ($385)

https://www.amazon.com/gp/product/B0BPR9L1ZX?ref_=dbs_p_pwh_rwt_anx_a_lnk

Serie B: Fronteras de la investigación genómica ($305)

https://www.amazon.com/dp/B0BQGZYZVT?binding=kindle_edition&ref=dbs_dp_rwt_sb_pc_tuk

Serie C: Cáncer y la oncología ($231)

https://www.amazon.com/dp/B0BQHMRK3C?binding=kindle_edition&ref=dbs_dp_rwt_sb_pc_tukn

Serie D: Biomedicina. Metabolómica, inmunología, enfermedades infecciosas, genómica reproductiva y endocr ($268)

https://www.amazon.com/dp/B0BR8P5TST

Serie E: Medicina centrada en el paciente ($217)

https://www.amazon.com/dp/B0BRGMCM8Q?binding=kindle_edition&ref=dbs_dp_rwt_sb_pc_tukn

 

URLs for the English-language Edition by e-Series:

 

Series A: Cardiovascular Diseases ($515)

https://www.amazon.com/gp/product/B07P981RCS?ref_=dbs_p_mng_rwt_ser_shvlr&storeType=ebooks

Series B: Frontiers in Genomics ($200)

https://www.amazon.com/gp/product/B0BSDPG2RX?ref_=dbs_p_pwh_rwt_anx_b_lnk&storeType=ebooks

Series C: Cancer & Oncology ($175)

https://www.amazon.com/gp/product/B0BSDWVB3H?ref_=dbs_p_mng_rwt_ser_shvlr&storeType=ebooks

Series D: Immunology ($325)

https://www.amazon.com/gp/product/B08VVWTNR4?ref_=dbs_p_pwh_rwt_anx_b_lnk&storeType=ebooks

Series E: Patient-Centered Medicine ($274)

https://www.amazon.com/gp/product/B0BSDW2K6C?ref_=dbs_p_mng_rwt_ser_shvlr&storeType=ebooks

 

These e-Books are  a comprehensive review of recent original research on Cardiovascular, Genomics, Cancer, Immunology and Precision Medicine written by Experts, Authors, Writers.  These e-books are ushered in the paradigm shifts in how we think about, diagnoses, diagnostics and therapeutics. The results of original research are gaining value added for the e-Reader by the Methodology of Curation. These Biomedical e-Books are well suited for medical and graduate school course curriculum development and as medical textbooks. 

All the articles in these e-books were published in

http://pharmaceuticalintelligence.com

an Open Access Online Scientific Journal is a scientific, medical and business multi expert authoring environment in several domains of  life sciences, pharmaceutical, healthcare & medicine industries. This journal was launched in 4/2012 by Dr. Aviva lev-Ari, PhD, RN who serves as the Editor-in-Chief to the Present.

The venture, DBA, LPBI Group operates as an online scientific intellectual exchange at their website http://pharmaceuticalintelligence.com and had published 37 Medical e-book in five Bilingual e-Series as Amazon’s Kindle Edition.

Crucial to innovation in the medical field is overcoming the scientific information overload. LPBI Group innovates by:

  • delivering curation and clinical interpretations of latest biological scientific findings with future goals of providing concept-driven search across the journal, the books and the conference e-proceedings on a networked blockchain platform. The curation methodology offers academic, clinical, and industrial research digital content globally accessible on the Internet and Web 3.0
  • providing a social platform for scientists and clinicians to enter into discussion using social media as evidenced by multiple comments to journal articles
  • continued updating to the article repository keeps the e-books content current. All new articles on these subjects, will continue to be incorporated, as published with periodical updates.
  • incorporation of information from conference covered in real time by EAWs
  • projects on Text analysis with machine learning
  • software application to drug discovery in the Galectins domain

 

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2022 FDA Drug Approval List, 2022 Biological Approvals and Approved Cellular and Gene Therapy Products

Posted in cell-based therapy, Drug Discovery Chemistry, FDA, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical R&D Informatics, Pharmacodynamics and Pharmacokinetics, Regenerative Biology and Medicine on January 17, 2023| Leave a Comment »

2022 FDA Drug Approval List, 2022 Biological Approvals and Approved Cellular and Gene Therapy Products

 

 

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

Tal Bahar’s post on LinkedIn on 1/17/2023

Novel Drug Approvals for 2022

FDA’s Center for Drug Evaluation and Research (CDER)

New Molecular Entities (“NMEs”)

  • Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022. 
  • Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. 

