Speakers
Abby Clark
David Simpson
Colin McKee
Panel
This panel session will explore the full lifecycle of Antibody-Drug Conjugate (ADC) development featuring insights from a therapy developer, CDMO, and clinical expert. From early design and scalable manufacturing to clinical delivery, speakers will highlight key innovations, challenges, and opportunities driving ADC success from lab to patient.
What does your role at BIA involve?
Abby leads BIA’s manufacturing policy work and supports the Manufacturing Advisory Committee. She represents BIA on the Medicines Manufacturing Industry Partnership (MMIP) and is secretariate for the High Potential Modalities MMIP workstream. Abby collaborates with the bioprocessing sector with a focus on complex medicines and sustainability within medicine manufacturing.
Previous experience and achievements
Abby began her career at CPI, where she successfully completed a Degree Level Apprenticeship in Biotechnology. She then advanced to the role of Downstream Scientist, specialising in RNA process development, automation, and continuous processing. Passionate about advancing the sector, Abby also volunteers her time as ATMP Manufacturing Community (AMC) Director, contributing to the advanced therapies sector and gaining valuable cross-modality insights.
If you could invite any scientist or entrepreneur to dinner, who would it be and why?
I’d love to have dinner with Rosalind Franklin, a brilliant scientist whose pivotal work on X-ray crystallography was instrumental in uncovering the structure of DNA. Her contributions, overshadowed by sexism, denied her the recognition shared by Crick and Watson. We would talk about the challenges she faced to provide insights into her resilience, intellect, and the untold stories of women in science that continue to shape our sector (and the Watson Crick Franklin model).
Dave founded Iksuda in 2012, now a clinical stage company which is focussed on the development of 1st/best in class ADCs by deploying a toolbox of chemistry and payload approaches to address the challenges of haematological and solid cancers. Iksuda’s operations in Newcastle, UK (Corporate HQ and Research) and Boston, US (Development) are committed to driving the differentiation of ADC therapies through innovation.
The Company is actively recruiting patients for Ph1 trials for its IKS014 (Anti-Her2) and IKS03 (anti-CD19) programs and recently announced dosing of its first IKS014 patient. Iksuda anticipates initiating pre-clinical/clinical development of it’s first in class, Anti-CA242 (IKS04) ADC for the treatment of GI cancers in Q1 2024 and continues to deepen its research stage portfolio.
Prior to Iksuda, Dave led Actavis’s biosimilar programmes and started his industrial career by joining Cobra Biologics before moving to Eden Biodesign, where he led its process development capabilities prior to its acquisition by Watson Pharma.
In addition, Dave holds the positions of NED at Leaf Expression Systems, Chairperson at Daresbury Proteins and advises several biotech companies, investment groups and provides local support to Newcastle University’s MRC Confidence in Concept Fund.
Colin is a seasoned biopharmaceutical process and analytical specialist with over 30 years’ experience in the development of novel complex biological entities; including proteins made in the milk of transgenic animals (10 years with PPL Therapeutics, Scotland) and antibody drug conjugates (7 years with Piramal Healthcare, Scotland and 14 years with ADC Biotechnology / Sterling Pharma Solutions, Wales). In the ADC field he has been involved in multiple clinical programmes and commercialisation of both ADCETRISÒ and ZYNLONTAÒ.
He is responsible for overseeing technical services and process development activities, managing all aspects of ADC development and manufacturing from initial proof of concept through to clinical trial production. As ADC Biotechnology transitioned from CRO to CDMO, he was involved in facility design / MHRA consultation and operational qualification to enable the second UK ADC clinical facility to come online.
Colin holds a BSc in Biology with Chemistry from Robert Gordons University and a MSc in Enzymology from the University of Cambridge.
Calum Polwart is a Consultant Oncology Pharmacist, based in the North East of England. He has been working in oncology pharmacy for more than 25 years. He has undertaken a number of roles within the North of England and Nationally to provide world class cacner care. He works in a variety of solid tumours mainly focussed on Breast and GI cancers.
Polwart first implemented Dose Banding in his trust not long after the turn of the millennium, undertook work subsequent to make logarithmic dose banding more palatable to pharmacists and was seconded to the NHS England National Dose Standardisation Project to find a national solution for dose banding in England. Today, he continues to support NHS England’s Dose Standardisation and Product Specification Standardisation workstream. He considers himself a pragmatic, practical user of complex medications, and is often frustrated by the lack of consideration of end users in early drug developments.