• 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
    Hygienic Packaging Technology

    Trends in Solid Oral Dosage Delivery

    5 Reasons Paper Has No Place in Contract Manufacturing

    Injectable Drug Delivery Trends

    Pharmaceutical Manufacturing Equipment Trends
    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
    Innoforce and dMed Enter Development Collaboration

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    Four Female Leaders Appointed to Cell & Gene CDMO

    Fusion Pharmaceuticals Acquires IPN-1087

    Strata Oncology Unveils Strata PATH Trial
    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

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    WuXi AppTec Completes OXGENE Acquisition

    Trends in Solid Oral Dosage Delivery

    Injectable Drug Delivery Trends

    Oral Solids: Market & Technology Trends
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Hygienic Packaging Technology

    Reshaping the Pharmaceutical Supply Chain

    Serialization: Level 5 Solution

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center
    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

    Innoforce and dMed Enter Development Collaboration

    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site

    Four Female Leaders Appointed to Cell & Gene CDMO

    Strata Oncology Unveils Strata PATH Trial

    Alimentiv Acquires McDougall Scientific
    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
    PCI Pharma Services

    Federal Equipment Company

    Emergent BioSolutions

    Reed-Lane

    Baxter BioPharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Reed-Lane

    PCI Pharma Services

    Aphena Pharma Solutions

    Alcami

    Federal Equipment Company
    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

    Contract Pharma’s 20th Anniversary Retrospective: Drug Development

    A look back at the role of CROs in drug development and what we can expect for the future

    Contract Pharma’s 20th Anniversary Retrospective: Drug Development
    Richard Staub, President of Research & Development Solutions, IQVIA
    Related CONTENT
    • Legacy Pharma Solutions
    • PCI Pharma Services
    • Catalent Pharma Solutions
    • Trial Runners
    • Mogene
    Kristin Brooks, Contract Pharma10.16.19
    Among the many industry changes over the years, regulatory efforts and data analytics have had a major impact on drug development and clinical research this past decade. Regulatory Breakthrough Therapy and Orphan Drug designations, and new and increasingly innovative ways to collect and evaluate data have both advanced and alleviated some of the road blocks in getting drugs to market. The challenges rare diseases present, and the growing regulatory evidence needed for drug approval, have necessitated change in clinical research. For example, Real World Evidence (RWE) and virtual trials have become important tools to evaluate safety and efficacy, particularly in an age where more personalized therapeutics for smaller patient populations have prevailed. Additionally, small and virtual biopharma have become more numerous, and with their unique needs, have a greater reliance on CROs. These and other industry developments have pharma and biopharma seeking out more advanced and comprehensive services across the drug development continuum.

    Richard Staub, President of Research & Development Solutions global business unit at IQVIA, discusses how CRO services have evolved over the years and what we can expect for the future of drug development.  –KB
     
    Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have greatly impacted contract service providers? 

    Richard Staub: The initial launch of the CRO industry was all about building therapeutic expertise, expanding global footprint, and developing operational capabilities to become viable R&D partners with our clients. That paradigm shifted with the big data era and the ability to apply data and analytics to program development and better inform our decisions and the strategies we develop for sponsors. These data and analytics capabilities have enabled us to deliver faster and smarter clinical trial site identification, more informed patient recruitment, and better study execution and in turn help save time and money for trial sponsors.

    While we continue to expand and refine our data and advanced analytics capabilities, the industry still has room for progress in incorporating these advances into drug development.

    CP: What are some of the changes you anticipate for the future of the industry and CRO services?

    RS: As we look to the future, the next area of opportunity is using our technologies to scale automation and drive further efficiencies and quality into the clinical development operational model, thus enhancing the more traditional services, such as clinical monitoring and all other aspects of operational delivery. We are moving rapidly into a digitally enabled era that is focused on interoperability within the ecosystem that combines therapeutic expertise with end-to-end technology to power solutions for clients.

