Spring 5-2017 Newsletter

Spring 5-2017 Newsletter

Spring Newsletter 5-2017


Kinexum Services Innovation team recently assisted a global pharmaceutical company with their evaluation of complimentary digital technology to assist their commercial team as they moved “beyond the pill”.

The Kinexum Innovation team was comprised of our Innovation Practice Lead, Elizabeth Whalley-Buono,  a clinical and outcomes specialist, a market and medical device specialist, and a human factors specialist. After learning about the challenge the innovation team formulated and detailed a Digital Technology Evaluation Process (D-TEP) for the client.  The D-TEP process was designed as a funnel taking Digital medicines and other product candidates through a three staged process. In the process candidates would be reviewed, assessed, and researched to determine if the product candidate should be moved to the commercial side for thier review or abandoned.

In the end, the client was very happy with the outcomes and planned to review with senior management.

To learn more contact Steve CaseyorElizabeth Whalley-Buono

Quality with good intent

By Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Confessions from the real world.  I worked with a virtual client for many years, submitting regulatory documentation to regulatory agencies, writing SOPs, and conducting external audits of their contract research organizations (CRO); clinical vendors, and investigator sites, etc. Everything was on track for the investigational product development, until the client received a Form FDA 483.

What happened?

The client purchased a marketed product taking over a New Drug Application a year earlier and neglected to submit the quarterly safety reports to the FDA.  FDA came to inspect and noted the following:

• There is no Quality Plan- (there was a plan but the VP of Quality had not signed- thus no

plan).  This is often one of the FDA's top findings.

• Contractual agreements with Contract Manufacturers were not complete or signed.

• Safety reports had not been submitted within the required timeframe.

• A medical director (safety officer) resigned and there was a lapse of a several days before


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By Giora Davidai, MD

I would like to discuss two projects that illuminate the same issue, what is the optimal scope and size or an NDA package.

When I worked for Glaxo Welcome I was involved in the development of a second drug for a neurological indication.  The first drug of the same class has been developed and successfully commercialized by GW several years before.  At the same time another pharmaceutical company was developing a similar drug.  We had designed a very comprehensive phase III package with the intention to sail through the FDA approval process and serve as solid basis for commercialization. 


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The newest members of the Kinexum team

We would like to introduce:


Giora Davidai, MD

Clinical Development 

To learn more about Giora



Monalisa Chatterji, Ph.D



To learn more about Monalisa

Thomas Seoh

Business Strategy & Management

To learn more about Thomas



Michael Trautmann, MD

Clinical development & EU Regulatory

To learn more about Michael

Rob Walsh, MD

Medical Device & Clinical development

To learn more about Rob




Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Project Management & Clinical Operations

To learn more about Julie

Simon Bruce, MD

Clinical development

To learn more about Simon

Contact us:

Kinexum Services LLC

PO Box 1260

550 East Ridge Street

Harpers Ferry, WV 25425

P - 304-535-3037

F - 304-535-3166