Heather Myler

Heather received her PhD in Biochemistry and Cell Biology from Rice University (TX, USA) and completed her postdoctoral training at Pfizer (NY, USA) in Drug Safety Evaluation, later holding positions of increasing responsibility at Amgen (CA, USA), Merck (NJ, USA) and Bristol-Myers Squibb (NY, USA) supporting PK, immunogenicity and biomarker bioanalysis with an expertise in biologics. Heather currently serves as the Director of R&D, Immunochemistry at PPD (NC, USA) leading a group of scientists responsible for bioanalytical and biomarker method development, validation and automation supporting gene and cell therapies, biosimilars and novel biologics. Heather has a strong external scientific presence, currently serving as past chair of the bioanalytical community within AAPS serving over 1,000 members. Heather is also leading an AAPS team focused on the harmonization of ADA validation testing and reporting, comprised of over 30 key opinion leaders from across industry and various health authority agencies with a strong FDA presence.

What three things would you take if you were stranded on a desert island?

Besides the obvious of a clean water source, replenishing food source and sunscreen, I would take my kindle. I love to read, mostly psychological thrillers, historical fiction and business strategy. I would also take everything oral hygiene (toothbrush, toothpaste, floss and mouthwash). And lastly, I would take my daughters and their iPhones to document our adventures.

If you weren’t a bioanalysts what would you be?

An author. I love to read and write. I plan on publishing outside of the technical space when I retire.

What is your favorite city?

This one is hard, but if I had to pick one, I’d say London. I love the combination of history, cutting edge technology, refinement and grit.

Why have you decided to become a Zone Leader?

Bioanalysis is a great venue to continue my volunteerism. I am continuously impressed with how far this community has come in the last decade and the reach it has within biopharmaceutical, regulatory agencies and CRO.

Journal articles from Bioanalysis Interviews
Measuring biotherapeutics with endogenous counterparts and pre-existing antibodies: an interferon case study

Biotherapeutic bioanalysis: a multi-indication case study review

Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4–Fc fusion protein, in renal and liver transplant patients

Validation of an integrated series of ligand-binding assays for the quantitative determination of antibody–drug conjugates in biological matrices

Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients

Perspectives on exploring hybrid LBA/LC–MS approach for clinical immunogenicity testing

Biotransformation and stability of antibody–drug conjugates: payload metabolism and linker cleavage delineation

Recommendations for the development and validation of confirmatory anti-drug antibody assays

Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples

An integrated multiplatform bioanalytical strategy for antibody–drug conjugates: a novel case study

Concerted application of LC–MS and ligand binding assays to better understand exposure of a large molecule drug

Antibody–drug conjugate bioanalysis using LB-LC–MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding assays

2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS)

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)