THE NCRI PARTNERSHIP LAUNCHES NEW FIVE-YEAR STRATEGY TO ACCELERATE PROGRESS IN CANCER RESEARCH

news 2

The National Cancer Research Institute (NCRI) launches its new five-year strategy today (Tuesday) to accelerate progress in cancer research through collaboration. The strategy will help cancer research funders to maximise opportunities to improve the health and quality of life of people who have had, or may one day develop, cancer. It will also ensure research continues to drive improvements in prevention, treatment, and patient care and support.

Cancer survival rates have doubled in the last 40 years and research has been central to this success. However, many challenges lay ahead that are too vast for one organisation to tackle alone. The NCRI Partnership will work together to achieve four goals: to accelerate the translation of cancer research into clinical practice, to improve the quality and relevance of research related to cancer, to address major opportunities and challenges in cancer research and to ensure a coordinated portfolio of cancer research in the UK.

Around 2.5 million people are living with, or have experienced, cancer across the UK and this number is expected to rise to around 4 million by 2030 as the population ages and research develops better treatments to help more people live longer with and beyond cancer.

Karen Kennedy, Director of the NCRI, said: “There has never been a more urgent need for collaboration to fund research that addresses the complex needs of cancer patients at every stage of their journey through and beyond cancer. Research is making life-changing advances in cancer treatments, but the long-term effects of cancer can have a far-reaching impact, affecting people’s health and quality of life.”

The NCRI Partnership enables collaboration between 19 of the biggest funders of cancer research from the UK’s charity and government sectors. It facilitates more than 250 meetings per year, to bring together the right clinicians, scientists, research nurses, patient experts and other specialists to tackle the big issues facing cancer research.

Its activities include co-ordinating a Clinical Trials Unit Group, where trial specialists collaborate to identify needs common to all cancer clinical trials, and its Clinical Studies Groups – a series of advisory groups spanning all cancer types that bring together UK experts to accelerate research to improve cancer treatments, and help those affected by cancer to live well.

One of the NCRI’s strategic goals is to seize opportunities and address challenges in cancer-related research, and as part of this it will encourage research that meets the needs of people living with and beyond cancer. In partnership with the James Lind Alliance, its new initiative in ‘Living with and Beyond Cancer’ will mean people affected by cancer and clinical health care professionals can pose the questions they feel are unanswered about living with or beyond cancer, so they can be addressed through research. People affected by cancer and health care professionals will work together to prioritise the questions in to a top-ten. The NCRI will also be working with researchers to help ensure research proposals to address the top-ten questions are successfully funded.

It’s through this kind of collaboration that NCRI will help improve the health and quality of life of cancer patients and the wider public.

Baroness Delyth Morgan, chair of the NCRI, said: “Collaboration is at the centre of the NCRI’s new strategy, ensuring patients, health care professionals and researchers all have a voice. Working together will ensure the cancer research community overcomes the enormous challenges facing them in this uncertain political and economic environment.”

The NCRI partnership was set up to facilitate collaboration between cancer research funders and to address gaps and challenges in research that wouldn’t be possible for one organisation to tackle alone. It comprises 19 key funders in cancer research across the four UK nations which, collectively, have spent more than £6 billion pounds on cancer research since the partnership was established in 2001.

WHEN LIVER IMMUNE CELLS TURN BAD

liver cells

A high-fat diet and obesity turn “hero” virus-fighting liver immune cells “rogue,” leading to insulin resistance, a condition that often results in type 2 diabetes, according to research published today in Science Immunology.

Using cells from mice and human livers, Toronto General Hospital Research Institute researchers demonstrated for the first time how under specific conditions, such as obesity, liver CD8+ T cells, white blood cells which play an important role in the control of viral infections, become highly activated and inflammatory, reprogramming themselves into disease-driving cells.

Scientists have been trying for many years to discover why the liver continues to pump out too much glucose in people with diabetes. This paper sheds light on the markers of activation and inflammation in CD8+ T cells and the Interferon-1 pathway which helps stimulate their function.

