Comparator Sourcing

As more drug companies adopt comparative effectiveness studies, drug supply professionals are challenged with sourcing and managing comparator drugs. This ebook examines research from the Tufts Center for the Study of Drug Development, and reviews the pros and cons of the transactional and strategic comparator sourcing models to aid in the development of effective sourcing approaches. Special considerations, and commonly encountered issues in biologics sourcing are discussed. In addition, areas to consider in equivalence testing for comparability are reviewed.

Related Videos

Related Content

Advertisement

July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

May 30th 2025

Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries

Patrick Lavery

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

July 25th 2025

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Christopher Cole

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.

March 28th 2025

Transformations in Drug Development for Cell and Gene Therapies

PPD Thermo Fisher Scientific

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

July 24th 2025

Customizable Relationships Enhance Speed to Market

Patrick Lavery

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.

July 24th 2025

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

Patrick Lavery

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Related Content

Advertisement

July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

May 30th 2025

Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries

Patrick Lavery

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

July 25th 2025

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success

Christopher Cole

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and analytical issues despite early regulatory guidance. Review key risk points in analytical and tech transfer to better ensure commercial readiness.

March 28th 2025

Transformations in Drug Development for Cell and Gene Therapies

PPD Thermo Fisher Scientific

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

July 24th 2025

Customizable Relationships Enhance Speed to Market

Patrick Lavery

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.

July 24th 2025

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

Patrick Lavery

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.