Morell David presents at the EU MedDRA User Group Meeting 2014

Morell David, Principal Consultant in Pharmacovigilance and Drug Safety at NDA Group, has been invited to present at this year’s European MedDRA User Group Meeting on 28th March, on the subject of ‘MedDRA and Labeling – Use of MedDRA in Summary of Product Characteristics (SPCs)’.

Morell is a world-renowned MedDRA expert and sits on the Steering Committee of the European MedDRA User Group (EU MUG), a forum for professionals working in pharmacovigilance and drug safety. This face-to-face meeting occurs post the Euro DIA meeting and is well attended by pharmacovigilance and drug safety professionals from across Europe (including attendees who do not attend the DIA meetings).

Morell has been asked to discuss an important topic of interest to all European MedDRA users and his chosen subject is the guidance that is available for use of MedDRA in the Summary of Product Characteristics (SPC), as there is some confusion in Europe about the differences between the guidance for use of MedDRA in coding adverse events (AEs) and adverse drug reactions (ADRs) to biopharmaceutical products, and the use of MedDRA to communicate safety information to healthcare professional, patients and other stakeholders.

The Medical Dictionary for Regulatory Activities (MedDRA) is the international medical terminology that is mandated for use in all aspects of regulatory activities for biopharmaceutical products in the European Union (EU). This mandate applies to both regulators and the regulated pharmaceutical industry.

To find out more on the meeting, please click here

 

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Morell David, Principal Consultant in Pharmacovigilance and Drug Safety at NDA Group

NDA showcases new ATMP & risk management expertise at DIA EuroMeeting 2014

At this year’s DIA EuroMeeting, 25-27 March 2014 in Vienna, NDA Group participates with a full contingent of senior experts and consultants to engage with life science companies in all stages of development. For the first time, NDA will unveil the strategic biotechnology services portfolio that the company has been building up over the past year.

“ATMPs and gene and cell therapies will provide us with the next great leap in healthcare advances. It is still early days, but these novel technologies are no longer all in their infancy and experience and understanding are gradually being built up around the world. The expansion is easy to see just from the booming number of Scientific Advice procedures for these types of products in recent years. We’re looking at a veritable explosion,” said NDA Group CEO Johan Strömquist.

“The challenges are, however, significant – for many it’s a matter of walking a path tread by only a very small number of experts. Fortunately, many of those experts are part of the NDA team, some which have joined us as recently as last autumn. This means that there is now easy access to a growing experience and expertise through the services that we keep developing,” Strömquist continued.

During the EuroMeeting, NDA will have leading biologics experts on call and as speakers on key issues. These experts include NDA Advisory Board members Paul Chamberlain, Prof. Beatriz Silva Lima, Prof. Steffen Thirstrup and Dr. Jenny Sims. During the event, Jenny will present on Non-clinical development strategies for biosimilar monoclonal antibodies on Thursday 27th March and Beatriz is presenting on Innovation in pre-clinical and clinical safety sciences the same day.

NDA will also be showcasing the company’s biotechnology capabilities, encompassing ATMPs, biosimilars and biotechnology services. To find out more, please visit us at the event.

Increasing importance of Risk Management

NDA Group will also be presenting its complete portfolio of pharmacovigilance services at the DIA this year. EX-MHRA experts Morell David and Bridget King, alongside Dr. Brian Edwards, will be on hand to discuss the challenges and opportunities companies face. All three are holding workshops during the event, where Morell David and Bridget King will present on Signal Management (Tutorial 3 | Tuesday, 25 March, 09:00-12:30) and Dr. Brian Edwards will discuss Systematic approaches to deliver quality (Thursday, 27 March 16:00-17:30).

“Pharmacovigilance and Risk Management have become increasingly important parts of new drug approvals and for ensuring that products can stay on the market. Risk management should be factored into a drug’s development, to set the right expectations and focus the evidence generation on the right areas,” said Strömquist. “As a strategic risk management partner, our aim is to support clients factoring in risk management earlier in the lifecycle to ensure decisions are made based on the right information. In addition, we help ensure that any post authorisation commitments are relevant and managed in a way that optimises the product’s benefit / risk ratio, as well as ensuring that the activities are kept cost efficient.”

