Optimizing Value – Regulatory and Market Access Considerations

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.

In this seminar our presenters will share their experiences and provide their insights and considerations to optimize the value of your development program.


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

Presenters: 

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

 

 

Stephanie Krumholz, General Manager of the Swiss NDA Affiliate with a demonstrated history of working in the pharmaceuticals and biotech industry across multiple therapeutic areas in all phases of drug development. Expertise in EU, US and Swissmedic Marketing Authorisation Filings and conducting Due Diligence for clients.

 

 

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 HTA 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.

 

 


Agenda

09:00 am  –  Welcome – Claes Buxfeldt, Director NDA HTA Advisory Board and Stephanie Krumholz, General Manager NDA Switzerland
09:15 am  –  Session 1: Challenges in drug development – Professor Steffen Thirstrup
10:15 am  –  Coffee break
10:35 am  –  Session 2: HTA and Europe – where are we heading? – Professor Mira Pavlovich – Ganascia
12:05 am  –  Concluding remarks and take home messages
13:15 – 15:30 pm  –  Ask the Experts – To book a 20 min slot to speak directly with our experts send an email to anna.perrin@ndareg.com


Date: Tuesday 3rd of December 2019

Time: 09:00 am – 12:15 pm (with the opportunity to book 1-1 meetings from 13:15)

Venue: Bio-Technopark, Auditorium, Wagistrasse 25, 8952 Schlieren

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 zurich@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 29th November 2019 to zurich@ndareg.com

Contact: Stephanie Krumholz, General Manager Switzerland, +41 78 951 9929, or email s.krumholz@ndareg.com

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

 

We look forward to seeing you there!

 

 

 

The future of NDA in the Nordics

 

NDA has a new general manager


In August this year Robert Kronqvist joined the NDA team as General Manager for the Nordics. With his background from large pharma, small biotechs and research institutions he is bringing a plethora of experiences with him to the NDA team in the Nordics.

Through this short interview we tried to figure out what makes him tick.

 


 

You have worked for the best part of your career in life science. Tell us a little bit about what motivates you.

“Thank you! It’s great to have the opportunity.

To begin with I’ve always found life science and pharmaceutical development fascinating. Working in as diverse contexts as large pharma, where I’ve spent a significant part of my career at AstraZeneca, and then seeing things from both a small biotech and research institute perspective, I feel I’ve got a great breadth of experiences.

What ties them all together though is the wish to make a difference, and in drug development you really can make a difference – both every day at work, but of course at the end of the day for the patients we serve.”

So, what is the biggest difference between working at a large company and then taking over as CEO in a small biotech?

“Well, one of the most obvious differences is of course the access to resources. In a large pharma you have resources and capabilities that have been built up over many years relatively easily accessible, whereas in a small company you have to find partners and different ways to collaborate to get the different aspects of drug development covered.”

“It’s not uncommon to bring in different people to satisfy specific and very discreet needs in a small company, just because you have that need right there and then. There is always a risk that continuity will suffer from that, or that there are challenges with knowledge management across collaborators. In that respect it’s great that we have such an incredible breadth and depth of expertise here at NDA, since this gives so much expertise in one provider.”

How would you describe the Nordic Life Science scene right now?

“Nordic Life Science is quite remarkable, even though it certainly has its challenges. We have a very strong reputation of high-quality science and innovation in this corner of the world. We are also pretty good at taking science from academia and spinning out companies to take this forward, but we struggle more when it comes to financing of and doing good drug development when we reach those stages.”

“I think the situation for the industry has changed quite a bit in the last ten years. Both because we’ve got a good tradition and track record in spinning out innovation, but also because of large pharma’s increased willingness to rely on external innovation and in-licensing to fuel their pipelines.”

It seems like there are a few important hubs across the Nordics. Is this a trend you think will continue?

“Yes, I think so. Part of the explanation to the origin of these hubs comes from large pharma who have left or even continue to contribute to expansion of infrastructure in very specific locations that are attractive to smaller biotechs. But regardless of whether there is infrastructure in place or not we need proximity, partnerships and networks to build a creative environment for science and innovation to flourish.”

 

How do you think the Nordic Life Science scene will develop over the next couple of years?

“In two years’ time I believe we will see a number of the biotech companies with promising treatments will have achieved important scientific milestones as well as increased financing. With the current influx of biotech clients, I also believe that NDA as a consultancy company will have been able to have an even greater impact on the development of good medicines in the region.”

Speaking of which, what do you think that NDA will be able to contribute to the small biotechs?

