NDA Group will be attending the 10th Annual PEGS Europe, at the Lisbon Convention Center, Portugal 12-16 November, 2018.

NDA supported over 40% of the new medicinal products that were approved in the EU over the last five years. If you are planning to attend this year’s PEGS, we would really like to meet up with you. We will have a few of our experts available at the event:

  • Dr Niamh Kinsella, Biologics Expert
  • Dr Terese Johansson, Regulatory Consultant

If you would like to arrange a meeting, please contact Niamh Kinsella, who will be happy to assist, niamh.kinsella@ndareg.com

 

Experts that will present at the event:

Niamh Kinsella

 

Poster Presentation:
Integrated Early Stage Development Strategy as Risk Management Tool for Global Development
Viewing: Tuesday, 13 November: 10:30-11:15, 13:45-14:15 & 16:20-17:00

 

Terese Johansson

Poster Presentation:
Developing an Integrated Summary of Immunogenicity (ISI) to Effectively Manage Regulatory Risks in Product Development
Viewing: Thursday, 15 November: 10:35-11:15 & 13:15-14:00

 

 

Click here to find out more about the event.

We look forward to hearing back from you about a meeting and to seeing you at the event!

 

 

 

Meet NDA at DIA Biosimilars Conference in London

Steffen Thirstrup,Director, NDA Regulatory Advisory Board will be chairing this event:

Overview
Biosimilar medicines’ developments are maintaining their momentum, and the 2018 Biosimilars Conference programme delves into strategic discussions regarding:

• Market access and regulatory developments in the EU and globally
• National policy developments (e.g. education, incentives, government investments)
• The impact of biosimilar medicines on the competitive landscape of biological products and the sustainability of the biosimilar medicines sector

As the 5th conference of its kind, the 2018 programme will provide current updates and challenges related to biosimilar medicines. The conference will consist of plenary
sessions and multi-stakeholder panel discussions, which will allow for interaction with the audience. Participants will leave the conference with a wealth of new information
and an expanded network of contacts.

Paul Chamberlain, Biopharmaceuticals and Immunogenicity Expert, NDA Advisory Board, UK
DAY ONE | MONDAY, 22 OCTOBER
11:30 SESSION 2 – PHYSICIAN’S CHALLENGES – TREATMENT PATHWAYS
Immunogenicity – The Wrong Elephant in the Room

Click here for more details & to register

Healthcare White Paper published

On Thursday 4th October, at the prestigious Royal Society of Medicine in London, the Chartered Institute of Ergonomics & Human Factors (CIEHF), launched their much-awaited White Paper setting out CIEHF’s vision for the integration of Human Factors in Health & Social Care.

The launch event was a great opportunity for individuals working in Health and Social Care, both clinical and non-clinical, to understand how human factors expertise can help and benefit patients, staff and their organisations.

Dr Brian Edwards, Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group gave a talk, outlining the multi-faceted work of CIEHF’s unique Pharmaceutical Sector Group and its growing influence in a number of important areas such as manufacturing, technology and device design.

Click here to find out more

The White Paper is now available as a digital download. Get your copy here.

 

 

 

 

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

Meet NDA at DIA European Forum for Qualified Person for Pharmacovigilance (QPPV)

Helen Powell, & Brian Edwards, Principal Consultants at NDA Group have been invited to chair two Sessions at DIA European Forum for Qualified Person for Pharmacovigilance (QPPV), London, 10-11 October 2018

“Are You Compliant Enough? – Audits, Inspections And QMS”
Helen Powell, Principal Consultant, NDA Group has been invited to chair session 7

 

 

“Am I Impacted By Brexit?”
Brian Edwards, Principal Consultant, Pharmacovigilance and Drug Safety, NDA Group, will chair session 8

 

 

Overview
This is still the only forum designed for QPPVs by QPPVs. This Forum continues to identify key trends requiring QPPV awareness, input and oversight. This year’s objectives, will build on past successes which have been shaped by valuable feedback provided by the participants of the past eleven meetings, plus many years of QPPV and Regulator interaction at this Forum.

Objectives
• Hear the latest updates and hot topics relating to the role of the QPPV
• Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
• Network with colleagues and meet regulators
• Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
• Take away practical hints and tips
• Better understand regulatory and inspectorate expectations of the QPPV
• Identify the expanded expectations of the role in the context of the continually evolving regulatory framework
• Examine current areas of real challenge

To find out more about the event click here.