Hear NDA experts discuss key pharmaceutical issues

NDA’s experts have been invited to present on numerous pressing topics at this year’s DIA Euro meeting, including:

  • Ex MHRA regulators: Morell David and Bridget King (pre-conference tutorials, Tutorial 3 | Tuesday, 25 March, 09:00-12:30)
    Signal Management – the practical tools needed to address signal management, whether you are a small company or large organisation
  • Dr. Markku Toivonen (Session 0403 | Wednesday, 26 March, 14:00-15:30) Developing Medical products for older people – Getting on track
  • Prof. Beatriz Silva Lima (Session 1406 | Thursday, 27 March, 11:00-12:30)
    Innovation in pre-clinical and clinical safety sciences
  • Dr. Jenny Sims (Session 1407 | Thursday, 27 March, 14:00-15:30)
    Non-clinical development strategies for biosimilar monoclonal antibodies
  • Dr. Brian Edwards (Session 0607 | Thursday, 27 March, 14:00-15:30)
    Workshop: Systematic approaches to deliver quality: Learn from the experts!
    (Session 1008 | Thursday, 27 March 16:00-17:30)
    Regulatory simplification: vision, oxymoron, or “mission impossible”?

Alongside the presentations above, NDA Group has a team of experts present at the DIA that will be available to engage in discussions from our stand x.701 – x.800.

To find out more or schedule an appointment with members of the NDA team, please visit www.ndareg.com or email info@ndareg.com.

ENDS

NDA media contact: Paula Warmer, email: paula.warmer@ndareg.com, mobile: + 44 (0) 7713 308314

About NDA
NDA is an independent consulting group based in Germany, Sweden and the United Kingdom. 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 more than 25% ex-regulators from major EU Agencies, plus two specialist Advisory Boards, consisting of Europe’s leading regulatory and HTA experts. They are there to provide scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of drug approval applications from European regulatory agencies and payer bodies.

Panos Tsintis presents at DIA Risk Management Workshop in Japan

Panos Tsintis, NDA Group Medical Advisor and Advisory Board member, will present at the DIA Risk Management Workshop in Japan, 13-14 March in Tokyo. Panos will present two sessions on: ‘Risk Management in EU – Learning Points from Pioneers’ and an ‘Overview of EU Risk Management and Regulations’.

For the first session, Panos will explain the contents and system of EU Risk Management in the real world. Topics will include the Safety Specification, which is a core element of RMP; the necessity and/or difference of PvP and risk minimization activities (RMPs) corresponding to nature and degree of risks; methodology for completing RMAs; and a concept of Benefit Risk Balance assessment from both the perspectives of RMP development and from reviewer.

There is a difference in the understanding of RMPs between professionals in pharmaceutical companies and health authorities, and so the workshop is designed to bring them together and discuss RMP strategies, covering key topics including how to create a useful RMP for medical professionals.

The following day, Panos will present on Overview of EU Risk Management and Regulations, addressing important items in relation to PRAC, PBRER, and the integration of RMP activities, and will share the advantages and key issues. The aim is to give attendees a deeper understanding of what it is beyond RMP.

To find out more, please click here

Dr Panos Tsintis

 

 

 

 

 

Dr Panos Tsintis

NDA Group Medical Advisor and Advisory Board member

 

Dr Thomas Lönngren talks at “Licensed to Cure?” report launch at UCL

NDA’s Dr. Thomas Lönngren has been invited to speak at the launch of a new report entitled
Licensed to Cure?, being held at The Kohn Centre on Wednesday March 12th. The meeting is being run by UCL School of Pharmacy, supported by funding from the European Medicines Group.

This new publication investigates how organisations, such as NICE, value new treatments and discusses the use of unlicensed medicines as comparators in cost effectiveness appraisals.

