GCSG 2020 Global Virtual Conference: Program

Biography:

Since founding the Leadership Difference in 1995, over 350,000 people have attended Dave Mitchell’s “enter-TRAIN-ment” seminars on topics that include leadership, customer service, selling skills, and personal performance enhancement. His clients include Allstate Insurance, Bank of America, Universal Studios, Sub-Zero Wolf Appliances, Electrolux Appliances, Trek Bikes, Walt Disney World, and the CIA just to name a few.

Prior to starting his own organization development consulting firm, Dave was the Vice President of Human Resources and Quality for Buena Vista Hospitality Group, Corporate Director of Training and Development for Marshall Field’s and a television reporter and producer for CBS News. He has a B.A. in Mass-Communications with an emphasis in Business Administration and a Masters Degree in Global Human Resources Development. Dave is an adjunct professor at the University of Illinois and has been designated as a Certified Advanced Wine Sommelier by the International Wine Guild and is a founding shareholder of Pambrun Winery.

Dave is the author of the book Live and Learn or Die Stupid! The book focuses on personal contentment and performance excellence. His next book, The Power of Understanding People, was released in December 2013 by Wiley Publishing and was immediately selected as Best Business Book of the Month by Amazon. Dave was named Best Speaker of 2013 by Meeting Professionals International at the World Education Congress in Las Vegas and Top Speakers of 2015 by Meetings and Conventions Magazine.

Dave lives in the wine country of Walla Walla, Washington with his wife of 31 years, Lori; his two children, Brooke and Slade; three horses, two dogs and two barn cats: Socks and Stinkerbell.

Biography:

Stefanie Koleski is a Supply Chain Lead at Pfizer, Inc. She received her Bachelor of Science Degree in Biology and Psychology from the University of Michigan and her Master of Science Degree in Biology from Eastern Michigan University. Stefanie joined Pfizer (at the time it was Warner-Lambert Parke-Davis) in 1995 working in the Virology Drug Discovery group. She moved into Global Clinical Supply in 2001 and has been a Supply Chain Project Manager for 19 years. She has supported all phases of investigational development to coordinate and drive the clinical supply process by forecasting, managing and delivering worldwide investigational drug supplies. Most recently Stefanie led a team that worked to implement a supply chain to manage the Pfizer gene therapy portfolio. Stefanie currently works remotely and resides in Michigan with her daughter. In her spare time, she enjoys spending time with her family and friends, traveling, golfing, bowling and enjoying the sunshine. She can be contacted at Stefanie.koleski@pfizer.com

Biography:

Natalie Balanovsky is the Supply Chain Solutions Manager at Almac Clinical Services in Souderton, PA, managing the Strategic Product and Business Development, implementation, education and training of Almac’s JIT service suite.

Natalie has previously held other roles at Almac including Global Project Leader and Project Manager of Distribution, managing Phase 1 through 4 clinical trials of various size, and complexity. She has over 15 years of professional experience within Project Management, Business Development, GMP Operations, and Quality Compliance for various industries including pharmaceutical, financial and b2b.

She holds a Bachelor of Science degree in Business from Delaware Valley University and earned her Master of Business Administration with concentration in Finance from LaSalle University. She is a certified Project Management Professional and is a Member of the Delaware Valley Chapter of Project Management Institute.

Biography:

Bryan Thompson has worked in a manufacturing capacity with Almac Clinical Services for the last 13 years. He is responsible for the development and management of over 200 staff across a three-shift clinical packaging operation. Bryan has the additional responsibility of overseeing the generation of a complex production schedule, review of project specific generated batch documentation and quotation generation. At Almac, Bryan has gained extensive knowledge of the processes, equipment and materials utilized in clinical trials packaging and is a subject matter expert on cold room packaging.

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

Scott Ohanesian has held executive roles over the past 16 years for Clinical Logistics Organizations and Contract Manufacturing Organizations (CMOs), managing global logistics for Phase I through IV clinical trials.

He currently leads the QuickSTAT U.S. commercial operations team to build strategic relationships with pharmaceutical and biotech companies in order to provide comprehensive solutions for their global supply chain, ensuring product integrity and patient safety.

Prior to joining QuickSTAT, Scott managed the Asia Pacific commercial operations for Marken Limited, where he implemented the commercial strategy for his company in key markets, such as Australia, China, India, Japan, Singapore, South Korea, and Taiwan.  Prior to that position, he was in a global strategic management role at a CMO, creating mutually beneficial partnership models.

He is trained and well versed in Good Manufacturing Practices, (GMP) and has helped create innovative logistics solutions for numerous new drug products–from formulation development through to commercialization, including cutting edge cell, gene, and CAR-T therapies.

Scott is a graduate of Boston College with a Bachelor of Science in Finance and a Masters of International Law in Diplomacy from The Fletcher School at Tufts University, with affiliated course work at Harvard Law School and Harvard Business School.

Biography:

Jenny Bulthuis is a Supply Chain Lead at Pfizer, Inc. She received her Doctor of Pharmacy degree from the University of Michigan and holds a license from the State of Michigan as a Registered Pharmacist. After graduation, she worked as a part-time retail pharmacist and completed a 1-year pharmacy residency at William Beaumont hospital in Royal Oak, Michigan. After completing the residency, she worked at Beaumont Hospital as a clinical/staff pharmacist for a year, where she managed patient care on antibiotic and anticoagulant therapy as well as general patient care. Jenny joined Pfizer in 2000 and has been a Supply Chain Project Manager for 19 years. She has supported all phases of investigational development to coordinate and drive the clinical supply process by forecasting, managing and delivering worldwide investigational drug supplies. Jenny currently resides in Michigan with her husband Chris and 3 children. In her spare time, she enjoys spending time with her family, reading and being active outdoors. She can be contacted at jennifer.bulthuis@pfizer.com.

