Webinar – Integrated Product Development for ATMPs to Meet Regulatory and HTA Requirements

Join us on Thursday 3rd October 15:00 BST, 16:00 CEST, 10:00 EDT for this engaging webinar where Dr Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board and Claes Buxfeldt, HTA Director NDA Advisory Board will describe an integrated product development process for ATMPs, which will take key aspects of both reviews into account from the beginning, thus ensuring a positive path from clinical trials up to pricing and reimbursement.

Advanced Therapy Medicinal Products (ATMPs, or cell and gene therapy and tissue engineering products) is an increasing group of innovative products, often targeting diseases and conditions with high unmet medical need.

The success of first CD 19 CAR T products against B-cell malignancies has raised awareness of the high potential of these new products, but also shown the several challenges relating to their manufacturing and regulatory approval. The prices of the first approved ATMPs have been high and not always supported by the national pricing and reimbursement bodies.

In such cases, the discrepancy between regulatory approval and negative result of a health technology assessment (HTA) has raised concerns and questions within the industry, as to how to ensure an approved product also gets to the market and patients. Many jurisdictions have created early access schemes and ways to communicate with regulatory and HTA bodies early on to ensure successful outcomes of both reviews. However, the ATMP industry is facing challenges in both aspects.

Why you should attend:

  • See how the regulatory and HTA expectations differ
  • Learn how to build an Integrated Regulatory / HTA Product Development for ATMPs
  • Identify the need for interactions with regulatory and HTA authorities

Click here to book your place today!


 

Paula 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. Paula 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.

 

Claes joined pharma-industry in 1992, have 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 he 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 has a MSc from University of Karlstad and more recently a postgraduate diploma in health economics from University of York.

 

Robert Kronqvist joins NDA Group as General Manager Nordics

Robert Kronqvist joins NDA Group as General Manager Nordics


 

We are happy to announce and welcome Robert Kronqvist to the NDA team as General Manager for our Nordic affiliate head-quartered in Stockholm, Sweden. Robert brings with him 20 years’ experience from working in the Nordic Life Science Sector.

Working in both large pharma and as the CEO of a smaller biotech has provided Robert with invaluable insights into the industry, allowing him to help NDA’s clients overcome the hurdles of developing and getting novel products to market.

“I am thrilled to join the NDA Group with its strong track record of delivering value to clients” says Robert. “The Nordic innovation and Life Science community is thriving, and I am looking forward not only to supporting our existing clients but also reaching out to new and emerging Biotech companies here in the Nordics and helping them to bring their innovative products to the market with minimal delay.”

As the new General Manager for the Nordics, Robert will be responsible for developing, managing and driving the NDA team and business in the region. With his network and skills NDA’s capabilities will become more available and easier to access to large and small companies alike, than ever before.

“I’m very excited to have Robert join our team” commented Johan Strömquist, CEO of NDA Group. “His sense of focus, pragmatism and long experience from industry will enable us to engage with our clients and their challenges in new and more flexible ways.”

Robert started his career in biochemistry research that he continued at AstraZeneca. There he rapidly took on increased responsibilities and became a trusted leader within CNS & Pain R&D. His main focus was pre-clinical activities and supporting his teams through times of change.

At the close of AstraZeneca’s site in Södertälje Robert stepped in as CEO for BioChromix, one of the companies supported by Karolinska Development.

Since then Robert has both helped the Swedish Police authority develop their processes and practices for DNA analysis for forensics purposes as the head of the biology section and six teams of over 100 staff, and most recently as Director Analytical Development & Head of Quality control at RISE Research Institutes of Sweden.

“Robert’s experience provides us with a great opportunity to expand our reach in the Nordic market and for more clients to discover the many services and options that we have to offer to accelerate their drug development activities” continues Johan Strömquist. “Robert’s background gives our clients the ideal counterpart in NDA, with a thorough understanding of the situation and challenges that they are going through.”

If you would like to know more about our services in the Nordics contact us at info@ndareg.com or  contact Robert direct at  robert.kronqvist@ndareg.com

 

 

 

Pediatric Development – Regulatory Aspects in EU and US

Neither the EMA nor FDA will approve a new drug without the pediatric patient population having been appropriately considered.

This seminar will focus on legislative requirements and pediatric incentives available in both jurisdictions in order to maximise the rewards and avoid delays in registration.


The seminar will provide insight into:

  • The importance of preparing a global pediatric strategy early
  • How to capitalize on the incentives for pediatric research
  • How to avoid unnecessary delays in your drug development program

Presenters

With 20 years of experience from regulatory science, Daniela Gerl and Dr Isabel Schemainda will provide tangible and actionable advice into the requirements for an optimised pediatric strategy.


