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
  • Brian Edwards – Principal Consultant, Pharmacovigilance & Drug Safety

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

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

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


Sessions

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

Please look out for them:

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

European Regulatory Meetings – How to Best Prepare and Perform


Dr Brian Edwards – Principal Consultant, Pharmacovigilance & Drug Safety
SC03: Short Course 3 | Mon, 4th February – 14:00
Effective Global Quality Management System and Product Safety

 


Prof. Beatriz Silva Lima – Non Clinical Expert, NDA Regulatory Advisory Board member
S0206: | Thurs, 7th February – 10:45
Regulatory Innovation: Regulatory Science

 



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

 


Click here to download the Preliminary Programme.


 

Meet us at DIA Europe 2019

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

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

 


 

 

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.

 

 

 

The JP Morgan week – Catching the Trends!

The JP Morgan week in San Francisco in the early days of the New Year, known to some simply as “The Circus”, is one of the highlights of the year for those of us working in the life science industry. This is a week when drug developers, business folks, and investors get together to compare notes, strike deals, do business, and make new connections.

In this short series leading up to the event itself, members of the NDA Group talk about their favourite aspects of the week and the reason that they keep coming back for more!

Reason 1 – Catching the Trends

Having attended the JPM week and the Biotech Showcase many years running now, Barbara Clendenen, Director of BD US, is a veteran of the event. Over the years she’s met hundreds of people across an equally impressive number of companies as they’ve looked for clinical and regulatory solutions or for something to invest in.

Says Barbara: “The Biotech Showcase is a truly remarkable opportunity to check the pulse of the industry and to see what’s hot – and what’s not. During last year’s event, the emergence of trials leveraging the micro-biome was one of those observations that I’ve seen so many examples of throughout 2018.”

Over the last few years, many of the industry shaping mergers and acquisitions, as well as many of the industry driving scientific trends have been unveiled or clearly demonstrated at the event.

“If you keep your eyes peeled and listen in on the presentations at the Biotech Showcase you really have an opportunity to foresee the immediate future of biotech and the life science industry. I think that’s what I love the most about this event. That and the off-hour receptions of course. New science and cocktails – what can beat that?”

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

 

 

Mandatory use of eCTD in 2019 – Are you ready?

Mandatory use of eCTD for all submission types and procedures by 1 January 2019
From January 2019 all submissions in CP, DCP, MRP and NP, related to authorisation and regulatory maintenance (variations) of human medicinal products, must be submitted in eCTD format.

Baseline dossier
Submission of a baseline CTD Module 3 serving as a start of an eCTD is highly recommended by the agencies, as the baseline dossier facilitates the review and assessment of future applications. A baseline submission is a compiled submission of the current status of the dossier, i.e. resubmission of currently valid documents that have already been provided to an agency but in another format. The sections provided to make up a baseline can be defined by the applicant, but any omissions should not render the submitted content to be misleading. A baseline would typically consist of the Module 3 documents that tend to change over time during the lifecycle of the product.

NDA Service
NDA´s well experienced team may assist you with publishing of variations in eCTD format as well as with conversion of your current documentation to eCTD format.
For more information about eCTD publishing and NDA´s other services, please contact office@ndareg.com.

 

 

What Do Providers Need to Know About Biosimilars?

DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom

With a number of new biosimilars making their way to market and eventually to the clinic, it is crucial that healthcare providers become educated about and comfortable with biosimilar products. During a session at the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, experts addressed a number of key areas for provider education.

Paul Chamberlain, immunogenicity specialist at NDA Advisory Services, spoke about one of the biggest concerns for prescribers who are wary of biosimilars: immunogenicity

Here’s a summary:

Immunogenicity.
According to Paul, it is critical to clarify the definition of immunogenicity, which is an undesirable host immune response to administration of a therapeutic agent. The innate immune response, the adaptive immune response, and immune tolerance are the key drivers of immunogenicity, and product factors (such as glycans, process-related impurities, or process changes) and patient factors (such as comorbidities or concomitant therapy) can impact the balance of those 3 factors.

While it is not feasible to predict how each factor might interact with others to affect immunogenicity, he explained, individual factors can certainly be controlled within acceptable limits. Furthermore, regulators look at both the individual and population level for immune response, and they also require a well-defined risk management plan for a product.

