Expert Guidance for Your Pharmaceutical Quality and Intellectual Property Needs

Partners since childhood, sisters Shannon Phillips and Shayne Phillips are the principle owners of Six Points Consulting.

With a shared passion for intellectual property and research, the sisters founded Six Points Consulting based upon a combined forty years of top-level industry experience.

Pharmaceuticals: CFR 21 Parts 210, 211, 212; USP <823>, <797> and ICH Q7

Analytical Chemistry and R&D Experience in both traditional pharmaceutical and sterile injectable/medical device radiopharmaceuticals, with a focus on Quality Assurance.

Intellectual Property Creation, Management and Monetization

Intellectual Property management, monetization through various licensing and sales arrangements, and IP cost analysis from patent drafting through expiration.

ABOUT

Based in Houston, Texas, but with a reach throughout North America, Six Points Consulting was founded on the guiding principles of Expertise, Effectiveness, Efficiency and Ethics. While Shannon and Shayne’s combined expertise speaks for itself, they’ve also built an extensive network of trusted consultants in the related fields of law, physics, general chemistry, and compounding/commercial pharmaceuticals. They know that every client has unique needs and project work that often requires pull-in from these skilled advisors. Six Points Consulting’s proven workflow methods around IP search and monitoring, FDA regulatory audits, CMC, and GLP/GMP have been highly effective for their clients time and time again. Shannon and Shayne’s outgoing natures and strong communication and collaboration skills bring about final project work that’s both efficiently executed and affordable to their clientele. Finally, Six Points Consulting takes on every project as if it were for their own organization. They fully understand the ethics underpinning this industry and treat every client with the utmost respect, trust, and confidentiality.

PROFILES

LinkIn Profile

Shannon has been working in the Analytical Chemistry, Traditional Pharmaceutical, and Radiopharmaceutical industries for over eighteen years. She’s developed an expertise in Good Laboratory and Good Manufacturing Practices, and has worked on multi-discipline teams to develop, implement, and document CMC strategies for FDA IND, PAS and NDA submissions.

LinkIn Profile

Shayne has developed an expertise in many aspects of Intellectual Property, from ideation all the way to IP protection and monetization strategy development. With over twenty years of experience that spans the Consumer Products, Biochemistry, and Oil & Gas industries, Shayne brings a wealth of formal training and hands-on skills to her consulting role.

Shannon Phillips Bio

Dr. Shannon Phillips has been working in the pharmaceutical and chemistry industries for almost twenty years. She is an analytical chemist by training, focusing on chromatographic development and validation, including an expertise in supercritical fluid chromatography. The first 5 years of her career was spent at the Pharmaceutical Research Institute in Analytical R&D at Bristol-Myers Squibb Company (BMS). During this time Dr. Phillips made significant technical contributions to the CMC filing for an NDA application, including hands-on technical transfer of methodology in Europe. She was the analytical project leader for two products in early stage development, and she helped design and implement two GMP-regulated laboratories while at BMS. During her three years at The Dow Chemical Company she provided a broad range of technical expertise in Analytical Sciences in Core R&D. In 2010 Dr. Phillips transitioned to IsoTherapeutics Group (ITG) as their Director of Quality. At ITG Dr. Phillips has become a key lead, along with client QA and Regulatory consultants, in developing, implementing, and documenting their CMC strategies for IND, PAS and NDA submissions. She also coordinates the daily maintenance of ITG’s own Quality Management System in the development, validation, implementation, and maintenance of their GLP/GMP sterile injectable radiopharmaceutical production environment for product synthesis, filter-fill, and analytical release. Dr. Phillips has a Bachelor of Science degree in Chemistry from Youngstown State University, and a Doctor of Philosophy degree in Analytical Chemistry from The Ohio State University. She has also authored five peer-reviewed publications and regularly attends industry conferences around Analytical Chemistry and Radiopharmaceuticals.

Shayne Phillips Bio

Shayne Phillips has been working in the intellectual property (IP) arena for over twenty years, particularly in the areas of IP-related competitive intelligence and technical patent and nonpatent literature searching. Ms. Phillips began her career at Procter & Gamble (P&G) in Cincinnati, Ohio, working as a Technical Assistant in Corporate New Ventures (a group tasked with evaluating outside technology for the entirety of P&G). She then moved to the IP-practice group of Dinsmore & Shohl (also in Cincinnati), working as a Technical Consultant, providing both patent application prosecution support and IP litigation assistance. In 2000 Ms. Phillips moved to Columbus, Ohio, and began work at Chemical Abstracts Service (CAS) as an Editorial Analyst in the Mammalian Hormones Document Indexing Group of the Biochemistry Department of CAS’ Editorial Division. In 2002 she transitioned to the role of Applications Specialist at CAS, specializing in advanced STN training, focusing on protein and gene sequence searching in particular. Following her tenure at CAS, Ms. Phillips moved to Halliburton in Houston, Texas, working in their Intellectual Asset Management group as both the head of IP Competitive Intelligence and as a Senior Patent Liaison for the Cementing and Multichem Product Service Lines. Currently, Shayne is both the Founder of, and a Managing Member of, Six Points Consulting, LLC, based in the Houston metro area. Ms. Phillips holds a Bachelor of Science degree in Biology from Youngstown State University, a Master of Science degree in Biochemistry from the University of Cincinnati, and a Master of Business Administration degree from Capital University in Columbus, Ohio. She is also a registered US Patent Agent.

