Adress
Heidelberger Str. 32c
D-69198 Schriesheim
Mail & Web
info@helionpharma.com
www.helionpharma.com
Phone
+49 (0)176 8123 0027
Effective Drug Development is my Mission!
Services
Drug Development and
Registration Consulting
According to your needs, we provide a wide range of services:
Consulting
Clinical Development and Drug Regulatory Affairs
- Assessment of clinical development programs, both internal or external (“due diligence”)
- Generation of clinical development plans including timelines and budget
- Negotiation of clinical development programs and clinical studies with regulatory authorities and other stakeholders (e.g. patient organizations)
- Design of clinical development programs and clinical trials
- Competitive intelligence - the majority of information on your competitor’s clinical development programs is in the public domain. We identify and structure this information and condense it into a report
- Outsourcing of clinical development activities
- Clinical program and project management
- Scientific Advisory Boards and KOL management
Documentation
„What is not documented, was not done“ – documentation is key for effective drug development.
I offer “de novo generation”, review, optimization and updating of all documents related to clinical development:
- Investigator’s Brochures
- Clinical Development Plans
- Briefing Documentation for scientific advice, pre-IND and pre-NDA meetings
- Clinical Study Design and Study Protocols
- Pediatric Investigational Plans (PIP)
- Common Technical Document (CTD) clinical modules
- Scientific manuscripts and publications
Quality/Audits
Effective drug development requires planning of quality assurance (QA) and quality control (QC) throughout the development program. Small issues during the course of drug development often result in big issues in the marketing approval process. Rather than fixing issues after their occurrence, preventing issues may be a better strategy.
- Assessment of clinical development plans and study protocol for quality issues and recommendations for improved options
- Design of quality management plans
- Standard Operating Procedures (SOPs) that both fit to your organization and satisfy regulatory requirements
- Audits
- Evaluation of contract research organizations, ethics committees, investigational sites and other providers
- Documents (investigator’s brochure, study protocol, informed consent forms, clinical study reports)
- For-Cause (e.g. suspected issue)
- Systems (e.g. monitoring, safety reporting, data management or biostatistics)
Vita
Stephan Witte, PhD
Founder of Helion Pharma Dr. Witte
Founded Helion Pharma as consultancy in 2008. Recent success examples include:
– Restructuring of „failed“ clinical project to successful clinical proof-of concept– Coordinated clinical and regulatory activities from preclinical to completion of first in human study
Developed and implemented infrastructure for global clinical development, pharmacovigilance and medical affairs in a small company setting as Chief Medical Officer of Nitec Pharma
More than 15 years experience in biomedical research: clinical studies in phases I-III, design and implementation of large and small clinical development programs in indications relating to inflammation, respiratory, rheumatology, pain and gastroenterology
Successful interaction with relevant regulatory authorities in EU/US, including scientific advice, pre-IND, and end of phase 2, pre NDA & registration meetings
Coordinated clinical activities of the global development and registration of Lodotra/Rayos of Nitec Pharma
Designed and implemented large global clinical development programs as clinical program leader at ALTANA Pharma
Graduated in biochemistry & immunology, postgraduate studies in pharmaceutical medicine
Founded Helion Pharma as consultancy in 2008. Recent success examples include:
– Restructuring of „failed“ clinical project to successful clinical proof-of concept
– Coordinated clinical and regulatory activities from preclinical to completion of first in human study
Developed and implemented infrastructure for global clinical development, pharmacovigilance and medical affairs in a small company setting as Chief Medical Officer of Nitec Pharma
More than 15 years experience in biomedical research: clinical studies in phases I-III, design and implementation of large and small clinical development programs in indications relating to inflammation, respiratory, rheumatology, pain and gastroenterology
Successful interaction with relevant regulatory authorities in EU/US, including scientific advice, pre-IND, and end of phase 2, pre NDA & registration meetings
Coordinated clinical activities of the global development and registration of Lodotra/Rayos of Nitec Pharma
Designed and implemented large global clinical development programs as clinical program leader at ALTANA Pharma
Graduated in biochemistry & immunology, postgraduate studies in pharmaceutical medicine
Accreditations
Accredited for crédit d'impôt recherche (CIR)
Horizon 2020 accredited Coach
Memberships
Deutsche Gesellschaft für Pharmazeutische Medizin (DGPharmMed)
Drug Information Association (DIA)
Contact
Menü