Tag Archives: pharmaceutical

Prof. Lucien Abenhaim: There is an incredible challenge for the sustainability of health systems across the world

Prof. Lucien Abenhaim

LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.

The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.

“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,” says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.

“There is an incredible challenge for the sustainability of health systems across the world”, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,” he adds.

The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.

Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org

SOURCE: EuropaWire

Innovative Drug Discovery Business, Biosortia Pharmaceuticals, Lands Two Health Care Veterans

Kurt Dieck formerly SVP of Strategy and Business Execution at Cardinal Health, will lead early stage drug discovery business at Biosortia Pharmaceuticals. Dieck was named President and CEO in November 2012 and has quickly identified other key executives, including Dr. Guy Carter, former Natural Product head at Wyeth Pharmaceuticals, as his Chief Science Officer. In conjunction, other collaboration partners have joined the team, including NOAA (National Oceanic and Atmospheric Administration), NCI (National Cancer Institute) and key universities, to strategically accelerate the development of novel drug leads in the therapeutic areas of cancer, infectious diseases, inflammation and neurological disorders. Biosortia Pharmaceuticals has seen promising early results with dozens of novel compounds having already been requested, and are under evaluation with NCI and Eli Lilly.

Dieck has spent nearly 30 years in healthcare, including 18 years at Arthur Andersen as a global equity partner and then 10 years with Cardinal Health, a Fortune 20 public company, as a senior executive; there he worked with a broad spectrum of partners, including brand pharmaceutical manufacturers, throughout the supply chain. Dr. Guy Carter has over 30 years of experience working in pharmaceutical R&D, primarily in the discovery and development of microbial natural products. He previously was the leader of natural products drug discovery at Wyeth Research, as head of the Chemical Technologies Department.

“Kurt and Guy make a great team. Their complementary Pharma experiences and backgrounds create great opportunities to accelerate Biosortia’s objective to become the premier, aquatic natural products company with a primary focus in drug discovery,” says Ross Youngs, Biosortia’s Founder and Chairman. “Kurt and Guy bring a wealth of research and business experience along with deep industry relationships in building successful Pharma partnerships. Everyone involved with this young biotech is excited about the future.”

Industry observers have commented that late-stage R&D pipelines are not providing Pharma with the desired revenue growth the market is expecting. Therefore, large Pharma is evolving the way it performs R&D in order to optimize efficiency and to boost patent cliff defenses. These changes require shifting from relying solely on in-house chemistry-based R&D to acquiring and licensing external technologies and natural products based compounds in various stages of development. Biosortia’s ability to supply novel, highly active and potent compounds with drug-like characteristics will increase the productivity and success rate for Pharma as well as reduce the overall cost of the discovery process. The cost to discover, develop and launch a new drug is estimated to reach nearly $3B per drug by 2015. Biosortia’s business model is designed specifically to support Pharma’s needs.

“With nearly unlimited microorganisms (3.7 nonillion), the aquatic environment and its consortia represent an extraordinary opportunity…a new frontier, to access extremely potent and chemically diverse secondary metabolites with drug-like properties with unique mechanisms of action never researched before,” said Dieck. In describing the opportunity, Dieck goes on to say, “Biosortia is on the cutting edge of natural product discovery
and has the capabilities to deliver on its aspiration. Our powerful natural products research team, led by Dr. Guy Carter, in partnership with NOAA’s Dr. Peter Moeller, a leader in aquatic natural products research, has the experience and know-how to decipher the complex unexplored environment in a very efficient manner leveraging all the current state of the art instrumentation. The need for more efficient and effective approaches to drug discovery has never been more important. Biosortia’s innovative technologies, deep research skills and key relationships will efficiently provide thousands of unique natural products as candidates for drug discovery at a time when Pharma is in critical need for “high quality shots on goal.”

“Aquatic microbial consortia are a rich source of metabolically active organisms including microalgae, bacteria, fungi and their secondary metabolites,” states Carter. “Owing to the competitive nature of their habitat, chemical investigations of microbial consortia reveal unique structurally diversified natural products that are responsible for signaling and self-defense that have potential as therapeutics with novel mechanisms of action. Since they have been pre-optimized by nature, these compounds are typically closer to a drug candidate than a synthetic lead, thus requiring less optimization and shorter time when found as ‘hits’ in screening programs.”

The team has also focused on agreements with strategic collaboration partners as vital components to the strategy. Biosortia has recently entered into several collaboration agreements with NOAA, Analyticon and exclusive harvesting relationships, just to name a few. Several others will be advanced by the end of January. Biosortia’s cooperative research and development agreement (CRADA) with NOAA’s Center for Human Health Risk at Hollings Marine Laboratory provides a 5-year framework for research and development regarding the analysis and purification of novel bioactive compounds. According to NOAA’s Technology Partnerships Office, “Success will result in the commercial development of new and unique chemical compounds from the sea which have benefits to human health, either through disease prevention or new treatments for disease.”