The Licensed to Cure? report was authored by David Taylor, who has held a personal University of London chair in Pharmaceutical and Public Health Policy since 2000. He is a former NHS Trust chair and had responsibility for health care quality at the Audit Commission for England and Wales.

The meeting will be chaired by Ashok Soni, OBE FRPharmS.

For more information and to register please click here

 

Dr Thomas Lönngren

 

 

 

 

 

Dr. Thomas Lönngren
Strategic advisor, NDA Group

Bruno Flamion discussed the evolving regulatory approach to Biosimilars in the EU

Last week, Bruno Flamion, member of the NDA Advisory Board, was a keynote guest speaker at the 4th Biosimilars Congregation 2014 in London. He discussed the very topical issue of the evolving regulatory approach to Biosimilars in the EU, particularly in view of the first approval for a biosimilar monoclonal antibody (infliximab). As the next presentation focused on the FDA guideline for biosimilar development, a rich debate ensued comparing the regulatory approaches on both sides of the Atlantic.

The event was attended by top pharmaceutical, biotechnology and regulatory representatives, collectively interested in the key issues facing the industry today. This ranged from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. The conference focused on the many features of biosimilar product development to successfully deliver safe, biosimilar products to the market place.

For more information click here

Professor Bruno Flamion

 

 

 

 

 

Professor Bruno Flamion member of NDA’s Advisory Board

Marc Wiles Joins NDA UK as General Manager

Marc_WilesMarc Wiles has joined NDA’s UK team as the new General Manager for the UK office, one of NDA’s three offices across Europe (UK, Germany and Sweden). Marc was formerly a Director, Regulatory Affairs (Non Clinical and Clinical) and General Manager for ERA Consulting in the UK. He brings with him extensive pharmaceutical experience, particularly in the biologics / biosimilars/ ATMPs arena, as well as a strong interest in technology.

As General Manager for the UK, Marc’s main priority will be to lead and manage the UK team of consultants which includes a mix of regulatory and pharmacovigilance experts. The team is critical to supporting pharmaceutical clients based locally in the UK, across Europe, and the rest of the world. The team members, like their counterparts in Sweden and Germany, support strong interactions with the major regulatory bodies in the EU and collectively have a wealth of expertise, built up from working within the regulatory bodies themselves and the life science industry. Clients range from small biotech companies through to Top 10 global pharmaceutical organisations and Marc will be integral in working together with the team to ensure the delivery of first class services and support during a part or the complete life cycle of a medicine.

Further background on Marc

During his time at ERA Consulting, Marc was responsible for heading-up its entire UK-based regulatory group. As well as managing and directing the team, Marc supported business development, as well as driving all of its IT infrastructure upgrades.

Prior to ERA, Marc spent a year as Senior Vice-President, Operations for ProImmune Inc based in Oxford (but with UK and US based operations). In this role, Marc oversaw QA, research and development, Cellular Analysis Services, facilities, IT and HR. Marc also spent a year working for Novexel SA in France as Head of Toxicology/Drug Safety Evaluation, and a further four years at Shire, based in Boston in the US, as Senior Director, Nonclinical Development, and Senior Director, Preclinical Research. There, Marc was responsible for all nonclinical development activities (biologics; proteins) – based on enhancing HGT’s preclinical research capabilities; and managing change and growth of the nonclinical development organisation. Previously, Marc has overseen nonclinical development activities for 14+ current marketed products including antiviral, antibacterial, oncology, oligonucleotide and protein replacement therapies by way of example.

Earlier in his career, Marc spent a number of years as a Research Scientist / Research Associate Professor, a Medical Physiology Course Coordinator, Research Scientist, to name but a few, all at The George Washington University Medical School [GWUMS]; Department of Physiology and Experimental Medicine – Washington, DC.

