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9 am 5 pm (480 mins)

CMC Analytical, Comparability and Stability Studies

This course provides a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products from the preclinical phase through clinical trials to commercialization and post-approval. Analytical considerations for a wide variety of biopharmaceuticals are discussed, including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates). Details are presented on establishing and maintaining product reference standards, designing successful comparability tests (including specifics for biosimilar studies), setting meaningful product specifications, conducting forced degradation studies, technology transfer and bridging changes in analytical methods and generating effective stability protocols. Critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through cGMP are illustrated.

  • Course Instructor Nadine Ritter, Ph.D., Global Biotech Experts, LLC

9 am 5 pm (480 mins)

Introduction to Biopharmaceutical Manufacturing

This course provides a fundamental understanding of biopharmaceutical manufacturing. Organized along the development path, the course will describe the activities necessary to bring a biopharmaceutical from discovery to market. Included in the course will be the analytical, quality and regulatory challenges as well as the technical activities required. The instructors will discuss how development activities integrate and the best practices for drug substance and drug product production. At the conclusion of the course the attendee will have learned the steps needed to develop and produce a safe and effective biopharmaceutical that meets industry and patient needs. Identified during the course will be how to implement QbD in development and communicating with regulatory agencies throughout development.

  • Course Instructor Sheila G. Magil, Ph.D., BioProcess Technology Consultants
  • Course Instructor Frank Riske, Ph.D., BioProcess Technology Consultants

9 am 5 pm (480 mins)

Cell-Based Immunotherapies - From Concept to Commercialization

9 am 5 pm (480 mins)

Continuous Processing

9 am 5 pm (480 mins)

On Time and within Budget: Successful Program Management of Biologics Development – Tools, Techniques and Lessons Learned

Strong Program Management is critical to the successful completion of biologics programs. This workshop presents proven tools and methodologies while focusing on the idiosyncrasies of biotechnology. We will review the integration and management of R&D, CMC, preclinical and clinical programs from discovery to licensure/commercial launch. We will address partner and supplier management (CMOs, CROs…) as well as the securing and management of program funding (government and private equity).

Topics to be Covered:

  • Biologics Program Management
  • Shrinking development timelines
  • Cross functional integration
  • Working within smaller budgets
  • Becoming more virtual through partnering and subcontracting
  • Integrating biotechnology activities and organizations
  • CMO management
  • CRO management
  • Securing dilutive and non-dilutive funding
  • Peter Latham, Latham BioPharm Group, Inc., PgMP
  • Joshua Speidel, Ph.D., Latham BioPharm Group, Inc., PMP
  • Gretchen Stup, Latham BioPharm Group, Inc., PMP

9 am 5 pm (480 mins)

Modern CMC Regulatory Strategies and Insights - from Concept to Approval

On average, it still takes in excess of 10 years to develop a new biopharmaceutical drug product. It is estimated that the cost of developing a new biopharmaceutical drug product, and taking into account the > 90% failure rate, is over $2 billion. Conscious of this, the modern viewpoint is looking at ways in which to reduce this overall time and cost element. One strategy is to impart an approach of ‘accelerated development’ which, if done sensibly, can present an attractive and viable option. Quality focused planning, e.g. facilitated by quality by design, can also be used to potentially ‘shave off’ time to approval, whilst maintaining all important quality and regulatory maneuverability. Although faster development is attractive, regulatory aspects, particularly regulatory CMC also needs to keep up pace - which presents a number of difficult challenges. Pinch points:

  • Sometimes it may become necessary to ‘challenge the norm’ and push back on certain regulations, within valid reason.
  • FDA Breakthrough Therapy designation and EMA Priority Medicines (PRIME) designation provide an automatic ticket to enter the ‘fast lane’ - so welcome to the reality!
  • Above all it is still important to have a well authored and ‘watertight’ regulatory dossier by which the competent authority will review the drug product in order to issue final marketing approval.

