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June 9, 2021 || 9:30am-5:30pm EDT
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Process Progress: Staying Ahead of Challenges

Bioprocess technology implementation is hard. Get ahead by getting it right.

How do you know if you’re making the right decisions about bioproduction technologies?

There is no universal path to success. As a decision maker you are tasked with figuring out how to move forward from development to production in the most efficient way possible, while facing regulatory pressure and a need to trust the partners that support you. We get it. Our job is to make your job easier.

Join us at Process Progress ‘21 to gain insight, intel and inspiration. Understand how Thermo Fisher's industry knowledge, global manufacturing network, and best-in-class portfolio can help you anticipate and prepare for production challenges. Advance your projects by applying unique strategies—including adaptive innovation and tailored solutions—to your greatest challenges. When you’re developing vaccines and biotherapeutics, you need a partner who's committed to improving workflows, finding efficiencies, and increasing quality, while providing regulatory support to bring your life-changing products to market faster. This is what we do, because ultimately, your success is our success. Together, we’ll reach new frontiers—and together, we’ll pave the way forward.

 

What to Expect

Insight

  • Deep dive into today’s challenges and learn best practices from thoughtfully chosen industry leaders including regulatory experts, biotech strategists, and a patient’s perspective. Participate in live Q&A sessions focused on accelerating process development, adoption of innovative technologies, and tackling the challenge of assurance of supply.

Intel

  • Investigate the technologies and techniques required to scale up production and accelerate speed to market to meet patient needs.

Inspiration

  • Log on to participate in live sessions, explore solutions, deep dive into technical content, and network with peers. You will log off with a valuable mix of ideas and solutions to help you tackle the challenges of next gen biotherapeutic manufacturing.

Speakers

Show Resources
Agenda
Speakers

  • Scott Gottlieb, M.D., CMS
    Physician, Former Commissioner of the FDA (2017-2019); Former Senior Advisor, CMS; Contributor, CNBC & Face the Nation
    Biography

      Scott Gottlieb is an American physician who served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb's work focuses on advancing public health through developing and implementing innovative approaches to improving medical outcomes, reshaping health care delivery, and expanding consumer choice and safety. He is a resident fellow at the American Enterprise Institute, a member of the board of directors of drug makerPfizer, a member of the board of directors of the biotech company Illumina, a contributor to the cable financial news networkCNBC, and a partner at the venture capital firm New Enterprise Associates. Since March 2020, Dr. Gottlieb has also been a frequent guest on CBS's “Face the Nation” to discuss the COVID-19 pandemic.

      Dr. Gottlieb is an aggressive advocate for advancing the health of patients, promoting healthcare access, and driving innovation. The agency's historic and prolific advances in new policy distinguished his tenure as the FDA's commissioner, in addition to a record-setting number of approvals of novel drugs, medical devices, and generic medicines. Under his leadership, the FDA advanced new frameworks for the modern and safe and effective oversight of gene therapies, cell based regenerative medicines, targeted drugs, and digital health devices. The FDA implemented new reforms to standardize drug reviews and make historic improvements of post market data collection and the use of real-world evidence. They promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises.

      Previously, Dr. Gottlieb served as the FDA's Deputy Commissioner for Medical and Scientific Affairs and before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services, where he helped advance policies to improve healthcare quality and promote the effective use of new medical technologies.

      Dr. Gottlieb is widely published in leading medical journals and periodicals, including The Wall Street Journal, The New York Times, Forbes, and The Washington Post. He has held editorial positions with The British Medical Journal and The Journal of the American Medical Association. Fortune Magazine recognized him as one of the “World's 50 Greatest Leaders” in 2018 and 2019. Modern Healthcare named him amongst the “Most Influential Physician Executive and Leaders” in 2018, 2019, and 2020. TIME magazine named him one of its “50 People Transforming Healthcare” in 2018.

      Dr. Gottlieb lives in Westport, Connecticut with his wife and three daughters.

      PRESENTATION INFORMATION
    • Peter Dashwood
      MS&T Lead at Cell and Gene Therapy, Catapult
      Biography

        Peter is the lead on tech transfer and innovation projects on the MS&T agenda for the Cell and Gene Therapy Catapult Centre in Braintree, a new and interesting project. He works with with CMO's, technology providers and organisations to ensure that Cell and Gene Therapy Catapult is a true world leader in its manufacturing technology development capability.