Thus, said Paul, immunogenicity is “the wrong elephant in the room” for prescribers, because physicians typically conflate the incidence of antidrug antibodies (ADAs) with immunogenicity. “Please do not just use ADA rate … as a term which is equivalent to immunogenicity. It absolutely isn’t.”

To illustrate his point, Paul gave the example of CT-P10; in looking at ADA titters between the biosimilar rituximab and its reference, regulators can see that while ADA rates for the 2 products may not appear comparable, the ADA titters overlap very closely. However, he said, few physicians see these reassuring data.

For a more complete picture please see Pauls slide presentation.

To read more about what the experts had to share please click here.

 

 

 

Pharmacovigilance Audits and Inspections Summit – November 7, 2018

Shelley Gandhi has been invited to present a session at the Pharmacovigilance Audits and Inspections Summit – November 7, 2018 • Wyndham Philadelphia Historic District • Philadelphia, PA

Her session will cover:
Examine Evolving Global Pharmacovigilance Regulations and the Impact on Audit and Inspection Readiness

As regulations are changing domestically and around the globe, it is important to keep
up to date on the many different regulatory issues (including data integrity regulations)
that affect your audits and inspections. During this session, learn more about current
and pending regulatory developments that affect PV audits and inspections.


LEARNING OBJECTIVES

Align Global Data Collection and Analysis Systems • Ensure Cross -Functional Collaboration and Preparedness • Achieve Accurate and Timely Reporting

  • The volume of audits and inspections is growing rapidly
  • Audits and inspections currently consume an inordinate amount of PV’s time and attention
  • Global PV regulations are incredibly detailed
  • Managing, reviewing and sharing an increasing amount of data is tremendously complex
  • Cross-functional cooperation and seamless collaboration with 3rd parties is critical

ATTENDEE BENEFITS INCLUDE:

  • Understand areas of regulatory focus related to PV audits and inspections
  • Create internal processes and best practices for managing audits and inspections
  • Benchmark with colleagues — Consider ways to work in partnership with regulatory affairs, quality, medical affairs, clinical development and manufacturing
  • Examine ways to efficiently and effectively capture, manage and report on data
  • Consider the future state of PV audits and inspections

Click here to find out more.

 

 

Free Webinar – How to demonstrate value in drug development programs to improve chances of reimbursement

Being able to demonstrate the expected value for health care systems and society for a new pharmaceutical is critical for market access including chances of reimbursement. Having a clear strategy for value demonstration as an integrated part of your drug development program can improve your chances of reimbursement leading to a faster market access. Knowing different payer’s expectations in terms of endpoints and supportive data as well as having an understanding of Health Technology Assessment (HTA) and how this is applied is critical to success.

Join us on Thursday 29th November, at 15:00 GMT, 16:00 CET, 10:00 EST for this engaging webinar where Claes Buxfeldt, HTA Director, will cover the following:

  • The needs/requirements of the HTA bodies and payers in all countries
  • How strategy could be implemented in TPP, value proposition and messages to secure value and reimbursement
  • What activities are needed to investigate and at what stage in development
  • How to:
    • design and improve a clinical development program to satisfy HTA bodies and deliver value for payers
    • design and improve programs to strengthen unmet need and the economic story
    • prepare and improve the ability to communicate the value story and improve payer negotiations skills
    • validate your strategy and plans using the NDA Advisory Board, both regulatory and HTA / payer

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

Click here to book your place today.

 


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


 

 

NDA Group expands presence in Denmark

In time for the European BIO meeting in Copenhagen, global development consultancy, NDA Group, is expanding the physical presence in Denmark. With the appointment of Katja Gustafsson as Senior Consultant the company will be working closely with clients in the region. The news follows several recent announcements of the company’s expansions in Europe and the US.


Katja is joining NDA’s Professor Steffen Thirstrup, Director of NDA’s regulatory Advisory Board in Copenhagen.

Johan Strömquist, CEO of NDA Group commented: “We’re delighted to be joined by Katja in Copenhagen, further reinforcing our commitment to Nordic life science and the incredible development that we see in the Medicon Valley region. Even though the Nordics is the cradle of NDA and we’ve had a strong presence in the market through our Stockholm office, there is nothing like having feet on the ground when it comes to serving our clients.”

