Alava-team

markMark Backer, PhD, General Manager

Dr. Backer has technical management experience in the development and manufacturing of a wide variety of biopharmaceuticals including antibodies, proteins, viral-based vaccines and cell therapies.  He also has business experience as a biotech startup CEO, and was founding chairman of the contract manufacturing firm Molecular Medicine BioServices (now a division of SAFC Pharma, a Merck KGA company). Dr. Backer’s industry experience began in 1978, when he was the seventh employee of Genentech and initiated its pilot manufacturing operations.  He led pioneering efforts in large-scale cell culture technology and ex-vivo expansion and transfection of stem cells.  He was most recently Sr. VP, Technical Operations with Jennerex with responsibility for all CMC operations.  He also served as CEO of Vaxart (viral-based oral vaccine platform), VP Technical Development with Protein Design Labs, and previously served in positions of increasing responsibility with firms including Aviron (now MedImmune Vaccines), Systemix, IDEC, and Eli Lilly. Dr. Backer received a PhD in Chem. Engineering from the University of Washington, and a BS in Chemistry from Stanford University.

 

Peter H. Bach, PhD, MBAPeter H. Bach, PhD, MBA

Dr. Bach has worked in the biopharmaceutical and CRO industries, where he has been responsible for candidate drug selection, building nonclinical strategy that led to numerous first-time-in-human packages, and toxicology studies to support Phase II and III clinical studies. He has also been closely involved in interactions with US, Canadian, European and Eastern European Regulatory Agencies across a number of therapeutic areas. He has been closely involved in developing conventional, new generation and follow-on biologicals and Advanced Therapy Medicinal Products and devices. He also works with companies developing novel and re-engineered NCEs. All of these activities have expedited development resulted in successful global licensing. Prior to consulting, Peter was Director of Toxicology with AstraZeneca (CAT/MedImmune), and previously held positions of increasing responsibility with Celltech (UCB) and CRL Inveresk.

As an academic he contributed to the mechanistic understanding of toxicological changes in the kidney, using an array of in vivo and in vitro techniques. These published studies were completed by a multinational research and post-graduate group, using grant support from industry, and national and international research funding agencies and charities.   Peter also ran international toxicology symposia and contributes to several post-graduate training and Continuing Professional Development courses in Europe. His academic credentials include a PhD in Biochemical Safety from the University of Surrey, BS and MS degrees in Chemistry and Biochemistry from the University of KwaZulu-Natal, and a MBA from the Open University.

 

Robert Bayer, PhD

Robert Bayer, PhD

Dr. Bayer has over 25 years of experience in the biotechnology industry in the development of biopharmaceuticals including antibody drug conjugates, glycoconjugates including glycopegylated proteins, monoclonal antibodies, and enzymatic synthesis of small molecules. He has extensive experience in downstream process development, conjugation process development, leading cross-functional development and CMC teams, scale-up, process and technology transfer, and working with CMOs. Bob has held leadership positions at Genentech, Novartis, Neose Technologies, and Cytel Corporation.  Dr. Bayer is an inventor on about 100 US patents and patent applications, and has an Honors BS in Chemistry from the University of Michigan, as well as an MS and a PhD in Biochemistry from Cornell University.

 

Gregory S. Blank, PhDGregory S. Blank, PhD

Dr. Blank is a recognized global leader in Bioprocess development. He spent over 23 years at Genentech initially in the Recovery Sciences department and most recently as Director of the Late Stage Purification Department responsible for development of commercial processes, post approval changes, and process validation. Also reporting to Dr. Blank was the virus validation group. He became department director in 2000. While at Genentech he has focused on monoclonal antibody process technology and has led the development and commercial scale-up of recovery processes for both full-length antibodies (including Rituxan, Herceptin, and Raptiva) from mammalian cells and antibody fragments from bacteria. The purification processes Dr. Blank developed for Herceptin and Rituxan have formed the purification platform for all of Genentech’s monoclonal antibodies. He has also helped develop Genentech’s approach to process validation including virus validation, modular validation, and Quality by Design. Since 2010 Dr. Blank has consulted for organizations across the globe in the areas of purification process development, scale-up of manufacturing operations, process validation and characterization, virus validation, and regulatory filings. Dr. Blank received his B.S in Biological Sciences and his Ph.D. in cell biology both from the University of Southern California.