Marc is a present and past member of a number of societies, including: Society for Leukocyte Biology (SLB), American Physiological Society (APS), American Association for Cancer Research (AACR, and American Association for the Advancement of Science (AAAS). He has contributed and written a number of papers, as well as providing peer reviews for the American Journal of Physiology [Lung Cell & Molecular Biology, Cardiovascular Physiology & Cell Physiology Sections] , Blood, Cancer Research, Circulation Research, Journal of Leukocyte Biology, Free Radicals in Biology and Medicine, and Microvascular Research. In addition, Marc has been a key contributing author to a recent authoritative publication on the development of ATMPs (Advanced Therapy Medicinal Products).

We are delighted to have Marc joining our team!

NDA Group at DIA Euromeeting 2014

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NDA Group will be attending this year’s DIA Euromeeting on 25-27 March in Vienna. We will have a range of experts covering preclinical, clinical, pharmacovigilance, health technology assessment and the complete regulatory affairs spectrum available on the stand and for private meetings, including:

Paul Chamberlain, Biopharmaceuticals expert

Prof. Beatriz Silva Lima, Non clinical expert

Dr. Markku Toivonen, Expert in clinical development and clinical strategies

Dr. Brian Edwards, Pharmacovigilance veteran and expert

Dr. Thomas Lönngren, Former head of the EMA and strategic advisor to NDA

Johan Strömquist, CEO of NDA

Plus, many of our Regulatory Advisory Board and consultancy team

 

If you would like to arrange a meeting with our Regulatory Advisory Board members or consultants email Anna Perrin: anna.perrin@ndareg.com or visit us on stand X.701 – X.800.

 

Sessions

We will also have some of our team presenting on interesting industry topics during the event.

Morell_David

 

 

Morell David pre-conference tutorials, Tutorial 3 | Tuesday, 25 March, 09:00-12:30
Signal Management – the practical tools needed to address signal management, whether you are a small company or large organisation

 

Markku_Toivonen

 

 

Dr. Markku Toivonen Session 0403 | Wednesday, 26 March, 14:00-15:30
Developing Medical products for older people – Getting on track

 

Beatriz_Silva_-Lima2

 

 

Prof. Beatriz Silva Lima Session 1406 | Thursday, 27 March, 11:00-12:30
Innovation in pre-clinical and clinical safety sciences

 

 

Jenny_Sims2

 

 

Dr. Jenny Sims Session 1407 | Thursday, 27 March, 14:00-15:30
Non-clinical development strategies for biosimilar monoclonal antibodies

 

Brian_Edwards

 

 

Dr. Brian Edwards Session 0607 | Thursday, 27 March, 14:00-15:30
Workshop: Systematic approaches to deliver quality: Learn from the experts!
and
Session 1008 | Thursday, 27 March 16:00-17:30
Regulatory simplification: vision, oxymoron, or “mission impossible”?

 

Meet us at the Euro meeting

To book a meeting contact Anna Perrin: anna.perrin@ndareg.com or visit us on stand X.701 – X.800
We look forward to hearing back from you about a meeting and to seeing you at the event!

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Will real-world evidence make an impact in 2014?

Collecting real-world data will present a huge challenge for pharmaceutical companies developing a new medicine, so they need to start planning for it early in development says Dr Thomas Lönngren, strategic adivsor, NDA Group in the latest issue of Pharma Times.

Full article:  Vision 2014

Dr Thomas Lönngren

 

 

 

 

 

Dr. Thomas Lönngren
Strategic advisor, NDA Group

NDA’s Beatriz Silva Lima to Lead IMI Scientific Committee

Professor Beatriz Silva Lima, a member of NDA’s Advisory Board, will be the new Chair of the IMI Scientific Committee. The Scientific Committee provides the IMI Governing Board and Executive Office with strategic, scientific advice and consultations on new topics for Calls for proposals. Members are nominated by IMI’s States Representatives Group and appointed by the Governing Board.

Beatriz_Silva_-Lima2‘The IMI Scientific Committee consists of some of the most skilled scientists in Europe, and being part of it is one of the highlights of my scientific career. To be appointed Chair is a great honour,’ said Professor Silva Lima.

