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IPEC AmericasBoard of Trustees Meeting

www.ipecamericas.org 1

December 7, 2011

Executive Committee• Chair Dale Carter, JM Huber• Past Chair Janeen Skutnik Wilkinson. Pfizer• Chair Elect David Klug, Sanofi• VC Administrative Affairs John Giannone,

BASFBASF• VC Harmonization & Compendia Priscilla

Zawislak, Ashland• VC Science & RA David Schoneker• VC User Relations – Tom Schultz, J&J• XC Nigel Langley, BASF• XC Gwyn Murdoch, Lilly

Executive CommitteeVoting Today• VC Membership – 3 years• VC Maker Distributor Relations – 3 years• 2 XC At large 2 years

Responsibilities• VC Maker & Distributor Relations

– Maker position filled by someone who is very well connected to chemical & food ingredient industries such as IFAC, GMA, ACS, NACD, and the like organizationsg

– Updates committee on actions or initiatives from these group that involve excipients and speaks up to get IPEC involved

– Ambassador for IPEC at these events– Prepares reports\presentations of interest to

Maker/Distributor Members

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Responsibilities• VC Membership

– Focus on member retention – Facilitate networking opportunities for member– Recruitment of new members– Develops marketing tools– Hold review meetings with VCs User & Maker

Relations and VC Administrative Matters to improve membership satisfaction

– Manage annual membership survey to gauge satisfaction and reports results to the executive committee

ExcipientFest is the leading international forumdevoted to scientific, regulatory and sourcingDevelopments in Excipient Technology.This conference & expo is a true educational bridgebetween Excipients Manufacturers and the demandingPharmaceutical Industry.

Event History

Europe(Ireland)2007 & 2009US

(Baltimore)2011 Asia

(China) 2012

Americas (Puerto Rico)2001 – 20102012

2012

Sponsors

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Day 1: April 23rd, 2012

4 Full Day Workshops:I - Pharmaceutical Formulation Workshop on Tablet Dosage Forms

II - Overview and Implementation of Selected IPEC GuidesII Overview and Implementation of Selected IPEC Guides

III - IPEC's initiatives in the area of QbD and Excipient Variability

IV - Excipient Supplier Auditing & Qualification

Day 2: April 24th, 2012Theme: Corporate Responsibility: Supplier Selection and Supply Chain Security7:00 AM Registration, Coffee & Pastries

Conference Hall A (Expo Area) Conference Hall B (Expo Area)8:30 – 9:15 AM KEY-NOTE SPEAKER: “Corporate Responsibility” Michael Beatrice – Abbott (IPEC)9:15 – 10:00 AM “Risk Management for Excipients”

Ms. Londa Ritchey - Pfizer (IPEC)“Excipient News for Novel Formulations”Mr. Stephen Levine – Emerson Resources

10:00 – 10:45 PM “The method of fine dissolution control of tablets by direct compression in different test media using novel pregelatinized starch” Ms. Yurika Tanaka – Asahi Kasei

“What does it mean to have an IPEA Certification? (International Pharmaceutical Excipient Audit)” Invited Speaker from Grace Davison – (IPEC)

10:45 – 11:15 AM Coffee & Networking BreakG f f C f S11:15 – 12:00 PM “cGMP Enforcement for the Pharmaceutical

Industry” Mr. Edwin Ramos - FDA SJDO Compliance Director (IPEC)

“Meeting Formulation Challenges for Poorly Soluble Drugs” Mr. Nigel Langley – BASF

12:00 – 1:30 PM Lunch and Networking at Vista Mar Terrace1:30 – 2:15 PM “Up-Stream Supply, Chain Security for Excipients

through Distribution” Ms. Griselle Vargas - Mutchler Inc.