Agenda

09:00 Registration and complimentary breakfast
09:30 Welcome: Andrea Aschenbrenner, Director Business Development Europe
09:40 Presentation: Pediatric Development – Daniela Gerl & Dr Isabel Schemainda
10:30 Question and answer session
10:50 Concluding remarks

Take the opportunity to book a 20 min slot to speak directly with our experts.
Email munich@ndareg.com


Email: munich@ndareg.com to book your time now.

Date: 16th July 2019

Time: 09:00 – 11:00 (with the opportunity to book 1-1 meetings afterwards)

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

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

Registration: RSVP by Friday 12th July 2019 to munich@ndareg.com

Contact: Thomas Trache +49 8935 854 000

If you are unable to attend, please advise us no later than two days before the seminar.

 

We look forward to seeing you there!

 

 

 

Meet the NDA Group at DIA in San Diego 23-27 June

Optimising the development of innovative medicines

NDA is a world leading drug development consultancy helping clients achieve regulatory and market access success in the US and EU.

Our goal is to streamline the global development and commercialisation process in order to accelerate patient access to important medical therapies.

Over the last 5 years, NDA Group has supported the approval of over 40% of new medicinal products in the EU and among our FDA advisory committee clients 80% have achieved product approval. We work across a range of disease areas including oncology, hematology, infectious disease, metabolic and immunologic disorders and CNS and have supported the development of over 50 rare disease programs.


Presentations by NDA’s experts

Lisa Peluso
Director, Coaching and Client Engagement
Kaia Agarwal
Strategic Advisor and Global Regulatory Affairs Consultant

(Pre-Conference Short Course)
Short Course 3 | Sun, 23rd June- 09:00-12:30
Preparing for a US FDA Advisory Committee Meeting

More information


Lisa Peluso
Director, Coaching and Client Engagement
Steffen Thirstrup
Director NDA Advisory Board

(Pre-Conference Short Course)
Short Course 3 | Sun, 23rd – 13:30-17:00
European Regulatory Meetings: How Best to Prepare and Perform

More Information


Brian Edwards
Principal Consultant, Pharmacovigilance & Drug Safety

Session #106 | Mon, 24th June- 11:00-12:00
Moving forward in EU Pharmacovigilance

Session #155 | Mon, 24th June- 15:30-16:30
Incorporating Systems: Theory and Human factors into the Investigations of Serious Harm in Clinical Research

Session #403 | Thur, 27th June- 09:00-10-15
Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars


NDA supported over 40% of the new medicinal products that were approved in the EU during the last five years.

Do you want your product to reach the world’s two largest markets with minimum delay?

Arrange to meet us at the DIA USA now.

GET IN TOUCH

info@ndareg.com

 

 

Navigating the Regulatory Maze – Initiating Your Phase 1 Trials

Researchers across the globe face common barriers in translational research that can delay the development of new interventions for patients in need.

This seminar, presented by Dr Niamh Kinsella on 2 July 2019 in Cambridge, will focus on describing the strategies and benefits of implementing a stage-gate approach for Phase 1 clinical development.


Benefits include:

  • Clear go no-go decision points
  • Higher probability of success with Phase 1 submissions
  • Clear and favourable exit strategies

Presenter

With 20 years of experience from biologics development, Dr. Niamh Kinsella provides tangible and actionable advice to optimise early drug development plans.

 


Agenda

12:00 Registration and complimentary lunch
12:30 Welcome: Andrew Monaghan, General Manager NDA UK
12:40 Presentation: Navigating the Regulatory Maze – Dr Niamh Kinsella
13:30 Question and answer session
13:50 Concluding remarks
14:00 Coffee and mingle

Take the opportunity to book a 20 min slot to speak directly with our experts.


Email: ndaseminar@ndareg.com to book your time now.

Date: 2nd July 2019

Time: 12:00 – 14:00 (with the opportunity to book 1-1 meetings afterwards)

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

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

Registration: RSVP by Friday 28th June 2019 to ndaseminar@ndareg.com

Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372 860 623

If you are unable to attend, please advise us no later than two days before the seminar.

 

We look forward to seeing you there!

 

 

 

Optimizing Value – Regulatory and Market Access Considerations

Welcome to NDA’s seminar on 21st May 08:30-13:00 on Optimizing Value – Regulatory and Market Access Considerations.

NDA would like to invite you to join Professor Steffen Thirstrup and Professor Mira Pavlovich-Ganascia share their experiences and provide their insights and considerations to optimize the value of your development program.

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.


