Christina Nicolodi

International Regulatory Affairs Consulting Services

Where medical innovation and mission collide

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.

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_nobg

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_nobg

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 drugs_nobg

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

View publication…

Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1

View publication…

Orphan drug designation in Europe-Procedural guidance and challenges

View publication…

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
Imprint
Disclaimer
Privacy Policy

SAY HELLO!