Head of Quality Assurance

 

Do you have a strong background in quality and want to work in an international environment? Become a part of NDA’s growing, highly qualified team!

As the Head of Quality Assurance at NDA, you will ensure that NDA’s Quality Management System (QMS) meets the requirements of our clients and conforms to relevant international standards and regulations. We are looking for someone with a strong quality background that will drive our quality activities to ensure a consistent quality approach in the development and introduction of new and modified services across NDA.

Location: Stockholm

Qualifications

  • An academic degree appropriate for the role or relevant work experience,
  • A strong quality background (GxP, ISO 9001 or similar) with at least 10 years of experience,
  • Experience from leading quality activities in a global environment with international interactions and responsibilities,
  • Leadership experience demonstrated in informal leadership roles, with ability to build and lead cross functional/cross country teams,
  • A strong commercial understanding,
  • Excellent English, both spoken and written,
  • Project Management skills,
  • Experience within the Life Science Industry,
  • Professional consultancy organisation experience would be advantageous.

In order to succeed in this role, we think that you have the ability to collaborate and influence and negotiate with others. You are analytical with structure and process thinking with a creative drive to make things better

About the role

You will monitor the development of external trends, regulations, practices and tools within the quality area. An important part of the role is to initiate and lead quality improvement initiatives and advise CEO and Leadership Teams on appropriate actions and resource deployment to integrate quality and quality thinking into planning and service development. The more operational part of the role includes monitoring the quality management system as a whole, to oversee management and control of Controlled Quality Documents and support creation and maintenance of procedural documents. You will also coordinate activities within the quality function, including quality coordinators and all additional roles and functions. It is a global role and you will liaise with and advice management and other staff across all sites on quality related matters.

Is this you? Welcome with your application!

Application

Send your application (CV and letter) in an email labelled “Head of Quality Assurance” to recruitment@ndareg.com. Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.

By sending your application, you agree that you have read and understood the Privacy Notice for Candidates.


About NDA Group

NDA is a world leading drug development consultancy with a dedicated team of over 150 consultants supported by an expert network and a specialist Advisory Board. Our goal is to streamline drug development in order to accelerate patient access to important medical therapies. We support life science companies all over the world and across all phases of development, from pre-clinical to post marketing, to the needs and requirements of regulators and payers alike. We work together with our clients to address key strategic regulatory and reimbursement challenges. Our scientific expertise covers all major therapeutic areas.

Over the past five years NDA has supported over 40% of the new medicinal products approved in Europe.

 


 

 

The future of Health Technology Assessment in Europe – Free Seminar

On the 24th October NDA Group invites you and your colleagues in the market access department/HEOR to a complimentary seminar on the future of HTA.

The market access environment is getting increasingly challenging. The ability to develop plans and strategies for access, for today as well as tomorrow, is critical to bring new medicines to patients.

With 17 years as Executive Director for NICE, Carole Longson has unparalleled experience in understanding how HTA bodies work and collaborate in the EU. In June 2018 she joined NDA as a HTA Advisor.

This seminar will discuss the past, present and future of HTA and market access. On stage Carole is joined by an esteemed panel comprising Professor Steffen Thirstrup, former Division Head at the Danish Medicines Agency and CHMP member, Dr Fredrik Andersson, Senior Director Global HEOR Ferring, Claes Buxfeldt former Global Director of Pricing and Reimbursement at AstraZeneca and Mark Aalgren, Senior Director Market Access and Public Affairs, ALK.

Date: 24 October 2018

Time: 8:30 – 12:00

Ask the Experts: 12:00 – 14:00 – Book a 20 min slot for a chat directly with our experts by contacting Rachel.stonebridge@ndareg.com.

Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor

SIGN UP


Agenda

8:30
Registration and light breakfast

9:00
Welcome
Claes Buxfeldt, HTA Director, NDA Advisory Services Ltd

Session 1 – Challenges on development programs for new drugs
Professor Steffen Thirstrup, Director, NDA Regulatory Advisory Board (previous Danish Medicines Agency / EMA)

  • Clinical trial guidelines and how to deliver patient centric critical data for regulatory and HTA bodies. Implications and mitigations.

