The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.
The 2020 Bio/Pharma Virtual Congress event will connect bio/pharma formulation, development, manufacturing, and quality experts with a full day of technical presentations, panel discussions, interviews, and vendor meetings, through an interactive portal.
This online event will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry.
On-Demand
Anytime
Your Computer
FORMULATION
Topics included in this session are drug development, drug delivery, APIs, excipients, formulation trends, modified release, injectable drug formulation, and more.
Session 1: Improving Patient Outcomes through the Stratum Technology Platform: Revolutionized Injectable Solutions
Session 2: Data-Driven Strategies to Accelerate Your Molecule’s Development Path
Session 3: Excipients Update: Formulations, Supply, and Quality
Session 4: When Drug Meets Device: How to Assess Compatibility
DRUG DOSAGE FORM TRENDS
Topics include in this session are vaccines, biologics, solid dosage drugs, controlled release, cell and gene therapies, and more.
Session 1: Delivering on the Promise: Overcoming Biopharma Development and Manufacturing Challenges
Session 2: Mapping the Transition from Drug Discovery to Development and Beyond
Session 3: Editors’ Series: Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis
Session 4: Demystifying AI in Pharma
MANUFACTURING
Topics included in this session are manufacturing strategies, process analytical technology, process and operational intelligence, data integrity, predictive maintenance, scale up, fluid-bed coating, and more
Session 1: The Future of Life Sciences Production Automation: Greater Visibility with Audit-Ready Solutions
Session 2: Technology Advances in Process Operations: Using Real-time Monitoring and Artificial Intelligence to Optimize Manufacturing Operations
Session 3: End Point Determination and Scale-up of Fluid Bed Coating Through the Use of Process Tools
Session 4: 21CFR part 11 Data Integrity Challenges for Cleanroom Routine Environmental Monitoring Programs
Four Interactive Tracks
BIO/PHARMA INDUSTRY CHALLENGES
Topics included in this sessions are drug quality, regulatory inspections, COVID-19 pandemic impact, good manufacturing practices, regulated documents, and more.
Session 1: Cleanrooms Qualification Vs Cleanroom Monitoring: Annex 1 V12 Requirements
Session 2: Ensuring Container Closure Integrity of Sterile Vials
Session 3: Establishing a “New Normal” for Pharma Quality Practices
Session 4: Expedite Regulated Documents in the Era of COVID-19: From Development to Trials and Manufacturing
Emerging technologies and processes that impact, enable, and advance bio/pharmaceutical development and manufacturing will be explored in Editors’ Series panel discussions and technical session presented by industry experts in four topic areas:
The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.
The 2020 Bio/Pharma Virtual Congress event will connect bio/pharma formulation, development, manufacturing, and quality experts with a full day of technical presentations, panel discussions, interviews, and vendor meetings, through an interactive portal.
This online event will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry.
Keynote Panel Discussions
The bio/pharma industry has demonstrated its R&D capabilities by accelerating development of vaccines and therapeutics to combat COVID-19. At the same time the industry faced intense scrutiny and political pressure. What are the short-, medium-, and long-term implications for bio/pharma development and manufacturing? Representatives of PhRMA, BIO, and other industry organizations will discuss and debate crucial business, regulatory, science-based issues facing the industry.
James Mayne, Ph.D.
Vice President
Science & Regulatory Advocacy
PhRMA
Phyllis Arthur
Vice President for Infectious Diseases and Diagnostics Policy
Biotechnology Innovation Organization
Supporting Sponsor:
Sponsors:
Schedule at a Glance
Wednesday, November 11th
8:30 a.m. _____________________________________________________________
9:00 a.m. ______________________________________________________________
9:45 a.m_________________________________________________
10:00 a.m._______________________________________________________
11:00 a.m._______________________________________________
11:30 a.m._______________________________________________________
12:30 p.m._______________________________________________
1:30 p.m._______________________________________________________
2:30 p.m._________________________________________________
3:00 p.m._______________________________________________________
4:00 p.m.________________________________________________________________
Registration Opens
Keynote Speaker
Networking Break in Exhibit Hall
Track Breakout Sessions
Networking Break in Exhibit Hall
Track Breakout Sessions
Networking Break in Exhibit Hall
Track Breakout Sessions
Networking Break in Exhibit Hall
Track Breakout Sessions
Event Close
Schedule at a Glance
Wednesday, November 11th
Supporting Sponsor:
Featured Speakers
November 11, 2020
8:30 am to 4:00 pm ET
Your Computer
Sponsors:
Nathan Dormer, Ph.D.
