Copenhagen, Denmark

+45 31 68 88 52

CVR: 38561464

mt@pipadviser.com

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leading
PIP adviser
Europe

Leading PIP adviser in Europe

Meet
Mette Due Theilade Thomsen

Mette is CEO of “PIP Adviser” which provides expert regulatory advice on PIPs, PSPs and a plentitude of other tasks related to paediatric drug development.

She has a background in authorities & industry. In the Danish Medicines Agency (2000-2006), she was a Senior Nonclinical Assessor of EU marketing authorisation applications and EU Scientific Advice, in addition to providing company advice at meetings and assessing clinical trial applications.

She frequently had meetings in the EMA as a member of the CHMP Safety Working Party, Gene Therapy WP, Biosimilar WP and Pharmacogenetics WP, and she acted as Rapporteur for several CHMP and ICH guidelines.

Later, as Scientific Officer in EMA (2007-2009), Mette handled PIP procedures with PDCO, participated in the FDA-EMA paediatric cluster and established the PDCO Nonclinical Expert Group.

In Novo Nordisk (2009-2017), Mette lead the majority of PIP/PSP procedures, was paediatric strategy advisor across the company and was member of the EFPIA paediatric group.

Mette also spent a year as Senior Director in Shionogi, London before establishing her own Consultancy in 2017.

Associate Partners

Beatriz
Silva-Lima

Pharm D,
Ph.D

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Ingrid Brück Bøgh

European Registered Toxicologist

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Caroline Le Barbier

Ph.D.

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Julie Mou Larsen

Senior Specialist

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Our Skills

Mette Due Theilade Thomsen,
CEO at PIP ADVISER since 2017

Location Copenhagen Area, Denmark

Consultancy expertise on EMA/FDA Paediatric Investigation Plans
– provided by expert with unique industry and regulatory agency background.
 

Since the inception of PIP Adviser, Mette has provided strategic advice on more than 40 PIPs, PSPs and other paediatric procedures and has written more than 10 PIPs, PSPs and PPSRs successfully approved by the EMA/FDA.

 
 

Senior Director, EU Regulatory Lead.

Shionogi Limited

Dates EmployedMay 2016 – Apr 2017

Employment Duration1 yr

LocationLondon, United Kingdom

Senior Director, EU Regulatory Lead.
 

Global Regulatory Lead, Principal Scientist

Company Name

Novo Nordisk

Dates Employed2009 – Apr 2016

Employment Duration7 yrs

LocationCopenhagen Area, Denmark

During my years in Novo Nordisk, I defined and built up the paediatric area in the company

– Global Novo Nordisk advisor on PIPs.
– RA Global Regulatory Lead of PIPs and PSPs in GLP-1 & Obesity area (8 ongoing processes).
– Ran PIP procedures, authority interactions, meetings with upper management, involved in running paediatric trials, international policy-making.
– Taught the Chinese agency (cFDA) on EU paediatric legislation/international cooperation (2015)
– Chair of cross-functional PIP/PSP knowledge-sharing group
– Teacher at a number of in- and external PIP courses
– EFPIA Paediatric Group member

 

Scientific Administrator

European Medicines Agency (EMA)

Dates EmployedDec 2007 – Nov 2009

Employment Duration2 yrs

LocationLondon, United Kingdom

As scientific officer in EMA, I participated in the PDCO meetings, cooperated with PDCO Rapporteur and Peer Reviewer on the PIPs, wrote summary reports on PIPs, and took part in the FDA-EMA paediatric cluster meetings.

