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Two new RACs specifically focus on the pharmaceutical and the medical device regulations in the healthcare environment. 
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"Summary of a survey designed to better understand the factors considered when establishing an analytical-testing strategy"
Judy Curtis / SIPR's insight:
Pharmatech Associates’ Bikash Chatterjee explores analytical testing strategies for clinical and commercial operations in a guest column in Life Science Leader and Outsourced Pharma.
The drug development marketplace has grown complex, moving from small molecules to large molecules, to complex molecules, such as cellular and gene therapy products, bringing enormous technical challenges to managing a broad diversity of analytical testing requirements.
Yet, central to every drug development program is the need to establish a capable analytical testing strategy...
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Tech transfer is key to succession advancing pipeline products from research to preclinical.
Judy Curtis / SIPR's insight:
Pharmatech Associates' Barrett Fallentine examines how 21st-century biopharma and biotech companies advance pipeline products to preclinical phases, and shares best practices for technology transfer all along the way, in an article titled “Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture," Pharmaceutical Technology Partnering for Bio/Pharma Success Supplement (February 2019).
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Wai Wong of Pharmatech Associates discusses how mobile workstations—one of many types of different smart devices—are key components in moving the industry to Pharma 4.0.
Judy Curtis / SIPR's insight:
Pharma 4.0 is an Industry 4.0 concept applied to pharmaceutical manufacturing. Pharma 4.0 envisions highly efficient automated processes driven by an integrated manufacturing control strategy (i.e. smart factory and the IoT), where sensors, data, and cloud technologies work together to bring a new era of safety, control, and efficiency to manufacturing facilities. Wai Wong's presentation is part of a webinar organized by Pharmaceutical Processing on Nov 29, 2018 https://event.webcasts.com/starthere.jsp?ei=1217544&tp_key=77f6e22947
Pharmatech Associates consists of four divisions – Validation, PPD, Compliance, and Regulatory Affairs, encompassing the entire product development lifecycle. At Pharmatech, a product lifecycle approach to pharmaceutical product development and manufacturing--with the key idea of compliance through science--helps clients to build quality into their products from the start. https://pharmatechassociates.com/
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"At the ISPE annual meeting today, Pharmatech Associates introduced Pharmatech Associates International Contracting and Services, LLC (PAICS), a new company with headquarters in Doha, Qatar. PAICS provides a global, single-source platform for clients and investors from which next-generation pharmaceutical facilities can be designed, constructed, and operated, anywhere in the world.
Judy Curtis / SIPR's insight:
"From our decades of industry experience serving clients, we created PAICS as a single-source solution to producing capital-efficient life science facilities for product development, manufacturing, and quality control assurance with fully integrated, optimized QMS," said Warren G. Baker, CEO and Chairman of Pharmatech Associates, Inc. "PAICS heralds an era of local design and management of new facilities purpose-built to comply with all regulatory requirements to meet the highest standards of the FDA, EMA and WHO."
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The 21st Century Care Act (CCA) offers the promise of a quicker regulatory review and lower cost for medical devices, drugs, and combination products. Within the medical device and combination product sectors the autoinjector is positioned as a major contender with the potential to expand the target patient audience for many biotech therapies.
Judy Curtis / SIPR's insight:
Lynn Hansen, Director of Regulatory Affairs at Pharmatech, describes how the autoinjector platform is expanding as a viable solution for many disease therapies previously relegated to physician-administered treatments.
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Excerpt from 2018 CPhl Annual Report, from article by Bikash Chatterjee, President and CSO, Pharmatech Associates: “We have seen groundbreaking drug therapies and diagnostics approved in the last five years that position regulatory bodies to embrace these new innovations. Whether risk is managed via enhanced control and oversight--such as with the EUs GDPR legislation-- or is a by-product of intelligently gathered real-world data, as provided under the US’s 21st Century Cures Act, the regulatory evaluation in each framework required to evaluate these new technologies will be grounded in today’s scientific tools and analytic techniques. Technology is playing an increasingly large role in improving rates of attrition. Over the next five years, big data will catalyse drug discovery, with R&D leading to quicker advancement of more targeted therapies” said Chatterjee.
Judy Curtis / SIPR's insight:
In his paper on "regulatory philosophy divergence and innovation convergence in the next decade," Pharmatech Associates' Bikash Chatterjee predicts China’s rate of advancement is still accelerating and that we can very quickly expect full harmonization with ICH standards. The next result will be that China’s overall standards will improve quickly and poor quality manufacturers will drop out of the market in the next two to three years. CAR-T and NGS have opened a potential regulatory pathway for even 3-D bioprinting of organs to follow.
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Industry specialist Kerri-Anne Mallet of Pharmatech Associates writes about maneuvering through FDA's accelerated pathway.