“Exipact Update on Excipients” Mr. Steven Lane – NSF International (IPEC)

2:15 PM – 3:00 PM “Supplier Management, Assuring a Secure Supply Chain”Louis Yu - Perrigo (IPEC)

“Application Studies of L-HPC and HPMCAS for Pharmaceutical Solid Dosage forms - An Update”Mr. Sakae Obara – Shin-Etsu

3:00 PM – 3:45 PM Coffee Break & Networking Break3:45 – 5:00 PM SPEAKERS’ ROUND TABLE:

“Visible Particles in Excipients” (Moderated by Pharmaceutical Technology)Speakers from FDA - Ms. Cindy Buhse, Pfizer - Ms. Londa Ritchey*, DowWolff Cellulosics - Ms. Ann Van Meter, USP- Ms. Catherine Sheehan

5:00 – 7:00 PM ExcipientFest Cocktail with Live Local Music

Day 3: April 25th, 2012Theme: Developments in Excipient Legislation and RegulationFrom 7:00 AM Registration, Coffee & Local Pastries

Conference Hall A Conference Hall B

9:00 – 9:45 AM KEY-NOTE SPEAKER: "Future of Excipient Regulation - Revised GMPs and Excipient Expectations"Ms. Maridalia Torres, FDA Director SJDO

9:45 – 10:30 AM “Legislative Update; An Industry Perspective“ Mr. James Willtraut - Buchannon Ingersoll (IPEC))

“Innovative Techniques for Effective Cleaning of Time Release Polymers and Color Coatings”Mr. James Sullivan – Dober

10:30 – 11:15 AM Coffee Break & Networking Break

11:15 – 12:00 PM “USP Monograph Modernization Initiative: Excipient update”Ms. Catherine Sheehan - USP

“Inactive Ingredient Database”Ms. Priscilla Zawislak – Ashland (IPEC)

Ms. Catherine Sheehan USP 12:00 – 1:30 PM Lunch and Networking at Vista Mar Terrace

1:30 – 2:15 PM “Rapid-Screening for Excipient Verification Initiative” Ms. Cindy Buhse, Director, Div. Pharmaceutical Analysis, CDER, FDA (IPEC)

“Beware of the Non-Critical Excipient in QbD”Mr. Brian Carlin – FMC

2:15 - 3:00 PM “Controlled Release the Co-Processed "Whey"Mr. Joseph Zeleznik – Meggle

“NSF Reference Standards for Excipients”Mr. Edward Wyszumiala – NSF International (IPEC)

3:00 – 3:30 PM Coffee Break & Networking Break

3:30 – 4:15 PM “Quality by Design Approach for Determining Excipient Specifications"Mr. Madhu Kallam – Avantor Performance Materials

“Elemental Impuritites - Excipient Realities”Mr. Dave Schoneker – Colorcon (IPEC)

4:15 – 5:15 PM KEY-NOTE SPEAKER: “To be determined”*Invited Speaker (IPEC)Poster Award & Closing Remarks

5:15 – 7:00 PM ExcipientFest Cocktail with Live Music

1 Half Day Workshop:Troubleshooting the film coating process: R&D through production scale

Hotel Accommodations

ExcipientFest Exclusive Rate: $209.00/night LIMITED ROOM BLOCK

For reservations use Group Code MIEMIEA Contact Veronica Sostre, Reservation Coordinator

at 787-253-1700 ext. 4161, 787-253-8051 il t i t @ it ltor e-mail at veronica.sostre@ritzcarlton.com

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Exhibitors:

- Leading Ingredient Manufacturers - R&D/Laboratory companies- Drug Manufacturers

Target

Exhibitors interested in Business & Tech contacts

WELCOMEAND

SEE YOU SOON

WELCOMEAND

SEE YOU SOON

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IPEC History & Guidance Documents

EQ 1IPEC/PQG Audit

Excipient GMPUSP 10 8

Safety Evaluation of New ExcipientUSP <1074>

GMP Audit DistributorsCert. of AnalysisUSP <1080>

GMP Rev1

EMF

Sig. ChangeUSP <1195>EIP

GDPIPEC/PQG GMP

EQ 1, 2, 3Pedigree Paper

Sig Change R1EIP TemplateQuality Agree

11

1009

0807

0605

0403

0201

0099

9897

9695

9493

9291

IPEC Forms

Reg. Affairs Confer. combines with Excipient Fest

Reg. Affairs Conf.

Reg. Affairs Conf.

Reg. Affairs Conf.