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. 

INNOVATION   PREDICTABILITY   ACCESS FDA’s Center for Drug Evaluation and Research

January 2023

Table of Contents

 SOURCE

2022 Biological Approvals

The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities.  See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.

Biologics License Applications and Supplements

New BLAs (except those for blood banking), and BLA supplements that are expected to significantly enhance the public health (e.g., for new/expanded indications, new routes of administration, new dosage formulations and improved safety).

Other Applications Approved or Cleared by the Center for Biologics Evaluation and Research (CBER)

Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.

Key Resources

SOURCE

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2022-biological-approvals

 

Approved Cellular and Gene Therapy Products

Below is a list of licensed products from the Office of Tissues and Advanced Therapies (OTAT).

Approved Products

 

Resources For You

SOURCE

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products

 

2022 forecast: Cell, gene therapy makers push past regulatory, payer hurdles to set up high hopes for next year

By Arlene Weintraub
Dec 22, 2021 03:00am

There are five FDA-approved CAR-T treatments for blood cancers and two gene therapies to treat rare diseases now on the market in the U.S. The late-stage pipeline could produce several more cancer CAR-Ts and gene therapies to treat a range of diseases.

RELATED: ASH: Bristol Myers’ Breyanzi, Gilead’s Yescarta lock horns in race to move CAR-T therapy to earlier lymphoma

One of the biggest races to watch in the cell therapy space will be that between Gilead Sciences’ Yescarta and Bristol Myers Squibb’s Breyanzi, both of which are gunning to move their CAR-Ts into earlier lines of treatment in large B-cell lymphoma (LBCL). At ASH, both companies rolled out impressive data from their trials in the second-line setting, but Gilead could have the upper hand by virtue of its three-year head start in the market, analysts said. Gilead expects to hear from the FDA on a label expansion in the second-line setting in April.

SOURCE

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Verily announced other organizational changes, 1/13/2023

Posted in Artificial Intelligence Applications in Health Care on January 16, 2023| Leave a Comment »

Verily announced other organizational changes, 1/13/2023

Reporter: Aviva Lev-Ari, PhD, RN

The layoffs come just a few months after Verily raised $1 billion in an investment round led by Alphabet. At the time of the investment round, Verily said the $1 billion would be used to expand its business in precision health. 

In addition to the layoffs, Verily announced other organizational changes.

“We are making changes that refine our strategy, prioritize our product portfolio and simplify our operating model,” Gillett said in his email. “We will advance fewer initiatives with greater resources. In doing so, Verily will move from multiple lines of business to one centralized product organization with increasingly connected healthcare solutions.”

The company will specifically focus on AI and data science to accelerate learning and improving outcomes, with advancing precision health being the top overarching goal. In addition, the company will simplify how it works, “designing complexity out of Verily.” 

Among its product portfolio, Verily plans to “do fewer things” and focus its efforts within research and care. The company is “discontinuing the development of Verily Value Suite and some early-stage products, including our work in remote patient monitoring for heart failure and microneedles for drug delivery,” Gillet said. By eliminating Verily Value Suite, some staff will be redeployed elsewhere, while others will leave the company, Gillet said.

The 15% of eliminated staff include roles within discontinued programs and redundancy within the new, simplified organization. Gillet also announced leadership changes, including expanding the role of Amy Abernethy to become president of product development and chief medical officer. Scott Burke will expand his responsibilities as chief technology officer, adding hardware engineering and devices teams to his responsibilities, as well as serving as the bridge between product development and customer needs. Lisa Greenbaum will expand her responsibilities in a new chief commercial officer role, overseeing sales, marketing and corporate strategy teams.

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SOURCE

https://healthexec.com/topics/patient-care/precision-medicine/verily-lays-15-workers-months-after-raising-1b?utm_source=newsletter&utm_medium=he_news

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