Are you attending the Virtual DIA Europe 2020 Conference?

We would love to connect with you during the DIA and discuss how we can support you to optimise your path to market approval.

Working together we can:

  • Accelerate your drug development program to reduce your time to approval
  • Optimise the management of the regulatory process to provide accurate and predictable outcomes
  • Reduce your risks and increase the probability of gaining Market Authorization

Don’t miss our  great speakers sharing their knowledge in different forums throughout the conference:


Brian Edwards – Principal Consultant

Wednesday, July 1st, Oral Poster Presentation -#CHR 102: Skills, Communication and information in Pharmacovigilance – Oral Poster Presentations

 

 


Dr Mira Pavlovic – HTA Expert, NDA Regulatory Advisory Board member

Tuesday, June 30th, 13:00 – 14:00, Session title:#S0407 L: Drug Assessment for Regulatory and HTA Purposes: Similarities and Differences, the Way Forward. Track:04: Value-Access.

This session will explain similarities & differences about regulatory and HTA requirements to support product authorization and access to market, as well as the concept of added therapeutic benefit both from regulatory and HTA points of view.


Prof. Beatriz Silva Lima – Non Clinical Expert, NDA Regulatory Advisory Board member

Wednesday, July 1st, 18:00 – 19:15, Session title:#DL04 SL: Industry – Regulator Dialogue: Tailor-made Regulatory Guidance for Non-clinical to Clinical Development. Track:01: Clinical Trials.

i) First in human programs
Since the implementation of the new revised EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, there has been an interest as to the response by the Pharmaceutical Industry. Would the guideline be interpreted as too conservative and force companies to conduct FIH studies in non-EU geographies? EFPIA conducted a survey among 12 member companies with 54 FIH studies.

ii) Programs in Severe Diseases/Conditions
For a small number of severely debilitating or life-threatening (SDLT) diseases/conditions, regional guidance’s exist encouraging the use of “ICH S9-like” approaches. A lack of incentives for drug developers to engage into costly development may lead to unclear prospective. This session item will address a harmonized and focused approach on development options for SDLT indications to reduce resources to start early clinical development, to bring innovative medicines to patients faster.

Panellist: How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe

Speaker: Beatriz Silva Lima, NDA Group, Advisory Services


Click here to download the Preliminary Programme.


Pre-book a meeting with one our team, via the DIA App or simply
contact us meet-us@ndareg.com

Preparing for the Medical Device Regulation

An interactive webinar

On Friday the 3rd July 2020, 9:00 BST | 10:00 CEST , Dr Tina Amini, Medical Device Division Director, NDA Group will guide you through the key points to consider in your efforts to become Medical device regulation (MDR) compliant and focus on the implementation of MDR Article 117.

During this interactive seminar Tina will clarify the requirements applicable to medical devices under the new Regulation, highlight the major changes and provide an understanding of the impact on the industry. She will also highlight the impact to the manufacturers of integral drug-device combination products as the result of MDR and provide guidance on documentation to be submitted to the notified body.

Highlights:

  • Understanding the new regulatory requirements under MDR
  • MDR Article 117
  • Notified Body expectations for Device aspect of Combination products Drug/Device (regulated as medicinal products) or Device/Drug (regulated a medical device)

To learn more about NDA’s Medical Device division and services click here


Click here to book your place today!


About the Speaker

Dr Tina Amini, a pharmacist with a PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group.

She has over 30 years’ experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry in a variety of disciplines.

 

 

Interview with Kurt Stoeckli, President NDA Advisory Services

Driven by the desire to understand the human nature, and eventually seeking to understand the physics that construct it all. Kurt Stoeckli’s road to becoming the new President of NDA’s Advisory Board may seem as long and winding as any rising mountain road in the alps in his native Switzerland, but just like them, it does follow a coherent logic and destination.

“It’s all about being curious, asking the right questions, staying passionate and being open to new inspiration”, says Kurt Stoeckli, the new President of NDA’s Advisory Board. “Because knowledge is changing rapidly, and the life cycle of innovation is shorter.”

Growing up in a rural area in Switzerland, between Basel and Lausanne, he dreamt to become a farmer and wanted to drive trucks as a schoolboy and then he became fascinated by climbing

high mountains in the alps; a seemingly unlikely background for someone who would move on to become a leader in the pharmaceutical industry. On his way there, the study of philosophy caught his attention.

“It was more of a hobby and an inspiration”, he says of his early academic career.

