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DIA: Driving Insights to Action

DIA

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DIA: Driving Insights to Action

DIA: Driving Insights to Action

DIA

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About Us

DIA is a global, multidisciplinary, membership association of healthcare professionals that works towards the advancement of lifesaving medicines, therapies, and technologies around the world.

Latest Episodes

FDA Guidance: Flexibility But No Compromise on Patient Safety

In late March 2020, FDA issued Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency: Guidance for industry investigators and institutional review boards. In the agency statement accompanying its release, FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah stated, "FDA released this guidance to emphasize that at all times patient safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants."

16 MIN1 w ago
Comments
FDA Guidance: Flexibility But No Compromise on Patient Safety

Digital Tools Powering More and Safer Clinical Trials

Even under COVID-19 quarantine, patients wearing remote sensors keep clinical research moving forward digitally. “Now suddenly, very suddenly, we're faced with an intense patient safety issue where we really are risking patients' lives by having them come into these clinical sites,” explains Paul O’Donohoe, Medidata Solutions. "I suspect we're going to see a significant uptake in the acceptability and use of technology as a way of allowing patients to now provide us that data in the safety of their own homes.” Bill Byrom, Signant Health, moderates this podcast with Paul and Jennifer Goldsack, Digital Medicine Society, and serves on the Steering Committee for the August 2020 virtual Digital Technology in Clinical Trials conference co-sponsored by DIA and the ePRO Consortium of the Critical Path Institute.

36 MINMAY 5
Comments
Digital Tools Powering More and Safer Clinical Trials

Latin America's COVID-19 Regulatory Response

Latin America, a region of more than 640 million people, is experiencing significant outbreaks of COVID-19 since its first confirmed case on February 25, 2020. Health regulatory authorities are required to adapt to new challenges as the regions face medical supply shortages and halted clinical trials. “In our region, governments will learn even more the value of an independent regulatory authority that does regulation based on science and scientific evidence,” says Cammilla Horta Gomes, Latin America Regulatory Policy Lead at Roche, Brazil. She discusses the outbreak’s impact on the region’s regulatory landscape and the solutions that have been implemented to improve regulatory efficiencies in the face of the outbreak.

30 MINAPR 28
Comments
Latin America's COVID-19 Regulatory Response

Partnerships Essential to SAHPRA Pandemic Response

The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating health products intended for human and animal use, the conduct of clinical trials, and other duties in South Africa. “Around the COVID-19 pandemic, as regulators, we are having to work very closely with each other because in some jurisdictions clinical trials are ongoing, and we need to access that data. In some jurisdictions, products have been registered and we need to access that data,” explains SAHPRA CEO Dr. Boitumelo Semete-Makokotlela. “It's been humbling to be part of the broader health sector where we contribute to not only saving the lives of South Africans but contribute to the knowledge base across the world and to averting this pandemic.”

20 MINAPR 13
Comments
Partnerships Essential to SAHPRA Pandemic Response

EFPIA Shares Industry View of EMA Regulatory Framework

Scientific advancements in pharmaceutical R&D are simultaneously benefiting patients and challenging industry and regulatory frameworks throughout Europe. “The pharmaceutical R&D of today is driven by groundbreaking innovation which has the potential to transform patient treatments and improve patient outcomes, as we move more and more from treating symptoms to really treating the underlying cause of diseases,” explains Dr. Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA). “Developing this new generation of treatments raises new and challenging questions of our regulatory system, underlying the need for evolution to adapt to such advanced technologies.”

10 MINMAR 31
Comments
EFPIA Shares Industry View of EMA Regulatory Framework

Time to Press the Pause Button on Speedy Drug Approvals?

New drugs are getting through the FDA approval process faster. According to a study published in January 2020, the review time for standard drug applications has decreased from more than 36 months in 1983 to approximately ten months in 2018. “It can be a good thing for drugs to reach the market faster, if those drugs offer large benefits. But often drugs offer only very small benefits over existing treatments,” says Dr. Jonathan Darrow, pharmaceutical policy expert and Assistant Professor at Harvard Medical School in Boston. “The system we have is a patchwork of various policies,” explains Dr. Joshua Sharfstein, former FDA Principal Deputy Commissioner, now Vice Dean and Professor at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We should take a step back and say, ‘Are there ways to align incentives more so we have more money to spend for treatments that make a huge difference for people who need them?’”

20 MINMAR 23
Comments
Time to Press the Pause Button on Speedy Drug Approvals?

Reach More Patients While Improving Data Quality?

