5/29/2012

1

IPEC-Americas

General Update

May 16, 2012

Membership Update

With this weeks approval of Capsugel and Sensient, IPEC-Americas

already has attracted 6 new members in 2012,

4 Full Members,

2 Associates

Capsugel,

Sensient Pharmaceutical Coating Systems

Abbott Laboratories (a former member who has rejoined), and

Air Liquide Industrial U.S.

The new associates: NSF International and PSC Biotech, Inc.

5/29/2012

2

Membership Update

During ExcipientFest 2012, contact information was received from 10 more full member

candidates and 2 potential associate members:

ACG North America LLC

AstraZeneca

Bayer Healthcare

Bristol-Myers Squibb

DFE Pharma

Grain Processing Corporation

Nutrilite Health Institute (Amway)

Patheon

Sensient Pharmaceutical Coating Systems

Tris Pharma

The potential associates include a professor of pharmaceutics from the University of Puerto

Rico, Evone Ghaly, and an industrial freight company, C&F Worldwide Agency Corp.

Membership Update

• Initial membership materials have been sent to most contacts and the rest will be sent this week.

• Regarding other potential candidates, follow up with them also is underway to attract companies such as:

Glenmark Generics,

Corn Products,

Noven Pharmaceuticals (subsidiary of Hisamitsu),

Mylan,

Teva,

Novartis,

Endo Pharmaceuticals,

Cephalon,

PAR Pharmaceutival, and

Lonza.

Names of possible contacts in those companies are invited and needed.

5/29/2012

3

Upcoming Booths/Shows

• July 15 – 18 CRS (Controlled Release

Society) Poster Session for NESEP & Marketing

Opportunity – Quebec

• Oct. 14 – 17 AAPS – Chicago

• Booth - Foundation awards & dinner

Current Income – Cash Flow

Report

• Member dues – TOTAL TO DATE: $661,968

– 41 of 47 full members have paid

– Dues from the other six full members are expected

– 19 of 27 associates have paid

– $41,282 from 5 new members

• Other income • Multiview – newsletter advertising

• IPEC training – 2011 webinars

• GMP, Interest,

5/29/2012

4

Current Income – Cash Flow

Report

•Legislative Contributions $103,129

•$20K moved from 2011 to 2012 (included in figure above)

•2012 To date: Spent $65,431,73

•Currently have $37,286 expect addtl. 4K

•If all expected contributions are received

we can fund leg. initiative UP TO August

ICH Q3D Workshop

Bethesda, MD April 4-5, 2012

ICH Q3D Workshop Increases Awareness of

Current Elemental Impurities Issues

On April 4-5, representatives of 39 pharmaceutical companies,

ingredient suppliers, the U.S. Food and Drug Administration, The

United States Pharmacopeia, officials of the three sponsoring

organizations, e.g., IPEC-Americas, SOCMA, and the Consumer

Health Care Products Association all came together with

pharmaceutical industry press personnel for a one and a half day

workshop at the Marriott Hotel in North Bethesda, MD.

5/29/2012

5

ICH Q3D Workshop

Bethesda, MD April 4-5, 2012

ICH Q3D Workshop

Bethesda, MD April 4-5, 2012

• Speakers 6

• Press 4

• FDA/Govt/USP 5

• Attendance 71 (41 Member / 15 Non-Member)

• Financial loss of $34,000 ($11,000-IPEC-Americas)

Among the companies represented were excipient and API suppliers, non-prescription drug manufacturers, generic pharmaceutical product suppliers and companies that develop and gain approval to market innovative drug formulations.

A report summarizing the discussions and outcomes from the workshop has been forwarded to the ICH EWG for their consideration.

