The Drug, Chemical & Associated Technologies Association (DCAT) is celebrating its 125th anniversary of its founding as an organization, a milestone that will be recognized at the association’s flagship event, DCAT Week ’15, which will be held March 16-19 in New York. As pharmaceutical and biopharmaceutical companies, suppliers, and contract manufacturers assemble for this year’s event, Contract Pharma spoke to Margaret Timony, DCAT’s Executive Director, to get an update on the association’s activities and the key issues and trends impacting the pharmaceutical manufacturing value chain that will be addressed at this important industry event. More Information about DCAT and DCAT Week ’15 can be found at www.dcat.org.

—Tim Wright

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Contract Pharma: As DCAT celebrates 125-years, can you provide a brief history of the association and why it has been such a fixture in the industry for so many years?

Margaret Timony (DCAT): The Drug, Chemical & Associated Technologies Association (DCAT) is a non-profit business development association for the pharmaceutical manufacturing industry with more than 380 member companies consisting of the large and mid-sized pharmaceutical and biopharmaceutical companies and suppliers and contract manufacturers offering products and services to those companies. The membership of DCAT is involved in the entire spectrum of the pharmaceutical manufacturing value chain: from raw materials, to intermediates, to active pharmaceutical ingredients—small molecules and biologics—to formulation development and drug-product manufacturing, to packaging, to logistics and related supply chain services.

DCAT was founded in 1890 with 50 charter members under the New York Board of Trade, a local chamber of commerce. In 1961, the organization separated from the chamber due to its increasing national and international membership. From its founding to today, the core mission of DCAT has been to foster business relations by helping members expand their network of customers, suppliers, and colleagues in the industry. Its core goal is to be the premier business development association for the global pharmaceutical manufacturing industry, which we believe can be achieved through offering forums for face-to-face meetings, networking events, and education programs at events, such as DCAT Week, Sharp Sourcing, and others held throughout the year.

Recently, we’ve added digital opportunities to engage our members through DCAT Connect, the association’s online member community, as well as through other informational services, such as webinars and DCAT Value Chain Insights, a weekly information resource on pharmaceutical manufacturing, sourcing/procurement, and supply management.

However, DCAT’s longevity and continuing growth can be attributed to its volunteer leaders, committees, and task forces that are comprised of representatives of its member companies. They provide their time, talents, and strategic insights that are essential in providing to their colleagues the programs and events, networking opportunities, informational services, and education programs that are so important to the industry.  Volunteers are definitely the backbone of the organization.

Contract Pharma: DCAT Week ’15 will be held March 16-19 in New York. Can you highlight the key elements of the event and what is new for this year?

Timony (DCAT): DCAT Week is one of the largest gatherings in the world for the pharmaceutical manufacturing and related industries. It is not a trade show, but instead, its model brings together a variety of industry CEOs, presidents, supply management, sourcing, procurement, business development, sales, and marketing professionals for high-level meetings, strategy sessions, education programs, and networking events.

DCAT Week ’15 will feature many of the activities that the industry has come to expect: education programs, networking events, and the culminating event, the 89th DCAT Annual Dinner. For DCAT Week ’15, we also will be holding special networking and education sessions for DCAT member companies in recognition of the association’s 125th anniversary. These include a special installment of the annual DCAT Member Networking Reception and the DCAT Business Builder Session: Strategies and Tools for Successful Collaborations and Even Better Negotiations, with guest speaker Mario Moussa, Ph.D., MBA, Co-Director, Wharton Strategic Persuasion Workshop, Wharton School, University of Pennsylvania, Senior Fellow, Wharton Executive Education, and President, Moussa Consulting.

Contract Pharma:  What are some key topics impacting manufacturing that will be addressed?

Timony (DCAT): Pharmaceutical manufacturing is influenced by the broader trends impacting the pharmaceutical industry as a whole and specific issues affecting the different segments in pharmaceutical manufacturing. To that end, one of our most anticipated education programs, PharmaChem Outlook: The Market Opportunities and Challenges, will feature a presentation by Graham Lewis, Vice President Global Pharma Strategy, IMS Health, who will examine the global pharmaceutical market with the latest market data. The program will also feature a presentation by Glen Giovannetti, Global Life Sciences Leader, EY, who will look at the public and private financing trends in the biopharmaceutical sector, an important source of new product development and innovation for pharmaceutical companies.