Biography:

Lisamarie Georgen is currently the Director of Clinical Supplies at MacroGenics. She has had over 20 years of experience within the Pharmaceutical Industry. Lisamarie leads a team of Clinical Supplies Managers at MacoGenics and has been with the company for a year. Previous to MacroGenics, Lisamarie worked at Fisher Clinical Services for 12 years in various positions of increasing responsibility.

Biography:

Biography:

A Chartered biologist, with a Masters in Pharmaceutical Sciences, Harry has over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Harry currently holds the position of Senior Director, Quality, EMEA, leading the EMEA Quality function across the Clinical Trials Division at Thermo Fisher Scientific. Based in Horsham, UK, Harry oversees 6 sites specializing in the Manufacture, Packaging and Distribution of Investigational Medicinal Products (IMPs). Harry previously led Quality at the Thermo Fisher Scientific Horsham site for several years. Harry is an experienced Qualified Person (QP) for clinical and commercial products.

Biography:

Sherri Willson has nearly 25 years’ experience at Pfizer within their Global Clinical Supply Chain supporting various aspects of the clinical supply chain. Sherri’s experience ranges from managing Operations, such as warehousing, inventory management, packaging, labeling, external vendor management/ partnership and distribution & logistics, to planning and strategy, such as clinical supplies planning, strategy & management, process mapping / process improvements, documentation & audit readiness, Today she is a Director in the Clinical Supply Strategy Management group responsible for a team of colleagues planning and coordinating clinical trials globally. She has worked in both the US and UK and has considerable experience in optimizing international clinical supply chain distribution lanes. Sherri received her degree from the University of Connecticut and is an active member of the Global Clinical Supplies Group currently serving as Conference Vice Chair and as Presentation Coordinator for the past 3 years.

Biography:

Rob is a seasoned executive with 30 years combined global experience in Pharmaceutical R&D with a focus on clinical supply chain leadership, quality assurance, process re-engineering and leadership of change initiatives. After obtaining a PhD in Analytical Chemistry from Southampton University UK Rob joined The Upjohn Company as a scientist and has subsequently held roles of increasing responsibility with Pharmacia & Upjohn, Pharmacia, Pfizer, Schering Plough and Merck. Rob has had extensive experience in clinical supply quality assurance and laboratory operations including proposing regulatory specifications and reviewing CMC regulatory submissions for drug candidates. He has a strong track record of optimizing international Clinical Supply Chain operations and a proven ability to forge global relationships across lines and disciplines. A valued and effective change leader with extensive experience in helping organizations navigate organizational change without compromising business performance. During his career Rob led large clinical supply chain organizations through six mergers while maintaining business continuity. He also has had the opportunity to lead a number of high profile process improvement initiatives:• Co-led a corporate wide initiative to globalize, and optimize clinical supply chain across multiple country sites• Collaborated on a cross functional initiative with clinical partners to optimize planning and delivery of clinical supplies• Negotiated and successfully managed the integration of commercial and R&D logistics business units• Established cross functional governance between clinical and clinical supply organizationsIn February 2014 Rob co-founded and is now a Managing Partner at Brizzey LLC, a small firm of professionals with a track record of success in the areas of clinical supplies, R&D change management & process optimization.

Biography:

Lorna Briddick is an accomplished team leader with 19 years of experience in the leadership of business process management and large scale process improvement initiatives with the last 15 years focused on the clinical supply chain. She has successfully led numerous initiatives to re-engineer and optimize clinical supply chain end to end processes from design to implementation. Lorna joined the pharmaceutical industry as a consultant to Pfizer, where she led a corporate wide initiative to optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures. Lorna then joined Schering Plough to lead the optimization of the clinical supply chain, supporting 3 large workstreams that integrated processes across multiple business units. She also held the position of Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations teams in 9 countries, with responsibility for audit and qualification of depot partners.

Biography:

David is a pharmaceutical services professional with over 15 years’ experience in the provision of GXP compliant services. He is a Clinical Supplies Specialist and one of the few GMP/GDP professionals whose experience includes the administration of investigational products in a clinical setting, gained whilst working as a Research Physiologist with a Phase 1 Clinical Research Unit. David holds a post-graduate diploma in clinical research and is currently Global Account Director at World Courier where he is often called upon to assist in solving the supply chain challenges associated with novel therapies. He has previously worked as a Clinical Supplies Lead for Penn Pharma where he managed pharmaceutical development and supply chain projects for a variety of small, medium, and large pharmaceutical companies.

Biography:

Mark Woolf – Global Manager, Depot Network, Catalent

• Over 35 years logistics and operational experience
• Extensive background in global storage and distribution including residency for over 15 years in many European, Middle East and APAC countries.
• Zuellig Pharma Asia Pacific (4 years) where he was resident, working in the Philippines
• Almac Clinical Services (6 years) both in the UK and USA.
• Freight Forwarder and Distributor within Free Trade Zones in Turkey & Africa.
• 12 years of Clinical Trial Logistic, Operations and Vendor management

Biography:

Katy Ostertag is Senior Manager, Clinical Supply Chain at PCI Pharma Services. Katy joined PCI in October 2016 with over 10 years of clinical supply experience in the pharmaceutical industry at Vertex, Sunovion, and Takeda. She earned her Bachelor of Science in Kinesiology in 2001, and Master of Science in Kinesiology in 2004; both degrees coming from Indiana University. In January 2016, Katy earned her Project Management Professional certification, and is a member of the Project Management Institute.

In her role as Senior Manager, Clinical Supply Chain, Katy is growing a team of clinical supply professionals who can bring PCI’s experience to the clinical trial, providing expertise throughout the clinical study supply lifecycle. She is responsible for acting as the single point of contact in coordinating the necessary information between clinical functions, ensuring the clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study.

