Accelerating Access to Medicines
MARCH 27 & 28, 2023 // WASHINGTON, D.C.
About the event:
We’re delighted to invite you to join the „Accelerating Access to Medicines“ Workshop, held on March 27 and 28, 2023 at the Austrian Embassy in Washington DC. The workshop features top experts from FDA, eminent pharma companies, pharma equipment providers, academics and RCPE.
The goal of the workshop is to identify bottlenecks in the development pipeline and to propose solutions for bringing medicines to patients much faster.
Reasons to Attend:
STOP WAITING; START IMPROVING
Learn more about proven solutions that could revolutionize your manufacturing practices and improve your developmental processes immediately.
GET A HEADSTART
Experience the latest developments and technologies that will shape the future of pharmaceuticals today, and outperform your competition for years to come.
IT’S ALL ABOUT IMPLEMENTATION
Benefit from the collective experiences and mistakes by outstanding industrial and academic researchers when implementing innovative manufacturing technologies, so you can avoid them.
CONTRIBUTE AND BE A PART
Help us to shape a collaborative vision for pharmaceutical development and manufacturing. Contribute and be the change YOU want to see.
GROW YOUR NETWORK
Get direct access to industrial decision-makers, key suppliers and govermental authorities. Grow your personal and professional network for future collaborations and opportunities.
Partners & Sponsors:
Key Topics:
Click the topic for more details:
RAPID PROCESS & PRODUCT DEVELOPMENT
> Reducing cost and time in bringing a product to market
> Drug substance and drug product examples
> Advanced techniques and methodologies
MODELING & SIMULATION AS A REGULATORY BENEFIT
> Model-based process and product development
> Risk and sensitivity analysis, multidimensional virtual DoEs
> M&S from discovery to manufacturing
NEXT-GENERATION DIGITAL TOOLS
> Pharma 4.0 and data-centric product & process development
> Advanced process control and digitalization
> Continuous process validation, quality oversight
ADVANCED & NOVEL PHARMACEUTICAL PRODUCTS
> New modalities, emerging molecules, complex products
> Biologics, mRNA, cell therapy, nano-medicines
> Personalized delivery systems
120
540
20
8
Tickets:
This event is explicitly open to the public, whether you represent a life science company, a non-profit organization, or are simply interested in pharmaceutical manufacturing. We firmly believe in the enriching experience of debating different perspectives, discussing opportunities and challenges with open minds, and fostering cross-industry collaborations.
TICKET PRICE:
€642.58 / $690*
* INCL. TAXES,
EXCHANGE RATE ON FEB 10, 2023
If you require other forms of payment such as pay-per-invoice, please contact our organizational staff.
Keynote Speakers:
THOMAS O'CONNOR
XIAOMING XU
GENG TIAN
PROF. JOHANNES KHINAST
CARSTEN LOSCH
MALCOLM BERRY
THOMAS ROPER
LUCA EMILI
MARTIN WARMAN
JAE YOO
PROF. NICOLIN GOVENDER
Session Overview & Speaker List:
Click the session title for more details:
WELCOME & PLENARY LECTURE
Johannes Khinast
RCPE / GRAZ UNIVERSITY OF TECHNOLOGY
Thomas O’Connor
FDA
Experience in Pharmaceutical Innovation: Perspective on CDER Advanced Manufacturing Initiatives
SESSION 01: DRUG SUBSTANCE MANUFACTURING
Malcolm Berry
MB CHEMISTRY CONSULTING
Continuous API Manufacturing: The Benefits, and the Hurdles to Implementation
Nima Yazdanpanah
PROCEGENCE
Rapid and Efficient Product and Process Development, Scale-Up, and Tech-Transfer
Jason Williams
RCPE / KAPPE LAB
Automation, PAT and Modelling Strategies for Data-Rich Continuous Process Development
Haichen Nie
TEVA
Understanding Excipient Induced Recrystallization of Spray Dried Amorphous Solid Dispersion
Martin Spörk
RCPE
Advanced Continuous Manufacturing: From API Synthesis to Final Dosage Form
Thomas Roper
MEDICINES FOR ALL / VIRGINIA COMMONWEALTH UNIVERSITY
An Automated Selectivity Optimization Routine for PAT Model Development Demonstrated by Concentration Analysis for API and Related Impurities
SESSION 02: DRUG PRODUCT MANUFACTURING
Martin Warman
MARTIN WARMAN CONSULTANCY
Realizing the Full Potential of CM in the Pharmaceutical Innovator Space
Thomas Brinz
SYNTEGON
Fully Automated and DoE-Based Development of an Oral Solid Dosage Form
Thomas Kipping
MERCK
Advanced Manufacturing Concepts for Oral Solid Dosage Forms
Andrea Raffa
PHYLLON
OSeeT – Optical Coherence Tomography for the In-Line Measurement of Film Coatings
Andrew Birkmire
GEA SYSTEMS NA LLC
A Streamlined Approach to Continuous Direct Compression
Kieran Drain
AMAT
Novel Technology to Accelerate Drug Product Development and Enable Pharma Manufacturing ESG Compliance
