Tuesday, March 25, 2014

BDP Week: Takeaways from Day One

Today kicked off Biopharmaceutical Development and Production Week in San Diego.

Here are just a few highlights from today's sessions:

Peter H. Calcott, President, of Calcott Consulting LLC shared that the key content found in any quality agreement should be: purpose/scope, terms (including effective date and termination clause), dispute resolution, responsibilities including communication mechanisms and contracts and change control and revisions.

Fi Alonso-Caplen, Ph.D., the Senior Director, Biotherapeutics & Vaccines Outsourcing at Pfizer, Inc. explained that the guiding principles for externalization that should be taken into consideration are -quality, risk, cost, time, flexibility and adaptability. However, cost is not a major driver. There is consideration for cost in relation to expertise.

Sonia Kansal, Ph.D., Senior Manager, Biotherapeutics & Vaccines Outsourcing at Pfizer and Frank Marchesani, Business Development Executive at Cook Pharmica LLC took a deeper dive into their partnership, which they termed "partnersourcing". They put an emphasis in trust in their outsourcing relationship. This allowed them to streamline their tech transfer for all future projects.

Justin Skoble, Ph.D., Director, Biodefense and Process Development, Aduro BioTech spoke about their streamlined targeted process to hind the correct technology transfer partner. Their step by step methods for a CMO seletion process were:

  • • Define the critical selection criteria and create a list of suitable CMO
  • • Contacted CMOs to determine interest and availability
  • • CMOs prospectively ranked by stated capabilities
  • • Sent RFP to top 6 CMOS for each program
  • • 10 proposals returned
  • • Proposals ranked
  • • Site visits completed
  • • Top CMOs selected
  • • Quality audits scheduled
  • • Final selection made

Vincent Lau, Senior Supervisor, Cell Culture Development, Biogen Idec spoke about the internal technology transfer to an international biotechnology facility. Three things they discovered while moving the internationally were that it was key to have a single person to lead the tech transfer. This allows for simplified information to flow and maintain continuity between programs and relationship building was simplified. One of the negatives was it was difficult to ensure each program received right amount of attention.

We'll be back the next three days bringing you the key take aways from this year's event.  Do you see one of your big takeaways missing from this list?  Comment below!

Share this article with your social network, just click below to share now!

No comments :

Post a Comment