Biography:

Biography:

Stefanie Koleski is a Supply Chain Lead at Pfizer, Inc. She received her Bachelor of Science Degree in Biology and Psychology from the University of Michigan and her Master of Science Degree in Biology from Eastern Michigan University. Stefanie joined Pfizer (at the time it was Warner-Lambert Parke-Davis) in 1995 working in the Virology Drug Discovery group. She moved into Global Clinical Supply in 2001 and has been a Supply Chain Project Manager for 19 years. She has supported all phases of investigational development to coordinate and drive the clinical supply process by forecasting, managing and delivering worldwide investigational drug supplies. Most recently Stefanie led a team that worked to implement a supply chain to manage the Pfizer gene therapy portfolio. Stefanie currently works remotely and resides in Michigan with her daughter. In her spare time, she enjoys spending time with her family and friends, traveling, golfing, bowling and enjoying the sunshine. She can be contacted at Stefanie.koleski@pfizer.com

Biography:

Jake Rashid is Supply Chain Lead at Pfizer within the Global Clinical Supply department. Jake joined Pfizer in 2017, bringing with him 3 years of prior experience in clinical supply program management and strategy. He has managed the clinical supply chain for company assets at all stages in the development lifecycle: FIH, Phase 1-4 and post marketing requirements. In addition to clinical supply expertise, he has a background in R&D aspects of large-scale biopharmaceutical production and clinical operations management. Jake received his bachelor’s degree in Health Science from the University of Iowa, and master’s degree in Medical Biotechnology from the University of Illinois at Chicago.

Biography:

Olive McCormick is the Head of Quality at Almac Clinical Services residing at the main headquarters in Craigavon, Northern Ireland. Olive is responsible for the QA, QC and the QP teams at this site and also at the Dundalk facility in Ireland. Olive has been with Almac for over 20 years where she has gained extensive experience in the practices employed in the manufacture, packaging and labeling of IMPs and has been acting as a QP for over 16 years. Her role involves management and oversight of the Pharmaceutical Quality System at the facilities in the UK and Ireland and extends to include the routine duties of the QP.  Olive has extensive experience in performing on-site audits of manufacturing, testing, packaging and labeling sites and distribution centers globally.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Greg Hottell holds the role of Director, Clinical Supply Chain at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies (D&OP), helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, implemented and operates a monthly clinical demand governance process (Demand Review), implemented the Smart Supplies Forecasting tool, and has overseen GSK’s performance with on-time delivery of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee. Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops and presenting at annual meetings. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services, and GSK. He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CPIM-F) through APICS.

Biography:

Michael is currently the CEO of Myoderm, where he has worked the past 18 years.  Michael’s passion, leadership, and commitment to meeting each client’s unique needs have been a driving force in making us a global leader in clinical trial supply. Before Myoderm, Michael served in positions in the publishing, advertising, financial, and utility industries. He holds a B.S. in Statistics from the University of Pittsburgh, and an M.B.A. from the university’s Katz Graduate School of Business. 

Biography:

Laurie is currently a Director of Solutions Consulting- Clinical Trial Supplies and Logistics at PAREXEL. She is responsible for managing a team of solutions consultants who provide subject matter expertise in order to develop supply strategies to meet each client’s unique need. She has been with PAREXEL since 2012, and held positions in clinical supply project management and account management. Prior to joining PAREXEL Laurie’s primary focus was project management of the full drug supply lifecycle from forecasting and planning through returns and destruction. Since joining PAREXEL she has expanded her area of focus to include ancillary supplies management and laboratory logistics.  Laurie has worked in the clinical trial industry for 20 years. She is an experienced clinical supply professional with 10+ years of global clinical supply chain project management experience. She has a B.S in Biochemistry and an MA in Kinesiology from the University of Texas.

Biography:

Nicole Gray is currently Director, Strategic Supply Solutions for Catalent Clinical Supply Services, responsible for developing the Direct to Patient business and other new strategic service offerings. She has been in the Pharmaceutical industry for 15 years and has held multiple roles in clinical supplies project management. Prior to moving to her new role in August 2018, Nicole spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers, and Sr. Project Managers. Prior to moving to Catalent Philadelphia, Nicole was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).

Prior to joining Catalent, Nicole held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives.

Biography:

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140+ company-owned offices in 50+ countries, with focus on direct-to-patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service / operations, director of new service development and director of regional accounts, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

Sashin has 16 years of clinical supply experience supporting packaging and labeling operations, global scheduling, forecasting, planning, IVRS, randomization and drug supply management. Sash currently holds the title of Associate Director, Drug Supply Manager in the Clinical Supply Operations group at Bristol-Myers Squibb. In this role, he provides drug supply support for Investigator Sponsored Trials (IST/ISRs), Early Patient Access (EPA), and Phase IV or Late Phase Post Marketing Clinical Research. Sash obtained his Bachelors of Science from Philadelphia College of Pharmacy and his MBA from Drexel University. At home, Sash loves to spend time with his wife and two kids. He has coaches his daughter in softball. He is an avid New York Mets and New York Giants fan.

Biography:

Biography:

Carrie is a Senior Manager in Clinical Supply Chain at Agios.  In her current role, she is a program lead within the oncology portfolio and manages drug supply for the Expanded Access Program and Investigator Sponsored Trials. Prior to joining Agios in April 2019, Carrie worked in Clinical Supply Chain at Alkermes, a global pharmaceutical company, managing drug supply for a large multiple sclerosis program and all Phase 1 studies.  She received her Bachelor of Arts degree in Chemistry from College of the Holy Cross and her PharmD from MCPHS University.  In 2016, Carrie completed a two-year post-PharmD Clinical Supply Chain Fellowship at Sanofi Genzyme.

Biography:

Biography:

Kevin began his career at Clintrak (later purchased by ThermoFisher Scientific) in May 2004 in the Manufacturing Division and was directly involved with label production. He joined the Client Services Department where he worked closely with clients in order to insure the successful completion of their jobs from protocol interpretation to label production. Throughout his tenure, Kevin has gained broad knowledge of the clinical label production process and the clinical supply chain as a whole while developing innovative solutions for clinical labeling challenges. Over the past few years, Kevin has spearheaded the development of translation and regulatory review solutions for clinical trial labels as a Label Program Director. Kevin provides customer service support including client and site visits, quarterly meetings, trade meetings, exhibitions, seminars, whitepapers and leads industry discussion groups. He works closely with ThermoFisher Scientific specialists to develop customized solutions to meet client’s unique needs. Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. He currently resides in Patchogue, NY with his wife and two children.