-Drafted approximately 40 scientific summary reports on PIPs.
– Responsible for EMA paediatric formulation group.
– Responsible for PDCO nonclinical working group
– Implemented the new European Paediatric Regulation
– Participated in the PDCO meetings, cooperated with PDCO Rapporteur on PIPs, took part in the FDA-EMA paediatric cluster meetings.
– Made juvenile animal/PIP workshop for European Nonclinical assessors with SWP and PDCO

 

Senior Preclinical Assessor

Danish Medicines Agency

Dates EmployedMar 2000 – Jan 2006

Employment Duration5 yrs 11 mos

Location Copenhagen Area, Capital Region, Denmark

Toxicologist/Senior Preclinical Assessor.
For a prolonged period of time, I was the only toxicologist working in the DMA and I therefore undertook all toxicological tasks in the agency.

– Wrote more than 25 nonclinical assessment reports on new MAAs in the EU Centralised procedure.
– Provided national and EU nonclinical scientific advice,
– Assessed the nonclinical part of clinical trial applications.
– Key expertise person for biotechnological drugs and new/advanced therapies in the DMA.

Official Danish CHMP delegate (2000-2006) in: Safety Working Party, Expert Group on Pharmacogenetics, Biosimilar WP, Gene Therapy WP.
Rapporteur and co-author for several CHMP/ICH guidelines. At ICH in Japan and Washington, I drafted guidelines in cooperation with regulators of the three regions (Europe, USA, Japan).

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Beatriz Silva-Lima,
PharmD, Ph.D.

Maria Beatriz Silva Lima is PharmD and PhD in Pharmacology and is full professor of Pharmacology and Regulatory Science at the Universidade de Lisboa, Faculty of Pharmacy, and head of the Department of Pharmacological Sciences.

Beatriz Silva Lima has more than 20 years of experience as an expert in nonclinical and regulatory science at the medicines agency in Portugal, Infarmed, and at the EMA, UK.

She has been up to July 2012 member of the Committee of Human Medicines (CHMP), Committee of Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). She has been Chair of the Safety Working Party (SWP) and has been involved as Co-­‐Deputy in ICH discussions on ICH M3R2, S6R1 and S1 guidelines on behalf of the European Commission.

Since October 2012 she consults on nonclinical drug development strategies and has founded a consultancy Company, Silva Lima Preklinika Limited in the UK. From January 2014 to 2018 she Chaired the Scientific Committee of the Innovative Medicines Initiative (IMI).

Areas  of research:

Regulatory Science NonclinicalOncology, Safety; Pharmacology  of metabolic diseases;

Expertise

Beatriz has an extensive regulatory expertise in nonclinical regulatory requirements. Her expertise with the PIPs are among other things that during her time with EMA, she was involved in the PDCO nonclinical working group, advising PDCO on nonclinical expectations to the PIPs.

As a previous CAT member she also has nonclinical expertise in advanced therapies. She supports PIP adviser with her vast nonclinical experience whenever needed.

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Ingrid Brück Bøgh,
DVM, PhD, DVSc, European Registered Toxicologist

Ingrid holds a veterinary degree (Justus-Liebig University, Germany), a PhD (Melbourne University, Australia) and a DVSc, University of Copenhagen, Denmark).

Ingrid has solid expertise within pre-clinical safety evaluation of new drug candidates from early development stages to marketing and post marketing commitments. Her experience embraces a large variety of non-GLP and GLP toxicology programs, outsourcing strategies and drug safety evaluation for NCEs and NBEs (peptides, mAbs, antibody drug conjugates, radioimmunotherapy). 

Her speciality lies in the field of reproductive, developmental and juvenile toxicology. Ingrid has overlooked 100+ non-clinical parts of INDs/IMPDs and marketing applications, with more than 30 drug candidates successfully reaching clinical trial stage and several new compounds obtaining approval for marketing in US/EU/worldwide.

Apart from her academic career, Ingrid has worked for more than 11 years in pre-clinical safety of drug development; 

this includes 

  • CiToxLAB Scantox (Study Director, 1 year)
  • Novo Nordisk A/S (Head of Toxicology and Safety Pharmacology, 9 years) 
  • IBB Consulting (Founder, CEO and Preclinical Safety Consultant, since 2017)

Key positions include:

  • Professor of Veterinary Reproduction and Obstetrics at University of Copenhagen (2005-2008)
  • Vice President of Toxicology and Safety Pharmacology at Novo Nordisk (2015-2017)

Ingrid is a strong driver of cross-functional collaborations and has held various professional international membership positions with strategic representative or advisory functions. She is an experienced leader/manager with a track record of achieving ambitious goals in science-driven environments.

