In recent years, the global trend in drug development has included more active and influential patient activity. Patient and caregiver voices have become a key part of the regulatory process, and FDA Advisory Committee Meetings are no exception. At the Open Public Hearing (OPH) part of these meetings, patients have an opportunity to educate the committee and the Agency, impact regulatory decision-making and even help guide the future of drug development. This is particularly important for rare disorders.
The webinar will be followed by a Q&A session for you to get direct feedback on key areas of uncertainty.
Lisa Peluso is Director of Coaching and Client Engagement at PharmApprove/NDA, where she helps development teams, doctors, patients and advocates to create and deliver clear, consistent, and convincing messages to regulators in the US and Europe. Lisa has coached hundreds of individuals and provided presentation/Q&A training and workshops to teams in pharma and biotech, and has helped over 45 clinical development teams prepare to present at FDA Advisory Committee meetings and EMA Oral Explanations. Her experience and familiarity with high-stakes regulatory meetings allows her to get to the heart of the challenge, and she excels at giving presenters and responders clear and actionable feedback, to instill confidence and help them communicate with clarity and impact. Prior to joining PharmApprove, Lisa worked at Kyowa Pharmaceuticals, where she supported both commercial and clinical teams and served as the principal liaison between the Tokyo, UK and US offices. Lisa spent 12 years in Japan, where she worked in communications in the legal, financial and hospitality industries.
We will be attending this year’s DIA Annual Meeting, June 24-28, at the Boston Convention & Exhibition Center.
If you are planning to be there, we would really like to meet up with you!
Over the last 5 years, NDA Group has supported the approval of over 40% of new medicinal products in the EU and among our FDA advisory committee clients 80% have achieved product approval. We work across a range of disease areas including oncology, hematology, infectious disease, metabolic and immunologic disorders and CNS and have supported the development of over 50 rare disease programs.
Do you want your product to reach the world’s two largest markets with minimum delay? Arrange to meet us at DIA USA 2018 now.
#140: How Inspection Ready is your Organization?
Dr Edwards will also be involved in the following DIA Community Round Table Discussions taking place at the DIA Community Zone, North East Lobby, BCEC.
Click here to download the Final Programme.
We look forward to hearing back from you about a meeting and to seeing you at the event!
NDA’s Paula Salmikangas, Niamh Kinsella and Paul Chamberlain have co-authored the article “Chimeric Antigen Receptor T-Cells (CAR T-Cells) for Cancer Immunotherapy – Moving Target for Industry?
Read the full article written by Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board, Niamh Kinsella, Principal Consultant, VP Early Stage Development and Paul Chamberlain Biopharmaceutical and Immunogenicity Expert which discusses the product-and patient-related variables that may pose challenges for the industry and developers both from the scientific and regulatory perspective.
This will be featured in Volume 35, Issue 8, August 2018 – in the Topical Collection of Pharmaceutical Research and is currently available online.
Pharmaceutical Research is an Official Journal of the American Association of Pharmaceutical Scientists, which presents papers that describe innovative research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval. Small drug molecules, biotechnology products including genes, peptides, proteins and vaccines, and genetically engineered cells are an integral part of papers published here.
We look forward to attending the 2018 BIO International Convention at the Boston Convention and Exhibition Center June 4-7th.
Over the last 5 years, NDA Group has supported the approval of over 40% of new medicinal products in the EU and among our FDA advisory committee clients 80% have achieved product approval.
We work across a range of disease areas including oncology, hematology, infectious disease, metabolic and immunologic disorders and CNS and have supported the development of over 50 rare disease programs.
To read more about the event click here.
Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the European Medicines Agency (EMA), has been invited to present at the Chief Medical Officer Summit, Omni Parker House, Boston, MA on 7th May.
Is a global regulatory and market access strategy the way to go?
Why isn’t EMA approval the same as market access in Europe?
What is the difference between EMA and FDA in regulating and approving medicines?
What is the best strategy to interact with regulators and payers?
How will trends like Real World Evidence influence regulatory decision making?
As well as presenting at the event, NDA Group is ‘Associate Sponsor’ of the CMO Summits, demonstrating its commitment and support towards the CMO community.
The CMO conference is an annual gathering for physicians and scientists in biotech to exchange best practices in the advancement of drug development and business management. Although the program is primarily designed for CMOs of emerging biotech companies, CMOs of large pharma and other R&D decision-makers will also benefit.
NDA supported over 40% of the new medicinal products that were approved in the EU during 2013 -2017. In 2016 NDA acquired PharmApprove, the market leader in managing critical FDA interactions to help us achieve the same results in the US.
Jenny Sims: Monday 30th April 12.20 pm, Immunogenicity Case Studies and Clinical Management Track.
We will be attending in full force during this year’s DIA Europe Meeting 17- 19 April, in Basel, Switzerland.
In addition, there will be many of NDA’s expert consultants attending the event and happy to help.
We definitely recommend booking a meeting in advance to ensure availability, but do feel free to pop by booths 72 & 73.
Click here to download the Preliminary Programme.
To book a meeting contact Anna Perrin: anna.perrin@ndareg.com or visit us at booths 72 & 73.
