The past years have seen a dramatic increase in the level of development of innovative medicinal products. Especially advanced therapy medicinal products (ATMPs) and orphan drugs products for rare diseases often require the development of unique medicinal products. A tailor-made regulatory support in legal compliance with European and US regulatory requirements is at the heart of development and determines its success.
Where medical innovation and mission collide
As a Senior Regulatory Affairs Professional at Nicolodi Regulatory Affairs Consulting Services with more than 15 years of experience in global regulatory affairs management, clinical development and quality assurance for biotechnological and advanced therapy medicinal products (ATMPs), I support your pharmaceutical company in the development of novel products – in the planning of your first development phase before drug approval as well as during the entire pharmaceutical life cycle.
ABOUT CHRISTINA NICOLODI
International know-how meets personal consulting
Christina Nicolodi brings an almost 20 years experience as International Regulatory Affairs Manager with a special focus on the development of novel, innovative medicinal products. Particularly, the regulatory planning and execution of the early development of Advanced Therapy Medicinal Products (ATMPs), Genetically Modified Organisms (GMOs) but also chemical or antiviral drugs are key elements of Christina’s operating area.
After 17 years at global pharmaceutical players such as Takeda Pharmaceutical Company Limited/Shire Pharmaceuticals and Baxter/Baxalta Innovations as International Regulatory Affairs Lead Christina decided to found the company Nicolodi Regulatory Affairs Consulting Services and supports both global companies and start-ups.
Benefit from Christina’s international project experience and holistic, individual consultancy for your Regulatory affairs.
PROFESSIONAL EXPERIENCES
Takeda Pharm. Company / Shire Pharmaceuticals
International Regulatory Affairs Lead
AAV-8 Gene therapy (FVIII und FIX)
More about this company…
Baxter Innovations / Baxalta Innovations
International Regulatory Affairs Lead
Obizur® (Porciner FVIII)
Vaccines (Lyme, Influenza)
More about this company…
AVIR Green Hills Biotechnology AG
Global Regulatory Affairs Lead
Life-attenuated influenza vaccines
Gruenenthal GesmbH Austria
Regional Regulatory Affairs Manager
Pain killers, Antibiotics, Contraceptives
More about this company…
EDUCATION
2010 - 2014 | Medical University of Vienna: Doctoral degree in Medical Sciences
Medical Sciences in Clinical Pharmacology and Immunology
Doctoral thesis: “Evaluation of immunological correlates of protection for delNS1-live-attenuated influenza vaccines”
Moessler et al, 2013
1999 - 2004 | Karl Franzens University Graz: Master’s degree in Microbiology
Undergraduate Studies in Microbiology, Genetics und Virology
Master thesis: “Phage-host systems in the aerobic water column and sediment ot the Kuehwoerther Wasser, a mesotrophic, macrophyte-dominated oxbow lake.”
Every pharmaceutical product is individual
Throughout the development of novel, innovative medicinal products, not only Research and Development plays an important role, but also regulatory compliance. Novel medicinal products are often biotechnologically manufactured products for complex therapeutic or prophylactic purposes and demand specific regulatory requirements on product development and marketing authorisation. Almost always individual and strategic decisions must be made and careful steps must be taken for each unique medicinal product. To help you developing your investigational product or to maintain your medicinal product throughout its lifecycle Christina Nicolodi will guide you through strategic decisions in compliance with regulatory requirements.
DRUG DEVELOPMENT
PRECLINICAL PHASE
The development of medicinal products demand unique solutions. Christina Nicolodi supports you when it comes to the strategic planning, screening and early stage and basic research.
CLINICAL TRIALS
At the center of every clinical trial there is an expert bringing the right expertise for research, and planning of clinical trials: R&D is Christina’s passion!
MANUFACTURING
The manufacturing and control plays a critical role during development and throughout the entire product lifecycle. Christina Nicolodi ensures that your CMC practices are carried out in accordance with the requirements of regulatory bodies.
PHARMACEUTICAL LIFE CYCLE
MARKETING AUTHORIZATION
After years of research and development it all comes down to filing the marketing authorization. With years of experience Christina Nicolodi guides you through the exhausting licensing procedure to finally reach market access and it will be worth it.
LIFE CYCLE MANAGEMENT
Pharmaceutical life cycle management is about optimizing the value of your product. Christina Nicolodi provides you a successful life-cycle management with the experience to manage changes as the product moves through its economic life.
GXP SERVICES
Compliance is a constant compound of a functional pharmaceutical quality system. Christina Nicolodi has a broad spectrum of GxP requirements and supports you in establishing and auditing your processes and quality system.
Novel, innovative medicinal products
In recent years, the development of innovative, advanced medicines (ATMPs) has increased dramatically. In particular, medicines for people with rare diseases (so called orphan drugs) often require the development of unique chemical or biotechnological products.
ATMPS
Advanced therapy medicinal products: tissue engineered products, somatic cell and gene therapy medicinal products.
At Shire / Takeda, Christina Nicolodi was responsible for the early development of the Factor VIII and IX gene therapy and led the central procedure of Obizur®, a porcine factor VIII for the treatment of bleeding episodes in adults with acquired hemophilia.
VACCINES AND IMMUNOTHERAPIES
(Prophylactic) Medicinal products used to activate the immune system to protect against infectious diseases or to fight diseases.
The development of vaccines and immunotherapies is one of Christina’s core competencies (e.g. Lyme disease, influenza, HPV-16, SARS CoV-2).
CHEMICAL SUBSTANCES
Chemical substances for diagnosis, treatment, or prevention of a disease.
Whether setting up your first GMP production, planning clinical studies or managing product changes, this is what Christina Nicolodi is constantly into.
MORE ABOUT CHRISTINA NICOLODIS WORK
Scientific papers
Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1
Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1
Orphan drug designation in Europe-Procedural guidance and challenges
TV, Online & Print
COVID-19: Current facts & fakes about vaccination
21. September 2021 –Webinar for European Researchers Night: Life is Science! (Video in German)
Discover now…
SARS-CoV-2: background, vaccines, outlook
21. Mai 2021 – Webinar for Open Science – Lebenswissenschaften im Dialog. (Video in German)
Discover now…
How vaccines are updated
15. März 2021 – Publication and Interview in the Austrian broadcast ORF. (Article in German)
Discover now…
Interview about Corona virus
19. Jänner 2021 –Lower Austrian Broadcast. (Video in German)
Discover now…
Now is the time to test and vaccinate – was that the last lockdown?
25. November 2020 – ORF Talk 1 – Panel discussion. (Video in German)
Discover now…
Virologist Nicolodi on CoV vaccines
23. November 2020 – ORF ZIB Night. (Video in German)
Discover now…
License procedure for vaccines in the European Union
23. November 2020 – Publication and Interview in the Austrian broadcast ORF. (Article and interview in German)
Discover now…
Is Corona splitting the society?
03. September 2020 – Servus TV, Talk im Hangar-7 – Panel discussion. (Video in German)
Discover now…
Russia skips tests and approves world’s first Corona vaccine
11. August 2020 – Interview for Austrian newspaper DERSTANDARD. (Interview in German)
Discover now…
The long way to a CoV-vaccine
07. Mai 2020 – Publication and Interview in the Austrian broadcast ORF. (Article in German)
Discover now…
CONTACT
Hold the vision, trust the process!
Contact Christina Nicolodi for a free initial consultation. I support you and offer an individual and product-specific advice.
Mag. Dr. Christina Nicolodi
Leopold Figl Straße 7C, 2361 Laxenburg
office@nicolodi-consulting.com
+43 (0) 650 58 29 650