For further information on the IMI, please click here

For further information on NDA’s Advisory Boards, please click here

Dr. Brian Edwards in the programme committee at the 8th QPPV European Forum

NDAs Dr. Brian Edwards is in the programme committee at the 8th European Forum for Qualified Person for Pharmacovigilance, QPPV, at Millennium Gloucester Hotel London Kensington, UK 14-15 May 2014.

For more information click here

Brian_Edwards

 

 

 

 

 

Dr. Brian Edwards
Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group

Specialises in PV quality management and all aspects of safety compliance, risk management, QP for pharmacovigilance services and clinical trial safety.

 

NDAs Liz Pollitt member of the Roundtable panel at the Phacilitate Vaccine Forum

NDAs Liz Pollitt will be a member of the Roundtable panel for the ‘Emerging Pathogens’ at the Phacilitate Vaccine Forum 2014, Washington, DC 27th January.

For more information click here

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Liz Pollitt
Senior Consultant NDA Group

Liz Pollitt is a senior consultant at the NDA Group, providing advice and technical expertise to a broad range of pharmaceutical companies on regulatory and quality/CMC aspects. Liz is involved in a wide range of projects on product development, clinical trials, interactions with regulatory authorities, scientific advice procedures, and EU MAA.
Her main area of expertise is biological medicinal products, with a particular knowledge and experience of working on vaccines.
Formerly a senior pharmaceutical assessor at the MHRA, Liz holds a PhD in Viral Immunology from University of Leicester and a BSc in Microbiology, as well as completing postdoctoral studies at the Institute of Virology, at the University of Glasgow.

 

Dr. Steffen Thirstrup attended a BDA workshop

Dr. Steffen Thirstrup (MD, PhD), Medical Advisor on NDA’s Regulatory Advisory Board, attended a BDA (Biotherapy Development Association) workshop on access to innovative oncology medicines in EU, on 16-17 January in Bonn, Germany. The aim of the workshop was to encourage ‘collaborative discussion between regulatory bodies, HTA organisations, healthcare providers, patients and industry on the key reasons for inequalities in access to oncology treatments within and between countries and possible ways to overcome these access disparities.’

Steffen contributed to a session on ‘Equal access – Differences and how to deal with it’ giving a presentation entitled: Regulatory & HTA: How can we define common grounds?

Steffen took part in the following panel-discussion focusing on how to build bridges between the regulatory requirement for approval of new oncology products and the subsequent request for data relevant for HTA-assessment.

For more information, please click here

Dr Steffen Thirstrup

 

 

 

 

 

Dr. Steffen Thirstrup
Medical Advisor NDA Regulatory Advisory Board

 

Dr. Steffen Thirstrup spoke on Protein Therapeutics

Dr. Steffen Thirstrup (MD, PhD), Medical Advisor on NDA’s Regulatory Advisory Board, spoke on Protein Therapeutics at the Danish Society for Pharmacology Annual meeting. The meeting, held on 15th January at Syddansk Universitet, Odense in Denmark, was attended by a broad range of members of the Society, which is an umbrella organisation covering five different Danish academic societies within the areas of basic and clinical pharmacology, toxicology as well as pharmacy and medicinal chemistry.

The one-day meeting included a session on ‘protein therapeutics’ and their clinical pharmacology as well as a poster-session and free oral communications among the members. Furthermore, two workshops were part of the day – one on medication reviews and one on assessment on toxicological substances within the 3R perspective.

Dr. Thirstrup, who is a member of the society, was invited to give the introductory speech to the morning session on protein therapeutics with his background as a clinical pharmacologist and former member of CHMP.

Dr Steffen Thirstrup

 

 

 

 

 

Dr. Steffen Thirstrup
Medical Advisor NDA Regulatory Advisory Board

 

 

Thomas Lönngren speaks at FT Biotechnology and Biosimilars Forum

Thomas Lönngren, strategic advisor to NDA Group, was invited to speak at the FT’s Julphar Mena Biotechnology and Biosimilars Forum in Dubai 9th December 2013. Thomas held a keynote on the subject of ‘The Biosimilar Framework in EU’.

