Mahler has extensive experience in drug product development and manufacturing.
For more than 15 years, he worked for Merck and Roche in leadership roles, most
recently as Head of Pharmaceutical Development & Supplies Biologics EU
(Roche). Hanns-Christian Mahler was involved for several product IND/IMPD
submission and numerous market launches including i.a. Erbitux, Gazyvaro,
Actemra SC, Pegasys PFS/pen, Herceptin SC and Mabthera SC. He has extensive
industry experience in parenteral formulation & process development, line
extensions, primary packaging development, device development, drug product clinical
manufacturing and commercial product support.
studied Pharmacy and holds a Ph.D. from the Institute of Pharmacy at the University
of Mainz (DE), Specialist Pharmacist (Fachapotheker) degrees in Pharmaceutical
technology and Toxicology & Ecology, a Habilitation in Pharmaceutical
Technology from the University of Frankfurt (DE) and is also Professor for Pharmaceutical
Technology at the University of Frankfurt (DE) and adjunct faculty member and
lecturer at the University of Basel (CH). Having published more than 60
scientific manuscripts and submitted more than 20 patent filings,
Hanns-Christian was elected an AAPS fellow in recognition of his scientific achievements
Susanne Jörg has extensive experience in drug product formulation
development. For more than 10 years, she worked in leadership roles at Novartis
Biologics. She worked on drug products of monoclonal antibodies, recombinant
protein, fusion proteins, bioconjugates, antibody fragments, nanobodies, and
antibody-drug-conjugates for parenterals including intravitreal application.
She has extensive experience in liquid and lyophilized early- and late phase
Drug Product development. In collaboration with Merck KGaA, Darmstadt (DE), she
developed liquid high-concentration MAB formulations, implementation of
different concentration and analytical techniques such as ELISA, DSC, FTIR, nephelometry
and viscometry and supported the registration filing of Erbitux®.
studied Pharmacy at the University of Mainz (DE), and holds a Ph.D. from the
University of Munich (DE).
has extensive experience in drug product analytical development and quality
control release and stability testing, as well as characterization,
investigations support and specification setting. His eight years of industry
experience include managing Roche’s Particle lab, activities for visible,
subvisible and submicron particles as well as responsibility for various
programs in Analytical Development & QC of Drug Products. Prior to joining
Roche, Atanas also worked as a Lab Head, Analytical Development at Novartis
published extensively in the field of protein aggregation and particles and is
the immediate past chair of the AAPS Protein Aggregation & Biological
Consequences Focus Group. He holds
a Ph.D. in Biochemistry from the University of Notre Dame, IN (USA), earned his
M.Sc. in Molecular Biology and Clinical Chemistry from Sofia University (BG)
and worked as Postdoctoral Fellow at the Scripps Research Institute in San
Diego, CA (USA).
Satish Singh has more than 25 years of experience in biopharmaceutical product development. His expertise includes process development, scale-up and technology transfer and ranges from discovery support to development, manufacture and final drug product commercialization.
Prior to joining Lonza, Satish was a Research Fellow and Group Leader in Pfizer's Biotherapeutics Pharmaceutical Sciences R&D Unit. Satish has also lead technical teams that focused on particulates, drug substance storage, ADC structure/property relationship, immunogenicity risk evaluation, and the development and application of computational tools in CMC aspects of biotherapeutics.
Satish has a strong technical background and understanding of regulatory challenges and the evolving global regulatory landscape. He has served as a member of the USP Expert Panel on <771> Ophthalmic Ointments and <787> Subvisible Particulate Matter in Protein Injections, as well as the A-mAb Quality by Design Case Study team and a number of other industry consortia.
Satish holds a Ph.D. and MS in Chemical Engineering from Kansas State University and a B.Tech. in Chemical Engineering from the Indian Institute of Technology, New Delhi, India. He has published more than 70 scientific publications on various topics related to the field and is also an Adjunct Professor in the Department of Physical Pharmaceutical Chemistry, BMC, Uppsala University, Sweden.