Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind

Welcome to NDA’s free lunch seminar on Tuesday 11th December at 12:00 -14:00 on Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind

All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should not be compromised if these risks are suitably evaluated from the earliest stages of development.

Join us to hear Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert and NDA Advisory Board member, explain how to anticipate and avoid issues for biopharmaceutical development. Grab this opportunity to benefit from his experiences and insights.


Learning aspects:

  • How to apply immunogenicity risk assessment at the lead candidate selection stage
  • Minimizing incremental risks associated with manufacturing
  • Understanding what and how to evaluate, at different stages of clinical development
  • Integrated presentation of data to regulatory agencies

When: Tuesday 11th December 2018, 12:00 -14:00

Where: Queen Edith’s Room, The Cambridge Building, Babraham Research Campus, Cambridge

The Lunch seminar will be an open and interactive workshop with the opportunity to ask questions to Paul. Questions can also be sent in advance to ndaseminar@ndareg.com
Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.


Registration: RSVP by Tuesday 4th December 2018 to: ndaseminar@ndareg.com

Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372 860 623, or email ndaseminar@ndareg.com

 

We look forward to seeing you there!

 

 

 

What Do Providers Need to Know About Biosimilars?

DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom

With a number of new biosimilars making their way to market and eventually to the clinic, it is crucial that healthcare providers become educated about and comfortable with biosimilar products. During a session at the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, experts addressed a number of key areas for provider education.

Paul Chamberlain, immunogenicity specialist at NDA Advisory Services, spoke about one of the biggest concerns for prescribers who are wary of biosimilars: immunogenicity

Here’s a summary:

Immunogenicity.
According to Paul, it is critical to clarify the definition of immunogenicity, which is an undesirable host immune response to administration of a therapeutic agent. The innate immune response, the adaptive immune response, and immune tolerance are the key drivers of immunogenicity, and product factors (such as glycans, process-related impurities, or process changes) and patient factors (such as comorbidities or concomitant therapy) can impact the balance of those 3 factors.

While it is not feasible to predict how each factor might interact with others to affect immunogenicity, he explained, individual factors can certainly be controlled within acceptable limits. Furthermore, regulators look at both the individual and population level for immune response, and they also require a well-defined risk management plan for a product.

Thus, said Paul, immunogenicity is “the wrong elephant in the room” for prescribers, because physicians typically conflate the incidence of antidrug antibodies (ADAs) with immunogenicity. “Please do not just use ADA rate … as a term which is equivalent to immunogenicity. It absolutely isn’t.”

To illustrate his point, Paul gave the example of CT-P10; in looking at ADA titters between the biosimilar rituximab and its reference, regulators can see that while ADA rates for the 2 products may not appear comparable, the ADA titters overlap very closely. However, he said, few physicians see these reassuring data.

For a more complete picture please see Pauls slide presentation.

To read more about what the experts had to share please click here.

 

 

 

Interactions with the Agencies during development

How to fully leverage on oral explanations and other opportunities to convince EU regulators

Welcome to NDA’s free breakfast seminar on 4th December 8:30 – 10:00

There are many opportunities for bringing your message across to regulators, by interacting with the right EU Agencies at the right time, dependent on the type of product, applicant, procedure and stage of development. Find out whether you’re making the most of all these opportunities to facilitate your drug development program.

Join us to hear Steffen Thirstrup & Rosalind Cox share their experiences and provide their insights.


About the speakers

Professor Steffen Thirstrup: Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority; Committee for Human Medicinal Products Member; Committee for Advanced Therapies member; Chairman of the Committee for Human Medicinal Products Respiratory Drafting Group and Co-Chair of the European Commission Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in EU. Steffen is a NDA expert in clinical development and regulatory strategies.

 

Dr Rosalind Cox: Dr. Cox has held senior positions in European and International Regulatory Affairs within the pharmaceutical industry for 24 years, followed by 8 years at NDA. She is experienced in MAA submissions and other EU procedures such as Scientific Advice (national and EMA), PIP, ODD. Roz specialises in European Regulatory strategy within the context of global development, particularly for development products.

Key messages:

  • Get an overview of the opportunities for interacting with National Regulatory Agencies and EMA throughout development and how to optimise your interactions
  • Learn about procedure and product type specific interactions with special consideration for SMEs
  • By failing to prepare, you are preparing to fail [Benjamin Franklin] – an oral explanation is your ultimate chance to engage with EU regulators in getting your product approved

When: 4th December 2018 | 09:00 – 10:00 | Breakfast from 08:30am – Q&A afterwards

Where: Am Klopferspitz 19a, 82152 Martinsried/Planegg, BioM Seminarraum

The breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Roz & Steffen. Questions can also be sent in advance to ndaseminar@ndareg.com

Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.