The Forum was chaired by Andrew Jack, Pharmaceuticals Correspondent, Financial Times, and brought together ‘industry experts, investors, policy makers and regulators from across the region and internationally to discuss the emerging opportunities and challenges for the development a vibrant biotechnology sector in the MENA’.

For further information on the event, please click here

Kjell Strandberg wins Topra lifetime achievement award

NDA Group’s Professor Kjell Strandberg (MD, PhD), recently retired chairman of the NDA Regulatory Advisory Board and current counsellor to the chairman of NDA Group, was last Wednesday night awarded the prestigious Lifetime Achievement Award at the TOPRA Awards, held at the IoD in London.

The Lifetime Achievement Award is open to individuals only, awarded for a ‘consistent history of contribution in Regulatory Affairs’. The judging panel comprised of 15 well-respected members of regulatory bodies, academia and the pharmaceutical industry, looking for someone that had demonstrated going ‘over and above the call of duty throughout their career’, together with having an ‘exceptional contribution to TOPRA and/or the profession and development of Regulatory Affairs or Regulatory Science and a significant impact being made on Regulatory Affairs in the healthcare sector.’

“I’ve thoroughly enjoyed working with the pharmaceutical industry over the past 36 years, seeing many new and exciting new medicines being introduced, new technological advances being made, and fundamental process changes to the industry to make the process of new drug development more efficient, all to the benefit of patients. I am truly proud to have been part of these developments and it is an honour to have won this award,” said Kjell Strandberg.

 

 

About Professor StrandbergProfessor Kjell Strandberg

Professor Strandberg has devoted most of his professional career (36 years) to improving the regulatory process. Recognising the need for high caliber in-house staff, Kjell advanced the Medical Products Agency to becoming one of EUs most respected, utilised and appreciated regulatory agencies s over the full range of activities.

To the benefit of patients, industry and regulators alike, Kjell engaged in harmonisation, cooperation and educational activities in order to minimise undue delays in the review of new medicines and safety issues. This rests on true belief in the value of co-operation and a genuine interest in front-line research. It has been accompanied by a willingness to share the MPA positions at conferences aimed at open discussions between regulators and industry representatives; activities which many times Kjell has orchestrated or encouraged his staff to take part in.

After ending his tenure at MPA, Kjell established a truly unique group of ex-regulators supported by former highly ranked Heads of international Regulatory Affairs and former EMA project leaders. Today, the NDA Regulatory Advisory Board consultancy comprises 15 members, including 10 renowned ex-regulators, among them all three former chairpersons of the Scientific Advice Working Party. Approximately, 80% of Big Pharma utilises the Advisory Board’s services, e.g. review of development plans, strategic advice and training sessions, advice on Risk Management Plans etc.

The Advisory Board advice also serves the regulatory authorities well. Thus constructive criticism of strategies, design of pivotal studies often lead to changes, even to projects being permanently put to rest. This twofold effect, i.e. investments saved and scarce regulator resources spared, is of mutual benefit.

‘Once again the shortlisted nominees in this year’s Awards reflected the very best in the regulatory world,’ says Lynda Wight, TOPRA’s Executive Director. ‘The winners – from promising new regulatory professionals to those with a lifetime of regulatory service at the highest international level – are examples of real regulatory excellence and I congratulate them all.’

 

Lifetime Achievement Awards criteria

The Lifetime Achievement award addressed five different criteria: consistency, quality, contribution, achievements and impact, as outlined by TOPRA below:

Consistency: making a consistent contribution to the profession, not just in performing their job function but over and above the expected call of duty
Quality: demonstrate how contribution has been of a truly high quality over their career, enhancing Regulatory Affairs or the regulatory affairs profession in general
Contribution: the nature and extent of contribution to TOPRA or the profession of Regulatory Affairs as a whole
Achievements: a catalogue of achievements throughout their career, highlighting significant those that were above and beyond their remit
Impact: has made an impact that has a reach or longevity greater than would be expected