The Catalyst

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Week in Review: The Many Voices of Biopharmaceutical Collaboration 

10.11.13 | By Kaelan Hollon

Every day, our industry strives to connect patients, families and advocates from across the globe who share our common goals of preventing diseases, improving health and saving lives. Read more. 


A Year Into Implementation, Stakeholders See Great Promise in PDUFA V 

10.10.13 | By John Castellani

In the last 20 years, the Prescription Drug User Fee Act (PDUFA) has resulted in timelier patient access to more than 1,500 new drugs and biologics, decreasing review times for these treatments by more than 60 percent. Read more. 

Guest Blogger and CEO Steve Pasierb Highlights New Documentary

10.09.13 | By Kaelan Hollon

We’re excited to host a guest blog post by Steve Pasierb, the passionate CEO of The Partnership at We’ve been longtime partners with, and Steve’s blog will be the first of regular updates about what’s new in’s world. It’s a busy, active organization, and I encourage anyone concerned about prescription drug abuse to get involved. Read more. 

Conversations: Medicines in Development for Rare Disease 

10.08.13 | By Stephanie Fischer

The world’s biopharmaceutical research companies continually strive to develop new medicines that prevent diseases, improve patient health, and help save lives.  There are currently more than 5,000 medicines in development globally.  Read more. 

Week in Review: Collaborating for Continued Innovation 

10.04.13 | By Kaelan Hollon 

The significant disease progress we've made reminds us to not only recognize and appreciate what we've already accomplished on behalf of patients, but also to look into the future and determine what more can be done. Read more.  

PhRMA Co-Hosting Forum on Alzheimer's: The Puzzle, The Partners, The Path Forward

10.02.13 | By Dr. Bill Chin

The best and the brightest spanning the innovation ecosystem have been trying for years to unlock the mysteries of Alzheimer’s disease with the common goals of delaying, treating or outright preventing progression of the disease. Read more. 

Conversations: PDUFA V 

10.01.13 | By Matt Bennett 

In 1992, under the Prescription Drug User Fee Act (PDUFA), the U.S. Food and Drug Administration (FDA) began collecting fees from biopharmaceutical companies to provide much needed resources to keep new medicines moving through the approval process and into the hands of patients.  Read more. 

Conversations Wrap Up: Medicare Part D 10 Years Later

09.30.13 | By John Castellani

In 2003, through the Medicare Modernization Act, Congress established the Medicare prescription drug benefit - better known as Part D. Ten years later, at a cost significantly below initial estimates, the program is successfully providing affordable access to prescription drugs for more than 30 million seniors and people with disabilities. Read more. 

Week in Review: Participation in Health Care Ecosystem Means Continued Progress 

09.27.13 | By Kaelan Hollon

From programs that provide access to medicines, to the development of innovative new treatments, the recent progress we’ve made is staggering. Our CEO John Castellani noted in a blog post this week that all members of the R&D process, from patients to researchers to academics, play a significant role in development process. It is through their participation that we have seen continued advances. Read more. 

Protecting Patient Health and Innovation

09.27.13 | By Scott LaGanga

Millions of patients around the world depend on innovative medicines to help them live healthy lives. Every time I travel to a different country, I am reminded of this fact. Just last week in Tokyo, PhRMA EVP for Advocacy Chip Davis specifically addressed how the innovative new medicines our member companies develop have enhanced the country’s health care system. Read more. 

Conversations: Is Medicare Part D Still Living Up to its Promise?

09.25.13 | By Matt Bennett

With more than 5,000 medicines in development globally, the prospects for incredible breakthroughs in medicine – many of which may one day help those suffering from diseases that are currently untreatable – are exceedingly bright. With this general backdrop, we wanted to know what potential advances in biopharmaceutical science most excite people. Read more. 

Patients Are Critical Collaborators in Parkinson's Disease

09.25.13 | By Elizabeth Joyce, Marketing & Communications Officer, The Michael J. Fox Foundation for Parkinson's Research

Recruiting volunteers to participate in clinical trials is a well-known and enduring obstacle to research progress, and the effect is staggering: 85 percent of trials across all diseases face delays and 30 percent never even get off the ground due to low enrollment. And Parkinson’s disease (PD) trials are no exception – fewer than 10 percent of Parkinson’s patients participate. Today, there are more promising Parkinson’s drugs in the development pipeline than we’ve seen in decades, if not ever. Read more. 

Conversations Round Up: Future Innovations in the Biopharmaceutical Pipeline

09.23.13 | By John Castellani

With more than 5,000 medicines in development globally, the prospects for incredible breakthroughs in medicine – many of which may one day help those suffering from diseases that are currently untreatable – are exceedingly bright. With this general backdrop, we wanted to know what potential advances in biopharmaceutical science most excite people. Read more. 

World Alzheimer's Day and Alzheimer's Prevention

09.20.13 | By Jennifer Wall

As the nation recognizes World Alzheimer’s Day this Saturday, the federal government announced that it is awarding a $33.2 million grant to test an Alzheimer’s medicine in pre-symptomatic seniors (60 to 75 year olds) with two copies of the AD gene. Read more. 

Week in Review: Making Progress to Give Patients Hope

09.20.13 | By Kaelan Hollon

As Senior VP of Communications Matt Bennett noted on the Catalyst this week, years of hard work go into developing and testing new medicines, and this perseverance has resulted in great progress in clinical trial research. A new person is affected by Alzheimer’s every 70 seconds, and clinical trials not only provide patients with devastating diseases like cancer and Alzheimer’s with innovative new treatments, they also provide hope for the future for patients across the country. Read more. 

FDA Spends $182k to Monitor Social Media While Biopharma Industry Waits for Social Media Guidance

09.20.13 | By Stephanie Fischer

In this austere fiscal environment, I must admit to being a little surprised by the news that the Food and Drug Administration (FDA) is spending $182,000 on a tool to monitor what people are saying about the Agency on social media. Read more. 

