Free Webinar – Be Heard: The Patient Voice at FDA Advisory Committee Meetings

In recent years, the global trend in drug development has included more active and influential patient activity. Patient and caregiver voices have become a key part of the regulatory process, and FDA Advisory Committee Meetings are no exception. At the Open Public Hearing (OPH) part of these meetings, patients have an opportunity to educate the committee and the Agency, impact regulatory decision-making and even help guide the future of drug development. This is particularly important for rare disorders. 

Join us on September 27th, 15:00 UK / 16:00 CEST / 10:00 EDT, for this engaging webinar where NDAs Lisa Peluso, Director of Coaching and Client Engagement, will cover:

• Quick guide to FDA Advisory Committees
• The Open Public Hearing and what it means
• Registering, Preparing, Delivering
• Tips on making sure your voice is heard

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

Click here to book your place today.

Lisa Peluso is Director of Coaching and Client Engagement at PharmApprove/NDA, where she 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.

 

 


 

Meet NDA at the DIA Annual Meeting in Boston

 

 

 

 

 

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

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

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

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

 

TWO OF OUR EXPERTS WILL BE PRESENTING AT THE EVENT:

 

Shelley Gandhi – Strategic Advisor, Pharmacovigilance & Drug Safety

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

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

 


Dr Brian Edwards – Principal Consultant, Pharmacovigilance & Drug Safety

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

 

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

Host Community: Clinical Safety & Pharmacovigilance

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

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

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


Click here to download the Final Programme.


MEET US AT THE DIA ANNUAL MEETING IN BOSTON

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

 

CAR T-Cells for Cancer Immunotherapy – Moving Target for Industry?

NDA’s Paula SalmikangasNiamh Kinsella and Paul Chamberlain have co-authored the article “Chimeric Antigen Receptor T-Cells (CAR T-Cells) for Cancer Immunotherapy – Moving Target for Industry?

Read the full article written by Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board, Niamh Kinsella, Principal Consultant, VP Early Stage Development and Paul Chamberlain Biopharmaceutical and Immunogenicity Expert which discusses the product-and patient-related variables that may pose challenges for the industry and developers both from the scientific and regulatory perspective.

This will be featured in Volume 35, Issue 8, August 2018 – in the Topical Collection of Pharmaceutical Research and is currently available online.

Pharmaceutical Research is an Official Journal of the American Association of Pharmaceutical Scientists, which presents papers that describe innovative research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval. Small drug molecules, biotechnology products including genes, peptides, proteins and vaccines, and genetically engineered cells are an integral part of papers published here.

Meet us at BIO International Convention in Boston

We look forward to attending the 2018 BIO International Convention at the Boston Convention and Exhibition Center June 4-7th.

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.

The following individuals will be representing NDA Group as we participate in a week of networking and education with 16,000+ attendees from 74 countries. If you would like to arrange a face-to-face meeting with the NDA Group Team, please contact Barbara Clendenen, who will be happy to assist barbara.clendenen@ndareg.com

 

Barbara Clendenen, Director, Business Development

 

 

 

 

 

Eva Lilienberg, Service Area Lead, Global Development

 

 

 

 

 

Dr Laurie Smaldone Alsup, COO and CSO

 

 

 

 

 

 

Tony Baker, VP Strategic Development

 

To read more about the event click here.

 

Dr. Thomas Lönngren to Present at the Chief Medical Officer Summit, May 7th

Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the European Medicines Agency (EMA), has been invited to present at the Chief Medical Officer Summit, Omni Parker House, Boston, MA on 7th May. 