Judy Curtis / SIPR's insight:
A new article in MD +DI from Pharmatech Associates' Kerri-Anne Mallet discusses CDRH's proposed Innovation Pathway. This is a priority review program to help breakthrough medical devices reach patients in a timely manner by improving collaboration between FDA and manufacturers and shorten the time and reduce the costs from concept to commercialization for innovative medical devices.
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Technical transfer to a contract development and manufacturing organization (CDMO) mobilizes the efforts of a technical team, from start through commercialization activities and throughout the life cycle of a product.
Judy Curtis / SIPR's insight:
Sandra Wassink demonstrates that success in manufacturing at the CDMO is reliant on full disclosure of early development history, collaborative fine-tuning of critical attributes through Phase III and continued teamwork into commercial manufacturing. In turn, the flexibility, experience and professionalism of both companies is required to achieve safe, consistent, and quality product commercialization.
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Chief Editor’s Note: An Outsourced Pharma reader wondered about the handling of incoming bulk drug substance, leading to this feature article by Bikash Chatterjee, of Pharmatech Associates.
Judy Curtis / SIPR's insight:
Biologic drug development consists of two fundamental components: the drug substance (DS) development, which can include the master and working cell bank development, manufacturing process development, and scale-up; and the drug product (DP) development, which includes the filling of the drug substance into the primary container.
Today’s CMO or contract testing lab is charged with executing critical development activities but will also provide insight based upon their own experiences with multiple processes.
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Development, validation, regulatory approval, compliance, and continuous improvement are all features of the overall process of manufacturing and releasing product that can be enhanced by proper use of risk assessment.
Judy Curtis / SIPR's insight:
In Pharmaceutical Online, Moria Feighery-Ross of Pharmatech Associates discusses risk management. Development, validation, regulatory approval, compliance, and continuous improvement are all features of the overall process of manufacturing and releasing product that can be enhanced by proper use of risk assessment.
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12/16/17 Pharmaceutical Online Newsletter In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.
Judy Curtis / SIPR's insight:
Rounding off the year 2017, Bikash Chatterjee's two-part article on the FDA's New Quality Agreement Guidance is among the top 10 most popular articles published this year in the Pharmaceutical Online newsletter.
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The findings from the final section (part iii) of the CPhI Annual Report have been announced by event organisers UBM.
Judy Curtis / SIPR's insight:
Bikash Chatterjee, president and chief science officer of Pharmatech Associates, argued that the emergence of a global marketplace with shared regulatory compliance is one of many factors driving change in pharmaceutical regulation.
Key to this is the adoption of the PIC/S by 50 regulatory entities, he revealed, as well as other important legislation changes that have been introduced, such as the 21st Century Cures Act. Chatterjee highlighted the increasing role of data in illustrating performance and compliance and stressed that improvements in big data analytics will be crucial in identifying the most suitable candidate drugs more quickly from e-clinical, lifestyle diagnostics and digital health initiatives. However, he also emphasized cyber-security as a potential risk factor, especially as the industry increases dependence on patient data for drug development. “The industry’s ability to manage the constantly evolving threats to data management and integrity will define how we develop new drug therapies in the future,” he explained.
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The contribution of functional excipients has greatly increased over the last decade. The key impacts made by functional excipients in finished products include solubility and range in some cases from drug efficacy to masking taste and extending product shelf life.
Judy Curtis / SIPR's insight:
Mark Mitchell and Bikash Chatterjee of Pharmatech Associates contributed commentary on this topic.
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Priority review should not be confused with accelerated approval or fast track designation.
Judy Curtis / SIPR's insight:
In R&D magazine's Regulatory Forum column, Bikash Chatterjee discusses how the FDA issues a limited number of special “priority review” vouchers that allow drug manufacturers to expedite the review of any one of its new drug products.
Priority review reduces the standard drug submission review time to an expedited six-month review cycle, to increase the number of rare disease therapies pursued.
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The biopharmaceutical market has risen exponentially on the back of innovation, and science will continue to move forward in areas where innovation is more biology related. So, just as the market has shifted from small molecules to large molecules, development efforts will now focus more on gene- and cell-based therapies.
Judy Curtis / SIPR's insight:
Bikash Chatterjee and Barrett Fallentine of Pharmatech Associates weigh in on the factors that have expanded the biopharma market, commenting on the way forward for new therapies and biosimilars on the horizon.
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"Among the most remarkable technical advances seen within the healthcare sector over the last decade is the fast growing sector of regenerative medicine."
Judy Curtis / SIPR's insight:
Breakthrough technologies are empowering regenerative medicine through the introduction of new, more accurate, easy-to-use tools and new drug therapies with the potential to be disease modifying -- capable of reversing the damage of certain diseases. And selecting a contract manufacturing organization (CMO) is one of the seminal decisions that affects the overall success of a development program.
This latest article in Pharmaceutical Outsourcing by Bikash Chatterjee and Matthew Finch discusses a recent case study using human cells, tissues, and cellular and tissue-based products that are regulated by the Center for Devices and Radiological Health (CDRH) as medical devices, and others regulated by the Center for Biologics Evaluation and Research (CBER).
