FIERCE BIOTECH & CYTIVA PRESENT
 

Tapas & TECH Talks

For emerging biotech leaders, with support from IQVIA

 

Quick Links: Panelists  | Agenda Day 1  | Agenda Day 2  | Agenda Day 3

Watch On-Demand! Group

About

 

When developing a new therapy, it is more important than ever to have the future in mind from the outset. The choices you make at each step can set you up for success. Join experts from Cytiva and IQVIA for a 3-part discussion about strategies for robust and scalable processes: from research through late-stage trials. 
 

15

TUESDAY,
SEPTEMBER 15 

 

Pre-Clinical

 

11:00AM - 12:00PM ET
CRO and PD Strategy: Start Planning Early to Achieve Long-Term Success 

 

 

 

16

WEDNESDAY, SEPTEMBER 16 
 

  Phase I/II

 

11:00AM - 12:00PM ET
Early Clinical Development: Leverage Data to Inform Decisions and Ensure GMP Readiness 

 

 

 

17

THURSDAY,
SEPTEMBER 17

 

Phase III to Market

 

11:00AM - 12:00PM ET
Late-Stage Proficiency: Optimize Clinical Execution to Establish Commercial Viability 

 

 

 

 

AGENDA

TUESDAY, SEPTEMBER 15

 

11:00AM - 12:00PM ET
Day 1: CRO and PD strategy: Start planning early to achieve long-term success (Preclinical)

Contract Research Organization (CRO)

  • Navigate the pathway from animal studies to IND clearly
    • Engage with regulatory early on
    • Perform animal toxicology studies
  • Understand the regulatory and competitive landscape
    • Select and validate optimal clinical endpoints early

Process Development (PD)

  • Align process design and early PD with regulatory needs
    • Initiate cell line characterization
    • Set reasonable ranges and define operating parameters
    • Choose purity/impurity profile testing methods to support PD
  • Think about toxicology needs and considerations for production
    • Control bioburden and endotoxin effectively
    • Engage in best practices for GLP’s and documentation
    • Ensure suitable process scale-up

PANELISTS

Patrick

Moderator

Patrick McMahon

Global Business Development Manager, Fast Trak CDMO Services

Cytiva

 

Patrick

Patrick Guertin

Global Technical Manager, Fast Trak CDMO Services

Cytiva

 

Edwards

Edward Hines

Global Technical Manager, Fast Trak CDMO Services

Cytiva

 

Micheal

Michael Kardas, PharmD

Vice President and Global Head of Strategic Drug Development

IQVIA

 

Andy

Andy Kinley, PhD

Global Head of Oncology Strategy

IQVIA Biotech

 

 

WEDNESDAY, SEPTEMBER 16
 
 
 
 

11:00AM - 12:00PM ET 
Day 2: Early clinical development: Leverage data to inform decisions and ensure GMP readiness (Phase I/II)

Contract Research Organization (CRO)

  • Analyze bio samples
    • Perform immunogenicity analysis
    • Ensure data cleanliness and visibility to expedite decision making
    • Evaluate mechanism of action with PK/PD analysis
    • Conduct exploratory analysis
  • Execute operational strategy and design
    • Develop the timeline
    • Select the country site
    • Conduct competitive analysis

Process Development (PD)

  • Adhere to cGMP standards
    • Document appropriately ‒ reference established SOP’s and batch records
    • Choose appropriate data collection methods and ensure part 11 compliance
    • Train operators effectively
  • Perform process scale-up and validation for early clinical phase
    • Create master and working cell banks
    • Conduct test method qualification and reference standard characterization
    • Perform Bulk DS and DP stability studies
    • Confirm early clinical phase viral clearance

 

PANELISTS

Patrick

Moderator

Patrick McMahon

Global Business Development Manager, Fast Trak CDMO Services

Cytiva

 

Patrick

Patrick Guertin

Global Technical Manager, Fast Trak CDMO Services

Cytiva

 

Edwards

Edward Hines

Global Technical Manager, Fast Trak CDMO Services

Cytiva

 

Micheal

Michael Kardas, PharmD

Vice President and Global Head of Strategic Drug Development

IQVIA

 

Andy

Andy Kinley, PhD

Global Head of Oncology Strategy

IQVIA Biotech

 

 

THURSDAY, SEPTEMBER 17
 
 
 

11:00AM - 12:00PM ET
Day 3: Late-stage proficiency: Optimize clinical execution to establish commercial viability (Phase III to Market)

Contract Research Organization (CRO)

  • Complete BLA/NDA submissions
  • Build pivotal studies with clinical and commercial targets in mind
  • Choose the right regions and sites based on robust EHR and Claims data
    • Understand regional standard of care ‒ patient population aligned to treatment

Process Development (PD)

  • Execute process validation ‒ commercial phase
    • Conduct process validation series (BLA registration lots through consistency lots)
    • Perform final test method validation and set specifications
    • Conduct final viral clearance study validation
    • Perform final process validation ‒ CQA's, SUT vs SS, raw materials, process intermediates

 

PANELISTS

Patrick

Moderator

Patrick McMahon

Global Business Development Manager, Fast Trak CDMO Services

Cytiva

 

Patrick

Patrick Guertin

Global Technical Manager, Fast Trak CDMO Services

Cytiva

 

Edwards

Edward Hines

Global Technical Manager, Fast Trak CDMO Services

Cytiva

 

Micheal

Michael Kardas, PharmD

Vice President and Global Head of Strategic Drug Development

IQVIA

 

Andy

Andy Kinley, PhD

Global Head of Oncology Strategy

IQVIA Biotech

 

About Cytiva & IQVIA

 

Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Cytiva’s diverse portfolio includes well-recognized brands such as ÄKTA, Amersham, Biacore, FlexFactory, HyClone, MabSelect, Whatman, and Xcellerex. Cytiva brings speed, efficiency, and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients. Visit cytiva.com for more.

 

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective, and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. Visit www.iqvia.com/about-us for more information.