Excipient World is an IPEC-Americas event

Excipient World 2019May 6 – 8, 2019: Conference ProgramMay 7 – 8, 2019: ExhibitionGaylord National Resort & Convention CenterNational Harbor, MD

Gold Sponsors

Exhibitors

Premier Media Sponsor Media Sponsors

Thank you to all of our Sponsors and Exhibitors

PROGRAM GUIDE

Dear fellow colleagues and friends,

Since the acquisition of ExcipientFest and rebranding of the event to Excipient World, IPEC-Americas, our advisory board and the education committee have been hard at work developing the most comprehensive and innovative educational programming to date. We are proud to present the expanded conference program, many opportunities to network with industry experts and your peers and two full days to source excipient solutions and services from leading suppliers around the world.

Excipient World continues to prepare pharmaceutical, biologic, combination device, veterinary medicine and healthcare product manufacturers to tackle the toughest challenges in formulation, quality and supply chain and learn the latest emerging trends and global regulation updates. This year’s focus, “The Evolving Global Role of Excipients,” will bring a worldwide perspective on formulation, regulation & compliance, supply chain and emerging trends.

We want to thank all of those individuals and companies that have made Excipient World 2019 a success – the attendees, exhibitors, sponsors, speakers, and especially our event team, who worked tirelessly to produce this vital event for our industry.

We hope you take away many new ideas, solutions and connections that can make a positive impact at your company now and in the future. Enjoy your time at National Harbor, make new friendships and have fun!

Welcome to the inaugural Excipient World Conference & Expo 2019!

Janeen Skutnik-WilkinsonAssociate Director Quality Intelligence BiogenIPEC-Americas Chair 2019 - 2020

Janeen

American Pharmaceutical Review is a journal covering the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies.

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Advantages of being an IPEC-Americas member:

• Input into the development and writing of guidance for excipients via committees made up of a balanced group of both excipient users and makers

• Updates on regulations from around the world through IPEC-Americas

• Direct interaction with regulatory individuals from your suppliers/customers

• Networking opportunities with other pharma companies to get perspective on how the industry is addressing common challenges

• A forum to educate global policy makers (US FDA, USP, global regulators and trade associations) through committee participation

• Access to other working groups and USP stakeholder forums as an IPEC-Americas member

• Opportunity to contribute to the Excipient World Conference agendas

• Input into the global harmonization process for compendial monographs, including selection of candidates for harmonization as well as feedback on early drafts

• Ability to comment on regulation or USP activities through a recognized and well-respected organization dedicated to safe excipients

• Discounts on educational programs, training sessions and webinars

Will you play on our Team? IPEC-Americas is part of a global federation that brings together manufacturers, distributors and users of pharmaceutical excipients to promote quality standards and industry best practices. We strive to achieve harmonization of pharmacopeial monographs and cGMP-regulatory guidelines for world-class qualification of excipient suppliers.

Key Players Wanted

www.ipecamericas.org

3138 10th Street N. Suite 500 Arlington, VA 22201 Tel: 571-814-3449

Excipient World 2019 Conference Program (as of April 24, 2019)

Monday, May 68:00 AM – 1:00 PM Registration Open (Azalea Foyer)

Azalea 1 Azalea 2 Azalea 3 Presidential Boardroom

9:00 AM - 12 PM

Essential new IPEC Guides: What every-

one should know!

Drug Delivery (Part 1 of 2) Data Integrity Addressing Pharmaceutical

Industry Challenges

12:00 - 1:00 PM Networking Lunch (Camellia 3-4)

1:00 - 4:00 PM

Regulatory and GMP Considerations for

Inactive Ingredients in FDA Regulated

Products

Drug Delivery (Part 2 of 2)

Excipient Impact on

Continuous Manufacturing, and Vice-Versa

1:00 - 6:00 PM Exhibitor Move-in & Booth Set-up (Riverview Ballroom)5:30 – 7:00 PM Excipient World Welcome Reception (Riverview North Terrace)Tuesday, May 7

7:00 AM – 5:00 PM Registration Open (Riverview Foyer)7:15 – 8:00 AM Coffee & Networking Break (Exhibit Hall)

8:00 – 9:00 AM Welcome Address & Keynote 1 (Session Room A): Civica Rx a Disruptive Force Martin Van Trieste - Civica Rx

9:00 AM Exhibit Hall Open (Riverview Ballroom)9:00 – 9:30 AM Coffee & Networking Break (Exhibit Hall)

Session Room A Session Room B Session Room C

9:30 – 10:30 AM

The Value of Setting Mean-ingful Compendial Specifica-tions for Excipients – a USP

Perspective

Quality by Design: An Excipient Manufacturer’s

Perspective

Improving Manufacturing Efficiency and Functional

Performance: Co-processed Multifunctional Excipients

10:30 – 11:00 AM Coffee & Networking Break (Exhibit Hall)

11:00 AM – Noon

Excipients and Manufactur-ing Technologies Addressing

Future Needs

Addressing Emerging Issues for Pharmaceutical Products

and Industry Actions

Excipients: Appropriate Selection, Sourcing, Testing

and Filing in a Global Environment

Noon – 1:30 PM Networking Lunch (Eastern Shore)

1:30 – 2:30 PM

Material Properties Influence in the Feeding Operation of

Direct Compressible Continuous Manufacturing

Need for Science and Risk Based Excipients Specification

Setting

Challenges Related to Stability of Excipients and

their Supply Chain

2:30 – 3:00 PM Coffee & Networking Break (Exhibit Hall)

