Posts Tagged ‘Personalized and Precision Medicine & Genomic Research’

A Timeline of Dr. Gottlieb’s Brief Tenure at the FDA: 2017-2019

Posted in BioSimilars, Drug Development Process, FDA, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Patient Experience: Personal Memories of Invasive Medical Intervantion, Value-based Drug Pricing, tagged Biopharmaceutical, FDA, FDA commisioner, Food and Drug Administration, health costs, New Drug Application, Personalized and Precision Medicine & Genomic Research, pharma, Pharmaceutical industry, Scott Gottlieb on March 8, 2019| Leave a Comment »

A Timeline of Dr. Gottlieb’s Tenure at the FDA: 2017-2019

Reporter: Stephen J. Williams, Ph.D.

 

From FiercePharma.com

FDA chief Scott Gottlieb steps down, leaving pet projects behind

FDA Commissioner Scott Gottlieb was appointed by President Trump in 2017. (FDA)

Not quite two years into his stewardship of the FDA, Scott Gottlieb, M.D., is stepping down. His sudden departure will likely send shock waves through biopharma, because the commissioner was popular for his market-based policies to lower drug costs and work to speed new brands to approval.

Gottlieb won Senate confirmation as FDA commissioner back in May 2017, an uncertain time for the drug industry. During the selection process, his name had been favored by a majority of biopharma executives polled by an analyst. At the time, one anonymous executive said he’s the “least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States”—unlike at least one other candidate for the job.

That preference proved out after Gottlieb took over the agency, as his policies favored speed and competition. And when the news broke Tuesday afternoon, the industry trade group PhRMA praised his “exemplary leadership.”

“During his tenure, he focused on innovation in drug development and review, increased competition, and advanced the regulatory framework for approving novel technologies, including gene therapies,” the organization said in a statement. “His efforts have made a meaningful impact for patients in need of innovative medicines.”

Gottlieb tweeted Tuesday that he’s “immensely grateful” for the opportunity to lead the FDA. In a letter to colleagues, he wrote that “there’s nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and two young children.”

President Donald Trump tweeted that he’s done an “absolutely terrific job” and will be missed.

In his resignation letter, tweeted by STAT reporter Matthew Herper, Gottlieb reviewed his efforts at the agency over the past two years. It’s a long list, but here are a few examples:

• The FDA worked to avoid drug shortages after a hurricane struck Puerto Rico,
• led a global investigation into drug impurities,
• advanced reviews of cell and gene therapies, and
• bolstered approvals of complex generic drugs.

Also under his command, the FDA took quick and decisive action on drug costs. The commissioner worked to boost generic approvals and crack down on regulatory “gaming” that stifles competition. He additionally blamed branded drug companies for an “anemic” U.S. biosimilars market and recently blasted insulin pricing.

His sudden departure will likely leave many agency efforts to lower costs up in the air. After the news broke, many pharma watchers posted on Twitter that Gottlieb’s resignation is a loss for the industry.

During his tenure as FDA commissioner, Gottlieb’s name had been floated for HHS chief when former HHS secretary Tom Price resigned due to a travel scandal, but Gottlieb said he was best suited for the FDA commissioner job. Now, former Eli Lilly executive Alex Azar serves as HHS secretary, and on Tuesday afternoon, Azar praised Gottlieb for his work at the agency.

Also read from FiercePharma:

Gottlieb’s quick goodbye triggers investor panic, biopharma bewilderment and at least one good riddance

AUDIT Podcast

An emergency Scott Gottlieb podcast

 

Why is Scott Gottlieb quitting the FDA? Who will replace him?

 

A Timeline of Dr. Gottlieb’s Tenure at the FDA

From FiercePharma.com

New FDA commissioner Gottlieb unveils price-fighting strategies

New FDA commissioner Scott Gottlieb laid out some approaches the agency will take to fight high prices.

During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices.

Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year.

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At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies.

RELATED: Trump to pharma: You’re ‘getting away with murder,’ and I’m the one to stop it

On the first point, Gottlieb said a regularly updated list of off-patent meds could “entice competitors into the market” and ultimately lower costs. One such old, off-patent med with no generic competition is infamous to industry watchers: Daraprim.