Director
Drug Product Development
Adare
Daniel Kuntz
Associate Principal Engineer
Lonza Pharma & Biotech
Erin Hyde
Scientist II, Product Development
Lonza Pharma & Biotech
Nathan Dormer, Ph.D.
Drug Product Development
Adare
Bikash Chatterjee
CEO
Pharmatech Associates
Amit Samel
Life Sciences Technical Solution Consultant
Honeywell
Pamela Docherty
Life Sciences Industry Manager
Siemens
Kirsten Schaub
AVP- Commercial Sales, Healthcare and Life Sciences
DocuSign
Christina S. Wong
Marketing
Regulated Industries
DocuSign
Ellen Reilly
Vice President
Global Partners
IQVIA
David R. Schoneker
President/Owner/Consultant
Black Diamond Regulatory Consulting, LLC
Amos Dor
General Manager of the Pharma Team Automation Products Group
Applied Materials
Bob Lenich
Global Life Sciences Director
Emerson
Gilberto Dalmaso
Technical Science Director
Europe & Asia
Veltek Associates Inc.
Nigel Langley
Global Technology Director
BASF Corporation Pharma Solution
Eric Langer
Managing Partner
BioPlan Associates, Inc
Lisa Caralli
Director of Science and Technology Pharmaceutics
Catalent Pharma Solutions
Joe Zeleznik
Technical Product Manager
IMCD US
Tiffany Barnes
Life Sciences Technical Solution Consultant
Honeywell
Siegfried Schmitt Ph.D.
Vice President
Parexel
Scott Deckebach
MBA, Director of Compliance,
Lachman Consultant Services, Inc
Marty Lipa
Pharmaceutical Regulatory Science Team member and doctoral student at Technological University Dublin
Executive Director of Knowledge Management
Merck and Co., Inc
Tony Harrison
Senior Manager Biotechnology Business Unit
Beckman Coulter Life Sciences
Ed Gump, PhD
Vice President
USP Science Small Molecules
Neal Gordon
Managing Director
BPTG (BioProcess Technology Group)
Dr. Derek Duncan
Director Product Line
LIGHTHOUSE Instruments
Ruth Verplaetse, PhD
Study Director
Nelson Labs Europe, a Sotera Health Company
Lise Vanderkelen, PhD
Pharmaceuticals and Microbiology Expert
Nelson Labs Europe, a Sotera Health Company
Ron Najafi, PhD
CEO
Emery Pharma
Toni Manzano
Co-founder and Chief Science Officer
Aizon
Andreas Woppmann, PhD
Managing Director and Principal Consultant, BPTG (BioProcess Technology Group)
Ron Najafi, PhD
CEO
Emery Pharma
David Light
CEO
Valisure
James Blackwell
Founder and Principal Consultant
The Windshire Group
Featured Speakers
Four Interactive Tracks
FORMULATION
Topics included in this session are drug development, drug delivery, APIs, excipients, formulation trends, modified release, injectable drug formulation, and more.
Session 1: Improving Patient Outcomes through the Stratum Technology Platform: Revolutionized Injectable Solutions
Session 2: Data-Driven Strategies to Accelerate Your Molecule’s Development Path
Session 3: Excipients Update: Formulations, Supply, and Quality
Session 4: When Drug Meets Device: How to Assess Compatibility
MANUFACTURING
Topics included in this session are manufacturing strategies, process analytical technology, process and operational intelligence, data integrity, predictive maintenance, scale up,
fluid-bed coating, and more
Session 1: The Future of Life Sciences Production Automation: Greater Visibility with Audit-Ready Solutions
Session 2: Technology Advances in Process Operations: Using Real-time Monitoring and Artificial Intelligence to Optimize Manufacturing Operations
Session 3: End Point Determination and Scale-up of Fluid Bed Coating Through the Use of Process Tools
Session 4: 21CFR part 11 Data Integrity Challenges for Cleanroom Routine Environmental Monitoring Programs
DRUG DOSAGE FORM TRENDS
Topics include in this session are vaccines, biologics, solid dosage drugs, controlled release, cell and gene therapies, and more.