“In high school, I was engaged in literature and theater. I wanted to learn more about what drives humans.”

However, when the time came to aim for a professional career – “reading Kierkegaard, Wittgenstein or Heidegger can be fascinating, but epistemology is not a profession”, he points out – he was inspired by a teacher to turn his focus towards chemistry, and later on, biology..

“I loved experiments. You can set up a hypothesis and you can verify or falsify your hypothesis under defined conditions. I like it. Moving from chemistry to biology was a natural evolution in my scientific career. You start by understanding the structure of molecules which is incredibly useful to then understand their function.”

Becoming increasingly interested in physiology and pathophysiology, Kurt Stoeckli worked his way down towards the basics of immunology, fascinated by the immune system’s fundamental importance in keeping a multi-cellular organism, like the human body, in balanced and healthy state; unlike any other organ system of the body with a defined place, the immune system is more like a mobile organ system, doing its job effectively – regardless where it is needed.

When eventually entering the pharmaceutical industry, his leadership skills turned out to come in handy. He headed up the Biologics Division at the French pharma company Sanofi, later becoming the CEO of Glenmark Switzerland and the global CSO of the group.

“It’s all about being curious, asking the right questions, staying passionate and being open to new inspiration”

What are you most proud of during your career?

“Two major things. Having critically contributed to the development of at least two marketed drugs, dupilumab (Dupixent) and sarilumab (Kevzara); they are approved for multiple indications like severe asthma and RA; right now, sarilumab is also used in clinics to dampen excessive immune reactions associated with COVID-19. The other important achievement concerns the development of key talents. High potential people that could unfold their talents and grow into leadership positions, taking major decisions today, and developing next-generation talents for tomorrow. In that way, the cycle continues.”

What about your biggest challenges?

“The shutdown of entire research sites and separating from people that were completely committed to the company and gave their best. Yet I had to go through this twice during my 18 years at Sanofi, based on the company’s strategic direction. That was tough for me.”

Growing up on the border between the German- and French-speaking areas, Kurt Stoeckli speaks German, French, and a little Italian – as well as English, of course. Has the time come for a new challenge – Swedish?

“Hopefully, I will get more familiar with it. My son, who studied in Uppsala, told me it’s not so difficult.”

He calls himself an entrepreneurial scientist because entrepreneurial scientists make use of scientific innovations and must deliver results that make sense from a business perspective.

“While I was within big pharma, I learned how to work with start-ups, how to help them. I have been a co-founder of some companies as well as an investor. I built my own consultancy for start-ups, so my new role as an advisor at NDA isn’t completely new to me.”

What are your intentions for this job and for the Advisory Board?

“The NDA Advisory Board thrives on being proactive and understanding the big areas of growth and innovation. Let us take the Advanced Therapy Medicinal Products (ATMP) as an example. Gene therapies are emerging. Today’s approaches will further innovate, and fully targeted gene delivery along with controlled and precise repair mechanisms will offer new ways of treatment. It will require new regulation and development strategies. We need to know how to bridge emerging sciences and related regulatory challenges, so that new treatments can bring the benefit to patients and value to the healthcare system without delay. That is what we strive for, and that is why we have scientists, physicians and ex-regulators working together at NDA. This is what drives me.”

Where do you see yourself and NDA in the coming years?

“I see NDA offering unique value to clients by understanding the value chain for innovative medicines and providing differentiated premium services that are composed of expertise in translational sciences, integrated development, perhaps companion diagnostics, and definitely innovative regulatory sciences. My role is to set up a strategy and bring in my network to make sure we deliver on this promise.”

Are you looking for deep regulatory and strategic knowledge to support your drug development program?

Learn more about NDA Advisory Board and its members here.

Enhancing Pharmacovigilance

To give oncology products the best possible opportunity

By: Dr Brian Edwards, Principal Consultant, NDA Group 

In this article, Dr Brian Edwards follows on from his very successful webinar, Opportunities to enhance Pharmacovigilance in Oncology, to argue that to maximise the benefits of innovation in our products we need innovative pharmacovigilance.


We are witnessing a tremendous expansion in oncology products with great opportunities that will benefit patients. Regulatory agencies have responded with expedited review pathways and schemes to enable early access. Data sources such as patient reported outcomes and real-world evidence are being adopted, especially once the product is marketed. The products may often be dependent on biomarker kits which have arisen from the exciting progress in genomic and stratified medicine.