Biography:

I started my career in Pharma at Pfizer in 2001. I joined the Fisher Clinical Services team in 2007 as Senior Project Manager and have held positions as Packaging Project Manager, Clinical Supply Chain Manager and Program Director. My experience has proven invaluable in my current role as Global Relationship Director. Today I leads a cross-functional team dedicated to providing high-quality, global “end-to-end” service to key clients. I serve as a client advocate, recommending new processes aimed at improving the client’s global service experience.

Biography:

Kristen DeVito is Global Director, Clinical Supply Services at Catalent Pharma Solutions. In this role, she is global lead for Customer Service Excellence, Project Management, Clinical Supplies Management and Strategic Supply Solution functions of the business. With over 20 years of industry experience, she previously held the positions of General Manager of the CSS site in Mt. Laurel, NJ and Director, Project Management with Aptuit and Quintiles Clinical Supplies. Kristen is a committee member and former Chair of the ISPE Investigational Products COP Steering Committee and former instructor for the Center for Professional Advancement Course, Clinical Trial Materials.

Biography:

Regulatory Scientist at Eli Lilly and Company.

Biography:

Having worked in the pharmaceutical industry for almost 20 years within various quality positions, in his position as Global Clinical Quality Director, Tristram is responsible for quality within PCIs clinical trial supply services division; In this role Tristram engages with PCI clinical teams in the USA, UK and Ireland, also liaising with global customers on various clinical supply chains generally advising on quality matters.  Tristram is an EU Qualified Person (QP), qualifying under the permanent provisions in 2011, Tristram is responsible for the QP certification of both commercial and investigational medicinal products on various PCI UK MHRA site licences across a range of dosages forms.  Tristram joined PCI back in in 2007 within one of PCIs acquired companies, Biotec Services International where Tristram held various Quality Management and Director positions.

Biography:

Stefanie Koleski is a Supply Chain Lead at Pfizer, Inc. She received her Bachelor of Science Degree in Biology and Psychology from the University of Michigan and her Master of Science Degree in Biology from Eastern Michigan University. Stefanie joined Pfizer (at the time it was Warner-Lambert Parke-Davis) in 1995 working in the Virology Drug Discovery group. She moved into Global Clinical Supply in 2001 and has been a Supply Chain Project Manager for 19 years. She has supported all phases of investigational development to coordinate and drive the clinical supply process by forecasting, managing and delivering worldwide investigational drug supplies. Most recently Stefanie led a team that worked to implement a supply chain to manage the Pfizer gene therapy portfolio. Stefanie currently works remotely and resides in Michigan with her daughter. In her spare time, she enjoys spending time with her family and friends, traveling, golfing, bowling and enjoying the sunshine. She can be contacted at Stefanie.koleski@pfizer.com

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

Erin is a Project Manager at Catalent Pharma Solutions with over 22 yrs. experience in the Japanese Market with more than 10 yrs. working both in Japan and the US, with Japanese clients and Global clinical trials going into Japan.    She has extensive design and strategy expertise for Japanese clinical supplies and advising foreign companies wishing to do business in Japan.   Erin previously managing the North Carolina Japan center and was responsible for consultancy on technology transfer and bridging cultural gaps with Japanese and US entities doing business in the US or bridging into Japan.

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Sandra Cook, Ph.D., is a project management, strategy and training consultant with thirty years experience in the pharmaceutical industry. The past twenty have been focused on Investigational Products where she has held both line management and senior level project management roles facilitating high performing teams in the delivery of worldwide clinical supplies, including materials supporting key priority blockbuster products for large pharma.  Additionally, she has been instrumental in the design, development and implementation of several global process improvement projects for R&D Supply Chain.  An active contributor to the IP Metrics Task Team of the International Society of Pharmaceutical Engineering, Cook also manages the bi-annual Equal Partners in Clinical Supplies industry forum

Biography:

Bill Brocious is a Director at Eli Lilly and Company and is responsible for global clinical trial master label development and packaging/labeling operations. He has 31 years of experience at Lilly and remains passionate in delivering medicines that make life better for people around the world. Earlier in his career at Lilly, Bill set up their initial external network to source large molecule assets for clinical development. He is a graduate of Purdue University, where he majored in Chemistry and played on the college golf team. He currently lives in Zionsville, Indiana with his wife and two children. When he is not busy with work or family, you can usually find him on a golf course. Fun fact, one of his distant relatives, Curly Bill Brocious, was laid to rest by Wyatt Earp in a gun fight.

Biography:

Lisamarie Georgen is currently the Director of Clinical Supplies at MacroGenics. She has had over 20 years of experience within the Pharmaceutical Industry. Lisamarie leads a team of Clinical Supplies Managers at MacoGenics and has been with the company for a year. Previous to MacroGenics, Lisamarie worked at Fisher Clinical Services for 12 years in various positions of increasing responsibility.

Biography:

Biography:

Sherri Willson has nearly 25 years’ experience at Pfizer within their Global Clinical Supply Chain supporting various aspects of the clinical supply chain. Sherri’s experience ranges from managing Operations, such as warehousing, inventory management, packaging, labeling, external vendor management/ partnership and distribution & logistics, to planning and strategy, such as clinical supplies planning, strategy & management, process mapping / process improvements, documentation & audit readiness, Today she is a Director in the Clinical Supply Strategy Management group responsible for a team of colleagues planning and coordinating clinical trials globally. She has worked in both the US and UK and has considerable experience in optimizing international clinical supply chain distribution lanes. Sherri received her degree from the University of Connecticut and is an active member of the Global Clinical Supplies Group currently serving as Conference Vice Chair and as Presentation Coordinator for the past 3 years.