Agenda:
08:30 Registration and light breakfast
09:00 Welcome – Claes Buxfeldt, Director NDA HTA Advisory Board
09:30 Session one: Challenges on development programs for new drugs – Professor Steffen Thirstrup
10:00 Coffee and mingle
10:30 Session 2: HTA and Europe – where are we heading? – Professor Mira Pavlovich – Ganascia
11:00 Question and answer session
11:30 Concluding remarks and take home messages

12:00 – 13:00 Ask the Experts – Book a 20 min slot to speak directly with our experts, email: frukostseminarium@ndareg.com


About the speakers

Professor Steffen Thirstrup,
Director NDA Advisory Board, Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, and CHMP member. Steffen is an expert in clinical development and regulatory strategies.

 

Professor Mira Pavlovich-Ganascia,
NDA HTA Advisory Board member, practicing physician and former Deputy Director for Health Technology Assessment at the Hauté Autorité de Santé (HAS), France. Mira is an expert in HTA activities related to early dialogues with developers, disease-specific guidelines and methodology of assessment for reimbursement purposes.

Claes Buxfeldt,
HTA Director at NDA Group, former Global Price & Reimbursement Director in Respiratory & Inflammation at AstraZeneca. Claes has 20 years’ experience in the market access and health economic areas and has extensive experience in developing the market access strategy/payer strategy/payer evidence generation for drug development programs from pre-                                            clinical to launch phase.


Learning aspects

  • How to secure value in your development program considering both regulatory and market access requirements
  • Learn about how, when and why it is critical to consider HTA and market access requirements in your development program
  • Understand how to mitigate differences in demands/requirements between regulatory and HTA bodies

When: Tuesday 21st May 2019

Time: 08:30 – 13:00 (opportunity to book 1-1 meetings from 12:00)

Venue: SciLifelabs, Tomtebodavägen 23a, 171 65 Solna, Sweden

The seminar will be an open and interactive workshop with the opportunity to ask our presenters questions.

Specific questions can also be sent in advance to frukostseminarium@ndareg.com. Indicate if you would like to discuss them openly during the meeting; otherwise we can book separate meetings to discuss them after the seminar.

Registration: RSVP by Friday 17th May 2019 to frukostseminarium@ndareg.com

Contact: Denise Strömquist, Marketing and Management Coordinator, +46 (0)8 590 778 00, or email frukostseminarium@ndareg.com

The seminar is free however if you are unable to attend, please advise us no later than two days before the seminar.

 

We look forward to seeing you there!

 

 

Interactions with Agencies During Drug Development

Welcome to NDA’s free Lunch seminar on Tuesday 30th April 12:00- 14:00 on Interactions with Agencies During Drug Development

There are many opportunities for bringing your message across to regulators, by interacting with the right EU Agencies at the right time, depending 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.


About the speakers

Professor Steffen Thirstrup

Director NDA Advisory Board, Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, and CHMP member. Steffen is an expert in clinical development and regulatory strategies.

 

Dr Rosalind Cox
Principal Consultant NDA UK, formerly Divisional VP with Abbot. Roz specialises in European Regulatory Strategy and Global Development.

 

 


LEARNING ASPECTS:

  • Get an overview of the opportunities for interacting with National Regulatory Agencies and EMA throughout development and how to optimise your interactions
  • Learn about procedures 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: Tuesday 30th April 2019

Time: 12:00 – 14:00 (opportunity to book 1-1 meeting afterwards)

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

The lunch seminar will be an open and interactive workshop with the opportunity to ask our presenters questions.

Specific questions can also be sent in advance to ndaseminar@ndareg.com. Indicate if you would like to discuss them openly during the meeting; otherwise we can book separate meetings to discuss them after the seminar.

Registration: RSVP by Friday 26th April 2019 to ndaseminar@ndareg.com.

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

The lunch seminar is free. If you are unable to attend, please advise us no later than two days before the seminar.

 

We look forward to seeing you there!

 

 

 

Interactions with Agencies During Drug Development

Welcome to NDA’s free Breakfast seminar on Wednesday 20th March 08:30- 10:00 on Interactions with Agencies During Drug Development

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, Director NDA Advisory Board member, formerly Division Head at the Danish Medicines Agency and CHMP member share his experiences and provide his insights into making the most of the opportunities to interact with EU Agencies during the drug development process.


LEARNING ASPECTS:

  • Get an overview of the opportunities for interacting with National Regulatory Agencies and EMA throughout development and how to optimise your interactions
  • Learn about procedures 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: Wednesday 20th March 2019

Time: 8:00 – 8:30 Breakfast, 8:30 – 10:00 Presentation, 10:00 – 12:00 meet with NDA experts

Venue: SciLifeLab (Air & Fire at ground floor) Tomtebodavägen 23A, Solna, Sweden

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

To book a meeting with our experts after the seminar please write 1-1 meeting and specify the topic and participants from your company in the registration email. You will recieve a confirmation email with the time slot for your meeting.

