Enhancing Pharmacovigilance

To give oncology products the best possible opportunity

By: Dr Brian Edwards, Principal Consultant, NDA Group 

In this article, Dr Brian Edwards follows on from his very successful webinar, Opportunities to enhance Pharmacovigilance in Oncology, to argue that to maximise the benefits of innovation in our products we need innovative pharmacovigilance.


We are witnessing a tremendous expansion in oncology products with great opportunities that will benefit patients. Regulatory agencies have responded with expedited review pathways and schemes to enable early access. Data sources such as patient reported outcomes and real-world evidence are being adopted, especially once the product is marketed. The products may often be dependent on biomarker kits which have arisen from the exciting progress in genomic and stratified medicine.

Throughout healthcare and the life sciences, technologies such as machine learning or artificial intelligence are being introduced with great expectation about increased cost efficiency and productivity. With this greater importance of pharmacovigilance (PV) within a changing environment, we need to adapt to recognise limitations of certain data so that the quality that can be reasonably expected will differ if we are to strengthen current standards of PV.

However, we put all this progress at risk if we do not respond effectively to warning signs about medical quality, timely follow up and completeness of adverse drug reaction (ADR) case reports that could undermine confidence in novel oncology products by impairing the ability to make informed decisions.

For that reason, in their 2015 Guidance, the FDA urges sponsors not to report all serious adverse events, including those where there is little reason to consider them suspected adverse reactions.* Study investigators agree. There seems to be misinterpretation of what should be sent to sites resulting in examples where all reported adverse events are sent to every site that conducts a trial that uses that agent, regardless of relevance.

The full article was published in Volume 69 Spring 2020 of Pharmafile – Therapeutic areas in focus. 

Click to the full article
 

To learn more about NDA’s Pharmacovigilance services and how we can help you, click here.

*Safety assessment for IND safety reporting guidance for industry, Food and Drug Administration, 2015, https://www.fda.gov/files/drugs/published/Safety-Assessmentfor-IND-Safety-Reporting-Guidance-for-Industry.pdf

Hopes and challenges in the future of the immuno-oncology field

There is no doubt that the area of oncology development has exploded in the last few years. The global oncology pipeline at the end of 2019 had almost doubled since 2014, reaching an all-time high with 374 drugs entering Phase 1 and the approval of several new drugs with unique modes of action. But all is not rose-tinted news, in this article published in the February addition of Pharmafocus, Dr Laurie Smaldone Alsup, Chief Medical and Chief Scientific Officer at NDA predicts some challenges in the field of oncology.

“Historically, clinical trials are designed so that the patient is relatively unencumbered by other diseases, to make it easier to assess whether the drug works or not. But in reality, people may be elderly, have organ failure and/or have other disorders that require chronic medications for other conditions. Understanding how these new therapies behave in the real world is critical”

 

Click here to read to Article

NDA Advisory Board expands to improve access to world leading oncology expertise

Today NDA Group announced the expansion of the unique NDA Advisory Board with the appointment of Dr. Susan Jerian a NCI trained oncologist with over two decades of leadership and experience in the Industry and the FDA.


Dr. Jerian is a NDA expert in drug and biologic development for hematology and oncology indications, combination product development including companion diagnostics, biosimilars, clinical trial design and regulatory strategy with special emphasis on US FDA requirements.

The announcement follows on to NDA Group’s expansion in the US in the regions of Princeton, Boston and San Francisco. The appointment of Dr. Jerian expands on NDA Group’s already formidable expertise in the oncology area, providing companies in this space with improved access to world leading FDA oncology experience.

Dr. Jerian is joining the NDA Advisory Board, a unique team of experts comprising some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.

Dr. Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:

“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am very excited to welcome Dr. Jerian on board. With her experience in and in-depth knowledge of oncology product development as well as her FDA expertise she will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”


 

NDA media contact: anna.perrin@ndareg.com

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Princeton, Boston and San Francisco. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies. www.ndareg.com


 

Athersys

Athersys is a US-based clinical stage biopharmaceutical company with a growing pipeline of therapeutics to treat significant and life-threatening diseases. To ensure the global success of its drug, it was necessary to broaden this clinical trial programme to include Europe. However, the company recognised the need for specialist regulatory support to advise how to best approach this region.