10:15
Coffee break

10:45
Session 2 – HTA alignment in Europe – what does the future of HTA have in store?
Professor Carole Longson, Life Science Policy, Research and Market Access, NDA Advisory Services Ltd (previous executive Director NICE UK)

Conversation leaders at stage:

Claes Buxfeldt, HTA Director, NDA Advisory Services Ltd
Professor Steffen Thirstrup, Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd
Dr Fredrik Andersson, Senior Dir Global HEOR, Ferring
Mark Aalgren, Senior Director Market Access and Public Affairs, ALK

  • EU clinical effectiveness review (Parliaments proposal), where is it going? Will EU get a ‘super-HTA body’ in the future?
  • EUnetHTA and EMA, directions and implications for future collaborations
  • NICE after Brexit?

12:00
End of meeting – conclusions and take-home messages
Claes Buxfeldt, HTA Director, NDA Advisory Services Ltd

12:00 – 14:00
Ask the experts
Please ask for a 20 min slot for a chat directly with our experts by contacting rachel.stonebridge@ndareg.com

 

Carole Longson
Claes Buxfeldt
Steffen Thirstrup

 

 

 

 

 

 

Looking forward seeing you at the event!

 


 

Accelerate the development of your product to market – in the EU, US and Switzerland

Mirjam Cramer
Stephanie Krumholz

Kick-start your regulatory strategy with an hour of free advice.
Meet NDA at Bio-Technopark® Schlieren-Zürich, 2nd October 10:00 – 17:00.

 


NDA has supported more than 40% of the new medicinal products approved in Europe over the last five years and is spearheading an increasing number of successes with the US FDA and Swissmedic. Take this opportunity to tap into the expertise behind the success.

Dr. Stephanie Krumholz and Dr. Mirjam Cramer invite you to explore how a tailored drug development strategy can maximize your product’s potential value and reduce time to approval.

Book a free, 1 hour consultation to discuss your drug/device/drug-device development strategies.

Where?

Bio-Technopark® Schlieren-Zürich,
1st floor (GHZ: Gewerbe – und Handelszentrum Schlieren AG),
Wagistrasse 23, 8952 Schlieren, Zürich

When?

2nd October 10:00 – 17:00

RSVP

Book your free consultation before 28th September, zurich@ndareg.com

Looking forward hearing from you!


 

Dr Paula Salmikangas presents at the ISCT Europe 2018 Meeting

If you are planning to attend the ISCT Europe 2018 meeting in Florence 12th-14th September, don´t miss the opportunity to meet our expert, Dr. Paula Salmikangas, who will present on Testing requirements for viral vectors in Session 2a on 13th September.

In addition Dr. Salmikangas and Dr. Christopher Bravery will be running a pre-conference workshop Common Technical Document (CTD) Hands on Training Workshop on 12th September.

This is a great opportunity to consider your own development and what data are needed for each CTD section for the final approval dossier.

Dr. Salmikangas is available for meetings during the event to discuss how to address regulatory challenges of drug development and accelerate time to drug approval.

Click here to find out more about the event.


 

Meet NDA at LSX Nordic Congress 29-30 August in Stockholm

Are you planning to attend the LSX Nordic Congress next week?
If so we hope you have the time to see Dr Thomas Lönngren, NDA Strategic Advisor and Former Executive Director of the European Medicines Agency (EMA ) moderate the opening Keynote Panel: ‘Building a thriving world class life science hub in the Nordics’.

Both Thomas and NDA’s CEO Johan Strömquist are available for meetings during the event to discuss their thoughts on the subject and how NDA can support Life Science companies in the Nordic Region to create a tailored global drug development strategy to maximize your product´s potential value and accelerate time to drug approval.

To book a meeting with them please register here.

If you would like to book a meeting with us on a different date click here.

We are looking forward to seeing you at the event.

Johan Strömquist
Thomas Lönngren

 

 

 

 

 

 


 

Meet NDA at Nordic Life Science Days 10-12 September

NDA Group will be attending and presenting at this year’s Nordic Life Science Days, the largest Nordic partnering conference dedicated to the life science industry, 10-12 September in Stockholm, Sweden.

