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    Interview with Julia Apple-Smith, Manager of Employee Development at Sauer-Danfoss Ames, Iowa about Facilitation Skills:

    Q: Would you tell me a little bit about the culture at Sauer-Danfoss?

    Julia: About nine years ago, Dave Pfeifle, President and CEO had a vision for us to chang
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    e our culture. We, at one time, were part of the Sundstrand Corporation, and as such, over time, had evolved into a company that was fairly autocratic and not very customer focused. It was not only Dave’s vision for that to change, but it was also a time when our customers were beginning
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    to let us know that if that was the way we were going to do business, they were going to need to find other companies to provide the same type of product that we provide. Dave’s vision then became what is now known as Reaching for Excellence. It is not a program. It is our company’s visi
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    on statement. It represents our philosophy of who we are. There was not a training program here at that time. Part of Dave’s vision was to have a learning base to help promote and support that kind of cultural changes. It’s really been an evolutionary process over the last eight or nine
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    years. It is something that CMOE has played and integral part in.

    Q: How did your relationship with CMOE begin?

    Julia - One of the first things we did was to preview the Coaching Skills Workshop in California. We decided that it was a class that we wanted to bring in-house. That clas
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    s and a Customer Awareness Class, that I created, were really the cornerstone classes for what now has become one of our core courses in the whole training program. As time evolved, we continued to build on that foundation of learning with other classes such as Teamwork I and Teamwork II a
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    nd other types of learning. So there was a lot of internal training going on.

    Q – Can you tell me about how Facilitation Skills came about?

    Julia – About five years ago, I was getting feedback from team leaders, facilitators (supervisors), and when I sat in on meetings, it was clear th
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    t we were still struggling. We had structured ourselves into teams throughout the organization, but we struggled, when we got people together, to make those meetings as effective as possible. From (my) observation and from feedback, it was very clear that we needed to be doing some thing
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    to build on the Coaching Skills training to give these people some skills on how to facilitate a group. Coaching, I think does a superior job of giving people skills for one-on-one coaching situations. You can even apply a lot of those skills to a group session, but we really wanted somet
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    hing that was more specific to facilitating groups. So a couple of managers went with me to Des Moines to preview a two-day class on Facilitation Skills, and we found that it was pretty typical of what is out there in the industry. We wanted more of what I would call the soft side or the
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    behavioral side of group facilitation. In other words, when people were facilitating groups, they wanted to enhance involvement, help to focus the group without directing the group, how to help the group feel good about what they were doing and actually have fun with it, while helping the
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    group be more effective and efficient.

    Even as we started to develop this Facilitation Skills program with CMOE, we struggled. Early on, I remember getting on the phone with Steve Stowell to just talk out some of the issues because it was so different from anything either of us had seen i
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    n the consulting industry. Steve and I continued to struggle with how we should put this course together, and what it should look like, because for me, it is really on that soft side. It is not a skill. It’s being able to use your intuition and read a group and read the dynamics in a gro
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    up and know how to react to the flow of what is going on in a group, and pull people in or help to redirect other people if they are not contributing in a positive manner, again without controlling the group.

    Q – So is there just not a lot of material out there on Facilitation Skills?

    Ju
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ia – There is a lot of courses out there on Facilitation, but nothing like what CMOE has created. If you look at what is out there on the market they don’t have the same focus that CMOE’s course does. A lot of what we were seeing out there under the name of Facilitation Skills is really m
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    eeting management. There is a big difference. This is really more facilitating group interaction or ‘high performance’ facilitation.

    Q – What is the target audience for Facilitation Skills?

    Julia – The plan was that it would end up being for everybody. The original goal was to first g
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ive the skills to management, and then give it to all employees. When managers were first going through the course, the feedback we got was that it would be extremely useful for the team members to have the same skills. It would make facilitating the group so much easier if everyone under
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    stood what was going on in terms of task, climate, and behavior.

    Q – Can you see any improvement in your facilitators as a result of being committed to the Facilitation Skills Workshop?

    Julia – Absolutely! The people that were in the first class have definitely noticed an improvement in
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    their facilitation skills. We haven’t done any structured observations, but just from our ad hoc types of settings where they are leading the group and I am a part of the group, I have definitely seen an improvement. I think it plays out, not only in terms of a structured meeting, but al
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    so in how they go about doing their jobs on a day-to-day basis, because the principles that are taught in Facilitation Skills, as with Coaching, go beyond just the structured setting. Yes, I have seen a lot of improvement in those people, and it mainly has to do with their confidence level


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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