Key themes from the breakout sessions included:

• Potential misinterpretations regarding testing and risk assessments

• Recommendations on clarification of risk assessments and testing

• Request for additional detail about types of metals likely to be present

• Bioavilability and exposure to the patient

• Timelines and implementation

• Reformulation of existing products

5/29/2012

6

ICH Q3D Workshop

Bethesda, MD April 4-5, 2012

ICH Q3D Workshop

• ICH Q3D Workshop Results ICH Q3D Workshop - April 4-5, 2012

Income Total participants 71

Paid Registrations

Speakers 6 comp

Press 4 comp

Member 41 $600 early bird or $650

Non member 15 $900 early bird or $950

FDA/GOVT/USP 5 $350

71 $ 40,715.00

Expenses

Bethesda North Marriott Hotel $ 50,087.21

Legal fees $ 21,412.50

Related travel and hotel costs - STAFF $ 1,220.60

Printing (program, signage) $ 312.76

Credit Card processing fees $ 1,796.97

Income/Expense Results $ 74,830.04

$ (34,115.04)

5/29/2012

7

ICH Q3D Workshop

•CHPA & SOCMA – Owe IPEC-A $10,000 each

•IPEC-Americas total loss: $14,115

•All agree value for price paid worthwhile

investment.

ExipientFest Americas 2012

5/29/2012

8

ExipientFest Americas 2012

ExipientFest Americas 2012

5/29/2012

9

ExipientFest Americas 2012

5/29/2012

10

Top read articles and links: 1. USP Workshop on Supply Chain Integrity Will Discuss Good Distribution

Practices (wrong link) 2. Recent China Gelatin Capsule Adulteration Case Appears Resolved 3. FDA Expands Global Initiative 4. USP Update on Elemental Impurities (link to hot topics) 5. Certification to the Upcoming Excipient GMP American National Standard

5/29/2012

11

Strategic Planning 2013

• January 14 – 17, 2013

• Marriott Hilton Head

• Hilton Head, SC

• Facilitator: Chris Moreton

• Committee Chair strategic planning

meeting ½ day

Office Space

• Current lease expires December 2012

• Space available on 1st floor

• $39/sq. ft

• 2567 sq. ft

• Turn-key improvements - if 5 year lease

5/29/2012

12

Alan Mercill honored for years of IPEC service at the Executive Committee dinner Monday night, at

Morton’s Steakhouse

5/29/2012

13

Alan Mercill honored for years of IPEC service at the

Executive Committee dinner Monday night, at Morton’s Steakhouse

Alan Mercill honored for years of IPEC service at the Executive Committee dinner Monday night, at

Morton’s Steakhouse

5/29/2012

14

IPEA Update

• Financial • Current balance: $8,488

• Accounts Receivable: $14,500

• Accounts Payable : $5,500 (2 x Certification board meetings)

• May payroll ($4,200) rent share ($1,166) paid to IPEC

• Business 2012 • 2 Surveillance audits-January + 1 being planned

• IPEA 2012 Budget Projection: 5 surveillances

• EXCiPACT July workshop Brussels

• IPEA 2012 Budget Projection: 1 on site workshop

• 1 (Arlington) Excipient Auditing Workshop-March: 18 attendees / profit of $ 19,000

• 1 (Houston) Excipient Auditing Workshop-October 23-25 (scheduled)

• IPEA 2012 Budget Projection: 2 workshops, each = $12,000 profit

• 0 Excipient GMP Conformance Certification audits

• IPEA 2012 Budget Projection: 4 Certifications

• 5 Audit Reports sold: 3 Certification /2 standard audit

• IPEA 2012 Budget Projection: 11 reports

IPEA Update

• Unplanned/Not budgeted

Expenses • Trademark affidavit fee: $13,680 – was paid in 3 installments

• IPEA 2012 Budget Projection: $5,000

Income • 1 Gap Assessment (Europe) TBD

• 1 Auditor Training session for EXCiPACT

• 3 Audits (standard)

• October Auditing workshop

Opportunities 1. Rx360: Accepted the IPEA application and asked for an agreement and cost estimate

• Agreement prevents IPEA from certifying any company we audit

• Lack of information impedes development of cost estimate

2. NSF: agreement provides nothing for IPEA. Will submit to NSF an outline for a mutually beneficial agreement.

3. ANSI Accreditation scope addition: Good Distribution Practices.

5/29/2012

15

IPEC Foundation

• Updated website complete

• Application season open – 2 received

• Meeting with AAPS –April 30 Possible 5 K

partnership with AAPS and/or

ExcipientFest to raise money for awards

• Gala Dinner for 2013?