“I think it’s a matter of providing coaching and guidance. We have so much experience from helping companies from all over the world optimize their development programs and it offers us a fantastic opportunity to bring this experience to the Nordic market.

This can provide such great benefits to companies, both in terms of plotting their route to market to enable good execution of their development activities, and, if they are contemplating earlier stage exits, to make sure that they get maximum value out of any out-licensing deal that they might be considering.”

Based on your experiences, what do you think that you can bring to small biotechs as a part of NDA?

“I think it’s really two things. Firstly, I have a lot of experience that is highly relevant to the small biotech company’s situation. As a CEO of one of the companies out of Karolinska Development’s portfolio I’ve been there and seen what it is like.

Secondly, I’ve got a pretty good network by now. This will be beneficial both because I know many companies out there that will benefit from the support that NDA can offer, but also because science and innovation really is a team sport and identify the right players for your team requires a large network. This is something that I can help with.

These two things coupled with a great commitment and enthusiasm for drug development is really what I think I can contribute with.”

What do you see as NDA’s greatest challenge in the Nordic region?

“I believe strongly that we have some fantastic opportunities engaging with small biotech companies in the Nordic region, supporting their development and augmenting their capabilities. That said, we have for the past ten years been an incredibly international company with our client facing people spending almost more time in the United States than here in our home markets.

I think that this has created the perception that we are not interested in supporting our local biotech scene, something that couldn’t be further from the truth. The fact that we have been very international and learned a lot from companies from all around the world is of course fantastic, but the perception that we are not available for our colleagues here in the Nordics is a challenge. I will work a lot on ensuring that we are present – that we are visible here at home – and that we are available, flexible and responsive. I think all those things will be necessary for us to be allowed to share our experiences in the Nordics.

I am really looking forward to the opportunity to meet with and get to know more of our colleagues in the Nordic Life Science community to learn more about their thoughts and needs so we can find ways to support in an optimal way.”


 

Let’s celebrate the launch of our new service: NDA Accelerator!

On the 21st of October we will be launching our new NDA Accelerator service in The Nordics and we think this is well worth celebrating, so why not join our team on Friday the 18th of October for drinks, snacks and networking of course.

Date: 18th October 2019
Time: 16:15 – 18:00
Place: 7A Centralen, Vasagatan 7, Stockholm
On the menu: Champagne and snacks

For more information and to register email denise.stromquist@ndareg.com

NDA Accelerator
Our NDA Accelerator is a unique resource to support small biotech companies in The Nordics. It brings together specially designed services, unique thought leadership and personal and team training opportunities in one place all created with needs of small biotech companies as the focus. NDA Accelerator allows you to do more with the resources you already have.

To learn more and register your interest click https://teaser.ndaaccelerator.com/

 

 

Navigating the Regulatory Maze – Early Stage Development Strategies

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

This seminar will focus on describing the strategies and benefits of implementing a stage-gate approach in early non clinical development and for Phase 1 clinical development.


Benefits include:
  • Clear go no-go decision points
  • Higher probability of success moving from non clinical to clinical phase
  • Clear and favourable exit strategies

Presenter: Dr. Niamh Kinsella

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

 


Agenda

10:00 am    Registration and coffee
10:30 am    Welcome: Dr. Stephanie Krumholz, General Manager NDA Switzerland
10:40 am    Presentation: Navigating the Regulatory Maze – Dr. Niamh Kinsella
11:30 am    Question and answer session
11:50 am    Closing remarks
12:00 pm    End of seminar

13:30 – 17:00 Take the opportunity to book a one to one 30 min meeting to speak directly with our experts.

Email zurich@ndareg.com to book your time now.


Date: 31st October 2019

Time: 10:00 am – 12:00 pm (with the opportunity to book 1-1 meetings afterwards)

Venue: Bio-Technopark, Auditorium, Wagistrasse 25, 8952 Schlieren

The seminar is held in collaboration with Bio-Technopark® Schlieren-Zürich and will be an open and interactive workshop with the opportunity to ask questions. Specific questions can be sent in advance to zurich@ndareg.com

Registration: RSVP by Friday 25th October 2019 to zurich@ndareg.com

Contact: Katharina Gerstl at katharina.gerstl@ndareg.com

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

 

We look forward to seeing you there!

 

 

 

Global capabilities for local growth

In this commentary, NDA’s Johan Strömquist and Thomas Lönngren provide their reflections on the unique opportunities the Nordics present for the Life Science Sector.


