Claes Buxfeldt joins NDA Group as new HTA Director

Claes Buxfeldt, former Global Price and Reimbursement Director at AstraZeneca, has joined the NDA Advisory Board. Claes brings with him a wealth of knowledge and experience from his time in industry. For clients of the leading drug development consultancy this means faster provision of market access enabling advice and support.


During the last 18 years Claes has worked on a variety of disease areas, supporting more than 30 molecules/brands in a global position. He has represented the payer voice in the development programs including the development of payer evidence strategies, pricing and market access strategy, economic models, PROs, RWE and clinical program input.

He joined AstraZeneca in 2009 as Value Demonstration Leader in Global Health Economics & Outcomes Research, moving onto becoming the Global Price & Reimbursement Director in Respiratory & Inflammation.

Claes is joining the NDA Advisory Board as HTA director, where he aims to drive and develop NDA’s leading service offerings in the HTA area.

The NDA Advisory Board is a unique team of experts comprising of 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:
“We are very happy to welcome Claes on board as our new HTA Director. The impact of HTA and market access on the pharma industry is growing every day. Claes’ expertise and long experience in these areas will allow us to provide an even better service to our clients.”


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

 

 

NDA Group celebrates 20 years of championing treatments for rare diseases

Stockholm, 28 February 2018 – Leading drug development consultancy acknowledges the extraordinary contributions of patients and patient organisations around the world on global Rare Disease Day.

 

For 20 years the NDA Group has supported pharmaceutical and biotech companies around the world with strategic regulatory guidance across a range of diseases. Increasingly more companies have been trying to solve the puzzles for a diversity of untreated rare diseases. NDA has been there every step of the way.

Over the years NDA has been involved in the development of more than 50 products for individuals with rare diseases and several of the key breakthroughs have been supported by the company.

Johan Strömquist, CEO of NDA Group:
“At NDA we take great pride in helping companies address large unmet medical need. The need is most significant when it comes to rare diseases.”

Strömquist continues:
“Through the experience and knowledge of our regulatory scientists and clinical experts from agencies and the industry we feel privileged to have made a significant difference for thousands of patients living with rare diseases previously considered impossible to treat.”

The expansion and increased involvement of patients in the drug development process is one of the key factors that have stimulated the development in the rare disease space over the last few years.

Dr. Markku Toivonen, MD, Scientific Director at NDA and former Chairman of EMA’s Scientific Advice Working party and former CHMP member comments:
“The development of patient advocacy and the involvement of patients in the development and regulatory process has truly been game changing. At many levels the experience of the patient brings perspectives that no amount of objective, scientific scrutiny can bring to the process. At NDA we take great pride in helping to empower patient advocates through training in regulatory science and medical research with Eurordis, the European Organisation for Rare Diseases. ”

At NDA, the process to support the development of novel treatments for rare disease continues. Dr. Laurie Smaldone Alsup, MD, CSO and COO of NDA commented:
“We are driven by our passion and commitment to bringing new treatments to people in need. The rare disease landscape is still a vast area of unmet medical need with few options for many serious and life threatening conditions. We continue to provide leadership in solutions for diseases without regulatory precedent staying at the forefront of novel product development by guiding industry through the regulatory hurdles. Importantly we help to find and listen to the patient voice that has been a crucial contributor to the understanding of these rare conditions.”

Smaldone Alsup continues:
“I believe we are still at the beginning of addressing rare diseases. With new scientific and technical advances every day we will be turning a corner where many more novel treatments will be discovered to address a range of difficult to treat disorders. We are poised and ready to support these innovators and help enable treatments to reach people in need around the world.”


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

 

 

Senior Consultant, US West Coast

 

Are you an experienced specialist in regulatory affairs within drug development? Become a part of NDA’s growing, highly qualified team!

As Senior Consultant at NDA you provide strategic and operational support concerning regulatory affairs within drug development on a global, regional or national level. You manage large, complex and/or unpaved projects from international companies or local start-ups.

