• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Spark Therapeutics Appoints CTO

    Cryoport Launches ESG Program

    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail

    Thermo Fisher Scientific Completes Mesa Biotech Acquisition

    Ashfield Engage, Popit Form Digital Monitoring Collaboration
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Solid Dose Market Trends

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    C2 Pharma Completes Multiple Regulatory Filings

    Bormioli Opens New Glass Research Center
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Ashfield Engage, Popit Form Digital Monitoring Collaboration

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    CrownBio & JSR Life Sciences Partner with Cambridge Quantum Computing
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Reed-Lane

    Emergent BioSolutions

    test company saurabh

    Adare Pharma Solutions

    Almac Group
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    PCI Pharma Services

    Aphena Pharma Solutions

    Alcami

    Emergent BioSolutions

    Baxter BioPharma Solutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    CPhI Annual Report 2019: Part 1

    FDA should withdraw ANDAs, and new technologies could bring massive improvements in efficiency if implemented correctly.

    Related CONTENT
    • Legacy Pharma Solutions
    • PCI Pharma Services
    • Catalent Pharma Solutions
    • Mogene
    • Regis Custom Pharma
    10.29.19
    CPhI Worldwide—the world’s largest pharma event taking place in Frankfurt, Germany from November 5-7—has released the first part of its 2019 Annual Report. Experts Bikash Chatterjee, president and chief science officer at Pharmtech Associates and Girish Malhotra, president of EPCOT International discuss how manufacturing could be revolutionized by new technologies, but warn, that regulators must change to prevent hindering future innovation.
     
    Mr. Chatterjee forecasts a positive outlook for the medium and long-term future of the industry, foreseeing that Pharma 4.0, the Internet of Things (IoT), and Artificial Intelligence (AI) could ultimately deliver huge shifts in how we discover and develop medicines—even if the short term applications may not bring the results people are striving for.
     
    “There is no doubt we will see broader adoption of IoT on the shop floor and in the distribution portion of the supply chain in the short term,” said Mr. Chatterjee. “The biggest impact operationally, I believe, will be seen in the clinical trial management stage of the drug development lifecycle, over the next five years. However, over the next decade, AI could have a transformational impact on molecular selection and design.”
     
    Despite the call for these advances, Mr. Chatterjee emphasizes that such improvements within the industry will not come about unless they are used in the right way, and address the right questions. He forewarns, “the focus on technology in the absence of understanding the basic question to be answered can derail a cross-functional initiative in the blink of an eye.” He also calls for both AI and pharmaceutical companies to gain a better understanding of each other’s fields in order to expedite the process of disruptive technology adoption.
     
    “The challenge with anything new in our industry is that the organizations selling into life sciences don’t know drug development, and the drug sponsors interested in AI don’t really understand AI, so they cannot direct the solution provider very effectively,” said Mr. Chatterjee. “As this knowledge gap dissipates through experience on both sides, more effective pilot projects and solutions will be developed and brought to term.”
     
    Moving into the longer-term future, Mr. Chatterjee envisages AI being used to deliver significant changes in therapies by 2040, when “it will be standard practice in the design of drug therapies, their processes and in the treatment of disease.” He predicts that ultimately this will mean personalizing dosing and drug regimens designed around each patient’s genetic markers and circumstances.
     
    Mr. Malhotra explores the cost of manufacturing globally and the still high levels of regulatory infringements, postulating that regulators should use powers to remove ANDAs for repeat offenders. “With U.S. FDA being short staffed, even the use of ‘risk-based inspections’ may be insufficient to catch less than quality/cGMP producers,” he said. “Repeated non-compliance to FDA’s requirements and guidelines should be a cause to forbid shipments to the United States.”
     
    Additionally, he suggests a 90-day approval process, which will necessitate that companies filing applications have complete command of every facet of manufacturing, product quality, and labeling.
     
    Taking this a step further, he also advocates enforcing mandatory deposits (circa $200,000) for first deviation from FDA’s expectations, with forfeiture of the deposit and, ultimately, being barred from importing into the U.S. should further problems occur.
     
    Fundamental to Mr. Malhotra’s regulatory proposals is the proposition that governing bodies should stick to enforcement—not preach to the market on how best to implement manufacturing processes.
     
    “Pharma has not explored increased profitability through continued process improvements and my conjecture is that the regulators are the obstacle to this,” said Mr. Malhotra. “The FDA should refrain from suggesting to companies what types of manufacturing processes (batch or continuous) they need or practice, instead they should concentrate on helping ensure manufacturing processes are repeatable using continuous improvement principles.”
     
    The CPhI Annual Report highlights the key issues and trends affecting the industry, according to Orhan Caglayan, brand director, Europe, CPhI. “Our experts explore the benefits of streamlined regulations and how technology could deliver tremendous improvements across the supply chain,” he said. “Significantly, this year is also CPhI Worldwide’s 30th anniversary, which provides us with an opportunity to reflect on both how far the industry has come during this time, as well as where it is heading in the years to follow. With over 45,000 executives attending, our event is designed to help meet new partners and drive forward innovation. By bringing the supply chain together—from APIs and FDF, to machinery, packaging, outsourcing and, biopharma—we enhance the industry’s ability to find new cost-effective solutions and learn about new developments that will sustain growth in the year ahead.”
     