The research is entitled, “Type 1 Interferon Responses Drive Intrahepatic T cells to Promote Metabolic Syndrome,” by first authors Magar Ghazarian, a former graduate student, Dr. Xavier Revelo, a post-doctoral fellow in the lab of Dr. Daniel Winer, and senior authors Dr. Shawn Winer, Laboratory Medicine, St. Michael’s Hospital, Laboratory Medicine and Pathobiology, University of Toronto, and Dr. Daniel Winer, Diabetes Research Group and the Department of Pathology, Toronto General Hospital Research Institute and the Departments of Laboratory Medicine and Pathobiology and Immunology, University of Toronto.

“We found that under conditions of obesity and a high-fat diet, the cells that typically strengthen our immune system by killing viruses and pathogens instead increase blood sugar. They become pathogenic and worsen insulin resistance,” explains Dr. Dan Winer. In fact, the normal function of the immune cells becomes misdirected. The pathways they would typically use to fight infection create inflammation, unleashing a chemical cascade which impacts insulin and glucose metabolism.     

“The immune system in the liver represents a key missing link in our understanding of how the liver malfunctions in obesity to dysregulate sugar levels,” adds Dr. Revelo.

In the study, researchers fed mice a high-fat diet, 60 per cent of which was saturated fat, for 16 weeks. Compared with normal chow diet-fed mice, the high-fat diet mice showed worsened blood sugar, increased triglycerides, a type of fat (lipid) in the blood, and a substantial increase in the numbers of CD8+ T cells in the liver.   

Instead of responding to viruses or other foreign invaders in the body, the activated CD8+ T cells launch an inflammatory response to fat, and to bacterial components that migrate to the liver from the gut through the blood.

The activated T-cells divide rapidly, pumping out increased numbers of cytokines, proteins that assist them in an active and excessive immune response.  This pro-inflammatory response in turn interferes with normal metabolism in the liver, specifically jamming up or blocking insulin signaling to the liver cells.

Since the liver stores and manufactures glucose or sugar depending upon the body’s need, the hormone insulin signals whether the liver should store or release glucose. This system keeps circulating blood sugar levels in check. If that signal is disrupted or blocked, the liver continues to make more sugar, pouring it into the bloodstream. If the liver is over-producing glucose, it becomes difficult to regulate blood sugar.

“This response never manifested itself until humans started to eat high-sugar, high-fat, high-calorie diets,” says Magar Ghazarian, now a medical student in Ireland.

Adds Dr. Shawn Winer: “We’re moving from studying diabetes as a metabolic syndrome – a combination of nutritional and hormonal imbalances – to include the role of the immune system and inflammation. That’s the developing link. Inflammation is emerging to be a major mediator of insulin resistance.”

Insulin resistance is a pathological condition linked to obesity, in which cells fail to respond normally to the hormone insulin which helps the body metabolize glucose. This results in poor absorption of glucose by cells, causing a buildup of sugar in the blood. Long-term insulin resistance eventually leads to diabetes.

The findings were confirmed in genetically-modified mice, as well as in human liver cells.

The researchers found that in genetically-modified mice lacking Interferon-1, who were also fed a high-fat diet, the CD8+ T cells did not produce an inflammatory response, and the mice had near normal blood sugar levels.

In further investigations of human liver cells from nearly 50 donor tissues of humans with varying degrees of body mass index (BMI) and liver fat, higher levels of CD8+ T cells were linked with higher levels of blood sugar or more advanced fatty liver disease. Donor tissues were obtained from Saint Louis University Hospital, Washington University School of Medicine and Mid-American Transplant Services from St. Louis and University Health Network.

The researchers note that CD8 + T cells could potentially be used as markers for the progression of fatty liver disease, which is expected to become the leading indication for liver transplantation within the next one or two decades. 

