Posts Tagged ‘Personalized and Precision Medicine & Genomic Research’

Real Time Conference Coverage: Advancing Precision Medicine Conference,Morning Session Track 1 October 3 2025

Posted in Biological Networks, Cancer Genomics, Clinical Genomics, Evidence-based decision-making, Nobel Prize Winners, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, Single Cell Genomics, Transcriptomics, Translational Research, Translational Science, tagged Advancing Precision Medicine, biomedical collaboration, gene expression profiling, genomics, HIF-1a, international consortium, liquid biopsy, mutational specrum, nobel leureates, oncogenes, Personalized and Precision Medicine & Genomic Research, Transcriptomics, Warburg Effect on October 3, 2025| Leave a Comment »

Real Time Conference Coverage: Advancing Precision Medicine Conference,Morning Session Track 1 October 3 2025

Reporter: Stephen J. Williams, PhD

Leaders in Pharmaceutical Business Intellegence will be covering this conference LIVE over X.com at

@pharma_BI

@StephenJWillia2

@AVIVA1950

@AdvancingPM

using the following meeting hashtags

#AdvancingPM #precisionmedicine #WINSYMPO2025

 

Agenda Track 1: WIN Symposium

WIN SYMPOSIUM

Co-Chairs

Wafik S. El-Deiry, MD, PhD, FACP, Chair, WIN Consortium, Director, Legorreta Cancer Center Brown University, Director, Joint Program in Cancer Biology, Brown University and Brown University Health; Associate Dean, Oncologic Sciences, Warren Alpert Medical School, Brown University; Attending Physician, Hematology/Oncology, Brown University Health Mencoff Family University; Professor of Medical Science, Professor of Pathology and Laboratory Medicine, Brown University; Professor, American Cancer Society Research Professor

Razelle Kurzrock, MD, FACP, Chief Medical Officer, WIN Consortium; Professor of Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Chair of Precision Oncology, MCW Cancer Center and Linda T. & John A. Mellowes Center for Genomic Sciences and Precision Medicine

MULTI-OMICS

Chair

Arutha Kulasinghe, PhD, Associate Professor, Frazer Institute, University of Queensland; Founding Scientific Director, Queensland Spatial Biology Centre

8:40 – 9:00

Welcome and Introduction

Wafik S. El-Deiry, MD, PhD, FACP, Chair, WIN Consortium, Director, Legorreta Cancer Center Brown University, Director, Joint Program in Cancer Biology, Brown University and Brown University Health; Associate Dean, Oncologic Sciences, Warren Alpert Medical School, Brown University; Attending Physician, Hematology/Oncology, Brown University Health Mencoff Family University; Professor of Medical Science, Professor of Pathology and Laboratory Medicine, Brown University; Professor,American Cancer Society Research Professor

Dr. El-Diery welcomes all to this joint symposium with Advancing Precision Medicine and the Win Consortium, which he is currently the head of.  More in the WIN Consortium: (Worldwide Innovation Network Consortium in Precision Oncology).  The WIN Network  is involved in setting up internationalclinical tumor board collaboration

Source: https://winconsortium.org/ 

WIN was formed on the premise that we can accomplish more together than each organization can achieve working alone. We aim to improve cancer patients’ survival and quality of life. View WIN’s history and unique attributes:

• 01
  WIN History
• 02
  Diversity of Stakeholders – WIN Members
• 03
  Studies with a diverse, gender equality global population
• 04
  Sharing information to promote use of personalized, targeted cancer therapy: WIN Symposia

---

Clinical trials, projects and publications

WIN members collaboratively design and carry out global studies designed to achieve breakthroughs for patients worldwide. Our distinguished Scientific Advisory Board oversees WIN studies. Current trials include:

• 01
  Identification of a central network hub of key prognostic genes based on correlation between transcriptomics and survival in patients with metastatic solid tumors
• 02
  Digital Display Precision Predictor: the prototype of a global biomarker model to guide treatments
• 03
  SPRING – Landmark Lung Cancer Tri-Therapy Clinical Trial
• 04
  WINTHER: the WIN Consortium’s first global personalized medicine clinical trial, published in Nature Medicine

View a summary of the WIN Consortium here:

Click to access Brochure_WIN_v24.0_2025_08_13__.pdf

They guide WIN’s strategic, operational, and scientific direction.

