How to Keep up With The Fast-Evolving World of ATMPs

Join us on Thursday 19th November 2020, 15:00 GMT | 16:00 CET | 10:00 EST, when Dr Paula Salmikangas and Professor Steffen Thirstrup discuss how to keep up with the Fast-Evolving World of ATMPs.

The development of novel advanced therapy medicinal products (ATMPs) is moving fast, as witnessed by the growing number of products appearing in clinical trials. Investments and ATMP developers are also increasing worldwide. Innovative technologies like gene editing have enhanced the design of products to better target the indications – for example, by allowing the move from autologous products to allogeneic, off-the-shelf products.

Advances in virus vector production systems have greatly improved the safety profiles of current gene therapy products. However, the design and engineering of ATMPs are becoming more and more complex, which brings new and possibly unknown risks and regulatory concerns. The availability of non-clinical models for safety testing is limited for these products and it may be that some risks are identified only through human exposure; this requires careful planning of the clinical studies and robust strategies for risk mitigation and long-term pharmacovigilance.

The challenges of persistency and immunogenicity for some products, such as adeno-associated viruses (AAVs), are currently hampering their long-term effectiveness and the overall clinical outcomes. Outstanding efficacy results for approved products like Kymriah®, Yescarta®, and Zolgensma® are strongly encouraging the field towards curative treatments, but the risks related to novel technologies should remain manageable and well-controlled to ensure real benefits for patients.

The key discussion points of this webinar will include:

  • An overview of the current status of approved ATMPs and those in clinical trials worldwide
  • Recognition of novel manufacturing technologies and their perceived risks
  • Understanding the pros and cons of non-clinical studies, including risk identification and mitigation strategies
  • An update on recent clinical results and new trial designs, including histology agnostic trials

 

Click to book your place today

If you require further information, please do not hesitate to contact us.

 

We are expecting this webinar to generate a lot of audience interest, so please send in your questions now to ensure the speakers have time to answer them in the Q&A: email our moderator on conor@pharmafile.com. If your question is for a specific presenter, please include this in your email.


Speakers:

Dr Paula Salmikangas, Director of Biopharmaceuticals and ATMPs, NDA Group

Paula is the Director of Biopharmaceuticals and ATMPs and has been at NDA since 2017. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and the CMC aspects of biopharmaceuticals. As a former EU regulator, Paula was actively involved in establishing the regulatory guidelines for ATMPs and applies her unique experience to provide companies with technical & strategic advice for their drug development programs.

 

Professor Steffen Thirstrup, Director NDA Advisory Board, NDA Group

Steffen has been with NDA since 2013 and excels at advising companies on their development strategies to meet the expectations of regulatory agencies around the world. He applies his skills to a broad range of therapeutic areas and has successfully helped numerous clients interact with regulatory agencies throughout the stages of development and during regulatory review.

 

Moderated by Conor Kavanagh, Journalist and Editorial Assistant, Pharmafocus

 

Leveraging Expedited Regulatory Pathways to Optimize Drug Development

A Pharmafocus webinar

Join us on Thursday 24th September 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, when Dr Frank Casty, Judith Plon and Professor Steffen Thirstrup will guide you through the expedited regulatory pathways available in the EU and US and discuss how to effectively leverage these to accelerate and optimize your drug development program.

A timely market introduction is a critical component of any drug development strategy – not only from a commercial standpoint, where an earlier market entry can lead to a competitive advantage, but also for patients awaiting better treatment options.

Regulators worldwide have developed specialized pathways to expedite review and approval of new drugs. Navigating these pathways can be a daunting task for sponsors.

Partnering with experienced regulators both in the US and EU is critical to achieving expedited reviews since getting the strategy right, developing effective documentation, and preparing for regulatory interactions can make the difference between a standard regulatory review and a successful expedited review

Our panel will discuss:

  • Which pathways are available
  • When to apply for specific designations
  • What data are required and what to expect if the designation is granted
  • Best practice to create a successful strategy

Click here to book your place today!


About the Panel

Dr Frank Casty: Senior Clinical Regulatory Advisor, NDA Group

Frank works with small and large companies across several therapeutic areas including cardiovascular, respiratory, inflammation, oncology and rare diseases.  He has led numerous FDA interactions, IND and NDA filings as well as presented at successful FDA Advisory Committee Meetings.

