TranScrip Infectious Diseases

TranScrip has extensive experience across the Infectious Diseases area, including antibacterials, antifungals and antivirals. TranScrip has supported small to large pharma companies in licensing and funding activities, due diligence, development strategies, clinical development, regulatory submissions, medical affairs and commercial activities.

Additional therapeutic areas

Oncology, Respiratory, Internal Medicine, CNS/Pain

Expertise
Experience

TranScrip Infectious Diseases Experts

TranScrip’s Infectious Diseases team has extensive experience in projects from early development to medical affairs. It supported clinical development programmes, regulatory submissions and peri-launch activities for a number of anti-infective products for big pharma as well as biotech companies. Our ID group is able to provide therapeutic and operational expertise of highly skilled experts, either working as individuals to fulfil specific client needs or forming multifunctional strategic and operational teams to support complex projects.

Marcin Mankowski
Head of Infectious Diseases

Marcin is the Deputy Managing Partner of TranScrip of which he was a co-founder in 2008. He has worked in the industry for almost 20 years. Throughout his career Marcin has held a number of senior positions in big pharma and biotech companies and has been involved in the development of many anti-infective products, including antibiotics, antifungals and antivirals. He has led TranScrip’s Infectious Disease team in the preparation of six successful MAAs/NDAs for antibiotics and antifungals, involving many interactions with regulatory agencies and academic experts. In addition, he has given extensive support to the launch and medical affairs activities of several anti-infective products. Marcin is a physician who is board certified in Internal Medicine.

Latest Infectious Diseases News

31 May
2017

TranScrip’s Infectious Disease and Oncology teams are strengthened by the appointment of Edward Currie as a Senior Partner

TranScrip’s Infectious Disease and Oncology teams are strengthened by the appointment of Edward Currie as a Senior Partner.

Company Product Phase Indication and Service
SME Systemic Antibiotic Phase III MDR Infections: Input into phase III development plan. Regulatory and clinical advice on EU-related activities.
CRO Novel Broad-Spectrum Beta-Lactam Antibiotic Phase III Pneumonia: Review of audit findings, including but not limited to review of site audit reports.
SME Novel Systemic Antibiotic Translational MDR Infections: Advice on regulatory and clinical strategies for pre-NDA meeting with the FDA.
Medium Generic Broad-Spectrum Antibiotic Mature Various Gram +ve and Gram -ve Infections: Development of strategy for regulatory variations and authoring of clinical expert statements to support the regulatory procedure.
SME Novel Fabl Enzyme Inhibitor Translational Rare, Difficult to Treat Infections: Strategic advice on clinical development.
Top 50 mAb Antibiotic Conjugate Translational Gram -ve Infections: Design of clinical development plan.
SME Novel Topical Antimicrobial Translational Skin Infections: Advice on clinical development programme. Support for MHRA and FDA scientific advice meetings.
SME Novel Systemic Antibiotic Translational C. difficile Infection (CDI): Attendance at an Advisory Board meeting.
SME New Class Systemic Antibiotic Translational Gram +ve Infections: Preparation of clinical development programme. Strategic regulatory advice.
Top 50 Lipoglycopeptide Launch Pneumonia: Coordination of various microbiology activities, including responses to regulatory requests, preparation to advisory boards and conferences, input into publication plan, internal training.
Top 50 Glycopeptide Registration Pneumonia: Preparation of an MAA.
Top 50 Novel Systemic Antibiotic Launch C. difficile Infection (CDI): Medical affairs and medical information support to a launch of a newly registered antibiotic.
Top 50 Novel Broad-Spectrum Beta-Lactam Antibiotic Registration Pneumonia: Preparation of an MAA.
Medium Novel Monobactam Antibiotic Translational Gram –ve Infections: Preparation of clinical development programme.
SME Novel Broad-Spectrum Beta-Lactam Antibiotic Registration Skin Infections/Pneumonia: Preparation of an MAA and responses to Day 120 and Day 180 questions.
SME New Class Systemic Antibiotic Registration Pneumonia: Preparation of a Paediatric Investigational Plan.
SME New Class Systemic Antibiotic Phase III Skin Infections/Pneumonia: Preparation for MHRA inspection of phase III clinical study sites.
SME Novel Broad-Spectrum Beta-Lactam Antibiotic Launch Pneumonia: Training of medical and sales staff prior to product launch. Preparation of medical information materials.
SME Novel Systemic Antibiotic Phase III C. difficile Infection (CDI): Consulting services related to clinical development, microbiology and regulatory affairs.
SME Novel Systemic Antibiotic Translational Preparation of clinical development programme.
SME New Oxazolidinone Antibiotic Launch Skin Infections: Microbiology and publication planning support.
SME New Systemic Antibiotic Registration Tuberculosis: Strategic support to MAA preparation and defence.
SME Novel Antibiotich Technology Translational Various Gram +ve and Gram -ve Infections: Preparation of business and development plans, assistance in fund raising and partnering discussions, design of clinical trials.
Top 50 Established Beta-Lactam Mature Various Indications: SmPC harmonisation.