Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

Vaccines 52

Vaccines FDA Dosage 52

pharmaphorum

MAY 13, 2022

Its chief digital and technology officer Lidia Fonseca offered a fascinating insight into how one biggest pharmaceutical companies – and one of those most closely associated with the pandemic (alongside the likes of BioNTech, Moderna and AstraZeneca) – has been transforming itself. About the author.

Pharmaceutical Companies 130

Pharmaceutical Companies Pharmaceutical Companies Vaccines FDA 130

ISPE

AUGUST 7, 2023

She noted the speed with which the industry developed vaccines and treatments as well as how regulatory agencies adapted to carrying out inspections remotely using digital technologies while maintaining GMP and GCP standards even as the necessary resources came under great pressure. “At Clearly, we could not do it alone,” she said.

Vaccines 52

Vaccines Communication 52

pharmaphorum

JUNE 17, 2022

It defined decentralised trials (DCTs) as those which include the use of technology to communicate with participants and collect data, via telemedicine and mobile/local healthcare providers, sometimes with the help of wearable devices and sensors.

Communication 72

Communication 72

pharmaphorum

NOVEMBER 27, 2022

To combat such challenges, pharmaceutical companies need to adopt processes that are not just efficient, but agile. Instead, companies should be looking towards a future where speed and agility are the key components in developing business resilience, rather than a reliance on inventory stockpiles and large quality assured batches.

Communication 105

Communication Pharmaceutical Companies Pharmaceutical Companies Packaging 105

ISPE

JUNE 27, 2023

This is a good starting point for sponsors to have discussions regarding regulatory approaches and questions as well as an opportunity to teach regulators about the proposed new, innovative technology. There is also an opportunity for consortia working on the same or similar technologies to request interactions.

Communication 52

Communication FDA Vaccines 52

ISPE

MARCH 3, 2023

At the upcoming 2023 ISPE Europe Annual Conference, you will have an excellent opportunity to hear about GAMP ® 5 directly from the authors, discuss the content of the guide with peers and regulators, and ask all the questions you did not get answers to until now. Link them through a TM, otherwise the FDA will give you a 483!”

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

NOVEMBER 15, 2022

The original iteration of ISPE GAMP 5 was released in 2008 arriving in the nascent stages of what has become the cloud revolution and certainly before the widespread adoption of agile development methodologies, meaningful augmented reality, machine learning and artificial intelligence use cases in the life sciences industry. References.

Documentation 82

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 82

European Pharmaceutical Review

APRIL 2, 2024

Pharma Horizons: Environmental Monitoring About the authors Evelyn Der joined Genentech, a member of the Roche Group, in 1999 and currently is in the Analytical Sciences chapter of Roche. Lindsey is a highly skilled analytical scientist with a track record of developing and implementing technology to build agility for biologic products.

Method Validation 85

Method Validation Medical Schools 85

pharmaphorum

JANUARY 18, 2022

David Rhew, MD, global chief medical officer and VP of healthcare at Microsoft, tells us, “Using Microsoft technology, CVS Health will develop a more agile, digital-first technology foundation.” About the author.

Prescription Filling 119

Prescription Filling Insurance 119

pharmaphorum

AUGUST 4, 2022

Harness technology. If the pandemic taught us anything, it is the importance of technology and its role in learning. COVID-19 forced companies to innovate and utilise technologies to adapt to the disparate nature of remote working. About the Author. Embrace mobile learning. Raising the profile.

Customer Service 98

Customer Service Vaccines 98

pharmaphorum

MARCH 25, 2021

Just as it did across the pharmaceutical industry , COVID’s medical imperative swept aside any lingering doubts and delays to greater use of technology, kick-starting a major digital transformation of healthcare. GPs want an informed choice over the technology that they implement. The NHS’ digital future.

Vaccines 142

Vaccines 142

Pharmaceutical Technology

JUNE 5, 2023

The problem, he explains, is not necessarily the technology, but rather the way in which these platforms are used. Our defences can be much more agile than they are today. How we handle these questions from a technological and regulatory perspective is really critical.” Cybersecurity is necessary for biosecurity.”