Location: US West Coast (home based)

Qualifications

  • 8-15 years of relevant experience in US regulatory affairs/drug development
  • Experience in the coordination and preparation of document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies
  • Experience of direct interaction with US regulatory agencies on defined matters including successful filing and approval of NDA/BLA
  • Experience and expertise with regulatory related development procedures (e.g., scientific advice, orphan designation, paediatric development plans, fast track)
  • Global experience or knowledge about EU regulations is a merit
  • Keeps abreast of US regulatory procedures and changes
  • Proven ability to lead project teams providing strategic and operational regulatory advice and guidance
  • Ability to contribute to Business Development activities, with main focus on the US West Coast
  • Ability to work independently is very important
  • Strong communication skills and intercultural sensitivity

To succeed as Senior Consultant you are probably proactive, adaptable and confident in decision-making.

Is this you? Welcome with your application!

Application

Send your application (CV and letter) in an email labelled “NDA Senior Consultant US West Coast” to recruitment@ndareg.com. Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.

To read more about NDA Group click here.


 

 

NDA Group welcomes proposal for new HTA regulation in Europe

Stockholm 2018-02-07 – NDA Group, the world’s leading drug development consultancy, signals their appreciation of the EU Commission’s proposal for a new HTA regulation in EU. The particular focus on Relative Effectiveness Assessment, the establishment of a new Coordination Group of clinical experts from the Member States and the continuation of the practices established by the voluntary European HTA network were all cited as reasons for a promising future for the regulation.


On Wednesday January 31st the EU Commission released its proposal for a new regulation on HTA for all Member States of the EU. The new regulation builds on the long-standing activities of the Member States HTA agencies, and particularly the voluntary network and joint action programs hosted by the EUnetHTA network.

Based on the EUnetHTA recommendation and the Impact assessment report (1) that provides an in-depth analysis of four policy options, the Commission has chosen to propose the option 4, advocating permanent cooperation on common tools, procedures, early dialogues and joint HT assessments. In the proposed regulation, the use of joint assessment of clinical aspects of technology evaluation becomes mandatory; all other aspects, such as cost-effectiveness and economic assessment, legal, ethical and societal aspects, are left for the Member States to continue to manage.

While specifying that regulatory and HTA process will remain well separated, the regulation focuses on three particular areas of interest to the drug developing industry:

  • Joint clinical assessments limited to innovative technologies,
  • Provision of scientific advice and guidance to developers, and
  • Identification of emerging health technologies.

The execution of these activities will primarily be carried out via a new Coordination Group of Member State experts, helped by specific sub-groups for each area of interest, and a new Commission Secretariat supporting the processes.

The regulation can be expected to be adopted in 2019, if successfully negotiated and approved by European Parliament and Council of Ministers, after which two subsequent three-year transition periods would kick in before it is fully adopted by the Member States.

The NDA Group has supported drug developing companies with joint regulatory and HTA assessment since 2011. Many of the experts employed by the company in this process have been involved in setting up the systems in place today, and the new regulation is no exception.

NDA’s Dr. Mira Pavlovic-Ganascia, who formerly coordinated the work on several EUnetHTA guidelines and work packages as well as the SEED (Shaping European Early Dialogues) sponsored by the Commission, commented:

“It is reassuring to see that the Commission has taken so much of the work of the [EUnetHTA] network on-board. I truly believe that a new Coordination Group will continue to profit from the actions achieved and structures already put in place, such as Early Dialogues Working Party and ED secretariat. As joint clinical assessments are the Commission’s key measure to promote market access for innovative technologies, Option 4 became the natural default position and with some minor modification this is what the Commission has chosen to go for.”

NDA’s Dr Thomas Lönngren, former Executive Director of the European Medicines Agency added:

“The work that was started over 20 years ago has now finally reached the legislative phase. This is a breakthrough, but the legislative process in Europe is difficult to navigate and it will take time before we eventually see this proposal adopted and implemented.”

When NDA established its Joint Advice service, it was to reduce the uncertainties inherent in drug development, particularly in gaining approval from regulators and efficiently ensuring that the product could be reimbursed by the national payers. One of the challenges has been the fragmentation and varying degrees of maturity across the Member States and an evolution towards the Commission’s proposal has been a favorite discussion topic in the consultancy over the last few years.

Johan Strömquist, CEO of NDA Group, commented:
“It’s quite incredible to see what we’ve expected, for such a long time, presented as a clear legislative proposal. Our experts predicted this development several years ago and the new regulation will certainly make the lives of hundreds of developers easier and more predictable.”

Strömquist continued:
“As the leading experts in the field we welcome the Commission’s proposal. We stand at our clients’ disposal to support in the creation of the necessary submissions and preparation for engaging with the new Coordination Group to attain the best possible advice for their product.”


