DCAT Week '15 Essentials Booklet

NETWORKING • BUSINESS DEVELOPMENT • EDUCATION

DCATWEEKESSENTIALS

Founded in 1890, the Drug, Chemical & Associated Technologies Association (DCAT) is a not-for-profit, member-supported business development association for the global pharmaceutical manufacturing industry. We are committed to providing programs, events and

services that help our members expand their network of customers, suppliers and colleagues in the industry.

Comprised of more than 370 member companies, DCAT is the only industry association specifically designed tobring buyers and sellers together.

DCAT Week would not be possible without the generous support and valuable direction provided by thevolunteers from our member companies.

DCAT WEEK: A MEETING LIKE NO OTHER

JOIN US!DCAT Week is one of the largest gatherings in the world for the

pharmaceutical MANUFACTURING and related industries. Held annually in New York City, DCAT Week is the flagship event of the Drug, Chemical & Associated Technologies

Association (DCAT) and is a must-attend event for key decision makers involved in every aspect of the global pharmaceutical manufacturing industry.

DCAT Week delivers access to all your key business partners inone convenient location.

DCAT Week offers a forum for high-level strategic meetings between pharmaceutical and biopharmaceutical companies and their suppliers, enabling companies to schedule upwards of more than 100 meetings. DCAT Week

is not a trade show with booths; meetings take place in business meeting suites. DCAT members may reserve specially-priced suites at Official DCAT Week Hotels.

DCAT Week offers relevant industry education programs and countless networking opportunities.

From the highly-anticipated PharmaChem Outlook program on Monday to the famed DCAT Annual Dinner on Thursday night, DCAT Week offers a variety of opportunities to learn and network with colleagues, customers and

friends. DCAT members receive registration discounts and access to members-only networking events.

The OrganizationThat Brings You

In 2015, the Drug, Chemical & Associated Technologies Association (DCAT) is celebrating the 125th anniversary of its founding. In honor of this important milestone, we invite you to join in the celebration by exploring our special anniversary website and attending anniversary events during DCAT Week.

Support the Celebration!Help DCAT celebrate this important milestone with specially designed sponsorship and marketing opportunities. For more

information on available opportunities, contact Laura Kuhen at [email protected] or +1.800.640.DCAT(3228).

THANK YOU TO OUR 125TH ANNIVERSARY SPONSORS

DCAT Member Company Networking Reception

DCAT Member Company Networking Reception

Member Company Photo Parade

125th Anniversary Website 125th Birthday Cake

125th Commemorative Pins

Member Reception

Tuesday, March 17, 20154:30pm to 6:30pm

Empire Room, Waldorf Astoria

• Member Company Photo Parade •• Time Capsule Ceremony •

89th DCAT Annual Dinner

Thursday, March 19, 2015Ballrooms, Waldorf Astoria

• Celebration Birthday Cake •• Member Company Photo Parade •

• DCAT Anniversary Video Premiere •

• Media Galleries •• History Timeline •

• DCAT by the Decades Publications •• Member Contributions and More •

Celebration Central!

Visit the DCAT Anniversary Website 125.dcat.org

125th Anniversary Website

MONDAY, MARCH 16thDCAT’s 2015 PharmaChem Outlook: The Market Opportunities and Challenges (with Networking Reception) 1:15pm to 4:30pm (Empire Room, Waldorf Astoria)Networking Reception immediately following: 4:30pm to 6:00pm (Vanderbilt Room, Waldorf Astoria)

TUESDAY, MARCH 17thQuality Metrics: The FDA’s Initiative and its Impact on Pharma Manufacturers and Suppliers9:00am to 11:30am (Empire Room, Waldorf Astoria)

Excipient GMPs: Risk Assessment, Supplier Selection, and the Global Supply Chain1:30pm to 3:30pm (Astor Room, Waldorf Astoria)

DCAT’s 2015 BioPharmaceutical Forum: The Latest Market Opportunities/Trends and How to Establish and Ensure the Supply Chain (with Networking Reception)*1:30pm to 3:30pm (Vanderbilt Room, Waldorf Astoria)*Networking Reception will be held the following afternoon, Wednesday, March 18th