This June, NDA will be attending the DIA USA and BIO convention with a strong line-up of world-leading speakers and experts.
The 53rd DIA Annual Meeting 2017 is being held on June 18-22, at McCormick Place, Chicago. Whilst, the BIO International Convention is on June 19-22, at San Diego Convention Center, San Diego.
If you are planning to attend this year’s DIA or BIO, we would really like to meet up with you. If you’d like to arrange a meeting with us, please email anna.perrin@ndareg.com.
NDA’s experts will present on a number of critical drug development related topics at both the DIA and the BIO meeting.
Title: Future Regulatory Goals of the Periodic Benefit-Risk Evaluation Reports (PBRER ): Are They Being Achieved?
We look forward to hearing back from you about a meeting and to seeing you at the events!
NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services span Development Strategy, Translational Science, Procedure & Submission Management, High-Stakes Meetings and Process Design & Optimisation. Clients are supported by a team of over 150 regulatory affairs, health technology assessment, pharmacovigilance, quality assurance and strategic communications professionals. Backing all major NDA projects is the unique NDA Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. Learn more at www.ndareg.com and follow them at www.linkedin.com/company/nda-group-ab.
The NDA PharmApprove team comprises leading strategic, regulatory, and scientific communications professionals. PharmApprove focuses on strategic and tactical support to companies facing high-profile, high-stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at https://www.pharmapprove.com/ and follow them socially at twitter.com/pharmapprove.
GLASGOW, Scotland, March 28, 2017 /PRNewswire/ — NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the United States, ahead of this year’s DIA EuroMeeting in Glasgow. This year’s Status of New Drug Approvals report emphasises the need for a streamlined global development and commercialisation process across the world’s two biggest markets.
The report – based on preliminary research figures from the EMA and FDA websites in January 2017 – found that there has been a drop in US approvals but not in EU. For 2016 there were 74 new drug approvals granted in the US and EU. Of these new products, 19 were approved only in the EU, 19 only in the US, and 36 were granted in both regions. However 17 drugs that were approved in the EU in 2016 had received prior approval in 2015 or earlier in the US, while only six products registered in the US in 2016 were previously approved in the EU.
The pooled statistics showed that of the new drug approvals, 35 were classified as novel drugs (e.g. NAS, NME or BLA), nine were approved only in the EU, nine only in the US and 17 in both regions. For the EMA, the number represents the fewest NASs approved since 2011, while the FDA has not approved this few NMEs/BLAs since 2010. Big pharma represented 53% of the new drug approvals in 2016 vs 47% from small and medium sized pharma. For big pharma this is a decrease compared to previous years. Of all new products that received marketing approval in 2016, 30 products underwent special approval procedures like Conditional, Fast Track, Breakthrough, Accelerated Approval and Priority Review, 18 in the US, seven in EU and five in. In many cases more than one of these pathways was granted per product.
NDA Strategic Advisor and former Chief Exec of the EMA, Dr. Thomas Lönngren, as well as the company’s Scientific Director, Dr. Markku Toivonen and the Director of NDA’s Regulatory Advisory Board, Prof. Steffen Thirstrup will be present at DIA EuroMeeting together with a line-up of experts, and available to discuss these findings.
For more about NDA’s involvement with the 2017 DIA EuroMeeting, visit https://www.ndareg.com/meet-nda-at-the-dia-euromeeting-2017/.
To explore the full Status of New Drug Approvals for 2016 report, visit https://www.ndareg.com/wp-content/uploads/2017/03/NDA-Infographic-2016.pdf.
How to Prepare for an FDA Advisory Committee Meeting?
Lawrenceville, NJ (June 21, 2016) – PharmApprove – a member of the NDA Group and the leading strategic, regulatory, and scientific communications consultancy in the U.S. – will lead a tutorial on FDA advisory committee preparation at the 2016 DIA Annual Meeting. The session will take place on Sunday, June 26th at 1:00 p.m. at the Philadelphia Convention Center, during DIA’s 52nd Annual Meeting. PharmApprove has more than 15 years of experience preparing companies for advisory committee meetings, and boasts an over 85 percent success rate.
Peluso will lead the tutorial, which was developed with support from PharmApprove Founder and Executive Communications Strategist, Pete Taft. The tutorial helps corporate executives and other professionals across all R&D disciplines to effectively prepare for successful advisory committee meetings. PharmApprove has led thousands of training workshops and coaching sessions for regulatory, Medical Science Liaison, business development and payer negotiation teams at pharmaceutical companies around the world.
Visit https://dia201652ndannualmeeting.sched.org/event/61Nm for registration and scheduling information about the upcoming tutorial. Follow the social conversation online with the hashtag #DIA2016.
PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. PharmApprove merged with NDA in March of 2016. Learn more at pharmapprove.com or ndareg.com/pharmapprove and follow them socially at twitter.com/pharmapprove and facebook.com/pharmapprove.
NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services incorporate regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. Clients are supported by a team of over 100 consultants and a unique Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. For more information, visit ndareg.com.
I enjoyed working with you and your colleagues. I feel like I benefit so much from the expertise, coaching, and suggestions you and your team have offered, and feel quite fortunate to have had this opportunity.