 

lucyLucy Chang, PhD

Dr. Chang has more than 20 years of executive experience developing protein therapeutics, gene and cellular therapy products, from preclinical research through commercialization.  Her strengths include setting up and managing technical development and Quality systems, with hands-on leadership and creativity in working within limited budgets.  She has extensive experience in working with contract testing labs and CMOs, including negotiating contracts, scale up and technology transfer, analytical methods development and validation, establishment of Quality and GMP compliance systems, and IND/BLA/NDA regulatory submissions.   Dr. Chang served most recently as VP, Quality and Analytical Development with Jennerex.  Previously she served as COO of Being, Inc. and VP, Manufacturing Operations with Raven Biotechnologies, as well as prior positions of increasing responsibility with GeneTrol, Coulter Pharmaceuticals, Systemix and XOMA.  Dr. Chang received a PhD in Virology from UC Davis, and a BA in Biochemistry from UC Berkeley.

 

ElizabetElizabet Kaisheva, PhD

Dr. Kaisheva has 25 years of drug development experience in the biopharmaceutical industry, focused on formulation and stability, analytical development and drug product development of therapeutics, vaccines and small molecules.  She has expertise in lyophilization, designing real-time and stress testing protocols, identifying and optimizing stability indicating assays, and managing fill/finish and supply chain vendors.  She has recently been consulting for companies in the US, Japan and India. Her most recent positions were Sr. Dir., Pharmaceutical Development at VaxGen and  Director at Protein Design Labs (currently Abbott) responsible for Formulation Development, Preclinical Supply and Stability Testing Groups.  Dr. Kaisheva has a PhD in biophysical chemistry and MS in biophysics, and numerous patents and publications.

 

R-KawahataRussell Kawahata, PhD

Dr. Kawahata has 30 years experience directing the development and manufacture of biologics and small molecule NCE’s, including CMC strategy, tactical planning and execution for R&D programs from research through market launch.  He managed in-house and contract CMC development and manufacturing including API/drug substance, drug product, formulation and process development, clinical and commercial supply and regulatory submissions.  He has managed contract manufacturing in both international and domestic locations, and held executive positions with a wide range of technical management responsibilities in small, dynamic biopharmaceuticals companies.  Most recently Dr. Kawahata served as VP, Pharmaceutical Science with Neurogesx, and previously VP, Technical Development and Operations with Intermune.  He holds a Ph.D. in Pharmacology from UC Davis, and a BS in Biochemistry from UC Berkeley.

 

Patty H. Kiang, PhDPatty H. Kiang, PhD

Dr. Kiang specializes in pharmaceutical packaging and delivery devices for liquid and lyophilized products, prefilled syringe systems, and CMC support for combination products. Patty helps clients selecting or developing prefilled syringe and injection devices, identifying and managing fill/finish CMO vendors, and managing assessment of extractables and leachables for primary container closure systems and in-process components such as single-use containers. Patty was Head of Device Development for Genentech and led the development of a new autopen injector for human growth hormone. Prior to joining Genentech, she held positions as Director, Drug Products for Schering Plough, and Director of Technology Development for West Pharmaceutical Services in Lionville, PA, a developer and manufacturer of parental drug packaging components, where she collaborated with corporate partners in Japan and Germany in the development of various new products. Patty is a member of the faculty of the PDA’s Training and Research Institute, where she teaches courses on Prefilled Syringe & injection devices and Parenteral Packaging; she also served has committee or conference chair for USP Packaging Expert Committee, PDA Sterilization of Polymeric Materials Committee and PDA Global Prefilled Syringe & Injection Device Conference. She was president of the Chinese Bioscience Association in Northern CA – 2011, Dr. Kiang holds five patents in the field of polymeric surface coatings. She received a Ph.D. in Analytical Chemistry from Villanova University and holds an MBA from Pennsylvania State University.