    For more information on the CPhI Annual Report, please visit here. (https://www.cphi.com/europe/visit/news-and-updates/annual-industry-report-2019-final)
    Related Searches
    • cGMP
    • Pharma
    • artificial intelligence
    • supply chain
    Suggested For You
    Legacy Pharma Solutions Legacy Pharma Solutions
    PCI Pharma Services PCI Pharma Services
    Catalent Pharma Solutions Catalent Pharma Solutions
    Mogene Mogene
    Regis Custom Pharma Regis Custom Pharma
    Contract Pharma’s 20th Anniversary Series: CDMO Insight Contract Pharma’s 20th Anniversary Series: CDMO Insight
    Finalists Revealed for CPhI Worldwide’s 2019 Awards Finalists Revealed for CPhI Worldwide’s 2019 Awards
    CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline
    CPhI Worldwide Celebrates 30 Years CPhI Worldwide Celebrates 30 Years
    Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future
    Bavarian Nordic CDMO Services Bavarian Nordic CDMO Services
    Emergent BioSolutions Emergent BioSolutions
    Evonik Evonik
    R-Pharm Germany GmbH R-Pharm Germany GmbH
    Valsynthese Valsynthese

    Related Online Exclusives

    • Solid Dosage/Creams/Ointments
      Solid Dose Market Trends

      Solid Dose Market Trends

      A Q&A with Mark DaFonseca, chief business officer at CoreRx.
      Tim Wright, Editor, Contract Pharma 02.26.21

    • Drug Delivery
      Aerosol Delivery Devices Market

      Aerosol Delivery Devices Market

      Advantages over conventional drug delivery devices, rise in prevalence of COPD and asthma drive the growth of the global aerosol delivery devices market.
      Allied Market Research 02.16.21

    • Biologics, Proteins, Vaccines | Clinical Trials
      Inside a Vaccine Trial

      Inside a Vaccine Trial

      Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
      Kristin Brooks, Managing Editor 02.05.21


    • Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
      The Future of Vaccines and Biologics

      The Future of Vaccines and Biologics

      Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.
      Kristin Brooks, Managing Editor, Contract Pharma 02.04.21

    • Clinical Trials | Information Technology
      The State of Clinical Trial Technology

      The State of Clinical Trial Technology

      Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.
      Kristin Brooks, Contract Pharma 01.26.21

    • Analytical Services | Laboratory Testing
      Improving Product Profitability

      Improving Product Profitability

      Using PAT/QbD/CM as tools to increase profitability of products.
      Emil Ciurczak, Contributing Editor 01.21.21


    • Analytical Services | Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Fill/Finish
      A New Era of Vaccine and Biologic Drug Development

      A New Era of Vaccine and Biologic Drug Development

      As a result of COVID-19, unprecedented investments in vaccines, diagnostics, and treatments have had a tremendous impact on the Biotechnology industry.
      Kristin Brooks, Managing Editor 01.12.21

    • Clinical Trials | Drug Development | Information Technology
      Advancing Digital Endpoints in Clinical Trials

      Advancing Digital Endpoints in Clinical Trials

      An end-to-end approach to managing wearable devices through clinical development.
      Kristin Brooks, Contract Pharma 12.14.20

    • Drug Delivery | Drug Development
      Inhaled Drug Delivery Technology Trends

      Inhaled Drug Delivery Technology Trends

      The success of new inhaled medicines relies on the correct combination of formulation and device technology.
      Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20


    • Bioanalytical Services | cGMP Manufacture | Drug Development | Scale-up/Technology Transfer
      CDMOs: Keeping up with Science & Technology

      CDMOs: Keeping up with Science & Technology

      Enhancing the development of increasingly advanced and complex drug candidates is needed to drive growth in the industry.
      Kristin Brooks, Contract Pharma 11.12.20

    • Excipients
      Pharmaceutical Excipients Market Poised for Growth

      Pharmaceutical Excipients Market Poised for Growth

      The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.
      Contract Pharma Staff 11.03.20

    • cGMP Manufacture | Fill/Finish | Scale-up/Technology Transfer
      Ramping Up COVID-19 Vaccine Fill and Finish Capacity

      Ramping Up COVID-19 Vaccine Fill and Finish Capacity

      As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
      Kristin Brooks, Contract Pharma 11.03.20


    • Biologics, Proteins, Vaccines
      India Emerges as Hot Spot for Manufacturing COVID-19 Vaccines

      India Emerges as Hot Spot for Manufacturing COVID-19 Vaccines

      CMOs expand and ‘repurpose’ capacities.
      S Harachand, Contributing Editor 10.20.20

    • Clinical Trials | Drug Development | Preclinical Outsourcing
      Accelerating R&D Trends

      Accelerating R&D Trends

      The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.
      Kristin Brooks, Contract Pharma 10.20.20

    • Drug Delivery
      Topical Drugs Poised for Growth

      Topical Drugs Poised for Growth

      The topical drug delivery market is projected to reach $129.8 billion by 2025 from $95.2 billion in 2020, at a CAGR of 6.4%.
      Contract Pharma Staff 10.12.20

    Trending
    • Pfizer Selects Seven Bridges To Support RNA Sequencing Data
    • Pfizer Partners With Medicines Manufacturing Innovation Center
    • Catalent Acquires Delphi Genetics
    • Charles River Acquires CDMO Cognate BioServices
    • Spark Therapeutics Appoints CTO
    Breaking News
    • Spark Therapeutics Appoints CTO
    • Cryoport Launches ESG Program
    • U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    • Thermo Fisher Scientific Completes Mesa Biotech Acquisition
    • Ashfield Engage, Popit Form Digital Monitoring Collaboration
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    ACI Urges Senate to Approve Regan as EPA Administrator
    Estée Lauder Signs Actress Ana de Armas
    GUM Recalls Oral Spray
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login