Biography:

 “It’s not the note you play that’s the wrong note — it’s the note you play afterwards that makes it right or wrong.” —Miles Davis

For over 20 years, Travis has performed as an improvisational comedian, performance coach, and corporate training specialist. His coaching practice combines the principles of improvisation and personal performance to help individuals and organizations with mindset, culture, and collaboration. He has worked with companies including JP Morgan Chase, Janssen Pharmaceuticals, PepsiCo, Under Armor and Cintas.

For the past 4 years Travis has worked solo under his company Live Yes, And… He works regularly with Georgia football, the Chicago Cubs, Miami Marlins, Cincinnati Reds, and New York Yankees. He is the host and creator of The Weekly Yes, And Podcast, and the author of “3 Words for Getting Unstuck: Live Yes, And!” Travis lives in Jupiter, FL with his wife and three kids.

Get Unstuck with 3 Words. Buy Travis’ book!

Listen to Travis on The Weekly Yes, And Podcast on iTunes!

Biography:

Natalie Balanovsky is the Supply Chain Solutions Manager at Almac Clinical Services in Souderton, PA, managing the Strategic Product and Business Development, implementation, education and training of Almac’s JIT service suite.

Natalie has previously held other roles at Almac including Global Project Leader and Project Manager of Distribution, managing Phase 1 through 4 clinical trials of various size, and complexity. She has over 15 years of professional experience within Project Management, Business Development, GMP Operations, and Quality Compliance for various industries including pharmaceutical, financial and b2b.

She holds a Bachelor of Science degree in Business from Delaware Valley University and earned her Master of Business Administration with concentration in Finance from LaSalle University. She is a certified Project Management Professional and is a Member of the Delaware Valley Chapter of Project Management Institute.

Biography:

Bryan Thompson has worked in a manufacturing capacity with Almac Clinical Services for the last 13 years. He is responsible for the development and management of over 200 staff across a three-shift clinical packaging operation. Bryan has the additional responsibility of overseeing the generation of a complex production schedule, review of project specific generated batch documentation and quotation generation. At Almac, Bryan has gained extensive knowledge of the processes, equipment and materials utilized in clinical trials packaging and is a subject matter expert on cold room packaging.

Biography:

Scott Ohanesian has held executive roles over the past 16 years for Clinical Logistics Organizations and Contract Manufacturing Organizations (CMOs), managing global logistics for Phase I through IV clinical trials.

He currently leads the QuickSTAT U.S. commercial operations team to build strategic relationships with pharmaceutical and biotech companies in order to provide comprehensive solutions for their global supply chain, ensuring product integrity and patient safety.

Prior to joining QuickSTAT, Scott managed the Asia Pacific commercial operations for Marken Limited, where he implemented the commercial strategy for his company in key markets, such as Australia, China, India, Japan, Singapore, South Korea, and Taiwan.  Prior to that position, he was in a global strategic management role at a CMO, creating mutually beneficial partnership models.

He is trained and well versed in Good Manufacturing Practices, (GMP) and has helped create innovative logistics solutions for numerous new drug products–from formulation development through to commercialization, including cutting edge cell, gene, and CAR-T therapies.

Scott is a graduate of Boston College with a Bachelor of Science in Finance and a Masters of International Law in Diplomacy from The Fletcher School at Tufts University, with affiliated course work at Harvard Law School and Harvard Business School.

Biography:

Rob is a seasoned executive with 30 years combined global experience in Pharmaceutical R&D with a focus on clinical supply chain leadership, quality assurance, process re-engineering and leadership of change initiatives. After obtaining a PhD in Analytical Chemistry from Southampton University UK Rob joined The Upjohn Company as a scientist and has subsequently held roles of increasing responsibility with Pharmacia & Upjohn, Pharmacia, Pfizer, Schering Plough and Merck. Rob has had extensive experience in clinical supply quality assurance and laboratory operations including proposing regulatory specifications and reviewing CMC regulatory submissions for drug candidates. He has a strong track record of optimizing international Clinical Supply Chain operations and a proven ability to forge global relationships across lines and disciplines. A valued and effective change leader with extensive experience in helping organizations navigate organizational change without compromising business performance. During his career Rob led large clinical supply chain organizations through six mergers while maintaining business continuity. He also has had the opportunity to lead a number of high profile process improvement initiatives:• Co-led a corporate wide initiative to globalize, and optimize clinical supply chain across multiple country sites• Collaborated on a cross functional initiative with clinical partners to optimize planning and delivery of clinical supplies• Negotiated and successfully managed the integration of commercial and R&D logistics business units• Established cross functional governance between clinical and clinical supply organizationsIn February 2014 Rob co-founded and is now a Managing Partner at Brizzey LLC, a small firm of professionals with a track record of success in the areas of clinical supplies, R&D change management & process optimization.

Biography:

Lorna Briddick is an accomplished team leader with 19 years of experience in the leadership of business process management and large scale process improvement initiatives with the last 15 years focused on the clinical supply chain. She has successfully led numerous initiatives to re-engineer and optimize clinical supply chain end to end processes from design to implementation. Lorna joined the pharmaceutical industry as a consultant to Pfizer, where she led a corporate wide initiative to optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures. Lorna then joined Schering Plough to lead the optimization of the clinical supply chain, supporting 3 large workstreams that integrated processes across multiple business units. She also held the position of Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations teams in 9 countries, with responsibility for audit and qualification of depot partners.

Biography:

Jenny Bulthuis is a Supply Chain Lead at Pfizer, Inc. She received her Doctor of Pharmacy degree from the University of Michigan and holds a license from the State of Michigan as a Registered Pharmacist. After graduation, she worked as a part-time retail pharmacist and completed a 1-year pharmacy residency at William Beaumont hospital in Royal Oak, Michigan. After completing the residency, she worked at Beaumont Hospital as a clinical/staff pharmacist for a year, where she managed patient care on antibiotic and anticoagulant therapy as well as general patient care. Jenny joined Pfizer in 2000 and has been a Supply Chain Project Manager for 19 years. She has supported all phases of investigational development to coordinate and drive the clinical supply process by forecasting, managing and delivering worldwide investigational drug supplies. Jenny currently resides in Michigan with her husband Chris and 3 children. In her spare time, she enjoys spending time with her family, reading and being active outdoors. She can be contacted at jennifer.bulthuis@pfizer.com.

