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, especially Pandemrix, 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 Pandemrix 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.

 

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/

 

 

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

 

 

 

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

Prime – The European approach to expedited pathways

By: Steffen Thirstrup, Director, NDA Advisory Board & Eva Lilienberg, Principal Consultant 


Steffen Thirstrup, Director, NDA Advisory Board

A timely market introduction is a critical component of any drug development strategy – not only from a commercial stand point, where an early introduction can mean beating competition to market or simply significantly increased revenue, but also to patients awaiting better or alternative treatment options.

The debate around how regulators can facilitate this process on both sides of the Atlantic has resulted in new pathways for new medicines of major public interest. The FDA have the Breakthrough/RMAT pathways, and in the EU, EMA has put the PRIME process in place.

In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.

To read the full article download the PDF

Download PDF

How we can help?

NDA Group supports life science companies all over the world with the aim to streamline the global development and commercialization process in order to accelerate patient  access to important medical therapies.

Whatever regulatory hurdle you’re facing, we can help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.

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

Or contact us at meet-us@ndareg.com to talk to one of our experts.

Business Development Professional UK

Are you an experienced Business Development Professional with experience in the Life Science sector?

As Director of Business Development you will be responsible for the generation and management of external opportunities, the assessment of potential new clients and operational support of business development objectives.

This role’s focus is to drive the prospecting and new business development for NDA in the UK market. You will work closely with our experts to identify and seize commercial opportunities to ensure a strong positive impact on the business growth and profitability.

Office Location: Leatherhead, UK

Become a part of the NDA Group’s growing, highly qualified team!

Key responsibilities

  • Create awareness of NDA’s full service offering in the UK market
  • Build and expand strong relationships with existing and potential NDA clients.
  • Implement strategies focused on pipeline management to identify and develop opportunities for growth
  • Attend relevant conferences, networks, industry meetings to seek opportunities
  • Work collaboratively with internal stakeholders to ensure that NDA continues to operate effectively as one firm.
  • Manage the operational BD activities; management and follow-up of leads, including hand-over to appropriate people within NDA

Qualifications

  • 5-10 years of experience in Business development or comparable business function
  • Demonstrated ability to identify and pursue new business opportunities
  • Good understanding of the life-science/bio tech industry in the UK
  • Proven networking skills where an established network of potential clients is a merit.
  • Entrepreneurial and collaborative
  • Can work independently and takes own initiatives
  • Excellent communication skills
  • Flexibility and willingness to travel frequently
  • Proactivity and drive to develop our client base
  • Confidence to build productive relationships on many levels

Application

Send your application (CV and cover letter) in an email labelled “Business Development UK” to recruitment@ndareg.com. Selection of candidates & interviews will be conducted continuously, thus submit your application as soon as possible.

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!

 

 

 

European Regulatory Meetings – how best to prepare and perform

By: Steffen Thirstrup, Director, NDA Advisory Board 

In this article, NDA’s Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.


Steffen Thirstrup, Director, NDA Advisory Board

Having the possibility to engage face-to-face
with EU regulators is the ideal situation to help with authorisation of your product. However, most interactions in the EU are in writing and very few sponsors have the opportunity for a meeting with the EMA.

The most critical meetings are those where the scientific committees of the EMA would like to question the sponsor to fully understand the data and the sponsor’s position.

Such ‘high-stakes’ meetings like CHMP oral explanations are often the final chance for a pharmaceutical sponsor to convince the EU regulators that the benefit/risk balance of their product is positive.

We recommend that you apply the pertinent Benjamin Franklin quote,throughout your planning for a successful EU ‘high-stakes’ meeting.

“By failing to prepare, you are preparing to fail”

1.  Be prepared

Being well-prepared and performing professionally is the key to success. The sooner you can establish your team the better. Having your process and timelines mapped out will help prepare your team and maximise the chances of success. Plan for rehearsal sessions where you can work on the presentation, back-up slides and train comprehensively for questions and answers. If time allows, the team can be further coached by bringing in a ‘challenge panel’ of external experts who can act as a test-panel for your presentation and Q&A performance.

 

2. Know your data

EU regulators expect meetings like an oral explanation to be a scientific discussion based on data. To ensure this is the case, you should demonstrate intimate knowledge of your data to meet the regulators’ concerns as well as being able to present your position in a confident manner. To get to this stage takes meticulous preparation of key messages, slides and the script for the presentation and for potential questions.

One pitfall is to make use of already prepared slides as they will have been prepared with another aim in mind. Starting with a blank piece of paper, writing down the key messages that you believe the regulators need to hear gives you the best basis for creating slides that convey your key messages.

It is very important to make your slides as simple as possible, omitting any unnecessary information and this can be a challenge. Complicated slides distract the audience from your presentation; remember that the slides are there as an ‘aide memoire’ and not for the regulators to read verbatim as they will then not be listening to you!

In addition, keep graphics as simple as possible. A rule-of-thumb is a maximum of six points per slide with no more than six words in each.

 

3. Know your team

In many cases it makes sense to create sub-teams to address the individual topics, agree on key messages and create the slides. Group sessions can then be used to merge the slides into one presentation, optimise the script and ensure all information is in keeping with the key messages.

Additionally, there may be a need to coach key opinion leaders and/or patient representatives to speak or respond to questions on your behalf.

Finally, determining potential questions and being able to respond clearly and unequivocally to these are equally important to increase your chances of success. One way of doing this is to create a Q&A grid where all members of your team add likely questions, and questions they find difficult to answer. The team can prepare top-line responses, a more detailed explanation and any supporting slides for these potential questions and, of course, determine who is going to respond if the question is raised.