Dr. Peter Moeller, NOAA’s Research Scientist who leads the Toxins Natural Products Program stated after analyzing fractions of Biosortia’s biomass, “Coupling NOAA’s mission of characterizing toxins affecting environmental and/or human health with Biosortia’s drug discovery focus turns one man’s toxin into another’s chemotherapeutic. The microorganisms analyzed in the Biosortia biomass identified more unique activity than I have seen in my 30 year career. The volumes achieved from a single harvest delivered an equivalent of 30 years of accumulation. This could materially change the landscape for natural products drug discovery research.”

As of December 31, 2012, Biosortia has identified more than 30 bioactive candidate compounds (hits) from a fresh water eutrophic lake consortium. Therapeutic areas of focus include treatments for cancer, infectious diseases, inflammation and neurological disorders. In addition, more than a dozen of its patent protected compounds are in initial evaluation stage within Eli Lilly’s Open Innovation Drug Discovery Program.

Dieck states, “Looking forward, it is with great optimism. We have a great team built around mutual respect, deep experience, and a desire to succeed and make a difference. We are aligning with the right partners and collaborators to execute our strategy with speed and discipline to provide Pharma with much high quality & diverse compounds vs. “me-too” drugs than they have had in the past 10 years. We are excited about what this company can accomplish, not only for its shareholders but also for the millions of people who have been diagnosed with various forms of chronic diseases who are looking for Pharma to identify better ways to help them extend their lives or live a more productive life. Biosortia can play a big role in identifying compounds that can help Pharma achieve these goals. I am looking forward to the challenge and opportunity to build an industry leading drug discovery company.”

Via EPR Network
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New National Website Reaches Out To Millions Who Took Defective Acne Treatment Accutane

Since 1982, 5 million Americans and 8 million persons in other countries were prescribed Accutane to fight severe acne. In doing so, they were exposed to a defective drug that’s caused serious intestinal injuries requiring surgery – even colon removal. Now Accutane is off the market in America, and Americans have a fighting chance to recover their medical and other expenses via Accutane lawsuits which already are prevailing in courts.

To launch the process, new legal website Accutane-Lawsuit-Lawyer.com is reaching out to Accutane victims needing representation for Accutane lawsuits in all 50 states. Such suits already have made news this year with jury verdicts favoring plaintiffs, including an Alabama man who received over $25 million for his Accutane-caused inflammatory bowel disease (IBD) which led removal of his colon.

Even Hollywood has entered the picture, via a recent Accutane lawsuit launched by actor James Marshall, star of TV’s Twin Peaks and the Oscar-nominated film A Few Good Men. After taking Accutane, Marshall, like many others, suffered an IBD and eventually had to have his colon removed. This severely impacted not only his health, but also his once-promising acting career.

The defective drug’s side effects even were referenced on a recent episode of the hit Fox TV series Glee.

Why has this happened? Indeed, why was it allowed to happen?

“Juries are finding that Swiss-based Roche Pharmaceuticals, creator of Accutane, knew that its product was unsafe but kept selling it anyway,” said a spokesperson for Accutane-Lawsuit-Lawyer.com. “Roche was making up to $1.2 billion per year in profits from Accutane. For Roche, eventual lawsuits were a trade off, and the human suffering was collateral damage.”

Juries are now holding that Roche did not adequately warn potential Accutane users of the drug’s serious side effects dangers. Thus, jury awards totaling more than $56 million already have been awarded in just a handful of Accutane lawsuits.

The Food and Drug Administration provides proof for such lawsuits. Though the FDA first approved Accutane’s use in 1982, the federal agency now calls Accutane’s active ingredient, Isotretinoin, “a potentially dangerous prescription medicine.” The FDA eventually required special warnings with Accutane.

Also in agreement is a Harvard University researcher who’s called Accutane “one of the most dangerous products on the market today.”

The FDA even has linked Accutane to such harmful side effects as severe depression, suicidal impulses and, for women who took Accutane during pregnancy, birth defects in babies. But for many sufferers, the problems involve an IBD such as Crohn’s Disease or ulcerative colitis. Each is a lifelong, incurable and debilitating digestive disorder – not to mention a costly one in terms of medical bills, lost salary and pain and suffering.

To recover such costs via an individual lawsuit – not a class-action suit — Accutane-Lawsuit-Lawyer.com says it can provide victims with an experienced Accutane defective drug lawyer in all 50 states of America. Many such suits may be handled in out-of-court settlements without a jury trial.

