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

Pediatric Development – Regulatory Aspects in EU and US

Neither the EMA nor FDA will approve a new drug without the pediatric patient population having been appropriately considered.

This seminar will focus on legislative requirements and pediatric incentives available in both jurisdictions in order to maximise the rewards and avoid delays in registration.


The seminar will provide insight into:

  • The importance of preparing a global pediatric strategy early
  • How to capitalize on the incentives for pediatric research
  • How to avoid unnecessary delays in your drug development program

Presenters

With 20 years of experience from regulatory science, Daniela Gerl and Dr Isabel Schemainda will provide tangible and actionable advice into the requirements for an optimised pediatric strategy.


Agenda

09:00 Registration and complimentary breakfast
09:30 Welcome: Andrea Aschenbrenner, Director Business Development Europe
09:40 Presentation: Pediatric Development – Daniela Gerl & Dr Isabel Schemainda
10:30 Question and answer session
10:50 Concluding remarks

Take the opportunity to book a 20 min slot to speak directly with our experts.
Email munich@ndareg.com


Email: munich@ndareg.com to book your time now.

Date: 16th July 2019

Time: 09:00 – 11:00 (with the opportunity to book 1-1 meetings afterwards)

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

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

Registration: RSVP by Friday 12th July 2019 to munich@ndareg.com

Contact: Thomas Trache +49 8935 854 000

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

 

We look forward to seeing you there!

 

 

 

Meet the NDA Group at DIA in San Diego 23-27 June

Optimising the development of innovative medicines

NDA is a world leading drug development consultancy helping clients achieve regulatory and market access success in the US and EU.

Our goal is to streamline the global development and commercialisation process in order to accelerate patient access to important medical therapies.

Over the last 5 years, NDA Group has supported the approval of over 40% of new medicinal products in the EU and among our FDA advisory committee clients 80% have achieved product approval. We work across a range of disease areas including oncology, hematology, infectious disease, metabolic and immunologic disorders and CNS and have supported the development of over 50 rare disease programs.


Presentations by NDA’s experts

Lisa Peluso
Director, Coaching and Client Engagement
Kaia Agarwal
Strategic Advisor and Global Regulatory Affairs Consultant

(Pre-Conference Short Course)
Short Course 3 | Sun, 23rd June- 09:00-12:30
Preparing for a US FDA Advisory Committee Meeting

More information


Lisa Peluso
Director, Coaching and Client Engagement
Steffen Thirstrup
Director NDA Advisory Board

(Pre-Conference Short Course)
Short Course 3 | Sun, 23rd – 13:30-17:00
European Regulatory Meetings: How Best to Prepare and Perform

More Information


Brian Edwards
Principal Consultant, Pharmacovigilance & Drug Safety

Session #106 | Mon, 24th June- 11:00-12:00
Moving forward in EU Pharmacovigilance

Session #155 | Mon, 24th June- 15:30-16:30
Incorporating Systems: Theory and Human factors into the Investigations of Serious Harm in Clinical Research

Session #403 | Thur, 27th June- 09:00-10-15
Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars


NDA supported over 40% of the new medicinal products that were approved in the EU during the last five years.

Do you want your product to reach the world’s two largest markets with minimum delay?

Arrange to meet us at the DIA USA now.

GET IN TOUCH

info@ndareg.com

 

 

Navigating the Regulatory Maze – Initiating Your Phase 1 Trials

Researchers across the globe face common barriers in translational research that can delay the development of new interventions for patients in need.

This seminar, presented by Dr Niamh Kinsella on 2 July 2019 in Cambridge, will focus on describing the strategies and benefits of implementing a stage-gate approach for Phase 1 clinical development.


Benefits include:

  • Clear go no-go decision points
  • Higher probability of success with Phase 1 submissions
  • Clear and favourable exit strategies

Presenter

With 20 years of experience from biologics development, Dr. Niamh Kinsella provides tangible and actionable advice to optimise early drug development plans.

 


Agenda

12:00 Registration and complimentary lunch
12:30 Welcome: Andrew Monaghan, General Manager NDA UK
12:40 Presentation: Navigating the Regulatory Maze – Dr Niamh Kinsella
13:30 Question and answer session
13:50 Concluding remarks
14:00 Coffee and mingle

Take the opportunity to book a 20 min slot to speak directly with our experts.