Biologics represent a growing area of product development and commercialization and require specialized manufacturing and supply strategies. At DCAT’s 2015 BioPharmaceutical Forum: The Latest Market Opportunities/Trends and How to Establish & Ensure the Supply Chain, David A. Dunn, Ph.D., Practice Consultant, Life Sciences Professional Services, IP & Science, Thomson Reuters, will provide data and insight into the innovator biologics market and its key segments (i.e., monoclonal antibodies, recombinant proteins, vaccines, antibody drug conjugates, and other specialty products). Pharmaceutical companies are tasked with developing their biomanufacturing and supply networks to meet growing demand for these different types of biologics. Maria Nieradka, Senior Vice President, Global Supply Chain, Biogen Idec, will offer a perspective, as well as Fred Jacobson, Ph.D., Staff Scientist, Genentech Inc.,  a member of the Roche Group, who will examine manufacturing and supply strategies for antibody drug conjugates.

In considering the issues impacting pharmaceutical manufacturing, we must also look to the future, and we will be examining some emerging technologies, tools, and processes and how they may impact the future direction of pharmaceutical development, manufacturing, and related business functions. The educational program, Cutting Edge Technologies: The Future of the Pharmaceutical Value Chain, will address: digital medicines and smart and mobile technologies’ impact on drug delivery presented by Nick Bonny, Director, Pharmaceuticals and Life Sciences Operations, PwC; the possibility of integrated continuous manufacturing for both drug substances and drug products will be delivered by Timothy Jamison, Ph.D., Principal Investigator, Novartis-MIT Center for Continuous Manufacturing, and Professor of Chemistry, Massachusetts Institute of Technology (MIT); cloud computing in pharmaceutical manufacturing will be discussed by Jerry Megaro, Director of Manufacturing Analytics and Innovation, Merck & Co., Inc.; and crowdsourcing will be covered by David Thomson, Director of Organizational Engagement, Boehringer Ingelheim Pharmaceuticals, Inc.

Contract Pharma: What are some key topics impacting pharmaceutical outsourcing that will be addressed?

Timony (DCAT): Suppliers and contract manufacturers play an important role, not only in terms of meeting supply requirements, but also in contributing to value creation through deeper, more collaborative and strategic partnerships. We are examining these strategic partnerships in an education program, Value Creation Through Strategic and Collaborative Sourcing, which will look into the organizational structures, operational and risk-mitigation approaches, and metrics used in these partnerships. We are gaining perspectives from leading pharmaceutical companies: 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; and Patricia Turney, Executive Director, External Supply Chain, Amgen.

Contract Pharma: What are some important regulatory issues that will be addressed during DCAT Week programs?

Timony (DCAT): For pharmaceutical manufacturing, issues relating to quality and good manufacturing practices (GMPs) are obviously of utmost importance. Two education programs will address two topical issues. In the first program, Quality Metrics: The FDA’s Initiative and Its Impact on Pharma Manufacturers and Suppliers, FDA will provide the latest developments into the FDA’s Quality Metrics Initiative as part of the agency’s risk-based inspection approach. The program will also examine the implications for pharmaceutical manufacturers and suppliers, as well as provide perspectives on best practices in quality oversight and management for external manufacturing relationships. Frances Zipp, President, Lachman Consultants, Mary Oates, Vice President, Global Quality Operations and EHS, Pfizer Inc., and Robin Jones, Vice President, Quality Compliance, Teva Pharmaceuticals, will offer perspectives.   

A second program, Excipient GMPs: Risk Assessment, Supplier Selection, and the Global Supply Chain, will examine recent regulatory measures and industry programs focused on quality, risk management, supply-chain security, and supplier integrity impacting excipient manufacturing and the related supply chain as well as best practices for supplier selection, qualification, and evaluation. Perspectives will be provided by: David B. Klug, Senior Manager, GMP Audit, Sanofi US and Immediate Past Chair of IPEC-Americas; William Dale Carter, Global Director Quality, J.M Huber Engineered Materials Silica Business Unit and Past Chair of IPEC Americas, and Dr. Frank Milek, Head of GMP and SHEQ Operations, Aug. Hedinger GmbH & Co. KG and Chair of IPEC-Europe.

We look forward to seeing our member companies during DCAT Week ’15.