The pharmaceutical industry in the United States of America is a pioneer in terms of the discovery of new cost effective and life saving drugs. Being a comparatively free market, the pharmaceutical industry also focuses on research and development. It has in fact emerged as the leader in global pharmaceutical industry. The industry is considered the largest pharmaceutical market globally with huge opportunities in the growing generic market.
The US pharmaceutical industry is a highly globalized industry, dominated by multinational companies that engage in significant business activity in many countries and whose products are distributed and marketed worldwide. The industry has undergone dramatic structural changes over the past few decades, with the rise of the biotechnology sector, substantial growth in demand driven by demographics and substitution away from other therapeutic modalities such as surgery, and increased competition from globally active generic manufacturers.
Each year, the U.S. biopharmaceutical industry spends billions of dollars on intensive research to discover new medicines for patients. Though the research process is long, uncertain, and expensive, the treatments that eventually result save lives and improve the health of people all around the world. Recent decades have seen enormous progress in the fight against major causes of death and disability, including cancer, HIV/AIDS, mental illness, and diabetes, as well as against numerous rare diseases. In addition, advances by companies in the biopharmaceutical sector play an important role in controlling costs of health care by reducing hospitalizations, surgeries, and other costly care.
This dynamic and innovative industry directly supports hundreds of thousands of jobs and indirectly supports millions more across the United States. The sector contributes significantly to the economy on the national, state, and local levels.
The US pharma industry is undergoing redefinition and revitalization. The 2012 to 2020 period is likely to witness by industry discontinuities, innovation and change. What worked in the past will not work in the future. Pharmaceutical industry norms in 2020 will be radically different than they were at the end of 2011.Large number of patent expiries and stringent regulations are among the threats to the industry.
INTERPHEX USA , the world’s most trusted forum for leading-edge technology, education and sourcing of products and services that improve manufacturing and supply chain performance of pharmaceutical, biologic, generic and service provider professionals , is taking place at a time when many dynamic changes are taking place in global pharma industry.
The event , being held from April 23 to25 2013 at the Javits Center in New York City, brings pharmaceutical and biotechnology professionals together with suppliers through a unique combination of conference, exhibition, workshops, partnering opportunities, and networking events.
INTERPHEX is organized by Reed Exhibitions, which manages more than 460 trade events annually worldwide and is a member of the Reed Elsevier Group plc, a world-leading provider of information-driven services and solutions.
The INTERPHEX Conference Program has been developed to span the pharmaceutical manufacturing life cycle. The conference tracks and accompanying sessions have been configured to reflect the project team environment firms use to usher products from development to commercial distribution.
From expert Quality by Design and Process Analytical Technology tutorials to sound development of a design space, industry thought leaders will be providing keen insights from a variety of arenas including academia, consulting, and pharmaceutical manufacturing. All functional areas are addressed in five comprehensive session tracks: Regulatory QA/QC, product development, facility & process design, manufacturing & packaging, and supply chain.
Of particular note is a compelling session entitled “Current Continuous Process Validation Program (CCVP) Following FDA Current Guidelines”, being presented by Victor Hernandez, EMD Millipore Corporation. CCVP is a vital area where today, firms are frantically backfilling knowledge in order to maintain products throughout their life cycle. Additionally, Robert Dream's innovative session entitled “Biopharma's Flexible Imperative” will be discussing the new model biopharmaceutical facility, one far less rigid than earlier prototypes. Dream, from HDR Company LLC, will be discussing external influences on the new flexible model, including the timely role of biodefense.
Congressman Bill Cassidy M.D’s keynote presentation, “Policy Recommendations for Improving Patient Access to Drugs in Shortage”, will touch upon potential improvements to the current reimbursement system to avoid future drug shortages. Additional keynote sessions include “Reorganizing for the Future: Succeeding in the New Pharmaceutical Industry” being presented by Dr. Rajesh Nair, President, Indegene and “Recalibrating the Pharmaceutical Services Opportunity” presented by Jim Miller, President, PharmSource Information Services.
Rounding out INTERPHEX’s educational component will be a series of Exhibit Hall Technology Floor Tours: OSD Technologies, Advanced Aseptic Technologies, Biomanufacturing Technologies, and Modular Construction Technologies. Tours will offer critical insights followed by a walking tour to select vendors showcasing the latest technology and equipment on the show floor.
Visitors profile include Industry professionals from pharmaceutical, biotech and generic facilities and contract service providers involved in specifying, recommending or purchasing manufacturing and packaging equipment and products for the drug and device manufacturing industry. More than 650 exhibiting companies will be present at INTERPHEX 2013.
The Facility of the Year Awards Judging Panel has named six Category Award Winners in the 2013 Facility of the Year Awards (FOYA) program. The winning projects for 2013 were selected from 27 well-qualified entries and are located in Ireland, Switzerland, the United Kingdom and the United States.
"The FOYA program is about recognizing the pharmaceutical industry's innovation and technical advances in facility manufacturing, which ultimately is about helping patients who need and depend upon us for a reliable supply of quality medications," said Chaz Calitri, Vice President of Network Performance at Pfizer and chair of the 2013 FOYA Judging Panel.
"The six facilities honored by this year's awards program embody innovation, exemplified by advances in areas including flu vaccine manufacturing, which is very relevant in parts of the world right now where outbreaks have occurred, threatening public health. All of this year's honorees are to be commended for their important contributions to our industry and, most importantly, to improving people's lives.", he added.
Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards (FOYA) is an annual program recognizing state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a superior project, as well as reduce the cost of producing high-quality medicines.
Now in its ninth year, the awards program effectively demonstrates the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
In the last year's event more than 11,000 professionals from 49 states and 48 countries attended the three days of exhibits, conference sessions, keynote presentations, technical workshops and technology floor tours. Among the new offerings was a conference program re-engineered into five tracks that mirror how companies bring products to market and whose strategy further aligned the event’s educational component with its traditionally strong exhibitor platform.
According to Pharmaceutical Technology, the event’s conference sessions and exhibits reflected “the new paradigm for pharmaceutical manufacturing: one based on deeper process knowledge and understanding using a science and risk-based approach to manufacturing that can meet the always foremost goal of product quality.”
Other highlights included the keynote presentations, featuring a return of PharmSource PresidentJim Miller on the new bio/pharma business model, Jeffrey Backer, Ph.D. of CDER, FDA on assuring a reliable drug supply and Richard Smith, Director of Life Sciences & Specialty Services at FedEx on international cold chain solutions.
Adding to the event was recognition of the eighth annual Facility of the Year Awards, sponsored in conjunction with INTERPHEX by event partner the International Society of Pharmaceutical Engineers (ISPE) and Pharmaceutical Processing magazine, as well as the U.S. Environmental Protection Agency’s Energy Star Award winners.
INTERPHEX 2012 was supported by a number of industry organizations and publications, including Corporate Partners Baxter, DSM, EMD Millipore and FedEx, Corporate Supporter Iron Mountain, and Industry Partners BioPharm International, BioProcess International, Contract Pharma, Life Science Leader, Pharmaceutical Online, Pharmaceutical Processing, Pharmaceutical Technology and The Gold Sheet.
It was clear that INTERPHEX continues to be viewed by exhibitors as an opportunity to nurture existing relationships and develop new ones.