Email: ndaseminar@ndareg.com to book your time now.

Date: 2nd July 2019

Time: 12:00 – 14:00 (with the opportunity to book 1-1 meetings afterwards)

Venue: Queen Edith’s Room, The Cambridge Building, Babraham Research Campus, Cambridge

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

Registration: RSVP by Friday 28th June 2019 to ndaseminar@ndareg.com

Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372 860 623

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

 

We look forward to seeing you there!

 

 

 

Optimizing Value – Regulatory and Market Access Considerations

Welcome to NDA’s seminar on 21st May 08:30-13:00 on Optimizing Value – Regulatory and Market Access Considerations.

NDA would like to invite you to join Professor Steffen Thirstrup and Professor Mira Pavlovich-Ganascia share their experiences and provide their insights and considerations to optimize the value of your development program.

The market access environment is getting increasingly challenging. The ability to develop plans and strategies for access, for today as well as tomorrow, is critical to bring new medicines to patients.


Agenda:
08:30 Registration and light breakfast
09:00 Welcome – Claes Buxfeldt, Director NDA HTA Advisory Board
09:30 Session one: Challenges on development programs for new drugs – Professor Steffen Thirstrup
10:00 Coffee and mingle
10:30 Session 2: HTA and Europe – where are we heading? – Professor Mira Pavlovich – Ganascia
11:00 Question and answer session
11:30 Concluding remarks and take home messages

12:00 – 13:00 Ask the Experts – Book a 20 min slot to speak directly with our experts, email: frukostseminarium@ndareg.com


About the speakers

Professor Steffen Thirstrup,
Director NDA Advisory Board, Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, and CHMP member. Steffen is an expert in clinical development and regulatory strategies.

 

Professor Mira Pavlovich-Ganascia,
NDA HTA Advisory Board member, practicing physician and former Deputy Director for Health Technology Assessment at the Hauté Autorité de Santé (HAS), France. Mira is an expert in HTA activities related to early dialogues with developers, disease-specific guidelines and methodology of assessment for reimbursement purposes.

Claes Buxfeldt,
HTA Director at NDA Group, former Global Price & Reimbursement Director in Respiratory & Inflammation at AstraZeneca. Claes has 20 years’ experience in the market access and health economic areas and has extensive experience in developing the market access strategy/payer strategy/payer evidence generation for drug development programs from pre-                                            clinical to launch phase.


Learning aspects

  • How to secure value in your development program considering both regulatory and market access requirements
  • Learn about how, when and why it is critical to consider HTA and market access requirements in your development program
  • Understand how to mitigate differences in demands/requirements between regulatory and HTA bodies

When: Tuesday 21st May 2019

Time: 08:30 – 13:00 (opportunity to book 1-1 meetings from 12:00)

Venue: SciLifelabs, Tomtebodavägen 23a, 171 65 Solna, Sweden

The seminar will be an open and interactive workshop with the opportunity to ask our presenters questions.

Specific questions can also be sent in advance to frukostseminarium@ndareg.com. Indicate if you would like to discuss them openly during the meeting; otherwise we can book separate meetings to discuss them after the seminar.

Registration: RSVP by Friday 17th May 2019 to frukostseminarium@ndareg.com

Contact: Denise Strömquist, Marketing and Management Coordinator, +46 (0)8 590 778 00, or email frukostseminarium@ndareg.com

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

 

We look forward to seeing you there!

 

 

Interactions with Agencies During Drug Development

Welcome to NDA’s free Lunch seminar on Tuesday 30th April 12:00- 14:00 on Interactions with Agencies During Drug Development

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


About the speakers

Professor Steffen Thirstrup

Director NDA Advisory Board, Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, and CHMP member. Steffen is an expert in clinical development and regulatory strategies.

 

Dr Rosalind Cox
Principal Consultant NDA UK, formerly Divisional VP with Abbot. Roz specialises in European Regulatory Strategy and Global Development.

 

 


LEARNING ASPECTS:

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

When: Tuesday 30th April 2019

Time: 12:00 – 14:00 (opportunity to book 1-1 meeting afterwards)

Venue: Queen Edith’s Room, The Cambridge Building, Babraham Research Campus, Cambridge, UK

The lunch seminar will be an open and interactive workshop with the opportunity to ask our presenters questions.