OrganizationThe WIN Consortium is organized in the following groups who collectively work together to achieve WIN’s common goals

 

 

Nigel Russell, Founder and CEO, Advancing Precision Medicine

Christopher P. Molineaux, President & Chief Executive Officer, Life Science Pennsylvania

Life Sciences Pennsylvania (LSPA) is the statewide trade association for the commonwealth’s life sciences industry. Founded in 1989, LSPA works to ensure Pennsylvania has a business and public policy climate that makes the commonwealth the most attractive location to open and operate a life sciences company. Our membership is comprised of organizations statewide, representing the entire ecosystem of the life sciences: research institutions, biotechnology, medical device, diagnostic, pharmaceutical, and investment entities, along with service providers who support the industry. Together, we unify Pennsylvania’s innovators to make the Commonwealth a global life sciences leader.

As president & CEO of Life Sciences Pennsylvania, Christopher Molineaux serves as the chief advocate and spokesman for the life sciences industry that calls Pennsylvania home. Molineaux oversees the strategic direction for the association, assuring Life Sciences Pennsylvania continues to be the catalyst that makes Pennsylvania the top location for life sciences companies.

Molineaux brings to Life Sciences Pennsylvania more than 25 years of experience in the bio-pharmaceutical and health care industries, with front-line experience in developing and executing strategies to navigate a shifting economic and political environment.

9:00-9:40

Keynote Lecture – WIN Consortium

Targeting the Achilles’ Heel of Cancer: Synthetic Lethality and Hypoxia in Precision Oncology

William G. Kaelin, Jr, MD,  2019 Nobel Laureate, Sidney Farber Professor, Harvard Medical School and Dana-Farber Cancer Institute

William Kaelin was born in New York City. He studied chemistry and mathematics at Duke University in Durham, North Carolina, and received his doctor of medicine degree there in 1982. He then did his residency at Johns Hopkins University in Baltimore, Maryland. In 2002 he became a professor at Harvard Medical School in Cambridge, Massachusetts.

Work

 

Animals need oxygen for the conversion of food into useful energy. The importance of oxygen has been understood for centuries, but how cells adapt to changes in levels of oxygen has long been unknown. William Kaelin, Peter Ratcliffe, and Gregg Semenza discovered how cells can sense and adapt to changing oxygen availability. During the 1990s they identified a molecular machinery that regulates the activity of genes in response to varying levels of oxygen. The discoveries may lead to new treatments of anemia, cancer and many other diseases.

TRACK 1  204BC

 

WIN SYMPOSIUM

MULTI-OMICS

9:40 – 10:40

SESSION 1

From Base Pairs To Better Care:

AI and Omics in Precision Oncology

9:40-10:00

Multi-Omic Profiling and Clinical Decision Support in Precision Oncology

David Spetzler, PhD, MBA, MS,  President, Caris Life Sciences

10:00-10:20

Integrating Omics and AI for Next-Gen Precision Oncology

Keith T. Flaherty, MD, FAACR, Director of Clinical Research, Massachusetts General Cancer Center; Professor of Medicine, Harvard Medical School;
President-Elect: 2025-2026, American Association for Cancer Research (AACR) 

10:20-10:40

Real-World Data and AI in Precision Oncology: Making Data Work for Patients – Q&A

MODERATOR: Jeff Elton, PhD, Vice Chairman, Founding CEO
ConcertAI

PANELISTS: David Spetzler, PhD, MBA, MS, President, Caris Life Sciences

Keith T. Flaherty, MD, FAACR, Director of Clinical Research, Massachusetts General Cancer Center; Professor of Medicine, Harvard Medical School;
President-Elect: 2025-2026, American Association for Cancer Research (AACR) 

0:40 – 11:10

Break and Exhibits

TRACK 1  204BC

TRACK 2  204A

WIN SYMPOSIUM

MULTI-OMICS

11:10 – 1:10

SESSION 2

The Evolution of Precision Oncology:

Integrating MRD, AI, and Beyond

11:10-12:00

Precision Cancer Consortium

Gabriele Allegri, MBA, Vice President, Global Commercial Precision Medicine, Johnson & Johnson Innovative Medicine

Shruti Mathur, MS, Pharma Diagnostic Strategy Leader, Global Product Strategy (GPS), Genentech

Daryl Pritchard, PhD, Interim President, Personalized Medicine Coalition

Keith T. Flaherty, MD, FAACR, Director of Clinical Research, Massachusetts General Cancer Center; Professor of Medicine, Harvard Medical School;
President-Elect: 2025-2026, American Association for Cancer Research (AACR) 