More Voices Enter Clinical Trials Data Sharing Debate in Europe

09.20.13 | By Mark Grayson

A new paper released this week highlights issues surrounding the discussions on clinical trial data sharing. The paper, Clinical Trials and Data Transparency: The Public Interest Case, highlights specific problems to the current draft European Medicines Agency (EMA). Read more. 

Ellie's Story of Hope

09.19.13 | By Christian Clymer

Delivering hope to millions of patients is the foundation of our industry. While the word 'hope' is highly personal to each patient, a common thread exists that unites all of us regardless of age, geographic location or socio-economic status. Without it, we would not be in a position to advance critical research that provides innovative new medicines to patients across the globe. By all accounts, 'hope' is the driver that keeps us looking forward. Read more. 

PhRMA Alzheimer's Forum to Focus on Partnerships and Clinical Trials

09.19.13 | By Jennifer Wall

There have been a number of media reports over the last week about the challenges surrounding Alzheimer’s research. From a piece in the Asbury Park Press about a woman’s plight to reduce the risk of her daughter developing Alzheimer’s to a series on NBC focusing on promising research currently underway by scientists in academia and the biopharmaceutical industry, there is much to be hopeful for. Read more. 

Conversations: The Biopharmaceutical Pipeline

09.18.13 | By Matt Bennett

There are more than 5,000 new medications in the research and development pipeline. Some of these medications may one day result in effective treatments for diseases and conditions that exact a tremendous personal and financial toll on patients around the country and the world. The approval process takes a long time, and years of hard work go into developing and testing new medications with no guarantee they will prove effective or gain approval. Read more. 

Conversations Wrap Up: Vaccines key to continued improvements in public health 

09.17.13 | By John Castellani  

Biopharmaceutical scientists work daily to identify and develop potential preventative and therapeutic medicines for some of the most difficult conditions and diseases, with the unified goal of helping people live longer and healthier lives.  Read more. 


CDC Director Tom Frieden on Vaccines Acceptance, Public Health Value

09.15.13 | By Karl Uhlendorf

So far this year, according to the Centers for Disease Control and Prevention (CDC), 159 cases of measles have been reported in 16 states  – 36 percent of those occurring in children less than five years of age. It’s the second largest number of cases since 2000 – a sobering statistic that should serve as a wake-up call about the importance of parents and healthcare professionals adhering to the CDC’s guidelines and recommendations for the measles, mumps and rubella (MMR) vaccine. Read more. 

Week in Review: Vaccines for a Healthy Future 

09.13.13 | By Kaelan Hollon

Despite some tremendous strides in vaccine development over the years, vaccines remain a major public health challenge for patients and their families throughout the world. This week we released our Medicines in Development: Vaccines report, which shows there are more than 270 vaccines in the pipeline to prevent and/or treat a wide array of diseases, including various forms of cancer and neurological disorders. Read more. 

Montana's Clinical Research - A Health Dose of Dedication and Compassion

09.13.13 | By Jeff Trewhitt 

It doesn't take long to understand why biopharmaceutical research companies have conducted more than 800 clinical trials in Montana. As you enter downtown Billings from the airport, you see an unexpected sight: several blocks of gleaming medical research buildings and clinics.  On Friday, I learned that these complexes are staffed by dedicated, compassionate veteran clinicians such as Dr. Benjamin Marchello, a Billings native and principal investigator of the Montana Cancer Consortium and president of St. Vincent Frontier Cancer Center.  Read more. 

WUSA 9 - TV Puts Spotlight on PhRMA Research & Hope Awards 

09.13.13 | By Jennifer Wall 

WUSA 9 - TV highlighted the importance of vaccines and immunizations during a segment that aired on the evening news here in Washington last night.  The segment comes on the heels of PhRMA’s annual Research & Hope Awards ceremony celebrating individuals and teams in the medical innovation ecosystem who are contributing greatly to the advancement of public health. Read more. 

Turkey's Health Care Reform: The 2023 Challenge

09.13.13 | By Mark Grayson

Turkey is at the vanguard of a global trend of implementing universal health coverage. Building on that leadership position, Prime Minister Erdoğan has set a goal for Turkey to become a global leader in the delivery of health services over the next decade. A key element of developing the health care market in Turkey is expanding the country’s biopharmaceutical sector. Read more.

Conversations: The Future of Vaccines

09.11.13 | By Matt Bennett

Today, PhRMA and its 2013 Research & Hope Awards partners are honoring visionaries in the vaccines and immunization field. These inspiring scientists and public health champions continue the impactful legacy of vaccines – a field of biomedical science that has dramatically reduced the burden of disease for countless people around the world. Read more.

Vaccines: Saving Lifes, Changing the World, Giving Hope

09.11.13 | By John Castellani

To say that vaccines have changed the world for the better is a dramatic understatement. Vaccines have helped us to eradicate smallpox. They’ve helped to dramatically reduce the scourge of polio around the globe. Read more.

U.S. Rep. Clyburn Explains How Clinical Trials Provide Opportunity to Address Health Disparities

09.10.13 | By Chip Davis 

As you may know from a previous Catalyst post, late last month we unveiled a new report on “Research in Your Backyard: Pharmaceutical Clinical Trials in South Carolina”. We were honored to be joined by U.S. Representative James E. Clyburn who addressed the importance of clinical trials to making new medicines available to patients, and how the participation of minority patients in clinical trials is necessary to reduce health disparities.  Read more. 

Yes You Can Says Team Hoyt 

09.09.13 | By Preet Bilinski

I recently had the opportunity to speak to Team Hoyt, a father and son team, that have run over 1,000 endurance races together. Team Hoyt has been inducted into the Ironman Hall of fame, honored with a life size bronze statue of their likeness by the start of the Boston marathon and presented with the Jimmy V perseverance award. Read more. 