Throughout healthcare and the life sciences, technologies such as machine learning or artificial intelligence are being introduced with great expectation about increased cost efficiency and productivity. With this greater importance of pharmacovigilance (PV) within a changing environment, we need to adapt to recognise limitations of certain data so that the quality that can be reasonably expected will differ if we are to strengthen current standards of PV.

However, we put all this progress at risk if we do not respond effectively to warning signs about medical quality, timely follow up and completeness of adverse drug reaction (ADR) case reports that could undermine confidence in novel oncology products by impairing the ability to make informed decisions.

For that reason, in their 2015 Guidance, the FDA urges sponsors not to report all serious adverse events, including those where there is little reason to consider them suspected adverse reactions.* Study investigators agree. There seems to be misinterpretation of what should be sent to sites resulting in examples where all reported adverse events are sent to every site that conducts a trial that uses that agent, regardless of relevance.

The full article was published in Volume 69 Spring 2020 of Pharmafile – Therapeutic areas in focus. 

Click to the full article
 

To learn more about NDA’s Pharmacovigilance services and how we can help you, click here.

*Safety assessment for IND safety reporting guidance for industry, Food and Drug Administration, 2015, https://www.fda.gov/files/drugs/published/Safety-Assessmentfor-IND-Safety-Reporting-Guidance-for-Industry.pdf

Potential Consequences of SARS-CoV-2 to ongoing clinical programs

The FDA Perspective

By: Laurie Smaldone, CMO/CSO, NDA Group 

In this white paper, NDA’s Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.


Laurie Smaldone
CMO/CSO

The virus SARS-CoV-2 and the resulting COVID-19 disease have created devastating impacts around the globe on lives and livelihood, including major disruption of ongoing research and development activities for innovative therapies. From many perspectives the spread of SARS-CoV-2 has impacted and will continue to impact ongoing global registrational programs for a variety of disorders especially those not directly addressing the treatment or prevention of the SARS-CoV-2.

This disruption impacts all facets of the drug development process, from the Sponsor company, to the supply chain of investigational treatments to the productivity of study sites. The FDA has issued guidance to address the challenges that may arise from a range of disruptions that could impact the validity and integrity of clinical programs.

The FDA has noted that the spread of the virus may lead to GCP violations and protocol deviations, including impact on trial endpoints and safety collection.   FDA’s Center for Drug Evaluation and Research Director Janet Woodcock stated that “trials may be able to shift to tele-outcome assessments”, but others “may be damaged and may have to halt and not start up again until we can interact more freely”.

FDA’s recent guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”  addresses the potential impacts to ongoing trials.  The guidance provides stakeholders in the drug development and approval process with critical considerations for ongoing trials.

Potential COVID-19 impacts

Trials may be impacted in a variety of ways. Some sites have had to close down or have witnessed significant recruitment delays due to the inability of patient travel, illness, or redeployment of study personnel to address COVID-19 patients or trials.  These limitations can greatly impact study continuity and procedures to maintain study integrity.  In making decisions on trial continuity, Sponsors will need to do a robust   assessment of  trial conduct that may impact patient safety, GCP, drug storage and administration, and protocol procedures .

 

Click to read the full white paper

What did we learn from the 2009 pandemic?

By: Thomas Lönngren Strategic Advisor, NDA Group

In this commentary, NDA’s Thomas Lönngren discusses the regulatory learnings from the 2009 pandemic and how these are applicable to the current pandemic.


In April 2009 we were in the middle of an ongoing influenza pandemic and as the Executive Director of the European Medicine Agency I was ultimately responsible for the Agency’s response.

EMA’s responsibility was to ensure that we could get a vaccine approved as soon as possible and evaluate potential antivirals for the prevention and treatment of the infection. We also set up a robust surveillance system monitoring the safety of vaccines and antivirals when they were put on the market. All of this had to be done while ensuring that staff and experts working at the agency could continue to operate and deliver advice to developers of vaccines and antivirals while maintaining their own well-being.

One of these proposals was the idea to create what became known as the Mock-up vaccines. Specific guidance was developed by the Agency for an assessment procedure for pandemic influenza vaccines

 

It was an intense period with many meetings, ensuring the operation of the agency as well as daily teleconferences with European Commission, WHO, other regulators such as the FDA, and the industry. Luckily there were preparations in place.