References
1. http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdf

 

 

Andrew Monaghan joins NDA Group as UK General Manager

NDA Group today announced the appointment of Andrew Monaghan, PhD as General Manager for NDA’s UK affiliate based in London. Andrew brings over 35 years’ of experience in the drug development industry to the well-established UK team of close to 50 consultants and support staff.


Under Andrew’s leadership, drug developing companies from all over the world can expect a continuation of the many years of high-quality development consulting that the NDA Group has made a reputation for.

“I’m delighted to welcome Andrew on-board to join our highly skilled UK team,” commented Johan Strömquist CEO of NDA Group. “Andrew brings a wealth of experience to us and our clients and under his leadership we will continue to expand our impressive capabilities in the UK.”

As the new UK General Manager, Andrew will be responsible for developing, managing and driving the UK NDA team and business. Through his background Andrew has extensive experience of the challenges and opportunities in the biopharma industry.

“I am excited to join the NDA team and supporting NDA’s mission to help get the best medicines to patients with minimal delay” said Andrew. “I look forward to using my experience and knowledge to continue to build upon the fantastic work already done in the UK and supporting the growth of our global services.”

“From Andrew clients can expect not only great technical knowledge, but also a deep understanding of how drug development organisations work and operate” continues Johan Strömquist. “The demands on pharma and biotech companies are continually increasing and to navigate these waters requires the type of experience that he brings to the table”.

Prior to joining NDA Andrew worked at Worldwide Clinical trials as Global Head of Pharmacovigilance. He was responsible for all aspects of global Pharmacovigilance, including the development and management of teams in both Europe and North America.

His previous pharmaceutical positions include: Head of Pharmacovigilance at Chiltern. Andrew was at Roche/Genentech for 14 years, where he started as EU Head of Regulatory Affairs and Global Head of Medical Writing, before taking on the role of Global Head of Clinical Management and then the Global Head of Drug Safety Operations. He worked for Pfizer Central Research for 14 years, while in the UK he was responsible for the clinical development of a NCE and produced the clinical documents for the NDA/MAA, he then moved to the DRA group in the USA to manage its successful passage through FDA. Andrew has been involved the implementation of new technologies, enhancing business processes, and also improving organisational effectiveness.


 

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


 

Common failures in drug development

Dr. Thomas Lönngren, Strategic Advisor NDA Group and former head of the EMA, has been invited by BioMelbourne Network to present at the CEO lunch forum entitled “A CEOs nightmare – Regulatory and Market access failure, How to get a good sleep?”

This exclusive forum is being held on 2nd February at Norton Rose Fulbright, Melbourne.

Dr. Lönngren will present and discuss the common failures in drug development from a regulatory and market access perspective and how to avoid these failures; best practices for regulatory and market access strategies and discuss with the audience the latest pharma sector hot topics including the Brexit.

 

 

Meet us at the Phacilitate Cell & Gene Therapy World 2018

Dr Paula Salmikangas, NDA Director for Biopharmaceuticals & ATMPs, will be moderating a 1-hour ‘Working Lunch’ Panel Discussion on “Safety aspects of genetically modified cells” at 1.00-2.00pm on Tuesday, January 23rd 2018 at the Phacilitate Cell & Gene Therapy World conference in Miami.

Paula was previously Chair of the Committee for Advanced Therapies at EMA and has a longstanding experience on ATMPs as a CAT Rapporteur and CMC expert.

The conference brings together industry leaders from the pharma and biotech communities to deliver the ultimate in strategic knowledge exchange and networking.
Reflecting the growing enthusiasm around cell and gene therapy by small and large companies, investors and regulators.

To read more about the event click here.

 


Free Webinar – Development of Cell based Cancer Immunotherapy products

Optimising the quality of cell-based immunotherapy products is critical to maximising safety and efficacy of novel cancer treatments. Employing the right manufacturing approach is necessary to ensure your product’s long term success.

Join us on 8th February to hear NDAs Dr Paula Salmikangas, Director of Biopharmaceuticals and ATMPs, discuss:

  • How the CMC aspects impact safety and efficacy of cell-based cancer immunotherapy products
  • The importance of early product characterization
  • Cellular markers and correlation with responders
  • Critical quality aspects to ensure safety

She will also provide an overview of recent updates in the EU regulatory system for ATMPs.