    The intersection of technology, data scientists and healthcare is going to have a profound effect on the industry. We are already witnessing the impact that big data and mobile health are having in transforming healthcare. Along with personalized and precision medicines, we see the use of apps and wearable technologies that help patients monitor symptoms and manage their diseases. Virtual trials are making it possible to bring trials to patients, reducing geographical constraints and reliance on trial sites to find participants. Artificial intelligence is driving significant clinical trial efficiencies and better decision-making. Embedded intelligence is also helping us protect patient safety and ensure the quality of the clinical trial data being collected.

    Emerging biopharma is also going to continue to accelerate research. EBPs now account for over 70 percent of the development pipeline, up from over 60 percent 10 years ago. The growth of this segment requires CROs to adapt their business models to meet the specific needs of these customers.

    It is also likely that we will see more innovation from emerging markets, such as China. While the industry is still dominated by the U.S. and Europe, other emerging markets could be much more competitive in the future.

    CP: What are some of the major regulatory changes that have impacted the industry in the past 20 years?

    RS: The 21st Century Cures Act was a significant regulatory change that provided the framework to accelerate the development of new therapies, reduce the barriers for the next generation of therapies, and expand the use of real-world evidence to supplement conventional clinical trial data. These changes paved the way for new treatments to enter the market. The legislation also provides funding for projects such as the Precision Medicine Initiative which seeks to identify genetic and lifestyle factors that could be used to better predict who will develop certain diseases.

    Another significant regulation is the Food and Drug Administration Safety and Innovation Act, which gave the FDA a new and powerful expedited drug development tool, known as the "breakthrough therapy" designation. This designation helps the FDA assist drug developers to expedite the development and review of new drugs with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. 

    The FDA has also provided guidance on adaptive designs and master protocols to make drug development more efficient and less costly. By modernizing the approach to clinical trials, the hope is these adaptive designs can provide answers faster than traditional trials and improve patient access to new medicines.



     
    Richard Staub is president of the Research & Development Solutions global business unit at IQVIA, where he leads the world’s largest contract research organization (CRO). Richard also serves as chair of the Research & Development Solutions Executive Committee. Previously, Richard was president of Novella Clinical, a Quintiles company, a specialty clinical research organization acquired by Quintiles in 2013, and the leader of QuintilesIMS’s Global Functional Resourcing business. Joining Novella in 2004, he served as both president and CEO from 2008-13. Under his leadership, Novella became a distinctively agile, results-oriented CRO in the highly complex and fast-growing areas of specialty pharma and medical technology. Prior to joining Novella, he was senior vice president of global business development for one of the world’s largest CROs.

     
    Related Searches
    • it
    • ceo
    • contract pharma
    • Contract research organization
    Suggested For You
    Legacy Pharma Solutions Legacy Pharma Solutions
    PCI Pharma Services PCI Pharma Services
    Catalent Pharma Solutions Catalent Pharma Solutions
    Trial Runners Trial Runners
    Mogene Mogene
    SGS Life Sciences SGS Life Sciences
    Regis Custom Pharma Regis Custom Pharma
    Adare Pharma Solutions Adare Pharma Solutions
    CONTRACT PHARMA Adds Media Sales Directors CONTRACT PHARMA Adds Media Sales Directors
    Like It’s 1999 Like It’s 1999
    20 Year Retrospective 20 Year Retrospective
    Contract Pharma’s 20th Anniversary Retrospective Contract Pharma’s 20th Anniversary Retrospective
    VIDEO: Pharma Packaging Solutions VIDEO: Pharma Packaging Solutions' Scott Garverick
    VIDEO: CPL VIDEO: CPL's David Tyler
    VIDEO: Alcami VIDEO: Alcami's Brittany Jackway

    Related Online Exclusives

    • 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 | 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

    • 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

    • Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
      Expediting a COVID-19 Vaccine: FDA Approval Process

      Expediting a COVID-19 Vaccine: FDA Approval Process

      The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.
      Kristin Brooks, Contract Pharma 08.25.20


    • Drug Development | Information Technology
      Trade Secret Litigation: Vulnerabilities Within Pharma Amid Hacking Efforts

      Trade Secret Litigation: Vulnerabilities Within Pharma Amid Hacking Efforts

      Theft of IP belonging to companies developing biologics and other drugs, including COVID-19 treatments and vaccines, poses a threat to innovation.
      Kristin Brooks, Contract Pharma 08.19.20