When the pandemic broke out in April 2009 we were not taken by surprise. Warning signals came from WHO as early as the beginning of 2000. The SARS outbreak in 2002 had also served as a wakeup call. The outbreak of bird flu caused by H5N1 virus was an additional indication that a pandemic was imminent.

Click here to read the full commentary
 

To learn more about our how our advisors can support your drug development program click here

 

Related article: What do we need to know before the next influenza pandemic: by Vaccines Expert Peiter Neels

Medical Device Regulation: Key Changes and what it means for Combination Products

A Pharmafocus webinar

On Thursday 4th June 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, Dr Tina Amini, Medical Device Division Director, NDA Group will guide you through the key points to consider in your efforts to become Medical device regulation (MDR) compliant and focus on the implementation of MDR Article 117.

The EU MDR continues to provide challenges for the medical device industry and pharma/biotech companies.

Medical device manufacturers must meet new obligations under the new regulations such as correct classification of devices, general safety and performance requirements, UDI systems, new vigilance reporting timescales, sufficient clinical evidence, a person responsible for regulatory compliance and other obligations as per Article 10 of MDR. To date, only a few devices have been certified under the new MDR.

The regulation also impacts pharma/biotech companies. MDR Article 117 amends the medicinal product directive (Directive 2001/83/EC) and requires that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body depending on the device classification.

Manufacturers who are developing integral DDCs need to consider this change in requirements and assess the impact on their development programmes. Companies must identify a notified body to provide an opinion on the conformity of the device to the MDR. For some, this is a new and unknown process with no defined timelines.

Topics covered will include:

  • Medical Device Regulation key changes
  • Possible bottlenecks
  • The requirements of Article 117 as it applies to new drug/device combination marketing applications and variations
  • Notified Body selection and interaction process
  • Submission requirements to facilitate Notified Body review and the latest guidance with respect to Notified Body Opinions

To learn more about NDA’s Medical Device division and services click here


Click here to book your place today!


About the Speaker

Dr Tina Amini, a pharmacist with a PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group.

She has over 30 years’ experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry in a variety of disciplines.

 

 

Medical Devices and their growing regulatory challenges

By: Tina Amini, Division Director Medical Devices, NDA Group 

In this article, NDA’s Tina Amini explains what companies need to look out for in the growing area of device regulation.


Tina Amini

Recent scientific advances and improvements in enabling technologies have opened new avenues for convergence among medicines, diagnostics, and devices. The medical technology industry continues to be one of the most diverse and innovative sectors.

Major shifts in the health care environment including regulatory requirements make it increasingly difficult for medical technology companies to sustain traditional growth and profitability.

Why can we say that the regulatory challenges in the medical device field are growing?

With the introduction of the new Medical Device Regulation (MDR), and the pending In Vitro Diagnostics Regulation (IVDR), the regulatory landscape in the EU has undergone tremendous change. The new situation gives rise to uncertainties and unknowns and it will take time before it settles and becomes predictable again.

 

Why was the new regulation introduced?

“The new regulation aims to boost patient safety and effectiveness of all the medical devices that are commercialised but also to increase transparency to make the process clearer to everyone involved.”

“Shortcomings in the Directive in divergent interpretations also resulted in different output from the Notified Bodies. The new regulation attempts to address this as well.”

 

How does the new regulation change the European device market?

“The situation is currently uncertain. The delay in the database EUDAMED, an insufficient number of designated Notified Bodies, and lack of sufficient Guidance documents are all causing challenges. There is a lot of guess work awaiting official decisions and guidance. It is however certain that the new regulations will bring substantial change to how medical devices are brought to and maintained in the market.”

“The regulation also impacts the Notified Bodies as they have to be re-designated under new regulations. The time and cost associated with this has actually resulted in some Notified Bodies not applying for designation under the new regulations.”

“Up until now only eleven Notified Bodies have been designated under MDR, and three under IVDR and not all with full scope, compared to about 80 Notified Bodies that were operating under the MDD in the early 2010s. Today there are not enough Notified Bodies to pick up all the work. For companies this means longer timelines as you queue to have your product reviewed. We’re already seeing the manufacturers struggling to find a Notified Body to take them on.”

 

Article originally published in the April 2020 issue of Pharmafocus

Click to read the full article

How we can help?

NDA’s Medical Device Division has extensive experience with both medicines and medical devices. We can support you with your interactions with Notified Body  and assess your product from a scientific, technical, and regulatory perspective to be adequately prepared to meet the requirements. We also have the expertise to help manufacturers to implement the requirement of the MDR and IVDR regulations.