Draft Guidance on Expedited Programs demonstrates FDA has broad regulatory flexibility to eastablish the safety and efficacy of innovative medicines to address unmet medical needs

09.09.13 | By Stephanie Fischer

PhRMA has long supported the FDA’s appropriate use of innovative approaches and regulatory flexibility to establish the safety and efficacy of innovative medicines to address unmet medical needs.  We strongly supported the passage last year of the Food and Drug Administration Safety and Innovation Act (FDASIA) which enhanced the authority of FDA to consider appropriate scientific data, methods, and tools, and to expedite development. Read more.  

Week in Review: Recognizing the Significance of Preventative Medicine

09.09.13 | By Kaelan Hollon 

Innovative research and development has led to revolutionary medical treatments and practices that have impacted how we think about preventative medicine. While colloquialisms like “an apple a day keeps the doctor away” still hold true, thanks to hardworking researchers, academics and individuals throughout the health care ecosystem, we now have an increasing selection of cutting-edge treatments that can protect us from some of the most debilitating diseases.  Read more. 

Falling Back Into Healthy Routines 

09.05.13 | By Kaelan Hollon 

With the start of school and everyone resuming their normal routine, now is the time to schedule your regular doctor’s visit. Given the craziness of summer, health is often an afterthought -- but now is the time to make it a priority. Read more. 

What's Next? TPP Heading Into the Final Stretch

 08.30.13 | By Mark Grayson 

The 19th round of Trans-Pacific Partnership (TPP) negotiations in Brunei conclude today, and with countries looking to finalize the agreement by the end of this year, there is much to be done in the coming months.  Read more. 

Week in Review: The Many Facets of R&D

08.30.13 | By Kaelan Hollon 

Making a new treatment available to patients takes more than a decade and a billion dollars. Given the time and resources it takes to successfully bring a drug to market, the need for strong intellectual property (IP) protections in the U.S. and abroad has never been more important. Read more. 

Conversations: Medication Adherence 

08.29.13 | By Matt Bennett 

As we’ve previously noted on the Catalyst, medication adherence continues to be a serious challenge with significant consequences to patient health and costs associated with acute care, hospitalizations and surgery. Today, nearly 145 million Americans suffer from chronic disease, but only one-third take their medications as prescribed. Read more. 

Partnership for Safe Medicines India Initiative Hosts National Multi-Stakeholder Forums to Help Protect Patients 

08.28.13 | By Scott LaGanga 

Across the globe, millions of patients are put at risk by counterfeit, substandard or otherwise unsafe medicines. As Executive Director of the Partnership for Safe Medicines in the United States, I traveled to India this week to participate in two national workshops hosted by the PSM India Initiative, an organization working to raise awareness and empower consumers across the country. Read more. 

More Than 3,200 Clinical Trials Conducted in South Carolina With a Growing Emphasis on Diversity 

08.28.13 | By Jeff Trewhitt

At a time when there is growing concern about diversity in clinical trials, we learned yesterday that 26 percent of people who participate in treatment trials at the Medical University of South Carolina's Hollings Cancer Center (HCC) are African American. Read more. 

Looking for Research Opportunities That Will Benefit Patients? Read on.

08.28.13 | By Liz Magsig 

The PhRMA Foundation is seeking applications for its Young Investigator Center for Adherence Improvement Award. The award will provide stipend support for individuals who are doing research that will advance and improve medication adherence. Read more. 

Balancing the Public Health Benefit of Clinical Trials Data Sharing with Patient Privacy and Continued Innovation

08.27.13 | By John Castellani

Last month, PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) endorsed joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers. At the time, I wrote that “these principles reflect the biopharmaceutical sector’s strong support for responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems, and maintains incentives for continued investment in biopharmaceutical research.” Read more. 

International Cancer Advocacy Network Provides Personalized Assistance to Stage IV Cancer Patients

08.26.13 | By Stephanie Fischer 

I recently learned of the International Cancer Advocacy Network which provides personalized assistance to patients facing stage IV cancer.  I invited Marcia Horn, President and CEO of ICAN, to elaborate on the mission and programs the organization offers. Read more. 

The Best - Not Fastest - Deal Should Be U.S. Goal in TPP 

08.26.13 | By Jay Taylor 

With the Asia-Pacific Economic Cooperation (APEC) leaders meeting scheduled for October and participating countries emphasizing their desire to complete Trans-Pacific Partnership (TPP) negotiations this year, there is a heightened sense of urgency to come to an agreement. Read more

National Psoriasis Foundation Invites You to be a Citizen Pscientist

08.21.13 | By Noe Baker, Public Relations Manager, National Psoriasis Foundation  

In addition to raising awareness, funding research and providing educational resources for patients and healthcare providers, the National Psoriasis Foundation is now encouraging psoriasis patients to actively participate in research.  The initiative, called Citizen Pscientist, was unveiled earlier this month as part of Psoriasis Awareness Month. Read more. 

Mental Illness: Promise in the Biopharmaceutical Pipeline

08.20.13 | By Salvatore Alesci

The New York Times today put a spotlight on mental health, mistakenly pointing out that we are facing a crisis in innovation for medicines that can help patients suffering from debilitating psychiatric diseases. On the contrary, biopharmaceutical researchers around the world are working in this challenging area to unravel these diseases using an array of new approaches. Read more. 

Clinical Trials Data: Balancing Transparency and Patient Privacy

08.20.13 | By Karl Uhlendorf

Bringing a medicine to patients, from discovery through FDA review, is a lengthy, costly and sometimes unpredictable process. On average, it takes 10-15 years and an investment of more than $1 billion. As noted previously on the Catalyst, only one out of 5,000-10,000 potential new medicines make it through the multiple and rigorous pre-clinical and clinical trials phases and is ultimately approved by the FDA for patient use. Read more. 

