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View, browse and sort the ever-growing list of sessions by pass type, track, and format. With this Session Scheduler, you can build your schedule in advance and access it during the show via export or with the Mobile App, once live. Sessions do fill up and seating is first come, first serve, so arrive early to sessions that you would like to attend.

Tuesday | 9:45 am

API - Part 1 - Advances in API Synthesis and Manufacturing

Speaker: Brian Haney (AMRI)

Location: E353c

Track: Drug Manufacturing

Building a Better Drug: Strategies to Enhance Patient Drug Regimen Adherence

Moderator: Rita Peters (Pharmaceutical Technology)

Speakers: David Lyon, Ph.D. (Lonza Pharma and Biotech), Ronak Savla (Catalent Pharma Solutions)

Location: E353b

Track: Drug Development

Tuesday | 10:30 am

API Part II - Advances in API Synthesis and Manufacturing

Speaker: Stephen Hancock (AMRI)

Location: E353c

Track: Drug Manufacturing

Development & Manufacturing Considerations of High Potent Drug Products - a CDMO's Perspective

Speaker: Anil Kane (Patheon Inc. part of Thermo Fisher Scientific)

Location: E353b

Track: Drug Development

Nitto Avecia Pharma Services, your west coast comprehensive CMC Solutions Partner

Speaker: Raymond Kaczmarek (Nitto Avecia Pharma Services)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

“Pharmaceutical vitamins in patient care: Current applications and future opportunities”

Speaker: Nick McCormick, PhD (DSM Nutritional Products)

Location: Insight Brief Theater

Track: Insight Briefing

Tuesday | 11:00 am

Industry’s Uptake of Single-Use Technology and How it Has Driven Vendor Consolidation: A Business Journalist’s Point of View

Speaker: Dan Stanton (BioProcess Insider)

Location: bioLIVE Theater

Track: The BPI Theater

Pharma 4.0 - The Impact of Industry 4.0 on Pharmaceutical Manufacturing

Speaker: Jerome Wong (Grantek)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Tuesday | 11:15 am

Networking Break

Tuesday | 11:20 am

Single Use Technology for Containment During ADC Handling

Speaker: Scott Patterson (ILC Dover)

Location: bioLIVE Theater

Track: The BPI Theater

Tuesday | 11:30 am

Lacamas Laboratories: Your Manufacturing Partner for Pharmaceutical Intermediates

Speaker: Dr. Jim Tung (Lacamas Laboratories)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Tuesday | 11:45 am

Navigating Regulatory Compliance and Building Relationships with Government Agencies

Moderator: Michael Kennedy (Kennedy Law and Policy)

Panelists: FBI Speaker (FBI), Monika Chrzaszcz (Environmental Protection Agency), Eric Choy (Cybersecurity and Infrastructure Security Agency), Kathryn Young (Cybersecurity and Infrastructure Security Agency)

Location: E353c

Track: Drug Manufacturing

Revealing the Marketed and Pipeline Drug Trends - What are the Outsourcing Opportunities

Speaker: Peter Shapiro, PhD. (PharmSource and Pharma Intelligence Center)

Location: E353b

Track: Drug Development

Tuesday | 12:00 pm

Grifols Partnership: parenteral CDMO

Speaker: Marga Viñes (Grifols International, S.A.)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

How has single-use increased access to biomanufacturing solutions for both CDMOs and end-users?

Panelist: Scott Patterson (ILC Dover)

Chairperson: Dan Stanton (BioProcess Insider)

Location: bioLIVE Theater

Track: The BPI Theater

Tuesday | 12:30 pm

Pharmaceutical Sterility Assurance: Concepts and Options for Terminal Sterilization

Speaker: Martell Winters (Nelson Labs)

Location: Insight Brief Theater

Track: Insight Briefing

Tuesday | 1:00 pm

J-STAR Research, Inc.: Process Improvements Supporting Preclinical and Phase 1 Programs.

