Pharma in a Postmodern World
It’s hard to ‘do’ science in a world where, increasingly, data and evidence matter less and less. What will the limit be of all this? And how will it impact our industry over the next several years?
- VP Project Solutions, Black Diamond Networks
- Science & Public Health Task Force
- Professor of Public Health and Healthcare Economics
- Healthcare Futurist
Ben Locwin is a healthcare executive and industry expert. His work has involved bringing new and innovative medical treatments (drug therapies, vaccines and medical devices) to patient populations with unmet needs across a variety of indications and health conditions. He has also worked with investors on the ‘next big things’ in the industry. He has been featured in The Wall Street Journal, Forbes, USA Today, The Associated Press and other top-tier media.
Robust Outsourcing Relationships
Forming positive partnerships with contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) is vital for meeting corporate deliverables. This presentation covers the following essential topics to ensure robust outsourcing relationships:
- Defining the Outsourcing Relationship (SOWs/RFIs and RFPs/Vendor Qualification Questionnaires/FTEs versus FFS)
- Developing the Outsourcing Relationship (Relationship Team RASCI/Defining Two-way Expectations/Outlining Communication Mechanisms)
- Maintaining the Outsourcing Relationship (Risk Assessment Reviews/KPIs and Scorecards/Rewards and Recognition)
Ellie Krasney, Senior Director of Analytical Operations, Eidos Therapeutics
Ellie Krasney is Senior Director of Analytical Operations at Eidos Therapeutics (an affiliate of BridgeBio Pharma, Inc.). She has over 34 years of analytical R&D pharmaceutical experience in companies including GlaxoSmithKline, Sterling Winthrop Pharmaceutical Company (was part of Kodak), Pfizer and Akebia Therapeutics. Her areas of expertise include management of the analytical chemistry relationships with CROs/CDMOs, strategic sourcing and outsourcing processes, due diligence and outsourcing governance.
In her current role, the combined Eidos analytical development and quality control team is responsible for the strategic management of globally outsourced analytical studies from method development to registration stability testing for small molecule drug substances and products. Ellie is the past-chairperson of the American Association of Pharmaceutical Scientists’ (AAPS) outsourcing community. She is also on the advisory board for Women in the Enterprise of Science and Technology (WEST). Ellie has a B.A. in Chemistry from the University of Virginia and a M.S. in Chemistry from Vanderbilt University.
CRO Landscape Trends — Sponsor Demand, Sector Growth and the Impact of COVID-19
Clinical development sponsor reliance and demand for outsourcing services continues to grow. At the same time, the CRO landscape is consolidating and maturing. This session presents new and updated data on landscape trends, growth strategies and changes brought about by COVID-19, the shift to decentralized trials (DCT), and acquisitions and mergers among major players.
- New Tufts CSDD research on CRO market trends and major player strategies
- Insights into future growth areas and service areas that are maturing
- Discussion on the implications of these trends for CROs and the industry as a whole
Emily Botto, Research Analyst, Tufts Center for the Study of Drug Development (Tufts CSDD)
Emily Botto joined the Tufts Center for the Study of Drug Development (Tufts CSDD) as a Research Analyst in October 2020 after graduating from Brandeis University. Her work focuses on studies relating to clinical research execution strategies and practices as well as clinical trial diversity and inclusion. In her time at Tufts CSDD, she has been published in Applied Clinical Trials for her research on the effect of remote and decentralized clinical trials on global monitoring regulations and practices, as well as in Therapeutic Innovation in Regulatory Science for her work in participant and staff diversity. She is currently working on earning her master’s in public health at Tufts University.
Critical CMC Issues for CGT Products
Chemistry, Manufacturing and Controls (CMC) issues have proven to be a significant hurdle in both early and late stages of the Cell and Gene Therapy (CGT) product development and regulatory approval. This talk will provide an introduction to CMC issues for the CGT products and an awareness of the critical development issues from a regulatory perspective.
Gautam Ranade, Founder and Principal Consultant, PharmaFalcon Consulting
Gautam Ranade, Ph.D. is an active consultant to the pharmaceutical industry and a member of several technical advisory boards. He was a senior director (pharmaceutical sciences) at Pfizer Worldwide R&D, where he directed the development of multiple commercial, parenteral dosage forms; and managed the GMP sterile manufacturing facility for small molecules and biologics. He is well-versed in sterile product development, dosage form development, novel drug delivery and outsourcing. He is a member of the ASGCT, the ISCT and AAPS. He is the inventor for 19 US patents related to pharmaceutical product development.
Challenges in Manufacturing and Quality Assurance in the Cell and Gene Therapy Space
Cell and Gene Therapy (CGT) is a comparatively new modality and differ considerably from traditional pharmaceuticals. For autologous CGT, each batch starts with cellular material from a single patient that goes through a selection/purification process followed by activation, expansion and cryopreservation. The cryopreserved material is then thawed and infused back into the same patient. The manufacturing and quality challenges for CGT include very short product cycle times, maintaining a robust Chain of Identity, setting up a reliable manufacturing site, scaling out, and very short batch review and release times. These and other challenges will be discussed at the presentation.
- CGT is an emerging modality in the pharmaceutical industry and brings in challenges very different from those of traditional pharmaceuticals.
- Meeting CGT challenges requires development of new processes, business models and unique approaches to Quality Assurance.
Marazban Sarkari, Head, Cell and Gene Therapy, Quality Assurance, GSK
Marazban Sarkari, PhD, is Head of the Cell & Gene Therapy Quality Assurance group at GSK and manages their quality operations at multiple CMOs and internal sites. Previously, he led the CGT external quality assurance (QA) team at Iovance Biotherapeutics, helping build their quality systems and operations teams. He is a chemical engineer by training and has more than 20 years’ experience in outsourced pharmaceutical drug product manufacturing, and formulation and analytical development covering both large and small molecules. His teams have been involved in vendor selection, contract negotiation, project management and process scale-up and optimization.