Specific questions can also be sent in advance to ndaseminar@ndareg.com. Indicate if you would like to discuss them openly during the meeting; otherwise we can book separate meetings to discuss them after the seminar.

Registration: RSVP by Friday 26th April 2019 to ndaseminar@ndareg.com.

Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372  860 623, or email ndaseminar@ndareg.com.

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

 

We look forward to seeing you there!

 

 

 

Interactions with Agencies During Drug Development

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

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

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


LEARNING ASPECTS:

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

When: Wednesday 20th March 2019

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

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

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

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

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

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

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

 

We look forward to seeing you there!

 

 

 

Passionate about solutions for patients with rare diseases

 

1 in 20 people will live with rare disease at some time in their life*.

Johan Strömquist CEO NDA says: “There are more than 6 000 identified, untreated rare diseases in the world. A lot has been done in recent years to address this by regulators and innovators but for many it is still not enough.”

At NDA much of the work we do go into supporting companies working to address this. We care passionately about this work and about getting treatments to the patients affected. Rare Disease Day is our opportunity to show this to the world and to promote the vital work that is going on in this space by so many passionate patients, physicians and scientists.


What is Rare Disease Day?

Rare Disease Day was first launched by Eurordis and its Council of National Alliances in 2008 with the goal to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. 1 in 20 people will live with rare disease at some time in their life but despite this there is no cure for the majority of rare diseases and many go undiagnosed.

For 20 years the NDA Group has supported pharmaceutical and biotech companies around the world with strategic regulatory guidance across a range of diseases. Increasingly more companies have been trying to solve the puzzles for a diversity of untreated rare diseases. NDA has been there every step of the way.

Laurie Smaldone Alsup, MD, CSO and CMO of NDA says: “I believe we are still at the beginning of addressing rare diseases. With new scientific and technical advances every day we will be turning a corner where many more novel treatments will be discovered to address a range of difficult to treat disorders.”

She continues: “For me Rare disease day is a call to arms to create awareness of the continued need to address serious rare disorders to improve and extend patients’ lives.”

The theme of 2019 – Bridging health and social care

The theme for this 2019 Rare Disease Day is ‘Bridging health and social care’ For most people living with a rare disease, as well as their family members or carers, the reality of daily life can include any combination of the following: collecting and taking medicines, attending appointments, participating in physical therapy, using specialist equipment and accessing various social and community support services and respite care. Managing these care-related tasks alongside their usual daily activities such as work, school and leisure time can be challenging.

In support of patients with rare disease

2018 Rare Disease Day theme, ‘Patient Involvement in Research’, helped to underpin the importance of including patients in the drug development process.

Dr. Markku Toivonen, MD, Scientific Director at NDA, former CHMP member and Chairman of EMA’s Scientific Advice Working Party comments:
“The development of patient advocacy and the involvement of patients in the development and regulatory process has truly been game changing. At NDA we take great pride in helping to empower patient advocates through training in regulatory science and medical research with Eurordis, the European Organisation for Rare Diseases. ”

Markku continues: “Personally, it has been a privilege to participate in Eurordis Summer School for patient experts, advocates and researchers annually over the past 10 years as one of the trainers. Based on the candid feedback Eurordis has received over the years, the enthusiastic and highly motivated participants with varied backgrounds have benefited from the interactions with peers. They have returned home with new tools to help them in their endeavors and to navigate in the maze of science, medicines development, licensing and real-world challenges. It has been a pleasure to meet many of them again over the years, and to see how they have contributed at various levels from new medicinal product development to regulatory authority activities and overcoming the ultimate hurdle: access to treatment.”

* www.rarediseaseday.org

 

 

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!

 

 

 

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 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


 

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: 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 – 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!

 

 

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

Welcome to NDA’s free lunch seminar on Tuesday 11th December at 12:00 -14:00 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: Tuesday 11th December 2018, 12:00 -14:00

Where: Queen Edith’s Room, The Cambridge Building, Babraham Research Campus, Cambridge, UK

The Lunch seminar will be an open and interactive workshop with the opportunity to ask 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: RSVP by Tuesday 4th December 2018 to: ndaseminar@ndareg.com

Contact: Anna Perrin, Marketing Assistant, +44 (0) 1372 860 623, or email ndaseminar@ndareg.com

 

We look forward to seeing you there!