Registration: RSVP by Tuesday 27th November 2018 to ndaseminar@ndareg.com

Contact: Nathalie Brodale-Breinbauer, +49 (0) 89 3585 4036 or email nathalie.brodale-breinbauer@ndareg.com


We look forward to seeing you there!

 

Pharmacovigilance Audits and Inspections Summit – November 7, 2018

Shelley Gandhi has been invited to present a session at the Pharmacovigilance Audits and Inspections Summit – November 7, 2018 • Wyndham Philadelphia Historic District • Philadelphia, PA

Her session will cover:
Examine Evolving Global Pharmacovigilance Regulations and the Impact on Audit and Inspection Readiness

As regulations are changing domestically and around the globe, it is important to keep
up to date on the many different regulatory issues (including data integrity regulations)
that affect your audits and inspections. During this session, learn more about current
and pending regulatory developments that affect PV audits and inspections.


LEARNING OBJECTIVES

Align Global Data Collection and Analysis Systems • Ensure Cross -Functional Collaboration and Preparedness • Achieve Accurate and Timely Reporting

  • The volume of audits and inspections is growing rapidly
  • Audits and inspections currently consume an inordinate amount of PV’s time and attention
  • Global PV regulations are incredibly detailed
  • Managing, reviewing and sharing an increasing amount of data is tremendously complex
  • Cross-functional cooperation and seamless collaboration with 3rd parties is critical

ATTENDEE BENEFITS INCLUDE:

  • Understand areas of regulatory focus related to PV audits and inspections
  • Create internal processes and best practices for managing audits and inspections
  • Benchmark with colleagues — Consider ways to work in partnership with regulatory affairs, quality, medical affairs, clinical development and manufacturing
  • Examine ways to efficiently and effectively capture, manage and report on data
  • Consider the future state of PV audits and inspections

Click here to find out more.

 

 

Free Webinar – How to demonstrate value in drug development programs to improve chances of reimbursement

Being able to demonstrate the expected value for health care systems and society for a new pharmaceutical is critical for market access including chances of reimbursement. Having a clear strategy for value demonstration as an integrated part of your drug development program can improve your chances of reimbursement leading to a faster market access. Knowing different payer’s expectations in terms of endpoints and supportive data as well as having an understanding of Health Technology Assessment (HTA) and how this is applied is critical to success.

Join us on Thursday 29th November, at 15:00 GMT, 16:00 CET, 10:00 EST for this engaging webinar where Claes Buxfeldt, HTA Director, will cover the following:

  • The needs/requirements of the HTA bodies and payers in all countries
  • How strategy could be implemented in TPP, value proposition and messages to secure value and reimbursement
  • What activities are needed to investigate and at what stage in development
  • How to:
    • design and improve a clinical development program to satisfy HTA bodies and deliver value for payers
    • design and improve programs to strengthen unmet need and the economic story
    • prepare and improve the ability to communicate the value story and improve payer negotiations skills
    • validate your strategy and plans using the NDA Advisory Board, both regulatory and HTA / payer

The webinar will be followed by a Q&A session for you to get direct feedback on key areas of uncertainty.

Click here to book your place today.

 


Claes Buxfeldt, joined pharma-industry in 1992 and has close to 20 years’ experience working in local and global market access and health economics positions, in a variety of disease areas. Prior to joining NDA Claes spent 10 years at AstraZeneca starting as a Value Demonstration Leader in Global Health Economics & Outcomes Research, and most recently as the Global Price & Reimbursement Director in Respiratory & Inflammation, in addition to CNS/Pain. He has supported more than 30 molecules/brands in development in a global position. He has represented the payer voice in many development programs, including the development of payer evidence strategies, pricing and market access strategy, economic models, PROs, RWE and clinical program input. Claes have a MSc from University of Karlstad and more recently a postgraduate diploma in health economics from University of York.


 

 

NDA Group expands presence in Denmark

In time for the European BIO meeting in Copenhagen, global development consultancy, NDA Group, is expanding the physical presence in Denmark. With the appointment of Katja Gustafsson as Senior Consultant the company will be working closely with clients in the region. The news follows several recent announcements of the company’s expansions in Europe and the US.


Katja is joining NDA’s Professor Steffen Thirstrup, Director of NDA’s regulatory Advisory Board in Copenhagen.

Johan Strömquist, CEO of NDA Group commented: “We’re delighted to be joined by Katja in Copenhagen, further reinforcing our commitment to Nordic life science and the incredible development that we see in the Medicon Valley region. Even though the Nordics is the cradle of NDA and we’ve had a strong presence in the market through our Stockholm office, there is nothing like having feet on the ground when it comes to serving our clients.”

