Medtech market access

 Bringing a Medical Device to the Market . A Scientist’s Perspective

Pharma and Medtech market access

 Commercializing Successful Biomedical Technologies

Contents

1 - The biomedical drug, diagnostic, and devices industries and their marketspp 1-35

2 - Markets of interest and market research stepspp 36-62

3 - Intellectual property, licensing, and business modelspp 63-103

4 - New product development (NPD)pp 104-171

5 - The regulated market: gateway through the FDApp 172-225

6 - Manufacturingpp 226-263

7 - Reimbursement, marketing, sales, and product liabilitypp 264-316

Wellbeing as a top priority

Wellbeing. Alternative Policy Perspectives

Open access book by Tim Besley et al.

Why not focus directly on increasing measured human happiness? Why not try to improve people’s overall quality of life, as it is subjectively seen by citizens themselves?

Contents:

 Introduction: Making Wellbeing Policies Effective

Timothy Besley & Irene Bucelli

Wellbeing as the Goal of Policy

Richard Layard

Accounting for Consequences and Claims in Policy

Paul Dolan

Weighing the Costs and Benefits of Public Policy: On the Dangers of Single Metric Accounting

Johanna Thoma

Wellbeing in Public Policy: Contributions Based on Sen’s Capability Approach

Paul Anand

Incorporating Wellbeing and Mental Health Research to Improve Pandemic Response

Michael Daly & Liam Delaney

COVID-19 and Mental Health and Wellbeing Research: Informing Targeted, Integrated, and Long-Term Responses to Health Emergencies

Annette Bauer

Health, Wellbeing, and Democratic Citizenship: A Review and Research Agenda

Christopher J. Anderson et al.

Health and Disability Gaps in Political Engagement: A Short Review

Mikko Mattila

Pharma competition and innovation

 My speech at the Reial Acadèmia de Medicina de Catalunya, 22/11/2022:

Reframing the human body as a cellular ecosystem

 The Song of the Cell. An Exploration of Medicine and the New Human

In The Song of the Cell, Mukherjee tells the story of how scientists discovered cells, began to understand them, and are now using that knowledge to create new humans. He seduces you with writing so vivid, lucid, and suspenseful that complex science becomes thrilling. Told in six parts, laced with Mukherjee’s own experience as a researcher, a doctor, and a prolific reader, The Song of the Cell is both panoramic and intimate—a masterpiece.

A must read!!! 

Storm warning (to whom it may concern) (2)

 Disorder: a history of reform, reaction, and money in american medicine

Precision medicine (4)

 Genomic and Precision Medicine. Foundations, Translation, and Implementation

Precision medicine (3)

The Politics of Personalised Medicine. Pharmacogenetics in the Clinic

Personalized, stratified or precision medicine: the expectations behind a concept

 Contested futures: envisioning “Personalized,” “Stratified,” and “Precision” medicine

Rather than pinpointing which of these terms is the “correct” one or delineating the “true” meaning of each, to know how we should critically approach the concepts we need an awareness of the discursive contexts in which they are mobilized. This is because the context ultimately structures the social and ethical implications that “personalization,” “stratification,” or “precision” will have for medicine and healthcare systems, and for different stakeholders. As big health data, predictive and systems-level analysis are, themselves, emergent phenomena, the terminology applied in the discursive spaces around these new biotechnologies and approaches cannot be abstracted from their context. Rather, when we apply the “personalization,” “stratification,” and “precision” terms, we invoke particular associations, connotations, “hopes” and “truths” that are part of pre-existing epistemologically and ethically loaded discourses that reflect broader and weightier struggles over what is a good future.

 

Pharma, big pharma (18)

Knowledge Accumulation and Industry Evolution

This book explores how the biotechnology and pharmaceutical sector is affected by innovation, growth and public policy.

Precision medicine (2)

 Genomics and the Reimagining of Personalized Medicine

Pharma, big pharma (17)

 Big Pharma. The Money Behind the Pills

Contents:

Chapter 1

Big Pharma’s New Deal: Acquisition and Little Innovation

Blockbuster Drugs Are So Last Century BY ALEX BERENSON

When Academia Puts Profit Ahead of Wonder BY JANET RAE-DUPREE

Grant System Leads Cancer Researchers to Play It Safe BY GINA KOLATA

Are Doctors Too Wary of Drug Companies? BY PAULINE W. CHEN, M.D.

