Course Information

Industry Live Course

55th Annual International Industrial Pharmaceutical Research and Development Conference 
“Particle Engineering in API and Drug Product Design”

June 9-12, 2014
Fluno Center
Madison, WI

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin- Madison



Register online:

Register Now button

$1800

Other ways to register:

1. Register by phone at 608.262.3132 or toll free: 877.947.4255

2. Download the registration form, complete and mail to:

June Land O'Lakes Conference
Division of Pharmacy Professional Development
UW-Madison, School of Pharmacy
777 Highland Ave.
Madison, WI 53705

Or fax your registration form to us with your credit card number.

Goals and Objectives

Fluno center

Particle engineering is an emerging field that applies new technological advances in powder processing and characterization allowing the scientist to control particle properties.   The application of particle engineering has influenced drug development to advance delivery systems once thought too complex to be manufacturable and commercially viable.  The importance of this field to pharmaceutical portfolios is recognized within the industry and many companies now have a dedicated group of scientists and engineers practicing this discipline.  However, significant technical and regulatory challenges remain in both the production of these complex particles and in formulation design.  The purpose of this three-day conference is to provide an educational forum to discuss issues in the manufacture of engineered particles and applications to formulation design and development.  The focus of this conference will include:

  1. Advances in drug delivery systems requiring API characteristics that can be achieved through particle engineering. 
  2. Fundamentals of particle engineering.
  3. Analytical and physical characterization techniques.
  4. Technologies to produce engineered particles.
  5. Regulatory and IP issues regarding particle engineering.

View 2013 course evaluation results.

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General Information

Location and Travel

Short Course

The conference will be conducted at the Fluno Center located on the University of Wisconsin campus in Madison, Wisconsin (http://fluno.com/). The Fluno Center is located on the edge of the UW campus and within a short walk of the State Capital, shops on the State Street pedestrian mall and lakes Monona and Mendota. The conference atmosphere offers an informal setting for interaction and networking with industrial peers.

The venue offers many advantages:

  • Choice of hotel locations/accommodations
  • Conference facilities on the University of Wisconsin-Madison campus
  • Easy and quick access to the Madison airport; as well as airports in Chicago and Milwaukee
  • New condensed format resulting in one day less away from work!! Same number of educational contact hours
  • Evenings free to explore Madison's restaurants and attractions while networking with collegues
  • All the above while retaining the quality of learning, hours for learning, and a continued relaxed environment to maximize learning

For those registrants flying into Madison (MSN), the Fluno Center is approximately 20 minutes from the airport. For those driving, the location is only 20 minutes from the intersection of Interstates 90 and 94 leading into Madison.

Lodging & Meals

Short Course

Hotel accommodations are the responsibility of the registrant. The Division of  Pharmacy Professional Development has reserved a block of guest rooms at the Fluno Center, Campus Inn, (2 blocks away) at the DoubleTree (1 ½ blocks away) and the Hampton Inn (2 1/2 blocks away). These are available on a first come basis. View information about guest rooms at these facilities and a list of additional hotels within walking distance.

Madison Area Information:

Things to do, attractions, restaurants: http://www.visitmadison.com
Interactive Visitor Guide: http://www.nxtbook.com/nxtbooks/greatermadison/guide_2012fallwinter/

Registration & Fees

Early Registration $1550
Registration after 5/12/2014 $1800
Special rate for academic and government employees (prior to 5/12/2014) $1050

Fee includes: 1) education: instruction; handout materials (electronically as pdf files); and documentation of completion; and 2) daily continental breakfast, mid-am/pm breaks, lunches and all social events listed in the program. Because the handout material will be provide electronically, registrants are encouraged to bring a laptop for the conference.

Enrollment Deadline / Limits

A check in the total amount payable to UNIVERSITY OF WISCONSIN should accompany your application to ensure that space will be held for you. Credit card payment is also acceptable. Total payment will be returned /refunded if space is not available.

In the event your registration is confirmed and at a later date you are unable to personally attend, a refund (less a $50 administrative fee) will be provided prior to May 12; after May 12, no refunds will be made. You may fax your registration (608) 262-2431.

Laptops encouraged

Conference materials will no longer be presented in the traditional large blue binders. Instead all presentations will be provided as PDF files on memory sticks distributed at the beginning of the conference.

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NEW FOR 2014 – An Optional Short Course

Optional Pre-Conference Short Course

Scientists arriving early may wish to take advantage of this optional short course opportunity on Monday, June 9, 2014
1:00-5:15 PM Fluno Center, Madison, WI

"Particle Engineering Technology Selection and Partnership: A Roadmap to Commercialization"


Goals and Objectives:

Particle engineering is a applied in the pharmaceutical industry to enable the development of New Molecular Entities (NMEs) and as life-cycle management strategy in reformulation and product line extensions. An array of particle engineering technologies are available and include controlled crystallization techniques, co-crystal formation, co-processing via spray-drying or hot melt extrusion and nanoparticle approaches. However, formulation scientists, business development executives and decision makers are often contemplating  a number of questions: 1) which technology to use based on the physicochemical properties of the API for expeditious feasibility and proof-of-concept studies? 2) what are some of the technology and vendor selection criteria and due diligence challenges? and, 3) what are the key legal/IP and business considerations and decisions? It is the objective of this short course to address these and other questions by experienced stakeholders from technology developers and end users, management and business executives and consultants. Upon completion of this short course, participants should be able to:

    1.        Better understand the pharma needs in particle engineering, vendor and technology selection criteria;    
    2.        Timely address technical, legal and business considerations and issues;
    3.        Apply knowledge and lessons learned to a rational product design and development.