        PRESENTATION INFORMATION
      • Nikki Nogal, Ph.D.
        Senior Consultant, CMC Consulting, Latham BioPharm Group
        Biography

          Dr. Nogal leads pharmaceutical Process Development at Lathambiopharm Group (LBG) helping clients generate, secure and execute on grants and contracts for the production of biopharmaceuticals (API, mAbs, vaccines, therapeutic proteins and enzymes). She is a biotechnology professional with more than twenty years in pre-discovery through lifecycle management of mature products, leading CMC projects that contrasted from “fast to market” or “quick to clinic”. She also supports the Strategic and Non-clinical Consulting sector offerings at LBG providing subject matter expertise and advisory services on pharmaceutical product development, strategic business development, and due diligence to clients. 

          As a Senior Engineer at Genentech (Roche), she led process sciences operations to optimize commercial scale performance and global investigations for drug substance manufacturing, applying Quality by Design (QbD) concepts to process improvement, quality decisions, validation and audit risks. At Gilead, Dr. Nogal supported upstream process development for several late-stage clinical manufacturing campaigns of several high value new molecular entity. Her responsibilities also included internal/external technology transfer into GMP/commercial manufacturing for production of biotherapeutic proteins. 

          Dr. Nogal graduated with BS and MS degrees in Chemical Engineering from the University of Maryland and her PhD in Biomedical Engineering from Florida State University. She completed postdoctoral training at Johnson & Johnson Pharmaceutical R&D, and the University of California San Diego in Pharmacology and Bioengineering. Currently Dr. Nogal is an adjunct professor at the University of California San Diego's graduate drug development department where she teaches courses in Biologics and Biosimilars Drug Development and Biopharmaceutical Program Management.

           

        • Eric Langer, MSB
          President and Managing Partner, BioPlan Associates, Inc.
          Biography

            Eric has over 25 years experience in life sciences market assessment, valuation, marketing, management, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies and is an experienced biotechnology strategist; he and his team have advised 100s of companies on marketing strategy development, valuation, pricing and message strategy, and have developed strategic plans based on quantitative analysis of market trends and buyer needs.  In 1989 he co-founded BioPlan Associates, Inc. to provide strategy, valuation services, pricing, and market analysis to biotechnology and healthcare organizations.  As Strategy Advisor for the International Mergers and Acquisitions Partnership / Falls River Group of life sciences investors, he provides insights and valuation services to investors and senior managers to maximize shareholder value.  He teaches graduate biotechnology marketing at Johns Hopkins University and biomedical valuation to the NIH Graduate School; he has developed courses in commercialization and marketing, and seminar programs including ROI in the Life Sciences.  He has published, edited and authored numerous books and texts. 

             

             

            PRESENTATION INFORMATION
          • Ho-Young 'Grace' Lee, Ph.D.
            Cell Therapy Analytical Development Group Leader, Senior Scientist, Genentech
            Biography

              Ho-Young ‘Grace' Lee is a Group Leader for Cell Therapy Analytical Development at Roche/Genentech. Her group supports release and characterization assay development, qualification/validation, assay transfer, regulatory filing, and control strategy in close collaboration with process development, research, QC, and other preclinical teams. Previously, she was a group leader supporting diverse pipeline projects including monoclonal antibodies, bispecific antibodies, ADC, TDC, and T cell immunotherapy projects for bioanalytical development and has published multiple bioassay papers. She received her Ph.D. at Stanford University and finished her postdoctoral research at UC Berkeley, focusing on research areas in synthetic biology, metabolic engineering, and RNA biology.

              PRESENTATION INFORMATION
            • Matthew Moon
              UCAR-T Therapy Patient
              Biography

                Matthew is a regular guy from London. He was 25 years old when his Mum insisted on taking him to the accident and emergency department as he was looking very pale and hadn't been feeling well for several weeks, something he put down to his rather hectic lifestyle. What he didn't know at the time was that he was suffering from Acute Lymphoblastic Leukemia (ALL), a cancer of the blood.

                What began as a reluctant visit to the accident and emergency department was the start of a journey leading Matt through several rounds of chemotherapy, two bone marrow transplants, cerebral fluid injections, a liver infection and two bouts of neutropenic sepsis. This resulted in being offered palliative care and being given a projected time to live of 3 months. That was four years ago.

                PRESENTATION INFORMATION
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