Before joining NDA, Frank worked for more than 25 years in small and large pharmaceutical companies leading Global Clinical Research and Medical Affairs organizations as well as serving as technical consultant for Business Development activities.

Judith Plon: Principal Consultant, NDA Group

Judy works with small and large companies across multiple therapeutic areas. She serves as a US Agent for clients leading the submission of their INDs, NDAs, and special designation requests (i.e. Orphan Drug Designations).

Prior to joining NDA Judy spent over 25 years in the Biopharma Industry, primarily working in the discipline of regulatory affairs. She held positions of increasing responsibilities and last served as a Vice President of Global Regulatory Affairs.

Professor Steffen Thirstrup: Director NDA Advisory Board, NDA Group

Steffen excels at advising companies on their development strategies to meet expectations of regulatory agencies around the world. He applies his skills to a broad range of therapeutic areas and have successfully helped numerous clients interact with regulatory agencies throughout the stages of development and during regulatory review.

Prior to joining NDA in 2013, Steffen was employed as the head of Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority where he also acted as Danish member of the Committee for Human Medicinal Products (CHMP) at the EMA.

 

 

Optimising the path to market for ATMPs

A two part webinar series

Together with Cirio Advokatbyrå would like to invite you to our two-part interactive webinar series, Optimising the path to market for ATMPs.

ATMPs, Advanced Therapy Medicinal Products, are an increasing and diverse group of innovative products. They are complex  products with unique development challenges, and several have shown very promising efficacy results in treating highly debilitating diseases and conditions. However, the prices of the first approved ATMPs have been high and not always supported by the national pricing or reimbursement bodies or other payers.

This interactive webinar series will focus 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.

Session 1: Integrated Product Development for ATMPs to meet Regulatory and HTA requirements

Date: 22nd September

Time: 11am – 12pm CET

Session 2: Models for realizing ATMP- value

Date: 29th September

Time: 11am – 12pm CET

Our panelists are available to answer questions at the end of each session. You can ask your questions during the webinar or send them in advance to denise.stromquist@ndareg.com


Click here to book your place today!



Panelists 

Paula Salmikangas: Director of Biopharmaceuticals and ATMP, NDA Group

Paula joined NDA in 2017 from her position as a Research Professor at the Finnish Medicines Agency (2003-2017). She has served as a member of the EMA Committee for Advanced Therapies (CAT) from 2009 to 2017 and as the Chair of the CAT 2014-2017. She has also been the Chair of EMA CPWP and a member of the BWP. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals.

Steffen Thirstrup: Director NDA Advisory Board, NDA Group

Steffen joined NDA in 2013 from his position as head the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority where he alos acted as Danish member of the Committee for Human Medicinal Products (CHMP) at the EMA. Steffen excels at advising companies on their development strategies to meet expectations of regulatory agencies around the world. He applies his skills to a broad range of therapeutic areas and have successfully helped numerous clients interact with regulatory agencies throughout the stages of development and during regulatory review.

Anders Burén: Senior Counsel, Cirio Advokatbyrå

Anders specialises in strategic collaborations in the pharmaceutical industry and in regulatory law. He advises on Swedish and international aspects of agreements of all kinds governing research, development and commercialisation in the pharmaceutical industry and on product approvals, marketing and other regulatory considerations. Anders has previous experience as Assistant General Counsel for the AstraZeneca Group’s transaction lawyers based outside the US. Before that he was Assistant General Counsel for the Group’s lawyers based in Sweden.

Per Hedman:  Partner, Cirio Advokatbyrå

Per Hedman is head of Cirio’s Life Science, Health and Food practice – the Biological team. Per advises companies in all aspects of their business and legal affairs, including regulatory advice, R&D arrangements (such as non-disclosure, material transfer, clinical trial and joint development agreements), commercial relationships (such as manufacturing, supply and distribution agreements), M&A (such as product acquisitions and spin-outs, domestic and cross border), capital-raising transactions (debt and equity), and IPO:s and other capital market transactions.


To learn more about NDA’s ATMP capabilites click here


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.

 

 

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.

 

 

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.

 

 

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!

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.