 

D-NelsonDenise Nelson

Ms. Nelson has been providing quality system and CMC-regulatory consulting services to pharmaceutical, biopharmaceutical and medical device firms for nearly 20 years.  She has implemented GMP-compliant QA systems in startups, supported gap analysis and remediation efforts for PAI and for commercial products, and is an experienced auditor, familiar with international and FDA requirements.  She has expertise with small molecule, peptide, protein, DNA, antibody, vaccine, and radiolabeled drug products, manufactured using parenteral, solid and liquid oral, transdermal, and topical dosage forms.  Prior to consulting, Ms. Nelson served as Director, QA/QC with Celtrix and as Sr. QC Microbiologist with Berlex.  Ms. Nelson received a BS degree in Biochemistry from UC Davis.

 

G-RothGeorg Roth, PhD

Dr. Roth has over 20 years of experience in the biopharmaceutical industry. After graduating in Chemical Engineering at the Technical University in Berlin, Germany, he worked for German and US companies mainly in the process development of biologics. At Berlex Laboratories (now part of Bayer AG) he worked predominantly on protein therapeutics and viral gene therapy vectors and served on the scientific advisory committee. As Director of Technical Affairs at Dynavax he was responsible for the development and manufacturing of therapeutics and vaccines. In 2008 he founded his own consulting company leveraging his experience with due diligence, audits and managing CMOs. He has worked on all CMC aspects of selecting mammalian and microbial cell lines, developing protein therapeutics from recombinant and natural sources, conjugating PEGs and oligonucleotides to proteins and VLPs and the manufacturing of viral vectors for gene therapy and vaccine applications.

 

William (Bill) TurnerWilliam (Bill) Turner

Bill Turner has over 20 years of experience in the regulatory and quality management of vaccine, adjuvant, antibody, and small molecule drug development – early pre-clinical through product licensure and launch.  His specialty is developing and executing worldwide regulatory strategies; he led the filing of numerous Investigational New Drug Applications (IND), Clinical Trial Applications (CTA), Biologic License Applications (BLA) and Marketing Authorisation Applications (MAA).  In addition, Bill has established and managed phase-appropriate quality systems for all phases of drug development.  His most recent experience was as the Vice President of Regulatory Affairs and Corporate Quality Systems at Dynavax Technologies from 2006 through 2013.  He previously headed the Regulatory departments for Neosil, Inc and MedImmune Vaccines and is an experienced member of executive teams.  Bill provides regulatory and quality assurance guidance and operations for small and medium sized companies.

 

Additional Resources

Alava BP has agreements with additional contractors and consultants to provide the following capabilities:

 

Project Management

Alava has project managers with extensive experience in the pharmaceutical, biotechnology and medical device industries, supporting development projects from discovery into development, commercialization and life cycle management.  Alava will work with your internal project managers and executives to coordinate CMC with clinical and other activities, or supply CMC project management services to achieve the best outcomes for your project.

 

Upstream Process Development and Manufacturing

Alava team members bring decades of cell culture engineering and tech transfer expertise, including Pharma and commercial product experience relevant to biosimilars.

 

Cellular Therapy Development and Manufacturing

Alava team members helped pioneer the development of stem cell based therapeutics at Systemix. More recently, our lead consultant led the development of a late stage autologous cellular therapy, and directed operations for four years at a commercial cellular therapy contract manufacturing firm.

 

Small Molecule Development and Manufacturing

Alava can manage the outsourcing of small molecule manufacturing to US or overseas suppliers. We can also provide scaleup and tech transfer support, and mechanism-based troubleshooting of process, yield or impurity issues. Our lead consultant developed numerous commercial projects for major pharma and has supported dozens of manufacturing projects as a consultant in addition to publishing a book on best practices in synthetic chemistry R&D. We have experts with particular expertise in peptide manufacturing and drug-device combinations.

 

Facilities, Equipment and Quality Systems

An Alava expert with over 20 years of experience is available to support facility and equipment evaluation, qualification and cleaning validation, along with related quality system support such as remediation of 483 and audit observations. Another team member specializes in QA information systems and 21 CFR Part 11 compliance.

 

Manufacturing Operations and Supply Chain

Alava has manufacturing, facilities and operations experts from Manager through VP level. We can support Operations strategic planning, supply planning and COGS analysis, logistics, interim management, or person-in-plant activities. Our Clinical Supply Chain experts will work closely with your clinical operations team to achieve timely and well-controlled delivery of clinical trial materials.