To learn more about how we can support your company, click here to see our full range of services.

Kurt Stoeckli joins NDA as President NDA Advisory Services

We are happy to announce and welcome Kurt Stoeckli to the team as President NDA Advisory Services.

Kurt brings significant experience from leadership positions in the pharmaceutical industry and has extensive expertise in the areas of immuno-oncology, autoimmune diseases and tolerogenic vaccination. His experience also spans medical devices and advanced digital e-health platforms.

As President of NDA Advisory Services Ltd, closely supported by Prof. Steffen Thirstrup, Director NDA Regulatory Advisory Board, Kurt will manage the operations, strategy and development of the NDA Advisory Board, including business development, sales, marketing and service development. His intimate understanding of the working conditions in large pharmaceutical, as well as small biotech companies, will enable him to ensure close interactions and a rapid response to the shifting conditions that these companies are facing.

The NDA Advisory Board comprises some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.

 

Johan Strömquist, CEO of NDA Group, commented on the appointment:

“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am delighted to welcome Kurt to our team. His experience, extensive network and industry reputation will break barriers and help us ensure that the best products get the attention they deserve. I very much look forward to working with him to help bring more good medicines to people all over the world.”

Kurt is joining NDA from Glenmark Switzerland where he was CEO and the groups global CSO. Prior to this he headed up the Biologics Division at Sanofi as Group VP & Global Head.

 

Steffen Thirstrup, Director NDA Advisory Board:

“Having Kurt on board is very exciting. He brings exactly the right blend of expertise and connectivity that is so important for us to have maximum impact on development of important therapies. His leadership experience and track record of launching new and bold initiatives will also be very welcome to our Advisory Board as we prepare to take the next step in our evolution.”

To learn more about the how the NDA Advisory board experts can support you and your drug development challenges click here

 

Webinar – Opportunities to Enhance Pharmacovigilance in Oncology

On Thursday 23 April 2020, 15:00 BST, 16:00 CEST & 10:00 EDT,  Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group, will discuss current best practices and opportunities for future improvement in oncology safety processes.

Oncology has seen tremendous advances in treatments with impressive results for some previously incurable solid cancers. This is best illustrated by immunotherapies such as immune checkpoint inhibitors. In addition, the use of predictive biomarkers helps identify patients who may truly benefit from treatment.

To maximise benefit of these therapies, we need to enhance pharmacovigilance. We are all keen to ensure pharmacovigilance work transforms from volume-based operations to value-based work through effective use of technology to allow automation and machine learning without comprising quality and early risk detection.

The use of accelerated procedures for regulatory approval means more and more that real world evidence gathering and assessment is deferred to the post-authorisation phase, putting more responsibility on pharmacovigilance professionals.

The webinar will focus on:

  • How best to increase operational efficiency using technology and the consistency of data quality when processing ICSRs, including applying severity grading and collecting patient reported outcomes
  • Novel approaches to signal detection when faced with large amounts of data
  • How best to manage off label use and medication errors
  • Planning for risk management of immunotherapy-related toxicity, which can be variable, occurring at any time throughout treatment or even after completion of treatment

To learn more about NDA’s Pharmacovigilance specialists and services click here


Click here to book your place today!


About the Speaker

Brian has a BSc (Hons), M. B. B.S., MRCP, MD.  and is a GMC registered physician with previous experience in hospital, renal medicine and clinical research, as a pharmacovigilance assessor in the UK regulatory authority (MHRA), clinical trials and post-marketing pharmacovigilance in a global CRO, deputy QP for pharmacovigilance at Johnson & Johnson. He joined NDA in 2007 and specialises in PV quality management and all aspects of safety compliance, risk management, QP for pharmacovigilance services, clinical trial safety.

In addition, Brian is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors group.

 

 

NDA Medical Device Division launched

We are proud to announce the creation of a new division within NDA, focusing on advice and support to companies facing increasing regulatory challenges in the device space.

The new medical device division is led by Dr. Tina Amini, formerly Head of Notified Body and Certification Authority at LRQA, and aims to support drug development and medical device companies under pressure from increased regulatory requirements.

Recent scientific advances and improvements in enabling technologies have opened new avenues for convergence among medicines, diagnostics, and devices. The medical technology industry continues to be one of the most diverse and innovative sectors.

