Meet the NDA experts in March

March is a busy month for our NDA experts and there are plenty of opportunities to meet them and discuss.

This month 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!

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

GCC Pharma Regulatory Summit

Where: Oberoi Hotel, Dubai, UAE

When: 13th – 14th March

Session: Pharmacovigilance Training

Lisa Peluso
Director, Coaching and Client Engagement is speaking at: 

DIA Medical Affairs and Scientific Communications Forum

Where: Loews Sapphire Falls Resort, Orlando, Florida, USA

When: 18th – 20th March

Steffen Thirstrup
Director, NDA Advisory Board is speaking at: 

3rd Annual Nordic Precision Medicine Forum

Where: Hotel Birger Jarl, Stockholm, Sweden

When: 18th – 19th March

Session: Examining the Influence of Current Regulatory Frameworks in Facilitating the Progress & Implementation of Precision Medicine

Steffen Thirstrup
Director, NDA Advisory Board is also key speaker at NDA’s breakfast seminar: 

Interacting with the Agencies during drug development

Where: SciLifeLab, Tomtebodavägen 23A, Stockholm, Sweden

When: 20th March

Paula Salmikangas
Director of Biopharmaceuticals & ATMPs, NDA Advisory Board is speaking at: 

EBMT – 45th Annual Meeting of the European Society for Blood and Marrow Transplantation

Where: Messe Frankfurt, Frankfurt, Germany

When: 25th – 27th March

Session: Regulatory issues of genetically modified cells

Thomas Lönngren, Andrea Aschenbrenner & Monika Eck-Schaupp
are attending: 

Bio Europe Spring

Where: Messe Wien Exhibition and Congress Center, Vienna, Austria

When: 25th – 27th March

Paul Chamberlain
NDA Advisory Board is speaking at: 

17th Biosimilar Conference, Medicines for Europe

Where: Hotel Okura, Amsterdam, The Netherlands

When: 28th – 29th March

Session: Biosimilarity demonstration & regulatory fitness-for- purpose towards a tailored approach to comparative clinical trials


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


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.


  • 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

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

Contact: Denise Strömquist, Client relations Nordics, +46 (0)8 590 778 00, or email

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!




Design and optimisation of a quality target product profile for ATMPs

The quality target product profile (QTPP) is an inherent part of product development and provides an overview of all the elements that have an impact on the quality, safety and efficacy of the product in a given clinical indication. The concept is defined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guideline Q8 and may be more familiar for those developing conventional pharmaceuticals.

However, it also provides an excellent tool for advanced therapy medicinal product developers and should be used to consider all elements that have an impact on the ultimate quality of the product and, consequently, the safety and efficacy in clinical and commercial use. Building up the QTPP should start at the research phase and continue up to the marketing authorisation application (MAA) phase; if it is put together properly and regularly updated, it provides the skeleton for the entire chemistry, manufacturing and control module of the MAA.

To find out more read the full article written by NDAs Director of Biopharmaceuticals and ATMPs Paula Salmikangas. The article is also featured in Regulatory Rapporteur – Vol 16, No 2, February 2019.



By Paula Salmikangas – Director of Biopharmaceuticals and ATMPs, NDA Advisory Board






Rare Diseases and FDA Advisory Committees: Be the Experts in the Room

checkWhen it comes to advisory committees that are convened for rare diseases, everyone must become an ‘educator’. This includes the applicant, external experts and open public hearing participants.

By definition, a disease is considered rare if it affects fewer than 200,000 people in the United States. However, an estimated one in ten Americans has a rare disease and about one third of all new drugs approved by FDA are now for rare diseases. In fact, in 2017 the FDA approved a record 80 new treatments for are diseases.

Whenever an FDA advisory committee is convened as part of the approval process, the stakes are high and there can be communication challenges. However, for applicants preparing for an advisory committee that is for a rare disease, the challenges are unique.

Read the full article written by Neelu Agrawal, expert in high stake meeting preparations, including FDA Advisory Committees, Oral Explanations, and Scientific Advisory Groups, to learn about some of those challenges, along with key factors for success.




By Neelu Agrawal – Principal, NDA Group/PharmApprove







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.”




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.


  • 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  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:

Contact: Nathalie Brodale-Breinbauer, +49 (0) 89 3585 4036 or email


We look forward to seeing you there!




Effective presentation of immunogenicity related data in regulatory dossiers

NDAs Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert and NDA Advisory Board member, provides practical advice about how to present immunogenicity-related information in regulatory dossiers, with a particular focus on a model for an Integrated Summary of Immunogenicity to be submitted in the marketing authorization application for novel biopharmaceutical products in ICH regions (EU, USA and Japan) in the latest publication of Bioanalysis.

A format that links the analysis of potential risk factors to a justification of the methodology applied for risk evaluation and conclusions for riskmitigation is presented as a model that can be adapted according to the weight of evidence to be submitted in support of the assessment of impact on overall clinical benefit versus risk for the particular situation.




If you are interested in hearing more from Paul he will be presenting at the following events in March:

DDF Summit on; Biosimilars – Regulatory Primer for Formulation Scientists 12th March in Berlin. To learn more click here.

NDAs breakfast seminar; Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind, 14th March in Munich. To learn more and to sign up for the event click here.



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.

NDA media contact:




Free Webinar – Brexit Impact: Are you ready?

The current political turmoil in the UK surrounding Brexit is causing confusion and uncertainty across the board. With so much uncertainty, how can the Pharmaceutical and Life Science sector prepare for the upcoming changes? With less than two months to go until the 29th of March, solutions and plans need to be put in place.