This session provides an overview of modern regulatory CMC strategies which may be selectively applied for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the overall time and cost. This ‘interactive’ session will focus on biopharmaceuticals, biologics, ATMPs, vaccines and biosimilars. Collective team discussions, whiteboard exemplification and work-throughs will be made on key topic points.

Topics to be Covered:

  • Understanding of ‘the nature of the challenge’: from concept to authorization
  • Modern mindsets: Technically driven approaches: ‘accelerated development’ pros and cons
  • Be ready to ‘fast-track’- Breakthrough Therapy designation & Priority Medicines (PRIME); accelerated approval; ‘rolling’ submissions
  • Exploration of the lifecycle of the investigational and final dossier:
  • Breakdown of Timelines: Important Milestones
  • High level dissection of CTD module 3: IND/IMPD – BLA/MAA - essential content and structuring
  • The bridge between US and EU - important considerations
  • Navigation of the essential guidelines and building blocks: biopharmaceuticals, biologics, ATMPs, vaccines, biosimilars; objective strategies of each
  • Using Quality by Design to your best advantage
  • Rest of World (RoW) CMC / regulatory considerations.
  • Case Study of common issues: regulatory CMC
  • Richard Dennett, Ph.D., Voisin Consulting Life Sciences

9 am 5 pm (480 mins)

Supply Chain Security and Transparency from Starting Materials to Patient

Symposium Moderator and Opening Remarks

Introduction to Rx-360 and our Patient-Centric Work
Mark Paxton, CEO, Rx-360 International Pharmaceutical Supply Chain Consortium

Morning Session: Why Upstream Quality Matters

Supply Chain Mapping: Better Do it!
Rob Welsh, Vice President, Bioprocessing Segment Solutions, VWR and Rx-360 International Pharmaceutical Supply Chain; Consortium Board Member & Co-Chair of Supply Chain Security Steering Committee

Rx-360 Response to Supplier Qualification
Ben Mills, Pharmaceutical Technical Lead, British Standards Institution

What We Expect of Suppliers
Lucy Cabral, Head, Supplier Quality Management, Genentech, Inc.

Why Standardizing Quality Agreements and Supplier Assessment Questionnaires is Important
Rick Calabrese, Global Director of Corporate Quality Systems, Sartorius Stedim North America

Afternoon Session: Who are Your Trading Partners and Why?

Why Managing a Global Problem Cannot Be Solved Locally
Brian Johnson, Senior Director Supply Chain Security, Pfizer, Inc.

Amgen Efforts to Resolve Global Requirements
Tim Valko, Executive Director, US Supply Chain, Amgen, Inc.

Compliance with Good Distribution Practices: How Many Standards? 
David Ulrich, QA Director - Supply Chain, Abbvie

Where is the Last Mile, and Why Do We Care?
David Bang, CEO LifeConEx, DHL Global Forwarding

Cargo Thefts: Oh Yeah, They Occur!
Brad Elrod, Director, Global Conveyance Security, Pfizer Pharmaceuticals

1 pm 6 pm (300 mins)

Sartorius UniQure Site Tour

Sartorius will be hosting a Site Tour to the UniQure Facility in Lexington, MA on Tuesday, October 4th. Buses will leave the BCEC at 1pm and will return 6pm.  Please select the 'Sartorius UniQure Site Tour' option on the registration page if you would like to attend.  All registrations are subject to approval.

uniQure, a leading fully integrated AAV-based gene therapy company and the manufacturer of the first EU approved gene therapy product Glybera, has graciously offered to share its cutting edge Boston area manufacturing facility through a tour at BPI supported by Sartorius Stedim Biotech. The innovative facility construction implemented a design build process in just 10 months and is capable of simultaneous multi-product production at BSL-2. Capabilities include cell bank and seed stock production, DS production,  DP filling and final product packaging. The facility showcases single-use production scale rocking motion and stirred tank bioreactors up to 500L and a custom automated vial filling system. Please join us for an evening of cocktails and appetizers along with a facility overview and tour. 

View the Lexington Site Layout at: https://lifesciences.knect365.com/bioprocessinternational/sartorius-uniqure-site-tour

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