Prof. Dr. Hanns-Christian Mahler, Head Drug Product Services
 
Prof.Dr. Hanns-Christian Mahler     

Hanns-Christian 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.


Hanns-Christian 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 in 2013.

     

 

 

Dr. Susanne Jörg, Head Formulation Development
 
Dr. Susanne Joerg    

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®.

 

Susanne studied Pharmacy at the University of Mainz (DE), and holds a Ph.D. from the University of Munich (DE).

     

 

 

Dr. Atanas Koulov, Head Drug Product Analytical Development and Quality Control
 
Dr. Atanas Koulov    

Atanas Koulov 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 Biologics.

 

Atanas has 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).            

       
 Dr. Satish Singh, Head Drug Product Process Development
       
     

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.