Jillian Whidby, PhD

The Director of Medical Writing role at Invivyd was complex and fast-paced. I assisted with the strategy and planning of an IND and an EUA for a COVID-19 prophylactic mAb, including timeline development, team coordination (clinical, nonclinical, and CMC), and authoring (clinical and nonclinical). I managed an internal direct report and coordinated with contractors for QC and Medical Writing support. I interfaced directly with members of the ELT to assist with regulatory strategy and development of novel platform protocol designs. I actively participated in contractor onboarding and job candidate interviews and promoted cross-pollination of medical writing processes and guides during high turnover. I was identified as an Invivyd Top 10 Performer in 2024, as was my direct hire.

In this position, I managed all Medical Writing deliverables associated with RTA 901 (cemdomespib for neuropathy) and RTA 402 (bardoxolone methyl for chronic kidney disease; facilitated program closeout in collaboration with Regulatory Affairs), while supporting RTA 408 (Skyclarys for Friedreich ataxia). This position included collaborative preparation and quality control of submission-ready regulatory documents and post-approval protocols. I was also able to assist in the preparation of an EMA audit for Skyclarys that took place in June 2023. I was required to manage, lead, and assist contracted writers and collaborate with consultants for strategic EMA responses and redaction work. Leading cross-functional meetings and ensuring compliance with operating procedures were essential to the role. I was also able to contribute to the development of a QC staff, formal QC process/SOP, style guide, and lexicon. After the Biogen acquisition, I was fortunate to be hired as a permanent employee of Biogen and worked tirelessly to communicate and collaborate with new teams, maintaining all Reata goals and timelines and implementing creative solutions to keep Reata legacy products on track.

Managed all medical writing needs/deliverables in hereditary angioedema (recently approved Andembry®) and progressed the product to submission in multiple countries, including Japan (included 2 phase 1 studies, 1 phase 2 study, and 2 phase 3 studies). This was the most complex program underway at CSL and operated on an accelerated rare disease timeline. I received 8 colleague-nominated (across various functional areas) Celebrate the Promise awards, recognizing my commitment to both the Medical Writing team and the Andembry study team. I was nominated for and awarded the CSL Retain and Grow award in 2020. I actively participated in the CSL response to the SARS-CoV-2 pandemic, developing our first emergency amendment and participating in process development. I also led the preparation of our CSR COVID Guidance to promote consistency within the department. I engaged in a company-wide initiative to establish a standard reference management software and led the roll-out within Medical Writing.

Responsibilities included preparation and strict QC of clinical protocols, informed consent forms, and clinical study reports for a novel hepatitis D virus treatment. In a short period of time, I participated in the advancement of 7 phase 1 studies and 1 phase 3 study, and 6 CMC documents all delivered on time or ahead of schedule. I contributed to the establishment of a key partnership with a prestigious client.

On-the-job learning with the mentorship of CEO David Smith, MD and Principal Investigator Joel Neutel, MD. Responsibilities included preparation of protocols, informed consent forms, and clinical study reports predominantly in the areas of hypertension/heart disease and diabetes. This position enabled exposure to a wide variety of therapeutic areas in high volume and included work on generics/bioequivalence.

Research into the production of complex glycoproteins in mammalian cells. While continuing to work on the project that helped me to earn my PhD, I was able to focus a great deal of attention on supporting all lab members with their research and technical troubleshooting. As the senior member of our lab, I acquired full responsibility for lab organization, maintaining safety, managing grants and ordering, fostering relationships with sales representatives, and communicating effectively with our extensive list of worldwide collaborators.

The primary aims of my thesis work included developing a system for the expression of hepatitis C virus envelope 2 protein (E2) for complex biochemical and biophysical studies. A mammalian protein expression platform was established, which uses a lentiviral packaging system in combination with a novel bioreactor to express E2 ectodomain at quantities exceeding 50 mg/L (patent pending). This system made high-throughput crystallography studies possible and resulted in the expression of other challenging biophysical targets that have failed to express by other methods. We used this system to solve the crystal structure of E2 core, which was published in Nature in 2014. Secondly, in collaboration with Dr. Arash Grakoui (Emory University), we engineered cysteine mutant viruses and mutant E2 proteins which displayed unique phenotypic properties and emphasized the importance of disulfide linkages in virus assembly, egress, and infection. Also in collaboration with the Grakoui lab, a diverse panel of monoclonal antibodies against E2 was purified, characterized, and mapped by ELISA and ultimately used as a tool to assist in structural determination.

Molecular virology and protein purification, Doms lab. Expression of Pen-2 and Nicastrin (components of γ-secretase complex involved in β-amyloid generation in Alzheimer’s disease), as well as CCHFV glycoproteins. Various expression systems and purification strategies were used, with particular emphasis on baculovirus expression in insect cells. In addition, pseudovirus production and testing was performed under the instruction of Andrea Bertolotti-Ciarlet. The development of pseudoviruses for Andes Virus (AndV) using a VSV core was completed and published.