WORKSHOP DAY - MARCH 3RD

 
The Festival of Biologics USA will begin with an afternoon of workshops, taking place on the 3rd March from 1pm, finishing at 4pm .
 
This workshops and panels will be on challenging topics across the antibodies, immunotherapy, clinical trials and biosimilar industries, with an additional session being run in conjunction with SDCPI, the San Diego Centre of Precision Immunotherapy. 

Across the afternoon, there will be 16 workshops, as well as the SDCPI seminars, run by leading experts in their field, and are available to all fully registered attendees, speakers, sponsors and exhibitors.
 

LAST TICKETS REMAINING - BOOK NOW

 

 

 
 

 

13:00 - 13:45 AI for antibody drug discovery and development

  • An overview of how AI is currently used for in silico antibody discovery and development
  • Real life examples of how this is currently used, with challenges and case studies
  • Workshop on how AI can be implemented into the antibody industry
Stanley Krystek , Senior Principal Scientist, Bristol Myers-Squibb

Dana Filoti , Senior Scientist, NBE Analytical R&D, AbbVie
Sandeep Kumar , Senior Research Fellow, (Biotherapeutics) and Group Leader, Boehringer Ingelheim
Qing Chai , Principle Scientist, Lilly Biotechnology Center

13:45 - 14:30 Current approaches and future trends in antibody discovery

  • Immunization-dependent and -independent Approaches to Ab Discovery
  • Strategies for Early Screening and Assessment of Antibody Candidates
  • Format and Developability Considerations in the Antibody Discovery Process
  • Brainstorming Discovery Approaches for Complex Targets
Anusuya Ramasubramanian , Scientist, Sanofi

14:30 - 15:15 Women in Science – panel discussion

  • Experiences that have influenced thinking around gender in the workplace
  • How companies are promoting diversity in the workplace
  • How can we advocate change, successes and challenges?
  • How can male advocates help?

Chaired by: Marilyn Kehry , Vice President, Cell and Functional Biology, AnaptysBio

PANELLISTS:
Marilyn Kehry
, Vice President, Cell and Functional Biology, AnaptysBio
Jill O’Donnell-Tormey , CEO and Director of Scientific Affairs, Cancer Research Institute
Stephen Demarest , Senior Research Fellow, Protein and Antibody Engineering, Lilly Biotechnology Center
Line Ledsgaard
, Research Assistant, Technical University of Denmark
Heidi Chokeir
, Managing Director, Canale Communications

15:15 - 16:00 Investment in antibody therapeutics panel

  • Panel session lead by senior investors, actively investing within the biologics industry
  • What do investors look out for in start-ups?
  • What are the current trends for biologics? 
  • Where do we see the industry moving to in the next 5-10 years?
  • How can you gain investment?

Moderated by: Stuart Collinson , Partner, Forward Ventures 
Kevin Johnson , General Partner, Medicxi
Bruce Steel , Managing Director, BioMed Ventures

Marc Nasoff , Biologics, Chief Scientific Officer, Centre of Innovation (COI)
 

13:00 - 14:00 Progress and challenges in the design and clinical development of microbial therapies

  • Influence of the gut microbiome on autoimmunity
  • Gut microbes and immunotherapy responses
  • Leaky Gut Syndrome in autoimmune diseases – a potential target for therapy
  • Success in a probiotic trial in Irritable Bowel Syndrome – a new therapeutic perspective targeting the dysbiosis and beyond
  • Designing multi-targeted bacterial therapy – what tools do we need?

Shahram Lavasani , CEO, ImmuneBiotech

14:00 – 16:00 San Diego Center for Precision Immunotherapy (SDCPI) - A series of short presentations by members of the SDCPI

Moderated by:  Ezra Cohen , Associate Director, U.C. San Diego Moores Cancer Center
 

Immunotherapy for cervical cancer clinical trials: what we know, and what we are still searching for
  • Rationale for immunotherapy in cervical cancer
  • Review of clinical trial outcomes
  • National clinical trial ongoing design
  • Rationale for immunotherapy biomarkers and early response prediction 
Jyoti Mayadev , Associate Professor, Chief, Gynecology Oncology Radiation Services, UCSD 
 
 
Title TBC
Sonia Sharma , Assistant Professor, Director Division Cell Biology, La Jolla Institute for Immunology 
 
