• 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
    Fusion Pharmaceuticals Acquires IPN-1087

    Strata Oncology Unveils Strata PATH Trial

    Alimentiv Acquires McDougall Scientific

    Q BioMed Inks Strontium89 Supply Pact

    PCI Pharma Services Appoints SVP, CFO
    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

    WuXi AppTec Completes OXGENE Acquisition

    Celonic Group Announces Plans for New Facility in Switzerland

    BMS Expands Cell Therapy Manufacturing Capabilities

    Novo Nordisk Invests $80M in Tablet Production

    Arcline Investment Acquires ChargePoint Technology
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Reshaping the Pharmaceutical Supply Chain

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing
    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

    Strata Oncology Unveils Strata PATH Trial

    Alimentiv Acquires McDougall Scientific

    WuXi AppTec Completes OXGENE Acquisition

    Live Webinar - Formulation Strategies for Poorly Soluble Molecules

    Celonic Group Announces Plans for New Facility in Switzerland
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Guide to Maintaining Validation of Older Facilities: Why, When and How

    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
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Aphena Pharma Solutions

    Federal Equipment Company

    Reed-Lane

    Cytovance Biologics

    Alcami
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Aphena Pharma Solutions

    PCI Pharma Services

    Reed-Lane

    Adare Pharma Solutions

    Syngene
    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
    Features

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation

    Lonza’s Director of Commercial Development, Sean Diver, was recently named President of DCAT.

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    Tim Wright, Editor, Contract Pharma11.17.20
    Contract Pharma asked Sean Diver, the newly appointed President of the Drug, Chemical & Associated Technologies Association (DCAT), to discuss the important role the industry is playing during the COVID-19 pandemic, trends in drug manufacturing, and technology’s role in formulation and drug delivery.

    Mr. Diver has been in the pharmaceutical industry for over 30 years, having served technical and commercial leadership roles for both innovator companies and contract development and manufacturing organizations (CDMOs). Currently, he is the Director of Commercial Development in the Lonza Pharma Biotech & Nutrition Segment at Lonza focused on late-stage, small-molecule drug substances. Mr. Diver has been an active member of DCAT for many years by participating on various committees, including serving as chair of the DCAT Technology Committee, as a member of the Advisory Council, and as a member of the Board of Directors. Mr. Diver holds a B.S. in Chemical Engineering from Lehigh University.

    Contract Pharma (CP): In these unprecedented times, the pharmaceutical industry is playing a particularly important role. How has the industry—both pharmaceutical companies and their suppliers—met the challenges thus far and what would you identify as key contributions as it relates to COVID-19 and overall?

    Sean Diver (SD): COVID-19 has certainly presented significant challenges to the pharmaceutical industry. Patients need medicines for treatment of serious, life-threatening symptoms, and the general population needs prevention options. The industry has demonstrated the ability to provide solutions for both, not just in the creation of the medicine, but also working with suppliers to manufacture these products to support patients. It is not sufficient to just understand the science well enough to innovate new medicines; these medicines also need to be produced at a scale large enough to support the patient population. The key contribution to the fight against COVID-19 from the pharmaceutical industry is that together, innovators and their suppliers, rapidly bring safe and effective medicine to those that need it.

    CP: The industry’s rapid response and acceleration of development timelines to develop prevention, treatments, or disease mitigation for COVID-19 has been unparalleled. What lessons learned and/or experience gained will be useful for the industry not only as it relates to COVID-19, but also for future development and commercialization approaches overall?

    SD: The world has observed that when needed, new medicines can be developed quickly and effectively. The experience of innovators, manufacturers and regulators working so closely together is likely going to shape the future expectations for speed to market of safe and effective medicines. Certainly, the focused effort by innovators and suppliers with respect to COVID-19 is extreme, but with aligned goals, we have seen that timelines to get safe and effective medicines to the market can, and likely will be, accelerated substantially.

    CP: Aside from the issues presented by the global novel coronavirus, what do you see as the major issues and trends impacting the pharmaceutical industry today?

    SD: I see a few issues and trends for the industry today that come to mind. For one, the cost of development and affordability of medicines are still major obstacles in getting medicines to patients globally.

    At the same time, technical innovation has been outstanding and will continue to be critical in the future for treatment (and cures!) of rare diseases.

    In addition, capacity to manufacture everything coming out of the clinic across all of the technology platforms will continue to be a challenge.

    CP: One of the ongoing important issues for the industry is looking at how the product mix—both from the industry’s pipeline and recently commercialized products—is evolving. From an industry view, what are some key trends in small molecules, biologics, and newer modalities, such as cell therapies and gene therapies? What is the associated impact on manufacturing and supply decisions?