SESSION 3

The Shifting Landscape:

Tumor Plasticity and Resistance

12:00-12:20

Mathematical and Evolutionary Modeling in Precision Radiation Oncology

Jacob Scott, MD, DPhil, Professor and Staff Physician-Scientist, CWRU School of Medicine and Cleveland Clinic

12:20-12:40

Plasticity and Persistence: The Role of EMT in Cancer Progression and Therapy Resistance

Sendurai A. Mani, PhD, Professor of Pathology and Laboratory Medicine, Brown University; Associate Director of Translational Oncology, Brown University Legorreta Cancer Center

12:40-1:00

Targeting Molecularly Defined Subsets: Challenges in Translational Oncology

Benedito A. Carneiro, MD, MS, Director, Clinical Research
Director, Cancer Drug Development; Associate Director, Division of Hematology/Oncology
Legorreta Cancer Center, Brown University Health

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Conference Coverage 2025 Advancing Precision Medicine Conference, Philadelphia PA October 3-4 2025

Posted in Cancer Genomics, Cancer Informatics, Cardiovascular Pharmacogenomics, Circulating Tumor Cells (CTC), Clinical & Translational, Clinical Genomics, Conference Coverage with Social Media, Genomic Expression, Precision Cancer Medicine, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, Scientific & Biotech Conferences: Press Coverage, tagged Advancing Precision Medicine, Biomarker discovery, biomarker panels, Cancer Genomics, cancer genomics and therapy, cardiogenomics, functional proteomics, liquid biopsy, Personalized and Precision Medicine & Genomic Research on October 2, 2025| 1 Comment »

Conference Coverage 2025 Advancing Precision Medicine Conference, Philadelphia PA October 3-4 2025

Reporter: Stephen J. Williams, PhD

The Annual Advanced Precision Medicine Conference will be held at the Pennsylvania Convention Center October 3-4 2025 in Philadelphia PA.   Advancing Precision Medicine is an organization dedicated to provide education and discourse among medical professionals to advance the field of precision therapeutics and diagnostics in cancer, cardiovascular, and other diseases.  The Annual symposium is held in Philadelphia.

The event will consist of two parallel tracks composed of keynote addresses, panel discussions and fireside chats which will encourage audience participation. Over the course of the two-day event leaders from industry, healthcare, regulatory bodies, academia and other pertinent stakeholders will share an intriguing and broad scope of content.

This event will consist of three immersive tracks, each crafted to explore the multifaceted dimensions of precision medicine. Delve into Precision Oncology, where groundbreaking advancements are reshaping the landscape of cancer diagnosis and treatment. Traverse the boundaries of Precision Medicine Outside of Oncology, as we probe into the intricate interplay of genetics, lifestyle, and environment across a spectrum of diseases and conditions including rare disease, cardiology, ophthalmology, and neurodegenerative disease. Immerse yourself in AI for Precision Medicine, where cutting-edge technologies are revolutionizing diagnostics, therapeutics, and patient care. Additionally, explore the emerging frontiers of Spatial Biology and Mult-Omics, where integrated approaches are unraveling the complexities of biological systems with unprecedented depth and precision.

https://www.advancingprecisionmedicine.com/ 

Leaders in Pharmaceutical Business Intellegence will be covering this conference LIVE over X.com at

@pharma_BI

@StephenJWillia2

@AVIVA1950

@AdvancingPM

using the following meeting hashtags

#AdvancingPM #precisionmedicine #WINSYMPO2025

APM is a mission-driven team dedicated to advancing clinical practice through education in precision medicine, oncology, and pathology. Our expert-led programs bring together clinicians, pathologists, pharmacists, nurses, and researchers from across the country.

What We Offer

In 2025, we’re proud to offer three specialized event series—each tailored to a different corner of the healthcare ecosystem:

Register here for the 2025 Conference: https://www.advancingprecisionmedicine.com/apm-home/apm-annual-conference-and-exhibition-in-philadelphia/ 

Where discovery meets application – and science transforms lives.

What’s New in 2025?