Registration: RSVP by Friday 15th March 2019 to frukostseminarium@ndareg.com

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

The breakfast seminar is free. If you are unable to attend, please advise us no later than two days before the seminar.

 

We look forward to seeing you there!

 

 

 

Passionate about solutions for patients with rare diseases

 

1 in 20 people will live with rare disease at some time in their life*.

Johan Strömquist CEO NDA says: “There are more than 6 000 identified, untreated rare diseases in the world. A lot has been done in recent years to address this by regulators and innovators but for many it is still not enough.”

At NDA much of the work we do go into supporting companies working to address this. We care passionately about this work and about getting treatments to the patients affected. Rare Disease Day is our opportunity to show this to the world and to promote the vital work that is going on in this space by so many passionate patients, physicians and scientists.


What is Rare Disease Day?

Rare Disease Day was first launched by Eurordis and its Council of National Alliances in 2008 with the goal to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. 1 in 20 people will live with rare disease at some time in their life but despite this there is no cure for the majority of rare diseases and many go undiagnosed.

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.

Laurie Smaldone Alsup, MD, CSO and CMO of NDA says: “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.”

She continues: “For me Rare disease day is a call to arms to create awareness of the continued need to address serious rare disorders to improve and extend patients’ lives.”

The theme of 2019 – Bridging health and social care

The theme for this 2019 Rare Disease Day is ‘Bridging health and social care’ For most people living with a rare disease, as well as their family members or carers, the reality of daily life can include any combination of the following: collecting and taking medicines, attending appointments, participating in physical therapy, using specialist equipment and accessing various social and community support services and respite care. Managing these care-related tasks alongside their usual daily activities such as work, school and leisure time can be challenging.

In support of patients with rare disease

2018 Rare Disease Day theme, ‘Patient Involvement in Research’, helped to underpin the importance of including patients in the drug development process.

Dr. Markku Toivonen, MD, Scientific Director at NDA, former CHMP member and Chairman of EMA’s Scientific Advice Working Party comments:
“The development of patient advocacy and the involvement of patients in the development and regulatory process has truly been game changing. 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. ”

Markku continues: “Personally, it has been a privilege to participate in Eurordis Summer School for patient experts, advocates and researchers annually over the past 10 years as one of the trainers. Based on the candid feedback Eurordis has received over the years, the enthusiastic and highly motivated participants with varied backgrounds have benefited from the interactions with peers. They have returned home with new tools to help them in their endeavors and to navigate in the maze of science, medicines development, licensing and real-world challenges. It has been a pleasure to meet many of them again over the years, and to see how they have contributed at various levels from new medicinal product development to regulatory authority activities and overcoming the ultimate hurdle: access to treatment.”

* www.rarediseaseday.org

 

 

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

Welcome to NDA’s free Breakfast seminar on Thursday 14th March 09:00- 10:30 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: Thursday 14th March 2019, breakfast from 09:00, presentations start at 09:30

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

The Breakfast 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: By Tuesday 12th March 2019 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!

 

 

 

Seasoned drug development professional Kim Forbes-McKean PhD to lead NDA Group’s US expansion

Kim Forbes-McKean PhD, joins NDA Group from a distinguished career spanning more than 30 years of leading research and development activities for large pharma, as well as small biotech companies.


“Kim brings with her tremendous experience of the challenges facing development companies all over the world,” commented Johan Strömquist, CEO NDA Group.
“I am very happy and proud to have her join the NDA Group management team to further expand our activities in the US and I believe her expertise and experience will be of great value to our clients.”

Prior to joining NDA Kim was responsible for worldwide development of dermatology products at various companies including, Rhône-Poulenc Rorer, Aventis-Sanofi and Aqua Almirall, overseeing seven successful regulatory approvals and product launches.

She co-founded a dermatological development company and has been an executive member of management teams who have successfully raised over $90 million to support business development, licensing objectives and drug development activities which lead to partnering or acquisition opportunities.

Kim has built and led teams across all phases of development to advance global drug and device programs as well as for support and maintenance of commercial products. She has extensive experience and has served as a company representative directly interacting with the FDA throughout the development and approval process.

