Biomanufacturing World Summit

Biotech Business Bootcamp – Treating Cultural Sclerosis…

Biotech Business Bootcamp – Treating Cultural Sclerosis…

  • Repetitive engagement survey results with no sustainable action plan for improvement?
  • Meeting mania dominating each and every day?
  • Data, metrics, KPI’s, and scorecards – Thermometers or Thermostats?
  • OPEX tools and governance models that feel abstract and disconnected?

Struggling with any of these symptoms? If so, your organization is suffering from Cultural Sclerosis. While not fatal, it is debilitating. Fortunately, we have developed a ‘Sustainable Treatment Plan’ based upon 25 years of work with organizations including GSK, Pfizer, Genentech, Gilead, and Alcon that will drive Clarity, Connectivity and Consistency into both your team and leadership culture.

Shane A. Yount is a nationally recognized author, consultant, and principal of Competitive Solutions, Inc., an international Business Transformation consulting and software firm. Shane’s team pioneered the acclaimed organizational governance system known as Process Based Leadership® (PBL) – A robust governance methodology designed to create a sustainable cadence of clarity, connectivity, and consistency. Shane’s ability to diagnose inefficient governance models and quickly design and deploy solutions that accelerate and amplify team performance has made him and his firm long-term partners with such organizations as Genentech, Pfizer, Alcon, Roche, GSK, Meridian Medical Technologies, and many others. Since 1991, Shane has led the offices of Competitive Solutions, Inc. while publishing three best-selling business novels. His latest novel, Leading Your Business Forward is required reading within many leadership development curriculums being taught within industry today.

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

  • Offering an overview of how breakthrough therapy designations have historically worked and how that process is changing
  • Are we as an industry ready for major changes in how drug development is expedited?
  • Discussing how our organizations’ Quality Culture must be an integral part at all stages of this transition
  • Working with all stakeholders to ensure we do not sacrifice safety and quality as we increase the pace of innovation
  • What should we be doing right now to prepare for the future of these developments?

Christie Bielinski, Vice President of Product Quality Management at Janssen Pharmaceuticals, leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product. In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage

  • Advantages of smaller more agile organizations’ ability to react to patient, regulatory & market pressures
  • Discussing internal innovations in production technologies and working with external partners to do the same
  • How do we adapt our leadership, organizational structure and people management strategies?
  • Lean implementations as a Smart Risk management tool
  • Leveraging collaborations with big pharma to foster innovation and increase speed to market


Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.


Tina M. Larson is Vice President of Technical Operations at Achaogen, a biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. Ms. Larson is accountable for Process Development, Manufacturing, Supply Chain, Quality Assurance and In Vitro Diagnostic Devices. Prior to Achaogen, she was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science and Technology, Process Development, and Global Business Operations. Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe. She was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star. Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.

Ashraf AmanullahVP of Biologics Development and Manufacturing of aTyr Pharma, is a drug development and manufacturing executive with more than 20 years of demonstrated leadership experience in global pharma and biotechnology organizations, with expertise in process development, technical operations, cGMP clinical manufacturing, commercialization and life cycle management of antibody therapeutics, vaccines, gene therapy, cell-based therapeutics and recombinant proteins. Prior to joining aTyr Pharma, Ashraf was Senior Director at Gilead Sciences where he built a world class CMC organization, Director of CMC Development at Genentech. Prior to Genentech, Ashraf held various positions at Merck & Co. Inc. over nine year tenure, with responsibility for process development, cGMP manufacturing, and technology transfer and commercialization of vaccines. He is the author of 55 peer-reviewed publications, and his work has been presented at over 90 conferences. Ashraf received his Ph.D. in Chemical Engineering from The University of Birmingham (UK) and conducted post-doctoral studies with The University of Birmingham, Novo Nordisk, Merck & Co. Inc. and University College London.

Mayo Pujols is currently VP Global Head Car-T Operations and Technology at Celgene located in Summit, New Jersey. Prior to Celgene, he was the SVP of Technical Operations at Advaxis, Inc., a clinical-stage biotechnology company located in Princeton, New Jersey. He leads a team responsible for manufacturing, quality operations, process/analytical development, engineering, supply chain/logistics, and project management. Prior to this role, he was Advaxis’s VP of Technical Operations. Prior to that role he was Executive Director of Technical Operations at Merck supporting the vaccines and biologics franchises. Mayo has also worked in a number of other global and domestic roles throughout his career, including the areas of technology transfer, new product launches, validation, regulatory submissions/inspections, commercial/clinical manufacturing, and quality assurance/systems at Astra-Zeneca (MedImmune), Schering-Plough, and Merck.

Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead of Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics. She began her career at Aviron working on vaccines for EBV, PIV, and influenza (FluMist®). She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy. Dr. Hoffmann returned to vaccine work by joining VaxGen, working on process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia® (abatacept) into the Celltrion manufacturing facility in South Korea. Dr. Hoffmann joined Sutro in February, 2011 and currently heads CMC and directs outsourced cGMP manufacturing for protein therapeutics and ADCs.