USP <1078>GMP Audit

EMFGMP Audit Rev

Quality Agree.StabilityComposition

2011 Webinar• Certificates of Analysis – Overview of IPEC's revised

guideline based upon changing regulatory requirements. Presenter: John Giannone, Business Manager, Cognis Corporation

• Significant Change - How to understand and evaluate changes involving the manufacture of pharmaceutical changes involving the manufacture of pharmaceutical excipients and when reporting is needed. Presenter: David R. Schoneker, Director Global Regulatory Affairs, Colorcon, Past Chairman, IPEC-Americas

• Excipient Pedigree - Why and how an understanding of the supply chain history of excipients is critical to the safety of drug products. Presenter: Linda Herzog, Marketing Director, Asahi Kasei America

2011 Webinar• Stability –Methods and rationale for determining

excipient stability; IPEC's common sense scientific approach to stability studies for excipients stored and transported via uncontrolled conditions. Presenter: Philip Merrell, Ph.D., Technical Marketing Manager, JostChemical Co.

• Validation - Learn about IPEC's needed validation guideline on manufacturing processes, analytic methods and cleaning. Presenter: Ann Van Meter, Senior Quality Systems Specialist, DowWolff Cellulosics.

• Quality Agreements - Defining Quality Agreements, General Provisions, and Key Quality Elements Presenter: Alexa Smith, Regulatory Services Manager, Colorcon

2011 Webinar• Good Manufacturing Practices (GMP) Global Regulations -

How they are applied to excipients and GMP for excipients . Understand and Review various global guidelines, IPEC GMP, ICHQ7, WHO GMPs & GDPs ANSI and EXCiPACThighlights. Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials

• Excipient Auditing - How IPEC Guidance Documents and the Excipient Information Package (EIP) Relate to the Supplier Audit Process Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials

• 3rd Party GMP Certification Preparation and maintenance -IPEA, EXCiPACT review Presenters: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials; and Dr. Irwin B. Silverstein. Vice President and Chief Operating Officer, IPEA, and President IBS Consulting in Quality LLC

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Committees• Quality by Design• Excipient Composition• Good Manufacturing Practices• Excipient Qualification• Compendia Review Committee• Regulatory Affairs• Excipient Safety

IPEC Meetings 2012

February May September December

Executive Committee11 ‐ 5

21Tuesday

14Monday

24Monday

3Monday

QbD (am)Exc. Comp (pm)

22Wednesday

15Tuesday

22Tuesday

4Tuesdayp (p ) y y y y

GMP  (am)Exc. Qualification (pmGeneral Update

23Thursday

16Wednesday

23Wednesday

5Wednesday

CRC (am)Reg. Aff./Safety (pm

24Friday

17Thursday

24Thursday

6Thursday

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Quality by Design• Conducted a QbD workshop with 100 FDA

reviewers and CDER compliance personnel on Dec 5, 2011at FDA White Oak office

• Conduct member updates webinairs to share the information presented to the FDAthe information presented to the FDA

• Continue to participate in PQRI working group studying excipient criticality to successfully manage risks associated with excipient-related product quality variation

Excipient Composition• Visible particles in Solid excipients

guideline under development and meeting with FDA to review when outline draft is completedoutline draft is completed

• Excipient Composition guide –Response to EMA

• Additives list compiled for meeting with FDA

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GMP• Validation guide almost complete• Reviewed ANSI NSF 363 standard and

EXCiPACT standardsRi k t id t t d• Risk assessment guide started

• Parking lot items collected for revising IPEC PQG GMP to align with ANSI and Excipact

Excipient Qualification• Revised CoA Guide with IPEC Europe --

- incorporating FDA comments• Subcommittee has completed update

Excipient Information Packagep g• Assisting FDA’s Effort to Develop

Spectral Library for screening of Pharmaceutical Excipients

• Revision to Significant Change Guide with IPEC Europe is planned

CRC• ICH Q3D – Elemental Impurities workshop planning for 2012• Work with USP & EP to implement bi-lateral harmonization on specific

monographs bilateral harmonization request sent to USP & EP, awaiting decision (TiO2, MHEC, Type 12 CMC)

• Work with counterpart committees from regional IPEC Federation members and IPEC-Pharmaceutical Discussion Group (PDG) in harmonization process