Digital tools that revolutionize information and communication technology are increasingly employed to transform the quality and quantity of clinical trial data. “The ability for us to reach patients in geographic locations and in demographic groups that the current system is missing is arguably the most important role of these technologies,” suggests Lauren Oliva, Global Regulatory Policy Lead for New Technologies, Biogen. “With the increased quantity of data, you do increase the quality to some extent in terms of your reach and the types of things that you could measure now that you wouldn't be able to measure in the past,” explains Josh Cosman, Principal Engineer, Digital & Quantitative Medicine, Biogen. Lauren will Chair the Drug Development Tools in a Digital Era session at DIA Europe 2020.

23 MINMAR 16
Comments
Reach More Patients While Improving Data Quality?

ATMPs May Deliver on Promise of Individualized Medicine

FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for assuring the safety and efficacy of biological products including vaccines, allergenic products, blood and blood products, and cellular tissue and gene therapies. “This area of advanced therapy medicinal products (ATMPs) is just an incredibly exciting one to be working in right now,” explains Center Director Dr. Peter Marks. “We have our work cut out for us here, but to me it's wonderful work to have to do because it shows how fast the science is advancing, how fast hopefully the technology will advance, to bring these medical benefits to patients.”

22 MINMAR 10
Comments
ATMPs May Deliver on Promise of Individualized Medicine

Relevance Will Put Europe on Investment Fast Track

The DIA Europe 2020 Keynote Address will focus on the intersections of science and business as explored by a scientist turned investor, Mr. Joep Muijrers, who currently serves as CFO of PureTech, a listed biopharmaceutical company that focuses on developing medicines for devastating diseases including cancer, CNS disease, and immunological disorders. “What is the value of a product that, quite often against the odds in this sector, makes it and gets to patients and then doesn't make a dent whatsoever – it's not being used. What's the relevance of that?” he asks. “Put it this way: In this industry, we tell the end user what's good for them. Isn't that crazy?”

16 MINMAR 2
Comments
Relevance Will Put Europe on Investment Fast Track

Risk Inherent in Benefits of Drug/Device Products?

Dr. Steven Murray, Group Vice President & Principal Engineer in the Electrical & Data Sciences Group for Exponent, assesses and analyzes potential risk and failure of products from underground lateral piping to surgical heart catheters. “In drugs and medical devices, developers really need to consider where their product lies on the scale of risk: Is this a product where it is impossible to disentangle the benefits from some other risk? Or is this a product that, if anything is even a little bit wrong, the benefit doesn't justify it?” he asks. “We're much more accepting to risks in things like cancer drugs or AIDS drugs, where the risk of death is highly present and you're averting it.”

27 MINFEB 25
Comments
Risk Inherent in Benefits of Drug/Device Products?

Latest Episodes

FDA Guidance: Flexibility But No Compromise on Patient Safety

In late March 2020, FDA issued Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency: Guidance for industry investigators and institutional review boards. In the agency statement accompanying its release, FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah stated, "FDA released this guidance to emphasize that at all times patient safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants."

16 MIN1 w ago
Comments
FDA Guidance: Flexibility But No Compromise on Patient Safety

Digital Tools Powering More and Safer Clinical Trials

Even under COVID-19 quarantine, patients wearing remote sensors keep clinical research moving forward digitally. “Now suddenly, very suddenly, we're faced with an intense patient safety issue where we really are risking patients' lives by having them come into these clinical sites,” explains Paul O’Donohoe, Medidata Solutions. "I suspect we're going to see a significant uptake in the acceptability and use of technology as a way of allowing patients to now provide us that data in the safety of their own homes.” Bill Byrom, Signant Health, moderates this podcast with Paul and Jennifer Goldsack, Digital Medicine Society, and serves on the Steering Committee for the August 2020 virtual Digital Technology in Clinical Trials conference co-sponsored by DIA and the ePRO Consortium of the Critical Path Institute.

36 MINMAY 5
Comments
Digital Tools Powering More and Safer Clinical Trials

Latin America's COVID-19 Regulatory Response

Latin America, a region of more than 640 million people, is experiencing significant outbreaks of COVID-19 since its first confirmed case on February 25, 2020. Health regulatory authorities are required to adapt to new challenges as the regions face medical supply shortages and halted clinical trials. “In our region, governments will learn even more the value of an independent regulatory authority that does regulation based on science and scientific evidence,” says Cammilla Horta Gomes, Latin America Regulatory Policy Lead at Roche, Brazil. She discusses the outbreak’s impact on the region’s regulatory landscape and the solutions that have been implemented to improve regulatory efficiencies in the face of the outbreak.

30 MINAPR 28
Comments
Latin America's COVID-19 Regulatory Response

Partnerships Essential to SAHPRA Pandemic Response

The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating health products intended for human and animal use, the conduct of clinical trials, and other duties in South Africa. “Around the COVID-19 pandemic, as regulators, we are having to work very closely with each other because in some jurisdictions clinical trials are ongoing, and we need to access that data. In some jurisdictions, products have been registered and we need to access that data,” explains SAHPRA CEO Dr. Boitumelo Semete-Makokotlela. “It's been humbling to be part of the broader health sector where we contribute to not only saving the lives of South Africans but contribute to the knowledge base across the world and to averting this pandemic.”