• AAPS actively promoting Shangraw &

Grad Student Awards

IPEC Legislative Update:

Capitol Hill Campaign

Presented By Buchanan Ingersoll & Rooney, PC

May 14, 2012

5/29/2012

16

Legislative Update: FDA User-Fee Legislation

Latest IPEC Hill Engagement

House E&C Health Subcommittee:

– House E&C Subcommittee on Health Hearing- “Reauthorization of PDUFA: What It Means for Jobs, Innovation, and Patients” (Feb. 1, 2012): FDA Commissioner appeared before the subcommittee. Remarks in the form of a letter to the subcommittee chair and ranking member submitted.

– Chairman Joe Pitts Meetings- (April 12 &26) Meetings with Monica Volente, Legislative Director for Chairman Pitts and Clay Alspach, Legislative Counsel for the Health Subcommittee to discuss Supply Chain Security issues in House User-Fee Bill.

– Chairman Pitts Fundraiser- (April 16) Had follow-up conversation with Chairman Pitts specifically about IPEC suggestions to Senate HELP “discussion draft” and prospects for House bill.

Senate HELP Committee: – HELP Committee “Discussion Draft”- (March 30) IPEC submitted written

comments with several suggested changes.

– HELP Committee Staff Meeting- (May 3) Meeting with Kathleen Laird (Committee/Harkin), Grace Stuntz (Committee/Enzi) and Elizabeth Jungman (Committee Counsel) to discuss two changes to “redlined” draft.

Legislative Update: Capitol Hill Campaign

Current Situation

Both House Energy and Commerce Committee and Senate HELP Committee have passes their version of FDA User-Fee legislation.

– House Energy & Commerce Health subcommittee passed their bill by voice-vote on May 8th and the full E&C Committee passed the legislation (46-0) on May 10th after a subcommittee “mark-up” false start in April.

– Senate HELP Committee approved their bill on April 25th by voice vote.

User-Fee Timeline

– House Majority Leader Eric Cantor indicated that the full House will consider User-Fee legislation by the end of May.

– Senate HELP staff (as of this morning) thought Senate would take up bill in May,

but are in discussion with Majority Leader Harry Reid late today or tomorrow.

Final Passage

– House Energy & Commerce Chairman Fred Upton has said he hopes that a final

bill will be sent to the President for his signature by July 4.

5/29/2012

17

Legislative Update: FDA User-Fee Legislation

Final Notes:

– The Senate HELP Committee-passed version is far better in terms of those

issues advocated by IPEC. The House version touches on some of the issues

IPEC finds important, but is very heavily dependent on FDA drafting the correct

regulations.

– The House draft bill has no real detail on third-party auditing (just a brief mention

in 809).

– Excipients are not specifically mentioned and so our concern is that, if the House

version were passed into law (highly unlikely), it is not expressly clear that

excipients are covered.

– Chairman Pitts (House Health Subcommittee) promised to work in conference to

support IPEC’s Senate position.

– Staff for Chairman Tom Harkin and Ranking Member Mike Enzi (Senate HELP

Committee) felt comfortable that IPEC’s suggested changes from May 3rd would

be part of Senate Floor activity.

Upcoming Meetings

• Important Industry Meetings June 5 – 7 PDG Meeting – Yokohama, Japan

• June 13-14 — NIPTE RESEARCH CONFERENCE , FDA Conference Facilities White Oak, Silver Spring, MD Register at www.nipte.org. July 15-18 — CRS 39th Annual Meeting, Smart Materials - From Innovation to Translation Centre des Congres de Quebec, Quebec City, Canada To register and learn more go to: http://www.controlledreleasesociety.org Sept. 24-27 — IPEC-Americas Committee/Working Group Meetings, see the schedule on IPEC-Americas website at: http://ipecamericas.org/content/2010-ipec-americas-calendar-events. Oct. 23-25 — IPEA GMP Auditing Workshop, Houston, Texas http://ipeainc.com/auditing-workshop

• Nov. 26-27 – 2nd Annual European Conference on Excipients, Berlin, Germany •

Nov. 28-29 — ExcipientFest China – www.excipientfest.asia