Many innovative pharmaceutical and biotech companies find that their medicinal products rely on appropriate diagnostics or delivery systems operating under a different regulatory framework. Major shifts in regulatory requirements have put increased pressure on traditional medical technology companies to sustain growth and profitability.

The increased scrutiny by regulators on both sides of the Atlantic, most recently embodied in the new European Medical Device Regulation (MDR), has created challenges for these companies to achieve marketing approvals and certifications, as well as to remain competitive.

The increased dependence on sophisticated diagnostics for patient stratification, along with the convergence of the fields through advanced combination products creates new scientific and regulatory challenges – how do you assess this product? Is it a device or a medicine?

“It is clear that the impact of different types of medical technologies, including software, on drug development and other crucial medical interventions is enormous”, comments Johan Strömquist, CEO

NDA. “With the promise of big data and AI, as well as stratification of patients down to the genome level, this is a trend that will only continue to expand.”

He continues:

“We see that even the regulators are struggling to understand the convergence of these new technologies and it is in such areas where clear advice and guidance is most valuable to innovative companies. With the creation of the NDA Medical Device Division, we are taking a crucial step to formally move into this area to partner with our clients on the medical device aspects of their development programs as well.”

NDA Group’s ambition to leverage synergies between drugs and devices has provided the company with a special focus for the new division. The challenges associated with borderline classifications, drug / device combinations and in-vitro diagnostics are core points for the new division.

Dr. Tina Amini, Division Director, Medical Devices, comments:

“The clear focus for us is to support companies with the medical device aspects of their development program to enable access to the market for the medicines that these products enable. NDA Group’s excellence in the field of medicines is now complemented by an impressive understanding of the regulations surrounding medical devices on both sides of the Atlantic.”

She continues:

“Being able to work with one partner to address the regulatory development challenges for both the drug aspects and the device aspects of their product is going to be a game changer for many companies. This will expedite faster access to market and will create great efficiencies compared to trying to manage and coordinate multiple vendors. When you pair that up with the unprecedented experience and expertise of the NDA team you’ve got an unmatched resource that will be able to make a huge difference in getting the right products to market as quickly as possible.”

Learn more about our new Medical Device Services here 

or

Contact us now to talk about how we can support your team.

ATMP and Market Access seminar in Sweden – Postponed

As a result of the increased spread of the Corona virus and due to the Public Health Agency’s now changed assessment of the risk level for the spread of the virus – an increase in risk level to “Very High risk” we have decided to postpone our planned seminar: Optimizing the path to market for ATMP’s.

We hope to reschedule the seminar later in the year and we will provide you all with more information closer to the time.

If you would like to talk to one of our team about how we can support, you and your teams drug development program please do not hesitate to contact us.

Kind regards

NDA Group & Cirio Advokatbyrå

 

NDA Group and Cirio Advokatbyrå would like to welcome you to our breakfast seminar, Optimizing the path to market for ATMPs.

Our presenters will discuss integrated product development for ATMPs to meet regulatory and HTA requirements and models for realizing product value.

Date: Tuesday 31st of March 2020 – Postponed
Time:  08:30- 11:30 (Breakfast served at 08:30, seminar starts at 09:00)
Venue: Cirio Advokatbyrå, Mäster Samuelsgatan 20, 8th floor, Stockholm
Registration: RSVP by Friday 27th March 2020

This seminar is focused on the challenges of ATMP development and market access with case examples of approved products. The option of an integrated product development to cover both regulatory and HTA expectations will be presented, together with information on regulatory, HTA and market access support available for ATMP developers

Our speakers for the day:

  • Paula Salmikangas, Director of Biopharmaceuticals and ATMP, NDA Group
  • Ben Continsouzas:  Senior Consultant, Project Manager at NDA Advisory Service
  • Per Hedman, Partner, Cirio Law firm
  • Anders Burén, Senior Counsel, Cirio Law firm

We would like to meet you at the DIA 2020

Are you and/or your team attending the DIA next month?  Stop by our booth, D5, and talk to one of our team about how we can support you to optimise your path to approval.

We know that the path to drug approval is littered with pitfalls which can lead to unnecessary delays getting your medicine to the people who need it the most – the patients.