Consultant and client interface

In her role as Senior Consultant, Katja will work closely with companies in the Copenhagen / Malmö / Lund region and act as client liaison, in addition to serving the need for professional regulatory development advice. Together with Prof. Thirstrup, Katja will ensure that the region’s clients gain access to the wealth of intelligence, advice and support represented by the capabilities of the NDA Group. Both Katja and Prof. Thirstrup will be available to meet with companies at the BIO Europe meeting in Copenhagen 5th– 7th November.

Prof. Thirstrup commented: “Copenhagen is my home and I’m delighted to see the vibrant activity in the region. With the expansion of NDA’s capabilities in Denmark we will be able to support the region even better in its growth and innovation. This can only be good news for patients.”
Katja joins NDA from Ferring Pharmaceuticals, where she has spent the last 18 years in different roles in Global Regulatory Affairs. Her previous role was as Associate Director in Life Cycle Management and Urology. Katja has been regulatory lead and team member for several development projects and driving global submissions and approvals for various pharmaceutical products. She has a MSc (Pharm) from the Royal Danish School of Pharmacy.

Margareta Busk, General Manager, NDA Nordics commented: ”Katja’s energy, professionalism and long international experience will be a great asset for the NDA team as well as for our clients. We are very much looking forward to continuing our expansion in the Medicon Valley with her support.”


NDA media contact: anna.perrin@ndareg.com

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Princeton, Boston and San Francisco. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies. www.ndareg.com

 

 

Recommendations from PRAC – Insights and implementation

Welcome to NDA’s free breakfast seminar Wednesday the 21st of November 08:30 – 09:30

All marketing authorization holders (MAH) are responsible for monitoring and implementing PRAC’s recommendations for signal detection, PSUSA procedures, and referrals, to name a few.

Join us to hear Shelley Gandhi, NDA’s Strategic Advisor of Pharmacovigilance & Patient Safety, share her experience and provide her insights into how PRAC works, how recommendations are decided and how these recommendations are expected to be implemented.


About the speaker

With 19 years experience at the MHRA, and her work with the European pharmacovigilance legislation, has provided Shelley Gandhi with an enormous breadth of experience and knowledge within this area. During her career she has focused on the processes that ensure the safety of medicines and related devices.


When: Wednesday 21st November 08:30 – 09:30. Breakfast from 08:00

Where: NDA Regulatory Service AB, Johanneslundsvägen 2, 2tr, 194 61 Upplands Väsby

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

Please advise if you would like to discuss them openly during the meeting; otherwise you can book meetings to discuss them separately after the seminar.


Registration: RSVP by Wednesday 14th November to frukostseminarium@ndareg.com

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


Welcome!

 

NDA Group will be attending the 10th Annual PEGS Europe, at the Lisbon Convention Center, Portugal 12-16 November, 2018.

NDA supported over 40% of the new medicinal products that were approved in the EU over the last five years. If you are planning to attend this year’s PEGS, we would really like to meet up with you. We will have a few of our experts available at the event:

  • Dr Niamh Kinsella, Biologics Expert
  • Dr Terese Johansson, Regulatory Consultant

If you would like to arrange a meeting, please contact Niamh Kinsella, who will be happy to assist, niamh.kinsella@ndareg.com

 

Experts that will present at the event:

Niamh Kinsella

 

Poster Presentation:
Integrated Early Stage Development Strategy as Risk Management Tool for Global Development
Viewing: Tuesday, 13 November: 10:30-11:15, 13:45-14:15 & 16:20-17:00

 

Terese Johansson

Poster Presentation:
Developing an Integrated Summary of Immunogenicity (ISI) to Effectively Manage Regulatory Risks in Product Development
Viewing: Thursday, 15 November: 10:35-11:15 & 13:15-14:00

 

 

Click here to find out more about the event.

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

 

 

 

The future of Health Technology Assessment in Europe

On 24th October, Carole Longson, Dr Steffen Thirstrup & Claes Buxfeldt, NDA Advisory Services Ltd, will be holding a complimentary seminar on market access/Health Economics and Outcomes Research (HEOR), discussing the future of HTA.

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.

This seminar will discuss the past, present and future of HTA and market access.

Click here for more details.