Four Specialized Tracks:

Track 1 – 2025 WIN Symposium: Progress and Challenges in Precision Oncology
Presented in partnership with Advancing Precision Medicine

As the official 2025 WIN Symposium, this dedicated track will explore the evolving landscape of precision oncology, highlighting both groundbreaking advances and the ongoing challenges of translating molecular insights into clinical impact. Curated by the WIN Consortium, the program will feature global leaders in cancer research, diagnostics, and therapeutic innovation—offering a comprehensive view of how precision medicine is reshaping oncology across tumor types and care settings.

Track 2 – Day 1 – Multi-Omics Integration, Day 2 – Precision Medicine Outside of Oncology

From genomics and transcriptomics to proteomics and metabolomics—this track highlights how multi-layered data is revolutionizing systems biology and clinical decision-making.

Diving into applications across cardiovascular, neurology, rare disease, infectious disease, and other therapeutic areas where precision tools are reshaping clinical practice.

 

Why Attend?

• Cutting-Edge Innovation: Explore AI-powered solutions, multi-omics workflows, clinical trial design, and real-world implementation.
• Renowned Speakers: Hear from global thought leaders in translational research, biotech innovation, and personalized therapeutics.
• Dynamic Format: Keynotes, fireside chats, panels, and audience-interactive discussions across four concurrent tracks.
• Unmatched Networking: Collaborate with scientists, startups, executives, regulators, and investors shaping tomorrow’s care.
• Philadelphia Advantage: Centrally located near premier academic institutions, hospitals, incubators, and venture capital networks.

Who Should Attend?

Researchers, clinicians, data scientists, regulatory experts, startup founders, investors, tech transfer professionals, and healthcare leaders.

Let’s advance a future that is more predictive, preventive, and precise—together.

Keynote Speaker

• 

  

  William Kaelin, Jr, MD

  2019 Nobel Laureate
  Sidney Farber Professor, Harvard Medical School and Dana-Farber Cancer Institute

  View Profile

2019 Nobel Laureate

Sidney Farber Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute 

Senior Physician-Scientist at Brigham and Women’s Hospital

Howard Hughes Medical Institute Investigator

William Kaelin is the Sidney Farber Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute, Senior Physician-Scientist at Brigham and Women’s Hospital and Howard Hughes Medical Institute Investigator. He obtained his undergraduate and M.D. degrees from Duke University and completed his training in Internal Medicine at the Johns Hopkins Hospital, where he served as chief medical resident. He was a clinical fellow in Medical Oncology at the Dana-Farber Cancer Institute and later a postdoctoral fellow in David Livingston’s laboratory, during which time he was a McDonnell Scholar.

A Nobel Laureate, Dr. Kaelin received the 2019 Nobel Prize in Physiology or Medicine. He is a member of the National Academy of Sciences, the American Academy of Arts and Sciences, the National Academy of Medicine, the American Society of Clinical Investigation, and the American College of Physicians. He previously served on the National Cancer Institute Board of Scientific Advisors, the AACR Board of Trustees, and the Institute of Medicine National Cancer Policy Board. He is a recipient of the Paul Marks Prize for cancer research from the Memorial Sloan-Kettering Cancer Center; the Richard and Hinda Rosenthal Prize from the AACR; the Doris Duke Distinguished Clinical Scientist award; the 2010 Canada International Gairdner Award; ASCI’s Stanley J. Korsmeyer Award; the Scientific Grand Prix of the Foundation Lefoulon-Delalande; the Wiley Prize in Biomedical Sciences; the Steven C. Beering Award; the AACR Princess Takamatsu Award; the ASCO Science of Oncology Award; the Helis Award; the Albert Lasker Basic Medical Research Prize; the Massry Prize; the Harriet P. Dustan Award for Science as Related to Medicine from the American College of Physicians.

Dr. Kaelin’s research seeks to understand how, mechanistically, mutations affecting tumor-suppressor genes cause cancer. His laboratory is currently focused on studies of the VHL, RB-1, and p53 tumor suppressor genes. His long-term goal is to lay the foundation for new anticancer therapies based on the biochemical functions of such proteins. His work on the VHL protein helped to motivate the eventual successful clinical testing of VEGF inhibitors for the treatment of kidney cancer. Moreover, this line of investigation led to new insights into how cells sense and respond to changes in oxygen, and thus has implications for diseases beyond cancer, such as anemia, myocardial infarction, and stroke. His group also showed that leukemic transformation by mutant IDH was reversible, setting the stage for the development and approval of mutant IDH inhibitors, and discovered how thalidomide-like drugs kill myeloma cells by degrading two otherwise undruggable transcription factors,