DCAT Member Company Networking ReceptionCelebrating the 125th Anniversary of DCAT!4:30pm to 6:30pm (Empire Room, Waldorf Astoria)

WEDNESDAY, MARCH 18thValue Creation Through Strategic and Collaborative Sourcing9:00am to 11:30am (Vanderbilt Room, Waldorf Astoria)

Cutting-Edge Technologies: The Future of the Pharmaceutical Value Chain9:30am to 11:30am (Empire Room, Waldorf Astoria)

DCAT Business Builder Session: Strategies and Tools for Successful Collaborations and Even Better Negotiations1:30pm to 3:00pm (Empire Room, Waldorf Astoria)

*BioPharmaceutical Forum: Networking Reception4:30pm to 6:00pm (Vanderbilt Room, Waldorf Astoria)

THURSDAY, MARCH 19thDCAT Women’s Networking Breakfast7:15am to 9:00am (Vanderbilt Room, Waldorf Astoria)

Pre-Dinner General ReceptionCelebrating the 125th Anniversary of DCAT!5:30pm to 6:30pm (Empire Room, Waldorf Astoria)

The 89th DCAT Annual DinnerCelebrating the 125th Anniversary of DCAT!6:45pm to 9:00pm (Grand Ballroom, East & WestFoyers, Astor Room, and Jade Room, Waldorf Astoria)

Networking Opportunity

(Program times and locations are subject to change.)

DCAT Week ’15At A Glance

DCAT Week ’15ESSENTIALS

MEMBER NAME BADGESOrder today at www.dcat.org.Increase your recognition in hotel lobbies, education programs, receptions and more. Visit the DCAT Office, in the Promenade Room in the Waldorf Astoria, during DCAT Week to pick up ororder a badge.

REGISTRATIONNetworking Events and Education Programs OnlyRegistration is only required for networking events and education programs. Online registration at www.dcat.org closes Wednesday, March 11, 2015 (5:00pm ET). Walk-ins are welcome if space permits, but must be paid by credit card or check.

HOTEL ACCOMODATIONSVisit www.dcat.org for information on reserving sleeping rooms at one of our five Official DCAT Week Hotels.

BUSINESS MEETING SUITESFor information on reserving business meeting suites in DCAT's specially priced blocks at one of our five Official DCAT Week Hotels, call +1.800.640.3228 or contact Jeanne Motola at [email protected] or Kelley Mishler at [email protected]. These blocks are reserved for Members Only and are accompanied by special services for our members.

THE DCAT OFFICE AT THE WALDORF ASTORIAFor general information and member name badge pickup during DCAT Week, visit the DCAT Office in the Promenade Room adjacent to the Waldorf Astoria Park Avenue entrance.

DCAT MEMBER LOUNGES AT THE WALDORF ASTORIAA place to relax between meetings; these spaces are not intended for company meetings. Marco Polo Room (Lexington Avenue Side) and Promenade Room (Park Avenue Side).

ST. PATRICK’S DAY PARADETuesday, March 17thPlease keep in mind when making your travel and meeting arrangements that many streets are closed for the day and traffic is slow due to the parade.

GENERATE NEW BUSINESS AT DCAT WeekGet a DCAT Week ’15 Let’s Meet! button on your company profile page on DCAT Connect so that others can send a meeting request to your company. To request a button, contact Erin Sanders at [email protected].

QUESTIONS?Visit www.dcat.org or contact the DCAT Office at +1.800.640.3228 for detailed information on all things DCAT Week. .

DATE Monday, March 16thTIME 1:15pm to 4:30pm (Reception: 4:30pm to 6:00pm)PLACE Empire Room, Waldorf Astoria (Reception: Vanderbilt Room, Waldorf Astoria)PRICE Member: $299.00 Non-Member: $759.00

The pharmaceutical industry faces unprecedented challenges. Pharmaceutical companies are confronting greater cost pressures and a higher bar for product innovation that reflects increased demand for value from both regulators and payers. At the same time, differing growth rates between developed and emerging markets and the shift to specialty medicines are influencing the direction of the market. So what lies ahead for the global pharmaceutical industry in the near- and long-term? Where do the market opportunities reside and how can and will they be realized?