20 MINAPR 13
Comments
Partnerships Essential to SAHPRA Pandemic Response

EFPIA Shares Industry View of EMA Regulatory Framework

Scientific advancements in pharmaceutical R&D are simultaneously benefiting patients and challenging industry and regulatory frameworks throughout Europe. “The pharmaceutical R&D of today is driven by groundbreaking innovation which has the potential to transform patient treatments and improve patient outcomes, as we move more and more from treating symptoms to really treating the underlying cause of diseases,” explains Dr. Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA). “Developing this new generation of treatments raises new and challenging questions of our regulatory system, underlying the need for evolution to adapt to such advanced technologies.”

10 MINMAR 31
Comments
EFPIA Shares Industry View of EMA Regulatory Framework

Time to Press the Pause Button on Speedy Drug Approvals?

New drugs are getting through the FDA approval process faster. According to a study published in January 2020, the review time for standard drug applications has decreased from more than 36 months in 1983 to approximately ten months in 2018. “It can be a good thing for drugs to reach the market faster, if those drugs offer large benefits. But often drugs offer only very small benefits over existing treatments,” says Dr. Jonathan Darrow, pharmaceutical policy expert and Assistant Professor at Harvard Medical School in Boston. “The system we have is a patchwork of various policies,” explains Dr. Joshua Sharfstein, former FDA Principal Deputy Commissioner, now Vice Dean and Professor at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We should take a step back and say, ‘Are there ways to align incentives more so we have more money to spend for treatments that make a huge difference for people who need them?’”

20 MINMAR 23
Comments
Time to Press the Pause Button on Speedy Drug Approvals?

Reach More Patients While Improving Data Quality?

Digital tools that revolutionize information and communication technology are increasingly employed to transform the quality and quantity of clinical trial data. “The ability for us to reach patients in geographic locations and in demographic groups that the current system is missing is arguably the most important role of these technologies,” suggests Lauren Oliva, Global Regulatory Policy Lead for New Technologies, Biogen. “With the increased quantity of data, you do increase the quality to some extent in terms of your reach and the types of things that you could measure now that you wouldn't be able to measure in the past,” explains Josh Cosman, Principal Engineer, Digital & Quantitative Medicine, Biogen. Lauren will Chair the Drug Development Tools in a Digital Era session at DIA Europe 2020.

23 MINMAR 16
Comments
Reach More Patients While Improving Data Quality?

ATMPs May Deliver on Promise of Individualized Medicine

FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for assuring the safety and efficacy of biological products including vaccines, allergenic products, blood and blood products, and cellular tissue and gene therapies. “This area of advanced therapy medicinal products (ATMPs) is just an incredibly exciting one to be working in right now,” explains Center Director Dr. Peter Marks. “We have our work cut out for us here, but to me it's wonderful work to have to do because it shows how fast the science is advancing, how fast hopefully the technology will advance, to bring these medical benefits to patients.”

22 MINMAR 10
Comments
ATMPs May Deliver on Promise of Individualized Medicine

Relevance Will Put Europe on Investment Fast Track

The DIA Europe 2020 Keynote Address will focus on the intersections of science and business as explored by a scientist turned investor, Mr. Joep Muijrers, who currently serves as CFO of PureTech, a listed biopharmaceutical company that focuses on developing medicines for devastating diseases including cancer, CNS disease, and immunological disorders. “What is the value of a product that, quite often against the odds in this sector, makes it and gets to patients and then doesn't make a dent whatsoever – it's not being used. What's the relevance of that?” he asks. “Put it this way: In this industry, we tell the end user what's good for them. Isn't that crazy?”

16 MINMAR 2
Comments
Relevance Will Put Europe on Investment Fast Track

Risk Inherent in Benefits of Drug/Device Products?

Dr. Steven Murray, Group Vice President & Principal Engineer in the Electrical & Data Sciences Group for Exponent, assesses and analyzes potential risk and failure of products from underground lateral piping to surgical heart catheters. “In drugs and medical devices, developers really need to consider where their product lies on the scale of risk: Is this a product where it is impossible to disentangle the benefits from some other risk? Or is this a product that, if anything is even a little bit wrong, the benefit doesn't justify it?” he asks. “We're much more accepting to risks in things like cancer drugs or AIDS drugs, where the risk of death is highly present and you're averting it.”

27 MINFEB 25
Comments
Risk Inherent in Benefits of Drug/Device Products?
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