Faculty – 6th Technology Transfer for Biologics

Russell Beste
Senior Director Global Process Development, MYLAN

view speaker profile

Russell Beste is a Chemical Engineer and Biochemist. He directs Global PD using QBD & PAT to rapidly transfer continuous biomanufacturing processes.

Karen Giraudo
Associate Director, Business Process Improvement, BIOMARIN

Mitch Goetz
Senior Engineer II, BIOGEN

view speaker profile

Mitchell Goetz is a technical development (TD) engineer at Biogen’s Research Triangle Park, NC facility and is responsible for scale-up and tech transfers of clinical and process validation campaigns at the 2KL and 15KL scales. Since joining TD in 2010 he has been responsible for harvest and downstream operation tech transfers at RTP and Hillerod, Denmark.

In seventeen years with Biogen, Mitchell has been involved with upstream and downstream operations as a process engineer, supervisor, and TD engineer.

Prior to Biogen, Mitchell worked ten years as an engineer and supervisor at a chlor-alkali facility in the bulk commodity chemicals industry along the Gulf Coast. Here he specialized in the manufacture of methyl chloroform, perchloroethylene, and ethylene dichloride. Mitchell holds a Bachelor’s in Chemical Engineering from the University of Tennessee, Knoxville and earned his North Carolina Professional Engineer license in 2006.

Carin Gray
Senior Engineer II, BIOGEN

Dr. Magdalena Leszczyniecka
Chief Executive Officer, President, STC BIOLOGICS

view speaker profile

Dr. Magdalena Leszczyniecka is President and CEO of STC Biologics. Magdalena founded STC in 2009 with the goal of bringing biosimilar products to patients who can’t afford branded equivalents. Since 2009, STC has worked on four biosimilar antibody products, some of which are being developed by STC and others by STC’s partners. Magdalena is very active in the biosimilar sector, presenting at more than four biosimilar business conferences a year. She is also an Advisor to Sectoral Asset Management, where she provides advice on biosimilar strategy. Twice a year, she does a call on biosimilars for Coleman Research, a company focused on providing market research for buy-side investors. Recently, she authored three patents relating to biosimilar product optimization; these patents cover methods to match biosimilar product quality to obtain fingerprint-like similarity. STC’s main goal is to bring a biosimilar product to the market with only one clinical trial by providing fingerprint analytical data on product similarity.

Besides biosimilar development experience, Magdalena has broad drug development experience in small molecules and various biologics — including IgG1, IgG4, two Fc fusion proteins and antibody single chains — as well as antibody targeted liposomal formulations. Before starting STC, she gained startup experience by working in venture capital at Flagship Ventures and Atlas Ventures. Before entering the venture capital field, she led the development of MM-121 and anti-HER3 antibody programs while at Merrimack Pharmaceuticals. She started her scientific career at Novartis Pharmaceuticals in 2002 as a project leader for two oncology development products. She received her Ph.D. from a joined program between Columbia University and NYU, an MBA from Babson College, and a B.S. in biochemistry from Rutgers University.

Jody Logan
Senior Manufacturing Technical Specialist, GENENTECH

Yolanda Mock Hawkins, Ph.D., M.B.A
Technology Transfer Specialist – Center for Drug Evaluation and Research (CDER), FDA

view speaker profile

Yolanda Mock Hawkins is a trained Molecular and Cell Biologist with several years of experience in Technology Transfer. In her current role as a Technology Transfer Specialist at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) she prepares, negotiates, and executes various transactional agreements in support of CDER’s collaborative research with government, industry, academia, and the nonprofit research community.

Prior to joining the FDA, she served as a licensing and patenting manager at the NIH Office of Technology Transfer (OTT). She received her Ph.D. in biomedical sciences from Meharry Medical College, received an M.S. in biology from Texas Southern University, and obtained a bachelor’s degree in Biology from Fisk University. She completed her postdoctoral training at the NIH-National Institute on Aging, obtained a certificate in Technology Transfer from NIH-FAES and earned her M.B.A from the Johns Hopkins Carey Business School.

Joseph Mulvey

view speaker profile

Joe Mulvey is President of Ealain Technology Solutions LLC (ETS). Founded in 2015, ETS is committed to delivering technology driven solutions to the Life Science Industry.  Joe holds degrees in Bioengineering as well as Electrical and Computer Engineering and has an MBA in Finance and Economics from the University of Chicago. He has over 25 years experience delivering solutions to the Life Science Industry through Project Management of Tech Transfer, Filling/Inspection/Packaging and ERP engagements as well as through biopharm process design, installation and qualification.  Joe is also a certified Project Management Professional and is certified in SAP (Production Planning).