2025 Steering Committee

Wafik S. El-Deiry, MD, PhD, FACP

Chair
WIN Consortium

View Profile

Marni Falk, MD

Distinguished Endowed Chair, Department of Pediatrics
Executive Director, Mitochondrial Medicine Frontier Program
CHOP

View Profile

Arutha Kulasinghe, PhD

Associate Professor, Frazer Institute, University of Queensland; Founding Scientific Director, Queensland Spatial Biology Centre

View Profile

Adrian Lee, PhD

Professor and Director
Institute for Precision Medicine
University of Pittsburgh

View Profile

Howard McLeod, PharmD

CHAIR

Professor & Center Director
Utah Tech University

View Profile

Emanuel Petricoin, PhD

Co-Director Center, Applied Proteomics & Molecular Medicine
George Mason University

View Profile

Jasmine Plummer

Founding Director, Center for Spatial Omics
Member, Comprehensive Cancer Center
St. Jude’s Children’s Research Hospital

View Profile

Giselle Sholler, MD

Director, Pediatric Oncology Research
Penn State Hershey Children’s Hospital

View Profile

Wafik S. El-Deiry, MD, PhD, FACP

Chair
WIN Consortium

View Profile

Marni Falk, MD

Distinguished Endowed Chair, Department of Pediatrics
Executive Director, Mitochondrial Medicine Frontier Program
CHOP

View Profile

Arutha Kulasinghe, PhD

Associate Professor, Frazer Institute, University of Queensland; Founding Scientific Director, Queensland Spatial Biology Centre

View Profile

Adrian Lee, PhD

Professor and Director
Institute for Precision Medicine
University of Pittsburgh

View Profile

Howard McLeod, PharmD

CHAIR

Professor & Center Director
Utah Tech University

View Profile

Emanuel Petricoin, PhD

Co-Director Center, Applied Proteomics & Molecular Medicine
George Mason University

View Profile

Jasmine Plummer

Founding Director, Center for Spatial Omics
Member, Comprehensive Cancer Center
St. Jude’s Children’s Research Hospital

View Profile

Giselle Sholler, MD

Director, Pediatric Oncology Research
Penn State Hershey Children’s Hospital

View Profile

Presentations

A diverse group of more than 90 key opinion leaders will convene to explore the critical forces shaping the future of healthcare. Representing a range of disciplines—including genomics, bioinformatics, clinical research, biopharma, technology, and investment—these experts will lead discussions on the latest advancements and challenges in precision medicine.

Topics will include the evolution of genomic sequencing technologies, ethical considerations in managing patient data, the integration of AI in diagnostics, and strategies for translating innovation into clinical practice. The inclusion of investors and strategic partners will also bring a vital perspective on funding models, commercialization pathways, and the acceleration of cutting-edge therapies. Together, these voices will offer a comprehensive view of the trends transforming personalized healthcare on a global scale.

Networking Opportunities

Our precision medicine event, hosting over 500 attendees, offers invaluable networking opportunities. Bringing together professionals, researchers, and industry leaders, the event facilitates engaging discussions, knowledge-sharing, and potential partnerships, driving advancements in precision medicine.

Why Exhibit

Exhibiting at the event provides a unique opportunity to showcase your cutting-edge solutions and connect with key stakeholders in the rapidly advancing field of personalized healthcare. As an exhibitor, you’ll gain visibility among industry leaders, researchers, and professionals, allowing you to forge strategic partnerships, highlight your contributions to precision medicine, and stay at the forefront of innovations shaping the future of healthcare. Don’t miss the chance to position your company as a leader in this dynamic and transformative space, driving meaningful collaborations and contributing to the advancement of precision medicine.

Register Now!

THE LOCATION

APM Annual Conference 2025

Pennsylvania Convention Center
1101 Arch Street
Philadelphia, PA 19107

Registration Fees

Student – free
Academic/Government/Non-Profit  – free
Healthcare Providers – free 
Investors – free
Vendor/Technology Provider $999

Other Live Conference Proceedings can be found on this Online Open Access Journal at:

Press Coverage

including a list of previous conference at:

Part Two: List of BioTech Conferences 2013 to Present

including Live Coverage of the 2024 Advancing Precision Medicine conference at:

Real Time Coverage Advancing Precision Medicine Annual Conference, Philadelphia PA November 1,2 2024

 

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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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