    SD: If I look at what I see in the industry pipelines, and absorb what I am reading in DCAT’s Value Chain Insights, among other sources, I see that these technology platforms are yielding very exciting drug candidates. More and more highly potent small molecules are emerging from the market, commercial biologic products are commonplace today, and not just for oncology and immunology, but across many therapeutic areas, and cell and gene therapies are bringing cures to our doorstep. The impact of all of this is that these products are driving technical innovation and need to be produced someplace. The worldwide capacity for the manufacturing of these products will need to expand to meet technical demands, so that these products can be delivered. In addition, facility design will need to continue to improve to deliver high-quality, safe and effective drugs in a cost-effective manner.

    CP: Looking ahead over the next five years, what challenges and opportunities do you see in the pharmaceutical manufacturing sector overall? In small-molecule APIs? In biologics? In drug products? What factors will respectively shape those segments?
    SD: For small molecules, I see a very robust pipeline of products, but they are very complex, and often quite potent. The ability to produce these products safely will require a wide variety of specialty equipment, at a variety of scales, to meet clinical and commercial demand.

    For drug products, I believe that more complex formulations will be required since APIs are increasing in complexity. Bioavailability issues will continue to push innovation on the drug-product side for products that are inhaled or that have novel delivery systems.

    In biologics, there are so many new products gaining approval, I believe that getting everything produced in the next five years will be the biggest challenge to overcome.

    Overall, I see that manufacturing over the next five years will be a challenge and that the right capacity for the particular technology will need to expand.   

    CP: In light of the pandemic, how is DCAT aligning with the business development needs of its member companies?

    SD: For starters, we proactively cancelled our DCAT Week 2020 event to ensure that the health and safety of our members were considered first and foremost. We have also been monitoring the voices of the membership, and they have clearly expressed that travel in 2021 will be limited until vaccines are available. Therefore, we have moved DCAT Week 2021 to July 12-15, 2021, so that we have a better opportunity to meet in person and do what we offer best—business development networking.

    DCAT also hosts year-round education and networking opportunities, and we have not stopped because of the pandemic. We have engaged virtual tools to bring webinars to the community. For example, in October, we offered two webinars. One webinar evaluated the market impact on the COVID-19 pandemic on companies’ pipelines, product launches, and performance and how industry fundamentals and growth prospects have been affected while the second webinar featured theater-based presentation techniques for effective, impactful presentations.

    Our benchmarking studies have continued virtually, and at present, we are working with our member companies on a study pertaining to maintaining operations during the COVID-19 crisis and business continuity planning processes. 

    Our committees are engaged, and meeting through virtual systems, and we will be holding our DCAT Scholarship Golf Outing on June 21, 2021 at TPC Jasna Polana Golf Club in Princeton, NJ.

    We are looking forward to seeing everyone in person in 2021 in NYC, but in the meantime, we are so pleased to remain engaged with our entire membership throughout the year.

    CP: Formulation and drug-delivery technologies play an important role in new product development, both in formulations with new active pharmaceutical ingredients (APIs) and in new routes of administration for existing APIs. From an industry view, what are some key trends in this sector?
    SD: I see a big trend toward inhaled products, which certainly shapes formulation and drug-delivery technology. In addition, solving difficult bioavailability issues with new and effective delivery technologies is certainly a major trend in the market today.

    CP: What do you see as the major technology trends impacting the pharmaceutical manufacturing sector overall? In active pharmaceutical ingredients? In dosage forms?

    SD: The major technology trends I see in the manufacturing sector are the ability to manufacture highly potent products and the ability to do this at a scale that supports the commercial needs of the products. 

    Related Features

    • Solid Dosage/Creams/Ointments
      High Drug Loading Amorphous Solid Dispersions

      High Drug Loading Amorphous Solid Dispersions

      A Novel Tablet Architecture for Amorphous Solid Dispersions to Achieve High Drug Loadings
      Deanna Mudie and Aaron Stewart, Lonza 01.27.21

    • Parenterals
      Parenteral Drug Delivery Trends

      Parenteral Drug Delivery Trends

      A Q&A with Lubrizol Life Science Health’s CDMO Division President, Rob Lee.
      Kristin Brooks, Managing Editor, Contract Pharma 01.27.21

    • Selecting the Right Outsourcing Model for Emerging Biotech

      Selecting the Right Outsourcing Model for Emerging Biotech

      Flexible outsourcing models help drive quality, control costs and enable better efficiencies and faster delivery.
      Timothy King and Elisha Talley-Roithner, PPD 01.27.21


    • Drug Delivery
      Inhaled Drug Delivery Technology

      Inhaled Drug Delivery Technology

      The success of any new inhaled medicine relies in a large part on the correct combination of formulation and device technology being chosen for its delivery.
      Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 01.27.21

    • Biologics, Proteins, Vaccines
      The Future of Biologics: Accelerating Production, Reducing Costs

      The Future of Biologics: Accelerating Production, Reducing Costs

      Yeast-based gene expression offers pharma the yield and efficiencies it needs to make pandemic-stopping vaccines faster and more economical.
      Mark Emalfarb, Dyadic 01.27.21

    • Analytical Services | Information Technology | Laboratory Testing
      Business Intelligence For (and From) the Lab