Previously Marazban has held positions in commercial and technical operations, process and formulation development and engineering at Teva, Cephalon, Endo Pharmaceuticals and RxKinetix gaining a broad experience in the outsourcing of formulation and analytical development as well as the manufacture of clinical and commercial API and drug products. He has presented and published in the areas of process development, vaccine formulation, novel drug delivery technologies, process optimization and monitoring.
Building Efficiency in Pharma Operations Through Automation and Data Analytics
A strong partnership between contract manufacturing organizations (CMO) and sponsors is critical for long term business success for both parties. It’s relevant for both entities to understand not only the business needs and objectives, but also the operating model, strengths and specific nuances around the individual businesses, systems and procedures. This talk will uncover some of the key success factors for a meaningful and solid relationship between CMOs and sponsors.
At the same time, this presentation will uncover how data analytics and automation in pharmaceutical operations has helped organizations, including CMOs and contract research organizations (CROs), improve operation efficiency and compliance across multiple functions including manufacturing, supply chain, quality assurance, distribution and delivery. This portion of the talk will also discuss some specific examples around pharma operations where organizations have benefited.
- Strengthening the CMO-Sponsor bond
- Data analytics and automation in pharma operations
Mayank Nagar, Vice President & Head of Technical Services and New Product Launches (North America) Dr. Reddy’s Laboratories Inc.
Mayank Nagar is a Pharma professional with over 25 years of global leadership experience in pharma operations, consulting, compliance and quality management systems. He has been employed with pharma corporates and advisory companies and provided services and solutions to broad range of companies/clients including innovators, generic manufacturers, biopharmaceutical companies, startups and global health organizations. His contributions include enabling new product launches, analyzing technical and business risks, developing operational strategies and helping to overcome regulatory crisis to achieve business targets.
Mayank is an accomplished professional in liaison and analytical skills with the ability to work in a multi-cultural environment. He has successfully handled several cross cultural/international responsibilities at various locations in India, the U.S., Ireland, Romania, Brazil, South Africa and Malaysia.
A Period of Rapid Change: COVID – Fast to Come, Fast to Go
The CDMO industry is rapidly evolving both because of, and in spite of, the demands of COVID. CDMOs have significantly expanded capacity, added capabilities, ramped headcount and invested in production redundancy. We’ll look at the upside and downside of COVID, growth rates and evolving strategies.
David H. Windley, CFA, CPA, Managing Director, Jefferies LLC
Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 20-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a 6-time Starmine award recipient. Dave is involved in the Nashville financial and healthcare community, serving on boards of the CFA Society Nashville and Owen Graduate School of Management. Dave also enjoys mentoring start-up companies. Dave earned his Masters of Business Administration from the Owen School at Vanderbilt University and his BA from Transylvania University. Dave is a CFA charter holder and certified public accountant.
Minimizing Risk in Sponsor-Contractor Relationships: A Regulatory Perspective
No matter the size of your company, some services in production, testing and distribution are inevitably outsourced to entities outside of your organization. The GxP regulatory environment has guidance around these outsourcing arrangements that is clearly outlined in both 21 CFR 211 and FDA guidance, with the bottom line that the manufacturer’s Quality Unit is responsible for approving or rejecting products or services provided under a contract (§ 211.22(a)). The Quality Systems Approach to Pharmaceutical CGMP Regulations assigns accountability to Senior Management as well as specifying that “[i]t is critical in a quality system to ensure that the management of the contractor be familiar with the specific requirements of the contract.” According to FDA guidance, the quality and compliance oversight of this arrangement must ensure that “the contract firm’s and contracting manufacturer’s quality standards should not conflict.” This concept may be overlooked in the race for cost savings, and potential other business drivers. In actions directed at contracted service providers, language is often used that demonstrates clearly that outsourced providers are considered to be an extension of the sponsor. In his presentation, Charles Koon will discuss the current regulatory climate with respect to enforcement actions focused on the sponsor-contractor relationship and will highlight “watch outs” to minimize risk for your organizations.
Charles E. Koon, M.S., Senior Associate at Lachman Consultant Services, Inc.
Charles E. Koon, M.S., is a Senior Associate at Lachman Consultants with three decades of progressive pharmaceutical experience. His broad background encompasses all aspects of Quality along with extensive experience in due diligence, business integrations, third party oversight and management, learning and development, team building, and remediations both domestically and internationally. He specializes in global GXP compliance for all types of pharmaceuticals (oral solid dose, aseptic, biopharmaceuticals, liquids, gels / creams / ointments, combination products) and medical device.
Keeping Quality Levels High in your CMO Relationships
While the gradual shift towards virtual operations has been slowly marching onward since the invention of the Internet, it has become
much more highly focused over the past two years since the pandemic caused this move to shift into high gear. The pharmaceutical industry in particular now finds itself in the midst of a move towards virtual global pharma, with many smaller pharma companies operating on a virtual basis, outsourcing main functions ranging from manufacturing to distribution and sales, and doing so on a global basis with an increasingly large network of contract manufacturing organizations (CMOs) in the U.S., and throughout the EU and Asia as well.
Bill Connell, Principal, Supply Chain Practice Leader, Tunnell Consulting
Bill Connell is Principal, Supply Chain Practice Leader at Tunnell
Consulting. He has more than 30 years of life sciences experience in the areas of supply chain strategy, planning and optimization, operational excellence, CMO selection/management and technology solutions such as ERP, product serialization and e-pedigree. His leadership skills and specialized insights have consistently delivered positive results, operational improvements and improved client profitability and performance. Bill can be reached at firstname.lastname@example.org.