Gain a competitive advantage and learn from industry experts on:

• The strengths and weaknesses of the global pharmaceutical market derived from the latest market data

• The financing trends (initial public offerings, venture capital, partnering deals, and mergers and acquisitions) in the biopharmaceutical sector plus highlights of the most significant deals

• Investment activity, trends, and valuations of life-science companies in emerging markets.

Following the presentations, the audience will have the opportunity to ask questions of our expert panel of speakers.

SPEAkERS:• Graham Lewis, Vice President, Global Pharma Strategy,

IMS Health• Glen Giovannetti, Global Life Sciences Leader, EY• Sanjay Sehgal, Managing Partner and CEO, East West

Capital Partners

2015 PharmaChem Outlook:The Market Opportunities and Challenges with Networking Reception

DATE Tuesday, March 17thTIME 9:00am to 11:30amPLACE Empire Room, Waldorf AstoriaPRICE Member: $259.00 Non-Member: $719.00

The quality of drug products and their active and inactive ingredients is of critical importance to ensure a reliable, safe, and sustainable supply of medicines. One of the tools used by the US Food and Drug Administration (US FDA) to monitor quality is the periodic inspections of manufacturing facilities for drug products, drug substances and other key materials.

As announced in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the US FDA is moving toward a risk-based inspection schedule. In support of and to strengthen this risk-based approach, the agency started developing quality metrics as objective measures of the overall quality of pharmaceutical manufacturing sites and of their products, processes and systems.

Several important questions arise. What quality metrics will be used? How will they be used to determine risk? What will be the agency’s expectations? And what will be the impact on drug product manufacturers and suppliers of active ingredients and other pharmaceutical materials?

Learn from leading regulatory and industry experts regarding: • The latest details on the FDA’s quality metrics initiative• The impact on pharma manufacturing and inspection

models• Best practices in supplier selection, qualification, and

evaluation• Evolving expectations between pharma companies and their

suppliers.


SPEAkERS:• Russell Wesdyk, Scientific Coordinator, Office of

Pharmaceutical Science, U.S. Food and Drug Administration• Frances Zipp, President, Lachman Consultants • Mary Oates, Vice President, Global Quality Operations and

EHS, Pfizer, Inc. • Robin Jones, Vice President Quality Compliance, Teva

Pharmaceuticals, Inc.

Quality Metrics: The FDA’s Initiative and ITS Impact on Pharma Manufacturers and Suppliers{ {

Exclusive Program Sponsor:

Program Partner Sponsor:

Beverage Break Sponsor:Audiovisual Sponsor:

Networking Reception Sponsor:

EDUCATION PROGRAMS Register online at www.dcat.org.

BioPharmaceutical Forum: The Latest Market Opportunities/Trends and How to Establish AND Ensure the Supply Chain with Networking Reception


Networking Reception Sponsor:

Audiovisual Sponsor: Beverage Break Sponsor:

Beverage Break Sponsor:Audiovisual Sponsor:


DATE Tuesday, March 17thTIME 1:30pm to 3:30pm PLACE Astor Room, Waldorf AstoriaPRICE Member: $149.00 Non-Member: $369.00

A new wave of excipient regulations and industry programs focused on quality, risk management, supply-chain security, and supplier integrity are creating both opportunities and challenges for the industry. How will regulatory agencies and manufacturers of excipients and drug products manufacturers collaborate to meet requirements under US and EU provisions, (including the Food and Drug Administration Safety and Innovation Act (FDASIA), the European Union's Falsified Medicine Directive, and Guidelines on the Formalized Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use)? Also, what role do industry initiatives, such as the NSF/IPEC/ANSI 363 GMP standard for pharmaceutical excipients and EXCiPACT, play?

Hear from industry experts to understand the implications for supplier selection, qualification, and evaluation that are critical for ensuring a secure and reliable excipient supply chain. Speakers from this session will provide insights into:

• The implications for excipient users and excipient manufacturers and suppliers

• Strategies for ensuring quality and integrity in the excipient supply chain

• Best practices for selection, qualification, and evaluation of excipient suppliers.