3:00 – 4:00 PMKeynote 2 (Session Room A): Quality Risk Management in Global Supply Chain Environment,

Regulatory Perspective Carmelo Rosa - FDA

4:00 – 4:15 PM Coffee & Networking Break (Exhibit Hall)

4:15 – 5:00 PM An Update for Novel Excipients from IQ Consortium, USP and IPEC-Americas (Session Room A)

05:00 PM Exhibits Close5:00 – 7:00 PM Excipient World Cocktail Reception (Exhibit Hall)

Wednesday, May 87:00 AM – 5:00 PM Registration Open (Riverview Foyer)

7:15 – 8:00 AM Coffee & Networking Break (Exhibit Hall)

8:00 – 9:00 AM Keynote 3 (Session Room A): Advancing Future Drug Development Science -

Who (patients), What (formulations) and How (emerging methods for manufacturing)? Keith Horspool - IQ Consortium

9:00 AM Exhibit Hall Open (Riverview Ballroom)9:00 – 9:30 AM Coffee & Networking Break (Exhibit Hall)

Session Room A Session Room B Session Room C

9:30 – 10:30 AMAtypical Actives: Challenges for Drug Product Manufac-

turers

The Value of High-Function-ality Excipients in Continuous

Manufacturing

Preservation of Products for the Pharmaceutical Industry

10:30 – 11:00 AM Coffee & Networking Break (Exhibit Hall)

11:00 AM – NoonInnovative Approaches to

Taste-Masking Bitter Drugs for Pediatric Patients

Excipient Regulation Update in China

Binders for DC Excipients: A Comparative Study

Noon – 1:30 PM Networking Lunch (Eastern Shore)

1:30 – 2:30 PM Enhancing FDA’s Inactive Ingredient Database

Influence of Excipients and Design Considerations in For-

mulating a Direct Compression ODT Dosage Form

How Excipient Supplier Certification is Adding Value

to the Pharma Industry

2:30 – 3:00 PM Coffee & Networking Break (Exhibit Hall)

3:00 – 4:00 PM

Establishing an Attribute Focused Approach to Identi-fy and Control Raw Material

Variability

Patient Compliance: Choosing the Path of Least Resistance

A Convenient Formulation of Orodispersible Mini-Tablets for Pediatric Administration

4:00 – 4:15 PM Coffee & Networking Break (Exhibit Hall)

4:15 – 5:00 PMKeynote 4 (Session Room A): Good Supply Practices: Practical Solutions You Can

Implement Today Marla Phillips - Xavier University

05:00 PM Exhibits Close5:00 – 6:00 PM Excipient World Thank You Happy Hour (Exhibit Hall)

Download the Excipient World App to view the most up-to-date schedule, search for sessions & speakers and connect with attendees. Find the App in the Apple App Store for iPhone

and Google Play for Android - search ‘Excipient World’.

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P R O G R A M P R O G R A M

Visit these leading excipient solution and service providers in the Excipient World Expo Hall. The Expo Hall, located in the Riverview Ballroom, is open for business on Tuesday, May 7, and Wednesday, May 8, from 9am to 5pm.

Dedicated to readers who formulate, manufacture, and package solid dosage forms.

ExcipientWrld.pdf 1 4/24/19 1:43 PM

The leading print and digital information source for bio/pharma professionals worldwide• Manufacturing Trends • Process Development • Formulation • Analytical Technology • Regulatory Compliance • Quality Assurance • Best Practices

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• Booth #105: Ashland• Booth #214: ASR / Domino Foods• Booth #207: BASF• Booth #303: BioSpectra• Booth #314: Chemroy• Booth #215: Chemtrade• Booth #116: Chosksi Laboratories Ltd. • Booth #310: Colorcon• Booth #210: DFE Pharma• Booth #304: DuPont Nutrition & Health• Booth #312: Eastman Chemicals• Booth #113: Evonik• Booth #118: George Uhe/Boai NKY• Booth #219: W.R. Grace• Booth #211: IMCD US Pharma• Booth # 108: Innophos• Booth #205: IOI Oleo GmbH• Booth #112: IPEC-Americas• Booth #106: JRS PHARMA• Booth #306: Mallinckrodt• Booth #212: Medelpharm• Booth #111: MilliporeSigma • Booth #107: Omya• Booth #301: Pace Analytical Life Sciences• Booth #213: Pharmaceutical Technology• Booth #104: SGS North America• Booth #204: Shin-Etsu• Booth #110: Solvay• Booth #206: Univar Solutions• Booth #100: USP

Posters: See the latest research and innovations

• Continuous Manufacturing• Development of sustained release gastroretentive

drug delivery system • Evaluation of deformation behavior using

continuous compression profile of directly compressible materials

• Polyelectrolytic complexes as alternative preservative systems

• Polyols Screening for Microneedle Delivery of a Novel Vaccine Against Gonorrhea

• Polyvinyl alcohol (PVA) in amorphous solid dispersions - Understanding the stabilizing effect

• USP Up-To-Date Quality Standards for Excipients: Petrolatum Monographs – Focus on Polycyclic Aromatic Hydrocarbons

• Utility of Films to Anticipate Properties of Amorphous Itraconazole Spray Dried Dispersions

• Re-imagining your Orally Dispersible Tablets formulation excipients, introducing a new lactose product

Download the Excipient World App to search for exhibitors and find their booths. Find the App in the Apple App Store for iPhone and Google Play for Android - search ‘Excipient World’.

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Gaylord Palms Resort & Convention Center Kissimmee, FL (Orlando area)

May 11 - 13, 2020