Biography:

Nicole Gray is currently Director, Strategic Supply Solutions for Catalent Clinical Supply Services, responsible for developing the Direct to Patient business and other new strategic service offerings. She has been in the Pharmaceutical industry for 15 years and has held multiple roles in clinical supplies project management. Prior to moving to her new role in August 2018, Nicole spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers, and Sr. Project Managers. Prior to moving to Catalent Philadelphia, Nicole was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).

Prior to joining Catalent, Nicole held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives.

Biography:

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140+ company-owned offices in 50+ countries, with focus on direct-to-patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service / operations, director of new service development and director of regional accounts, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

Mark Woolf – Global Manager, Depot Network, Catalent

• Over 35 years logistics and operational experience
• Extensive background in global storage and distribution including residency for over 15 years in many European, Middle East and APAC countries.
• Zuellig Pharma Asia Pacific (4 years) where he was resident, working in the Philippines
• Almac Clinical Services (6 years) both in the UK and USA.
• Freight Forwarder and Distributor within Free Trade Zones in Turkey & Africa.
• 12 years of Clinical Trial Logistic, Operations and Vendor management

Biography:

Katy Ostertag is Senior Manager, Clinical Supply Chain at PCI Pharma Services. Katy joined PCI in October 2016 with over 10 years of clinical supply experience in the pharmaceutical industry at Vertex, Sunovion, and Takeda. She earned her Bachelor of Science in Kinesiology in 2001, and Master of Science in Kinesiology in 2004; both degrees coming from Indiana University. In January 2016, Katy earned her Project Management Professional certification, and is a member of the Project Management Institute.

In her role as Senior Manager, Clinical Supply Chain, Katy is growing a team of clinical supply professionals who can bring PCI’s experience to the clinical trial, providing expertise throughout the clinical study supply lifecycle. She is responsible for acting as the single point of contact in coordinating the necessary information between clinical functions, ensuring the clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study.

Biography:

Biography:

A Chartered biologist, with a Masters in Pharmaceutical Sciences, Harry has over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Harry currently holds the position of Senior Director, Quality, EMEA, leading the EMEA Quality function across the Clinical Trials Division at Thermo Fisher Scientific. Based in Horsham, UK, Harry oversees 6 sites specializing in the Manufacture, Packaging and Distribution of Investigational Medicinal Products (IMPs). Harry previously led Quality at the Thermo Fisher Scientific Horsham site for several years. Harry is an experienced Qualified Person (QP) for clinical and commercial products.

Biography:

Olive McCormick is the Head of Quality at Almac Clinical Services residing at the main headquarters in Craigavon, Northern Ireland. Olive is responsible for the QA, QC and the QP teams at this site and also at the Dundalk facility in Ireland. Olive has been with Almac for over 20 years where she has gained extensive experience in the practices employed in the manufacture, packaging and labeling of IMPs and has been acting as a QP for over 16 years. Her role involves management and oversight of the Pharmaceutical Quality System at the facilities in the UK and Ireland and extends to include the routine duties of the QP.  Olive has extensive experience in performing on-site audits of manufacturing, testing, packaging and labeling sites and distribution centers globally.

Biography:

 “It’s not the note you play that’s the wrong note — it’s the note you play afterwards that makes it right or wrong.” —Miles Davis

For over 20 years, Travis has performed as an improvisational comedian, performance coach, and corporate training specialist. His coaching practice combines the principles of improvisation and personal performance to help individuals and organizations with mindset, culture, and collaboration. He has worked with companies including JP Morgan Chase, Janssen Pharmaceuticals, PepsiCo, Under Armor and Cintas.

For the past 4 years Travis has worked solo under his company Live Yes, And… He works regularly with Georgia football, the Chicago Cubs, Miami Marlins, Cincinnati Reds, and New York Yankees. He is the host and creator of The Weekly Yes, And Podcast, and the author of “3 Words for Getting Unstuck: Live Yes, And!” Travis lives in Jupiter, FL with his wife and three kids.

Get Unstuck with 3 Words. Buy Travis’ book!

Listen to Travis on The Weekly Yes, And Podcast on iTunes!

Biography:

Catherine Hall has over 15 years of Clinical Supply Chain experience and currently holds the position of Director of Clinical Supply Chain with Alnylam Pharmaceuticals. She has been an active member of the Investigational Products communities and is a member of both the New England Clinical Supply Organization and the North America ISPE Investigational Products Community of Practice Steering Committees. Catherine started her career as an academic scientist in the area of Molecular and Cellular Biology before finishing her MBA and transitioning into Supply Chain with Pfizer. She has also worked for Millennium/Takeda and more recently Biogen. During her career she has developed training programs, led process improvement initiatives, and helped build partnerships and solidify alliances. Catherine is probably the most well known for her efforts at Biogen where she led a team that focused on bridging the GMP/GCP gap to bring supply chain customer service through the last mile to patients.

Biography:

Summer Doty is currently Director, Clinical Supply Chain at Gossamer Bio, responsible for end-to-end clinical supply management and oversight for the IBD and Oncology programs with additional CMC project management responsibilities. Summer joined Gossamer Bio in September 2018 with 19 years of global supply chain management experience in commercial and clinical supplies at Becton Dickinson Biosciences and Fisher Clinical Services. She has a BA in Chemistry from University of San Diego and is Certified in Production and Inventory Management (CPIM) through APICS.