Speaker: Dr. Andrew Thompson (J-STAR Research, Inc.)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Reducing risk and improving timelines in the design, development and manufacture of Antibody Drug Conjugates (ADCs)

Speaker: Juan Cordova (Abzenal)

Location: bioLIVE Theater

Track: The BPI Theater

Tuesday | 1:20 pm

Biopharmaceutical Indications and Targets: Past, Present, and Future.

Speaker: Dawn Ecker (BioProcess Technology Consultants)

Location: bioLIVE Theater

Track: The BPI Theater

Tuesday | 1:30 pm

Innovation In Drug Development Scaleup and Manufacture For Accelerating The Critical Path To First In Human Trials

Speaker: Paul Quigley (Arcinova)

Location: Insight Brief Theater

Track: Insight Briefing

Keynote Presentation with Senator Jeff Flake (R-AZ) (2013-2018)

Keynote: Senator Jeff Flake

Location: E353c

Overview of Kodak Specialty Chemicals

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Overview of Kodak Specialty Chemicals

Speaker: Rajiv Bala (Kodak Specialty Chemicals)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Tuesday | 1:40 pm

Bioconjugation CMC – Successfully Executing a Complex Process

Speaker: Scott Miller, PhD (CARBOGEN AMICS AG)

Location: bioLIVE Theater

Track: The BPI Theater

Tuesday | 2:00 pm

Containment of HPAPI’s Using Task Specific Engineering Design

Speaker: Stephen Janz (Flow Sciences, Inc.)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

How are Service Companies Responding to the Increased Interest in New Modalities, and What Regulatory and Market Hurdles Still Exist?

Panelists: Juan Cordova (Abzenal), Scott Miller (CARBOGEN AMICS AG), Dawn Ecker (BioProcess Technology Consultants)

Chairperson: Dan Stanton (BioProcess Insider)

Location: bioLIVE Theater

Track: The BPI Theater

Tuesday | 2:15 pm

Chemical Facilities Outreach Exchange

Panelist: FBI Speaker (FBI)

Location: E353b

Track: Drug Development

Quality Risk Assessment in Pharmaceutical Industry

Speaker: Muhammad Naeem (Indus Pharma Pvt. Limited)

Location: E353c

Tuesday | 2:30 pm

Pediatric dosage form development challenges and opportunities

Speaker: Dr. Anthony Qu Ph.D. (Cambrex)

Location: Insight Brief Theater

Track: Insight Briefing

Tuesday | 3:00 pm

Challenges in Extractables and Leachables Studies of Plastic Process Materials

Speaker: Dujuan Lu, Ph.D. (SGS Life Sciences)

Location: E353c

Track: Drug Manufacturing

Five Pain Points Hiding in Your Pharma Supply Ch

Speaker: Jennifer Lott (SGS North America Inc.)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Tuesday | 3:30 pm

How Early Formulation Development Ensures Clinical Success

Speaker: Myke Scoggins, Ph.D. (Recro Gainesville)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Tuesday | 3:45 pm

Afternoon Networking Break

Tuesday | 4:00 pm

AI, IoT and the Road to Pharma 4.0

Speaker: Bikash Chatterjee (Pharmatech Associates)

Location: E353c

Track: Drug Manufacturing

High Potency API (HPAPI) Best Practices - Controlling Quality

Speaker: Andrew Leyhane (AMRI)

Location: E353b

Track: Drug Development

Wednesday | 9:45 am

Case Studies in Process Chemistry

Speaker: Francisco González Bobes (Bristol-Myers Squibb)

Location: E353b

Pharma's Problem with Data Integrity

Speaker: Brian Nadel (EAS Consulting)

Location: E353c

Track: Drug Manufacturing

Upstream Processing: A New Approach For Scalability and Transfer

Speaker: Guillaume Plane (MilliporeSigma)

Location: E353a

Track: Bio-Processing Symposium

Wednesday | 10:30 am

Extrusion Applications in Manufacturing Pharmaceutical Oral Drug Products

Speaker: Bei Chen, PhD. (AbbVie)

Location: E353c

Track: Drug Manufacturing

How Targeted Workforce Development Programs Can Support Derisking the Direct Materials Supply Chain

