Goal 4: Develop Workforce and Resources

Preparing a Diverse Biomedical Technology Development Workforce

How do we best develop a scientific workforce that is fluent in product development and commercialization issues? How can NHLBI best expand the training opportunities for early career scientists to prepare them for entry into the dynamic biomedical workforce landscape? There is a need for scientifically-trained experts from diverse backgrounds who also understand business needs relevant to biomedical technology development, ...more »

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

A well-trained biomedical technology development workforce would enhance the quantity and quality of research translated from the lab to the market focused on heart, lung, blood, sleep indications. A better understanding of the product development pathway would improve efficiency and resource usage, and accelerate the time for products to reach the market. Structured training would better prepare academic scientists for industry collaboration and provide an industry-ready scientific workforce. Ensuring these training opportunities are inclusive of scientists from different backgrounds would increase the diversity of the biomedical technology development workforce.

Feasibility and challenges of addressing this CQ or CC :

Industry is a large employer of research trainees, and trainees are becoming increasingly vocal about their interest in opportunities to be trained in areas beyond the academic lab that would prepare them for roles in industry. NHLBI can leverage recently launched educational opportunities, including the BEST (Broadening Experiences in Scientific Training), NCAI (NIH Centers for Accelerated Innovations), REACH (Research Evaluation And Commercialization Hubs), and CTSA (Clinical and Translational Science Awards) programs.

Transitioning scientific discoveries to inventions and products to benefit public health requires knowledge and education beyond what is traditionally learned during medical, graduate, and post-doctoral training.

 

Challenges to addressing this CQ include:

 

• Need for educators and mentors with relevant industry experience and expertise.

 

• This would be a culture shift in academic institutions, though the new NIH programs described above has already started to influence this shift.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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Goal 4: Develop Workforce and Resources

Increase and Support Research Based Faculty

As the current chair of the Research and Training Division, I would like to convey that the AAAAI membership would like the NHLBI to consider the following in the development of its strategic plan: There has been a decline in research-based faculty in the past few years.  The challenge is two-fold.  First, increase the research faculty pipeline with increased focus on training and recruitment of research focused fellows ...more »

Submitted by (@wheeze)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Name of idea submitter and other team members who worked on this idea : Mitchell Grayson on behalf of the American Academy of Allergy, Asthma, and Immunology

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Goal 4: Develop Workforce and Resources

Professional Development Pathway

Transformation of the professional development pathway – moving promising trainees and junior faculty to independent and productive investigators– is critical to ensuring a vibrant clinical and basic research workforce.

Submitted by (@skrenrich)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Name of idea submitter and other team members who worked on this idea : Cystic Fibrosis Foundation

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Goal 3: Advance Translational Research

Substituting scientific-medical insight before profit in drug development

Since the Pure Food and Drug Act of 1906 and the rise of the FDA, the US federal government has directly inserted itself into medical research, primarily from a business perspective. The Orphan Drug Act of 1983 monetarily incentivized the process for rare diseases, but for ultra-rare diseases of < 1,000 patients, it does not work. Successful drugs for rare diseases have enormous price tags to compensate their development ...more »

Submitted by (@mtothbsf)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

By harnessing the vast resources of US biomedical research and biomedical researchers, many of whom were trained with NIH funding, the US can more effectively translate scientific discoveries into clinical benefit--many treatments for many diseases using many PIs. While the monetary profit incentive has been a vital aspect of pharmaceutical development over the last 50 years, in this era of personalized medicine it may not be as relevant. The individual PI with a good idea and sound scientific background may hold the key to a cure for a rare or personal disease, but is prevented from translating this because of ignorance, lack of institutional support, or the need for substantial capital investment to perform a proper clinical study. The FDA could recalibrate its requirements for clinical studies to allow even a single PI to test their idea economically, and perhaps offer the funding to do it properly. It should not go unnoticed that by understanding and treating a specific rare disease, the medical world may use this knowledge to better understand and treat diseases that affect larger numbers of people. For example, understanding or treating heart failure in a specific rare disease, may offer benefits to the larger group of heart failure patients.

Feasibility and challenges of addressing this CQ or CC :

Meeting this challenge will require a major rethinking of the traditional FDA approach of drug development and testing in humans at least for the non-profit or single PI scenario. For ultra-rare diseases of < 1,000 individuals there seems little hope that the for-profit sector would choose to be involved. For that reason and to take advantage of the enormous biomedical research resources the the US federal government has sponsored though the NIH, the US could advance translational research and usher in an era of true "personalized medicine'.

Name of idea submitter and other team members who worked on this idea : Matthew J. Toth, PhD, Science Director, Barth Syndrome Foundation Inc.

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Goal 4: Develop Workforce and Resources

Modernizing Research Training

As the current chair of the Research and Training Division, I would like to convey that the AAAAI membership would like the NHLBI to consider the following in the development of its strategic plan:

 

Since the focus of research has changed over the past decade, training programs need to be encouraged to use newer models of research in their training and mentoring of potential research faculty.