Back in 2015, after picking up the medication from Marathon Pharma, Martin Shkreli’s Turing Pharma raised Daraprim’s price exponentially, triggering intense backlash.

In his opening remarks at the budget hearing, Gottlieb said he’s working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.

The FDA will work to “improve processes that enable generic versions of complex drugs to be approved for marketing,” and simplify the overall generic review process, Gottlieb said. He wants the agency to achieve those goals while “completely eliminating” a backlog of generic medications waiting for a review, he told members of Congress.

Further, the FDA will seek to stop misuse of Risk Evaluation Mitigation Strategies that have hurt generic drug developers’ ability to get samples of branded medications needed to develop copycats.

The proposals will likely be welcomed by those who’ve asked for drug pricing reform but have seen little action from Congress despite more than a year of calls from its members to rein in drug prices.

In a Thursday statement, the pharmacy benefit manager industry group PCMA hailed the proposals.

“As the Trump administration seeks to combat high drug costs, we applaud FDA Commissioner Gottlieb’s decision to publish a ‘watch list’ of off-patent drugs,” PCMA CEO Mark Merritt said in a statement. “This move, which PCMA and others have long advocated, will help deter manufacturers from buying the rights to drugs like Daraprim for the explicit purpose of raising their price.”

UPDATED 3/19/2019

National Cancer Chief, Ned Sharpless, Named F.D.A.’s Acting Commissioner

From the NYTimes

Dr. Norman E. Sharpless was named acting commissioner of the Food and Drug Administration on Tuesday. For the last 18 months, he had been director of the National Cancer Institute.CreditTom Williams/CQ Roll Call, via Getty Images

Image

By Sheila Kaplan

WASHINGTON — Dr. Norman E. (Ned) Sharpless, director of the National Cancer Institute, will serve as acting commissioner of the Food and Drug Administration, Alex M. Azar III, secretary of health and human services, announced on Tuesday.

Dr. Sharpless temporarily will fill the post being vacated by Dr. Scott Gottlieb, who stunned public health experts, lawmakers and consumer groups last week when he abruptly announced that he was resigningfor personal reasons.

Dr. Sharpless has been director of the cancer center, part of the National Institutes of Health, since October 2017. He is also chief of the aging biology and cancer section in the National Institute on Aging’s Laboratory of Genetics and Genomics. His research focuses on the relationship between aging and cancer, and development of new treatments for melanoma, lung cancer and breast cancer.

“Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for F.D.A.,” said Mr. Azar, in a statement. “There will be no let up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

Dr. Douglas Lowy, known for seminal research on the link between human papillomavirus and multiple cancer types including cervical, and ultimately leading to development of a vaccine, will be named head of the NCI to replace Dr. Sharpless. Dr. Lowy currently is Deputy Director of the NCI.

Other posts on the Food and Drug Administration and FDA Approvals during Dr. Gotlieb’s Tenure on this Open Access Journal Include:

 

Regulatory Affairs: Publications on FDA-related Issues – Aviva Lev-Ari, PhD, RN

FDA Approves La Jolla’s Angiotensin 2

In 2018, FDA approved an all-time record of 62 new therapeutic drugs (NTDs) [Not including diagnostic imaging agents, included are combination products with at least one new molecular entity as an active ingredient] with average Peak Sales per NTD $1.2Billion.

Alnylam Announces First-Ever FDA Approval of an RNAi Therapeutic, ONPATTRO™ (patisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

FDA: Rejects NDA filing: “clinical and non-clinical pharmacology sections of the application were not sufficient to complete a review”: Celgene’s Relapsing Multiple Sclerosis Drug – Ozanimod

Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

In 2017, FDA approved a record number of 19 personalized medicines — 16 new molecular entities and 3 gene therapies – PMC’s annual analysis, titled Personalized Medicine at FDA: 2017 Progress Report

FDA Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Skin Regeneration Therapy One of First Tissue Engineering Products Evaluated by FDA

FDA approval on 12/1/2017 of Amgen’s evolocumb (Repatha) a PCSK9 inhibitor for the prevention of heart attacks, strokes, and coronary revascularizations in patients with established cardiovascular disease

FDA Approval of Anti-Depression Digital Pill Tracks Use When Swallowed and transmits to MDs Smartphone – A Breakthrough in Medication Remote Compliance Monitoring

Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

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?)