Speaker: Mary Lynne Bercik (Merck Pharmaceuticals)

Location: CANCELLED

Track: Bio-Processing Symposium

How pharma packaging could now support the extension of personalized services across the serialized supply chain

Speakers: Rick Seibert (Sharp), Dan Stehn

Location: Insight Brief Theater

Track: Insight Briefing

Quality by Design: Methods for Optimizing Spray-Dried Dispersions for Bioavailability Enhancement

Speaker: David Lyon, Ph.D. (Lonza Pharma and Biotech)

Location: E353b

Track: Drug Development

Tailored Catalyst Processing

Speaker: Dr Jamie Conway-Baker (Mastermelt Group Of Companies)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Wednesday | 11:00 am

CMC Considerations for Commercial-Ready ADC Manufacturing Processes to Enable Accelerated Timelines

Speaker: Courtney Morget, Ph.D. (AbbVie)

Location: bioLIVE Theater

Track: The BPI Theater

The Art of Process Understanding in API Development

Speaker: James Springer (Albemarle)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Wednesday | 11:15 am

Networking Break

Wednesday | 11:20 am

Strategic Frameworks for Global Expansion & Commercialization in the Biopharma Ecosystem

Speaker: Kiran Chin (MKA Insights)

Location: bioLIVE Theater

Track: The BPI Theater

Wednesday | 11:30 am

Creating the Trusted Pharma Supply Chain – from Manufacturer to Patient

Speaker: Steve Tallant (Systech)

Location: Insight Brief Theater

Track: Insight Briefing

Optima Chemical; Boronic Acid and Organometallic Manufacturing Heritage

Speaker: Mike Harrison (Optima Chemical)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Wednesday | 11:40 am

Scaling Multi-Column Chromatography to the Production Suite

Speaker: Ramon LeDoux (YMC PROCESS TECHNOLOGIES, INC. (formerly LEWA Process Technologies))

Location: bioLIVE Theater

Track: The BPI Theater

Wednesday | 11:45 am

Filling The Gap in Skilled Workforce Shortage in Biomanufacturing

Speaker: Parviz A. Shamlou, PhD (Jefferson Institute for Bioprocessing)

Location: E353a

Track: Bio-Processing Symposium

Geographically Integrated CMC Supply Chain– Speed Your Drug to Market

Speakers: Jingling Chen, Ph.D. (STA Pharmaceutical, a WuXi App Tec Company), Xiaoyong Fu, Ph.D. (STA Pharmaceutical, a WuXi App Tec Company)

Location: E353b

Track: Drug Development

Innovation without Imitation: Utilizing U.S. FDA Drug Master Files

Speakers: Melissa Sayers, M.S. (Registrar Corp), Uma Kale (DuPont)

Location: E353c

Track: Drug Manufacturing

Wednesday | 12:00 pm

Where are Today’s Biomanufacturing Bottlenecks and How is industry Looking to Overcome Them?

Panelists: Kiran Chan (MKA Insights), Courtney Morget, PhD (AbbVie), Ramon LeDoux (YMC Process Technologies, Inc. (formerly LEWA Process Technologies))

Chairperson: Dan Staton (BioProcess Insider)

Location: bioLIVE Theater

Track: The BPI Theater

Wednesday | 12:30 pm

Improving the Patient Experience with Innovative Thermal Solutions

Speaker: Patti Blessing (CAVU Group)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Innovative Approaches to Large-Scale Biologics Manufacturing

Speaker: Kevin Sharp (Samsung Biologics)

Location: Insight Brief Theater

Track: Insight Briefing

Wednesday | 1:00 pm

Flow-Through Polishing and The Use of Multi-Mode Ligand Libraries to Improve Process Efficiencies

Speaker: Andy Davies (Prometic Bioseparations)

Location: bioLIVE Theater

Flow-Through Polishing and The Use of Multi-Mode Ligand Libraries to Improve Process Efficiencies

Speaker: Andy Davies (Prometic Bioseparations)

Location: The BPI Theater

Track: The BPI Theater

The critical role of label materials for ensuring patient safety and product security.