Biography:

David is a pharmaceutical services professional with over 15 years’ experience in the provision of GXP compliant services. He is a Clinical Supplies Specialist and one of the few GMP/GDP professionals whose experience includes the administration of investigational products in a clinical setting, gained whilst working as a Research Physiologist with a Phase 1 Clinical Research Unit. David holds a post-graduate diploma in clinical research and is currently Global Account Director at World Courier where he is often called upon to assist in solving the supply chain challenges associated with novel therapies. He has previously worked as a Clinical Supplies Lead for Penn Pharma where he managed pharmaceutical development and supply chain projects for a variety of small, medium, and large pharmaceutical companies.

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

Ana-Zeralda has been working in the pharmaceutical industry for over 12 years, working on the sponsor side. She has a broad experience concerning clinical operations, CMC, supply chain management, regulatory, IP, project management, and preclinical services.  Ana-Zeralda holds an MSc in Clinical Research Administration, as well as a PhD from the University of Oxford in Molecular Medicine. She is currently Senior Clinical Trials Supply Manager at Debiopharm and she has previously worked for Sanifit Therapeutics in different roles where she managed different clinical trials between Phase I and III, as well as all the supply chain management.

Biography:

Greg Hottell holds the role of Director, Clinical Supply Chain at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies (D&OP), helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, implemented and operates a monthly clinical demand governance process (Demand Review), implemented the Smart Supplies Forecasting tool, and has overseen GSK’s performance with on-time delivery of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee. Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops and presenting at annual meetings. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services, and GSK. He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CPIM-F) through APICS.

Biography:

David is a pharmaceutical services professional with over 15 years’ experience in the provision of GXP compliant services. He is a Clinical Supplies Specialist and one of the few GMP/GDP professionals whose experience includes the administration of investigational products in a clinical setting, gained whilst working as a Research Physiologist with a Phase 1 Clinical Research Unit. David holds a post-graduate diploma in clinical research and is currently Global Account Director at World Courier where he is often called upon to assist in solving the supply chain challenges associated with novel therapies. He has previously worked as a Clinical Supplies Lead for Penn Pharma where he managed pharmaceutical development and supply chain projects for a variety of small, medium, and large pharmaceutical companies.

Biography:

Sashin has 16 years of clinical supply experience supporting packaging and labeling operations, global scheduling, forecasting, planning, IVRS, randomization and drug supply management. Sash currently holds the title of Associate Director, Drug Supply Manager in the Clinical Supply Operations group at Bristol-Myers Squibb. In this role, he provides drug supply support for Investigator Sponsored Trials (IST/ISRs), Early Patient Access (EPA), and Phase IV or Late Phase Post Marketing Clinical Research. Sash obtained his Bachelors of Science from Philadelphia College of Pharmacy and his MBA from Drexel University. At home, Sash loves to spend time with his wife and two kids. He has coaches his daughter in softball. He is an avid New York Mets and New York Giants fan.

Biography:

Biography:

Carrie is a Senior Manager in Clinical Supply Chain at Agios.  In her current role, she is a program lead within the oncology portfolio and manages drug supply for the Expanded Access Program and Investigator Sponsored Trials. Prior to joining Agios in April 2019, Carrie worked in Clinical Supply Chain at Alkermes, a global pharmaceutical company, managing drug supply for a large multiple sclerosis program and all Phase 1 studies.  She received her Bachelor of Arts degree in Chemistry from College of the Holy Cross and her PharmD from MCPHS University.  In 2016, Carrie completed a two-year post-PharmD Clinical Supply Chain Fellowship at Sanofi Genzyme.

Biography:

Biography:

Kristen DeVito is Global Director, Clinical Supply Services at Catalent Pharma Solutions. In this role, she is global lead for Customer Service Excellence, Project Management, Clinical Supplies Management and Strategic Supply Solution functions of the business. With over 20 years of industry experience, she previously held the positions of General Manager of the CSS site in Mt. Laurel, NJ and Director, Project Management with Aptuit and Quintiles Clinical Supplies. Kristen is a committee member and former Chair of the ISPE Investigational Products COP Steering Committee and former instructor for the Center for Professional Advancement Course, Clinical Trial Materials.

Biography:

Stefanie Koleski is a Supply Chain Lead at Pfizer, Inc. She received her Bachelor of Science Degree in Biology and Psychology from the University of Michigan and her Master of Science Degree in Biology from Eastern Michigan University. Stefanie joined Pfizer (at the time it was Warner-Lambert Parke-Davis) in 1995 working in the Virology Drug Discovery group. She moved into Global Clinical Supply in 2001 and has been a Supply Chain Project Manager for 19 years. She has supported all phases of investigational development to coordinate and drive the clinical supply process by forecasting, managing and delivering worldwide investigational drug supplies. Most recently Stefanie led a team that worked to implement a supply chain to manage the Pfizer gene therapy portfolio. Stefanie currently works remotely and resides in Michigan with her daughter. In her spare time, she enjoys spending time with her family and friends, traveling, golfing, bowling and enjoying the sunshine. She can be contacted at Stefanie.koleski@pfizer.com

Biography:

Jake Rashid is Supply Chain Lead at Pfizer within the Global Clinical Supply department. Jake joined Pfizer in 2017, bringing with him 3 years of prior experience in clinical supply program management and strategy. He has managed the clinical supply chain for company assets at all stages in the development lifecycle: FIH, Phase 1-4 and post marketing requirements. In addition to clinical supply expertise, he has a background in R&D aspects of large-scale biopharmaceutical production and clinical operations management. Jake received his bachelor’s degree in Health Science from the University of Iowa, and master’s degree in Medical Biotechnology from the University of Illinois at Chicago.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Following a degree in Pharmacology at Cardiff University, and a PhD in Neuropharmacology at the Department of Anaesthesia- University of Leicester, Bev began her career at Pfizer in 1998. Firstly working on Endothelins within Cardiovascular Biology, moving onto Sildenafil research within Sexual Health, then onto Veterinary Medicine working on livestock and companion animal research. Working alone was not something that Bev enjoyed, therefore after the birth of her second child Bev moved into the Supply Chain. This will be Bev’s 12th year in Supply Chain, working in several areas including, Supply Chain Lead, Distribution Specialist within Logistics , before moving into the Senior Management role within Logistics and managing a global team. Although Bev is not utilising her Pharmacology background on a daily basis, she believes that she is making a difference to the patients that the supplies are being delivered to.