FDA: CAR-T therapy outweigh its risks tisagenlecleucel, manufactured by Novartis of Basel – 52 out of 63 participants — 82.5% — experienced overall remissions – young patients with Leukaemia [ALL]

‘Landmark FDA approval bolsters personalized medicine’ by Edward Abrahams, PhD, President, PMC

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Contributions to Personalized and Precision Medicine & Genomic Research: Larry H. Bernstein, MD, FCAP

Posted in Gene Regulation and Evolution, Genetics & Innovations in Treatment, Genetics & Pharmaceutical, Genome Biology, Genomic Testing: Methodology for Diagnosis, Personalized and Precision Medicine & Genomic Research, tagged Personalized and Precision Medicine & Genomic Research on February 19, 2016| Leave a Comment »

Contributions to Personalized and Precision Medicine & Genomic Research: Larry H. Bernstein, MD, FCAP 

 

Curator: Aviva Lev-Ari, PhD, RN

 

Open Access Online Scientific Journal

Launched on 4/30/2012

http://pharmaceuticalintelligence.com

Site Statistics on 2/18/2016

Date	Views to Date	# of articles	NIH Clicks	Nature Clicks
6/24/2013	199,857	1,034	1,275	661
7/29/2013	217,356	1,138	1,389	705
12/11/2013	293,694	1,464	1,693	828
10/17/2015	765,762	3,444	2,726	1,683

02/18/2016

886,454

4,162

2,911

1,813

 

On 2/18/2016, Aviva Lev-Ari, PhD, RN had curated 2,333 articles, since Journal’s Launch.

• The list of titles is on 118 pages on http://pharmaceuticalintelligence.com
• Links to each article to be found at

http://pharmaceuticalintelligence.com/?s=Aviva+Lev-Ari%2C+PhD%2C+RN

• Frontiers in Cardiology – 653 articles

http://pharmaceuticalintelligence.com/?s=Frontiers+in+Cardiology

These articles have been viewed, since the first article was published on 4/30/2012, by

+886,454 e-Readers

Author and Curator	e-Readers since 4/30/2012	Journal Articles on 2/18/2016
Aviva Lev-Ari, PhD, RN	248,163	2,333
Larry H Bernstein, MD, FCAP	155,253	1,183

 

Top Authors for all days ending 2016-02-18 (Summarized)

site stats 2-18-16

Top Authors for all days ending 2016-02-18 (Summarized)
Author			Views
Aviva Lev-Ari, PhD, RN			248,163
larryhbern, MD, FCAP			155,253
tildabarliya			37,900
sjwilliamspa			26,687
Dror Nir			20,295
Dr. Sudipta Saha			17,558
ritusaxena			13,846
Demet Sag, Ph.D., CRA, GCP			9,543
aviralvatsa			7,528
zraviv06			6,048
zs22			3,316
anamikasarkar			3,090
pkandala			2,056
Alan F. Kaul, PharmD., MS, MBA, FCCP			1,854
Aashir Awan, Phd			1,551
megbaker58			1,336
jdpmd			1,053
danutdaagmailcom			564
Irina Robu			543
howarddonohue			504
Ed Kislauskis			487
S. Chakrabarti, Ph.D.			476
apreconasia			276
evelinacohn			240
anayou1			221
jukkakarjalainen			216
Dr.Sreedhar Tirunagari			143
stuartlpbi			47
gerag2015			44
Rosalind Codrington, PhD			20

Contributions to Personalized Medicine

Larry H Bernstein, MD, FCAP 

Dr. Bernstein had advanced the Personalized Medicine Paradigm in a pursuit of over 40 years of a career in Medicine. 