Speakers: Markku Pietarinen (UPM Raflatac), Lottie Andersson (UPM Raflatac)

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Wednesday | 1:20 pm

China’s Focus on Innovation: Investments in Product and Process Development - Innovative Technologies from China are Coming

Speaker: Eric Langer (Bio-Plan Associates)

Location: bioLIVE Theater

Track: The BPI Theater

Wednesday | 1:30 pm

Flexible Manufacturing Solutions for Accelerated Programs

Speaker: Michael J. Valazza, R.Ph. (Catalent Pharma Solutions)

Location: Insight Brief Theater

Track: Insight Briefing

Keynote - Artificial Intelligence: Buzz word or industry changer?

Keynote: Brandon Allgood (Numerate)

Location: E353c

USP in the Supply Chain: More than Monographs (Part 1)

Speaker: John A. Giannone, MBA (US Pharmacopeia (USP))

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Wednesday | 1:40 pm

Raw Material Selects as a Means to Process Optimization

Speaker: Kelsey Achenbach (Roquette)

Location: bioLIVE Theater

Track: The BPI Theater

Wednesday | 2:00 pm

At What Point in Drug Development Must a Firm Look to Process Optimization, and How Critical is this Timing to a Product's Overall Success?

Moderator: Eric Langer (Bio-Plan Associates)

Panelists: Andy Davies (Prometic Bioseparations), Kelsey Achenbach (Roquette)

Chairperson: Dan Stanton (BioProcess Insider)

Location: The BPI Theater

Track: The BPI Theater

At what point in drug development must a firm look to process optimization, and how critical is this timing to a product’s overall success?

Chairperson: Dan Stanton (BioProcess Insider)

Speakers: Eric Langer (BioPlan Assocates), Kelsey Achenbach (Roquette)

Location: The BPI Theater

At what point in drug development must a firm look to process optimization, and how critical is this timing to a product’s overall success?

Panelists: Eric Langer (BioPlan Associates), Kelsey Achenbach (Roquette)

Chairperson: Dan Staton (BioProcess Insider)

Location: bioLIVE Theater

USP in the Supply Chain: More than Monographs (Part 2)

Speaker: John A. Giannone, MBA (US Pharmacopeia (USP))

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase

Wednesday | 2:15 pm

Basics of Computer System Validation (CSV) in the Pharmaceutical Laboratory. Ten years of GAMP 5: Pitfalls and Best Practices

Speaker: Tony Pezzolo (PerkinElmer)

Location: E353c

Track: Drug Manufacturing

Continuous, On-Demand Dehydration of Solvents in Flow Chemistry Manufacturing Processes

Speaker: Hannah Murnen (Compact Membrane Systems)

Location: E353b

Track: Drug Development

The Role of Bacteria in Drug Metabolism

Speaker: Abhinav Bhushan, Ph.D. (Illinois Institute of Technology)

Location: E353a

Track: Bio-Processing Symposium

Wednesday | 2:30 pm

Impurities for Development

Speaker: Ashok Dang, Ph.D. (US Pharmacopeia (USP))

Track: Exhibitor Showcase

Wednesday | 3:00 pm

Data as cGMP Records and Other Integrity Issues: Steps to Make Sure No Data is Forgotten

Speaker: Robert Voelkner (LabVantage Solutions, Inc)

Location: E353b

Investing in France for Potent Drug Manufacturing

Speaker: Frederic Desdouits (SEQENS CDMO)

Location: Exhibitor Showcase Theater

The Critical Approach to the Design of a HPAPI Suite in a Multi-use Facility

Speaker: Adam Kujath (Alcami Corporation)

Location: E353c

Track: Drug Manufacturing

Wednesday | 3:30 pm

Anhydrous Lactose Excipient Variation in relationship to functionality – A MultiVariate Approach

Speakers: Sunil Kumar (DFE Pharma), Marly Bastiaan Dickhoff (DFE Pharma), Bastiaan Dickhoff

Location: Exhibitor Showcase Theater

Track: Exhibitor Showcase