Nordic life science has been on a roller-coaster for the last twenty years. It was at the epi-centre of the creation of some of the world’s most successful pharmaceutical companies, such as AstraZeneca, Pharmacia, Novo Nordisk, Leo and Lundbeck. The downsizing and movements of the Swedish giants left a vacuum in the region that was hard to fill.

It has taken until now for the Life Science community to stage its comeback to the world stage. This time however, the success does not belong to one or two big companies, but to hundreds of small, agile and innovative biotechs. The problem these smaller companies have faced has been funding to allow them to properly develop and commercialise their innovations. But even in this arena, we see that great strides are being taken to address the challenges.

We are quickly approaching the four-year anniversary of the announcement that Janssen licensed one of Alligator Bioscience’s early stage immune-oncology agents for a sizeable amount. Last year Wilson Therapeutics was acquired for a whooping SEK 6.6 billion and AstraZeneca invested heavily in SOBI. This year we’ve seen significant scientific and/or financial successes from smaller companies such as Cantargia, Xbrane, Immunicum, Cereno Scientific and Xintela and more biotechs than ever have found their way to the stock market via Stockholm Nasdaq.

However, using the capital that this success unlocks comes with its own challenges. How should a small biotech prioritise and use the capital in an optimal way to ensure success and that scientific advances are within parameters that are both approvable and reimbursable?

For over twenty years NDA has worked to support companies overcome these hurdles and make sure that precious resources are used to optimise the outcomes.

Says Johan Strömquist, CEO NDA Group:

Johan Strömquist CEO

“The Nordic life science community is remarkable – it is resilient, innovative and able to create a lot from very little. What I see right now is incredibly exciting and encouraging – significant strides in cross-company and cross-border collaboration.”

He continues:

“Through organisations like Sweden BIO, Medicon Valley Alliance and, more recently, the LSX Nordic Congress in collaboration with Stockholm Nasdaq, I see companies getting together to discuss common concerns. As a trusted international advisor, we have a unique opportunity to bring learnings from all over the world into the Nordic life science scene for the benefit of everyone.”

 

NDA’s Strategic Advisor, Thomas Lönngren, formerly Chief Executive of the European Medicines Agency, agrees:

Dr. Thomas Lönngren

“The US remains the most important development region for new medicines in the world. How do they do it? By bringing everything together – capital, universities, hospitals, entrepreneurs and large companies. Just look at Boston; you have everything within walking distance!”

He continues:

“Though the goal may not be to emulate the American success story 100% the movements we see toward more collaboration and cross-fertilisation is very positive. We have strong academia and are very good at spinning out companies in the Nordics. Now we just need to improve the way we develop new medicines so they can reach the market and the patients that need them consistently to make the Nordics an important hub of drug innovation.”

To learn more about our services and how we can help click here

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!

 

 

 

Bienvenido a Miami!

 

NDA will be presenting at Phacilitate, the world’s largest advanced therapies partnering event which will be held from 22nd – 25th January 2019. Phacilitate attracts over 2,000 attendees, 150 exhibitors and 300 speakers representing every major stakeholder group. Could there be a better reason to visit Miami?

If three and a half days of presentations, panels and roundtables aren’t enough, there is also a host of extras you can get involved in outside of the conference rooms, including a Birthday party. Phacilitate celebrates its 15th birthday after the Super Plenary on the evening of Tuesday 22nd January – and don’t forget the yacht party fund raiser on the 24th!

In this three part series leading up to the event itself, members of the NDA team will give an insight into why this event is a must for them.

Having presented at last year’s event Paula Salmikangas, Director of Biopharmaceuticals and ATMP, NDA Group, gives us a brief glimpse into why she has returned to the podium:

“Phacilitate meetings have always raised wide interest within the cell and gene therapy community. Experts from industry, academia and regulatory agencies gather together to share the latest information, celebrate success stories and discuss emerging challenges.” 

She continues: “I was excited to see the conference program for 2019 since it is full of timely and interesting topics. And of course I wouldn’t miss the opportunity to with meet old friends and (hopefully) make new ones!”

Don’t miss the opportunity to attend Paula’s sessions:
24-Jan-2019 – 08:45 to 08:50 AM: Chair’s Introduction: Achieving global scale in advanced therapies: harmonizing regulatory environments around the world

24-Jan-2019 – 11:20 to 11:35 AM: How Quality Target Product Profile (QTTP) can support quality control of ATMPs

To find out more about this event please click here.

We look forward to seeing you at the event!

 

 

 

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!