– joint effort on propylene glycol assay, cellulose derivative viscosity, povidones, glycering

– ethylcellulose monograph issued, USP established expert panel on povidones -IPEC companies represented on panel, provided input to PDG on propylene glycol assay specs, providing support as needed for USP's monograph modernization project; providing support for USP/FDA initiatives on EMA

• Continue to support addition of additives/processing aids in specific monographs

– EC propyl gallate being added to monograph• Monitor nanotechnology developments with respect to impact on

monographs - monitor at each meeting, IPEC provided comments to FDA re: proposed guideline

Regulatory Affairs• Inactive Ingredient Database problems. IPEC Americas – FDA OGD

meeting Dec 9, 2011• Current PDUFA legislation that could impact the timing and

requirements (eCTD) for electronic DMF submission –IPEC RA group to approach FDA to offer input regarding system for electonic ExcipientDMF

• DMF in China –Regulations just announced in China• Complete revision of IPEC America's Excipient Master File Guide• Complete revision of IPEC-America s Excipient Master File Guide.• A file containing weblinks to global databases of approved excipient

and drug products has been created and posted in the IPEC Members Lounge under FORUMS.

• Develop a summary compilation of existing international excipientdrug master file guidance and/or applicable regulations.

• Phthalate issue position paper on web site• Japan Earthquake/Nuclear plant advisement paper posted on

website

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Safety• ICH M7 – Genotoxic Impurities: Complete an IPEC

position paper supporting genotoxicity paper by Dr. Brusick and assisted IPEC Federation in letter for observer status

• Promoted IPEC Excipient Safety Evaluation at 2012 CRS meeting2012 CRS meeting

• Article from the Excipient Safety Symposium in the American College of Toxicology Journal from annual meeting accepted for publication in the International Journal of Toxicology in 2012.

• IPEC position paper on Juvenile animal studies for excipients for pediatric use (on agenda for Dec 8)

Regional Voice with Global Influence

The IPEC Federation, established in 2010 and based in Belgium, is made of regional IPEC organizations.

– IPEC Americas • North South and Middle Americas

14141414

• North, South and Middle Americas

– IPEC Europe• Europe, North Africa, Middle East

– IPEC Japan– IPEC China

IPEC guidelines pursue harmonization across IPEC Federation organizations.

www.ipecamericas.org

IPEC Federation• Received application for IPEC India at

the November meeting in Strasbourg• Term IPEC applies to the Federation and

individual PECs should use the regional name – i e IPEC Americas name i.e. IPEC Americas

• Observer on ICH Q3D –Elemental Impurities

• Requested observer status on ICH M7 genotoxic impurities

• Sponsoring group for EXCiPACT project

IPEC Foundation

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The Awards

Joseph Borzelleca, Louis Blecher, Myra Weiner & Marshall Steinberg

The Awards

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AAPS Annual MeetingWashington DCWashington, DCOctober, 2011

Graduate Student Awards • Sunny Piyush Bhardwaj – Department of Pharmaceutics, University of

Minnesota – Nominated by Raj Suryanarayanan, Professor, Department of Pharmaceutics, University of Minnesota

• Justin R. Hughey – The University of Texas at Austin – Nominated by James W. McGinity, Professor of Pharmaceutics, The University of Texas at Austin at Austin

• Sarah Pyszczynski – The University of Kentucky – Nominated by Eric Munson, University of Kentucky

• Gaurav Tolia – University of Cincinnati – Nominated by Dr. S. Kevin Li, Associate Professor, University of Cincinnati

• Julia Christina Kasper – Ludwig Maximilans University Munich –Nominated by Dr. Wolfgang Friess, Professor in Pharmaceutical Technology, Ludwig-Maximilians University, Munich, Germany

Graduate Student Awards Ralph Shangraw Memorial Award

Stephen W. Hoag Professor, University of Maryland, School of Pharmacy

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Bob Pinco, Steve Hoag, Dale Carter, Dave Schoneker