In his own words:

A Perspective on Personalized Medicine

http://pharmaceuticalintelligence.com/2016/02/22/a-perspective-on-personalized-medicine/

My Life in Medicine: Larry H. Bernstein, M.D.

www.linkedin.com/pub/larry-h-bernstein/a/599/50

I retired from a five year position as Chief of the Division of Clinical Pathology (Laboratory Medicine) at  New York Methodist Hospital-Weill Cornell Affiliate, Park Slope, Brooklyn in 2008 followed by an interim consultancy at Norwalk Hospital in 2010.  I then became engaged with a medical informatics project called “Second Opinion” with Gil David and Ronald Coifman, Emeritus Professor and Chairman of the Department of Mathematics in the Program in Applied Mathematics at Yale.  I went to Prof. Coifman with a large database of 30,000 hemograms that are the most commonly ordered test in medicine because of the elucidation of red cell, white cell and platelet populations in the blood.  The problem boiled down to a level of noise that exists in such data, and developing a primary evidence-based classification that technology did not support until the first decade of the 21^stcentury. READ MORE

http://pharmaceuticalintelligence.com/contributors-biographies/members-of-the-board/larry-bernstein/

In my own words: 

The Young Surgeon and The Retired Pathologist: On Science, Medicine and HealthCare Policy – The Best Writers Among the WRITERS

Curator: Aviva Lev-Ari, PhD, RN

Of all the readings and reviews I completed to date, my appreciation got bonded to two Science and Medicine writers:

• a Young Surgeon, Atul Gawande, MD, MPH

and

• a Retired Pathologist, Pathophysiologist, Histologist, Bacteriologist, Chemical Geneticist, BioChemist, Enzymologist, Molecular Biologist, Mathematical Statistician and more, Larry H. Bernstein, MD, FCAP

I am inviting the e-Readers to join me on a language immersion during a LITERARY TOUR in Science, Medicine and HealthCare Policy. 

The Young Surgeon and The Retired Pathologist: On Science, Medicine and HealthCare Policy – The Best Writers Among the WRITERS

• Dr. Bernstein has expressed his views on Personalized Medicine in a series of articles on Predicted Cost of Care and the Affordable Care Act, Impact of 2013 HealthCare Reform in the US & Patient Protection and Affordable Care Act 

http://pharmaceuticalintelligence.com/biomed-e-books/series-a-e-books-on-cardiovascular-diseases/volume-two-cardiovascular-original-research-cases-in-methodology-design-for-content-co-curation/

• His views of advocacy for Personalized Medicine are expressed in EIGHT Books and another two in the Printing Process for 2016 publication, as follows:

2013 e-Book on Amazon.com

• Perspectives on Nitric Oxide in Disease Mechanisms, on Amazon since 6/2/12013

http://www.amazon.com/dp/B00DINFFYC

2015 e-Book on Amazon.com

• Metabolic Genomics and Pharmaceutics, on Amazon since 7/21/2015

http://www.amazon.com/dp/B012BB0ZF0

• Cancer Biology & Genomics for Disease Diagnosis, on Amazon since 8/11/2015

http://www.amazon.com/dp/B013RVYR2K

• Genomics Orientations for Personalized Medicine, on Amazon since 11/23/2015

http://www.amazon.com/dp/B018DHBUO6

• Milestones in Physiology: Discoveries in Medicine, Genomics and Therapeutics, on Amazon.com since 12/27/2015

http://www.amazon.com/dp/B019VH97LU

• Cardiovascular, Volume Two: Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation, on Amazon since 11/30/2015

http://www.amazon.com/dp/B018Q5MCN8

• Cardiovascular Diseases, Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics, on Amazon since 11/29/2015

http://www.amazon.com/dp/B018PNHJ84

• Cardiovascular Diseases, Volume Four: Regenerative and Translational Medicine: The Therapeutics Promise for Cardiovascular Diseases, on Amazon since 12/26/2015

http://www.amazon.com/dp/B019UM909A

Completed Volumes in PRINTING Process for 2016 publication

 

Series C: e-Books on Cancer & Oncology

Volume 2: Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery

Authors, Curators and Editors:

Larry H Bernstein, MD, FCAP and Stephen J Williams, PhD

2016

http://pharmaceuticalintelligence.com/biomed-e-books/series-c-e-books-on-cancer-oncology/volume-2-immunotherapy-in-oncology/

Series E: Patient-Centered Medicine

Volume 2: Medical Scientific Discoveries for the 21st Century & Interviews with Scientific Leaders

Author, Curator and Editor: Larry H Bernstein, MD, FCAP

2016

http://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/2014-interviews-with-scientific-leaders/

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