Thomas will present along with Jeffrey Sherman, CMO, EVP R&D, Horizon Pharmaceuticals, in the session ‘Taking a Strategy Approach to Global Regulatory and Market Access Challenges’, were they will discuss:

  • Is a global regulatory and market access strategy the way to go?
  • Why isn’t EMA approval the same as market access in Europe?
  • What is the difference between EMA and FDA in regulating and approving medicines?
  • When and how to generate evidence that will satisfy regulators and payers
  • What is the best strategy to interact with regulators and payers?
  • Early access schemes in EU and how to qualify
  • How will trends like Real World Evidence influence regulatory decision making?
  • Brexit and its consequences for the EU regulatory system and how will it affect pharmaceutical companies

As well as presenting at the event, NDA Group is ‘Associate Sponsor’ of the CMO Summits, demonstrating its commitment and support towards the CMO community.

Please come by booth #2 and meet us;

  • Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the EMA
  • Laurie Smaldone-Alsup, MD, COO/CSO
  • Barbara Clendenen, Director, Business Development

The CMO conference is an annual gathering for physicians and scientists in biotech to exchange best practices in the advancement of drug development and business management. Although the program is primarily designed for CMOs of emerging biotech companies, CMOs of large pharma and other R&D decision-makers will also benefit.

To find out more about the event click here.


Meet NDA Group at PEGS Boston

NDA Group will be attending PEGS Boston, that takes place in Seaport World Trade Center, Boston April 30 – May 4, 2018

NDA supported over 40% of the new medicinal products that were approved in the EU during 2013 -2017. In 2016 NDA acquired PharmApprove, the market leader in managing critical FDA interactions to help us achieve the same results in the US.

If you are planning to attend this year’s PEGS, we would really like to meet up with you. We will have a few of our experts available at the event at booth 437:

  • Dr Niamh Kinsella, Biologics Expert
  • Dr Jenny Sims, Non Clinical Expert
  • Dr Josefin-Beate Holz, Clinical Strategy Expert

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

Presentations

Three of our experts will present at the event:

 

Jenny Sims: Monday 30th April 12.20 pm, Immunogenicity Case Studies and Clinical Management Track.

Title: Early Development Strategy for Bacterial- or Viral-Vectored Gene Therapies: 2 Case Studies

Josefin-Beate Holz
Monday 30th April and Tuesday 1st May, Poster Session A
Developing an Integrated Summary of Immunogenicity (ISI) to Effectively Manage Regulatory Risks in Product Development

Niamh Kinsella
Wednesday 2nd May and Thursday 3rd May, Poster Session B
Maximising Value in Early Development

 

 

Click here to find out more about the event.

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

Meet NDA at DIA Europe 2018

We will be attending in full force during this year’s DIA Europe Meeting 17- 19 April, in Basel, Switzerland.

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: 72 & 73 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,
  • Dr Thomas Lönngren, Former head of the EMA and strategic advisor to NDA Group
  • Professor Steffen Thirstrup, Clinical development and regulatory strategies Expert
  • Dr Markku Toivonen, Clinical development and clinical strategies Expert
  • Shelley Gandhi, Ex MHRA regulator, Pharmacovigilance & Drug safety Expert

In addition, there will be many of 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 72 & 73.

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:

 

Shelley Gandhi – Strategic Advisor, Pharmacovigilance & Drug Safety
Dr Bill Richardson – Medical Assessor, Pharmacovigilance & Risk Management Expert
(Pre-Conference Short Course)
Short Course 3 | Mon, 16th April – 14:00-17:30
Moving from Risk Management to Benefit-risk Management-Embedding Pharmacovigilance Principles into the product life cycle


 

Prof. Beatriz Silva Lima – Non clinical Expert
DIAlogue 2 – Session 1100 | Tues, 17th April – 14:00 -15:30
The New EMA first-in-human (FIH) guideline Part1: Non – Clinical aspects

 


Dr Brian Edwards – Principal Consultant, Pharmacovigilance & Drug Safety
Session 0502 | Wed, 18th April – 14:00-15:15
Innovative approaches to safety information
A proposal for a new systems-based approach to medication errors

 


Shelley Gandhi – Strategic Advisor, Pharmacovigilance & Drug Safety
Session 0504 | Thurs, 19th April – 08:30-10:00
Five years on – pharmacovigilance legislation Delivers on long-promised elements

 


Click here to download the Preliminary Programme.