Public-Private Partnerships Hold Key to Future Treatment of Neurologic Diseases

08.16.13 | By John Castellani

Despite the great medical advances of the last century, there is still a lot of work to be done when it comes to developing medications and treatments to deal with neurological disorders such as Parkinson’s disease. These conditions pose vexing challenges for researchers trying to unlock the secrets that will improve the lives of millions living with the daily challenges that neurological diseases pose. Read more. 

Bringing Science to Life for Patients

08.15.13 | By Bill Chin

As I read the Wall Street Journal’s article this week on gene breakthroughs in cancer treatment, I felt a range of emotions. First was excitement. Decades of devotion to research have taken science to new heights and it’s important that people are aware of the tremendous progress that has been made. This awareness is what saved the life of Kellie Carey featured in the story. Read more. 

Study Shows Steady Stream of Innovation in Drug Discovery 

08.09.13 | By Gretta Stone 

In case you missed it, a blog post and article published in Health Affairs by FDA officials earlier this week highlights 25 years of steady and sustained innovation generated by the biopharmaceutical research sector. Read more. 


PMC Principles 

08.07.13 | By Randy Burkholder 

Last week, I highlighted a Hill briefing hosted by the Personalized Medicine Coalition and the great examples it provided of the impact of personalized medicine on patients. I was reminded why we must advocate for policies that support continued progress against disease and fulfill the promise of personalized medicine. Read more. 

Prescription Drug User Fee Rate Exceeds $2 Million per Application

08.06.13 | By Sascha Haverfield

Last week, the U.S. Food and Drug Administration (FDA) announced the prescription drug user fee rates for FY2014 –$2.169 million per application requiring clinical data review.  This reflects a significant increase of more than 10 percent over the FY2013 rates – and a twenty-fold increase in the user fees established in the Prescription Drug User Fee Act (PDUFA) of 1992. Read more. 

Encouraging FDA to Utilize Regulatory Flexibility to Facilitate the Development and Approval of New Antibacterials

08.05.13 | By Sascha Haverfield

As noted in past Catalyst posts, the urgent need for new antibacterials is undisputed.  A recent article in Nature states that, “Health officials are watching in horror as bacteria become resistant to powerful carbapenem antibiotics — one of the last drugs on the shelf.”Read more. 

MS Can't Take Away Hope

08.02.13 | By Preet Bilinski

We recently released our Medicines in Development for Neurological Disorders report, which includes 38 medicines for multiple sclerosis (MS). It is a condition that impacts approximately 500,000 Americans. We recently had an opportunity to speak with Jodi Dwyer, a health activist who has MS and hope for a cure. Read more. 

Newly Released Results from PhRMA's First Annual Health Survey - 'From Hope to Cures'

08.02.13 | By Kaelan Hollon

How long do you think you’ll live? Do you feel like you had a pretty good health year thus far? What about your neighbors and those in your community – how’s their year been, health-wise? What cures do you think will be discovered next in medicine? These questions, and lots more, were all part of PhRMA’s First Annual Patient Survey, a new venture whose results we released today. Read more. 

Conversations: What Can Be Done to Generate More Innovations from Public-Private Partnerships?

08.01.13 | By Matt Bennett

Biomedical research is behind the scientific advances that have helped increase the childhood cancer survivor rate and improve and lengthen the lives of people living with HIV/AIDs, heart disease and cancer. The next set of health care challenges to overcome include dementia and Alzheimer’s disease – neurological disorders that are on the rise and will have a major impact on our communities in the next 50 years. Read more. 

Great News for Part D Beneficiaries As It Nears Its 10 Year Anniversary

08.01.13 | By Liz Magsig

As we approach the 10 year anniversary of Part D being signed into law, more good news recently came out of CMS about the program. Their data showed that average monthly premiums are projected to stay stable at $31 for the 2014 plan year. Additionally, the Part D deductible will decrease from $325 to $310 next year – creating more savings for beneficiaries. Read more. 

The Complex Human Brain 

07.31.13 | By Preet Bilinksi 

The human brain, despite weighing just 3 pounds, contains over 100 billion neurons -- to say that it's complex is an understatement. These neurons are responsible for receiving messages and forwarding them to the appropriate parts of the brain, which in turn control everything we do. Read more. 

Walking in Many Shoes: A Metaphor for Understanding the Benefit-Risk Balance of Medicines 

07.30.13 | By Marilyn Metcalf, Senior Director, Benefit Risk Evaluation and Frank Rockhold, Senior Vice President, Global Clinical Safety and Pharmacovigilance at GlaxoSmithKline

Benefit-risk is one of those ideas that seem straightforward.  Does the good outweigh the bad?  As with most simple questions, the answer becomes more complicated when you start talking with someone whose life journey takes a different path from your own. Read more. 

Improving Access to Care Seen as Great Opportunity to Improve Patient Health 

07.30.13 | By John Castellani

Every person is unique, and so are the challenges they face when it comes to their health. However, there are some core opportunities to improve care across wide swaths of the population, and that’s why we asked last week’s Conversations question: “What are the biggest challenges and opportunities when it comes to improving patient health?” Read more. 

Answering the Call

07.25.13 | By Randy Burkholder

On Monday, the Personalized Medicine Coalition convened leaders from the field on Capitol Hill to discuss the promise of personalized medicine and the implications for policy-makers. A number of important issues were raised (more on that in my next post), but the highlight was remarks by Stephanie Haney. Stephanie is a lung cancer patient and mother of two who said she is alive today thanks to a novel personalized medicine. Read more.  

Responsibly Sharing Clinical Research Results Will Enhance Scientific Knowledge and Advance Patient Care

 07.24.13 | By John Castellani

The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. Today, PhRMA joins the European Federation of Pharmaceutical Industries and Associations (EFPIA) in strengthening our long-standing commitment by endorsing joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers. Read more. 

