Pharmaceutical Engineering: At the Frontier of Drug Substance and Drug Product

An ECI Conference

May 3-7, 2020
Kloster Irsee
Irsee, Germany

Germany_kloster_Irsee

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Preliminary Program

Call For Abstracts!  The deadline for oral and poster submissions is Jan. 15, 2020.

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Please forward this link to colleagues who may be interested in the conference topic.

About This Conference

It is well known that the physical and chemical properties of the DS (API) have major impacts on the formulation and the Drug Product (DP) process. In any dosage form including solid, liquid and semi-solid, the Drug Substance (DS) or Active Pharmaceutical Ingredient (API) goes through a formulation process. This process to make the final drug product serves many purposes, but all with the goal of eventually delivering the active ingredient to the desired sites in the patients’ body in the most convenient way and to achieve optimal therapeutic effect.

For most small molecule drugs, the final step in an arduous synthetic sequence is usually the crystallization or precipitation of the DS. This serves as both an isolation as well as purification step. In addition, many particle engineering techniques have been advanced that can tailor the physical and chemical properties of the drug substance during the final step in order to facilitate the design and scaleup of a rugged and reproducible DP processes. From historical and regulatory viewpoints, the blurring of the DS/DP interface while having the potential to offer competitive advantages, there will be regulatory and cultural hurdles that need to be ameliorated. The impact of DS properties on DP performance and the DP processes have attracted wide interest in the industry. However, many engineering issues and mechanistic understanding concerning the DS, the formulation, and their interface still need to be developed and explored. This conference seeks to bring scientists, engineers and regulators working at this critical interface for mutual discussion of current results, future improvement and to identify any technical and regulatory needs that still exist. Participants attending this conference will significantly benefit from learning the innovations from the integration of DS (API) and the formulation of the drug product.

Program Themes

  • Role of particle engineering
  • Material science of API/DS and formulation -Impact on drug product performance and process scaleup
  • Pharmaceutical composite materials

Confirmed Speakers

Particle Technology Session

Dr. Christopher Burcham, Senior Engineering Advisor          
Eli Lilly and Company, USA

Research Areas:  Pharmaceutical Process Development with an emphasis on Crystallization and particle formation process design; mechanistic modeling
Website

Presentation:Examples of Particle Engineering to Improve Patient Outcomes and Product Manufacturing”

Prof. Marco Mazzotti               
ETH Zurich, Switzerland
Research Areas:  Crystallization, Carbon Dioxide Capture and Storage systems
Website

Presentation:Size and Shape Engineering of Needle-like Crystals

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Prof. Allan Myerson                       
Massachusetts Institute of Technology, USA

Research Areas:  Crystallization, pharmaceutical manufacturing
Website

Presentation:  “Continuous Crystallization and Purification: The Role of Impurity Incorporation Mechanisms in Non-equilibrium Processes

Prof. Zoltan Nagy                      
Purdue University, USA

Research Areas:  Crystallization and particulate systems engineering, Process Systems Engineering, Process Intensification and Control, Advanced pharmaceutical manufacturing
Website

Presentation:  “Novel Process Intensification Approaches to Integrate Drug Substance and Drug Product Manufacturing

Dr. Jian Wang                   
Vice President, J-Star Research, Inc., USA

Research Areas:  Crystallization Process R&D, Polymorph Discovery & Studies, Pre/Early Formulation Evaluation, DS-DP Co-Processing
Website

Presentation: Bridging the Gap between API and Drug Product via Coprocessing

Materials Science Session

 Prof. Simon J.L. Billinge                           
Columbia University, USA

Research Areas:  Amorphous and nanostructured pharmaceuticals and molecular materials, methods for solving the nanostructure problem, nanoscale fluctuations in exotic electronic materials, nanostructured materials for energy and environmental remediation, software for complex modeling and nanostructure determination
Website

Presentation:  “Advanced X-ray Analysis of Disordered and Composite Materials

Dr. David Lechuga-Ballesteros                                       
Research Fellow, AstraZeneca Pharmceuticals LP, USA