 

Meet us at DIA Europe 2018

 

To book a meeting contact Anna Perrin: anna.perrin@ndareg.com or visit us at booths 72 & 73.
We look forward to hearing back from you about a meeting and to seeing you at the event!

 

Meet us at the DIA and BIO International conventions

DIABIO1

 

 

 

This June, NDA will be attending the DIA USA and BIO convention with a strong line-up of world-leading speakers and experts.

The 53rd DIA Annual Meeting 2017 is being held on June 18-22, at McCormick Place, Chicago. Whilst, the BIO International Convention is on June 19-22, at San Diego Convention Center, San Diego.

If you are planning to attend this year’s DIA or BIO, we would really like to meet up with you. If you’d like to arrange a meeting with us, please email anna.perrin@ndareg.com.

Hear the experts

NDA’s experts will present on a number of critical drug development related topics at both the DIA and the BIO meeting.

NDA at DIA USA

Neelu AgarwalPete_TaftNeelu Agrawal, Principal, PharmApprove

Pete Taft, Founder and Chief Executive Officer, Taft and Partners/PharmApprove

 

Tutorial:  Preparing for a US FDA Advisory Committee Meeting
Track: 5 Regulatory Affairs #30
Day: Sunday June 18
Time: 13:00 – 16:30

Shelley_GandhiShelley Gandhi, Pharmacovigilance and Drug safety Expert expert, NDA Group
Title: The Good Pharmacovigilance Practices in the EU: Global Applications
Track: 6 Safety & PV #43
Day: Sunday June 18
Time: 09:00 – 17:00

Title:  Future Regulatory Goals of the Periodic Benefit-Risk Evaluation Reports (PBRER ): Are They Being Achieved?
Track: 6 Safety & PV #280 Developing Pharmacovigilance Policy based on Impact
Day: Tuesday June 20
Time: 16:00 – 17:15

Lesley_WiseLesley Wise, Principal Consultant, Pharmacoepidemiology, NDA Group
Title: Incorporating Patient Preferences in Benefit-Risk Assessments: Interpreting ICH M4E (R2)
Track: 4 Patient Engagement, Forum #251 Defining the Science of Patient Input to Enhance Drug Development & Approval: Regulatory
Day: Tuesday June 20
Time: 14:00 – 15:15

 


NDA at BIO USA

Lisa-PelusoMarkku ToivonenLisa Peluso, Director Coaching and Client Engagement, PharmApprove

Markku Toivonen, Scientific Director, NDA Group

 

Title: Bridging the Atlantic: How to Involve Patients in Orphan Drug Development and Approval Processes Given Differences between FDA and EMA
Day: Wednesday June 21
Time: 15:00 – 16:00 Room 3

 


To find out more or schedule an appointment with members of the NDA team, please email anna.perrin@ndareg.com

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

 

About NDA
NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services span Development Strategy, Translational Science, Procedure & Submission Management, High-Stakes Meetings and Process Design & Optimisation. Clients are supported by a team of over 150 regulatory affairs, health technology assessment, pharmacovigilance, quality assurance and strategic communications professionals. Backing all major NDA projects is the unique NDA Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. Learn more at www.ndareg.com and follow them at www.linkedin.com/company/nda-group-ab.

About PharmApprove
The NDA PharmApprove team comprises leading strategic, regulatory, and scientific communications professionals. PharmApprove focuses on strategic and tactical support to companies facing high-profile, high-stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at https://www.pharmapprove.com/ and follow them socially at twitter.com/pharmapprove.

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA EuroMeeting in Glasgow

Drop in US drug approvals but no similar trend is seen in EU

GLASGOW, Scotland, March 28, 2017 /PRNewswire/ — NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the United States, ahead of this year’s DIA EuroMeeting in Glasgow. This year’s Status of New Drug Approvals report emphasises the need for a streamlined global development and commercialisation process across the world’s two biggest markets.