Dr Salmikangas will be available to answer questions at the end of the session.

 

Click here to book your place today.

 


Dr. Salmikangas is a clinical biochemist by original training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. Dr. Salmikangas joined NDA in 2017 from her position as a Research Professor at the Finnish Medicines Agency (2003-2017). She has served as a member of the EMA Committee for Advanced Therapies (CAT) from 2009 to 2017 and as the Chair of the CAT 2014-2017. She has also been the Chair of EMA CPWP and a member of the BWP. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals.


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


 

Assessing the consequences of the EMA’s relocation

The EMA is relocating to Amsterdam – but what are the consequences to the Agency’s priorities and to the industry?

In this commentary NDA’s CEO Johan Strömquist and Strategic Advisor Thomas Lönngren, formerly Executive Director at the EMA, assess the impact on the Agency in light of its business continuity plans.

 

 

By:

Thomas Lönngren
Johan  Strömquist

 

 

Strategic alliance to support efficient, ethical practices in biopharma industry

Clinton Allen CEO Ethiprax LLC
Fabiana Lacerca-Allen President Ethiprax LLC
Johan Strömquist CEO NDA Group

 

New Collaboration offers broad range of Compliance-and Risk Management Strategies in Europe and US to Life Science Industry


Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC – a leading Compliance and Ethics solutions consultancy based in the US – and NDA Group – a world leading integrated regulatory/drug development consultancy are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.

Fabiana Lacerca-Allen, President of Ethiprax LLC commented:
“As we are intimately familiar with compliance requirement both in the US and Europe, we are able to help clients develop and maintain effective cultures of compliance. Too often companies hire one firm for US and another for EU and fail to implement a compliance culture across the entire organization. This collaboration offers a single partner who can provide global solutions.”

Johan Strömquist, CEO of NDA Group commented:
“We recognize that life science companies operate in different regulatory environments but fundamentally they all need to implement global best practices to maximize their opportunities for success. This is where we can add tremendous value. Doing the right things right doesn’t just feel good – it is the optimal way to create value.”

Strömquist continues:
“Together with Ethiprax we extend the reach of our services and our geographic foot print on the US west coast – much in line with our growth strategy. This continues to bring the experience biotechs and pharmaceutical companies need closer to where they are.”

The NDA Group and Ethiprax collaboration will focus primarily on the following:

  • Assess regulatory compliance readiness in early stage programs.
  • Provide strategic assessments of emerging compliance needs, review existing programs and provide advice regarding best practices to optimize critical business processes.
  • Align diverse teams to support manufacturing, clinical and product safety reporting requirements to connect the dots in compliance program development and implementation.
  • Offer compliance assurance program design, policies, procedures and program execution.

 


About NDA Group
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.

NDA supported over 40% of the new medicinal products that were approved in the EU over the past four years. http://www.ndareg.com/

About Ethiprax
Ethiprax is a specialized consultancy operating out of Hayward CA in the USA. Ethiprax was formed to help companies manage compliance and ethics risk. Drawing upon extensive experience related to healthcare-related organizations, Ethiprax helps clients develop and maintain effective cultures of compliance. Ethiprax brings industry best practices to the life sciences industry, ensuring that compliance requirements are addressed. http://ethiprax.com/

NDA Media Contact
Anna Perrin anna.perrin@ndareg.com

Ethiprax Media Contact
Allen Clinton clinton.allen@ethiprax.com


NDA Group expands their Advisory Board

Dr Sif Ormarsdóttir former CHMP and SAWP member has joined the NDA Advisory Board. Dr Ormarsdóttir has a Ph.D. in medicine and is a specialist physician in gastroenterology, hepatology and internal medicine.


In 2001 Sif was employed by the Medical Products Agency in Sweden as a clinical assessor. In 2003, she moved to work for the Icelandic Medicines Agency and at the same time started her own private practice. Between 2004-2010 she was a member of the CHMP and the SAWP. As a member of the EWP, she was the coordinator for three regulatory guidelines in the field of gastroenterology and in 2010 she became the chair of the Gastroenterology Drafting Group at the EMA.

From 2011 to 2016 Sif worked for AstraZeneca as Associate Director Physician/Liver Safety Expert, where she was Chair and clinical lead of the Hepatotoxicity Safety Knowledge Group.