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

  • Investing capital in capacity expansion when a drug is early in development is challenging. There are new manufacturing models that reduce risk and add value to your decisions through a concept called optionality
  • Balancing options and critically evaluated risk against probability of success in to-build decisions
  • Introducing a new biomanufacturing solution that leverages manufacturing ecosystems to reduce the need to build infrastructure
  • Effectively transfer non-value added work from the manufacturing site to service providers with this new manufacturing model

Daniel Palmacci has nearly 20 years of leadership experience in Biologics in the area of manufacturing, technical development, supply chain, and Operations Management. He is a member of Novartis Biologics Leadership Team and is Technical Operations Head of Austria’s Country Executive Committee. In his previous role he was the Head of Biologics External Supplier Organization that manages all Contract Manufacturers (CMO) for the cross divisional network of Novartis, Sandoz and Alcon. Daniel was also responsible for Technical Development Project Management organization. As a Member of Sandoz Biologics Executive Committee he managed all TechOps activities (end to end) by coordinating internal and external manufacturing and supply chain to ensure supply of commercial Biosimilars. Prior to joining Novartis Daniel worked for BayerHealthCare for several years in positions with progressively senior roles in leading cross-functional teams responsible for Production, Manufacturing Science, Technical development, Operational Excellence, Supply Chain, Quality Assurance and Engineering.

Development of Biologics in China for Global Markets: Lessons From Wuhan, China

Development of Biologics in China for Global Markets: Lessons From Wuhan, China

  • Discussing the approach required to success in the unique business environment of the region
  • Walking through recent changes in the regulatory and operating environment in China
  • Offering lessons learned by JHL Biotech, a biologics development and manufacturing firm with headquarters in Taiwan and a commercial-scale production site in Wuhan, China
  • Highlighting JHL Biotech’s path to rapidly building and operating two production facilities in Asia, with an emphasis on JHL’s use of modular and single-use technologies to accelerate facility construction and accelerate product timelines

Racho Jordanov
CEO & Co-Founder
JHL Biotech Inc.

Racho Jordanov is Co-Founder, President, and CEO of JHL Biotech, a biologics development and manufacturing firm headquartered in Hsinchu, Taiwan. Mr. Jordanov started his biopharma career at Genentech in 1981, where he became a leader in technical operations. In addition, Mr. Jordanov has held senior leadership positions at Serono, Cholestech, and Telios Pharmaceuticals. Mr. Jordanov earned his B.S. in chemical engineering from the University of California, San Diego and his M.B.A. from National University, San Diego.


Establishment of Efficient Cell Culture Supply Chain through Partnerships

  • Understanding GMP production of biologic therapies is a long-term commitment throughout the life-cycle of a product
  • Discussing how for CDMOs this includes developing strong relationships with suppliers
  • Demonstrating the importance of a solid supplier partnership, from early stages of technology implementation, is essential for long-term success
  • Illustrating a successful Supplier-CDMO relationship in action using GE Healthcare and FUJIFILM Diosynth Biotechnologies as an example
  • Showcasing how this partnership rapidly added cell culture manufacturing capacity through the implementation of single-use production systems

Jeff Carter
Strategic Projects Leader
GE Healthcare

Dr. Carter has been a supplier to the bio/pharmaceutical manufacturing industry for over twenty years, and he has been with GE Healthcare Life Sciences since 2005, serving in R&D and Marketing capacities. He has served in R&D, product management, and acquisition integration. His present role as Strategic Projects Leader is to serve as an internal and external voice for evolving regulatory and de facto expectations related to the global implementation of single-use manufacturing. He has been active in organizations such as the Parenteral Drug Association, ASTM E55, and ASME-BPE, and is first vice chair and technical pillar lead of BPSA. He is presently co-leading BPSA efforts, in conjunction with BPOG, to develop best-practice stimuli on single-use Change Notification and User Requirements. Dr. Carter holds a PhD degree from Penn State University in molecular microbiology.

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

  • What are we doing today to get ready for the realities of our industry a decade from now?
  • Debating what we will need in terms of leadership, people, technology, territory, and resources to grow into new markets with new products in an ever-changing regulatory landscape
  • Is the answer steady growth, or improving agility and versatility, or some third option?
  • Making the case that our industry needs to work together better as individual actors on a shared stage

Kimball Hall serves as the Senior Vice President and Head of Drug Substance Biologics Manufacturing and is a member of the Genentech Executive Committee (GEC). Prior to joining Genentech in 2016, she previously worked at Amgen in a variety of leadership positions, most recently as the Vice President for Manufacturing of the Future, where she established advanced manufacturing facilities in Singapore that utilize disposable upstream technology. Kimball’s organization is responsible for managing the biologics drug substance supply – the active ingredient that gets filled at the drug product sites before delivery of the medicines to our patients. The biologics network is comprised of six sites in North America, Europe and Asia. At Genentech, she sponsors the Operational Development Rotational Program and is an advisor to the Genentech Women’s Professional Group.