The report – based on preliminary research figures from the EMA and FDA websites in January 2017 – found that there has been a drop in US approvals but not in EU. For 2016 there were 74 new drug approvals granted in the US and EU. Of these new products, 19 were approved only in the EU, 19 only in the US, and 36 were granted in both regions. However 17 drugs that were approved in the EU in 2016 had received prior approval in 2015 or earlier in the US, while only six products registered in the US in 2016 were previously approved in the EU.

Johan Strömquist, CEO, NDA Group “Understanding the evolving regulatory landscape and requirements is a key concern for the drug developing industry, as is it for us at NDA. It is intriguing to see how expedited pathways shape this year’s statistics just like it did last year, but with a very different outcome. It’s also interesting to see the continued rise of smaller companies in the percentage of products taken to market.”

“Our analysis for 2016 shows that NDA maintains an exceptional position in supporting new drug product approvals in Europe. During the last four years NDA supported over 40% of the new drugs approved with a broad range of services. I’m also excited to see the increase of products going through the FDA that received NDA’s support. NDA supported over 20% of new drugs that achieved approval by the FDA during 2016.”

Terese Johansson, PhD, NDA’s consultant behind the research commented: “The findings show that FDA has had a significant drop in drug approvals but continues to grant more expedited and nonstandard review approval status than the EMA. The drop is not as pronounced in the EU but is likely to be more prominent in 2017. Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. The US situation could be explained by the increased use of the shorter nonstandard approval pathways since there has also been a significant increase in complete response letter (CRL). During 2016 FDA issued 14 CRLs, compared to just two in 2015.”

“The report also highlights the continued trend that many companies first seek approval in the US. Both the EU and US show increases in drug approvals from small and medium sized pharma but big pharma still dominates the drug approval statistics. The busiest therapeutic area was oncology.”

NDA-Infographic-2016

The pooled statistics showed that of the new drug approvals, 35 were classified as novel drugs (e.g. NAS, NME or BLA), nine were approved only in the EU, nine only in the US and 17 in both regions. For the EMA, the number represents the fewest NASs approved since 2011, while the FDA has not approved this few NMEs/BLAs since 2010. Big pharma represented 53% of the new drug approvals in 2016 vs 47% from small and medium sized pharma. For big pharma this is a decrease compared to previous years. Of all new products that received marketing approval in 2016, 30 products underwent special approval procedures like Conditional, Fast Track, Breakthrough, Accelerated Approval and Priority Review, 18 in the US, seven in EU and five in. In many cases more than one of these pathways was granted per product.

NDA Strategic Advisor and former Chief Exec of the EMA, Dr. Thomas Lönngren, as well as the company’s Scientific Director, Dr. Markku Toivonen and the Director of NDA’s Regulatory Advisory Board, Prof. Steffen Thirstrup will be present at DIA EuroMeeting together with a line-up of experts, and available to discuss these findings.

NDA staff can be found at booth C 10, 11 of the Congress Center and in the following presentations:

  • Shelley Gandhi & Bill Richardson – Ex MHRA Regulators
    (Pre-Conference Short Course) Short Course 4 | Wed, 29th March – 09:00-12:30
    Moving from Risk Management to Benefit / Risk Management –  Embedding Pharmacovigilance Principles into the product life cycle
  • Dr Mira Pavlovic –  HTA Expert, Session Chair
    Session 0101 | Wed, 29th March – 16:30-18:00
    Global dossier for clinical development
  • Prof. Steffen Thirstrup – Director NDA Regulatory Advisory Board – Session Chair
    Session 0302 | Thurs, 30th March – 11:00-12:30
    EU clinical trial regulation and its implications
  • Prof. Beatriz Silva Lima – Non clinical Expert
    Session 1002 | Thurs, 30th March – 11:00-12:30
    Optimising the development of paediatric medicines
  • Dr Markku Toivonen – Scientific Director & Medical Advisor – Session Chair
    Paul Chamberlain – Biopharmaceutical Development & Immunology Specialist – Session Speaker
    Session 0303 | Thurs, 30th March – 14:00-15:30
    Immunogenicity assessment-risked-based approaches

For more about NDA’s involvement with the 2017 DIA EuroMeeting, visit https://www.ndareg.com/meet-nda-at-the-dia-euromeeting-2017/.