Type 2 diabetes is one of the fastest growing diseases in Canada with more than 60,000 new cases yearly. Nine out of 10 people with diabetes have type 2 diabetes. Being overweight or obese is an important risk factor for diabetes. It is estimated that 3.5 million, or about 9 per cent, of Canadians have diabetes.

The study was funded by the Canadian Institutes of Health Research, the Canadian Diabetes Association, the J.P. Bickell Foundation, and the Ontario Ministry of Research, Innovation & Science.

Biogaran takes over Swipha’s activities in Nigeria to produce generic drugs for the local market

Lagos, Largest City in Africa

 

In order to develop new markets to meet its commitment to provide all patients with quality medication, Biogaran, a pioneer in generics and a subsidiary of Servier, has just taken over Swipha, a Nigerian pharmaceutical company that produces generics to meet local health needs. Its portfolio is mainly focused on three families of products which treat Nigeria’s most widespread infections and health issues: antimalarial drugs and antibiotics, anti-anxiety and tranquillizers.

Lagos, Largest City in Africa

Nigeria is the largest economy in Africa and its most populated country (184 million inhabitants in 2016 according to the IMF).

Swipha was the first Nigerian pharmaceutical company to obtain ISO 9001 certification in 2007. Approved by the World Health Organization (WHO) in 2014, Swipha employs 300 people locally and generated record sales of NGN 4bn (approximately € 20 million) in 2012. Beyond its production unit, the company also has a wide distribution network covering most parts of Nigeria.

Health issues are particularly important in Africa. Beyond significant needs for good quality, inexpensive and effective medicines, the problem of counterfeits is also becoming of concern. The WHO estimates that 100,000 deaths are due to fake medicines in Africa every year[1]. In this context, supplying Nigeria’s population with reliable medicines that are produced locally is a strong commitment made by Biogaran.

“Biogaran’s international expansion strategy is to create synergies by bringing its expertise and investment capacity in production to existing structures”, commented Pascal Brière, President of Biogaran. “Nigeria quickly came out as the best entry point on the African continent with its strong population and solid economic fundamentals, including a very dynamic market economy; Swipha’s know-how, reputation and network have immediately convinced us that it was the right partner for us.”

Lilly Announces $850 Million Investment in U.S.

Lilly headquarters

Lilly has announced this month plans to invest $850 million in its U.S. operations in 2017. The company’s investments span facilities across its U.S. enterprise, including research laboratories, manufacturing sites, and general and administrative areas. The investments are being driven by demand for Lilly products, as well as its robust pipeline of potential medicines in development targeting cancer, pain,
diabetes and other unmet medical needs.

Company leaders were joined by federal, state and local government officials at Lilly Technology Center, where the details of the investments were unveiled, including plans for a new $85 million expansion of its Trulicity® (dulaglutide) device assembly operations in the U.S. This expansion is part of a massive five-year investment by the company to expand its diabetes products manufacturing operations in the U.S., which also includes a $140 million insulin cartridge production
facility that was officially dedicated at today’s announcement.

David A. Ricks, Lilly’s president and chief executive officer, said that Lilly’s potential for growth and its long-standing commitment to the U.S. market led to its decision to invest in its U.S. operations and expand its manufacturing footprint in Indianapolis.

“Our future at Lilly is bright, as we’re on a path to launch 20 new products in a 10-year time frame,” Ricks said. “As we have for our entire 140-year history, we continue to see Indiana and the United States as attractive places to research and make the medicines that we sell around the world.”

Ricks explained that Lilly’s $850 million investment will fund both projects that are already underway as well as new projects that will be initiated throughout the course of the year, including additional projects in Indianapolis.

Diabetes products manufacturing investment

Company officials focused much of today’s announcement around its massive investment in diabetes products manufacturing. Over the course of the last five years (2012-2016), Lilly has invested approximately $1.1 billion to boost its diabetes products manufacturing operations in the U.S. These investments include upgrades to existing facilities, as well as the addition of new capacity and capabilities based on the evolution of the company’s diabetes pipeline and portfolio and
the increased prevalence of the disease.