    • Drug Development | Industry News
      Top Companies Report: Biogen

      Top Companies Report: Biogen

      Expands pipeline of disease-modifying therapies for Alzheimer’s and Parkinson’s, adds gene therapies focused on AAV treatments, bolsters biosimilars portfolio.
      Kristin Brooks, Contract Pharma 07.10.20

    • Analytical Services | Biologics, Proteins, Vaccines | Drug Development | Drug Discovery | Laboratory Testing
      A Shifting Drug Development Landscape Amid COVID-19 Crisis

      A Shifting Drug Development Landscape Amid COVID-19 Crisis

      Responding to demand for challenging assays and custom solutions required for complex molecules, biologics, vaccines and other innovative therapies.
      Kristin Brooks, Contract Pharma 06.22.20


    • Drug Development | Information Technology
      Advancing AI Initiatives in R&D

      Advancing AI Initiatives in R&D

      Richard Lee of ACD/Labs discusses the possibilities of using AI in R&D, and what this outlook means for IT leaders at pharmaceutical organizations.
      Kristin Brooks, Contract Pharma 06.11.20

    • Clinical Trials
      Impact of COVID-19 on Winning New Business

      Impact of COVID-19 on Winning New Business

      WuXi Clinical’s Vice President of Biometrics, David Ng, talks about the impact of COVID-19 on clinical trials and business relations
      Tim Wright, Editor, Contract Pharma 06.03.20

    • APIs | cGMP Manufacture | Clinical Trials | Supply Chain
      Evaluating Pharma Amid COVID-19

      Evaluating Pharma Amid COVID-19

      Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation
      Kristin Brooks, Contract Pharma 05.18.20

    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
    • Innoforce and dMed Enter Development Collaboration
    • Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    • Four Female Leaders Appointed to Cell & Gene CDMO
    • Fusion Pharmaceuticals Acquires IPN-1087
    • Strata Oncology Unveils Strata PATH Trial
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Hygienic Packaging Technology
    • Trends in Solid Oral Dosage Delivery
    • 5 Reasons Paper Has No Place in Contract Manufacturing
    • Injectable Drug Delivery Trends
    • Pharmaceutical Manufacturing Equipment Trends
    • Oral Solids: Market & Technology Trends
    • Nutraceutical Manufacturing: Meeting the Challenges of Today, Planning for Tomorrow
    • 2021 Contract Manufacturing Survey
    • Small Molecule Development Trends
    • Challenges & Opportunities Facing Small & Emerging Biopharma Companies
    • 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

    Gadot Biochemical Launches New Magnesium Ingredients
    Low Levels of Vitamin D and Calcium Linked to COVID-19 Severity
    Probiotic Evidenced to Assist Digestive Recovery from a Complex Surgery
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    Benjamin Moore Launches COMMAND
    AOC Announces EMEA Price Increase
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety
    Philips, Disney Partner to Improve MRI Experience for Children
    FDA OKs Asensus' Senhance for General Surgery
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Innoforce and dMed Enter Development Collaboration
    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    Four Female Leaders Appointed to Cell & Gene CDMO
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    P&G Makes Progress Toward Packaging Circularity in Europe
    Coty Partners with LanzaTech to Introduce Sustainable Ethanol
    Remembering Fred Segal, a Trendsetting Retail Pioneer
    Happi

    Latest Breaking News From Happi

    Coty Partners with LanzaTech to Reduce Its Environmental Impact
    Waterless Beauty, Simplified Routines Shape Clean Beauty at Whole Foods
    Redken Updates Packaging, Adds New Products
    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

    Ashland announces PSA price hike in North America
    Arrow Systems and Sihl form flexible packaging partnership
    Flint Group Packaging announces global price increase
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Joa Announces Expandable Absorbent Core Wrap Solution
    Principle Business Enterprises Celebrates 60 Years
    Mann+Hummel Invests in Pamlico Air
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Spinal Elements Relaunches the Luna XD and Orbit Systems
    Coronavirus Triggers Double-Digit Revenue Dropoff at Smith+Nephew
    FDA Approves Accufix Surgical's Accu-Joint Hemi Implant
    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