Her publication record counts author/co-authorship of >45 international peer reviewed publications, 3 books/book chapters and more than 60 abstracts.

Expertise

Ingrid has a very strong scientific background in toxicology from Academia and Industry. She has among other things a strong background on the use of juvenile animals to support paediatric drug development, and supports PIP Adviser in these areas when needed.

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Caroline Le Barbier,
Ph.D.

Freelance Scientific CMC Assessor for Regulatory Agencies (PT & FR)

Yoga Teacher and Photographer

  • 2014-2018 Lisbon, Portugal and Europe,                                                                                                                                         Scientific & Project Manager at the European Medicines Agency (EMA)

2004-2013 London, United Kingdom                                                                                                                             

  • Regulatory affairs expert in CMC (Pharmaceutical) with extensive experience in writing scientific reports and peer-review;
  • Interaction with Regulatory Authorities and Industry;
  • Managing international projects of Centralised procedures;
  • Administrative and scientific support in the CMC area to European Committees
  • Processing external enquiries regarding regulatory and quality aspects;
  • Assessment of Paediatric formulations (PIP) and main coordinator for all paediatrics activities;

.

Scientific Pharmaceutical Assessor at the French Veterinary Medicines Agency

2000-2004 Fougeres, France                                                                                                                                                        

  • Assessment and writing reports for marketing authorization applications (centralised, national and mutual recognition procedures)
  • Scientific and regulatory support to Industry before the submission;
  • Meetings at QWP (Veterinary), EMA and Pharmacopeia (French and European)

Expertise

Caroline has a strong background in scientific research, regulatory affairs and writing in the area of pharmaceuticals, Caroline has broad experience in the regulation of medicines, public health, managing projects and deadlines as well as teamwork and communication. Caroline is involved as a pharmaceutical expert with extensive EMA experience. PIP Adviser makes use of Caroline’s huge expertise on paediatric formulations whenever needed for the PIPs and PSPs.

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Julie Mou larsen,
Senior specialist in drug safety assessment and toxicopathology

 

Julie Mou Larsen, .

Highly skilled senior drug safety specialist with profound knowledge of pathophysiology and drug interactions.

She has been responsible for pathological safety assessment on a broad range of compounds targeting diabetes, haemophilia, and growth disorders at the level of targeted triple blockbuster compounds from pre Phase I to MAA/NDA/BLA submission including Fiasp®, NovoEight®, N8-GP, and Somapacitan.

Her experiences comprise of more than 20 different development drug compounds with an array of targets, APIs, and added moieties with safety assessment involving evaluation of acute to chronic toxicity and carcinogenic potential evaluating full body organ systems in multiple species. In addition, Julie has taught and censored at international accredited MSc- and PhD-courses at University of Copenhagen and is a mentor for young scientists.

Expertise

Julie is involved as a nonclinical safety expert. PIP Adviser makes use of Julie’s extensive pathology expertise whenever needed for the PIPs and PSPs

Download CV
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Copyright © www.pipadviser.com

PIP Adviser is a danish based company owned by Mette Due Theilade Thomsen. I use hands-on and in-depth experience to navigate EU, US & UK regulatory requirements and provide high level strategic advice and support to keep you on track.
 
My unique strength as PIP Adviser, is a second-to-none expertise in PIP requirements, supplied by an extensive knowledge and experience.
 
PIP Adviser will cut the time and cost it takes to get your products to patients that need them.

Adress: Stengårds Alle 31A, 2800 Lyngby, Denmark

Phone: +45 31 68 88 52

Email: mt@pipadviser.com

CVR: 38561464

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