HIPAA 110

HIPAA Insurance Pharmaceutical Companies Pharmaceutical Companies 110

European Pharmaceutical Review

DECEMBER 22, 2022

mRNA technologies have emerged as an innovative and effective approach to developing new drugs that can potentially transform existing therapies or target difficult‑to‑treat indications including respiratory, cardiac, metabolic and autoimmune diseases, as well as cancer. Benefits of mRNA-based technology.

Vaccines 102

Vaccines Immunization Hospitals 102

pharmaphorum

APRIL 21, 2021

If NICE is to remain a “beacon of evidence-based medicine”, it must become more agile, more flexible, and more ready to adapt – and COVID-19 has proved that it is more than capable of doing so. How do we get innovative technologies to the frontline faster? Is it feasible to work sustainability into technology assessments?

Documentation 59

Documentation 59

pharmaphorum

OCTOBER 12, 2022

How digital technology can support compliance. By integrating a SaaS platform, it becomes possible to validate data faster by employing a more agile methodology. the use of digital technology enables companies to comply with minimal effort and maximum effect. About the author.

Documentation 103

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 103

European Pharmaceutical Review

JUNE 29, 2022

From our front row view of the pandemic these past three years, our mission necessitated that we leverage our years of vaccine expertise to help global health authorities address, control and eradicate the severe acute respiratory syndrome coronavirus 2 (SARS?CoV-2). References.

Vaccines 81

Vaccines Documentation 81

pharmaphorum

OCTOBER 26, 2021

Looking ahead, the “highly connected and interdependent” industry must adjust its policies to the new economic and technological realties, he said. The rather inflexible, old-fashioned regulatory regime in Europe should be modernised in order to attract investment, and to improve agility and flexibility”. About the author.

Generic Medicine 120

Generic Medicine 120

ISPE

MAY 17, 2023

In contrast, newer "Neo banks" like Revolut and Venmo, which started with a blank slate and embraced technology from the outset, have managed to surpass traditional banks in terms of digital experience. To overcome this disconnect, companies must prioritize building a solid foundation of data and technology.

Communication 52

Communication 52

pharmaphorum

JANUARY 12, 2022

It suggests enabling a “more agile, centralised” framework by removing “unnecessary interfaces” between the EC, EMA, working parties, and committees, and allowing member states to “bring forward their expertise”. About the author. Enhancing expediting pathways that support innovation is also recommended in the report.

FDA 104

FDA Vaccines 104

ISPE

OCTOBER 27, 2022

Challenges & Opportunities in Emerging Digital Health Technologies. Challenges & Opportunities in Emerging Digital Health Technologies. DHTTs are electronic technology tools intended for use in clinical investigations (inclusive of clinical trial and post-market settings) or clinical practice. Trudy Patterson. Ryan Hoshi.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

European Pharmaceutical Review

DECEMBER 23, 2022

Our ambition is to build a modern, industry-leading manufacturing network, by bringing together talented people and cutting-edge processes, technologies and data to reliably deliver high quality, affordable and sustainable medicines and vaccines to patients. About the authors. Simplify systems, applications and processes.

Vaccines 79

Vaccines Communication 79

pharmaphorum

APRIL 1, 2021

Driven by technology readiness, cost pressure, examples in other industries and now the COVID-19 pandemic, the industry is finally moving to omnichannel marketing, with integration between sales and marketing channels, orchestrated by pre-defined ‘’customer journeys’’. About the author. It’s a hybrid model now. About Exeevo.

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ISPE

OCTOBER 27, 2022

Challenges & Opportunities in Emerging Digital Health Technologies. Challenges & Opportunities in Emerging Digital Health Technologies. Emergency use authorization (EUA) to increase the availability of remote or wearable monitoring devices to treat patients and reduce the risk of exposure of health care providers to SARS-CoV-2 4. ,

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

pharmaphorum

MARCH 18, 2021

So, rather than trying to figure out what to use new technology for, it is better to focus on helping people get rid of problems or tasks. The question is can technology help with automating the creation of call notes. The question is can technology help with automating the creation of call notes. But it doesn’t stop there.