SERVICES

Regulatory Audit Assistance

Let us perform a pre-audit walk-through of your facility prior to your next regulatory audit. We’ll be able to point out potential problem areas and work with you on solutions that will help your next audit go more smoothly.

GLP/GMP Guidance

Good Laboratory and Good Manufacturing Practices are the guiding principles of every great facility. Contact us for a comprehensive audit of your GLP or GMP systems, or to help you create your very own from scratch.

Patent Application

When you’re ready to take the plunge into the drafting, filing and prosecution of United States Patent Applications around your hard-won inventions, we’re here to help from invention disclosure to granted patent.

IP General

Great products and the IP that underpins them start with the basics. Prior to investing significant capital or time on ideas and potential inventions, contact us for your prior art, patentability, and freedom-to-operate search needs, as well as for current awareness alert setup.

IP Intensive

Let us take your intellectual property portfolio to the next level. We can help you with broad industry and technology landscaping work, with traditional IP asset management as an outsourced function, and with long-term IP cost modeling based upon your desired IP protection strategies.

CMC Strategy Development

Let us help you with the implementation and documentation of your Chemistry, Manufacturing and Controls procedures according to FDA and ICH Q7 guidances. CMC compliance is critical when filing your FDA Investigational New Drug, your Prior Approval Supplement, or your New Drug Applications.

Client Testimonials

Thank you for the excellent service that you have provided to NanoInnovations over the years – from your advice and review on our most recent patent application and filing, to finding and connecting us with the appropriate professional services we required to move forward. I’m always amazed at how you’re able to find and provide us with resources in such a short span of time, and the fact that I can call you at any point and know that you’re ready to help guide me with a smile. On a personal note I cannot thank you enough for driving 40 miles from Houston over a weekend only to obtain a book for us that contained crucial content needed for our NSF application. Over the course of our working relationship, we’ve become good friends and I’m so glad to have had the privilege of knowing you and working with both of you and with Six Points Consulting.

Huma Jafry, PhD

Founder and CEO of NanoInnovations

In the News

Click on a member name to see where we’ve been speaking, meeting and publishing.

Shayne Phillips

Licensing Executives Society USA–Canada, Sponsorship Co-Chair, Houston Chapter, 2018-Present
Innography, Software Innovation Board of CPA Global, Board Member, 2019-Present
2018-2020: Board Member, LES Foundation (3-year term) LES USA Canada
2020, September: Solo Live Webinar, “Data Availability and Big-Data Analytics in IP: A Look at Recent Activities” LES USA Canada Houston Chapter Quarterly Meeting (Houston, TX)
2020, May: Solo Live Webinar, “Taking an Outside-In Perspective to Improve the Quality of Your IP Portfolio” CPA Global Innography Webinar Series (Houston, TX)
2019, October: Solo Presentation, “Recent Trends in IP Data Availability and Big-Data Analytics” LES USA Canada Houston Chapter Quarterly Meeting (Houston, TX)
2019, July: Panelist, “Data Licensing for AI and ML” 5^TH Annual LESI YMC Pan-American Meeting (Montreal, Canada)
2018, November: Co-Presenter, “IP Portfolio Quality: Tools and Tips for Quantifying the Effect of Good and Bad IP Decisions” CPA Global Innography Ignite User Meeting (Austin, TX)
2018, October: Panelist, “Long-Term Insight into the Future of the Licensing Practice” LES USA Canada Annual Meeting (Boston, MA)
2018, September: Panelist, “IP Protection of AI” 4^TH Annual LESI YMC Pan-American Meeting (Cancun, Mexico)
2018, August: Co-Speaker Lunch and Learn, “From Invention Disclosures to IP” LES USA Canada Houston Chapter Luncheon Meeting (Houston, TX)
2018, March: Co-Instructor Half-Day of 3-day Educational Course, “Business Development in IP Licensing” LES USA Canada LES University South (Houston, TX)
2016-2017: Chapter Chair, LES USA Canada Houston Chapter (Houston, TX)
2017: Nominated for Inclusion in Intellectual Asset Management Magazine IAM Strategy 300
2017, November: Solo Presentation, “Doing More with Your IP: A Halliburton Case Study” CenterForce 3rd Annual IP Strategy Summit (Boston, MA)
2017, June: Planning Chair, 3^RD Annual LESI YMC Pan-American Meeting (Los Angeles, CA)
2016, August: Live Webinar Co-Presenter, “Leveraging IP Data to Drive Breakthrough Innovation” Questel Orbit Webinar Series (Houston, TX)
2016, June: Panel Discussion Moderator, “Trends in Licensing” 2^ND Annual LESI YMC Pan-American Meeting (Ottawa, Canada)
2016, April: Co-Instructor Half-Day Educational Course, “Energizing Your Patent Strategies: How to Leverage IP Landscapes to Gain a Competitive Advantage” LES USA Canada Spring Meeting (Houston, TX)
2016, January: Panel Discussion Moderator, “Licensing in the Cloud” LES USA Canada Houston Chapter Quarterly Meeting (Houston, TX)
2009-2015: Committee Member, IPO Patent Search Committee
2014-2015: Co-Chair, IP Landscaping Subcommittee under Patent Search Committee, IPO (co-lead author of IP Landscaping IPO membership survey)
2015: Programs Chair, LES USA Canada Houston Chapter (Houston, TX)
2014, September: Solo Presentation, “How Intelligent are your Assets?” Driven Inc. E-Discovery Speakers Series (Houston, TX)
2013, September: Planning Committee Member, IPO 41^ST Annual Meeting (Boston, MA)
2011, October: Co-Presenter, “Patent Landscaping and Analysis: Tools, Tips and Tricks” PIUG Northeast Conference (New Brunswick, NJ)
2011, October: Solo Presentation, “Surveying the Landscape of Patent Analytics” LES USA Canada Houston Chapter Quarterly Meeting (Houston, TX)
2011, September: Panelist, “A Look at Patent Landscaping and Analysis” IPO 39^TH Annual Meeting (Los Angeles, CA)