Industry Research Achievement in Excipient Technology Award

Stephen EdgeNovartis Pharma AG – Basel Switzerland

Bob hugs all winners at dinner

And they had to listen to Dale’s stories at dinner

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Reflections at the dinner

ACT Annual Awards Ceremony

November, 2011Phoenix, Arizona

Marshall Steinberg Memorial Award Dr. Myra Weiner

Dr. Russette Lyons, Dr. Myra Weiner, Robert G. Pinco, Robin Guy

IPEC Foundation Gala Dinner

• ExcipientFest Puerto Rico April 24-25, 2012

• Corporate Sponsors neededPl id ti th l • Please consider supporting the gala dinner with a sponsorship – all levels of support are available

• Please Contact Robert Pinco or Kim Beals

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Please Donate!If you wish to make an end of the year

contribution to the foundation OR: If your company has a charitable

f d ti d b i t t d i foundation and may be interested in supporting education and research in the field of excipients, please contact:

kim.beals@ipecamerias.org• www.ipecfoundation.org

IPEC Legislative & Regulatory Update

CONFIDENTIAL: NOT FOR DISTRIBUTIONPresented By Buchanan Ingersoll & Rooney, PC

September 26, 2011

IPEC L&R Update

Latest Update:

– IPEC played a key role in the latest Senate HELP Committee Hearing "Securing the Pharmaceutical Supply Chain“ by supplying questions directly related to excipients and third-party auditing to Chairman Harkin and his senior committee staff. Our questions and additional comments from the chairman drew questions and additional comments from the chairman drew constructive responses from Commissioner Autor on which we intend to capitalize.

– After the hearing, IPEC was able to provide comments which will become a permanent part of the Hearing’s record.

IPEC L&R UpdateNext Steps:

– Continue to work with Senate HELP Committee, House Energy and Commerce and other relevant Congressional leaders to build on our success at the Senate hearing.

– Directly engage with Deputy Commissioner Autor and her staff regarding her support for the notion of third-party auditing and regarding her support for the notion of third party auditing and other ways to make the pharmaceutical supply chain more safe.

• This initiative is not just lobbying but includes working with FDA and research to support our agenda

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IPEC L&R UpdateSpecific Next Steps:

1) Continue to engage Senate HELP Committee staff of Chairman Harkin, Ranking Member Enzi, Senator Bennet and Senator Grassley, leaders on the issue of global supply chain safety, as they draft legislative language for PDUFA V.

2) Continue to work with House Energy and Commerce Committee and Health Subcommittee staff of Chairman Upton, Chairman Pitts, Ranking Member Pallone, Rep. Murphy and others as they draft their version of PDUFA V.

3) Make our case for third-party auditing to congressional appropriators as a budget-neutral approach to giving FDA the ability to protect America’s pharmaceutical supply chain against EMA and other unsafe products. Of special focus will be Chairman Jack Kingston (R-GA).

4) Pursue potential opportunities in appropriations bills for inserting our legislative language, including FY 2012 appropriations (likely omnibus appropriations or continuing resolutions), FY 2013 appropriations, Preserving Access to Life-Saving Medications Act, Pharmaceutical Market Access and Drug Safety Act, Drug Safety Enhancement Act, PDUFA, and others.

5) Following her positive comments during the HELP Hearing, work with Deputy Commissioner Autor and FDA on possibility of including our language in the final PDUFA recommendations it provides Congress.

IPEA Summary

Business 2011• 2 Surveillance audits• 2 On site Excipient Auditing Workshops (for member companies)

• 2 (Arlington) Excipient Auditing Workshops

• 1 Auditing workshop in conjunction with Xavier/FDA Global Outsourcing Conference • 1 (Arlington) Validation workshop• 1 (Arlington) Validation workshop• 1 On site GMP Training (non member company)

• 4 standard  IPEA Excipient GMP audits (2 nonmembers/2 members)

• 2 Excipient GMP Conformance Certification audits Non member companies; one is ongoing

These are the 5th and 6th certification audits for IPEA

• 11 Audit Reports sold

• 6 Certification Reports sold

Irwin Silverstein, IPEA

Business 2012• 4 Excipient GMP Conformance Certification audits (projected) 

• 1 standard  IPEA Excipient GMP audit (projected)

• 5 Surveillance audits 

• 1 On site Excipient Auditing Workshops (EXCiPACT)

• 2 (Arlington) Excipient Auditing Workshops