 

How we can help?

NDA Group supports life science companies all over the world with the single aim to streamline the global development and commercialization process in order to accelerate patient  access to important medical therapies.

In Europe, we assist with Scientific Advice Group meetings, Oral Explanations, PRAC meetings and preparation for intense pricing negotiations. In the US, our Principals and Communications Strategists are particularly experienced at preparing for FDA Advisory Committee meetings, in addition to pre-IND,  end of phase 2, pre-NDA/BLA, PMA, and mid- and late-cycle review meetings. We offer our clients an unparalleled breadth of global experience and expertise to drive efficient product development and health authority interactions across the US and Europe.

Whatever regulatory hurdle you’re facing,  we can help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.

Article originally published in the Jan/Feb 2019 issue of Pharmafocus

Click to original article

Importance of Excellence in Scientific and regulatory Communication

By: Lisa Peluso, Director, Coaching and Client Engagement, NDA Group/PharmApprove

In this white paper, PharmApprove’s Lisa Peluso, discusses how  excellent communications are  the backbone of streamlined, efficient programs achieving approval and market access.


Lisa Peluso, Director

The ever-changing complexities of the regulatory world demand excellence in communicating science, data, development program goals and intentions, as well as how foreseen risks are being managed.

These complexities also mean that drug development companies must engage candidly with regulators and lead the scientific conversation with clarity and flexibility, yet be poised to negotiate their position.

While we work with global companies to strategize and execute successful engagements with regulators  at critical junctures such as Oral Explanations and FDA Advisory Committee meetings, excellent communications are  the backbone of streamlined, efficient programs achieving approval and market access.

A number of potential pitfalls await companies with even the most solid science and robust datasets

To avoid costly delays along the path to regulatory approval and commercialization, companies need to:

1.  Communicate internally

To ensure alignment of clinical goals and regulatory approvability with the reality of a product’s potential market value and accessibility the company needs efficient internal communication. The danger lies in a narrow focus on just regulatory considerations: A product may be effective but if there is no place in the market or doubtful economic defense of pricing, the company is wasting time and money. Development plans must be based on all considerations, requiring careful coordination and collaboration across all divisions.

 

2. Communicate with regulators

Unfortunately, too many companies engage with regulators much too late, or not at all, or lack the candor and skill needed to usher a product  smoothly  through the approval process. Excellent communication means asking the right questions, clarifying any questions from the regulators and responding in a collaborative and transparent manner. Remember that specific expertise in your company’s product is rare, hence it’s critical to clearly shape the story of not just the data but also the program, goals and risk management commitments.

 

3. Communicate globally

Just as internal divisions must be aligned, regional requirements vary in Europe and across the globe. Companies risk costly mistakes and a need to “redo” when they don’t share knowledge freely internally.

This is particularly important for US/EU programs. Learnings from multiple regulatory authorities or groups of payers must be transferred so there is no duplication of effort – or waste of time – on the other side  of the pond. Constructive interactions speed efficiency.

 

4. Engage physicians, patients and advocacy groups

Get the community involved early, including doctors and potential study sites as well as patients and advocacy groups. Communicating with these stakeholders also demands delivering the messages behind the data in a concise and compelling manner to a wide variety of physicians, KOLs and other influencers.

With such deep knowledge of one’s product, it’s a daunting challenge to distill the information, refine the message and keep it brief and clear for the audience.

 

5.  Negotiate with payers

Companies put enormous effort into developing slide  decks, internal FAQs and value proposition documents.  This plethora of planning and information is to no avail if the company does a poor job of interacting with payers. In addition to understanding the audience around the table and their goals, the company must respond deftly to questions, defend the data, and communicate persuasively. Every interaction is an opportunity and certainly, when it’s time to negotiate pricing, excellence in communications is critical.

 

How we can help?

NDA Group supports life science companies all over the world with the single aim to streamline the global development and commercialization process in order to accelerate patient  access to important medical therapies.

Whatever regulatory hurdle you’re facing — a Type B meeting, a document submission, or a SAG hearing — our industry-leading professionals will help you strategize and execute successful engagements with any global authority. We’ll help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.

In the US, our Principals and Communications Strategists are particularly experienced at preparing for FDA Advisory  Committee meetings, in addition to pre-IND,  end of phase 2, pre-NDA/BLA, PMA, and mid- and late-cycle review meetings. In Europe, we assist with Scientific Advice Group meetings, Oral Explanations, PRAC meetings and preparation for intense pricing negotiations. We offer our clients an unparalleled breadth of global experience and expertise to drive efficient product development and health authority interactions across the US and Europe.

DOWNLOAD AS PDF

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!

 

 

 

Solve your most difficult regulatory challenge at BIO Philadelphia

The path to approval is littered with pitfalls leading to unnecessary delays getting your medicine to the people who need it the most….the patients.

With over 25 years experience from the Life Science industry and through her numerous interactions with both the FDA and European agencies, Dr. Laurie Smaldone Alsup is perfectly positioned to help you resolve the issues that could cost you time, money and potentially, approval.

Steps to success

Step 1: Identify your most difficult strategic regulatory question in the US or European market.

Step 2: Click on the link below and schedule a complimentary 30 minute session with Dr. Laurie Smaldone Alsup, CMO/CSO NDA Group and Advisory Board member.

Step 3: Receive valuable regulatory insights into your drug development program that will save you significant time and money.


Where: BIO International Convention in Philadelphia

When: 3 – 6 June 2019

Book a meeting: info@ndareg.com