SESSION 03: DIGITALIZATION
Luca Emili
INSILICOTRIALS
Hyper accelerate R&D with in silico trials
Sarah Stryeck
RCPE
Daniel Neuhold
LOCONIQ
Leading Pharmaceutical Sustainability & Digitalization
Salvador Garcia Munoz
ELI LILLY
Model Based Multivariate Monitoring of Drug Product Processes
Anthony Tantuccio
HOVIONE
Bridging the Divide Between R&D and Manufacturing through Digitalization: An Example of Continuous Tableting
Johan Remmelgas
RCPE
Development of a DEM-Based Digital Twin of a CDC Line for the Evaluation of Continuous Manufacturing Control Strategies
Tobias Miunske / Falk Pfitzer
HARRO HÖFLIGER
A Disruptive Approach of a Digitalization Kit for Pharmaceutical Machines
Michaela Laussegger
AUSTRIAN BUSINESS AGENCY
Austria: Top Center for Life Sciences
SESSION 04: MODELING AND SIMULATION
Nicolin Govender
CERN / UNIVERSITY OF JOHANNESBURG
Towards Manufacturing Digital Twins Using GPU Based Physics Simulations: A Particles Perspective
Geng Tian
FDA
Applications of Modeling and Simulation for Quality Risk Management of Advanced Manufacturing
Avik Sarkar
MERCK
The Emerging Significance of Predictive Modeling and Simulation in Large-Molecules Pharmaceutical Manufacturing
Christian Witz
SIMVANTAGE
Achieving Rapid Transfer from Lab to Production Floor with a Novel Digital Tool for Scaling and Optimizing Bioreactors
Matthew Flamm
MERCK
Computational Fluid Dynamics (CFD) Model for Predictive Scale Up/Down of Large-Molecule Drug Product Formulation
Dana Barraso / Sean Bermingham
SIEMENS
Application of Mechanistic Modeling to Quantify Risks and Inform Control Strategies
SESSION 05: NOVEL PRODUCTS / NANO-SYSTEMS
Carsten Losch
KNAUER
Scalable Lipid Nanoparticle Formulation Using Impingement Jets Mixing Systems
Xiaoming Xu
FDA
Opportunities in Continuous Manufacturing of Nanomaterials
Steve Mesite
MICROFLUIDICS
Scalable Technology Helps Overcome Pharmaceutical Nanoparticle Manufacturing Challenges
Patrik Johansson
LYNDRA
Continuous Manufacturing Enabling Early Development through Commercialization
Emre Türeli
MYBIOTECH
Bridging Nanomedicines Towards Clinic
SESSION 06: PHARMACEUTICAL SCIENCE AND TECHNOLOGY
Jae Yoo
FOUNDATIONLAYERS
Pharmaceutical Applications of 3DP/Additive Manufacturing: Challenges and Opportunities
Filip Francqui
GRANUTOOLS
Powder Characterization for Continuous Manufacturing with a Focus on Electrostatic
Daniel Müller
HARRO HÖFLIGER
Direct API Filling into Capsules
Daniel Treffer
MELTPREP
Free-D Molding: Helping 3D Printing to Deliver Its Rapid Prototyping Potential
Brian Haight
LEISTRITZ EXTRUSION TECHNOLOGY
Reducing Degradation of Ritonavir by Managing Melt Temperature in a Twin Screw Extruder
DAY 1 - 03/27/23
08:30 – 09:00 AM // REGISTRATION
09:00 – 09:50 AM // WELCOME AND PLENARY LECTURE
10:00 – 11:30 AM // SESSION 01: DRUG SUBSTANCE MANUFACTURING
11:30 AM – 12:45 PM // SPONSORED LUNCH & NETWORKING
12:45 – 02:30 PM // SESSION 02: DRUG PRODUCT MANUFACTURING
03:00 – 05:00 PM // SESSION 03: DIGITALIZATION
05:00 – 08:00 PM // DINNER SPONSORED BY ABA
DAY 2 - 03/28/23
09:00 – 10:45 AM // SESSION 04: MODELING AND SIMULATION
11:15 AM – 01:00 PM // SESSION 05: NOVEL PRODUCTS / NANO-SYSTEMS
01:00 – 02:00 PM // SPONSORED LUNCH & NETWORKING
02:00 – 03:30 PM // SESSION 06: PHARMACEUTICAL SCIENCE & TECH
03:30 – 03:45 PM // SUMMARY AND CLOSING
Abstract Submission:
DEADLINE: FEB 28, 2023
Outstanding science and groundbreaking developments should and must be shared to realize their full potential. RCPE invites researchers to submit abstracts of their work for the opportunity to present their work to industry and regulatory professionals, and academics.
Conference Chair and Contact:
HOSTED BY:
Research Center Pharmaceutical Engineering GmbH
Inffeldgasse 13 / 8010 Graz, Austria
Phone: +43 (0) 316/873 30901
Fax: +43 (0) 1/253 3033 1586
E-Mail: office@rcpe.at
Venue & Location:
Embassy of Austria
3524 International Court, NW
Washington, D.C. 20008
USA
WE ENCOURAGE YOU TO USE PUBLIC TRANSPORTATION
By METRO:
Get on the Red Line headed to Shady Grove, exit at Van Ness/UDC Station. Walk uphill on Van Ness. You will pass the University of the District of Columbia on your right. Turn right on International Court and turn right again at the fork in front of the UAE Embassy. You will see the Austrian Embassy on your left at the end of the Cul-De-Sac.
By Car – PARKING:
Visitor parking at the Embassy is very limited. Please note that parking is by permit only on International Court! Public parking is available behind the Embassy on 36th Street with access to the Embassy through the park. Parking is also available at the University of The District of Columbia on Van Ness Street. Parking fees may apply.