Articles & Presentations

Feel free to use these as training tools and talking points for any project

Biologics Development

Biologics development has some unique milestones and regulatory compliance aspects. Some in-depth reviews of these areas are outlined in the following presentations.

Regulatory Affairs for Biotech: Critical Steps for Compliance (training course)
Analytical Equivalence: Overview of Testing for Various Product Classes
Demonstrating Therapeutic Equivalence of Biotech-derived Products: Correlation of Structure-Activity Relationships (SAR) to Clinical Safety and Efficacy
Manufacturing Related Issues in Biotech Development
Analytical, Bioequivalence, & Surrogate Endpoint Equivalence
Specifications & Manufacturing Control: A Prototypic System for Electronic Document Tracking & Management
- 2002 DIA Electronic Data Management (EDM) presentation (Philadelphia, PA), which was the basis for an article in BioPharm (March 2002) by the same name

Biosimilars & Follow-on Biologics

Provided below are presentations, articles, legislative summaries, links to other sites, and much more. Some key documents include:

Multisource Biologics: Demonstrating Therapeutic Equivalence of Biotech-derived Products
IIR International Generics Strategy: Pre-Conference Symposium on Comparable Biotech Products (May 22, 2002) (Barcelona, Spain)
Points to Consider for the Multisource Biotech Initiative in the US: Comparability vs. Therapeutically Equivalent
40th Annual Drug Information Association (DIA) Meeting; Session on Regulatory and Development Considerations for Multisource Biotech (June 2004)
Demonstrating Therapeutic Equivalence of Biotech-derived Products: Correlation of Structure-Activity Relationships (SAR) to Clinical Safety & Efficacy
Management Forum: Comparability Issues in the Development of Biotechnology Products ... and Consideration of Biotech Generics (October 25, 2002) (London, UK)
Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-derived Pharmaceuticals
Drug Information Journal, Vol 34; 919-959, 2000
Chronology of Congressional Hearings regarding Biosimilars & Follow-on Biologics

Controlled Substances

This section contains presentations regarding controlled substances compliance, audit checklists, and more. Note that these presentations are from a seminar course last taught in 2002 so some of the regulatory aspects have changed, such corporate recordkeeping and legislative overview. Some key documents include:

Controlled Substances: Compliance Issues and Practices for the Pharmaceutical Industry
- Overview
- Analytical Registrants
- Manufacturer's Overview
- Internal Audits
- Import/Export
- Controlled Substances Legislation Overview
- Corporate Recordkeeping
- Roundtable Discussion: Compliance Questions
CS Audit Checklist (Note that this checklist was last updated in 2005 so there may be regulatory changes that need to be included.)

Miscellaneous Stuff

Topics that are still "under construction" include the following:

Quality by Design overview and its impact on both pioneer and biosimilar development
Reporting manufacturing errors for biological products
Remote viewing for regulatory inspections: cGMP compliance initiatives for the 21st Century
Ethical topics in biologics development
Overview of fraud in the pharmaceutical industry and Federal/State investigations
Informed consent in the military: an update from the initiatives after 9/11