Optimizing Value – Regulatory and Market Access Considerations

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.

In this seminar our presenters will share their experiences and provide their insights and considerations to optimize the value of your development program.


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

Presenters: 

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

 

 

Stephanie Krumholz, General Manager of the Swiss NDA Affiliate with a demonstrated history of working in the pharmaceuticals and biotech industry across multiple therapeutic areas in all phases of drug development. Expertise in EU, US and Swissmedic Marketing Authorisation Filings and conducting Due Diligence for clients.

 

 

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 HTA 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.

 

 


Agenda

09:00 am  –  Welcome – Claes Buxfeldt, Director NDA HTA Advisory Board and Stephanie Krumholz, General Manager NDA Switzerland
09:15 am  –  Session 1: Challenges in drug development – Professor Steffen Thirstrup
10:15 am  –  Coffee break
10:35 am  –  Session 2: HTA and Europe – where are we heading? – Professor Mira Pavlovich – Ganascia
12:05 am  –  Concluding remarks and take home messages
13:15 – 15:30 pm  –  Ask the Experts – To book a 20 min slot to speak directly with our experts send an email to anna.perrin@ndareg.com


Date: Tuesday 3rd of December 2019

Time: 09:00 am – 12:15 pm (with the opportunity to book 1-1 meetings from 13:15)

Venue: Bio-Technopark, Auditorium, Wagistrasse 25, 8952 Schlieren

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 zurich@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 29th November 2019 to zurich@ndareg.com

Contact: Stephanie Krumholz, General Manager Switzerland, +41 78 951 9929, or email s.krumholz@ndareg.com

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

 

We look forward to seeing you there!

 

 

 

Let’s celebrate the launch of our new service: NDA Accelerator!

On the 21st of October we will be launching our new NDA Accelerator service in The Nordics and we think this is well worth celebrating, so why not join our team on Friday the 18th of October for drinks, snacks and networking of course.

Date: 18th October 2019
Time: 16:15 – 18:00
Place: 7A Centralen, Vasagatan 7, Stockholm
On the menu: Champagne and snacks

For more information and to register email denise.stromquist@ndareg.com

NDA Accelerator
Our NDA Accelerator is a unique resource to support small biotech companies in The Nordics. It brings together specially designed services, unique thought leadership and personal and team training opportunities in one place all created with needs of small biotech companies as the focus. NDA Accelerator allows you to do more with the resources you already have.

To learn more and register your interest click https://teaser.ndaaccelerator.com/

 

 

Meet the NDA Experts in October

October is a busy month for our NDA experts and there are plenty of opportunities to meet them and discuss your challenges within regulatory and drug development.

We are participating in several events across the globe. If you would like to book a time to speak with one of our experts, contact us!

 

Niamh Kinsella, Andrew Monaghan and Helen Measures
are attending:

Topra Annual Symposium

Where: Dublin, Ireland

When: 30th Sep – 2nd Oct

Booth: # 32

 

 

Laurie Smaldone Alsup
MD, CSO/CMO NDA Group, is chairing a panel session at:

LSX World Congress USA

Where: Convene Convention Center, Boston, USA

When: 7th – 8th Oct

Session: Executive Panel: De-risking the Regulatory Approval Path – How to Optimize you Investment Dollars

Christian Redondo-Müller and Andrea Aschenbrenner
are attending:

European Biotech and Pharma Partnering Conference 

Where: Osaka, Japan

When: 8th Oct

and

Bio Japan 2019 

Where: Pacifico Yokohama, Japan

When: 9th – 11th Oct

Booth: D 53-6

Brian Edwards
Principal Consultant, Pharmacovigilance & Drug Safety NDA Group, is speaking at the:

DIA Learning Course

Where: Basel, Switzerland

When: 14th – 15th Oct

Session:  The Pharmacovigilance Quality Management System

Barbara Clendenen and Alison McGregor
are attending:

Bio Investor Forum

Where: San Fransisco, California

When: 22nd – 23rd Oct

Thomas Lönngren
Strategic Advisor NDA Group, is speaking at:

AusBiotech 2019 

Where: Melbourne, Australia

When: 30th Oct – 1st Nov

Session: Best practice biotech – Building your board

 

If you are interested in booking one of our experts to speak at your event, contact us.