Shannon Phillips

2020: Publication, Phillips, S.L.; Kleintop, B.; Khaselev, N.; “Investigating the use of SFC as an Alternative to HPLC for Impurity/Degradant Profiling of a Small Pharmaceutical Compound” manuscript in preparation
2018: Local Section (Brazosport) Outreach Volunteer of the Year-national award from the ACS (Brazosport Region, TX)
2014-2018: Outreach Chair of the Brazosport Section of the ACS (Brazosport Region, TX)
2014: Chair of the Brazosport Section of the ACS (Brazosport Region, TX)
2011, November: Invited Presenter, Phillips, S.L; Crump, D.; Rogers, J.A.; Baumeister, J.E. 2011 ‘Radiopharmaceutical Drug Development: Chromatographic Support’, Eastern Analytical Symposium 2011, invited speaker session: Hyphenated Chromatography, Somerset, NJ, 14-17 November
2011: Publication, J. Simón, R. K. Frank, D. Crump, J. Rogers, S. Phillips, S. Ellebracht, W. Erwin, N. Ueno, R. Wendt, “Preclinical Evaluation of Sm-153-DOTMP as a Therapeutic Bone-Seeking Radiopharmaceutical” J Nucl Med. 2011; 52 (Supplement 1):1751
2011: Publication, Phillips, S.L.; “LC with Enhanced Fluidity Mobile Phases,” Encyclopedia of Analytical Chemistry, invited manuscript contribution, 15 JUNE 2011
2007: Publication, Zhang, L.; Ha, K.; Kleintop, B.; Phillips, S.L.; Scheer, B.M.; “Differences in In Vitro Dissolution Rates Using Single-Point and Multi-Point Sampling” Dissolution Technologies 2007 14(4), 27-31
2005-2007: Secretary of the North Jersey Chromatography Group, a topical sub-group of the National ACS (Northern Region, NJ)
2003: Publication, Phillips, S.L.; Ding, L.; Stegemiller, M.; Olesik, S. V.; “Development of Water-Based Liquid Chromatography at the Critical Condition” Anal. Chem. 2003, 75(20), 5539-5543
2003: Publication, Phillips, S.L.; Olesik, S.V.; “Initial Characterization of Humic Acids Using Liquid Chromatography at the Critical Condition Followed by Size-Exclusion Chromatography and Electrospray Ionization Mass Spectrometry” Anal. Chem. 2003, 75(20), 5544-5553
2002: Publication, Phillips, S.L.; Olesik, S.V.; “Fundamental Studies of Liquid Chromatography at the Critical Condition Using Enhanced-Fluidity Liquids” Anal. Chem. 2002, 74(4), 799-808
2000, April: William Rand Kenan, Jr. Award-national award from Union Carbide (Charleston, WV)
1999: Mack Memorial Award Committee Chair, The Ohio State University (Columbus, OH)
1999: Elected President of The Graduate Student Committee, The Ohio State University (Columbus, OH)
1998: Mack Memorial Award Committee Member, The Ohio State University (Columbus, OH)
1998: Member of The Graduate Student Committee, The Ohio State University (Columbus, OH)
1997-1998: University GAAN Fellowship, The Ohio State University (Columbus, OH)