Astrid Schott

• Interim management (Head Clinical Development, CMO)
• Consulting in clinical research and drug development
• Evaluation of license opportunities
• Support in Due Diligence

Dr. Astrid Schott has over 25 years of experience in clinical medicine and drug development.

She graduated as MD from the University of Kiel, Germany, is board certified in General Medicine and joined the pharmaceutical Industry in 1996, working for Schering AG, their daughter company Berlex Inc. in the US and Bayer Schering Pharma, then joined Pharmion and 2007 started her own consulting business.

Her positive track record consists of several successful European Marketing Authorizations in the field of Oncology. She designed the global clinical development plans (phase I-III) of several novel products in the field of oncology, immunology and infectiology. She has experience with both positive as also negative proof of concept leading to expansion or canceling of projects and successfully initiated and used biomarker programs.

She has broad global management experience, including restructuring, change management and integration.

Astrid is founder of CONELIS e.v. and was member of the board from 2009 to 2014.

Broad clinical and industry background (>25 years clinical medicine, academic research, drug development in Pharma and Biotech)

Education:

Board certified in General Medicine, Dr. med.

Experience:

Consultant and Interim Manager for Global Clinical Drug Development
Senior Director International Clinical Development Pharmion, Windsor, UK
Executive Director Bayer Schering Pharma AG
Clinical Experience: Internal Medicine, Surgery, Radiology

Areas of Expertise:

Clinical Development, Interim Management, R&D Strategies

Typical assignments have been:

Member of the decision board of the "Helmholtz Validation Fund".

Acts as expert for the German Ministry of Education and Science.

Medical need evaluations, design of Target Product Profiles and support in trial design for a US based company developing therapies modifying the gut microbiome.

Supported a global pharmaceutical company in the development of Target Product Profiles and Phase II trial outlines in the indications head and neck cancer and NSCLC.

Developed Target product profiles and clinical development options for a new immunotherapy against cancer - integrated with commercial evaluation of the different scenarios

Supported a global Pharma company in the development of a pediatric investigational plan in the field of oncology.

Set up of several expert committees and conducted expert meetings in the fields of oncology, diabetes and infectious disease.

Advised a strategic consulting company in their value proposition and company presentation.

Performed the clinical and medical due diligence of a new product against solid tumors for a European company trying to license in new therapies against cancer.

Advised a European venture capital company regarding an investment in biotechnology.

Authored the target product profile and global clinical development plan of a new product in the field of infectious diseases for a global leader in near-patient diagnostics and health management services.

Advised a pharmaceutical company in the medical evaluation of a novel drug against chemotherapy induced nausea and vomiting.

Conduced combined commercial- clinical evaluations in the indications stem cell mobilization and anemia of cancer including authoring of development plan, target product profile and NPV calculations (with Dr. Hillgenberg).

Authored the study outlines of two Phase I studies for novel biotech products and assisted a small biotech company in writing the investigator brochures and preparing their first scientific advice procedures and CTAs at the EMA.

Authored global clinical development plans and target product profiles for the first two novel compounds moving into clinical development of a small biotech company in oncological and immunological indications.

Guided the clinical team of a global biotech company in answering the questions in the later successful approval process of a novel biotech drug against cancer, strategic input into the pharmacovigilance strategy.

Supported the stakeholders of 2 co-operating companies in structuring and conducting their decision process. Moderated a major strategic meeting in which the basis for a future structured decision approach was laid and approved.

Assisted a US/ European pharmaceutical company in the portfolio review consisting of novel cytotoxic drug conjugates.

Authored answers to the EMA questions in the field of drug safety including advice on the risk management plan during the later successful approval process of a new product against a hematological malignancy for a global pharmaceutical company.

Served as the interim global head of clinical development for an international company with several biotech products against solid tumors and hematological diseases in clinical development.

Advised a Singapore based venture capital holding regarding the investment in several novel oncological drugs.