Leveraging Global Change to Create Strategic Opportunity —and Design a New Future— for Manufacturing and Supply Chain Leaders

  • Discussing the global forces shaping the healthcare environment. How is the industry’s current business model being questioned and the definition of innovation shifting?
  • Understanding how the evolution of patients, consolidation of customers, and pressures on cost will accelerate while new players continue to enter the industry and redefine our paradigms
  • Shedding light on the impact of these changes on manufacturing, quality, and supply chain
  • Making the case that the strategic opportunity for our leaders has never been greater
  • Sharing examples of how Teva is taking a leading role in shaping our new future

R. Ananth (Raghunathan Ananthanarayanan) has more than 30 years of experience in the global pharmaceutical industry as a senior leader specializing in business development, R&D, manufacturing, regulatory affairs, sales and marketing, strategic sourcing, and mergers and acquisitions. Since December 2014, Ananth has been President and Chief Executive Officer of Teva Active Pharmaceutical Ingredients (TAPI), and was additionally appointed head of the company’s Biologics Operations in July 2016.

Prior to joining Teva, Ananth was a member of the management council at Dr. Reddy’s Laboratories Ltd., where he was President of Pharmaceutical Services and Active Ingredients. Ananth previously was a management committee member at Piramal Healthcare as the President of Pharma Solutions for APIs and Finished Dosage.

Earlier in his career, Ananth held several senior-level positions across multiple geographies at Galpharm International Ltd., Zydus Cadila Healthcare Ltd., Wockhardt Ltd., and Rhone-Poulenc Rorer.

Ananth earned a doctorate in Pharmaceutical Technology from the University of Mumbai in India.

Digital Transformation with Business Impact for Manufacturers

Digital Transformation with Business Impact for Manufacturers

Chris Dobbrow, the Senior Vice President of Sight Machine, spoke at the Biomanufacturing World Summit in San Diego, CA in November 2016. His presentation was entitled:

Digital Transformation with Business Impact for Manufacturers

  • Proving that the most valuable data in manufacturing is from production itself
  • Choosing the right goals and outcomes to make a difference
  • Connecting disparate IT systems together into a unified whole
  • Building a scalable approach for the enterprise, step-by-step: Start small to go big
  • Understanding why data lakes and bespoke projects don’t scale
  • Illustrating successful projects with concrete examples
Bringing a Quality Focus to CMO Management

Bringing a Quality Focus to CMO Management

Walter Cespedes led a roundtable lunch and learn discussion about bringing a quality focus to CMO management at the  2016 edition of the Biomanufacturing World Summit. We asked him a few questions about how it went.

Walter Cespedes is a seasoned executive with over 28 years of industry Quality experience. Mr. Cespedes serves as Executive Director, Third Party and Commercial Quality Americas for Teva (Actavis).  Prior to this appointment, he served as VP Corporate Quality for Durata Therapeutics, Inc.  Mr. Cespedes has also held a position as a Senior Director of Corporate Quality Assurance for MEDA Pharmaceuticals. Prior to his work at MEDA, he held Quality Assurance roles at Pfizer, such as Quality Operations Supervisor, Senior Manager for Quality Operations, and Drug Product Assurance Team Leader. Earlier in his career, he worked for Roche Diagnostic Systems, Inc., Hoffman La-Roche, Inc, and Biocraft Laboratories, Inc. Mr. Cespedes is a graduate of Seton Hall University and earned his Masters of Science in Executive Management from the New Jersey Institute of Technology.  He now serves on the board of NJIT College of Science & Liberal Arts.


The Role of Manufacturing in a Successful Biosimilar Strategy

Peter Moesta spoke on November 15th at the 2016 edition of the Biomanufacturing World Summit. His keynote presentation was entitled, The Role of Manufacturing in a Successful Biosimilar Strategy.

Peter Moesta has more than 30 years of experience in the biopharmaceutical industry and a strong understanding of manufacturing and launching complex biologics. Before joining TPI, he was senior vice president of Biologics Manufacturing at Bristol-Myers Squibb, where he oversaw the development, production and worldwide launch of numerous significant biologics, including oncology products Yervoy and Opdivo. Previous to this role, Peter held various leadership positions in biologics development and manufacturing at Abbott Laboratories and BASF AG.

The Role of Process Development in Next Generation Biologics Manufacturing

The Role of Process Development in Next Generation Biologics Manufacturing

Alison Moore delivered the opening keynote on November 15th of the 2016 edition of the Biomanufacturing World Summit entitled, The Role of Process Development in Next Generation Biologics Manufacturing.

Dr. Alison Moore is Senior Vice President, Process Development serving both Operations and R&D organizations. Prior to this role, Moore served as senior vice president, Operations Technology. Moore was previously vice president, Process and Product Engineering (P&PE) function, where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.