SPEAkERS:• David B. Klug, Senior Manager, GMP Audit, Sanofi US

(Immediate Past Chair of IPEC-Americas)• William Dale Carter, Global Director, Quality, J.M. Huber

Engineered Materials Silica Business Unit (Past Chair of IPEC-Americas)

• Dr. Frank Milek, Head of GMP and SHEQ Operations, Aug. Hedinger GmbH & Co. KG (Chair of IPEC-Europe)

Excipient GMPs: Risk Assessment, Supplier Selection, and the Global Supply Chain{ {

TWODAYS

=TWOWAYS

Please note that the education program and reception are scheduled on different days. That’s so you’ll have two great opportunities to meet with colleagues. DCAT members have the option to only register for the networking reception.

PROGRAM

DATE Tuesday, March 17th TIME 1:30pm to 3:30pmPLACE Vanderbilt Room, Waldorf AstoriaPRICE Member: $199.00 Non-Member: $499.00 (Includes Reception)

Biologic-based drugs are an increasingly important part of the pharmaceutical industry’s pipeline and commercial product portfolios. Market projections estimate that biologics will represent 20% of the global pharmaceutical market on a value basis by 2017 and outpace growth in small molecules. Where are the greatest opportunities, and what is needed for a successful biologics supply chain? Given the complexity of biopharmaceutical production and the related supply chain, how can pharmaceutical companies and suppliers optimize their biomanufacturing and supply networks to meet growing demand for the different types of biologics?

Speakers from this session will provide insights on:• Overall size and growth rates for the biopharmaceutical market

and its key segments (monoclonal antibodies, recombinant proteins, vaccines, antibody drug conjugates, and other specialty products)

• Analysis of the top-selling biopharmaceuticals, pipeline contenders, and leading trends in the innovator biologics market

• Case studies from leading biopharmaceutical companies on how to establish and ensure a reliable and robust biologics supply chain.


SPEAkERS:• David A. Dunn, PhD, Practice Consultant, Life Sciences

Professional Services, IP & Science, Thomson Reuters• Maria Nieradka, Senior Vice President, Global Supply Chain,

Biogen Idec• Fred Jacobson, PhD, Staff Scientist and Kadcyla Technical

Development Leader, Genentech Inc. — a member of the Roche Group

RECEPTION

DATE Wednesday, March 18thTIME 4:30pm to 6:00pmPLACE Vanderbilt Room, Waldorf AstoriaPRICE Member: $179.00 (Reception ONLY)

DATE Wednesday, March 18thTIME 9:00am to 11:30am PLACE Vanderbilt Room, Waldorf AstoriaPRICE Member: $149.00 Non-Member: $369.00

Sourcing, procurement, and supply management leaders face the challenge of delivering value in an environment marked by increasingly complex global supply chains, greater cost pressures, and dynamic business conditions. Collaborative sourcing has become a vital tool in which pharmaceutical companies and suppliers can partner to achieve cost savings while building a robust supply chain and contributing to growth and overall shareholder value. But what are the optimal organizational structures, operational and risk-mitigation approaches, and metrics that can be used? How can innovation be cultivated to the mutual benefit of both sponsor companies and their suppliers? More importantly, how can it be implemented and the benefits measured and shared appropriately? Learn from leading industry members who are applying collaborative models in their companies about what is needed to achieve operational excellence.

Achieve a competitive edge by gaining:• Practical peer experience on ways to cultivate and

implement supplier innovation in your organization• A better understanding of what it takes to be a truly

strategic and valued partner• Insight into value-based metrics and how they can be used

to drive performance.