Consultant and client interface

In her role as Senior Consultant, Katja will work closely with companies in the Copenhagen / Malmö / Lund region and act as client liaison, in addition to serving the need for professional regulatory development advice. Together with Prof. Thirstrup, Katja will ensure that the region’s clients gain access to the wealth of intelligence, advice and support represented by the capabilities of the NDA Group. Both Katja and Prof. Thirstrup will be available to meet with companies at the BIO Europe meeting in Copenhagen 5th– 7th November.

Prof. Thirstrup commented: “Copenhagen is my home and I’m delighted to see the vibrant activity in the region. With the expansion of NDA’s capabilities in Denmark we will be able to support the region even better in its growth and innovation. This can only be good news for patients.”
Katja joins NDA from Ferring Pharmaceuticals, where she has spent the last 18 years in different roles in Global Regulatory Affairs. Her previous role was as Associate Director in Life Cycle Management and Urology. Katja has been regulatory lead and team member for several development projects and driving global submissions and approvals for various pharmaceutical products. She has a MSc (Pharm) from the Royal Danish School of Pharmacy.

Margareta Busk, General Manager, NDA Nordics commented: ”Katja’s energy, professionalism and long international experience will be a great asset for the NDA team as well as for our clients. We are very much looking forward to continuing our expansion in the Medicon Valley with her support.”


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

 

 

Recommendations from PRAC – Insights and implementation

Welcome to NDA’s free breakfast seminar Wednesday the 21st of November 08:30 – 09:30

All marketing authorization holders (MAH) are responsible for monitoring and implementing PRAC’s recommendations for signal detection, PSUSA procedures, and referrals, to name a few.

Join us to hear Shelley Gandhi, NDA’s Strategic Advisor of Pharmacovigilance & Patient Safety, share her experience and provide her insights into how PRAC works, how recommendations are decided and how these recommendations are expected to be implemented.


About the speaker

With 19 years experience at the MHRA, and her work with the European pharmacovigilance legislation, has provided Shelley Gandhi with an enormous breadth of experience and knowledge within this area. During her career she has focused on the processes that ensure the safety of medicines and related devices.


When: Wednesday 21st November 08:30 – 09:30. Breakfast from 08:00

Where: NDA Regulatory Service AB, Johanneslundsvägen 2, 2tr, 194 61 Upplands Väsby

The breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Shelley. Specific questions can also be sent in advance to frukostseminarium@ndareg.com

Please advise if you would like to discuss them openly during the meeting; otherwise you can book meetings to discuss them separately after the seminar.


Registration: RSVP by Wednesday 14th November to frukostseminarium@ndareg.com

Contact: Denise Strömquist, Client Relations, Nordics, +46 (0)8 590 778 00 or email frukostseminarium@ndareg.com


Welcome!

 

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!

 

 

 

The future of Health Technology Assessment in Europe

On 24th October, Carole Longson, Dr Steffen Thirstrup & Claes Buxfeldt, NDA Advisory Services Ltd, will be holding a complimentary seminar on market access/Health Economics and Outcomes Research (HEOR), discussing 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.

This seminar will discuss the past, present and future of HTA and market access.

Click here for more details.

 

 

A New Oncology Era

Dr Terese Johansson, Regulatory Consultant, NDA Group has written a new article on tissue-agnostic drug development: A New Oncology Era 

Read about how recent developments in tumourigenesis genomics have paved the way for a molecular marker defining a disease that spans multiple histology-based tumours in a tissue-agnostic manner, in an article written by Terese Johansson, published in European Biopharmaceutical Review October 2018 pages 32-37.

To learn more please click on the brochure below and flick to pages 32-37.

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.

 


 

 

Are you ready for new EudraVigilance requirements?

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited to give a training on Signal Detection Management at Ramada Apollo, Amsterdam Centre, 20 – 21 September 2018.

Key topics that Shelley will cover:

  • Signal Detection Methods Qualitative vs. quantitative assessment of ICSRs
  • Finding a balance between efficiency and ensuring no safety signals go unnoticed
  • Signal Prioritisation differences between small, medium and big pharma
  • Regulatory and Industry Requirements and Standards
  • Quality system requirements: ensuring compliance and identifying gaps
  • New EudraVigilance requirements

Reasons to attend:

  • Get a comprehensive understanding of signal detection strategies
  • Improve and maintain your audit trail
  • Learn about current and future trends in signal collection
  • Hands-On case studies from the trainer‘s experience

To find out more about the event click here.