      Business Intelligence For (and From) the Lab

      How a digital ecosystem can harness the most data-rich environment in the CDMO.
      Bob Voelkner, VP Sales and Marketing, LabVantage 01.27.21


    • Communicating Your Contracting Priorities to Your Drug Company Customers

      Communicating Your Contracting Priorities to Your Drug Company Customers

      A discussion with Perrigo’s senior legal counsel, Susan Fyan, about issues that arise in very fact-specific contract negotiations between CDMOs and sponsors.
      Stephen Sayre, Dykema 01.27.21

    • COVID-19 Impact Report

      COVID-19 Impact Report

      Leaders across the pharmaceutical contract services industry reflect on the impact of COVID-19 in 2020, and what to expect in 2021.
      Tim Wright, Editor, Contract Pharma 01.27.21

    • Biologics, Proteins, Vaccines | Regulatory Affairs
      The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

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

      A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to “normalcy.”
      Chad Landmon, Michelle Divelbiss and Alex Alfano, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21


    • Excipients
      Bye-Bye China?

      Bye-Bye China?

      Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
      Michele Jermini and Enrico Polastro 11.17.20

    • Clinical Trials | Information Technology | R&D
      Decentralized Trials Fuel AI Revolution in Clinical Research

      Decentralized Trials Fuel AI Revolution in Clinical Research

      The life sciences industry is giving clinical a full makeover, dramatically improving how new therapeutics are developed.
      Nick Moss, Vice President of Analytics and Machine Learning, Medable 11.17.20

    • Drug Delivery | Injectables
      Self-Medication: Flexibility for Patients and Drug Manufacturers

      Self-Medication: Flexibility for Patients and Drug Manufacturers

      Bringing together self-medication with auto-injectors and sustainable secondary packaging.
      Matthias Heinrichs, Head of Product Management and Project Engineering, Syntegon Technology 11.17.20


    • The Single-Use Mixing Landscape: Evaluating Your Options

      The Single-Use Mixing Landscape: Evaluating Your Options

      Adoption of single-use technologies has increased markedly in recent years and will continue to grow.
      Mark A. Sitcoske, Founder & CEO, High Purity New England 11.17.20

    • Biologics, Proteins, Vaccines | Biosimilars | Drug Development
      Biopharma Contract Manufacturing: Robust Growth Ahead

      Biopharma Contract Manufacturing: Robust Growth Ahead

      The biopharmaceutical contract manufacturing market is projected to reach $6.3 billion in 2020, and it will continue to grow over the next five years.
      William Downey, HighTech Business Decisions 11.17.20

    • Injectables
      Catering for the Complex

      Catering for the Complex

      The rapidly changing landscape of pharmaceutical packaging.
      Marcelo Cruz, Director Business Development and Marketing, Tjoapack 11.17.20

    Trending
    • BMS Expands Cell Therapy Manufacturing Capabilities
    • AbbVie Opts To Acquire Mitokinin
    • Bormioli Opens New Glass Research Center
    • WuXi AppTec Completes OXGENE Acquisition
    • Arcline Investment Acquires ChargePoint Technology
    Breaking News
    • Fusion Pharmaceuticals Acquires IPN-1087
    • Strata Oncology Unveils Strata PATH Trial
    • Alimentiv Acquires McDougall Scientific
    • Q BioMed Inks Strontium89 Supply Pact
    • PCI Pharma Services Appoints SVP, CFO
    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

    Low Levels of Vitamin D and Calcium Linked to COVID-19 Severity
    Probiotic Evidenced to Assist Digestive Recovery from a Complex Surgery
    AHPA Submits Comments to FDA on Proposed Traceability Rule
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    AOC Announces EMEA Price Increase
    Mule-Hide Products Co. Introduces Seal-Fast Liqui-Flash
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    NAMSA Acquires American Preclinical Services
    Quidel's QuickVue At-Home COVID-19 Test Earns EUA
    Memic Receives FDA Marketing Authorization for Hominis
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Fusion Pharmaceuticals Acquires IPN-1087
    Strata Oncology Unveils Strata PATH Trial
    Alimentiv Acquires McDougall Scientific
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    IT Cosmetics Supports Women’s Confidence
    Inter Parfums Reports a Strong Fourth Quarter
    Universal Engraving Announces New President
    Happi

    Latest Breaking News From Happi

    Croda International Acquires Alban Muller
    Givaudan Active Beauty Launches Omegablue
    Sozio Acquires Scentessence
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Abbott Label installs Domino K600i dual bar digital UV inkjet printer
    Crossmark turns to Eagle Systems for cold foil
    Maxcess launches Tidland PressureMax Airshaft Pressure Monitoring System
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Domtar Completes Sale of Personal Care Business
    Mitsui to Sell Chinese Nonwovens Business
    Dr. J's Disinfectant Wipes Approved for Distribution in CA
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA Approves Accufix Surgical's Accu-Joint Hemi Implant
    FDA OKs Q-Collar Device to Protect Athletes’ Brains During Head Impacts
    SeaSpine Releases Reef TO (TLIF Oblique) Interbody System
    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