Research Areas:  Pharmaceutical materials science
Website

Presentation: The Relevance of Pharmaceutical Material Sciences in the Development of Inhaled Biologics

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Prof. Boris Rybtchinski                                    
Weizmann Institute of Science, Israel

Research Areas:  Supramolecular chemistry, crystallization mechanisms, sustainable and energy materials, as well as electron microscopy
Website

Presentation: Imaging Organic and Protein Crystallization Mechanisms

Dr. Christian Serre                                
Research Director, École Normale Supérieure (ENS) – PSL Research University, France

Research Areas:  Synthesis, structure determination, including the use of X-ray diffraction data, and applications related to health, environment and energy of porous stable and functional porous solids (Metal Organic frameworks…)
Website

Presentation: Porous Biocompatible Metal Organic Frameworks in Biomedicine

Prof. Clare Strachan                           
University of Helsinki, Finland

Research Areas:  The physicochemical characterisation and optimisation of solid drugs and dosage forms
Website

Presentation: Application of Non-Linear Imaging and Spectroscopy to Engineered Particles

Composite Materials Session

Dr. Deniz Erdemir                          
Bristol-Myers Squibb. USA

Research Areas:  Dr. Erdemir’s research focus lies at the drug substance-drug product interface with emphasis on crystal polymorphism and design of materials via particle engineering to enable robust drug products.
Website

Presentation: Co-Processing Methodologies to Improve Powder Properties of Drug Substances

Prof. Saif A Khan                            
National University of Singapore, Singapore

Research Areas:  Continuous Pharmaceutical and Materials Manufacturing, Microfluidics, Flow Chemistry, Particle Engineering
Website

Presentation: Drug Particle Engineering Using Microfluidic Emulsion-Based Crystallization

Prof. Korbinian Löbmann                                
University of Copenhagen, Denmark

Research Areas:  My research background lies in solid drug formulation and physico-chemical characterization thereof. This includes in particular the development of new enabling formulation strategies, such as amorphous solid dispersions containing proteins as stabilizers, co-amorphous drug delivery systems, and microwave amorphization (in situ amorphization); as well as novel excipients, such as mesoporous silica or cellulose nanofibers.
Website

Presentation: Co-Amorphous Systems and Multicomponent Amorphous Mixtures

Prof. Changquan Calvin Sun                           
University of Minnesota, USA

Research Areas:  Pharmaceutical Materials Science, Powder Technology, Solid-state Science, Crystal engineering
Website

Presentation: Challenges and Opportunities in Optimizing Mechanical Properties of Drugs by Incorporating Excipients

Conference Organization

Chair:  Daniel S. Hsieh, Bristol-Myers Squibb (Retired)

Co-Chair:  San Kiang, Industrial Consultant

Organizing Committee

Deniz Erdemir, BMS, USA
Mauricio Futran, Janssen, USA
Junbo Gong, Tianjin University, China
Ren Guobin, East China University of Science and Technology, China
Soojin Kim, Hanmi Pharmaceutical Co., South Korea
Alfred Lee, Merck & Company Inc., USA
Allan Myerson, Massachusetts Institute of Technology, USA
Srividya Ramakrishnan, Dr. Reddy’s Laboratories, India
Vidya Swaminathan, AstraZeneca, UK
Bing-Shiou Yang, Boehringer Ingelheim Pharmaceuticals, Inc., USA

Abstract Submission

The abstracts should be submitted as soon as possible and no later than the deadlines noted below.  The abstract should consist of 5 parts:  purpose, method, results, conclusion, and reference.  The abstract should introduce the proposed paper’s subject, summarize its contents, explain any unique aspects, and clearly indicate the specific relevance to the themes of the Conference.  The abstract must be at least half a page in length with a two page maximum.

Descriptions of the Three Sessions  You may pick one or two sessions that you feel your work fits into.

Submission deadline is January 15, 2020 for long & short oral presentations and poster presentation.