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"While the designation for what constitutes a combination product is clearly defined by the FDA, industry continues to push the boundaries for disease treatment with new innovative breakthrough drug therapies." - Lynn Hansen, director of regulatory affairs, Pharmatech Associates - November 2018
Judy Curtis / SIPR's insight:
Lynn Hansen's article in Pharmaceutical Online lays out the challenge for regulatory professionals in aligning breakthrough therapies with application-filing strategies for investigational new drug applications, biologics, and medical devices.
healthcare's curator insight,
January 27, 2024 9:40 AM
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The impending FMD is an affirmation of the commitment by the EU to address the escalating problem of counterfeit drugs.
Judy Curtis / SIPR's insight:
The European Union's new Falsified Medicines Directive (FMD) Directive is intended to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines. It also introduces new rules to more rigorously regulate the supply chain.
Pharmatech's Bikash Chatterjee highlights three major components of the FMD that ensure that the primary elements of the supply chain can verify the authenticity of the product throughout the supply chain all the way to dispensing to the patient: UTI and Tamper Evident Device, Verification Model, and Distributor Level Verification.
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Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.
Judy Curtis / SIPR's insight:
Reporter Flora Southey spoke with Lynn Hansen and Bikash Chatterjee in the lead-up to Pharmatech Associates' tutorial at DIA 2018 Global Annual Meeting in Boston, to discuss regulatory approval processes, manufacturing challenges, and the resurgence of the combination drug product in the 21st century.
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From
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"While this new guidance brings greater clarity and simplicity in device submissions, the success of this new philosophy will be greatly dependent upon sponsors’ ability to effectively lead and collaborate with the FDA to confirm alternative solutions that can address the agency’s regulatory questions," said Bikash Chatterjee of Pharmatech Associates.
Judy Curtis / SIPR's insight:
New draft guidance defines the seven guiding principles to be followed by both FDA and the medical device industry when taking a least burdensome approach to a regulatory issue, discussed in the latest Regulatory Forum column by Bikash Chatterjee, in Controlled Environments magazine.
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A small variation in the impurity profile, viscosity, particle size, dissolution characteristics, molecular weight etc. of an excipient could have drastic impact on the end performance of a pharmaceutical formulation or process.
Judy Curtis / SIPR's insight:
How have advances in raw materials functionality, supply and quality affected the pharm/biopharma industry? Sandra Wassink and Bikash Chatterjee of Pharmatech Associates weigh in on the topic, in an industry roundtable published in American Pharmaceutical Review.
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Judy Curtis / SIPR's insight:
In an article published in Pharmaceutical Outsourcing, Bikash Chatterjee of Pharmatech Associates uses a recent case study to illustrate specific areas at risk that can impact a drug sponsor’s regulatory risk profile and on-going commercial operations as a drug sponsor’s development program transitions to commercial launch.
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Judy Curtis / SIPR's insight:
What to expect from FDA’s updated guidance on use of electronic records & electronic signatures in clinical investigations under Part 11. Regulatory Forum column by Bikash Chatterjee of Pharmatech Associates in Controlled Environments magazine, Jan-Feb 2018.
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From a starting point of industry risk-aversion, the regulators have empowered manufacturers to keep evolving to combine industrial processes with new advanced analytics capability. The approach known as Pharma 4.0 represents a strategy for the future, derived from an intelligent and fully connected network across the entire value chain.
Judy Curtis / SIPR's insight:
A new article by Bikash Chatterjee of Pharmatech Associates highlights how regulatory guidance and directives over the past decade have encouraged a new approach to pharma manufacturing, based on "compliance through science."
"Pharma 4.0 is a term for the industry-specific global vision and initiative based on Industry 4.0. The idea behind Industry 4.0 is to develop the infrastructure and create standards that allow us to connect data, physical equipment, and human resources in the context of an overarching cyber-physical system. Of course, Pharma 4.0 promises to improve quality, productivity, and lead times through interconnectivity and automation, but the most dramatic potential is the ability to gather data beyond the four walls of the factory through the use of Internet of Things (IoT) and Big Data analytics."
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Lynn Hansen, RAC, of Pharmatech Associates writes in her latest Regulatory Forum column in Controlled Environments magazine about what is new in the new regulatory affairs certifications for 2019, and why it is important for regulatory professionals.
In summary, the new format accommodates the practical deployment of regulatory responsibilities in the industry, which is often regionally oriented with an emphasis on drugs and / or medical devices. While the RAC certification process and exams are voluntary, organizations that employ RAC certification professionals can be confident that these individuals have a firm grasp on the core components of each regulatory specialization.
RAC certified professionals can be confident that their foundational expertise is both current and correct; this often lays the groundwork to take on a more challenging role within an organization.