Q&A Session with Dr. Danielle Salha
Director, Ligand Binding Assays
Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the required preclinical studies to
Dr. Danielle Salha, Altasciences’ leading expert in the field, shares answers to the most frequently asked questions from sponsors worldwide.
As Director of the Ligand Binding Assay Department, Dr. Salha leads a team of over 40 Scientists, Quality Controllers, and Analysts dedicated to Method Development, Assay Validation and Sample Analysis to support clinical and preclinical PK, PD or Immunogenicity Studies. Danielle has a unique understanding of the close collaboration between Altasciences’ bioanalytical team with the organizations’ preclinical and clinical teams to deliver an integrated offering to our clients.
What differentiates Altasciences’ offering from other CROs?
A. Our ability to design and execute these trials across all segments, both in the clinic and bioanalysis, is very attractive to our clients. Our teams work very closely together to design the best solution for our clients, which can include preclinical research as well when required.
Our mix of experience with both innovator and generic medicines is a distinct advantage, as many studies include key elements of both market segments. Our experience in conducting studies with innovator biologics and high-risk compounds, and designing complex studies with multiple endpoints are why sponsors developing innovator drugs entrust their studies to us. On the other hand, those developing generic drugs are drawn to us because we understand that speed, quality, and an efficient study design that meets recruitment milestones and regulatory requirements are vital to their drug development programs.
Our effective approach to overcoming recruitment issues is also key, particularly for clinical pharmacology studies with biosimilars. Our multi-site offering and database of over 345,000 participants facilitate recruitment to complete studies faster.
Q. How many studies have you conducted with biologics and/or biosimilars?
A. We have over 25 years’ experience developing programs and conducting full-service pharmacology studies for novel biologics and biosimilars. On average, we conduct over 100 studies a year for various types of biologics. In 2019, 98 studies were conducted using Ligand Binding Assays (LBA), and 50 studies using Hybrid Mass Spectrometry assays for biologics specifically. For LBA, these include drug quantitation to support TK or PK studies, ADAs, and cell-based neutralization assays to support clinical and/or preclinical immunogenicity studies. In fact, more than 40% of our current preclinical and clinical studies are supporting biologic drug development. Those biologics include monoclonal antibodies, pegylated or fusion proteins, antibody-drug conjugates (ADCs), biospecifics and biobetters.
Our clinical research group has also conducted over 25 studies for biosimilar submissions, recruiting up to 250 participants per trial.
Q. Are your laboratories fully-equipped to meet our bioanalytical needs?
A. Altasciences has two state-of-the-art laboratories in North America (one in the U.S. and one in Canada) with over 100 highly-trained specialists with vast experience in LC-MS/MS and ligand binding bioanalytical platforms.
Our ligand binding group provides solutions for immunogenicity, PD, PK, BE, and biosimilar studies for both preclinical and clinical phases of drug development.
We leverage our decades of experience in LC-MS/MS to successfully transition our competencies to peptides, proteins (intact and surrogate peptide quantification), monoclonal antibodies, and antibody-drug conjugates for both preclinical and clinical phases of drug development. We are adept at performing automated immunoaffinity sample preparation, and producing high-throughput assays with impressive sensitivity.
Working with the latest equipment, we ensure compliant, on-time regulatory submissions, and have the capacity to analyze over 60,000 samples per month!
Q. Can you give some examples of compounds Altasciences has worked on?
A. Infliximab, Adalimumab, Evolocumab, Denosunab, and Trastuzumab are just some of the examples of biological products that our full-time pharmacists have been working with over the years. We have experience with large molecules, such as proteins, bi-specific antibodies, monoclonal antibodies, antibody-drug conjugates, small peptides, as well as small molecules such as oligonucleotides.