The legal website also has produced a special video for persons suffering acne to see. It demonstrates how-to tips on covering up acne with makeup, and advises against treating it with defective drug Accutane. The video can be viewed here: http://www.youtube.com/watch?v=YuptUKD_MGg

Via EPR Network
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Astral Pharmaceutical Industries Will Enter United States Market Very Soon

Astral Pharmaceutical Industries, a state of the art, manufacturing facility for Sterile Antibiotic powder injectables, at Vadodara, India is a specialized and dedicated site, having independent manufacturing infrastructure for Cephalosporin and Penicillin Range of powder Injectable Drug Products.

The company headed by President & CEO Dr. Dushyant R. Patel has highly successful track record of more than a decade ,catering to the domestic, LATAM, SEA and CIS markets for the powder injectable drug products. Astral is a leading player in this segment and has been associated with MNC’s and large Indian Pharma companies. Both the manufacturing lines, one for Cephalosporin Injectable Drug Products and other for Penicillin range of injectable Drug Products have been recently granted approval by US FDA. Prior to the facility approval from USFDA Astral has received several Regulatory accreditation such as HPFBI-Canada, TGA-Australia, MCC-South Africa, ANVISA-Brazil over and above accreditation from several Semi regulated countries.

Astral will soon be entering the US market in strategic alliance with Chicago based Sagent Pharmaceutical Inc. with whom more than 15 ANDAs have been filed.

While the development projects for more ANDA’s are in pipeline, Astral is actively working on consolidating its strong regulatory profile for entry into EU markets apart from fast tracking its filings for Canada, Australia and New Zealand markets.

Continuous technology up gradation and focused development in the core competency area of sterile manufacturing operations has been the strategy of growth. Astral is poised to expand its operations in the field of specialized and niche sterile dosage forms for critical care segments and hospital products.

For further information visit http://www.astralpharma.com or contact Dr. Dushyant Patel at dushyantpatel@astralpharma.com.

Via EPR Network
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Pharmacy College Teacher And Students Write On A Common Blog To Share Quickly Pharmaceutical Industry Technology Developments

Dr.Martin a former teacher in pharmacy college and now a director in a worlds biggest pharmaceutical company, was favorite amongst his students and colleagues for his innovative ideas on research and development teaching subjects on pharmaceutical and biotechnology.

One day he and his students on their last day in the college after completing the examinations in course in pharmacy , decided to stay in touch with each other ,and share technical knowledge regularly with each other , they in this process started writing on a common blog whoguideline.blogspot.com on the subjects on their own profession of pharmaceutical industry and biotechnology

This blog is now updated by then students and now top pharmaceutical industry professionals they never knew that this platform will soon become a favorite world wide amongst worlds pharmaceutical industry and pharmacists.

In pharmaceutical industry technology is moving so fast and to keep one self updated day today is a difficult task unless one join a group of a pharmaceutical association or a forums , where one is required to attend meetings and seminars there & one can discuss the latest happening in pharmaceutical industry.

The students says advantage of writing on this blog is just like attending a seminar on pharmaceutical or biotechnology industry , we write on vivid topics and the technical articles are very informative.There is not a single topic on pharmaceutical technology which is left untouched on this blog , be it biotechnology , microbiology or novel drug delivery system or latest happening in pharmaceutical regulatory affairs and latest news in pharma industry is published regularly.

Dr.Martin the cheap author and editor of the blog said that we started writing on our blog to share our knowledge amongst under graduate and post graduate , and doctoral students and industry professionals , as it is best tool to publish and share the knowledge quickly and easily , in this process so far about 1161 pharmaceutical industry professionals and students and have successfully subscribed to the blog , and this blog is now one of the preferred resource of technical knowledge on all topics in pharmaceutical industry.

Via EPR Network
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Catalent Expands Capabilities In Testing For Melamine In Food And Medicinal Products

At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues its legacy of innovation by rapidly developing new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.

The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products (21 CFR 211.84). It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product.

In response to the FDA’s new guidance titled “Pharmaceutical Components at Risk for Melamine Contamination,” Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 “GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid”).

Catalent is now able to provide its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.

Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and moldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.

“Catalent is proud to have satisfied the demanding regulatory standards the US FDA has provided for detecting melamine,” said Kent Payne, Vice President and General Manager of Catalent’s Respiratory, Analytical and Biotechnology Services business. “Detecting trace levels of melamine in food and medicinal products at these levels is a challenging process, but is key to help avoid future public health crises. In order to support this critical public health need, Catalent can expedite this testing and provide results within 48 hours from receipt of samples

Fore more information on the US FDA guidelines, please visit:

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceuticalbiotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion of annual revenue. For more information, visit www.catalent.com.

