2017 Chem Outsourcing Conference For Pharmaceutical Professionals, outsourcing pharma.#Outsourcing #pharma

Posted On Mar 20 2018 by

outsourcing pharma

Why should you contract the services of a second CMO during Clinical Stage Drug Development? Several recent cases underscore the importance of the added expense.

Deborah Minor, Ph.D.

Drug Discovery Alliances

Pharmaceutical Outsourcing Professional

(Formerly Bristol-Myers Squibb)

Round Table Two

During early and mid-stage development, a balance must be struck between planning for success and managing attrition of drug candidates, in order to be adequately prepared to move forward (in the event of success) or to cut losses (in the event of attrition). How this is best done depends on many variables, including sponsor culture, budget, risk tolerance, and the science. This round table will discuss participants’ experiences negotiating these competing but inevitable priorities.

Stuart G. Levy, Ph.D.

SGL Chemistry Consulting

Round Table One

  1. How much power the PM has (strong vs. weak model)
  2. Why the PM’s true value often comes out during crisis situations and during development there are going to be surprises.
  3. How much science do the PMs know. What is there manufacturing/analytical/business background
  4. Why PMs have to be able to go to the mat
  5. Why the PM tools are not going to make the PM

Head of Business Development US

Dottikon ES America, Inc.

Round Table Two

Categorization of HPAPI molecules and how it differs across the industry based on sponsor or CMO and the data available; How to best avoid cross contamination looking at facility design and equipment including considerations for risk assessment when determining where to manufacture.

Associate Director, Business Development

Round Table One

We all realize that pharmaceutical services cannot be itemized like a widget. However, in reality, there are many service offerings that clients want pricing on over and over again. In the current competitive pricing environment (Amazon, Trivago, etc. ), the pharmaceutical service industry lags behind, only showing pricing after confidentiality agreements signed and when specifically asked for a quote. Let’s discuss the pro’s and con’s of making pharmaceutical service pricing more transparent.

Bob Wenslow, Ph.D.

Vice President, Business Development

Round Table Two

Catalysis is used very frequently in drug development. Ggram quantities of chiral ligands are sold to pharma for their screens. When a ‘hit’ occurs, they ask for 100g in a scale up, followed by 10 kg runs. For instance, a catalyst was developed or a customer a few years ago; it was eventually scaled to 750kg for the commercial production of Januvia (their diabetes drug). All big pharm and many biotechs use ligands and catalysts.

Johannes Schranck, Ph.D.

Leading Scientist Catalysis

Round Table One

Continuous flow manufacturing has advantages over traditional batch production. It guarantees that the ideal “reactor” is available for each step in the process including the mixing of starting materials quickly, ensuring the correct stoichiometry everywhere, heating, cooling, addition of reagents, and removal of product. It also provides for the use of hazardous chemicals and extreme reaction conditions. Quality by Design (QbD) is built into the system as there is a high level of process control and reproducibility. Continuous processing using small-scale equipment results in improved energy and material use as well as increased capacity. What if you didn’t have to “scale up” but could “number up”?

Brittany Hayes, Ph.D.

Business Management Director, API

Round Table Two

Solid State science is a corner stone of drug development that could significantly impact the vital physical properties such as solubility and dissolution rate as well as API and drug product processability. Furthermore, it could extend the lifetime of the drug through IP protection. When should we do the solid state studies and what kind of studies should we undertake?

Mahmoud Mirmehrabi, Ph.D, PEng

Solid State Pharma Inc.

Round Table One

Modern pharma research rarely uses the go-it-alone approach. In-sourcing refers to the growing model where companies bring in scientists from an outside organization; they work side-by-side with the company’s internal team to enhance their project resourcing. We will share our experiences across multiple collaborations and seek open discussion among the participants.

  • Team management options: Should the insourced personnel operate as a sub-team or be fully integrated throughout the department’s scientists.
  • Scientific expectations from insourced vs internal employees? The same or different?
  • Coordination between organizations: What if the company wants to hire members of the insourced personnel?
  • Maintaining team cohesiveness between internal and insourced personnel: Challenges and successes in maintaining a harmonized team ethic.
  • IP Management: What risks may be introduced with “outside personnel”?
  • Typical costs of insourcing vs. internal or outsourcing

Jeffrey Albert, Ph.D.

Round Table Two

Our supply chain is long, convoluted and globalized. Our drug discovery and development efforts depend on timely and predictable availability of starting materials and key intermediates. Just how secure is our supply chain and how can we make it . more secure?

Round Table One

The FDA now allows for several forms of expedited pathways for serious conditions. In many instances this forces Phase II to become the defacto Phase III. This often requires that the process and method employed during Phase II manufacture to be viable for validation or at the least validation readiness within a very short time frame. It also can force initial commercial supply to be manufactured with less than optimized processes and methods. There is development work that can be done early to be prepared for expedited review but this comes at a cost. An open discussion of experiences would be helpful to many involved in the development process to be aware of what has worked and what has not for those who have experience with expedited development programs.

Last Updated on: March 20th, 2018 at 2:59 am, by

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