Webinar – Demonstrate, Communicate and Negotiate Successfully with Payers

Join us on Thursday 12th of December 15:00 GMT, 16:00 CET, 10:00 EST for this engaging webinar presented by Claes Buxfeldt, HTA Director NDA Advisory Board and Lisa Peluso, Director of Coaching and Client Engagement, PharmApprove.

Advanced medical treatments, including cell and gene therapies, are on the cusp of changing medical care around the globe. Developing and communicating cutting-edge science demands rigorous planning to mitigate challenges and set up your product for successful market access.

New treatments are complicated and competition is fierce. Are you planning appropriately to demonstrate the data you need, communicate effectively and be in a position to negotiate successfully with payers? Join this informative webinar to hear from HTA and Value Communications experts Claes Buxfeldt and Lisa Peluso on how to:

  • Steer development teams to demonstrate value, manage uncertainty in data and leverage external advice
  • Educate stakeholders early – from your internal team to payers – to ensure alignment and clarity around value and positioning
  • Create and deliver the clinical narrative of the data
  • Communicate complex data and science effectively and handle objections with confidence
  • Negotiate successfully with decision-makers

Waiting until submission time to align and prepare to communicate value is a mistake your team can’t afford to make. Sign up for this webinar to hear how to communicate impactfully to clear a path for a successful value journey to patients.


Click here to book your place today!


 

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.

Lisa helps development teams, doctors, patients and advocates to create and deliver clear, consistent, and convincing messages to regulators in the US and Europe. Lisa has coached hundreds of individuals and provided presentation/Q&A training and workshops to teams in pharma and biotech, and has helped over 45 clinical development teams prepare to present at FDA Advisory Committee meetings and EMA Oral Explanations. Her experience and familiarity with high-stakes regulatory meetings allows her to get to the heart of the challenge, and she excels at giving presenters and responders clear and actionable feedback, to instill confidence and help them communicate with clarity and impact. Prior to joining PharmApprove, Lisa worked at Kyowa Pharmaceuticals, where she supported both commercial and clinical teams and served as the principal liaison between the Tokyo, UK and US offices. Lisa spent 12 years in Japan, where she worked in communications in the legal, financial and hospitality industries.

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.”


 

What do we need to know before the next influenza pandemic?

Dr Pieter Neels

NDAs Advisory Board member and vaccines expert Pieter Neels together with a group of scientific and public health experts and key stakeholders convened for the 2nd International Alliance of Biological Science (IABS) to review the status of the current knowledge regarding the relationship between narcolepsy and the administration of the adjuvanted pandemic influenza vaccines, with the goal of being prepared for the next influenza pandemic.

The result of the discussions have been documented in the report: Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic?

The highlights from the report include:

  • The association between the reported influenza vaccine and narcolepsy has been consistent in the countries in which it has been studied.
  • There are no clear associations observed between development of narcolepsy and the other pandemic adjuvanted vaccines.
  • The public health response during a pandemic is critical.
  • International collaboration and the capacity for data sharing should exist before the next pandemic.
  • Research on narcolepsy therapy should be supported and clinicians skilled in management should be available.

To read the report in full click here.

 

Meet the NDA Experts in October

October is a busy month for our NDA experts and there are plenty of opportunities to meet them and discuss your challenges within regulatory and drug development.

We are participating in several events across the globe. If you would like to book a time to speak with one of our experts, contact us!

 

Niamh Kinsella, Andrew Monaghan and Helen Measures
are attending:

Topra Annual Symposium

Where: Dublin, Ireland

When: 30th Sep – 2nd Oct

Booth: # 32

 

 

Laurie Smaldone Alsup
MD, CSO/CMO NDA Group, is chairing a panel session at:

LSX World Congress USA

Where: Convene Convention Center, Boston, USA

When: 7th – 8th Oct

Session: Executive Panel: De-risking the Regulatory Approval Path – How to Optimize you Investment Dollars

Christian Redondo-Müller and Andrea Aschenbrenner
are attending:

European Biotech and Pharma Partnering Conference 

Where: Osaka, Japan

When: 8th Oct

and

Bio Japan 2019 

Where: Pacifico Yokohama, Japan

When: 9th – 11th Oct

Booth: D 53-6

Brian Edwards
Principal Consultant, Pharmacovigilance & Drug Safety NDA Group, is speaking at the:

DIA Learning Course

Where: Basel, Switzerland

When: 14th – 15th Oct

Session:  The Pharmacovigilance Quality Management System

Barbara Clendenen and Alison McGregor
are attending:

Bio Investor Forum

Where: San Fransisco, California

When: 22nd – 23rd Oct

Thomas Lönngren
Strategic Advisor NDA Group, is speaking at:

AusBiotech 2019 

Where: Melbourne, Australia

When: 30th Oct – 1st Nov

Session: Best practice biotech – Building your board

 

If you are interested in booking one of our experts to speak at your event, contact us.


 

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!

 

 

 

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