U.S.-E.U. Trade Deal Has the Potential to Set a New Global Standard

07.24.13 | By Jay Taylor 

Today, PhRMA President and CEO John Castellani testified before the House Energy and Commerce subcommittee on Commerce, Manufacturing and Trade about an ambitious new free trade agreement being negotiated between the United States and the European Union. Read more.  

In Malaysia, Protecting IP Fosters Economic Growth

07.23.13 | By Jay Taylor

This week, negotiators conclude the 18th round of Trans-Pacific Partnership (TPP) negotiations in Malaysia. The agreement, which includes Malaysia and 11 other nations, not only provides the United States with an entrée into the Asia Pacific region, but also opens new markets for all participating countries. But for this agreement to be beneficial globally, it must include strong intellectual property protections. Read more. 

Conversations: Addressing Diverse Patient Challenges and Opportunities

07.23.13 | By Matt Bennett

The United States faces a growing number of health care challenges. Rates of chronic disease continue to climb, and by 2020, more than half the country is expected to suffer from a condition such as obesity, diabetes or chronic obstructive pulmonary disease (COPD) by 2020. In addition, more than one in four Americans already lives with more than one chronic condition. Read more. 

Rx Response Raising Awareness Among Nation’s Lieutenant Governors

07.23.13 | By Grady Forrer 

Big storms – like Sandy, like Katrina – happen. The toll can be devastating.  Proper preparation to meet the human, logistical and supply-chain problems that come along with a big storm is critical. Read more. 

Intellectual Property and the Innovation Economy

07.22.13 | By John Castellani 

Last week’s ‘Conversations’ question “What steps should the U.S. take to protect and strengthen IP rights domestically and overseas?” prompted interesting responses from the U.S. Chamber of CommerceNational Health CouncilEli Lilly and Company and PhRMA’s own Jay Taylor. Read more. 

Week in Review: Paving the Way for Innovative Medicines

07.19.13 | By Daniel Seaton

The biopharmaceutical community has made tremendous progress in recent years developing innovative treatments for chronic conditions, thanks to advancements in science and medicine.  Read more.   

Early Detection of Alzheimer's Disease 

07.18.13 | By Jennifer Wall 

Today Show contributor Linda Carroll wrote a great article about the importance of detecting Alzheimer's disease earlier in life.  Warning signs, such as difficulty with language or reading, changes in mood or personality and challenges in problem solving, could provide clues to patients experiencing the early onset of this neurological disease. Read more

Conversations: Protecting Intellectual Property in a Global Marketplace

07.16.13 | By Matt Bennett 

This week in Malaysia, the United States continues Trans-Pacific Partnership (TPP) negotiations with many of its most important Asia-Pacific trading partners. As we’ve discussed extensively on the Catalyst, through TPP the U.S. aims to expand trade and exports, create new jobs, and help secure its competitive standing in the global marketplace. Read more. 

Mending a Broken Heart 

07.16.13 | By Preet Bilinski 

I’m not taking about a broken heart from love, but rather from heart disease. A recent article in Everyday Health discusses researchers at Mayo Clinic training stem cells harvested from a person’s bone marrow to become heart cells, by treating them with certain proteins that trigger heart development. Read more.

Individualized Care, New Innovations Key to Stemming the Tide of Chronic Disease

07.15.13 | By John Castellani

A chronic disease is detrimental to more than just the person who has it – its impact ripples through the health care system and economy as a whole. According to research by the Robert Wood Johnson Foundation, 80 cents of every dollar spent on health care in the United States goes to treat chronic disease. Its significance cannot be overstated. Read more.  

Week in Review: Supporting the Fight Against Chronic Disease

07.12.13 | By Daniel Seaton

The increasing burden of chronic diseases, as well as potential solutions to the problem, were a major focus for us this week. Conditions like cancer, diabetes and heart disease affect Americans in “epidemic proportions,” as Matt Bennett noted when he introduced this week’s Conversations forum question about chronic disease. Read more.  

Conversations: What Policy Initiatives Will Help Address the Growing Prevalence of Chronic Disease?

07.09.13 | By Matt Bennett 

From cancer and diabetes to heart disease and hypertension, prevalence of chronic disease in America has reached epidemic proportions. In the U.S., 75 percent of our health care dollars go toward its treatment. Read more.  

One Year Later: FDASIA Marks Its First Birthday

07.09.13 | By Stephanie Fischer

It was one year ago today that the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, reauthorizing the Prescription Drug User Fee Act (PDUFA), permanently reauthorizing the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, and creating a Breakthrough Therapy designation. Read more. 

‘Conversations’ Round-Up: Helping Aging Patients Remain Healthy Must Be a Centerpiece of U.S. Health Care Policy

07.09.13 | By John Castellani 

Every day, our industry works to develop new medicines that extend and improve the quality of life for patients. As the Baby Boom generation enters retirement age, one critical health care issue that we must address is how to keep our nation’s seniors healthy. It’s a topic that I come across regularly in my role at PhRMA. Read more. 

New Health Affairs Study Strengthens Argument For Policies to Improve Medication Adherence

07.08.13 | By Liz Magsig

Research shows that properly adhering to medications is a major challenge, but patients who take their medications as prescribed are more likely to have better outcomes. Read more. 

 New Insights into Part D Specialty Tier 

07.03.13 | By Liz Magsig

According to new research by Milliman, a leading actuarial consulting firm, only about 3.3 percent of Part D enrollees filled a prescription for at least one specialty drug in 2011, a very small portion of total Part D enrollment.  Read more. 

Harnessing the Power of Mobile Technology to Improve Health

07.03.13 | By Daniel Seaton

In the future, we just might be able to control non-communicable diseases with our phones. That's what a new report released yesterday suggests, as the IFPMA showcased the potential for using mobile phones for health (mHealth) to improve disease prevention, diagnosis, and management. Read more. 

An Encounter with Heart Disease

07.02.13 | By Preet Bilinski 

We all know someone impacted by heart disease or stroke. Well that applies to the researchers working on medicines to combat these deadly diseases, as well. Not surprising when you consider that heart disease is the leading cause of death for both men and women, with someone dying from a heart disease related event every minute. Read more. 