During this period, Lilly has increased its U.S manufacturing workforce by more than 1,000 employees—from 5,000 to 6,000 roles—with approximately 400 added in Indianapolis.

“More than 400 million people around the world have diabetes—and that includes approximately 30 million people in the U.S. alone,” said Enrique Conterno, president, Lilly Diabetes and Lilly USA. “Lilly has spent more than 90 years providing solutions to people with diabetes, and today’s announcement extends the deep commitment of our heritage. This manufacturing expansion, along with the introduction of several other new treatments over the last two and a half years, will allow Lilly to continue to be a leader in diabetes care.”

Conterno added that the new investments underscore Lilly’s diabetes manufacturing presence in Indianapolis. Lilly’s stateof-the-art manufacturing facility in Indianapolis is part of the company’s nine-decade legacy of producing insulin.

“In addition to providing the capacity necessary for the safe and reliable supply of medicines to patients, these investments have allowed us to add U.S. manufacturing jobs,” said Maria Crowe, president of Lilly Manufacturing. “These include highlyskilled technicians, scientists and engineers, which are an economic catalyst for local communities.”

Further, Crowe noted that during the past five years, construction-trade staffing has averaged nearly 500 jobs, and had a peak level of nearly 1,000 workers. The ongoing operations together with the investment programs will continue to require a significant level of construction-trade workers at the Lilly Technology Center.

“Lilly’s announcement today is a clear example of what a fiscally sound state with a strong business climate—coupled with a world-class company—can achieve,” said Indiana Gov. Eric J. Holcomb. “I am grateful for Lilly’s continued investment in Hoosiers and in our home state, and will work to maintain the strength of the life-sciences industry and advanced manufacturing in Indiana.”

“Despite a global presence and diverse interests, Lilly’s continued investment in Indianapolis is a testament to their exceptional level of faith in our workforce and a decades-long commitment to this community,” said Indianapolis Mayor Joe Hogsett. “As the biotech industry continues to grow in Indianapolis, Lilly remains a clear leader, bringing advancements to the field and high paying jobs to the city. I’m excited for what today’s announcement means for the company’s future and
look forward to Lily’s continued advancements as their footprint in our city grows.”

Ricks concluded by saying that Lilly has invested approximately $5 billion in its U.S. facilities during the last decade and that more investments can be expected, particularly if the U.S. adopts a more favorable tax environment.

“The equitable treatment of foreign earnings, a lower U.S. corporate tax rate, and U.S. innovation incentives—similar to the rest of the world—will encourage significant investment in the U.S., creating economic growth and good jobs for Americans,” said Ricks. “The House Republican Blueprint with border adjustability is designed to achieve these priorities, puts America’s global companies on a level playing field with competitors around the world, and creates economic growth and employment
within the U.S.”

Sanofi and Lonza Enter into a Strategic Partnership to Establish a Large-Scale Biologics Production Facility

Sano

Sanofi and Lonza have announced that they have entered into a strategic partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The strategic partnership in the form of a joint venture combines the strong biologics development pipeline of Sanofi with the expertise of Lonza to design, construct, start-up and operate a state-of-the-art large-scale mammalian cell culture facility. The initial investment will be around CHF 290 million (€ 270 million), to be split equally between each company.

The initial phase of the facility will commence construction in 2017, pending necessary regulatory approvals, and is expected to be fully operational by 2020. Lonza has previously built and licensed three similar facilities in the U.S. and Singapore.

“In addition to the investments we are making in building our own internal production capabilities, the joint venture between Sanofi and Lonza emphasizes our commitment to provide access for patients to high quality therapeutic monoclonal antibodies,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs, Sanofi. “Approximately sixty percent of our pipeline is made up of biologics, including monoclonal antibodies, dedicated to key disease areas such as cardiovascular, immunology and inflammation, neurology and oncology. Lonza is a highly experienced partner in this field and the capabilities which this joint venture will create are critical to meeting our patients’ needs for these important therapies.”