Dr Ormarsdóttir 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 Sif Ormarsdóttir on board. With her experience in and in-depth knowledge of gastroenterology, hepatology and diabetes as well as pharmacovigilance and liver safety 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 welcomes EMA’s relocation to Amsterdam

After over a year of uncertainty the decision has now been taken to relocate the European Medicines Agency to Amsterdam. The result comes after a day of voting that was ultimately concluded through the luck of the draw between the two final cities, Amsterdam and Milan.

Johan Strömquist, CEO of NDA Group commented on the decision:

“Though there were many strong alternatives to host the Agency, we at NDA are pleased that the decision ultimately fell on Amsterdam where the greatest opportunity to retain Agency expertise was possible.”

Amsterdam was the top location identified when EMA staff expressed their preferences. This is particularly important for the continuity of the Agency’s work and the retention of expertise across the transition period and beyond.

Thomas Lönngren, Strategic Advisor at NDA Group and former Executive Director at the EMA commented:

“For me it’s been a year of frustration waiting for this decision. My heart is still with the Agency and their mission is of such incredible importance to all European citizens and the pharmaceutical industry. The decision on Monday took away the uncertainty and the agency can now plan for the future.”

Amsterdam offers excellent connectivity to all EU countries as well as the rest of the world and the Dutch government has provided a building that can be shaped to the Agency’s needs.

Frits Lekkerkerker, Clinical Advisor and Member of the NDA Advisory Board, also former Chair of the Dutch Medicines Evaluation Board commented:

“I’m proud that the EMA will relocate to Amsterdam. The MEB always supported EMA in its work on better medicines available for European patients. The EMA will be welcomed with open arms and I’m convinced all stakeholders will work together to guarantee a smooth transfer and continuation of the Agency’s activities.”

Though Amsterdam is an excellent choice for the EMA, moving an Agency of close to a thousand people in a 16 month time frame is still a monumental task. Assessment of the Agency’s Business Continuity Plan in light of the relocation decision points to a few areas where biotech and pharma companies might want to review their options.

The following areas are some of those identified as being at risk of disruption:

  • Emerging regulatory science,
  • Collaboration with HTAs,
  • Development of new guidelines, and
  • Timely provision of Scientific Advice.

These areas are of particular importance to companies working in emerging scientific fields or with novel technologies. Assessing how delays in any of these areas will affect the development programs, as well as identifying alternatives to formal Agency guidance, will be important for all companies working on novel science.

Johan Strömquist, CEO of NDA Group commented:

“At NDA we will continue to work closely with our clients to provide timely scientific advice, through strategic regulatory and development assessments. We are in a unique position to reflect the current opinions and practices of the EMA better than any other alternative. We therefore have a great responsibility to support both biopharma companies and the Agency in ensuring that the transition goes as smoothly as possible.”

 


About NDA
NDA is an independent consulting group based in Germany, Sweden, Switzerland, United Kingdom and the USA. 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 services within regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team comprises 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.

Over the past four years NDA contributed to the development of over 40% of the new medicinal products approved in the EU.


 

Shelley Gandhi Chairs the 2nd Annual Biosimilars Europe Congress

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited to Chair the 2nd Annual Biosimilars Europe Congress Nov 23 – 24, 2017 at Hilton London Olympia, London.

The conference will bring together industry experts to explore the strategies to gain insight into new biosimilar development strategies, different characterization and analysis methods, clinical advancement and successful case studies.

This conference offers a rare opportunity to its participants to understand and learn from top experts in the biosimilars field and to share experiences. The conference will also provide a platform to discuss the current vital issues, regulatory issues, market assessment and commercialization and globalization.

Key themes:

  • Current status of Biosimliars market
  • Monoclonal antibody Biosimilars
  • Challenges faced when moving towards globalization
  • Opportunities in emerging markets
  • IP issues, naming and labelling issues related to biosimilars
  • Partnership, new investment and business models
  • Challenges and opportunities for biobetters and monoclonal antibody biosimilars
  • Clinical trials strategies and new guidelines for biosimilar clinical trials
  • Benefits and concerns of interchangeable and biosubstitutes and post authorization monitoring
  • Bringing biosimilars closer to patients and healthcare professionals
  • New solutions to demonstrate similarity and different characterization methods

To find out more about the event click here.

 

Shelley_Gandhi

 

 

 

 

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group