Valeant’s History of Deal-Making BY WILLIAM ALDEN

Roche to Buy InterMune for $8.3 Billion BY ANDREW POLLACK AND MICHAEL J. DE LA MERCED

Why Are So Few Blockbuster Drugs Invented Today? BY DAN HURLEY

$2.6 Billion to Develop a Drug? New Estimate Makes Questionable Assumptions BY AARON E. CARROLL

Stop Subsidizing Big Pharma BY LLEWELLYN HINKES-JONES

Ways to Fund Research on Rare Diseases THE NEW YORK TIMES

AstraZeneca to Acquire Majority Stake in Acerta Pharma BY CHAD BRAY

Explaining Valeant: The Main Theories BY STEVEN DAVIDOFF SOLOMON

Chapter 2

Monopolies and Exclusivity Drive Price Spikes

Runaway Drug Prices BY THE NEW YORK TIMES

Costly Hepatitis C Drugs for Everyone? BY THE NEW YORK TIMES

New Cholesterol Drugs Are Vastly Overpriced, Analysis Says BY ANDREW POLLACK

Inflated Drug Prices THE NEW YORK TIMES

Drug Goes From $13.50 a Tablet to $750, Overnight BY ANDREW POLLACK

Big Price Increase for Tuberculosis Drug Is Rescinded BY ANDREW POLLACK

Valeant Under Investigation for Its Drug Pricing Practices BY ANDREW POLLACK

Senators Condemn Big Price Increases for Drugs BY ANDREW POLLACK

No Justification for High Drug Prices BY THE NEW YORK TIMES

Another Drug Pricing Ripoff BY THE NEW YORK TIMES

The EpiPen, a Case Study in Health System Dysfunction BY AARON E. CARROLL

The Complex Math Behind Spiraling Prescription Drug Prices BY KATIE THOMAS

The Lesson of EpiPens: Why Drug Prices Spike, Again and Again BY ELISABETH ROSENTHAL

Chapter 3

Disease Branding and the Profusion of Diagnoses

Ritalin Wars BY JUDITH WARNER

Disease Branding BY BEN SCHOTT

Still the ‘Age of Anxiety.’ Or Is It? BY DANIEL SMITH

Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses BY KATIE THOMAS

A.D.H.D. Seen in 11% of U.S. Children as Diagnoses Rise BY ALAN SCHWARZ AND SARAH COHEN

Is It Really A.D.H.D. or Just Immaturity? BY KJ DELL’ANTONIA

Overselling A.D.H.D.: A New Book Exposes Big Pharma’s Role BY STEVE SILBERMAN

A Profusion of Diagnoses. That’s Good and Bad. BY DHRUV KHULLAR, M.D.

Chapter 4

The Money Behind Epidemics: Preventing, Treating and Healing

For Profit, Industry Seeks Cancer Drugs BY ANDREW POLLACK

F.D.A. Advisory Panel Backs Preventive Use of H.I.V. Drug BY DENISE GRADY

Advocating Pill, U.S. Signals Shift to Prevent AIDS BY DONALD G. MCNEIL JR.

Painkillers Resist Abuse, but Experts Still Worry BY ALAN SCHWARZ

The C.E.O. of H.I.V. BY CHRISTOPHER GLAZEK

The Insanity of Taxpayer-Funded Addiction BY THE NEW YORK TIMES

F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts BY SHEILA KAPLAN

As Opioid Prescriptions Fall, Prescriptions for Drugs to Treat Addiction Rise BY ABBY GOODNOUGH

Chapter 5

The Trump Administration vs. Big Pharma

The Real Reason Medicare Is a Lousy Drug Negotiator: It Can’t Say No BY MARGOT SANGER-KATZ

The Fight Trump Faces Over Drug Prices BY KATIE THOMAS

Trump Vows to Ease Rules for Drug Makers, but Again Zeros In on Prices BY KATIE THOMAS

Drug Lobbyists’ Battle Cry Over Prices: Blame the Others BY ERIC LIPTON AND KATIE THOMAS

Draft Order on Drug Prices Proposes Easing Regulations BY SHEILA KAPLAN AND KATIE THOMAS

Lower Drug Prices: New Proposals Carry Lots of Promises BY KATIE THOMAS AND REED ABELSON

What Big Pharma Fears Most: A Trump Alliance With Democrats to Cut Drug Prices BY ROBERT PEAR

Trump Proposes to Lower Drug Prices by Basing Them on Other Countries’ Costs BY ROBERT PEAR

Understanding Population Health

Population Health and the Future of Healthcare

Contents:

Defining Population Health

The Road to Population Health: A Changing Society

The Road to Population Health: A Changing Healthcare System

The Roots of Population Health

Health Status and How to Measure It

The Social Determinants of Health and Illness

Paying the Piper: Health Disparities

Population Health and Healthcare Delivery

Population Health and Public Policy

Traditional Approaches to Community Health Data

Data Needs for the Population Health Model

The Role of the Community in Population Health Improvement

Trends in Population Health

A History of Population Health. Rise and Fall of Disease in Europe

In A History of Population Health Johan P. Mackenbach offers a broad-sweeping study of the spectacular changes in people’s health in Europe since the early 18th century. Most of the 40 specific diseases covered in this book show a fascinating pattern of ‘rise-and-fall’, with large differences in timing between countries. Using a unique collection of historical data and bringing together insights from demography, economics, sociology, political science, medicine, epidemiology and general history, it shows that these changes and variations did not occur spontaneously, but were mostly man-made. Throughout European history, changes in health and longevity were therefore closely related to economic, social, and political conditions, with public health and medical care both making important contributions to population health improvement.