Please prepare your abstract according to this template: docx or doc.

All abstracts should be submitted electronically HERE.

Only a limited number of oral presentation slots are available and thus all submissions for oral sessions will be considered for both oral and poster presentation.

All accepted abstracts will be published as a proceeding before the conference.

Major Sponsors

 

Sponsor Levels

Please click HERE to view the levels of sponsorship.

Conference Venue

Kloster Irsee (Swabian Conference Centre at Irsee)  Nestling in the Alpine Foreland of the Allgäu and located only a few kilometers from walled town of Kaufbeuren, the former Benedictine monastery at Irsee – founded in the 12th century – now houses a modern conference center.  The magnificent Baroque church and the harmoniously designed four-winged monastery, surrounded by a well-kept park, away from major highways and yet easily reached, is particularly suitable for the conference.  The center offers a broad range of leisure activities including a bierstube in the cellar of the monastery and a game room with pool, table tennis and tabletop football.  There is also a bocce court and a sauna available for guests.  Nearby are many jogging trails, fitness trails, a tennis center, walking and hiking trails.  Across the court from the center is the Irsee brewery where conference attendees can enjoy beer directly from its source.  Note that there are no televisions in the bedrooms; however, one may be rented.

The nearest major airport is Franz-Josef Strauss Airport in Munich  and their web-link provides a great deal of useful information, including information for booking airport hotels.

A concert on the historic church organ is being arranged for early Sunday evening, May 3.  After the concert, conference participants are invited to go to the organ loft and informally meet the organist.

Kloster Irsee/Swabian Conference Center at Irsee is a good starting point for excursions and sightseeing tours to the Allgäu Mountains, to Lake Constance, to Austria and Switzerland. For those who plan to extend their stay, popular day-trips are to the Castles of Linderhof and Neuschwanstein (built by the Bavarian King Ludwig II), the scenic Tannheimer Valley and the Pfaffenwinkel with its famous Baroque churches (Wieskirche).

More information about Kloster Irsee can be found at this link.

Address:  Swabian Conference and Educational Centre, Kloster Irsee, Klosterring 4
D-87660 Irsee
Telephone: +49 (0)8341 906-00

Travel Information

Transportation to Conference Site  The Swabian Conference Center at Irsee rests in the Alpine Foreland of the Allgäu, yet is conveniently located near Munich and is easily reached by rail or road.  For those traveling from the airport by train, one can reach the Munich Main Station(Hauptbahnhof) in several ways: (1) by Lufthansa Airport Bus.  Departures are every typically 20 minutes for the 45 minutes trip.  Cost is approximately 10.5 € one- way and 17 € roundtrip . (2)  by Rapid Transit Train (“S-bahn” – either S1 or S8).  Departures are every 20 minutes for the 41 or 45-minute trip.  (3) by taxi.  The trip takes approximately 40-minutes and the price should be discussed with the driver.

From the Munich Main Station there are through trains to Kaufbeuren (about an hour ride).  In front of Kaufbeuren Station there is a taxi stand where you can hire a taxi to Irsee.

Conference Fees and Registration

Coming soon!

We expect to open registration in November 2019.   The estimated conference fee (including registration; single hotel room for nights of May 3, 4, 5 and 6, , and meals from Sunday dinner through Thursday lunch) is US$1900, dependent on exchange rates.

Preliminary Program

Click HERE to view the preliminary program.

General Information about ECI

Engineering Conferences International (ECI) is a global engineering conferences program, originally established in 1962, that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

The format of the weeklong research conference provides morning and late afternoon or evening sessions in which major presentations are made. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. This format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe that the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

All participants are expected both to attend the entire conference and to contribute actively to the discussions. The recording/photographing of lectures and presentations is forbidden. As ECI conferences take place in an informal atmosphere, casual clothing is the usual attire.

Engineering Conferences International
32 Broadway, Suite 314, New York, NY 10004
T: 1-212-514-6760 F: 1-212-514-6030 E: info@engconfintl.org