Conversations: Are We Equipped to Care for an Aging Population?

07.02.13 | By Matt Bennett 

As we continue to explore health policy through our ‘Conversations’ forum, today we’re introducing the next question and encourage you to weigh in with your thoughts: “Every day, thousands of Americans turn 65. How do we help ensure that the U.S. system is ready to meet their needs? Read more. 

PhRMA & BIO Establish Industry PDUFA Tracking Database

07.02.13 | By Sascha Haverfield

As a recent update on implementation of the Prescription Drug User Fee Act (PDUFA) explained, a new review program for new molecular entity (NME) new drug applications (NDA) and original biologic license applications (BLA) was established under PDUFA V to promote greater transparency and provide more opportunities for communication between biopharmaceutical companies and the Food and Drug Administration (FDA). Read more. 

Personalized Cancer Medicines Helping Patients Live Longer, Healthier Lives 

07.02.13 | By Jennifer Page Wall 

CBS News featured a segment over the weekend on the value of new cancer treatments and how precision medicine, also known as personalized medicine, is changing the way patients receive care. Read more. 

'Conversations' Round-Up: Education and Patient Engagement Critical to Improve Health Care

07.01.13 | By John Castellani 

Last week, we introduced ‘Conversations,’ a new forum that provides experts, innovators, patients and other stakeholders an opportunity to share ideas through a live, ongoing dialogue about the future of health care. We received some incredibly thoughtful responses to our inaugural question. Read more.

Getting to the Heart of the Matter: Medicines Save Lives and Money

07.01.13 | By Karl Uhlendorf 

We often discuss in the Catalyst the challenges and promise inherent in the drug discovery process and its impact on patients. And at times talk about how medicines, when used appropriately, can be a valuable part of the solution to controlling health care costs in the U.S. But we don’t always do the best job of connecting the two. Read more. 

Week in Review: Engaging in Conversations on Key Issues 

06.28.13 | By Kaelan Hollon 

This week, we launched our “Conversations” forum as part of our larger goal of engaging a broad spectrum of thinkers, patient advocates, providers and manufacturers on their thoughts about pressing health care questions. Read more. 

1,700 Illegal Pharmacy Websites Shut Down

06.28.13 | By Daniel Seaton

More than 9,600 websites that illegally sell potentially dangerous, counterfeit drugs to patients were targeted this week by a partnership that included INTERPOL, the FDA, international regulatory and law enforcement bodies, as well as pharmaceutical companies. Read more. 

Increased Understanding of LGBT Health Challenges Will Lead to More Informed Care

06.28.13 | By Josie Martin

As communities across the country celebrate June as National LGBT Pride Month, it is important to acknowledge the unique health challenges facing the LGBT community. In an effort to better understand and address these challenges, the National Health Interview Survey for 2013 will include questions specifically related to the LGBT population. Read more. 

AMA Recognizes Obesity as a Disease

06.27.13 | By Preet Bilinski 

Recently the American Medial Association endorsed recognizing obesity as a disease. The U.S. obesity rate increased almost 50 percent between 1997 and 2012, according to the Centers for Disease Control and Prevention (CDC). Read more. 

Hearing Highlights Problems with India's Industrial Policy 

06.27.13 | By Jay Taylor 

Today, Rep. Terry (R. NE) chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade held a hearing to highlight how India’s industrial policy is hurting U.S. companies and workers. Read more.  

PFCD Offers Ways to Lower Medicaid Health Costs 

06.26.13 | By Jeff Trewhitt

The Partnership to Fight Chronic Disease (PFCD) has released a thoughtful new policy paper outlining the most effective ways to lower Medicaid health care costs without compromising quality of care or patient health outcomes. Read more. 

Let's Have a Conversation

06.25.13 | By Matt Bennett

Following PhRMA CEO John Castellani's post last week, we are thrilled to announce the launch of our new forum, “Conversations.” We hope you will join the debate on as we ask some of the biggest questions in health care. Read more. 

Promising New Medicines in Development for Heart Disease and Stroke

06.24.13 | By Stephanie Fischer

In a previous post, I shared my personal experience with stroke and encouraged readers to know the warning signs and symptoms of stroke.  A new report by PhRMA on Medicines in Development for Heart Disease and Stroke provides cause for optimism. Given the enormous toll of strokes, both on a personal level and also for the national economy, effective new treatments are desperately needed. Read more. 

Week in Review: "Convening a Conversation" on Health Care Policy

06.21.13 | By Kaelan Hollon

As our President and CEO John Castellani emphasized, “Healthy debate is the foundation of progress and advancement.” This is something we feel very strongly about, and the initiatives announced this week show our commitment to being part of the ongoing dialogue around health care. Read more. 

Hope for Kids with Amniotic Bands Syndrome

06.21.13 | By Jennifer Wall 

Dean Kamen, a great scientist and inventor, said that “we now live in a world where technology, in many ways, has triumphed over death.”  As we look at the bigger picture around the value of innovation, particularly in a cost-containment environment, we must always keep this triumph in the back of our minds. Read more. 

PhRMA President and CEO John Castellani Tells POLITICO: Adding Value to Health Care Dialogue a Key Part of Industry's Mission

06.20.13 | By Jenni Brewer

Last week, POLITICO sat down with President and CEO John Castellani to discuss how he is working to elevate the biopharmaceutical industry’s role as a thought leader within the health care ecosystem, as well as a key player in policy discussions within Washington and beyond. Read more

PhRMA Conversations: Address Health Care Challenges Through Unique Ideas and Perspectives 

06.18.13 | By John Castellani

Inventor Thomas Edison once said, “If we did all the things we are capable of, we would literally astound ourselves.” As President and CEO at PhRMA, I have the opportunity to work closely with all members of the health care ecosystem on issues ranging from medical innovation to Medicare. Read more

New Coalition Seeks to Level the Playing Field for U.S. Businesses Competing in India

06.18.13 | By Jay Taylor 

A new alliance was launched today to begin educating the public and policymakers about the growing imbalance with the United States’ trading relationship with India and the potential consequences for American job losses if these concerns are not addressed. Read more. 