Submitted by (@wheeze)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Name of idea submitter and other team members who worked on this idea : Mitchell Grayson on behalf of the American Academy of Allergy, Asthma, and Immunology

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Goal 1: Promote Human Health

Critical Windows in Early Development to Maximize Lung Health

Is there a critical window of growth and development for maximizing lung function?

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Low lung function during childhood tracks to early adulthood and contributes to early onset disease. Lung health promotion is needed, but we know little about what can enhance and protect human health during rapid phases of lung development in utero and growth postnatally to adulthood.

Feasibility and challenges of addressing this CQ or CC :

Researchers could turn their attention on healthy and “maximally” health populations (human and model organisms) to understand genetic and environmental exposures that influence lung function at upper ends of the spectrum (>2 SD from the mean).

Recent findings suggest that there is an urban-rural continuum of lung function in specific ethnic groups; and interventions with maternal dietary supplements can enhance lung function in offspring. These set the stage for further study on developing knowledge of early life events that can inform lung health promotion.

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Goal 3: Advance Translational Research

Rx for HFpEF

HLBI should make it a priority to develop therapeutic options for the treatment of heart failure with preserved ejection fraction.

Submitted by (@johnrobinson)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Heart failure with reduced ejection fraction (HFrEF), formerly called systolic heart failure, is the classical form of heart failure that is characterized by defective ventricular contraction. The most common variant of heart failure is heart failure with preserved ejection fraction (HFpEF), formerly called diastolic heart failure, characterized by resistance to ventricular filling. The prevalence of HFpEF has been rising steadily over the past two decades at a rate of increase of 1% per year, while the prevalence of HFrEF which has remained stationary. The most common causes of HFpEF are ischemia, obesity, hypertension, diabetes and ageing. Since the population is increasingly obese, hypertensive, diabetic and ageing, the incidence of HFpEF will be the dominant heart failure phenotype over the next decade. The clinical management of HFpEF is complicated by lack of therapeutic options that provide survival benefit. Therapies of proven benefit in HFrEF have repeatedly been shown to add little if any benefit in HFpEF. The prognosis of HFpEF is about the same as HFrEF, with 5-year mortality ranging from 54% to 65%.

Feasibility and challenges of addressing this CQ or CC :

Recent developments in our understanding of the molecular mechanisms of myofilament regulation and assays can be used to develop lead compounds for treating HFpEF.

Name of idea submitter and other team members who worked on this idea : John Robinson

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Goal 2: Reduce Human Disease

Signaling in AVM Developmoent

BMP9 circulates in the blood and signals through the endothelial cell. IN the absence of Alk 1, such as in HHT, the vessels become over-active. The overactivity can be partially balanced by activation of a second signaling pathway: notch. Would targeting notch be a useful drug target to reverse AVM formation

Submitted by (@mariannes.clancy)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Name of idea submitter and other team members who worked on this idea : Marianne Clancy MPA, Chris Hughes PhD

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Goal 2: Reduce Human Disease

Fetal basis for Adult Disease

Maternal exposures during pregnancy have the potential to alter development and lead to lifelong susceptibility to disease. There is epidemiological evidence of this in the asthma field, where maternal smoking leads to increased asthma rates. However, the molecular mechanisms by which maternal exposures cause lung disease later in life are not known and the influence of in utero exposures on susceptibility to lung cancer, ...more »

Submitted by (@dc0000)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Addressing the impact of maternal exposures on fetal lung disease would make a major impact on human health by giving regulatory agencies the data they need to make educated decisions with respect to issues such as nicotine regulation, air pollution, water pollution, and other sources of maternal exposures.

Feasibility and challenges of addressing this CQ or CC :

With the established animal and stem cell models of development, this research is immediately feasible.

Name of idea submitter and other team members who worked on this idea : Diane Carlisle

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Goal 3: Advance Translational Research

Animal Models for Translational Research and Drug Development

There is a need to identify and develop suitable animal models (e.g. larger, non-primate animal models) that faithfully predict the outcomes of new medicines and treatments in heart, lung, blood, and sleep (HLBS) disorders prior to human clinical trials.

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

If animal models can faithfully predict the outcomes in human clinical trials of new medicines and treatments, it will reduce the economic burden for the failure of drug development.

Feasibility and challenges of addressing this CQ or CC :

Identification of current available animal models;

Development of new animal models with recent advances in mammalian genome projects and gene targeting technologies could be done over the next 5-10 years

Medical research, especially in basic discovery, has benefited significantly from the use of various animal models, such as gene-targeted and transgenic mouse models. However, many discoveries from animal models (e.g. mouse models) failed to translate into human applications.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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Goal 3: Advance Translational Research

Translating cardiac development/genetics knowledge into therapy

What is needed to translate our knowledge of cardiac development and congenital heart disease genetics into novel diagnostic and/or therapeutic strategies for congenital or acquired heart disease?

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Develop new therapies for congenital or acquired heart disease.

Feasibility and challenges of addressing this CQ or CC :

We are poised to take advantage of the incredible advances in our understanding of cardiac development and genetics which have resulted from the development of high throughput technologies.

Name of idea submitter and other team members who worked on this idea : NHLBI Staff

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