Working together we can:

  • Accelerate your drug development program to reduce your time to approval
  • Optimise the management of the regulatory process to provide accurate and predictable outcomes
  • Reduce your risks and increase the probability of gaining Market Authorization

In addition to our team at the booth we have some great speakers sharing their knowledge in different forums throughout the conference, see below:

 


Brian Edwards – Principal Consultant

Tuesday, March 17th, 12:15-13:40, Regulatory Science Hub – Poster Presentation -#CHR 102: Skills, Communication and information in Pharmacovigilance – Oral Poster Presentations

 

 


Dr Mira Pavlovic – HTA Expert, NDA Regulatory Advisory Board member

Wednesday, March 18th, 12:00 – 13:15, Hall 300 – Session- #S0407: Drug Assessment for Regulatory and HTA Purposes: Similarities and Differences, the Way Forward

 

 


Prof. Beatriz Silva Lima – Non Clinical Expert, NDA Regulatory Advisory Board member

Wednesday, March 18th, 10:30 – 11:45, studio 214 +216 – Session – #DL04: Industry – Regulator Dialogue: Tailor-made Regulatory Guidance for Non-clinical to Clinical Development

Panelist: How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe

More Information

Thursday, March 19th, 10:30 – 11:45 Panoramic Hall –  Session- #S0512/0612: Panoramic Hall – Regulatory Science Training and Network in European Academia

Session Chair: Beatriz Silva Lima

RegSci Training actions in Portugal and beyond
Speaker: Beatriz Silva Lima.

More information


Click here to download the Preliminary Programme.


Pre-book a meeting with one our team

To book a meeting contact meet-us@ndareg.com we look forward to seeing you at the in Brussels!

Hopes and challenges in the future of the immuno-oncology field

There is no doubt that the area of oncology development has exploded in the last few years. The global oncology pipeline at the end of 2019 had almost doubled since 2014, reaching an all-time high with 374 drugs entering Phase 1 and the approval of several new drugs with unique modes of action. But all is not rose-tinted news, in this article published in the February addition of Pharmafocus, Dr Laurie Smaldone Alsup, Chief Medical and Chief Scientific Officer at NDA predicts some challenges in the field of oncology.

“Historically, clinical trials are designed so that the patient is relatively unencumbered by other diseases, to make it easier to assess whether the drug works or not. But in reality, people may be elderly, have organ failure and/or have other disorders that require chronic medications for other conditions. Understanding how these new therapies behave in the real world is critical”

 

Click here to read to Article

Webinar – Demonstrate, Communicate and Negotiate Successfully with Payers

Join us on Thursday 12th of December 15:00 GMT, 16:00 CET, 10:00 EST for this engaging webinar presented by Claes Buxfeldt, HTA Director NDA Advisory Board and Lisa Peluso, Director of Coaching and Client Engagement, PharmApprove.

Advanced medical treatments, including cell and gene therapies, are on the cusp of changing medical care around the globe. Developing and communicating cutting-edge science demands rigorous planning to mitigate challenges and set up your product for successful market access.

New treatments are complicated and competition is fierce. Are you planning appropriately to demonstrate the data you need, communicate effectively and be in a position to negotiate successfully with payers? Join this informative webinar to hear from HTA and Value Communications experts Claes Buxfeldt and Lisa Peluso on how to:

  • Steer development teams to demonstrate value, manage uncertainty in data and leverage external advice
  • Educate stakeholders early – from your internal team to payers – to ensure alignment and clarity around value and positioning
  • Create and deliver the clinical narrative of the data
  • Communicate complex data and science effectively and handle objections with confidence
  • Negotiate successfully with decision-makers

Waiting until submission time to align and prepare to communicate value is a mistake your team can’t afford to make. Sign up for this webinar to hear how to communicate impactfully to clear a path for a successful value journey to patients.


Click here to book your place today!


 

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.

Lisa helps development teams, doctors, patients and advocates to create and deliver clear, consistent, and convincing messages to regulators in the US and Europe. Lisa has coached hundreds of individuals and provided presentation/Q&A training and workshops to teams in pharma and biotech, and has helped over 45 clinical development teams prepare to present at FDA Advisory Committee meetings and EMA Oral Explanations. Her experience and familiarity with high-stakes regulatory meetings allows her to get to the heart of the challenge, and she excels at giving presenters and responders clear and actionable feedback, to instill confidence and help them communicate with clarity and impact. Prior to joining PharmApprove, Lisa worked at Kyowa Pharmaceuticals, where she supported both commercial and clinical teams and served as the principal liaison between the Tokyo, UK and US offices. Lisa spent 12 years in Japan, where she worked in communications in the legal, financial and hospitality industries.