Women in Government: A Critical Resource to State Legislators in the Fight Against Chronic Disease

06.17.13 | By Jeff Trewhitt

Last week, we took another step in our fight against chronic disease by extending our successful partnership with the Women in Government Foundation, Inc. (WIG), a national non-profit, non-partisan organization of women state legislators. Read more.

Week in Review: Preserving What Works

06.14.13 | By Kaelan Hollon

The first step toward finding solutions in our health care ecosystem is to identify what works, protect what is successful and fix what isn’t. This includes access to medicines, continued research and development and developing programs that get patients the treatments they need. Read more. 

Castellani Highlights Part D's Success in Hill Blog

06.14.13 | By Liz Magsig

Craving some health policy news on a Friday afternoon? Check out an op-ed that ran in The Hill today from our CEO, John Castellani, on Part D. He discusses Part D’s remarkable track record, and calls out a brand new study on the off-setting power of Part D for beneficiaries with congestive heart failure (CHF).  Read more. 

Two Key Steps in Elevating Biopharmaceutical Science

06.14.13 | By John Castellani

Science has been on my mind lately – and for two very good reasons. As you might have heard, Dr. Bill Chin, Executive Dean for Research at Harvard Medical School, will be joining PhRMA to lead our Scientific and Regulatory Affairs department, starting July 1.  We are thrilled to be welcoming Dr. Chin to the team, as he brings a tremendous amount of experience in drug discovery, clinical research, regulatory sciences and academic-industry collaborations. Read more. 

PDUFA/FDASIA Implementation Update

06.13.13 | By Stephanie Fischer

As you may know from reading past Catalyst posts, the Prescription Drug User Fee Act (PDUFA) was reauthorized last July when the Food and Drug Safety and Innovation Act (FDASIA) was signed into law. Despite the  sequestration of the user fees collected under PDUFA, the Food and Drug Administration (FDA) has begun to implement elements of PDUFA V. Read more. 

Part D Preserves Access to Medicines for Beneficiaries with Diabetes

06.12.13 | By Liz Magsig

The Annals of Internal Medicine recently published a study that compared prescription diabetes medicine use between Medicare Part D and the Veterans Affairs (VA) program, specifically focusing on generic drug use. The study and subsequent media coverage overlook some important facts about prescription drug coverage in these two programs. Read more. 

Adhering to Heart Health

06.12.13 | By Preet Bilinski

Every 39 seconds an American dies from cardiovascular disease, and more than 83 million Americans have at least one type of the disease, the American Heart Association (AHA) reports. But today, America’s biopharmaceutical research companies are developing 215 medicines for two of the leading causes of death of Americans – heart disease and stroke. Read more. 

Week in Review: Innovation Provides Value for Patients...And Everyone Else, Too 

06.07.13 | By Kaelan Hollon

Medical innovation does an enormous amount of good for patients, but there is also a broader societal impact: innovative research positively impacts the economy, as well. Read more. 


U.S. Policy Makers Can't Ignore Storm Clouds from India 

06.07.13 | By Chip Davis 

This week, the Commerce Department released the latest data on America’s trade balance, and the news was not good. While exports of U.S. goods and services rose in April, our trade deficit grew to $40.3 billion, up more than 8 percent in a single month. Read more


Standardized CoI Policies Can Help Foster Collaboration and Innovation

06.07.13 | By Karl Uhlendorf

Earlier this week, PhRMA’s Gabriela Lavezzari, Assistant Vice President, Scientific Affairs, participated in an Institute of Medicine (IoM) workshop, titled “Conflict of Interest in Medical Innovation: Assuring Integrity while Facilitating Innovation in Medical Research.” Read more

Governor Pence Calls for Life Sciences Expansion in Indiana 

06.04.13 | By Jeff Trewhitt 

At the latest Research in Your Backyard event in Indiana today, Indiana Governor Mike Pence acknowledged the many positive impacts of the clinical research conducted by biopharmaceutical companies in the Hoosier State and said he’d like to expand the partnership. Read more. 

Cooperation for Patient Health 

06.04.13 | By Jennifer Wall 

At the American Society of Clinical Oncology (ASCO) meeting, U.S. Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg told attendees, “What motivates us every day is getting safe and effective innovative medical products to patients that need them.” Read more. 

PhRMA @ #ASCO13: Investing in Medicines Leads to Long-Term Savings 

06.04.13 | By Jennifer Wall 

Earlier this year, we revealed that there are currently more than 5,000 medicines in the biopharmaceutical pipeline around the world, including more than 3,000 potential medicines for cancer patients. Read more. 

PhRMA @ #ASCO13: Specialty Medicines Bring About Major Health Advances 

06.03.13 | By Jennifer Wall 

Specialty medicines often focus on treating the most complex diseases, including cancer, and are generally perceived to cost more. Contrary to popular belief, these medicines comprise only a small share of health care costs and yield major health advances. Read more

Feeling Good About Optimism at ASCO 

06.02.13 | By Brian Reid

Each year, optimism is the default mood at the American Society of Clinical Oncology annual meeting. And not without good reason: each year, new data is presented that changes the way oncology is practiced, in small ways and in big ways. Read more

PhRMA @ #ASCO13: It's Not A Breakthrough, It's Incremental Innovation

06.02.13 | By Jennifer Wall 

The term “medical breakthrough” evokes the notion of expediency, immediacy and achievement. However, we often forget that a new technology or medical discovery did not occur in a year, but is the product of years or even decades of hard work and dedication in the research lab. Read more

16 Year Old at ASCO Demonstrates Why Curiosity Is Our Best Weapon Against Cancer

06.01.13 By Brian Reid

There are many great tools on display at the American Society of Clinical Oncology meeting that are being used to better understand and attack cancer: genetic information, carefully crafted immunotherapies, antibody-drug conjugates. But the most important tool is the one often taken for granted: curiosity. Read more

PhRMA @ #ASCO13: Biopharmaceutical Sector Propels Economic Activity

06.01.13 | By Jennifer Wall 

As more than 25,000 oncology professionals meet for ASCO’s annual meeting, it’s clear that the U.S. has a unique advantage when it comes to biopharmaceutical innovation. Read more.

