Rethinking Emerging Biopharma’s Relationships with CROs

Life Sciences, Clinical Trials, Pharmaceutical, Drug Discovery & Development, Preclinical,
  • Friday, June 28, 2024

After approaching a contract research organization (CRO), does prioritization or working with the “A team” seem to be missing? Are turnaround times for sample analysis longer than anticipated?

Emerging biopharma and biotech often face several difficulties when outsourcing to generalized large CROs. However, a few tailored strategies can be deployed to avoid such hurdles and find specialized CRO partners that are a better fit for small- to mid-size companies.

Emerging biopharma have unique needs due to perhaps the level of resources and personnel capacity available or the funding and regulatory experience at hand. The traditional model of outsourcing has primarily evolved around the needs of large pharma over the past decades; owing to the growth in emerging biopharma today, the CRO–drug developer relationship needs to modernize and adapt to better serve small- to mid-size companies.

During this webinar, the panel will delve into the benefits of building specialized CRO partnerships for emerging biopharma and biotech. Various commonly faced hurdles will be analyzed to understand how R&D and drug development teams can rethink their outsourcing processes in the early stages to avoid issues in the future.

The increasing trend of outsourced testing across the pharmaceuticals industry is well known and shows no signs of abatement. So, the value driven by this model of drug development should not exclude small- to mid-size companies. The panelists will examine how to use outsourcing to speed up timelines, work within budgets and gain access to valuable scientific and regulatory experience.

Register for this webinar today to gain insights into effective outsourcing strategies tailored for emerging biopharma and biotech companies.

Speakers

Anitha Krishnan, Aviceda Therapeutics

Anitha Krishnan, PhD, Executive Director, Research, Aviceda Therapeutics

With a robust background in neuro-ocular immunology and a hands-on approach to disease models for CNS and ocular diseases, Anitha Krishnan’s journey from the bench to leading a drug development team showcases a deep understanding of the biological and analytical challenges within the biopharma industry.

Her experience has not only been pivotal in navigating the complexities of drug development but also in mastering the essential experiments that drive progress in this field. The knowledge acquired over the past five years at Aviceda, especially the ability to bridge CMC with biological efficacy, stands as a testament to success.

Read more...

Leveraging her experience from Harvard, and effectively addressing critical development aspects, and paving the way towards successful clinical trials, underscores her role as a key contributor to the biopharma sector. Her expertise is ever-evolving in this landscape of biotechnology, where understanding the multifaceted nature of drug development is crucial for innovation and advancement.

Read Less...

Message Presenter
R. John Stubbs, Stubbs & Hensel Pharma Consulting, LLC

R. John Stubbs, PhD, Principal & CEO, Stubbs & Hensel Pharma Consulting, LLC

John Stubbs has over 35 years of experience in majorpharma R&D, primarily in bioanalytical chemistry, analytical chemistry, drug metabolism and all phases of drug development.

Stubbs worked for Beecham and Merck Research Labs in the UK and then transferred to the USA with Merck Research Labs to work on drug metabolism. He worked in R&D for Johnson & Johnson, holding various positions of increasing responsibility.

Read more...

His last role was global head of bioanalytical supporting preclinical, clinical pharmacokinetics and toxicology departments using HPLC, LC-MS/MS, CE and immunochemistry technology. He also spent almost four years in the Quality and Compliance group, heading stability testing, lab investigations, new methods and lab IT groups.

He has been consulting in regulated bioanalytical chemistry for the past 14 years by providing technical expertise, performing GLP audits and preparing regulatory submissions.

He holds a BS in chemistry from the University of Salford, and a PhD in bioanalytical chemistry and drug metabolism from the School of Pharmacy, University of London.

Read Less...

Message Presenter
Charlie Zogzas,Sannova Analytical

Charles Zogzas, PhD, SVP Business Development, Sannova Analytical

Charlie Zogzas transitioned from a hands-on R&D role to business development where he combines a technical consulting approach to identify customer problems and delivers innovative solutions through collaboration with his operational colleagues. Charlie brings forth the same approach to Sannova, forging new partnerships with its valued customers and positioning the sales team to propel Sannova to the next phase of growth. With a work-hard, play-hard mentality, he strives to make himself and those around him great at what they do while enjoying the process along the way.

He holds a PhD in pharmacology from The University of Texas at Austin.

Message Presenter

Who Should Attend?

This webinar will appeal to decision-makers for drug development strategies:

  • Chief Scientific Officer (CSO)
  • Chief Medical Officer (CMO)
  • Director of Clinical Operations
  • Head of Research & Development (R&D)
  • Head of Toxicology
  • Head of Preclinical Development
  • Drug Discovery Managers
  • Head of Bioanalytical Development
  • Head of Pharmacokinetics (PK) & Pharmacodynamics (PD)
  • Bioanalytical Scientist
  • Clinical Trial Managers
  • Scientific Leads/Principal Investigators

What You Will Learn

Attendees will be introduced to:

  • Benefits of using specialized CROs to propel drug development pipelines within the necessary timelines, budgets and scientific goals
  • Real-life case studies of issues faced by biopharma and solutions put forth by specialized CROs
  • Improved models for analytical outsourcing early-on to avoid costly issues or delays in the later stages of development

Xtalks Partner

Sannova

Sannova is a boutique CRO with a unique Z factor approach, prioritizing high standards that extend beyond mere service. Institutionalized by our late founder, Dr. Rao Marepalli, the Z-factor approach is a guiding principle that ensures our method development, validation and sample analyses data has unparalleled accuracy and precision, exceeding even regulatory standards. We maintain this ethos throughout our operations, while upholding our core values of quality, speed, and flexibility—a Z-Factor that truly ‘Inspires Confidence’.

We offer fast, personalized, end-to-end analytical and bioanalytical services for complex, novel, and generic therapeutics.

Established over our 15+ year history, we are committed to delivering projects on time to promise. Our state-of-the-art lab occupies 21,000 square feet and is furnished with cutting-edge instrumentation. Our team of seasoned professionals is proficient in utilizing this technology to yield the most accurate and dependable outcomes.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account