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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

PARTICIPANTS

540

MINUTES OF USE CASES

20

SPEAKERS

8

HOURS TO NETWORK

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.

CONTACT US

Keynote Speakers:

THOMAS O'CONNOR

FDA (US)

XIAOMING XU

FDA (US)

GENG TIAN

FDA (US)

PROF. JOHANNES KHINAST

RCPE / GRAZ UNIVERSITY OF TECHNOLOGY (AT)

CARSTEN LOSCH

KNAUER (DE)

MALCOLM BERRY

CONSULTANT, FORMER GSK (UK)

THOMAS ROPER

MEDICINES FOR ALL / VIRGINIA COMMONWEALTH UNIVERSITY (US)

LUCA EMILI

INSILICOTRIALS (IT)

Jae Yoo

FoundationLayer (US)

MARTIN WARMAN

MARTIN WARMAN CONSULTANCY (UK)

PROF. NICOLIN GOVENDER

CERN / UNIVERSITY OF JOHANNESBURG (SA)

Session Overview & Speaker List:

Click session 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
PROGEGENCE

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 Dispersions

Martin Spörk
RCPE

Advanced Continuous Manufacturing: From API Synthesis to the 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
RCPE

OSeeT – Optical Coherence Tomography for the In-Line Measurement of Film Coating

Andrew Birkmire
GEA

A Streamlined Approach to Continuous Direct Compression

Kieran Drain
AMAT

Novel Technologies 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
AUSRIAN 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 Impingment 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 TECH

Jae Yoo
FOUNDATIONLAYERS

Pharmaceutical Application 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 INTRODUCTION

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 AND 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.

    UPLOAD* (max. A4 Page // accepted file types: .doc, .docx, .pdf // max. 10 MB)


    Conference Chair and Contact

    CONFERENCE CHAIR:
    Prof. Johannes Khinast
    RCPE / GRAZ UNIVERSITY OF TECHNOLOGY
    khinast@tugraz.at
    CONFERENCE CO-CHAIR:
    Nima Yazdanpanah
    Procegence
    nima@procegence.com
    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.