 

Navigating the Regulatory Maze – Early Stage Development Strategies

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

This seminar will focus on describing the strategies and benefits of implementing a stage-gate approach in early non clinical development and for Phase 1 clinical development.


Benefits include:
  • Clear go no-go decision points
  • Higher probability of success moving from non clinical to clinical phase
  • Clear and favourable exit strategies

Presenter: Dr. Niamh Kinsella

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

 


Agenda

10:00 am    Registration and coffee
10:30 am    Welcome: Dr. Stephanie Krumholz, General Manager NDA Switzerland
10:40 am    Presentation: Navigating the Regulatory Maze – Dr. Niamh Kinsella
11:30 am    Question and answer session
11:50 am    Closing remarks
12:00 pm    End of seminar

13:30 – 17:00 Take the opportunity to book a one to one 30 min meeting to speak directly with our experts.

Email zurich@ndareg.com to book your time now.


Date: 31st October 2019

Time: 10:00 am – 12:00 pm (with the opportunity to book 1-1 meetings afterwards)

Venue: Bio-Technopark, Auditorium, Wagistrasse 25, 8952 Schlieren

The seminar is held in collaboration with Bio-Technopark® Schlieren-Zürich and will be an open and interactive workshop with the opportunity to ask questions. Specific questions can be sent in advance to zurich@ndareg.com

Registration: RSVP by Friday 25th October 2019 to zurich@ndareg.com

Contact: Katharina Gerstl at katharina.gerstl@ndareg.com

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

 

We look forward to seeing you there!

 

 

 

Webinar – Integrated Product Development for ATMPs to Meet Regulatory and HTA Requirements

Join us on Thursday 3rd October 15:00 BST, 16:00 CEST, 10:00 EDT for this engaging webinar where Dr Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board and Claes Buxfeldt, HTA Director NDA Advisory Board will describe an integrated product development process for ATMPs, which will take key aspects of both reviews into account from the beginning, thus ensuring a positive path from clinical trials up to pricing and reimbursement.

Advanced Therapy Medicinal Products (ATMPs, or cell and gene therapy and tissue engineering products) is an increasing group of innovative products, often targeting diseases and conditions with high unmet medical need.

The success of first CD 19 CAR T products against B-cell malignancies has raised awareness of the high potential of these new products, but also shown the several challenges relating to their manufacturing and regulatory approval. The prices of the first approved ATMPs have been high and not always supported by the national pricing and reimbursement bodies.

In such cases, the discrepancy between regulatory approval and negative result of a health technology assessment (HTA) has raised concerns and questions within the industry, as to how to ensure an approved product also gets to the market and patients. Many jurisdictions have created early access schemes and ways to communicate with regulatory and HTA bodies early on to ensure successful outcomes of both reviews. However, the ATMP industry is facing challenges in both aspects.

Why you should attend:

  • See how the regulatory and HTA expectations differ
  • Learn how to build an Integrated Regulatory / HTA Product Development for ATMPs
  • Identify the need for interactions with regulatory and HTA authorities

Click here to book your place today!


 

Paula is a clinical biochemist by original training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. Paula joined NDA in 2017 from her position as a Research Professor at the Finnish Medicines Agency (2003-2017). She has served as a member of the EMA Committee for Advanced Therapies (CAT) from 2009 to 2017 and as the Chair of the CAT 2014-2017. She has also been the Chair of EMA CPWP and a member of the BWP. Her main areas of expertise are biological medicinal products, especially advanced therapy medicinal products and CMC aspects of biopharmaceuticals.

 

Claes joined pharma-industry in 1992, have close to 20 years’ experience working in local and global market access and health economics positions, in a variety of disease areas. Prior to joining NDA he spent 10 years at AstraZeneca starting as a Value Demonstration Leader in Global Health Economics & Outcomes Research, and most recently as the Global Price & Reimbursement Director in Respiratory & Inflammation, in addition to CNS/Pain.
He has supported more than 30 molecules/brands in development in a global position. He has represented the payer voice in many development programs, including the development of payer evidence strategies, pricing and market access strategy, economic models, PROs, RWE and clinical program input. Claes has a MSc from University of Karlstad and more recently a postgraduate diploma in health economics from University of York.