Interactions with Agencies During Drug Development

Welcome to NDA’s free Breakfast seminar on Wednesday 20th March 08:30- 10:00 on Interactions with Agencies During Drug Development

There are many opportunities for bringing your message across to regulators, by interacting with the right EU Agencies at the right time, dependent on the type of product, applicant, procedure and stage of development. Find out whether you’re making the most of all these opportunities to facilitate your drug development program.

Join us to hear Steffen Thirstrup, Director NDA Advisory Board member, formerly Division Head at the Danish Medicines Agency and CHMP member share his experiences and provide his insights into making the most of the opportunities to interact with EU Agencies during the drug development process.


LEARNING ASPECTS:

  • Get an overview of the opportunities for interacting with National Regulatory Agencies and EMA throughout development and how to optimise your interactions
  • Learn about procedures and product type specific interactions with special consideration for SMEs
  • “By failing to prepare, you are preparing to fail”Benjamin Franklin An oral explanation is your ultimate chance to engage with EU regulators in getting your product approved

When: Wednesday 20th March 2019

Time: 8:00 – 8:30 Breakfast, 8:30 – 10:00 Presentation, 10:00 – 12:00 meet with NDA experts

Venue: SciLifeLab (Air & Fire at ground floor) Tomtebodavägen 23A, Solna, Sweden

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

To book a meeting with our experts after the seminar please write 1-1 meeting and specify the topic and participants from your company in the registration email. You will recieve a confirmation email with the time slot for your meeting.

Registration: RSVP by Friday 15th March 2019 to frukostseminarium@ndareg.com

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

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

 

We look forward to seeing you there!

 

 

 

Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind

Welcome to NDA’s free Breakfast seminar on Thursday 14th March 09:00- 10:30 on Immunogenicity for investigational biopharmaceutical products – Start with the goal in mind

All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should not be compromised if these risks are suitably evaluated from the earliest stages of development.

Join us to hear Paul Chamberlain, Biopharmaceuticals & Immunogenicity Expert and NDA Advisory Board member, explain how to anticipate and avoid issues for biopharmaceutical development. Grab this opportunity to benefit from his experiences and insights.


LEARNING ASPECTS:

  • How to apply immunogenicity risk assessment at the lead candidate selection stage
  • Minimizing incremental risks associated with manufacturing
  • Understanding what and how to evaluate, at different stages of clinical development
  • Integrated presentation of data to regulatory agencies

When: Thursday 14th March 2019, breakfast from 09:00, presentations start at 09:30

Where: Am Klopferspitz 19a, 82152 Martinsried/Planegg, BioM Seminarraum, Munich, Germany

The Breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Paul. Questions can also be sent in advance to ndaseminar@ndareg.com.  Please specify if you would like to ask them openly during the seminar or prefer to discuss them privately afterwards.

Registration: By Tuesday 12th March 2019 to: ndaseminar@ndareg.com

Contact: Nathalie Brodale-Breinbauer, +49 (0) 89 3585 4036 or email nathalie.brodale-breinbauer@ndareg.com

 

We look forward to seeing you there!

 

 

 

Bienvenido a Miami!

 

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

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

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

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

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

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

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

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

To find out more about this event please click here.

We look forward to seeing you at the event!

 

 

 

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!

 

 

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.

 

 

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.

 

 

Meet NDA at DIA Biosimilars Conference in London

Steffen Thirstrup,Director, NDA Regulatory Advisory Board will be chairing this event:

Overview
Biosimilar medicines’ developments are maintaining their momentum, and the 2018 Biosimilars Conference programme delves into strategic discussions regarding:

• Market access and regulatory developments in the EU and globally
• National policy developments (e.g. education, incentives, government investments)
• The impact of biosimilar medicines on the competitive landscape of biological products and the sustainability of the biosimilar medicines sector

As the 5th conference of its kind, the 2018 programme will provide current updates and challenges related to biosimilar medicines. The conference will consist of plenary
sessions and multi-stakeholder panel discussions, which will allow for interaction with the audience. Participants will leave the conference with a wealth of new information
and an expanded network of contacts.

Paul Chamberlain, Biopharmaceuticals and Immunogenicity Expert, NDA Advisory Board, UK
DAY ONE | MONDAY, 22 OCTOBER
11:30 SESSION 2 – PHYSICIAN’S CHALLENGES – TREATMENT PATHWAYS
Immunogenicity – The Wrong Elephant in the Room

Click here for more details & to register

Meet NDA at the DIA Annual Meeting in Boston

 

We will be attending this year’s DIA Annual Meeting, June 24-28, at the Boston Convention & Exhibition Center.

If you are planning to be there, we would really like to meet up with you!

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.

Do you want your product to reach the world’s two largest markets with minimum delay? Arrange to meet us at DIA USA 2018 now.

 

Four of our Experts will be presenting at the event:

 

Martha Arnold – Principal Consultant, PharmApprove, a member of the NDA Group

and Lisa Peluso – Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group

Sunday, June 24 | 08:30-12:00
#24: Preparing for a US FDA Advisory Committee Meeting

 


 

Shelley Gandhi – Strategic Advisor, Pharmacovigilance & Drug Safety

Monday, June 25 | 15:00-16:15
#140: How Inspection Ready is your Organization?

Tuesday, June 26 | 16:15-17:30
#276: Patient Engagement in Pharmacovigilance

 


Dr Brian Edwards – Principal Consultant, Pharmacovigilance & Drug Safety

Wednesday, June 27 | 12:45-13:15
#351: Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance

 

Dr Edwards will also be involved in the following DIA Community Round Table Discussions taking place at the DIA Community Zone, North East Lobby, BCEC.

Host Community: Clinical Safety & Pharmacovigilance

Tuesday, 26 June | 15:15-16:15
01 7027101 – Risk Management: New Direction

Wednesday, 27 June | 08:00-09:00
01 7027113 – Pharmacovigilance: No Longer Going it Alone

Wednesday, 27 June | 13:00-14:00
01 7027109 – Patient Engagement in Pharmacovigilance


Click here to download the Final Programme.


Meet us at the DIA Annual Meeting in Boston

To book a meeting contact Anna Perrin: anna.perrin@ndareg.com
We look forward to hearing back from you about a meeting and to seeing you at the event!