The Life Science Effect

After recording a dozen takes of me reading from a script, my audio editor and I decided to just have a conversation about what this show is supposed to be about. He is shy so he edited out all of the pieces where he is talking. So, I hope you like the sound of my voice as much as I do. Because here is where I make my case for why you should tune in every week. TheLifeScienceEffect.com

Hugh Devine, Dir. Bus. Dev., Promedim and co-Founder Caledonian Informatics

As Director of Business Development for Promedim, Hugh oversees the company's sales and growth strategy. He is trained in US & EU IT Regulatory requirements and has led pilot projects for key IT systems within the regulated space. He has significant experience in Product/IT Design Control Validation, Data Centre qualification, Product/IT Quality Strategies, System Implementation and Support for the Life Science and Health IT Industry. Hugh has led high growth startups in both the US and EU and has extensive experience in strategic planning and partnerships to help develop and resource customer solutions. Hugh holds a Bachelor of Science Honours degree in Technology and Business from the University of Strathclyde in Glasgow.

Caledonian Informatics - https://www.caledonianinformatics.com/

Caledonian Informatics was founded in Scotland in 2017 by Life Science professionals in the US & UK. Our goal is to provide the Life and Health Science sector with a partner who understands the regulatory rigor necessary to develop and maintain health and patient impacting software.

Caledonian Informatics supports a host of international companies, we specialize in SaaS and Cloud enabled platforms while ensuring regulatory standards such as IEC62304 are followed and adhered to.

Our team can deliver a full application or augment an existing team all the while ensuring that when your software is ready your compliance burden is met.

Our significant experience in the FDA & MHRA regulated markets, and the NHS, has enabled us to bring a wealth of knowledge and pragmatism to the UK and EU IT/Software development space.

Promedim – https://www.promedim.com

Promedim's medical specialists provide comprehensive oversight for clinical trials using advanced cloud-based technology.

Our service combines industry-leading physician management technology with 24/7 real-time access to medical expertise.

Don't let his unassuming character fool you. Euan Cameron is a force to be reckoned with. After years making other peoples' projects happen, he had an idea. To transform how healthcare providers think about using digital health to add value - for the patient and for the bottom line.

Euan and Steve have a great conversation about motivation and drive; risk management; and loving what you do more than the reward that come with it. It's not what you are, it's who you do it for...

Cohesion Medical was founded by Euan in 2012 to realise the potential of turning the medical software projects he developed with his other business NewEngineering.Net into full specialist clinical software products and support services. Euan has over 20 years of business experience running his own internet services business providing application design, hosting and digital media services to a variety of clients, from small businesses through to national organisations. Euan is a graduate of the University of Strathclyde holding a Masters of Engineering in Manufacturing Sciences & Engineering and a Masters of Science in BioEngineering. With Cohesion Medical, he operates as General Manager responsible for all daily operations of the business as well as devising the longer-term business strategy.

Reach out to Euan at [email protected] or visit cohesionmedical.com to learn more.

Resources mentioned in this episode:

Black Box Thinking by Matthew Syed

www.cohesionmedical.com

Diana Caldwell co-founded Pearl Pathways to help get medical innovations to patients sooner. After a successful corporate career at a large pharma company, she knew there had to be a way to get drugs and devices to market more nimbly. Because, as is often heard around Diana's office - the Patient is Waiting!

Putting the patient first comes naturally to Diana. She caught the life science bug early on while working for her mentor Woody Myers as an intern at the Indiana State Board of Health. She never stopped wanting to make a difference for patients.

In this episode, hear how she went from serving patients in the public sector to becoming a successful corporate leader to being one of the leading entrepreneurs in Indiana. In addition, find out how Diana services the community through her volunteer service and how she is leading the way to inspire and assist the next generation of woman leaders.

Biotech, pharma, digital health inventors, researchers, entrepreneurs: Your inventions - your intellectual property (IP) - is at risk if you do not have a strategy for how you will protect it. IP protection is more than just patents. A comprehensive strategy - or even a relatively brief conversation with an IP expert attorney - is critical to ensuring you create value for yourself, your investors, and the marketplace. In this episode, Deborah Pollack-Milgate is both informative and inspirational. She and Steve discuss everything from how to protect IP to how to become a successful lawyer or other professional to how to inspire and promote women and minorities in the workplace. You don't want to miss this value-packed episode.