Who should attend:
Scientists and project leaders/managers who find themselves faced with issues of potential drug-drug interactions and want a greater understanding of models that can be used to assess such interactions.

To register

Go to: http://ce.pharmacy.wisc.edu/2014JuneLOLPreConfShortCourse

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Social Activities

In addition to the educational benefits of this program, the conference is designed to provide registrants with a relaxing environment to meet and share ideas with colleagues with similar interests and network for future collaborative efforts. There will be ample networking opportunities during the opening reception, round table discussions and the poster session/vendor exhibits. Evenings are free to explore Madison and the University of Wisconsin Campus.

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Course Contents for 2014


Monday, June 9, 2014

12:30-5:15  pm

 

OPTIONAL SHORT COURSE - SEPARATE REGISTRATION REQUIRED

5:30 pm

June Land O' Lakes Conference Registraion

5:30 pm

Opening Reception

6:30 pm

Dinner and welcome

7:15 pm

The Science of Cheese Making

ProgramSpeaker:
John A Lucey, PhD
Director of CDR and Professor of Food Science
University of Wisconsin-Madison

8:15 pm

Adjournment

Tuesday, June 10, 2014

8:30 am

Welcome and Conference Introduction

8:45 am

Key Note- "Particle Engineering for Drug Delivery: Why, When, and What"

            Speaker:  Marcus Brewster
            Janssen, Belgium

  • define particle engineering: why and when is it used and for what type(s) of products/reasons
  • drivers for and challenges of particle engineering in drug development
    • formation/stabilization/isolation/characterization... of particles
    • formulation and drug delivery using engineered particles
    • clinical outcomes and benefits to patients
    • commercialization/manufacturability of products using particle engineering
    • IP business drivers

9:40 am

Break

10:10 am

Fundamentals of Particle Engineering and Overview of Technologies

            Speaker: Daniel Jarmer
            Associate Engineering Advisor
            Eli Lilly & Co.

  • science oriented- theory behind technologies
  • what is an engineered particle?
  • fundamentals to produce an engineered particle
    • engineering fundamentals
    • materials science fundamentals
    • highlight technologies used
  • categorization and assessment of specific technologies at high level (more than just nanosizing)-speaker can add others
  • justification for using these technologies
  • particle size manipulation (milling)
  • crystallization-cocrystals, salts, etc
  • coprocessing- with excipients
  • stabilization and isolation
  • manufacturability/scale-up

11:05 am

Particle Engineering in API and Drug Product

Speaker: Chiajen Lai  
Associate Director, Drug Product Science and Technology
Bristol-Myers Squibb Co.

  • Integration of Particle Engineering to the drug product design
  • How particle engineering techniques can assist drug development in achieving the Target Product Profile - an example is the manufacture of engineered particles for lung delivery
  • Particle Engineering's impact on drug product CQA's
  • Crystallization and co-crystal and particle manipulation techniques that impact the drug product.
  • Techniques to impact particle control (particle size, bulk density, flow) to impact better processing properties.
  • Impact and manipulation of drug substance physical properties for drug product performance
  • Effect and manipulation of drug substance properties on drug product manufacturing process.

12:00pm

Lunch

1:05 pm

Overview of Analytical/Physical Characterization

            Speaker:  Ray Skwierczynski
            Sr. Director, Pharmaceutical Technology R&D Laboratory Boston,
            Takeda Pharmaceuticals International Co.  

  • techniques for characterization of engineered particles
  • PAT for engineered particles
  • quality control aspects

1:55 pm

 Particle Size Manipulation (milling)

            Speaker:  Kevin Girard
            Chemical Research and Development,
            Pfizer Global Research and Development

  • impinging-jet for nanoparticles
  • homogenization
  • nano-milling and wet-milling
  • microfluidization with 2 stream
  • stabilization of particles

2:50 pm

Break

3:20 -4:10 pm

Case Studies of Particle Size Manipulation

            Speaker: Robert Lee
            VP, Pharmaceutical Development Services (Particle Sciences)

  • API
  • drug product/route of administration: small molecule inhalation
  • formation/stabilization/isolation/characterization...
  • scale-up
  • handling/packaging
  • justification for the approach
  • drivers, critical quality attributes
  • particle size spec- bio performance, physical stability

5:00-6:30 pm

Networking Reception

6:30 pm

Evening free to explore Madison

Wednesday, June 11, 2014

8:30 am

Cocrystals: Formation, Solubility, and Streamlining Early Development

            Speaker:  Nair Rodriguez-Hornedo
            Department of Pharmaceutical Sciences
            University of Michigan