“By entering into this long-term strategic relationship we have developed a tailor-made business model that best fits both Sanofi’s and Lonza’s requirements. It provides to Sanofi dedicated capacity, which allows for a clear win-win situation for all participants,” said Marc Funk, COO Pharma & Biotech, Lonza. “As part of our strategic roadmap, we will develop further innovative business models based on the requirements of our customers. We intend to address these long-term market needs by establishing a state-of-the-art strategic biologics manufacturing platform. The strategic partnership with Sanofi represents the first module in this undertaking; and we are convinced that with this future-oriented approach, we can serve additional customers.”

The partnership provides both Sanofi and Lonza with substantial flexibility in an innovative setup:

  • Each party will share the available capacity in line with their equity shareholding in the joint venture
  • Sanofi will have additional access to bio-manufacturing capacity to support increasing demands for their portfolio of biologic therapeutic products, should they require it
  • Lonza will be free to market their share of capacity, if not required by Sanofi, and will also market unused Sanofi capacity, where available.
  • Lonza will construct the facility and will support the joint venture in its operation of the facility.

The strategic partnership enables Sanofi to react quickly to fluctuations in demand in a short timeframe, reinforcing their capability to launch high-quality, next generation biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture based therapeutic proteins, therefore allowing Lonza to better serve its customers. By adding flexibility in this way, this model will help to optimize biologics production capacity across the whole industry.

Spider web of cancer proteins reveals new drug possibilities

Senior author Haian Fu, PhD

Scientists at Winship Cancer Institute of Emory University have mapped a vast spider web of interactions between proteins in lung cancer cells, as part of an effort to reach what was considered “undruggable.”

This approach revealed new ways to target cells carrying mutations in cancer-causing genes. As an example, researchers showed sensitivity to an FDA-approved drug, palbociclib, for a gene that is commonly mutated in lung cancer cells, which is now being tested in a clinical study.

 

Senior author Haian Fu, PhD

Many genes that drive the growth of cancer cells don’t have any drugs available against them. For “tumor suppressor” genes, researchers are often not sure how to go after them. When the tumor suppressors are gone, cells often become more deranged, but there’s no bullseye left to target. Exploiting the cancer cells’ derangement remains a daunting challenge, says senior author Haian Fu, PhD.

“Our approach is to place tumor suppressors in the context of a network of cancer-associated proteins and link tumor suppressors to drugs through a known drug target protein” Fu says. “In this way, changes in a tumor suppressor may be linked with the response of the target to the connected drug.”

The study is part of a push by the National Cancer Institute’s Cancer Target Discovery and Development (CTD2) network to translate genomics data into therapeutic strategies, he says. Emory is a member of the NCI CTD2 network.

Fu holds the Winship Partner in Research endowed chair and is leader of Winship’s Discovery and Developmental Therapeutics Program, director of the Emory Chemical Biology Discovery Center and professor of pharmacology and hematology and medical oncology. Co-corresponding author Fadlo Khuri, MD, maintains his professor appointment at Winship Cancer Institute and is now president of the American University of Beirut in Lebanon.

Cancer researchers have been searching for ways to target mutations in the gene STK11/LKB1, found in 15 to 25 percent of non-small cell lung cancers. The tumor suppressor STK11/LKB11 encodes an enzyme that is thought to regulate cell migration and metabolism.

One of the Winship team’s newly identified interactions — a “thread” in the spider web — suggested that palbociclib, recently approved against metastatic breast cancer, may work against cells carrying mutations in LKB1, through LKB1’s connection to CDK4, the target of palbociclib.

That prediction was supported by genomic data analysis and cell culture experiments: lung cancer cells with LKB1 defects showed a tendency of increased sensitivity to palbociclib. Now a study led by Taofeek Owonikoko, MD, at Winship is using LKB1 status as a biomarker for interpreting the effect of palbociclib.

