Highlights from DCAT Week ’16

From tracking pharmaceutical industry growth patterns to evaluating sourcing and supply strategies for small molecules, biologics, and drug products, the DCAT Week ’16 education programs addressed a range of issues of paramount importance to the pharmaceutical manufacturing value chain.

So what is in store for pharmaceutical companies and suppliers supporting pharmaceutical and biopharmaceutical production? In the first of a series of articles, DCAT Value Chain Insights (VCI) provides a roundup of the key issues addressed at the education programs at DCAT Week ’16;

Key highlights 
The education programs at DCAT Week ’16, the flagship event of the Drug, Chemical & Associated Technologies Association (DCAT) that was held March 14-17 in New York, provided industry insight on the performance and outlook for the pharmaceutical and biopharmaceutical industry as a whole, perspectives from leading pharmaceutical companies on their supply and manufacturing strategies, and an update of important regulatory initiatives. Detailed coverage of the presentations at the education programs at DCAT Week ’16 will follow in upcoming issues of DCAT Value Chain Insights (VCI).

Graham Lewis, vice president, global pharma strategy, IMS Health, provided an overview of the global pharmaceutical market and the key trends impacting the market in the program, Pharmaceutical Industry Outlook: Market Overview, Macro Trends, and the Supply Lines. Led by the US, an overall compound annual growth rate (CAGR) of 4-7% is projected to 2019, when the global pharmaceutical market is projected to reach $1.3 trillion. The continued resurgence of the US pharmaceutical market with projected CAGR of 6-9% from 2015 to 2019 will lead CAGR in developed markets, which is projected at 4-7% CAGR to 2019, only slightly below the CAGR of 5-8% for pharmerging markets, defined by IMS as the most promising emerging markets, in the forecast period of 2015 to 2019. A slowing of growth in pharmerging markets and the rise of the US pharmaceutical market will lead the US to account for 45% of global pharmaceutical growth from 2016 to 2020.

On a product basis, one of the high-growth areas in the innovator drug market is oncology, specifically the immuno-oncology market. Rachel Webster, senior director, oncology, Decision Resources Group, offered a market review and analysis of the two leading commercial entries, respectively Merck & Co.’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab) as well as leading pipeline contenders from Roche, AstraZeneca, Pfizer/Merck KGaA, and a myriad of smaller companies developing stand-alone products or partnering with the larger pharmaceutical companies for combination therapies.

As pharmaceutical companies seek to innovate to drive revenue growth, a key issue facing the industry is drug pricing and reimbursement/payer trends. Roshawn Blunt, managing director, 1798 Consultants, offered insight on these trends for the US and European markets and the related impact on drug development and commercialization strategies. A key point raised in her discussion was the potential impact of manufacturing, drug delivery, or product forms in certain reimbursement criteria, offering several case studies to illustrate.

A new education program, Pharmaceutical Outsourcing: The Markets and Supply Strategies for Fine Chemicals, APIs, and Drug Products, provided two industry overviews. The first, by Enrico Polastro, vice president and senior industry specialist in the global pharmaceutical and fine chemicals practice of Arthur D. Little, provided the market numbers and growth rates for the fine chemicals and custom synthesis market on a global and regional basis. Jim Miller, president of PharmSource, provided an overview of the contract dosage form market overall and for the leading product forms, as well as insight on shifting service models by contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). Peter Comes, corporate vice president, supply network and process management for Boehringer Inghelheim, and Michael Boyson, senior director and head of oncology and biologics supply, global manufacturing and supply, Takeda Pharmaceuticals, offered perspectives on their companies supply strategies and approach for external manufacturing partnerships.