Deborah Pollack-Milgate is a partner in the Barnes & Thornburg Indianapolis office. She concentrates her practice in patent litigation, trade secrets litigation, trademark litigation, and complex commercial litigation, including antitrust litigation, contract litigation and appellate matters.

Ms. Pollack-Milgate has assisted and advised clients in a number of complex patent suits across multiple areas including: chemical products, digital radio, adhesives, healthcare, pest control, and insulation products. She has represented clients in appellate matters in the Indiana appellate courts and in federal courts of appeal, including the U.S. Court of Appeals for the Federal Circuit. Ms. Pollack-Milgate acts as outside in-house IP counsel for both national and international clients, assisting with virtually all aspects of Intellectual Property Portfolio management. She assists clients with putting systems in place, from the stage of invention to patent protection and enforcement, which will allow them to fully maximize the value of their intellectual property.

During her time at Barnes & Thornburg, Ms. Pollack-Milgate spent an extended stay in Mannheim, Germany, where she worked for and advised an international client of the firm in U.S. litigation and patent matters. She routinely presents in the German language on patent matters, and is the author of BLIPs, a quarterly German-language IP newsletter. Ms. Pollack-Milgate has been selected for inclusion in The Best Lawyers in America and Indiana Super Lawyers for several years and was recognized by The Best Lawyers in America as a 2018 Indianapolis "Lawyer of the Year" in patent litigation.

She is a member of the American Bar Association, the Indiana State Bar Association, and the Indianapolis Bar Association. She is also a member of the German-American Lawyers' Association (DAJV), the German American Chamber of Commerce, and the German Association for the Protection of Intellectual Property. She is a member of the Board of the Indiana Health Industry Forum (IHIF), and a founding member of the Indianapolis ChIPs Chapter, an international organization devoted to promoting women at the confluence of technology, law, and policy. She served on the board of Women & Hi-Tech for seven years and as president in 2013-2014. Over the years, Deborah has moderated panels for various organizations, and is currently a frequent moderator for the IHIF's monthly Life Sciences Luncheon series. (bio from http://www.btlaw.com/deborah-pollack-milgate/)

Resources mentioned in this episode:

• Book: Nevermoor: The Trials of Morrigan Crow by Jessica Townsend
• Author: Trenton Stewart
• For laughs: www.theonion.com
• IP news resources: www.btlaw.com www.patentlyo.com/ www.ipwatchdog.com/

Brad Moss started Patients Choice Laboratories with a team of entrepreneurs and Pharma veterans because he and his team saw an opportunity to partner with care providers.

In this episode, Steve and Brad discuss the challenges of leading a laboratory in the age of managed care.

A veteran of the healthcare industry, Brad chief Business Officer for SeKayi Management, a $10M healthcare management organization. While at SeKayi, Moss oversaw three subsidiaries that managed over 500,000 patients in four states. Before SeKayi, Moss served as National Director of Sales for DailyMed Pharmacy, a subsidiary Arcadia Resources, Inc., (NYSE Amex: KAD), a ~$100M healthcare provider. While at Arcadia, Moss led corporate sales for DailyMed, a comprehensive Medication Therapy Management and medication adherence program.

With Cambridge Analytica and the Facebook data breach in the news, my conversation with Valita Fredland could not be more timely. Is it possible to keep our health information safe? It is if Valita has anything to say about it. And as you will see, she has plenty to say about data privacy.

Valita Fredland - VP, General Counsel, and Privacy Officer for the Indiana Health Information Exchange (IHIE). Mother, wife, athlete, and passionate advocate for ethical data privacy. Today we talk about how Valita ended up as a leading influencer in the ethical responsibility of Big Data. She describes how she adapted the well-known medical ethical framework to an ethical framework for managing health data - or any personal data.

As parents of daughters, we have a great chat about the importance of raising girls to be strong leaders. And how to even the playing field so their hard work is as effective and as recognized as anyone else's.

This is a good one, folks. Please subscribe, leave a review, and share with your friends and colleagues.