To explore the full Status of New Drug Approvals for 2016 report, visit https://www.ndareg.com/wp-content/uploads/2017/03/NDA-Infographic-2016.pdf.

About NDA
NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services span Development Strategy, Translational Science, Procedure & Submission Management, High-Stakes Meetings and Process Design & Optimisation. Clients are supported by a team of over 150 regulatory affairs, health technology assessment, pharmacovigilance, quality assurance and strategic communications professionals. Backing all major NDA projects is the unique NDA Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. Learn more at www.ndareg.com and follow them at www.linkedin.com/company/nda-group-ab.

About PharmApprove
The NDA PharmApprove team comprises leading strategic, regulatory, and scientific communications professionals. PharmApprove focuses on strategic and tactical support to companies facing high-profile, high-stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at https://www.pharmapprove.com/ and follow them socially at twitter.com/pharmapprove.

PharmApprove Hosts Tutorial at 2016 DIA Annual Meeting

How to Prepare for an FDA Advisory Committee Meeting?
PharmApprove Hosts Tutorial at 2016 DIA Annual Meeting

The leading consultancy will share best practices and “must avoids” in advisory committee preparation

Lawrenceville, NJ (June 21, 2016) – PharmApprove – a member of the NDA Group and the leading strategic, regulatory, and scientific communications consultancy in the U.S. – will lead a tutorial on FDA advisory committee preparation at the 2016 DIA Annual Meeting. The session will take place on Sunday, June 26th at 1:00 p.m. at the Philadelphia Convention Center, during DIA’s 52nd Annual Meeting. PharmApprove has more than 15 years of experience preparing companies for advisory committee meetings, and boasts an over 85 percent success rate.

“We ensure that our clients are 100 percent prepared for all scenarios when they appear before the FDA,” explained Lisa Peluso, director of coaching and client engagement for PharmApprove. “We understand what it takes to make a winning case before an advisory committee, and how to avoid potential pitfalls. Our expert support and coaching allows drug and device developers to clearly articulate the case for approval, and then focus on what’s really important – bringing new cures and treatments to patients.”

Peluso will lead the tutorial, which was developed with support from PharmApprove Founder and Executive Communications Strategist, Pete Taft. The tutorial helps corporate executives and other professionals across all R&D disciplines to effectively prepare for successful advisory committee meetings. PharmApprove has led thousands of training workshops and coaching sessions for regulatory, Medical Science Liaison, business development and payer negotiation teams at pharmaceutical companies around the world.

“When PharmApprove merged with NDA Group a few months ago, it heralded a truly exciting time for the company, with expanded global reach, expertise and talent. But that’s only one part of the equation,” said Laurie Smaldone MD, COO/CSO of NDA Group. “Our experienced coaching team and unsurpassed advisory committee preparation practices remain our strongest assets, allowing us to continue offering the best FDA approval consulting in the business.”

Visit https://dia201652ndannualmeeting.sched.org/event/61Nm for registration and scheduling information about the upcoming tutorial. Follow the social conversation online with the hashtag #DIA2016.

 

About PharmApprove

PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. PharmApprove merged with NDA in March of 2016. Learn more at pharmapprove.com or ndareg.com/pharmapprove and follow them socially at twitter.com/pharmapprove and facebook.com/pharmapprove.

About NDA

NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services incorporate regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. Clients are supported by a team of over 100 consultants and a unique Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. For more information, visit ndareg.com.