Another new education program at DCAT Week ’16, Evolving Business Models and Partnership Strategies for Drug Development Challenges, further examined CDMO/CMO business models for formulation development and drug product manufacturing and partnership strategies. Nancy Barbour, vice president, drug product science and technology, Bristol-Myers Squibb explained the company’s fit-to-purpose model for resource allocation in pharmaceutical development and how this is applied to solid dosage products and resulting external partnerships. Deborah DuFresne, executive director, strategic portfolio selection & management, InnoPharma, Inc., a subsidiary of Pfizer, Inc., offered perspective on insourcing/outsourcing strategies for sterile drug products. Barbour and DuFresne also joined executives of CDMOs/CMOs to discuss the outsourcing business model of the so-called “one stop shop” of offering both API and drug product development and manufacturing. The panel further included Syed T. Husain, chief commercial officer, Alcami (the new brand identify for AAI Pharma Services/Cambridge Major Laboratories); Vivek Sharma, CEO, Piramal Pharma Solutions; and Laura Parks, senior vice president, corporate operations & strategic initiatives, Patheon.

Bio supply strategies, supplier risk, and regulatory change
Supply strategies were further examined for biologic-based drugs in the program, Biopharmaceutical Forum: Global Biomanufacturing Trends, Capacity and Technology Drivers. Patti Seymour, senior consultant of BioProcess Technology Consultants, provided on overview on biomanufacturing capacity and related trends and the impact on capacity utilization and related supply-demand fundamentals. William Downey, president of HighTech Business Decisions, provided an overview of the contract biomanufacturing market for drug substances and related issues in technology differentiation, capacity utilization, and key expansions. To gain an inside-the-trenches view, several leading companies offered insight into biologics supply strategies, which included Mike Cicio, vice president, commercial recombinant manufacturing, Baxalta; Bruce Smith, associate director, sourcing & procurement, AstraZeneca; and Chris Calabretta, global procurement leader, direct materials biologics & vaccines, Janssen Pharmaceuticals.

For sourcing, procurement, and supply management organizations, a key issue is how their organizations can move beyond traditional models to contribute to value creation while adapting to a changing marketplace as well as continually assuring supply and mitigating risk. The education program, Transformational Sourcing: Innovation in Sourcing, Supplier Practices, and Risk Management, addressed those issues. Rodney A. MacLea, director, supply chain, Amgen, explained how the company adapted out-of-industry approaches in supplier management, such as supplier mapping, to its sourcing and supply management practices. Isaac Young, senior director, supply chain operations, BioMarin Pharmaceutical Inc., offered perspective on how to deal with supplier and CMO consolidation and strategies for preparing and responding to these changes. The program also addressed how to manage supplier risk. Joseph Agresta, vice president, Johnson & Johnson Supply Chain, Procurement Excellence, spoke about the company’s Center of Excellence for Supply Chain Risk and the company’s rationale for a dedicated unit and how it integrates with sourcing, procurement, and supply management functions. Thomas Niemeyer, director, global external supply, Pfizer, discussed how the company manages supplier risk as it relates to clinical trial material supply, and Kelley T. Hinds, senior risk manager, compliance, sustainability, and supplier diversity, global pharma procurement-strategy realization and operations, Roche/Genentech, discussed sustainability as it relates to supplier selection and performance, including the use of supplier sustainability assurance audits and visits.

Regulatory changes are always of great importance to the pharmaceutical industry, and the education program, GFUDA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes examined the key issues impacting the pharmaceutical manufacturing chain. Fran Zipp, president of Lachman Consultants, provided an overview presentation, emphasizing data integrity as one of the top issues that regulators are focusing on in their compliance efforts. Terri Nataline, principal consultant, regulatory practice, Lachman Consultants, provided insight into the key issues under consideration as the industry and the US Food and Drug Administration (FDA) work out reauthorization for the Generic Drug User Fee Amendments (GDUFA), which is set for reauthorization in September 2017. Dilcia Granville, PhD, senior public affairs specialist, Office of Regulatory Affairs/OCQPM, FDA, provided an overview of the top ten inspection trends and the agency’s key findings in these areas. Robin Kumoluyi, vice president & global head, quality, third party operations, Novartis Pharmaceuticals Corporation, provided insight on the best practices in supplier management and oversight in light of these trends.

Detailed summaries of these programs will be provided in the upcoming issues of DCAT Value Chain Insights (VCI).

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