Monday, September 23, 2024 - Pre-Conference Workshops - ET (Eastern Time, GMT-05:00)
Monday, September 23, 2024 - Pre-Conference Workshops - ET (Eastern Time, GMT-05:00)
Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. They are introduced to the market at a lower price thereby enabling more patients to get treatment and to lower the medical treatment costs for society. I will share knowledge about some new techniques to enhance productivity whilst maintaining quality which is key to be able to successfully develop a biosimilar.
- David Vikström - CTO, Xbrane Bioscience
When I joined BioFactura over a decade ago, the biosimilar landscape was relatively unknown, yet cautiously optimistic. It was a good environment to raise adequate capital from high net worth individuals to begin the process of clone selection and process optimization for our first biosimilar candidate. As the company grew, along with the financial commitments for clinical trials, and the potential returns of biosimilar investment seemed less encouraging, one had to think out of the box in order to see our first asset successfully partnered. This talk will chronicle that journey and hopefully spark your own entrepreneurial spirit to see your therapeutics over the finish line!
- Jeffrey Hausfeld - Chairman of the Board, Biofactura
- Yanling Wang - Sr. Director of Synthetic Biology, Protein Expression, Henlius
- Qinghao Zhang - Senior Scientist, Process Cell Sciences, Merck & Co., Inc.
Objective: This comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
- Preeti Desai - Senior Principle Scientist, Sterile Product Development, Bristol Myers Squibb
- Kelvin Rembert - Senior Scientist - Drug Product Development, Replimune
- What to expect?
- Common pitfalls
- Navigating the patent landscape for biosimilars, including patent challenges and litigation strategies
- Developing effective IP strategies to protect biosimilar products and processes
- Charles Andres - Shareholder, Greenberg Traurig
- Approaches for efficient and consistent process development
- Case studies on Process Development challenges and Manufacturing scale up
- Overview and compoenents of next generation manufacturing
- Use of AI/ML assisted with QbD and PAT and its advantages
- Sanjeev Gupta - Sr. Vice President and Head Biosimilars, Ipca Laboratories
- Ken Baker - Senior Director, External Manufacturing, Fusion Pharmaceuticals
- Lior Shaltiel - CEO, NurExone Biologic
Objective: This comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
- Analytical technologies and testing techniques for early detection and prevention of aggregation in the formulation?
- Developing predictive models for looking at aggregation
- Doing a Lot With A Little: Formulation Studies on Low Product Volumes
The talk covers recent work aimed at establishing an understanding of fogging in freeze-dried (lyophilized) products. The severity of fogging in lyophilized products is impacted by a varied range of factors - formulation composition, pharmaceutical processing conditions and primary packaging. Hence, a systematic study to investigate the influence of each of these factors on fogging will enable a mechanistic understanding and consequently, the design of suitable mitigation strategies.
- Navpreet Kaur - Scientist, Biologics Drug Product Development, Sanofi
Examples of methods that are sensitive, specific, and capable of detecting minor differences between the biosimilar and the reference product.
- Alla Polozova - Director, Process Development, Amgen
- Justin Stebbing - Senior VP Clinical Strategy and Innovation, Graviton Bioscience
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Applications of generative AI within bioprocessing and next-gen therapeutics manufacturing
- Optimization of process parameters and product design for efficient production
- Ethical considerations and responsible development of AI in biomanufacturing – what to keep in mind.
Objective: This comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
One of the therapies which hold enormous potential for treating many terminal diseases includes protein-based therapies. Yet, the lack of universal technological approaches that enable the development of protein formulations with targeted attributes, blocks the clinical translation of these advanced therapies. This presentation explores and highlights a droplet-based microfluidic technology as an advanced platform for a streamlined screening and optimization of biotherapeutic formulations.
- Sabiruddin Mirza, PhD (Pharm.) - Senior Research Fellow, School of Engineering & Applied Sciences Harvard University
- Carl Mieczkowski - Scientist, ReCode Therapeutics
Although many new bioprocessing technologies have evolved over the past 40 years, biosimilars still tend to be made using their legacy production processes. However, the ability to precisely evaluate critical quality attributes in finished drug substances has also evolved. This capability can provide a pathway for adopting powerful new upstream and downstream production methods, where drug impacts can be controlled.
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
- What Are the requirements across several countries?
- How can we align requirements and gain approval across multiple regions?
- Why do the requirements differ so much?
- Potential of emerging modalities: the promise and potential novel therapeutics for the improved treatment outcomes, targeted delivery, and stability
- How will the difficulties in the manufacturing of these modalities be overcome with next-generation strategies and technologies
- Lessons we can learn from 'traditional' modalities to apply to emerging classes of therapeutics
- Strategies for navigating regulatory pathways and ensuring timely approvals when working with novel products
- Clinical development & adoption: hurdles around designing trials for novel therapeutics, and educating healthcare providers on benefits to encourage adoption
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Lior Shaltiel - CEO, NurExone Biologic
- Ken Baker - Senior Director, External Manufacturing, Fusion Pharmaceuticals
Objective: This comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
- Narendar Yeshwanth - Vice President of R&D and Innovation, Saint Gobain Life Sciences
- Nicolas Drolet - R & D Manager Bioprocess Solutions and Cell & Gene Therapy, Saint Gobain
- Example of inline mixing or real-time monitoring with process control strategies for product quality
- Non-Invasive Analytical Methods for Liquid Formulations To Reduce Contamination
- Using closed systems for sterility assurance and lack of contamination
- How to validate the process for regulatory requirements?
- Utilizing digital twin technology to simulate and optimize formulation and fill/finish processes, improving efficiency and reducing the risk of errors
- Leveraging AI and machine learning to predict formulation stability, optimize process parameters, and ensure consistent product quality
- What encapsulation techniques can prevent enzymatic degradation by stomach acid?
- Co-formulation techniques with molecules that can assist in absorption?
- How to maintain stability in the GI tract?
*This event requires a separate ticket which can be purchased at a discount during your conference registration*
The BWB Awards @ Biotech Week Boston brings together the faces and names that make the Boston community the beating heart of the biotech world.
This evening celebratory gala features a night of networking, food, drink, entertainment and recognition on September 23rd, 2024 in Boston. We're excited to roll out the red carpet and honor the top individuals, teams, and organizations that make the life sciences ecosystem vibrant and innovative.
Full details on the BWB Awards 2024 can be found at https://informaconnect.com/bwb-awards/