  • Solution and solid-state mediated methods of cocrystal formation
  • Meaningful characterization methods to guide cocrystal and additive selection without the time and material consuming requirements of traditional methods
  • Key indicators of cocrystal transition points
  • Overcoming the barriers in cocrystal stability by fine-tuning cocrystal/solution behavior

9:20 am

Particle Engineering for a Form Conversion Process with Thermodynamic Constraints

            Speaker: David Willcox
            Scientific Fellow II
            Vertex Pharmaceuticals                   

  • Phase diagrams
  • Monitoring kinetics of form conversion
  • Mathematical model of form conversion
  • Process parameters
  • Scalable process

10:10 am

Break

10:40 am

Co-processing with excipients: Key considerations for technology selection and formulation design in the development of amorphous particulate systems

            Speaker: Dave Miller
            Vice President, Research and Development
            DisperSol Technologies, LLC

  • drug-excipient amorphous dispersion systems
  • fundamentals of excipient(s) and technology selection
  • considerations for drug-excipient co-processing by melt extrusion, spray drying, anti-solvent precipitation, and KinetiSol

11:20 am

Case Studies for Coprocessing

            Speaker:  Marshall Crew
            President and CEO
            Agere Pharmaceuticals

  • API
  • drug product and route of administration:  spray drying of proteins
  • formation/stabilization/isolation/characterization...
  • scale-up
  • handling/packaging
  • justification for the approach
  • drivers, critical quality attributes

12:10 pm

Lunch

1:10 pm

      Case Studies-Nanoparticle Approaches to Particle Engineering

1:10 pm

Case Study #1   – Preclinical assessment of IV nanosuspension to address needs of              nanomedicine [ application of nanosuspension in HIV, pain]

            Speaker:  Barrett Rabinow, Baxter Distinguished Scientist-Medication Delivery, Baxter

2:00 pm

Case Study #2  - Oral nanoformulations for tox studies and early development

            Speaker:    Filipos Kesisoglou, Senior Principal Scientist, Biopharmaceutics,                                Pharmaceutical Sciences and Clinical Supply, Merck

2:50 pm

Break

3:20 pm

Needs Sharing Session

Discussion Leaders: to be announced

5:00 pm

Vendor Exhibits, Contributed Posters, Reception, Networking

7:00 pm

Evening free to explore Madison

Thursday, June 12, 2014

8:30 am

 Legal/Intellectual Property Issues

            Speaker: Eyal H. Barash
            SSCI, Inc
            Lafayette, IN

  • What is patentable in particle engineering?
    • are "formulations" patentable?
    • composition of processed materials (spray-dried amorphous dispersions, nanoparticles)
    • what processes/processed intermediates are patentable?
  • patent strategies- alignment with global patents
  • global perspective
  • patent case studies in particle engineering

9:20 am

Regulatory Perspective

            Speaker:Mansoor Khan
            Director, Division of Product Quality Research
            FDA

  • classification: drug substance vs drug product vs drug product intermediate
    • are "formulations" patentable?
    • composition of processed materials (spray-dried amorphous dispersions, nanoparticles)
  • specific concerns for nanoparticles
    • tox, PK, stability

10:10 am

Break

10:40 am

IP/Regulatory Round Table

  • Open fourm with previous Thursday a.m. speakers

11:40 am

The Future of Particle Engineering

            Speaker: James Litster
            Professor of Chemical Engineering and of Industrial/Physical Pharmacy
            Purdue University

12:30 pm

 Conference Adjournment


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2014 Conference Planning Committee

Panos P. Constantinides, BPDDC, Gurnee, IL
Manisha Dali, Bristol-Myers Squibb, New Brunswick, NJ
Ed Elder, University of WI-School of Pharmacy, Madison, WI
Randall H. Guthrie, RHG & Associates, Lodi, WI
Al Hanson, University of WI-School of Pharmacy, Madison, WI
Jayne Hastedt, JDP Pharma Consulting, San Carlos, CA
Patrick Hughes, Allergan, Irvine, CA
Ann Newman, Seventh Street Development, Lafayette, IN
Mark Sacchetti, University of WI-School of Pharmacy, Madison, WI
Jatin J. Shah, Perrigo Company
Ray Skwierczynski, Takeda Pharmaceuticals, Cambridge, MA
Hayden Thomas, Vertex, Cambridge, MA
James A. Wesley, Planning Committee Chair Eli Lilly and Company, Indianapolis, IN
Joseph Wong, Baxter Healthcare Corporation, Round Lake, IL
Weili Yu, Pfizer Groton Laboratories, Groton, CT
Lin Zhu, AbbVie, Abbott Park, IL
Tianhong Tim Zhou, Takeda Global Research & Development, Deerfield, IL

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Contact Us

If you should have questions or require more information, please contact:

Alan Hanson, Ph.D.
Conference Director
Department of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 262-3130

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Last modified: Monday, June 9, 2014, 2:29 PM