How OncoPPI works

If cells are complex machines, then a number of ways exist for figuring out how the machines’ parts, dominated by proteins, fit together. Some of them involve multiple washing steps to remove nonspecific partners after breaking cells apart, but FRET (Förster resonance energy transfer) does not. If two fluorescent molecules with colors that are near on the spectrum are close enough (less than 10 nanometers), that proximity can be detected by FRET.

Fu and his colleagues established a large-scale platform for tagging proteins with two different fluorescent molecules, introducing them into cancer cells, and then detecting interactions between the proteins. They call this network of cancer-associated proteins “OncoPPI.”

Emory 2

Starting witha set of 83 lung cancer-related proteins, the team detected more than 260 interactions that were not known previously. They tested the interactions several times, in different orientations, and in other lung cancer cell lines with selected interactions to establish reliability. More than 80 percent of the interactions the researchers detected could be confirmed by another method (GST pulldown).

As an additional example to illustrate the utility of a protein interaction web, the team focused on the prominent oncoprotein Myc, which was also considered “undruggable.” But the researchers could connect Myc indirectly through NSD3 to another protein called Brd4, against which inhibitors have been developed. Brd4 inhibitors are being currently tested in clinical trials. This finding revealed a new pathway Brd4-NSD3-Myc as potential targets for therapeutic intervention, Fu says.

The OncoPPI research was supported by the National Cancer Institute Cancer Target Discovery and Development network, lung cancer program project and Winship Cancer Institute and the Georgia Research Alliance, and the Emory University Research Committee. The clinical study of palbociclib is sponsored by Pfizer.

MilliporeSigma Opens Production Facility Exclusively for Meglumine in Spain

MilliporeSigma

MilliporeSigma opens a facility in Mollet des Vallès, Spain dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.

The facility, validated by the FDA, is the only location in Europe that manufacturesmeglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs. “Our new facility was optimized around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine,” said Andrew Bulpin, Head of Process Solutions Strategic Marketing & Innovation, MilliporeSigma. “The result is a high level of confidence in quality and security of supply for our customers.”

Lilly enhances its existing pain management portfolio for migraine with CoLucid Pharmaceuticals acquisition

Lilly

Lilly and CoLucid Pharmaceuticals Announce Agreement for Lilly To Acquire CoLucid

$960 million deal will enhance Lilly’s existing pain management portfolio for migraine; adds potential near-term launch to its late-stage pipeline

Eli Lilly and Company and CoLucid Pharmaceuticals, have announced an agreement for Lilly to acquire CoLucid for approximately $960 million. This transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.

More than 36 million people suffer from migraine in the United States alone. Lasmiditan, if approved, would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.

Lasmiditan is an important addition to Lilly’s emerging pain management pipeline, which includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache. In addition, tanezumab is being studied, in collaboration with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.

“Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine,” said David A. Ricks, Lilly’s president and chief executive officer. “This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine.”

Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. Over the past 12 years, CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan as evident by the first positive Phase 3 trial. At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly. Lilly has since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.

“We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization,” said Thomas P. Mathers, CoLucid’s chief executive officer. “We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients.”

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 and is developing lasmiditan oral tablets for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.

www.lilly.com/newsroom/social-channels

Pulmonary & nasal drug delivery experts to attend RDD Europe 2017

RDD Europe 2017

Register now to attend the RDD Europe 2017 Scientific Conference to be held April 25-28, 2017, in Antibes, France.

The Respiratory Drug Delivery (RDD®) Europe 2017 scientific conference will welcome pulmonary and nasal drug delivery experts from around the world to Antibes, France, April 25-28, 2017. The joint organizers
of this event, RDD Online® and Aptar Pharma invite you to register at www.rddonline.
com/rddeurope2017.

Bringing the Respiratory World Together
Respiratory Drug Delivery Europe is a major conference bringing together experts from around the world to exchange emerging scientific knowledge and providing a dynamic forum for business networking. Approximately 450 delegates from 29 countries attended the 2015 edition in Antibes, France. RDD Europe attracts high level academic, industrial and regulatory scientists and clinicians. It is a must attend conference for companies involved in the research, development, testing and marketing of medicines, devices and services associated with
pulmonary or nasal products.