 
Demystifying the IND: regulatory pathways to accelerate patient care
  • Learn about the “nuts and bolts” of an IND
  • Learn about expedited regulatory development pathways
  • Discuss regulatory strategies to optimize timelines
Elaine Eng , Senior Regulatory Advisor, UCSD
 
 
Clinical trials combining Radiation with Immunotherapy
  • Goals and future directions 
Andrew Sharabi , Assistant Professor, UCSD
 

 

 

 

13:00 - 13:45 Partnering with patient advocacy organizations to bring the patient voice into the development of clinical trials

  • Strategies for determining which advocacy organizations to partner with
  • Tactics for bringing in the patient voice early and often
  • Getting buy-in from Sr. leadership on the importance of advocacy relationships and inclusion of patient voice

Beth Zaharoff , Director, patient Focused Drug Development, Tesaro
Sheryl Lapidus , Director, Corporate Affairs and Patient Advocacy, Tesaro

14:30 - 15:15 Complex innovative designs in clinical trials

  • Design, implementation, and oversight of innovative clinical trials 
  • Benefits and challenges
  • What makes them more innovative than sequential designs?  
  • What can you do now that you couldn’t before?

Smita Asare , Executive Director, I-SPY Trials

15:15 - 16:00 Emerging markets and disruptive technology in clinical trials

  • How can blockchain and AI transform drug development?

Adama Ibrahim , Associate Director, Performance Operational Capabilities, Global Clinical Operations, Biogen
Representative from Embleema TBC

 
 
 
 

 

 

13:00 - 13:45 Analytics and innovation  - ​The role it plays in the current and future state of biosimilars 

 
Julio Baez , Former Head of Technology, Cipla BioTec
Tamal Raha , Lannett Company Inc
Steve Lehrer , Biologics Leader, Lannett Company Inc
Nathan Lewis , Professor, Systems Biology Research Group, UCSD

13:45 - 14:30 WHAT can the US derive from policy and strategy across Europe in promoting biosimilar uptake?

  • Who are the stakeholders and what benefits are to be gained from a positive approach to biosimilars?
  • How have professional healthcare  bodies help deliver the biosimilar agenda in Europe?
  • What policy approaches across Europe have driven market uptake?
  • What are the barriers and how can they be overcome
  • Are their any strategic difference in the delivery of healthcare in the US that need to be considered by biologic companies
 

Chair:  Maggie Dolan , Associate Director market Access EU Biosimilars, Biogen
Alain Vertès , Managing Director, NxR Biotechnologies GmbH

Kalveer Flora , Specialist Pharmacist Rheumatology and Biosimilars, London North West University Healthcare NHS Trust

14:30 - 15:15 Implementing modern Cell engineering and Process development approaches for affordable and sustainable biosimilar manufacturing

  • General Overview of Biosimilars/ Biologics and opportunities for the Biopharma players
  • Implementation of Gene editing tools CRISPR and TALENS for cell line engineering  and  production improvement
  • Modern approaches for high producer cell line and robust upstream process development
  • Use of cutting edge technologies to improve biosimilar development and manufacturing 
  • Factors influences protein expression and critical quality attributes including glycosylation of monoclonal antibodies 
  • mAb glycosylation and its overall Impact on biosimilarity and product performance
  • Case studies on titer and  quality improvement at clone and process level for affordable biosimilar development

Sanjeev Gupta , General Manager -Advanced Biotech Lab, Ipca Laboratories

14:30 - 15:15 Panel discussion: Clinical trials – do we need them to get biosimilars approved?

  • Clinical trials vs pharmacology studies, what does the current FDA and EU guidance say?
  • Clinical pharmacology studies: efficacy & safety
  • Future possibilities 
  • Q + A with the audience
Gerry Hoehn , Medical Director, Oncology, Teva
Ruediger Jankowsky , Managing Director, Cinfa Biotech
 
 
 
 

 

GET INVOLVED AT THE  FESTIVAL OF BIOLOGICS USA

 

To Sponsor Or Exhibit

 

Derek Cavanagh
derek.cavanagh@terrapinn.com
t/ +44 (0)207 092 1297

 

 

 

To Speak

 

Joan Shutt
joan.shutt@terrapinn.com
t/ +44 (0)207 092 1134

 

 

 

To Register

 

Tayyab Abbasi
Tayyab.Abbasi@terrapinn.com
t/ +44 (0)207 092 1210