Documentation 52

Documentation 52

pharmaphorum

APRIL 11, 2022

Chris Garabedian, CEO of Xontogeny, describes how his past experiences as CEO of Sarepta Therapeutics have led him on an exploration for technology that can effectively leverage wearable data in clinical trials. Regulatory authorities are asking for real-world evidence as opposed to in-clinic data, which we know has bias.

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Packaging 111

pharmaphorum

DECEMBER 22, 2022

The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept. Technologies such as BERT 3 and GPT-3 catapult NLP capabilities beyond basic processing, into the realm of language intelligence.

Medical Schools 96

Medical Schools FDA Patient Care 96

pharmaphorum

OCTOBER 5, 2021

The advent of COVID-19 has been a great testing environment for these technologies where, for example, the adoption of telemedicine was no longer an option but an urgent need to plug the gap in face-to-face medical care. The healthcare industry is also changing as its ‘customers’ move from ‘boomer’ patients to digital natives.

Hospitals 132

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 132

pharmaphorum

JUNE 11, 2021

New technologies and improved data flows among areas – for example, for production planning – are seen as essential to increased agility and will consequently become more widely used. There is a misconception that cyber resilience is driven solely by technology. About the author. Executive leadership and collaboration.

Vaccines 111

Vaccines HIPAA Immunization 111

pharmaphorum

OCTOBER 19, 2022

At Veeva, we’ve built technology to enable modular content in life sciences” Using modular content has helped companies such as Novo Nordisk to produce content four times faster than previous methods and allow for a 60% reduction in content spend efficiency. Agile collaboration internally and externally.

Communication 95

Communication Pharmaceutical Companies Pharmaceutical Companies 95

pharmaphorum

NOVEMBER 25, 2020

All with a speed and agility that could never be replicated by providers. COVID-19 has had a super booster effect on the adoption of digital technology to support patients. About the author. Even now, the sector continues to plug services while NHS and social care retains its focus on COVID-19.

Hospitals 115

Hospitals Vaccines 115

Pharmaceutical Technology

OCTOBER 13, 2022

Outdated technology forces businesses to work within its constraints, instead of doing what’s best for the business. According to Michael, legacy systems act as a barrier to business development and maintaining outdated technology becomes more expensive over time. However, sticking with legacy systems can be even more costly.

Customer Service 52

Customer Service Communication 52

pharmaphorum

JUNE 30, 2022

We must meet patients where they are and ensure implementation of agile trial methodologies. However, with COVID-19 re-emphasizing gaps in trial diversity and inclusion, there is a renewed focus on doing more, especially as we can leverage deep expertise and transformative technologies to knock down long-standing barriers.

Communication 64

Communication 64

pharmaphorum

DECEMBER 22, 2021

The proposals for “more agile, flexible processes that work better for all stakeholders”, include bids to align processes across NICE’s different technology evaluation programmes, and improve access and engagement through more virtual meetings and requiring companies to provide lay summaries of their submissions. About the author.

Documentation 105

Documentation 105

pharmaphorum

MAY 18, 2021

But with the proper planning and an agile approach, they can be more successful than they realise, says Veeva’s Ian Hale. Agile, scalable and data-driven. Companies should be agile, scalable, and data-driven to make the right decisions at the right time,” says Hale. About the author.

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52

pharmaphorum

FEBRUARY 15, 2021

In many ways our small size and agility was our strength. Through training programmes, we have upskilled the team in digital technology and the application of ideation techniques. We have also encouraged our Firestarters to enrol in Agile skills programmes. About the author. But I soon realised that was an excuse.

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pharmaphorum

NOVEMBER 20, 2022

Set-ups where there is direct access to those involved in assay development keeps the focus on pushing the optimisation of an assay, ensuring best method technology and adoption of innovative practices. About the author. Key pillars of success. Ultimately, this can support the goal of helping patients through effective therapies.

Vaccines 97

Vaccines Immunization 97