Mark Ramsey

view speaker profile

Mark Ramsey is the Senior Manager over the Manufacturing Science and Technology team at Thermo Fisher Scientific’s drug substance CDMO facility in St Louis, Missouri. He has considerable expertise both nationally and internationally with over 20 years of experience in Process Engineering, Manufacturing, and Technical support. Mark has successfully delivered upon tech transfer and drug substance production through both upstream and downstream areas ranging from lab-scale up to commercial production scale.

Jonathan Romero
Director, Biologics Development and Manufacturing, CELGENE

view speaker profile

Jonathan Romero, PhD is Director of Biologics Operations at Celgene where he is responsible for clinical and commercial manufacturing of Celgene’s biologics portfolio which includes the selection and oversight of Drug Substance and CMO’s. He also leads the development of a commercial manufacturing strategy for Biologics at Celgene and participate in its implementation within Global Pharmaceutical Development and Operations. Prior to Celgene, he was Senior CMC Leader at Biogen leading a multiple cross-functional, matrix team with overall responsibility for late stage biologics program, process life cycle, change control management, and global regulatory strategy. Jonathan also was Associate Director at Biogen managing cGMP Process Engineering activities to support Clinical and Commercial Manufacturing. Prior he held roles of increasing responsibility in Process Development, and Technology transfer at Biogen. He holds a PhD in Chemical Engineering from University of Delaware.

Daniel Rudolph, Ph.D.
Principal Engineer, Manufacturing Development, BioDefense Division, EMERGENT BIOSOLUTIONS

Adnan Sabir
Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS

view speaker profile

Adnan Sabir is currently employed by Kowa Pharmaceuticals of America, a subsidiary of a Japanese company, leading QA/CMC activities. Previously he was a Principal Consultant and Founder of “Pharma Consulting Services, Inc. (PCS),” where he provided solutions for regulatory issues, the implementation of QbD/PAT, and the risk-based development of products to big and small pharma companies globally. He has more than 30 years of hands-on and management experience and a proven track record for formulation and process development and technology transfer working in brand and generic industries such as GSK, Solvay, Actavis and UCB. He also served as a Vice President of R&D at Dr. Reddy’s Lab for three years in 2009 establishing product development optimization. He has significant knowledge in CMC, cGMP, 21 CFR Part 11 and ICH Guidelines, Serialization, and FDA regulations. He is a frequent speaker at various meetings in the United States and other countries globally.

Sebastian Schneider, Ph.D.
Group Lead Tech Transfer, Technical Product Management, F. HOFFMANN LA-ROCHE

view speaker profile

Sebastian Schneider, Ph.D. is leading the Technology Transfer execution of Roche`s portfolio of New Pipeline products. Sebastian is managing a team of Technology Transfer Leaders, he is acting Business Process Owner and is driving a business improvement project at Roche to reduce lead times of Roche`s Technology Transfer portfolio by 30%. Sebastian holds a Ph.D. in Pharmaceutical Sciences and has been working in Process Development & Clinical Supplies on Innovation Projects and Clinical Supply facility start-ups before entering the world of Technology Transfers.

Dr. Zahra Shahrokh
Chief Development Officer, STC BIOLOGICS

view speaker profile

Bringing a broad experience in biotechnology product development with a track record in global regulatory approvals of several biological products, Dr. Shahrokh provides development and regulatory strategy to advance STC’s products and Bioservices programs. She was Senior Vice President of Development at Aurabiosciences, where she was responsible for regulatory, nonclinical and CMC development of protein nanoparticle delivery systems. She led pharmaceutical and analytical development at Shire for 10 years, and was Head of CMC & PD Operations. She had technical and leadership roles at Genentech’s Pharmaceutical R&D department for 10 years, where she drove the pharmaceutical development of several classes of biologics and small molecules.

Dr. Shahrokh is the founder of ZDev Consulting, providing technical and strategic guidance to advance biotech products through the development life cycle. She has a Ph.D. in biophysics from UC Berkeley, a B.A. in chemistry and physics from the University of Pennsylvania, and a post-doctoral fellowship at UCSF. She holds several pharmaceutical patents and has had a role in more than 60 papers and invited presentations.

Jasmina Xie
Senior Process Engineer, BAYER

view speaker profile

Jasmina Xie is a Senior Process Engineer in Manufacturing Sciences and Technology (MSAT) within the Biotech Division at Bayer. She was a member of the technology transfer team for a €600M capital investment project in Germany and is now supporting the design and construction of a single-use facility with a cost of $130M in Berkeley, CA. In addition to supporting the project, Jasmina has been developing and implementing global systems and tools to manage internal and external technology transfers of biologics. Jasmina participated in the technology transfer work stream of the BioPhorum Operations Group (BPOG) and has been published in the PDA Journal 3 times in recent years. Previously, Jasmina managed the small scale purification lab for MSAT, supporting commercial hematology products and transferring in small scale models for pipeline products. Jasmina received her Bachelor’s Degree in Integrative Biology from the University of California, Berkeley.