Week in Review: Promoting Safe Medicines

05.31.13 | By Kaelan Hollon 

A troubling headline in the Wall Street Journal’s Africa section caught my attention earlier this week – “Africa’s Malaria Battle: Fake Drug Pipeline Undercuts Progress.” The article described customs officials in Angola finding a counterfeit Malaria drug disguised in a shipment of loudspeakers from China.  Read more

PhRMA @ #ASCO13: Innovation Extends, Improves and Saves Lives in the War Against Cancer

05.31.13 | By Jennifer Wall 

With the American Society of Clinical Oncology’s (ASCO) annual meeting kicking off today in Chicago, we are reminded that oncology patients are living longer, healthier lives compared to years past. Read more

Why ASCO Matters

05.31.13 | By Brian Reid 

Over the course of the past 24 hours, thousands of physicians, researchers, advocates and executives have poured into Chicago for the annual meeting of the American Society of Clinical Oncology. Read more.

Ending the Tobacco Epidemic for World No Tobacco Day 

05.31.13 | By Christian Clymer

As more U.S. cities become smoke free, we’re seeing first hand what the Centers for Disease Control and Prevention is saying – U.S. tobacco use has declined significantly. Read more. 

CMS Offers Informative Take on Physician Prep for Sunshine

05.31.13 By Jenni Brewer

CMS wrote an informative Perspective article in the New England Journal of Medicine (NEJM) that highlights the important role of the physician community in the implementation of the Physician Payment Sunshine Act.  Read more

Patients, Doctors Must Educate Themselves on the Dangers of Counterfeit Drugs

05.28.13 By Kaelan Hollon 

Today marks the 15th Global Anti-Counterfeiting Day, and the following guest post was submitted by Marvin Shepherd, Bryan Liang and Thomas Kubic of the Partnership for Safe Medicines (PSM), a leading nonprofit organization fighting against counterfeit drugs. Read more

Alliance for a Stronger FDA Explains Why Sufficient Funding for FDA is Critical

05.28.13 By Sascha Haverfield

The FDA regulates approximately twenty-five percent of products that consumers spend their money on in America.  The FDA is responsible for food safety and the review of the safety and efficacy of medical products.  The Agency protects the American people, their pets, and their farm animals from poorly made, counterfeit, and illegal food, drugs, and cosmetics.  Read more

Week in Review: Exercising the Mind & Body for Innovation

05.24.13 By Kaelan Hollon

If you’re like me, physical education class was a welcome break from history and math. Unfortunately, it is being cut from school programs. Yesterday, The Today Show featured a report released by the Institute of Medicine that found children need at least one full hour of exercise in school daily and that physical education needs to remain a core class. Read more

Happy 100th Birthday American Cancer Society

05.24.13 By Josie Martin

When President Nixon signed the National Cancer Act of 1971, there were three million cancer survivors. Today, there are more than 13 million. By 2022, this number will increase to 18 millionWhile far from over, the war on cancer is well underway. Within our lifetime, it’s likely that a cure will be within reach. Read more

Report Highlights Importance of Intellectual Property Protections

05.23.13 By Jay Taylor

With TPP, Indian and other IP infringement and innovation issues shaping international headlines in recent weeks, IP is increasingly being recognized as a central driver of growth, development and access to medicines. report released today by the Commission on the Theft of American Intellectual Property reinforces IP's critical importance... Read more

Bob Hugin's Call to Action: Protect Medical Innovation

05.23.13 By Jennifer Wall

Bob Hugin, Chairman and CEO, Celgene and Chairman of the PhRMA Board, recently sat down with Life Science Leader magazine to talk about the value of medical innovation.  If you haven’t read it already, I urge you to do so because Bob offers some very insightful thoughts on why we as a society should celebrate biopharmaceutical innovation because of the tremendous benefits it provides to patients and the U.S. economy.  Read more

Rick Smith Testified Before Congress Today About Why Part D Works

05.22.13 By Liz Magsig

PhRMA’s Rick Smith, Executive Vice President of Policy and Research, testified today in a hearing called, “10 Years Later: A Look at the Medicare Prescription Drug Program,” hosted by the Senate’s Special Committee on Aging. Read more. 

Protecting IP: Balancing Current and Future Interests

05.22.13 By Chip Davis

With the 17th round of Trans-Pacific Partnership negotiations taking place in Lima, Peru, the importance of strong U.S. trade and innovation policy is once again front and center. When it comes to protecting intellectual property, it’s critical that negotiators keep in mind the far-reaching implications of pro-IP measures on our economy, health and well being, and society overall. Read more. 

Research in Your Backyard May Soon Be in Latin America

05.22.13 By Jeff Trewhitt

In Colombia, unprecedented price controls in the private market are being contemplated and such policies – a threat to continued research and development of new medicines – are already in effect in El Salvador and also under consideration elsewhere in the region. Read more. 

STEM Education and Future Innovators in America

05.22.13 By Jennifer Wall

Did you know that fewer than 40 percent of students who enter college intending to major in a STEM (science, technology, engineering and math) field actually graduate with a STEM degree? This is very troubling. According to the President’s Council of Advisors on Science and Technology, the U.S. will need to produce one million additional STEM graduates over the next decade to maintain its position as the world leader in science and technology innovation. Read more. 


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