“In Kim, not only do we have an accomplished scientist and strategic regulatory thinker, but an experienced business professional who has been in our clients’ shoes,” commented Laurie Smaldone-Alsup, CSO/CMO NDA Group. “Kim understands the pressures and priorities of large pharma as well as small biotechs and the trade-offs facing CEOs and drug development executives on a daily basis. I am delighted to welcome her to our team. “


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

NDA media contact:
anna.perrin@ndareg.com

 

 

 

Meet NDA at DIA Europe 2019

 

We will be attending in full force during this year’s DIA Europe 2019 – 5 – 7 February 2019| Austria Center Vienna

If you are planning to be there, we would really like to meet up with you!

You can find us throughout the event at booths: B71 & B72 where we have a range of experts covering the full regulatory affairs spectrum – from preclinical and clinical to pharmacovigilance and health technology assessment – all of whom are looking forward to meeting you:

  • Professor Beatriz Silva Lima, Non clinical Expert
  • Professor Steffen Thirstrup, Clinical development and regulatory strategies Expert
  • Lisa Peluso – Director, Coaching and Client Engagement
  • Shelley Gandhi, Ex MHRA regulator, Pharmacovigilance & Drug safety Expert
  • Dr Mira Pavlovic – HTA Expert
  • Brian Edwards – Principal Consultant, Pharmacovigilance & Safety

In addition, there will be other NDA’s expert consultants attending the event and happy to help.

We definitely recommend booking a meeting in advance to ensure availability, but do feel free to pop by booths B71 & B72.

If you would like to arrange a meeting, please contact my colleague Anna Perrin who will be happy to assist: Phone +44 (0) 1372 860 610 or Email anna.perrin@ndareg.com


Sessions

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

Please look out for them:

Prof. Steffen Thirstrup – Director and Medical Advisor, NDA Regulatory Advisory Board
Lisa Peluso – Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
#SC02: Short Course 2 | Mon, 4th February – 14:00

European Regulatory Meetings – How to Best Prepare and Perform


 

Prof. Beatriz Silva Lima – Non Clinical Expert, NDA Regulatory Advisory Board member
#SP01: | Weds, 6th February – 15:15
Nanomedicines and Nanosimilars – Implications for Regulators, Payers and Prescribers Regulatory Considerations for the Approval of Nanomedicines and Nanosimilars

Hub 1 #CH104 | Thurs, 7th February – 09:15
Patient-reported, Patient-relevant, Patient-centred outcomes: definitions, roles and importance for health technology assessment

#S0206: | Thurs, 7th February – 10:45
Regulatory Innovation: Regulatory Science

 


Dr Mira Pavlovic – HTA Expert, NDA Regulatory Advisory Board member
Hub 1 #CH104 | Thurs, 7th February – 09:15
Patient-reported, Patient-relevant, Patient-centred outcomes: definitions, roles and importance for health technology assessment

 


Shelley Gandhi – Strategic Advisor, Pharmacovigilance & Drug Safety
#S0307 | Thurs, 7th February – 12:00
Capacity Building and Capability Building in Pharmacovigilance

 

 


Poster Presentation:

Brian Edwards – Principal Consultant, Pharmacovigilance & Drug Safety
Hub 2 | Tues, 5th February – 13:00
CAST analysis of UK pregnancies reported after isotretinoin administration

 


Click here to download the Preliminary Programme.


 

Meet us at DIA Europe 2019

To book a meeting contact Anna Perrin: anna.perrin@ndareg.com or visit us at booths B71 & 72.

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

 


 

 

NDA Group further expands their Advisory Board

Dr Patrick Salmon former Senior Medical Assessor at the Irish Medicines Board has joined NDA Advisory Board.


Dr Salmon is an expert in clinical development, strategies and a specialist in pharmaceutical medicine, with almost 25 years regulatory experience at both national and EU level.

His in depth regulatory expertise in rare diseases and other special therapeutic areas such as ophthalmology and the interrelated working of EMA’s committees and the CMDh will be a superb asset to the Advisory Board.

Dr Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:

“I’m very happy to welcome Dr Patrick Salmon on board as our newest Advisory Board Member. His expertise in regulatory affairs, clinical development and orphan medicinal products will be of tremendous value to our clients, enabling us to help them succeed in bringing their new medicinal products to the market”.

His previous roles include: Former Senior Medical Assessor at the Irish Medicines Board, (the Health Products Regulatory Authority), Committee for Human Medicinal Products Member (previously CPMP), Ireland, Committee for Orphan Medicinal Products Member Ireland, chair of CHMP ad hoc SmPC working party, chair of CMD(h) subgroup on SmPC Harmonisation and chair of working Group on Radiopharmaceuticals.

Dr Salmon has joined and is now part of 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

 


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

 

 

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, UK

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!

 

 

 

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, Munich, Germany

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!