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Getting To and Through FDA with Bill Hodnick

We recently caught up with Bill Hodnick, Product Development Champion at Facet Life Sciences about what it is like to work at facet and some of his favorite milestones.

Favorite Projects

I’ve worked on a lot of interesting projects at Facet Life Sciences. One of particular interest was for an imaging agent.  We ultimately helped the client file an NDA for it and it got approved.  This agent will be used to assess a rare pediatric disease.

The other project, actually two projects, are for targeted radiotherapeutics to treat various forms of cancer.

What gets me out of bed is that I’m helping companies ultimately bring new treatments, whether they be drugs or diagnostics or devices that improve peoples’ lives.


What Kind of Companies Does Facet Life Sciences Work With?

They’re small companies.  They can be people that either come out of academia and started a company, or they’re a company that bought tech or intellectual property.  They’re looking to us to help them beyond reading the same guidance documents that we know and probably have memorized good parts of it.  Collectively, the Facet team brings  a depth of knowledge and experience to our clients.  Meetings with the FDA are very formal and structured which can be a bit daunting.  It’s been likened to going to the principal’s office when you’re a kid.  We’re comfortable with the meeting process and we understand how to carry on a productive meeting and get useful feedback to help the client continue move forward or to get them moving forward again, such as helping getting the client’s off clinical hold.

The majority of our clients have limited regulatory experience because they’re usually small and relatively new.  They’re often companies that haven’t gotten a product through to market yet.  These are the companies  that really need our help because they don’t necessarily have all of the regulatory affairs experience and infrastructure in house.


What Do You Like About Working at Facet Life Sciences

Hands down, Facet is the best company I’ve ever worked for.

I feel really appreciated for what I you bring to the table and for what I contribute.  The corporate culture is very positive; we all get along great. The whole company is transparent in terms of what it’s doing.  So, what you don’t get are things going on at the C-level in the background and all of a sudden things get sprung on you.  We already know what the goals are, where we’re heading as a company, and what we can do to contribute.  We’re asked what we can do to contribute for ideas, effort, and so forth.

We’re a team.  We’re all in the same boat and we sink or sail together.  You know that your efforts are recognized and appreciated.


How is Facet Different?

In terms of the value added, what we do not say, “okay, here are all the boxes you need to check, and once you check all these boxes, you’re good to go.”  What we try to discover is which boxes our clients really need to check, and which they do not need to check.  Then we get agreement with the regulatory agency (FDA), confirming that we only have to check those boxes proposed so things can move along more efficiently in terms of time and money.

As I said previously, the Facet team has quite a breadth of knowledge and experience.  Facet has quite a brain trust.  That’s good for the client.  It’s also good for me personally because I’m learning things from others.  It helps me in terms of my knowledge base, my career, and things that I can share with clients and use in the work that I’m doing for clients.

The management structure is pretty flat, which means everyone is fairly accessible.  It means all team members have a say in what kinds of projects we take on.  As opportunities come in, we are asked collectively “Do we want to do this?”  Then we all decide if this is something we as a team would like to take on.


What Do You Love Best About Your Work?

The science is the most interesting part – that and the strategy.

I really focus on what has the most impact for Facet clients; the scientific and strategic approaches that we bring to our clients.  We are seeking ways to either make the client’s program more efficient to get them to the clinic and ultimately to the market sooner.

I like that my colleagues are so collaborative and the fact that we can sort of bounce ideas off each other.

What gets me up in the morning is what I’m doing, what I’m contributing not only to the company and to my career, but the world at large.  This is why I went into science to a large degree.  I like knowing that I am making a contribution to moving medical practice, and science forward.

The other thing is, I’m just a geek and this stuff’s interesting to me.  It also helps that Facet really is the best place I’ve ever worked.


What is the culture like at Facet?

You get good feedback, and it’s clear that management as well as my colleagues appreciate what I contribute.  You’ll hear, “great job,” or ”we’ve impressed the client and convinced them that we are the company they want to work with.”  You hear these kinds of things often, not just on rare occasion.  You’re always getting thanks and positive feedback and the team is always willing to help.

There’s this sense that we all are Facet Life Sciences.  Even though you may be the project lead or you’re contributing to this client’s project,  it’s also Facet’s project, and it’s the team’s project, and being successful helps us all.  That’s something you don’t see a lot in a lot of companies.  Most people do their work and you do your part and that’s it.

There are perks like the merchandise store where were treated to fun company stuff.  There’s a great deal of flexibility when it comes to taking care of your life outside of Facet.  You’re treated like adults and everyone knows they can count on you to get the work done.  There’s a great deal of mutual respect.

How Does the work you do at Facet Life Sciences help Clients Get to and Through the FDA?

Our impact is twofold.  One is providing either strategic advice or regulatory advice to say, “yes, you are  on the right path” or “here’s a better path.”  The other part is what I would call the day-to-day of regulatory affairs; things like preparing the various submission documents and shepherding that through to the FDA, contributing to FDA meetings with Facet being the mediator.  Facet does most of the communicating  with the FDA.  We always go into an FDA meeting with a well-organized plan.  This way we get everything we want across to the FDA, we get to answer the questions asked by the FDA, and we get the information that we need to help move the client’s program forward.

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