Biography:

Erin is a Project Manager at Catalent Pharma Solutions with over 22 yrs. experience in the Japanese Market with more than 10 yrs. working both in Japan and the US, with Japanese clients and Global clinical trials going into Japan.    She has extensive design and strategy expertise for Japanese clinical supplies and advising foreign companies wishing to do business in Japan.   Erin previously managing the North Carolina Japan center and was responsible for consultancy on technology transfer and bridging cultural gaps with Japanese and US entities doing business in the US or bridging into Japan.

Biography:

Michael is currently the CEO of Myoderm, where he has worked the past 18 years.  Michael’s passion, leadership, and commitment to meeting each client’s unique needs have been a driving force in making us a global leader in clinical trial supply. Before Myoderm, Michael served in positions in the publishing, advertising, financial, and utility industries. He holds a B.S. in Statistics from the University of Pittsburgh, and an M.B.A. from the university’s Katz Graduate School of Business. 

Biography:

Laurie is currently a Director of Solutions Consulting- Clinical Trial Supplies and Logistics at PAREXEL. She is responsible for managing a team of solutions consultants who provide subject matter expertise in order to develop supply strategies to meet each client’s unique need. She has been with PAREXEL since 2012, and held positions in clinical supply project management and account management. Prior to joining PAREXEL Laurie’s primary focus was project management of the full drug supply lifecycle from forecasting and planning through returns and destruction. Since joining PAREXEL she has expanded her area of focus to include ancillary supplies management and laboratory logistics.  Laurie has worked in the clinical trial industry for 20 years. She is an experienced clinical supply professional with 10+ years of global clinical supply chain project management experience. She has a B.S in Biochemistry and an MA in Kinesiology from the University of Texas.

Biography:

Nicole Gray is currently Director, Strategic Supply Solutions for Catalent Clinical Supply Services, responsible for developing the Direct to Patient business and other new strategic service offerings. She has been in the Pharmaceutical industry for 15 years and has held multiple roles in clinical supplies project management. Prior to moving to her new role in August 2018, Nicole spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers, and Sr. Project Managers. Prior to moving to Catalent Philadelphia, Nicole was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).

Prior to joining Catalent, Nicole held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives.

Biography:

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140+ company-owned offices in 50+ countries, with focus on direct-to-patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service / operations, director of new service development and director of regional accounts, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Sandra Cook, Ph.D., is a project management, strategy and training consultant with thirty years experience in the pharmaceutical industry. The past twenty have been focused on Investigational Products where she has held both line management and senior level project management roles facilitating high performing teams in the delivery of worldwide clinical supplies, including materials supporting key priority blockbuster products for large pharma.  Additionally, she has been instrumental in the design, development and implementation of several global process improvement projects for R&D Supply Chain.  An active contributor to the IP Metrics Task Team of the International Society of Pharmaceutical Engineering, Cook also manages the bi-annual Equal Partners in Clinical Supplies industry forum

Biography:

Bill Brocious is a Director at Eli Lilly and Company and is responsible for global clinical trial master label development and packaging/labeling operations. He has 31 years of experience at Lilly and remains passionate in delivering medicines that make life better for people around the world. Earlier in his career at Lilly, Bill set up their initial external network to source large molecule assets for clinical development. He is a graduate of Purdue University, where he majored in Chemistry and played on the college golf team. He currently lives in Zionsville, Indiana with his wife and two children. When he is not busy with work or family, you can usually find him on a golf course. Fun fact, one of his distant relatives, Curly Bill Brocious, was laid to rest by Wyatt Earp in a gun fight.

Biography:

Kevin began his career at Clintrak (later purchased by ThermoFisher Scientific) in May 2004 in the Manufacturing Division and was directly involved with label production. He joined the Client Services Department where he worked closely with clients in order to insure the successful completion of their jobs from protocol interpretation to label production. Throughout his tenure, Kevin has gained broad knowledge of the clinical label production process and the clinical supply chain as a whole while developing innovative solutions for clinical labeling challenges. Over the past few years, Kevin has spearheaded the development of translation and regulatory review solutions for clinical trial labels as a Label Program Director. Kevin provides customer service support including client and site visits, quarterly meetings, trade meetings, exhibitions, seminars, whitepapers and leads industry discussion groups. He works closely with ThermoFisher Scientific specialists to develop customized solutions to meet client’s unique needs. Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. He currently resides in Patchogue, NY with his wife and two children.

Biography:

I started my career in Pharma at Pfizer in 2001. I joined the Fisher Clinical Services team in 2007 as Senior Project Manager and have held positions as Packaging Project Manager, Clinical Supply Chain Manager and Program Director. My experience has proven invaluable in my current role as Global Relationship Director. Today I leads a cross-functional team dedicated to providing high-quality, global “end-to-end” service to key clients. I serve as a client advocate, recommending new processes aimed at improving the client’s global service experience.

Biography:

Regulatory Scientist at Eli Lilly and Company.

Biography:

Having worked in the pharmaceutical industry for almost 20 years within various quality positions, in his position as Global Clinical Quality Director, Tristram is responsible for quality within PCIs clinical trial supply services division; In this role Tristram engages with PCI clinical teams in the USA, UK and Ireland, also liaising with global customers on various clinical supply chains generally advising on quality matters.  Tristram is an EU Qualified Person (QP), qualifying under the permanent provisions in 2011, Tristram is responsible for the QP certification of both commercial and investigational medicinal products on various PCI UK MHRA site licences across a range of dosages forms.  Tristram joined PCI back in in 2007 within one of PCIs acquired companies, Biotec Services International where Tristram held various Quality Management and Director positions.