SPEAkERS:• Marielle Beyer, Head, Technical Operations, Procurement,

Roche Pharma• Peter Lyford, Commodity Director, Custom Manufacturing,

Production Procurement, GlaxoSmithKline• Craig Michael, Director, API External Manufacturing, Eli Lilly

and Company• Bill Rich, Vice President, External Supply, Amgen• Patricia Turney, Executive Director, External Supply Chain,

Amgen

Audiovisual Sponsor: Beverage Break Sponsor:


Value Creation Through Strategic and Collaborative Sourcing{

DATE Wednesday, March 18thTIME 9:30am to 11:30am PLACE Empire Room, Waldorf AstoriaPRICE Member: $129.00 Non-Member: $349.00

What are the next game-changers in the pharmaceutical industry? Stay ahead of the curve by better understanding the emerging technologies, tools, and processes that will impact the landscape of the pharmaceutical value chain.

Experts from industry and leading technologists will provide insights into what is on the horizon. Topics to incite your thinking:

• Smart and mobile technologies’ impact on drug deliveryQuestion: Will they move the industry into an era of digital medicines or even bioelectronic medicines?

• Switching from batch manufacturing to a new model for pharmaceutical manufacturingQuestion: Will it be possible to integrate under one continuous mode the manufacturing of both drug substances and drug products?SPEAkER: Timothy Jamison, PhD, Principal Investigator, Novartis-MIT Center for Continuous Manufacturing, and Professor of Chemistry, Massachusetts Institute of Technology (MIT)

• Crowdsourcing, the new technology for external innovationQuestion: Will it alter how traditional business functions are performed in the pharmaceutical value chain?SPEAkER: David Thompson, Director of Organizational Engagement, Boehringer Ingelheim Pharmaceuticals, Inc.

• Cloud computing, a viable tool for pharmaceutical manufacturingQuestion: How will it impact the interface between internal and external manufacturing?SPEAkER: Jerry Megaro, Director of Manufacturing Analytics and Innovation, Merck & Co., Inc.

Speakers will offer a current look on how these technologies are now used and the vision for the future. Following the presentations, the audience will have the opportunity to ask questions of our expert panel of speakers.

Cutting-Edge Technologies: The Future of the Pharmaceutical Value Chain{


Audiovisual Sponsor:

DATE Thursday, March 19thTIME 7:15am to 9:00amPLACE Vanderbilt Room, Waldorf AstoriaPRICE Members Only: $129.00

Guest Speaker:

Journalist, TV Producer, and Activist for Breast Cancer Awareness

Start your morning with inspiration, as Geralyn Lucas dares you to be a “life survivor” and rediscover the resilience and optimism it takes to reinvent yourself at any age.

A breast cancer survivor, Ms. Lucas doesn’t hold back as she presents a touching and hilarious story of how she harnessed her fighting spirit to battle the disease and face life’s new ups and downs with courage and optimism.

Ms. Lucas’ message is not just for women who have experienced the effects of cancer. This is a universal story about confronting negativity and living fearlessly. Her courageous and uplifting message empowers individuals to be strong and true to themselves when faced with tough situations in life and in the workplace.

Ms. Lucas was an editorial producer at ABC News for 20/20 before joining Lifetime Television as a producer and head of the Stop Breast Cancer for Life initiative. She is the author of the bestseller, Why I Wore Lipstick to My Mastectomy and recently released, Then Came Life.

Attendees will receive asigned copy of Ms. Lucas'

book, Then Came Life.

Please note this program is for Member Companies Only.

DCAT Women'snetworking breakfast

Meet & Greet Sponsors:

Raffle Prize Sponsor:Book Sponsor:

DCAT Week ’15Business builder Session

A special program for DCAT members in honor of the association’s 125th Anniversary!

DATE Wednesday, March 18thTIME 1:30pm to 3:00pm PLACE Empire Room, Waldorf AstoriaPRICE Members Only: $39.00

Strategies and Tools for Successful Collaborations and Even Better Negotiations

Guest Speaker:mario moussa, PhD, mbaCo-Director of the Wharton Strategic Persuasion Workshop at the Wharton School, the University of Pennsylvania; Senior Fellow, Wharton Executive Education; and President of Moussa Consulting Former Chrysler Chairman Lee Iacocca once noted: “You can have brilliant ideas; but if you can't get them across, your ideas won't get you anywhere." Building on Iacocca’s observation and drawing on over two decades of experience working with leading executives, Dr. Moussa will offer practical lessons about the strategies and tools for getting deals done and moving projects forward. Gain further knowledge of the communication and bargaining styles that can enhance your current skills and learn how to strengthen working relationships as you manage the negotiation process.