If you are planning to attend this year’s NLS days, we would really like to meet up with you. Markku Toivonen (MD, PhD), Scientific Director NDA Advisory Board, Thomas Lönngren, NDA Strategic Advisor and Former Executive Director of the European Medicines Agency (EMA) and Terese Johansson (PhD), NDA Consultant, are available for meetings during the event to discuss how a tailored global drug development strategy can maximize your product´s potential value and accelerate time to drug approval. To book a meeting with them please register here.

If you would like to book a meeting with us on a different date click here.

Dr Markku Toivonen will also present in Super Session 2 – Return on Engagement: Patient engagement as a strategic imperative in medicines development on 11th September 11:30-12:30 at Plenary Room Level 5. This session will look at what patient engagement actually means in practical terms, and its impact as a business development tool, drawing on concrete good practice examples from the rare diseases community and personalised medicines.

We are looking forward seeing you at the event.

 

Markku Toivonen
Thomas Lönngren
Terese Johansson

Mark Goldberger, MD, MPH Infectious Disease Expert has joined the NDA Advisory Board

We are pleased to announced the expansion of the unique NDA Advisory Board with the appointment of Dr Mark Goldberger, Infectious Disease Expert.


Mark brings with him a wealth of experience in and in-depth knowledge of infectious diseases and antimicrobial products as well as extensive FDA expertise. For the clients of the reputable drug development consultancy this means high calibre advice to move such products swiftly through development and to regulatory success.

Dr Goldberger has unparalleled insight in these fields, working at the FDA as an expert within the Center for Drug Evaluation and Research (CDER), for which he held various roles of increasing responsibility, including five years as the Director of the Office of Antimicrobial Products. He also spent one year in the Center for Biologics Evaluation and Research (CBER) as Medical Director for Emerging and Pandemic Threat Preparedness.

Following his time at the FDA, Mark joined Abbott as Divisional Vice President involved in multiple areas of both product and policy development, before becoming VP Regulatory Affairs and Senior Advisor following the AbbVie split, providing both regulatory and scientific input into multiple development programs.

Mark is board certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America.

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. Goldberger on board. With his in-depth knowledge of infectious diseases and antimicrobial products as well as his FDA experience he will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”

Dr Goldberger is joining an increasing number of former FDA thought leaders at NDA, who since announcing its expansion into the US in 2016, has grown a team of more than 30 regulatory, drug development and scientific communications specialists in their locations in Boston, Princeton and San Francisco.


NDA media contact: anna.perrin@ndareg.com

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Paris, 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

Paula Salmikangas presents on Regulatory and scientific challenges for global development

Dr Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board, has been invited to present at the World Advanced Therapies and Regenerative Medicine Congress, 16 – 18 May, Business Design Centre, London.

Dr Salmikangas will speak in the Plenary Round Table Discussion Session: Process Development & Manufacturing Focus, with the topic title: Regulatory and scientific challenges for global development.

At this event you will have the opportunity to Research, Develop, Collaborate & Commercialise.

  • Meet 600 industry leaders from the pharma, biotech and research industry
  • Take part in 20 free seminars focusing on human application for stem cells, bioelectronic medicine, investment for AI in Healthcare and more!
  • Discover and experience the latest and most innovative products and solutions in the market showcased by 50 industry leaders
  • Be inspired by industry thought leaders during live interviews conducted on the exhibition floor
  • Discover the companies of the future in our innovation zone

 

Click here to find out more about the event.


 

Professor Carole Longson to join NDA as Scientific Adviser

Carole Longson MBE, former Executive Director and Board member at the National Institute for Health and Care Excellence (NICE), has joined the NDA Advisory Board. Carole will act as an adviser within NDA on matters relating to drug approval, scientific advice and Health Technology Assessments, areas in which she has had great impact in her previous role.


Carole brings tremendous research, academic and pharmaceutical industry experience to the role, including seven years as a Research Lead at GlaxoSmithKline R&D.

She has extensive expertise of directing multidisciplinary life sciences research programmes, managing large scientific departments and collaborating on multinational research grants.

Carole was a past member of the Scientific Advisory Committee for Innovative Medicines Initiative (IMI), the leading pan-European public- private partnership which funds health research and innovation. She also holds non-Executive Director and advisory roles in other scientific organisations in the UK and abroad. These positions give her a unique and extensive perspective on the changing face of industry.