Session 1: Delivering on the Promise: Overcoming Biopharma Development and Manufacturing Challenges
Session 2: Mapping the Transition from Drug Discovery to Development and Beyond
Session 3: Editors’ Series: Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis
Session 4: Demystifying AI in Pharma
BIOPHARMA INDUSTRY CHALLENGES
Topics included in this sessions are drug quality, regulatory inspections, COVID-19 pandemic impact, good manufacturing practices, regulated documents, and more
Session 1: Cleanrooms Qualification Vs Cleanroom Monitoring: Annex 1 V12 Requirements
Session 2: Ensuring Container Closure Integrity of Sterile Vials
Session 3: Establishing a “New Normal” for Pharma Quality Practices
Session 4: Expedite Regulated Documents in the Era of COVID-19: From Development to Trials and Manufacturing
8:30 a.m. _________________________
9:00 a.m. ___________________________
9:45 a.m. __________
10:00 a.m.__________________
11:00 a.m.__________
11:30 a.m.___________________
12:30 p.m.__________
1:30 p.m.___________________
2:30 p.m.___________
3:00 p.m.___________________
4:00 p.m._________________________________
Registration Opens
Keynote Speaker
Networking Break in Exhibit Hall
Track Breakout Sessions
Networking Break in Exhibit Hall
Track Breakout Sessions
Networking Break in Exhibit Hall
Track Breakout Sessions
Networking Break in Exhibit Hall
Track Breakout Sessions
Event Close
Emerging technologies and processes that impact, enable, and advance bio/pharmaceutical development and manufacturing will be explored in Editors’ Series panel discussions and technical session presented by industry experts in four topic areas:
Amit Samel
Life Sciences Technical Solution Consultant
Honeywell
Bikash Chatterjee
CEO
Pharmatech Associates
Pamela Docherty
Life Sciences Industry Manager
Siemens
Ellen Reilly
Vice President
Global Partners
IQVIA
Kirsten Schaub
AVP - Commercial Sales, Healthcare and Life Sciences
DocuSign
Keynote Panel Discussion
The bio/pharma industry has demonstrated its R&D capabilities by accelerating development of vaccines and therapeutics to combat COVID-19. At the same time the industry faced intense scrutiny and political pressure. What are the short-, medium-, and long-term implications for bio/pharma development and manufacturing? Representatives of PhRMA, BIO, and other industry organizations will discuss and debate crucial business, regulatory, science-based issues facing the industry.
James Mayne, Ph.D.
Vice President
Science & Regulatory Advocacy
PhRMA
Phyllis Arthur
Vice President for Infectious Diseases and Diagnostics Policy
Biotechnology Innovation Organization
Christina S. Wong
Marketing- Regulated Industries
DocuSign
Erin Hyde
Scientist II, Product Development
Lonza Pharma & Biotech
Amos Dor
General Manager of the Pharma Team Automation Products Group
Applied Materials
Bob Lenich
Global Life Sciences Director
Emerson
Daniel Kuntz
Associate Principal Engineer
Lonza Pharma & Biotech
David R. Schoneker
President/Owner/Consultant
Black Diamond Regulatory Consulting, LLC
Gilberto Dalmaso
Technical Science Director
Europe & Asia
Veltek Associates Inc.
Eric Langer
Managing Partner
BioPlan Associates, Inc
Nigel Langley
Global Technology Director
BASF Corporation Pharma Solutions
Tiffany Barnes
Life Sciences Technical Solution Consultant
Honeywell
Joe Zeleznik
Technical Product Manager
IMCD US
Lisa Caralli
Director of Science and Technology Pharmaceutics
Catalent Pharma Solutions
Scott Deckebach
MBA, Director of Compliance,
Lachman Consultant Services, Inc
Siegfried Schmitt PhD
Vice President
Parexel
Marty Lipa
Pharmaceutical Regulatory Science Team member and doctoral student at Technological University Dublin
Executive Director of Knowledge Management
Merck and Co., Inc
Tony Harrison
Senior Manager Biotechnology Business Unit
Beckman Coulter Life Sciences
Neal Gordon
Managing Director
BPTG
Ed Gump, PhD
Vice President
USP Science Small Molecules
Ruth Verplaetse, PhD
Study Director
Nelson Labs Europe, a Sotera Health Company
Lise Vanderkelen, PhD
Pharmaceuticals and Microbiology Expert
Nelson Labs Europe, a Sotera Health Company
Dr. Derek Duncan
Director Product Line
LIGHTHOUSE Instruments
Toni Manzano
Chief Science Officer
Aizon
Andrej Ondracka
Innovation Lab Research Engineer
Aizon
Andreas Woppmann, PhD
Managing Director and Principal Consultant, BPTG (BioProcess Technology Group)
David Light
CEO
Valisure
Ron Najafi, PhD
CEO
Emery Pharma
James Blackwell
Founder and Principal Consultant
The Windshire Group