A premium, interactive three-day conference
This year, the conference will start with a plenary lecture entitled “Patient Focused Device Design: Addressing Inhaler Technique”, hosted by Federico Lavorini, M.D. PhD, Department of Experimental and Respiratory Medicine, Careggi University Hospital, Florence, Italy.

Subsequent sessions will focus on:
– Progress in Inhaled Drug Development
– Can Connected Devices Improve Respiratory Outcomes?
– Changing Regulations in Europe
– Achieving Deposition Equivalence
– Novel Approaches to Characterize Aerosol Dynamics
– Designing Inhalation Products in a Quality by Design Era

As part of the conference, RDD Europe 2017 will underline innovative research contributions in both podium and scientific poster sessions. Scientific posters will highlight recent nasal and pulmonary pharmaceutical research. Five of the best posters will be showcased during ‘Posters on the Podium,’ a fast-paced interactive session in
the main auditorium. All accepted graduate student poster abstracts are automatically eligible for the VCU RDD Peter R. Byron Graduate Student Award.

RDD Europe 2017 will also host 12 workshops led by device experts and service providers. Participants can self-select and attend interactive technical Workshops highlighting innovative technologies, products and services. Valuable networking opportunities RDD Europe 2017 offers numerous networking opportunities including the Technology
Exhibition. Exhibitors display innovative technologies and services throughout the conference in our signature table-top format. Device and equipment designers, and service providers, and consultants can interact and share their input.

A networking cocktail reception will take place on the evening of April 25 and a Gala Dinner sponsored by Aptar Pharma will be hosted on Thursday, April 27.

For many years, RDD Europe events have reached capacity, so early registration is strongly recommended. The early bird rate will be available until January 16, 2017.

Further information about RDD Europe 2017, including the detailed program and registration details, is available now here

Aptar Pharma nears completion of elastomer component capacity in North America

Aptar

Aptar Pharma, a leading provider of drug delivery systems, is nearing completion on its expansion at its Congers, NY state-of-theart manufacturing site. The new space will enable the company to better serve North American pharmaceutical customers, as injectable elastomeric component manufacturing will be completed in the United States for the first time by Aptar. Final construction is planned by the end of the first quarter of 2017 so that Aptar Pharma can anticipate shipping validation batches to customers in the second quarter of next year. The expansion is part of a stepped program to increase Aptar Pharma’s footprint in the United States, according to Bas Van Buijtenen, President of the Injectables Division of Aptar Pharma.

“This investment is continuing our commitment to growing and accelerating our footprint in North America. More significantly, the technology we are introducing will increase our ability to provide world-class manufacturing capabilities to our customers locally. This will provide premium products, shorter lead-times and more responsive service for the US elastomeric components markets,” Van Buijtenen said. The added space will house state-of the-art clean rooms and integrated best-in-class vision equipment, according to Van Buijtenen. “Vision equipment will be used to perform 100% of the automatic inspection of all parts during the finishing process to ensure PremiumVisionTM product quality,” he said. “The increased facility space also enables the company to conduct all of our finishing operations in the United States, including Aptar Pharma’s recently launched Premium Coat TM coated stoppers.”

The expansion was necessary to meet the continued growth of Aptar Pharma’s US injectables business and is part of Aptar’s multiyear investment program supporting the global growth of its injectables business. “We are bringing all of our knowledge and the value-adding parts of our process closer to the customer,” he added. “We want our customers to know us better. To understand what we can do for them on an entirely different level.” Van Buijtenen also commented, “We are a global player with a strong position in North America. Our integration into AptarGroup gives us access to the latest technologies, exceptional people and great financial stability. Our US business has been growing very rapidly, and this investment in capacity will support and accelerate our growth into the future.” he said.