Carole has unparalleled insight into the fast evolving medicines pipeline having spent the past 18 years at NICE where she has pioneered and led the organisation’s technology appraisal programme. Carole is highly respected as a leader in HTA & Market Access, both in the UK and internationally and was formerly President of Health Technology Assessment International.

Throughout her career and role at NICE, Carole has gained valuable understanding of how the public and private sector must continue to collaborate to meet the shared aims of ensuring medical innovation benefits patients in the UK.

Johan Strömquist, CEO NDA Group, commented on the appointment:
“I am delighted to see Carole join us. Not only will she bring a wealth of knowledge and experience to NDA that fits intimately with our strategic direction, her reputation in the industry and among her former Agency peers, also stems from her positive and collaborative personality.”

Werner Van den Eynde, Vice President NDA Advisory Services, commented:
“This appointment is a major step in our continuing aim to broaden our reach and expand HTA and market aspects into our drug development service offerings. It is also a testament to NDAs reputation amongst regulators and HTA bodies – NDA remains the undisputed prime destination for the greatest contributors to our regulatory and assessment systems.”


NDA media contact: anna.perrin@ndareg.com

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Paris, 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

 

 

Free Webinar – Rational EU risk management for oncology medicines: time for a rethink

It is timely to reflect on how we can best implement the revised GVP module (V) concerning risk management in the interests of patients throughout the life-cycle of a medicine.

Join us on Thursday, 24th May to hear NDAs Dr. Bill Richardson, Medical Advisor, discuss factors to consider include:

  • Taking into account the needs of the prescriber and other healthcare professionals
  • Applying the resources of the marketing authorisation holder (MAH) effectively to comply with regulatory expectation
  • Ensuring risk management plans reflect only measures that MAHs can reasonably control while retaining the MAH’s duty of care
  • Remembering risk management during clinical development is intrinsic to Good Clinical Practice
  • Providing precise instructions for minimising risk in the protocol and investigator brochure to form the basis of the EU risk management plan
  • Designing pivotal studies based on the anticipated target group once marketed
  • Defining recommended conditions for safe and effective use of a medicine to minimise risk

Thus, how can we now sensibly apply the revised GVP module for risk management?

Dr. Richardson is an experienced ex-EU regulator who understands the detail by which a typical RMP will be assessed and who will provide practical guidance to help you produce compliant RMPs effectively and efficiently.

Click here to book your place today.


 

Dr. Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He has over 25 years of regulatory affairs and pharmaceutical medicine experience, from clinical development to post-marketing. He joined NDA Group in 2014 after having worked for 11 years as a medical assessor at the UK medicines’ regulator (MHRA). He is an expert in pharmacovigilance and risk management – risk:benefit evaluation, risk management planning and scientific advice in the context of the current EU pharmacovigilance legislation, including the role of the QPPV. He has considerable expertise in the following areas:

  • Clinical development and clinical safety of medicines delivered by inhalation, particularly medicines for asthma and chronic obstructive pulmonary disease.
  • Clinical assessment of drug safety aspects of marketing authorisation applications in a wide range of therapeutic areas particularly: immunosuppressants including TNF inhibitors; epoetins; biosimilar products; oncology products including thalidomide and analogues, protein kinase inhibitors, and vascular endothelial growth factor (VEGF) inhibitors; anaesthetic agents/ICU medicines.
  • Assessment of new drugs, biologics, generics and EU safety referrals and major changes to marketing authorisations.
  • Training in pharmacovigilance particularly risk: benefit evaluation

 

Is a global regulatory and market access strategy the way to go?

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.


Thomas will present along with Jeffrey Sherman, CMO, EVP R&D, Horizon Pharmaceuticals, in the session ‘Taking a Strategy Approach to Global Regulatory and Market Access Challenges’, were they will discuss:

  • 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?
  • When and how to generate evidence that will satisfy regulators and payers
  • What is the best strategy to interact with regulators and payers?
  • Early access schemes in EU and how to qualify
  • How will trends like Real World Evidence influence regulatory decision making?
  • Brexit and its consequences for the EU regulatory system and how will it affect pharmaceutical companies

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.

Please come by booth #2 and meet us;

  • Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the EMA
  • Laurie Smaldone-Alsup, MD, COO/CSO
  • Barbara Clendenen, Director, Business Development

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.

To find out more about the event click here.