TGA is undergoing changes in response to a ‘Functional and Efficiency Review’ of the Department of Health – there is now a ‘Regulatory Service Group’ that includes TGA, the Office of Gene Technology Regulator and the Office of Chemical Safety. There is also a new Regulatory Performance Framework with KPIs that the TGA’s performance will be measured against. The first report is due in the second half of 2016.
How to overcome resistance to biosimilars that are now being listed on the Pharmaceutical Benefits Scheme in order to reap the financial benefits for the taxpayer is an issue for Government. This topic will be addressed as part of a PBS Access and Sustainability Package just announced, with $20 million funding for 2015-18.
by Dr. Richard O. Day, DIA Fellow; DIA Global Forum Regional Editor: Australia/New Zealand; Professor of Clinical Pharmacology, St. Vincent’s Hospital, Australia
A recent article by Shashi Amur and FDA colleagues on the future of biomarker development (Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization — http://onlinelibrary.wiley.com/doi/10.1002/cpt.136/abstract) provides a solid foundation for ongoing development and review process for biomarker qualification. FDA should be applauded for their progress in agency collaboration with the Critical Path Institute (in biomarker consortia development), the recent total kidney volume and plasma fibrinogen prognostic marker approvals, and sponsorship of interactive sessions such as the recent CERSI meeting at University of Maryland, as well as their EMA partnership to facilitate collaborative review of drug development tool qualification.
We would encourage additional measures to hasten biomarker development, including:
- Maximizing Expert Resources: FDA needs adequate resources to provide advice and oversee review and decision-making. One solution is to partner with an external entity (an Intramural Biomarker Consortium-IBC) to develop early advice and serve as an expert sounding board for nascent biomarker efforts. The IBC could be a required or voluntary resource in the review process, especially for initial data package reviews. This approach would allow FDA staff to focus on their primary role of product review and regulatory oversight.
- Refined Evidentiary Considerations: The product development and research community should collaborate to support FDA in developing a framework for the proper level of evidentiary substantiation required for qualification and the criteria used to evaluate them – such that FDA can issue guidance -standards which do not exist today. The IBC could be charged with overseeing relevant workshops and the drafting of initial guidance documents (consistent with FDA’s Good Guidance Practice recommendations and provided FDA is actively participating and has final approval).
- Qualification Plan: FDA should clarify the components of individual qualification plans and judge submitted data packages against them. Decisions not to qualify a proposed biomarker for a particular context should be accompanied by an explanation of the evidentiary gaps between the agreed plan and the submitted qualification package. IBC could work with biomarker developers to build these plans and perform initial data package reviews.
- Enhance Learning: Give FDA the authority to share information about biomarker qualification programs that are being advanced through collaborative efforts. Much can be learned by reviewing successes and failures across ongoing biomarker programs, and would inform the broader research community to enable refined evidentiary standards.
- Timeliness: FDA must clarify and communicate timelines for the qualification process in order to foster predictability and encourage participation. Such resources could be provided via PDUFA VI.
FDA can further solidify its place squarely in the center of the innovation ecosystem by fostering collaborative alliances with all stakeholders, enhancing qualification planning, sharing developmental endeavors, and clarifying standards.
Peter J. Pitts
President, Center for Medicines in the Public Interest
Former FDA Associate Commissioner
Timothy R. Franson, M.D.
Chief Medical Officer – YourEncore
Immediate Past President- US Pharmacopeial Convention
By Peter J. Pitts
The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, and between advocates on all sides.
And the red thread that ties these conversations together is responsible off-label communications. Not sales strategies. Not DTC tactics. Not managed market negotiations – the responsible sharing of truthful and accurate information. Continue reading
By Peter J. Pitts
Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.”
So said, CDER Director Dr. Janet Woodcock during yesterday’s webinar, “Understanding CDER’s “Super” Office Of Pharmaceutical Quality and Its Effect on You.” Dr. Woodcock was joined by Dr. Lawrence Yu. I was honored to moderate the FDA News-sponsored session.
(Janet is the acting director of the OPQ and Lawrence is the acting deputy.)
Let’s put the new OPQ into some historical context. Continue reading
By Peter J. Pitts
I am putting in a lot of miles on behalf of international regulatory fraternity.
Over the last few months I’ve visited Egypt, Indonesia, Vietnam, Taiwan, Mexico, and Brazil, where I’ve had privilege to meet with regulatory and healthcare officials. (And boy, are my arms tired.) Many things were discussed and shared, but the red thread was the urgency of quality.
I’ve learned many things and met many remarkable people. Perhaps the most important thing I’ve come to appreciate is that we need to stop talking about regulatory “harmonization” and focus our time and attention on regulatory “convergence.” Just as every nation has it’s own unique culture and cuisine, so too must it design it’s own regulatory philosophy and structure. It’s not about replicating the USFDA or the EMA – it’s about converging towards best practices — and beware the danger of regulatory imperialism. Continue reading
Mobilizing medical insight, discovery and invention to help patients is a team effort. Patients and their families expect that we will work collaboratively and use our collective skills to improve health – as efficiently and quickly as possible. No doubt, collaboration is a skill and a challenge. Honing that skill and exploring the challenge requires conversation and expression. The DIA 2015 51st Annual Meeting gathering in Washington, DC, is the perfect place to pursue our shared mission to improve health and well-being, and to learn how to be great partners in drug development from each other. Continue reading
Disruptive innovation, creating new markets and displacing the old, is currently in the midst of a “big bang.” Technology is serving as the catalyst and helping to develop new breakthroughs, which in turn are spurring on further developments. Hardware, wearable gadgets, and new medical technologies are raising the level of innovation in health care product development. These rapid advances are creating opportunities to advance research and connect patients to their care. Continue reading
Have you read the April issue of Global Forum yet? Featuring a new look, and in-depth content from an expanded editorial board, this issue is available open access (no log in required) at www.globalforum-online.org.
The April issue takes a deep-dive look at the 10 industry trends for 2015 identified in our recent “What Lies Ahead” report (view pdf). In addition to a Special Section with feature articles on three of the top trends, we also asked experts from around the globe to comment on how they see these trends shaping up in their area of the world.
Dr. Silke Vogel, Associate Dean at Duke-National University of Singapore, providing insight into which of the identified trends resonated for ASEAN community.
Dr. Richard Day surveyed his colleagues and peers in Australia and New Zealand for their opinions on the trends as they impact the “down under.”
Dr. Ling Su and Fuyu Song offered their take on What Lies Ahead in China.
For the European Perspective, John Lisman weighed in with the themes he sees trending in Europe.
We also look at areas where the industry is still growing. Professor Ranjit Roy Chaudhury lends his extensive expertise in a commentary on the trends in India, while Vincent Ahonkhai offers perspective on industry trends in Middle East/Africa.
How do you see these trends impacting work in your corner of the world? Let us know in the comments.
The April issue of DIA’s Global Forum online magazine is now available at http://globalforum-online.org. In this issue, experts take a deep dive look into several of the “trends to watch” from DIA’s “What Lies Ahead” report which was released in February. The April issue is the first in our new reader-friendly and content-rich format, featuring fresh perspectives from industry experts.
Included in the issue, two articles look at the #1 Trend on our list, “The Rising Influence of Payers: Driving the Need for Evidence-Based Outcomes.” Continue reading
Have you seen DIA’s What Lies Ahead 2015 report yet? The third annual report was released earlier this year, providing experts’ insights into the year ahead for pharmaceuticals, biotechnology and medical devices. To read the full report, click here.