Guilherme Ferreira Email & Phone Number

Brentford, Middlesex, Gb

- Designs clinical trial study protocols, supervises trial conduct, analyses and interprets study data, including development of innovative designs and clinical endpoints;- Drives the development and implementation of Clinical Development Plans (CDPs) at programme and study levels;- Gives clinical input to the Target Product Profile, aligning regulatory requirements, scientific rigour and commercial goals, leading the implementation of the Integrated Evidence Plan (IEP);- Develops Medical Review Plan and performed Medical Review (including Medical Data Review);- Supports the creation and review of regulatory documents (e.g., Investigator's Brochure, Clinical Study Reports, Briefing Books);- Engages with senior leadership team at governance bodies;- Supports discussions with Key External Experts (KEE);- Supports Clinical Operations in clinical feasibility exercises;- Leads subgroups and represents the Clinical Sciences function at programme and study levels

Raritan, New Jersey, Us

- Supported conduct and analysis of a phase I PK study for a mAb, giving input and clinical interpretation for modelling approaches and dose selection- Collaborated with Discovery, Clinical Pharmacology and Clinical Operations to implement biomarker and translational research plans for early development programs- Supported early development trial set up, conduct (ensuring adherence to GCP and ICH guidelines), monitoring (including medical review and protocol deviations) and database locks- Drove clinical trial design and protocol development for phase I-II studies- Supported review and analysis of study results as well as CSR writing- Aided the drafting of a clinical development plan for an early stage (pre-NME) asset

Tilburg, Nl

- Drove clinical development plans, clinical trial design and protocol development for phase I-II studies- Curated public and proprietary endpoint/biomarker data to inform study design

Amsterdam, Noord-Holland, Nl

• Developed the methodology, collected data and analysed comparatively the antimicrobial portfolio of pharmaceutical companies • Engaged with external stakeholders (pharmaceutical industry, investors and governments) to define priorities and implement actions for internal research programmes• Identified, categorised and evaluated companies’ access, pricing and supply policies for antimicrobial drugs in low- and middle-income countries

Utrecht, Utrecht, Nl

• Developed a framework to assess, validate and compare animal models of disease• Systematically reviewed high volume literature and conducted a meta-analysis• Mentored Master students on their 5-week drug development project• Analysed Investigator’s Brochures and Clinical Study Reports to determine the predictivity of preclinical data regarding human pharmacokinetic parameters• Prepared diverse media to communicate research results, ranging from departmental presentations, conferences and workshops

Darmstadt, De

• Managed vendors of a high-priority oncology programme, ensuring the delivery of high-quality output within dynamic deadlines• Provided the scientific support for clinical trial design, supporting the choice of population, endpoints and active comparators• Prepared competitor landscape analyses to inform product positioning from a scientific and market access perspective• Drafted a briefing book for regulatory (EMA) and health technology assessment authorities (NICE, IQWiG) scientific advice

Liempde, Noord-Brabant, Nl

• Prepared preclinical and clinical literature overviews to support the design of early-stage clinical trials• Compiled, interpreted and presented literature information to support the writing of Paediatric Investigation Plans (PIP)• Used regulatory databases (FDA’s and EMA’s websites, PharmaProjects®) to understand the competitor landscape and substantiate go/no-go decisions

Darmstadt, De

• Drafted the competitor landscape of a high-priority programme regarding dose selection for early-stage clinical trials• Reviewed the literature to identify potential biomarkers to support companion diagnostics development• Self-training on Phoenix Winnolin® softwareSupervision of Jürgen Scheuenpflug.

Darmstadt, De

• Drafted Request for Proposals (RFPs) for the development of economic models to support drug development• Delivered targeted literature reviews to support clinical trial design• Reviewed vendor proposals and output (e.g. cost-effectiveness/utility studies and budget impact analysis)• Support in IMI’s GetReal ProjectSupervision of Boris Pfeiffer.

Darmstadt, De

• Coordinated the implementation of the new Regulatory Information Management System (RIMS, LiquentInsight®)• Elaborated a weekly regulatory intelligence newsletter for the company’s managing directors• Prepared first submission and variation requests of small molecules and biologicals and handled regulatory authorities objections• Assessed new projects and their regulatory strategy in different agencies such as FDA and EMA • Assessed and filed all types of variations for biological, new, generic and branded generics products;• Responded to Health Authority objections; • Reviewed and approved the final arts (PIL and packaging) of productsSupervision of Renata Braga and Vanessa Gomes.

Whitechapel, England, Gb

• Analysed approval documents from FDA and EMA to define the dose selection drivers of oncology drugs in phase I studies• Participated in intervisie meetings, a cross-functional committee with several experts to discuss solutions for problems outside their expertiseSupervision of Edwin Spaans.

Darmstadt, De

Development and validation (technology transfer) of new analytical methods for drug analysis, including stability, dissolution, assay and impurities testing via HPLC (both gradient and isocratic) and spectrophotometry. Supervision of Fabiane Lisboa.

Rio De Janeiro, Rj, Br

Translation and review of translated patent applications, request of examinations, complying with office actions and direct contact with clients of chemical and pharmaceutical fields. Supervision of Tatiana Schuenck.

Br

Microbiological analysis of industrial waters, products and raw materials. Preparation and maintenance of pathogenic microorganisms. Preparation of growth medium for all analysis. Supervision of Ana Paula Soares.

Pharmacist (Pharmd), Pharmacy

Master Of Drug Innovation (Msc), Pharmaceutics And Drug Design

High School, Health