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Catalent To Present Webinar On Stabilities Studies In Pharmaceutical Development

Catalent Pharma Solutions will host a free Webinar featuring Senior Manager, Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology. The one-hour Webinar will cover stability studies as a critical part of the drug development process and the vital role they play for drug product marketing approval. The Webinar, titled “Stability Studies in Pharmaceutical Development,” will be held on Friday, November 20, 2009 at 2 p.m. (EST). To register for the Webinar please visit: https://www2.gotomeeting.com/register/280747146.

The presentation will address the principles and practices of stability studies in the drug development process. Pan and Waddle will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR211. Additionally, the Webinar will provide a comprehensive review of ICH and WHO stability guidelines by discussing the strategy used in stability protocols designed to support global registration.

Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Dr. Hans Westenburg, A Senior Scientist At Catalent Pharma Solutions, Will Present At The TIDES 2009 Conference

Dr. Hans Westenburg, a senior scientist of structural characterization and analysis at Catalent Pharma Solutions, will present this month at the TIDES 2009 Conference to be held in Las Vegas, NV, May 17-20, 2009. The conference agenda was put together by leaders in oligonucleotide and peptide development and manufacturing, and features a program full of novel, in-depth scientific presentations related to oligonucleotide and peptide drug development and manufacturing. The TIDES conference is produced by IBC Life Sciences.

Dr-Hans-WestenburgDr. Westenburg’s poster presentation is titled “Teriparatide Degradation Products Identified by Accurate Measured Mass LCMS.” Presentation abstract: The human parathyroid hormone (PTH) contains 84 amino acids. The biologically active region is 34 N-terminal amino acids (teriparatide) from the recombinant human PTH. Teriparatide is the first FDA approved agent for the treatment of osteoporosis that stimulates new bone formation. The safety of the drug product is dependent not only on the toxicological properties of the active drug substance, but also on the impurities that it contains. Therefore, identification of impurities in the drug product is an important part of drug development and regulatory assessment. Accurate measured mass liquid chromatography/mass spectrometry (LCMS) is a rapid technique to identify impurities at levels as low as 0.02% in the drug product. LCMS enabled the identification of fifteen low level impurities in teriparatide.

Based in Catalent’s Trade Place facility in San Diego, CA, part of the organization’s Respiratory, Analytical and Biotechnology group, Dr. Westenburg works to structurally identify impurities for virtual, generic, small-, and mid-size pharmaceutical companies. In his current capacity, he has been able to identify impurities belonging to a large number of structural classes. The identification of these impurities supports the client to enable greater reporting thresholds or, in some instances, identify an impurity causing discoloration of a drug substance or product. During the past two years, Dr. Westenburg has routinely monitored low level genotoxic impurities by QTOF LCMS in a drug product. Overall, the majority of his work is impurity identification for companies concerning impurities in drug substances [Q3A(R2)] and impurities in drug products [Q3B(R2)], in compliance with the International Conference on Harmonization (ICH) guidelines.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies catalentits local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

Via EPR Network
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Catalent Analytical Team Member to be Published in Journal of Pharmaceutical Research

Catalent Pharma Solutions, a worldwide leading provider of advanced technologies for pharmaceutical, biotechnology and consumer health companies, will be featured in the upcoming April edition of Journal of Pharmaceutical Research. Stephen P. Mayock, a member of Catalent’s analytical team, was a major contributor to the article that conveys the present challenges and future relevance of the science of USP 1 and 2 dissolution.

The article begins with the scientific origins of the dissolution test and discusses the roles of dissolution in product development, consistent batch manufacture and stability testing. It also reviews the ultimate role of dissolution testing where the end results correlate to in vivo results. Other topics that are covered in the article include the mechanical calibration versus performance testing, variability and hydrodynamics of USP Apparatus 1 and 2 and new initiatives in the industry such as quality by design, process analytical technology and design of experiment.

Mayock is the senior manager in Catalent’s Stability and Analytical Services Group. Catalent’s analytical team is part of its Respiratory, Analytical and Biotechnology group, with sites in the Research Triangle Park, N.C., San Diego C.A., and Middleton, W.I. Mayock joins fellow authors Vivian Gray, Gregg Kelly, Min Xia, Chris Butler and Saji Thomas. The article has been available online to subscribers since Jan. 25, 2009, and the print version will be available in the April edition.

About the Journal of Pharmaceutical Research
Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, presents papers that describe innovative research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval. Small drug molecules, biotechnology products including genes, peptides, proteins and vaccines, and genetically engineered cells are an integral part of papers published.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

Via EPR Network
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