A specialist in large-scale change initiatives, collaboration, and negotiation, Dr. Moussa advises senior leaders about strategy and competitiveness and has spoken to thousands of executives around the world. He has led consulting engagements at top pharmaceutical and energy companies, financial services firms, and leading universities. Dr. Moussa is co-author (with G. Richard Shell) of The Art of Woo: Using Strategic Persuasion to Sell Your Ideas. His work has been featured in Time Magazine, Business Week, U.S. News and World Report, HR Magazine, The Harvard Management Update, and The Financial Times. Dr. Moussa holds an MBA from the Wharton School at the University of Pennsylvania and a PhD from the University of Chicago.

Attendees will Receive acopy of Dr. Moussa's book,

The art of woo: Using Strategic persuasion to

sell your ideas.

Please note this program is for Member Companies Only.

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AAIPharma Services – Cambridge Major Laboratories

AbbVieACIC Fine Chemicals Inc.

BioVectra Inc.Bormioli Rocco Glass Co., Inc.

Borregaard SynthesisDeva Holding A.S.

Dottikon Exclusive Synthesis AGDPT Laboratories, Ltd.

Dr. Reddy's Laboratories, Inc.DSM Nutritional Products

Euticals S.p.A.Fareva USA

Flavine North America, Inc.Gyma Laboratories of America, Inc.

Hikal Ltd.Infa, Inc.

Interchem CorporationKingchem LLC

Mallinckrodt PharmaceuticalsMutchler Inc., Pharmaceutical Ingredients

Neuland Laboratories Ltd.Patheon, Inc.

Pfizer CentreSourcePharma Tech Industries

Piramal | HealthcareProcos S.p.A / CBC AmericasRochem International, Inc.

Rottendorf Pharmaceuticals Inc.Saltigo®

SST CorporationTangram Company, LLC

Teva API, Inc.Vinchem, Inc.

T O A L L O F O U R D C A T W E E K S P O N S O R S !THANK YOU

DCAT ANNUAL POST-DINNER HOSPITALITY SPONSORS3rd, 4th and 18th Floors, Waldorf Astoria

DCAT Week Pocket Guide Sponsors

DCAT Week ADDITIONAL Sponsors

DCAT Women'snetworking breakfast

DCAT Week Mints

Goodnight Gifts

NYC Street Banners

Notebooks

Welcome & WiFi

Member Lounge PensHotel Key Cards

eMarketing Package DCAT TV

Pocket Guide Mailer

Charging Stations General Reception

Digital Displays

Marco Polo Lounge WiFi

order your

MEMBER NAME BADGES online today!

Increase your recognition in hotel lobbies, education programs, networking receptions and more!

Pre-order your complimentary badge online at www.dcat.org to avoid any wait time on-site! During DCAT Week, visit the DCAT office in the Waldorf Astoria (Promenade Room, located to the right of the Park Ave. revolving door) to pick up pre-ordered badges or to request a badge.

Please note that Member Name Badges do not provide access to any programs or receptions. Only individuals who registered for programs or receptions will be admitted with their e-tickets.

USE HASHTAG #DCATWEEK TO FOLLOW AND CONTRIBUTE ON TWITTER.

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One UNION STREET, Suite 208Robbinsville, NJ 08691

1.800.640.DCAT(3228)www.dcat.org125.DCAT.ORGCONNECT.DCAT.ORG

Member Badge Registration Desk Sponsor:

Lounge Hours: Monday, March 16 Tuesday, March 17 Wednesday, March 18 Thursday, March 19 9:00am to 6:00pm 8:00am to 6:00pm 8:00am to 6:00pm 8:00am to 5:30pm

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Attention DCAT Member Companies

Marco Polo RoomLexington Avenue Side

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Sponsor this lounge WiFi!Contact Laura Kuhen at

+1.800.640.3228 or [email protected].

Documents

DCAT Week '15 Essentials Booklet