• 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
    Baxter BioPharma Solutions

    Alcami

    PCI Pharma Services

    Almac Group

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

    Almac Group

    Baxter BioPharma Solutions

    test company saurabh

    Aphena Pharma 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

    Accelerating R&D Trends

    The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.

    Accelerating R&D Trends
    Related CONTENT
    • Solid Dose Market Trends
    • AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    • Vetter continues its successful performance at the 2021 CMO Leadership Awards
    • FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site
    • Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine
    Kristin Brooks, Contract Pharma10.20.20

    The research and development (R&D) journey is inherently a long, complex and costly one. Drug developers large and small are partnering with Contract Research Organizations (CROs) early in the development process to help overcome critical challenges and achieve greater efficiencies across the drug development continuum.

    In addition to reducing drug development timelines and costs, there are several pharma and biopharma trends contributing to increased outsourcing of R&D activities. Among them, increasingly complex small molecules and biologics requiring extensive ground work, highly specific drug technologies, and expertise.

    Dr. David Shoemaker of Rho discusses R&D trends and challenges, efforts to streamline drug development, and the greatest motivators for outsourcing in today’s market. –KB

    Contract Pharma: What are the pharma/biopharma R&D trends impacting CROs and services?

    David Shoemaker: The bottom line is that any trends that affect pharma/biopharma affect CROs inasmuch as outsourcing has never been greater than today, with an anticipated outsourcing level reaching greater than 50% of pharma/biopharma outsourced R&D spend by 20241. The major trends occurring currently are the following:

    Migration to decentralized clinical trials

    Migration to use of real-world data

    Migration to use of artificial intelligence in selection of development candidates

    These are trends that have been in the works for some time, but the COVID-19 pandemic has thrust these topics into the forefront of everyone’s consciousness. CROs are attempting to make these migrations in double time, and the jury is out on how successful they will be over the course of the next few years as the industry recovers from the impact of the pandemic.

    CP: What are the current R&D challenges the industry faces? What areas of expertise are needed to overcome them?

    DS: The current R&D challenges the industry faces primarily revolve around the skyrocketing amount of work involved in the development of novel gene transfer, cellular and tissue-based products. As science has improved over the past decade, companies have increased their focus on developing potential therapies to target more specific populations rather than potential blockbuster therapies. This specialty approach to rare diseases was prompted by the high prices that companies have been able to charge in the U.S. for these types of products, and the institution of price controls similar to those present in other regions would be a first step toward reining in this development and refocusing pharma/biopharma on developing medicines for large proportions of the general public. Likewise, when it comes to focusing on targeted specific populations and rare diseases, it is also important for CROs to have the expertise and capabilities to design and execute natural history studies, or to engage with the right patient advocacy groups and entities to access patients and deal with patient-focused development.

    CP: What do you see as the greatest motivators for outsourcing in today’s market? Do you see opportunities to further engage existing customers?

    DS: The greatest motivator for outsourcing in today’s market is due to an evident shift in development work from big pharma/biopharma companies to smaller biotech companies, academia, private foundations and government agencies. The smaller entities do not have the internal resources of the big pharma/biopharma companies, and this necessitates the smaller entities outsourcing a greater proportion of the development work to CROs. To accommodate this need, large CROs have created divisions specifically targeting these small entities and have outfitted them with individuals skilled in all disciplines of integrated product development – especially as there is no predicting where a small entities’ deficiencies may lie. Of course, this also increases the ability of independent consultants to compete with CROs for these development activities.

    CP: What services are you seeing an increased demand from sponsors and from what sectors? Where do you think the biggest opportunities lie?

    DS: From our experience, the greatest demand is currently coming from the Quality/Chemistry, Manufacturing, and Controls (CMC) sector.  Whether it be at the Pre-IND, IND or NDA/BLA preparation stage, the request for assistance with manufacturing strategy and implementation and data compilation is overwhelming. Rho’s focus is on the small to mid-size pharma/biopharma, which is where we have perceived the biggest opportunities for significant work with the potential for repeat business. Historically, the majority of complete response letters are issued due to CMC deficiencies. Based on these trends, the demand and need for solid CMC support and appropriate focus on pharmaceutical product development will continue to grow.

    CP: What efforts are being made to streamline drug development among sponsors/service providers?

    DS: The greatest streamlining efforts occur in the integration of the service providers’ team with that of the product sponsor. Big CROs have long advocated “preferred provider” relationships with big pharma, but this has the unwanted effect of leaving the other clients as second-class citizens. Smaller CROs have successfully courted small pharma/biopharma for some time now and several have established reputations that rival big CROs for performance if not revenues. Ultimately, having an experienced, strong program manager on the product sponsor’s team who interfaces with an experienced, strong program manager on the CRO side is the only way to streamline product development, and this only occurs if these two individuals are provided day-to-day decision-making authority and sufficient resources from their respective organizations.

    1. https://www.statista.com/statistics/1085611/global-pharma-market-internal-vs-outsourced-services-expenditure-share/


    Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas.  Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities.  At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents destined for regulatory authorities and as an advisor to integrated product development program teams.

    Related Searches
    • Clinical Trials
    • Preclinical Outsourcing
    • Drug Development
    Suggested For You
    Solid Dose Market Trends Solid Dose Market Trends
    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    Vetter continues its successful performance at the 2021 CMO Leadership Awards Vetter continues its successful performance at the 2021 CMO Leadership Awards
    FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site
    Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine
    Anova Enterprises Acquires Corlexia Clinical Services Anova Enterprises Acquires Corlexia Clinical Services
    Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China Thermo Fisher, JW Therapeutics Form CAR-T Partnership in China
    Catalent, Trizell Enter Cell Therapy Deal Catalent, Trizell Enter Cell Therapy Deal
    Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement Immunome, Abzena Enter COVID-19 Antibody Cocktail Agreement
    UK Secures 40M Doses of Valneva COVID-19 Vax UK Secures 40M Doses of Valneva COVID-19 Vax
    Recipharm, Medspray Launch Resyca JV Recipharm, Medspray Launch Resyca JV
    Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership Cognate BioServices, Nucleus Biologics Form Cell & Gene Therapy Partnership
    Delivering Custom Client Solutions Delivering Custom Client Solutions
    20th Annual Contracting & Outsourcing Conference & Exhibition 20th Annual Contracting & Outsourcing Conference & Exhibition
    500+ Sites Join Inato’s Industry Marketplace 500+ Sites Join Inato’s Industry Marketplace

    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

    • 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

    • Clinical Trials
      Pioneering Medicine Forward

      Pioneering Medicine Forward

      May 20th marks Clinical Trials Day, celebrating 273 years of clinical trials
      Tina Bland, Senior Consultant, KCR Trial Execution Consulting 05.18.20

    Trending
    • Catalent Acquires Delphi Genetics
    • Inside A Vaccine Trial
    • Pfizer Selects Seven Bridges To Support RNA Sequencing Data
    • Pfizer Partners With Medicines Manufacturing Innovation Center
    • ICON Acquires Medpass
    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