My Goal is to help Industry partners connect with real clinical guidance for informed strategy and guidance whatever stage of development or launch they are at.

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Karla F. Loken DO OBGYN, FACOOG

Dr. Karla Loken DO OBGYN, FACOOG

Dr. Loken is a board-certified OBGYN and is passionate about the intersection of clinical science and industry. Her first role in industry was in safety at Eli Lilly, which laid a strong foundation in Good Clinical Practice and safety standards. She moved on during COVID times to incorporate laparoscopic procedures and products at Hologic Inc. as the Vice President of Clinical Development, GYN Surgical Div. At Roche Diagnostics, she served as a Disease area partner. After working in big corporate roles, Dr. Loken found that helping more small companies was the most fulfilling work, and her ability to establish and maintain relationships across industries helps more innovations reach patients. She is a firm believer that the right advice early in product development comes from early interaction with clinicians who will ultimately use the end product or resource your company is designing. If it won’t change cost, patient outcomes, or significantly affect workflows, it won’t work. Dr Loken knows what it takes to get from concept to FDA clearance. Dr. Loken has helped companies get ARPA funding, Present abstracts, white papers, and gap analysis in HOER. She has worked on three diagnostic tests that are cleared and in Guidelines via her work at Roche, and two medical Devices that are cleared. She has overseen many more devices in PMCF pathways for both US and OUS markets. Dr.Loken is one of the only physician advisors who understands Diagnostics, pharmaceutical, and Device pathways.

Dr. Loken has practiced OBGYN since graduating from residency in 2003. She has been in private practice, where her focus was on minimally invasive gynecology and robotics. She proctored many medical devices and was involved in product development. She also traveled to China with FIGO as a guest lecturer on Contraceptives and is active on service committees within ACOOG. She then moved to Indiana as the Director of the Joshua Max Simon OBGYN Clinic and DiVinci Instructor for the St. Vincent OBGYN residency. After a really bad car accident ( For which she is now 100% healed), she found a mentor in industry who showed her how many physicians help make a global impact on medicine and that your brain and clinical mind are the most valuable tool we hold.

Clients and Partnerships/ Advisory relationships

Hello Wisp.inc

LevLane Advertising

Obi Health

Aspen Medical

Roche

Extaltis pharmacuticals

FemSelect

Lasa Heath

Med Virtas

Menohealth

HerMD

Baymatob

Cleo Diagnostics

Services: For Industry Partners:

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Explore a range of services designed to help you move forward with confidence, wherever your team needs help. From Ideas to Implementation

  • Fractional CMO

  • Advisory Board development

  • Medical Affairs Strategy Development

  • Clinical Trial Development

  • Regulatory Preparation and Planning

  • KOL development and training

  • Conference and Event Planning

  • AVAmed and Sunshine Act

  • CMO development - mentoring

  • Device Summitives

Dr. Loken’s 20 plus years of clinical work, and her unique industry experience across Pharma, Diagnostics and Medical Device helped her develop the ability to bring strategy & connections to both large and small teams, & to work across silos at the intersection of Medical Affairs, and Clinical Development on project based work or as a fractional CMO.

Get In Touch

If you're interested in working with Loken and Associates, complete the form with a few details about your project. We'll review your message and get back to you within 48 hours.

Explore a range of services designed to help you move forward with confidence, wherever you're headed next.

For Clinicians

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I maintain a curated directory of physicians interested in collaborating with industry. Whether you’re seeking project-based work, serving as a research PI, or pursuing a full career transition, I provide an initial consultation tailored to your current situation. Together we’ll identify and develop your transferable skills, clarify opportunities, and create a practical plan to advance your industry engagement.

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Complete Transformation, Real Impact.

Courses For Clinicians:

Transitioning to Industry- 4 sessions

  • CV design

  • Optimizing LinkedIn

  • Searching for the right roles

  • Interview skills

Interview Skills — Stand-alone one-hour sessions

The First 90 Days

Path to Promotion

Working Safely in Industry -Sunshine Act and AvaMEd and Good Clinical Practice

Let’s Work Together

Submit the inquiry form to initiate a conversation regarding tailored strategies for your organization. Consults are free. I do request that all clients give a $25 minimum donation to a women’s health charity of their choice in exchange for my initial feedback.