Join us on 14th February at 15:00 GMT, 16:00 CET, 10:00 EST for this engaging webinar where Thomas Lönngren, Strategic Advisor, and Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety will discuss the following:

  • What are the changes that are relevant for the industry?
  • Which processes need to be examined for the necessary changes?
  • What solutions are available to facilitate these changes?

Although no one can pretend to have a crystal ball and predict the outcome of Brexit, there are practical arrangements that can be put in place to protect the legal status of your marketing authorisation and authority to operate in the EU!

This webinar will enable you to reflect on how well your own plans are progressing and what more needs to be done.

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

Click here to book your place today!

Thomas Lönngren, Strategic Advisor, NDA Group
Former Executive Director of the European Medicines Agency (EMA).

Dr Brian Edwards, Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group,
GMC registered physician with previous experience in hospital, renal medicine and clinical research, as a pharmacovigilance assessor in the UK regulatory authority (MHRA), clinical trials and post-marketing pharmacovigilance in a global CRO, deputy QP for pharmacovigilance at Johnson & Johnson.



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


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: 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!




The JP Morgan week – The patients we serve!

In our fourth and last post leading up to the JP Morgan week all three of our NDA attendees share the most important reason that keeps them attending.

Reason 4 – The patients we serve

Catching trends, engaging with the biotech community and bumping into friends and strangers alike are not the only reasons for attending the Biotech Showcase. All three NDA colleagues agree that one reason stands above all the others – understanding the impact the week has on patients all over the world.

Says Johan Strömquist, CEO NDA Group: “With such a strong focus on investments and deal making, it is easy to forget about the ultimate goal – serving the patients and improving health for people around the globe. If this isn’t always obvious during the week, it becomes so as the dust settles and new and preexisting endeavors continue their journey into the hands of physicians and patients, fueled by the investments made during this intense week and the discussions that follow it.”

Says Thomas Lönngren, Strategic Advisor NDA Group and former Chief Executive at the EMA: “The JP Morgan week is a celebration to scientific advancement and one way to put focus on important treatments and future opportunities to improve patient health. We need these meeting places to accelerate development of medicines – their impact is tangible.”

Says Barbara Clendenen, Director of BD US NDA Group: “Understanding the trends is also a way of looking into the crystal ball of global health. We’re steadily raising the bar on science and you can see the impact it has all around the world. The JP Morgan week is all about making the right investment decisions, but not just to achieve a meaningful financial return, but to progress the development of patient health. That, I think, is the most important aspect of the week.”

Are you attending the JPM week? Share your reasons for attending or why not reach out to Barbara, Thomas or Johan during the meeting to discuss how NDA can support you and your company.

We look forward to seeing you in San Francisco next week!

Read our previous posts with reasons for attending here:

Reason 1 – Catching the trends
Reason 2 – Community
Reason 3 – Serendipity



The JP Morgan week – Serendipity!

Our third reason in our series leading up to the JPM event is brought to us by Thomas Lönngren and talks about being in the right place at the right time!

Reason 3 – Serendipity

Thomas Lönngren, former Chief Executive Director of the European Medicines Agency and NDA Group’s Strategic Advisors, has pushed the frontiers of drug development and regulatory science for years. Attending the Biotech Showcase for him is equal parts learning the latest trends and meeting new and existing contacts. Building long lasting relationships is Thomas’s favorite part of JPM.

Says Thomas: “The JPM week is extraordinary in that virtually anyone that you’d like to meet in biotech and life science is gathered, for a short period of time, in a relatively small space. The kind of meetings you can have at a traffic light or over a beer at a reception is really quite unusual. You turn a corner and bump into Michael Dolsten [President, R&D, Pfizer] or you sit down at dinner opposite one of the key investors from Goldman Sachs.”

If you’re at the right place at the right time, you can make some pretty exciting connections.

“It is really the only place in the world where you have the chance to meet so many different people across the spectrum of drug development. It is really exciting and adds to my curiosity as I plan for the week. What will happen this year and who will I have the great fortune to meet?”

If you are attending the JPM week please share with us your reasons for attending!




The JP Morgan week – Community!

Next in our short series leading up to the JPM event, we hear Johan Strömquist talk about his favourite aspects of the week and the reasons that keep him coming back for more!

Reason 2 – Community

A relative new comer to the Biotech Showcase, NDA Group CEO Johan Strömquist attended his first “Circus” in 2018. A keen eye for the highly relevant, coupled with quick feet, allowed him to meet with more than a hundred companies over this intense week and he’s coming back for more.

Says Johan: “This is the best show, not just in town, but in our business, for making new connections. What I find to be notable with the JPM week is the great sense of community that is felt among the attendees. As I’ve walked around and talked to people from all over the world, there is such a great sense of pride and community expressed in conversations at the event. We’re all committed to developing great products and for many of us, the JPM week makes this a reality.”

The JPM week gathers many thousands of people from an impressive number of companies from all over the world. Regardless of origin, the passion for drug development and the opportunity to make these dreams come true for organizations and patients alike propels the week.

“Being from Sweden, it’s remarkable how many peers from my home country and from other Nordic countries I meet at this event. It’s amazing when you think about it – traveling halfway across the world and then meeting people that live and work half an hour down the road from your office. That’s part of the charm with this week – it truly reflects the global nature of drug development.”

If you are attending the JPM week please share with us your reasons for attending!



Interactions with the agencies during drug development

On the 23rd January 2019 we invite you and your colleagues in the development & regulatory departments to a complimentary seminar on how to fully leverage on oral explanations and other opportunities to convince EU regulators.

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 formerly Division Head at the Danish Medicines Agency and CHMP member and Rosalind Cox, formerly Divisional VP with Abbott share their experiences and provide their insights.

Click here for more details.