Your Launch Crew

Denise K. Pierce – Founder & CEO, DKP

Denise has more than 35 years of leadership in biopharmaceutical and healthcare consulting industries, including roles in sales, sales operations, brand management, pipeline drug development, health policy at Pfizer, BMS, and AMGEN. She founded DKP in 2000, a certified women’s business enterprise consultancy focused on creating meaningful solutions for complex conditions. To date, the company has be integral in the launch of 132 novel therapies for oncology and rare diseases, including more than half of all current FDA approved cell and gene therapies.

Denise has been identified by clients as a “strategic thought partner,” having hands-on launch expertise, enabling her to help companies create and execute successful commercialization plans and anticipate and navigate potential barriers for patient access to care.

After becoming paralyzed at 12 years old due to the autoimmune disorder called Transverse Myelitis, Cody Unser, along with her mother Shelley, founded The Cody Unser First Step Foundation to raise awareness, encourage medical collaboration, and improve the quality of life for those afflicted with Transverse Myelitis.

Through her foundation, she established Cody’s Great Scuba Adventures, which uses scuba diving as a therapeutic and psychological tool for people living with disabilities. The documentary “Sea of Change” explored the neurological and psychological effects of scuba on a group of chosen paralyzed Veterans. Due to her work with adaptive scuba diving, she was inducted into the Women Divers Hall of Fame, making her the first woman with a disability to be recognized with such an honor. She is a PADI AmbassaDiver and a certified Christopher Reeve Peer Mentor. She is a research consultant for MedStar Health, writing fact sheets related to paralysis issues as well as being a part of a Podcast Series. Cody is also a committee member on the Outreach Committee of the American Spinal Injury Association (ASIA), aiming at educating primary care physicians on how to treat individuals with spinal cord injury.

Currently 37 years old, Cody has become a leading advocate for people living with disabilities and spends much of her time traveling across the country to deliver keynote speeches, attend medical symposia, and help other grassroots organizations that have similar missions. She received her undergraduate degree at the University of Redlands in California where she created her own degree called “Biopolitics: The Interconnection Between Biology and Political Action in Human Health.” She received her masters in Public Health with an emphasis in Health Policy at the George Washington University in Washington, DC. She currently writes as a patient advocate for US News and World Report about everything she experiences relating to having a disability and navigating the world. She is passionate about the health care of women with disabilities and presents the issues they face at numerous University’s OBGYN Grand Rounds. Cody hopes to keep making an impact for people with disabilities.

Cody was born and raised in Albuquerque, NM and is currently a graduate student at The University of New Mexico pursuing a PhD in Medical Sociology with the goal to develop, deliver, and teach disability curriculum for medical schools across the country.

Shirley is a dynamic, innovative executive bringing over has over 30 years of experience specializing in market access. She brings a holistic, value-based approach to improve market understanding and access for patients. Her background includes building and leading US market access teams encompassing national accounts, trade, strategy, pricing and payer marketing. Shirley has considerable knowledge of ultra-rare, RNAi therapeutics oncology, and specialty markets.

She began her career at J&J Pharmaceuticals with growing positions of responsibility in field account management in several affiliates, including Janssen and J&J Healthcare Systems. She joined Medivation and, subsequently, Therapeutics MD before joining Alnylam as Vice President of US Market Access and growing their RNAi access team, launching four products, and generating over 60 value-based agreements with US payers.

Shirley has a Bachelor of Science in Business Administration from the College Of Charleston, Charleston SC.

As Chief Commercial Officer and Chief Operating Officer for bluebirdbio, Tom has deep passion for patients and experience across multiple commercial roles in both rare diseases and oncology. Tom served as Chief Commercial Officer at Gamida Cell, leading a high-growth, fast paced oncology cell therapy organization and establishing a culture of transparency, trust and empowerment. Prior to his tenure at Gamida Cell, Tom served in a variety of leadership roles at Atara Biotherapeutics, Navidea Biopharmaceuticals and Algeta U.S. where he led the successful commercial build-out and launch of Xofigo^®. Before Algeta, he held various commercial leadership positions at Dendreon. Tom began his pharmaceutical career at Eli Lilly where he held several positions of increasing responsibility and participated in the global launch of Cymbalta^®. Tom earned a B.A. in Business Administration and Marketing from Western State College.

Doctor Jay Weaver completed his Doctor of Pharmacy, Master of Public Health and postdoctoral residency training at the University of Florida. He has approximately 20 years of experience in executive leadership across the prescription benefits management and health plan industries building, developing and managing programs and teams. Jay has been a thought leader across various trade groups and professional societies serving the managed care pharmacy landscape with a platform of improving the partnership and collaboration between the pharmaceutical, payor and provider industries. Jay has served as Chief Pharmacy officer and VP of pharmacy over several health plans in his career and now provides strategic pharmacy consulting to health plans in his role as Associate Vice President of Health Plan Pharmacy Consulting for Gallagher Benefits Solutions.

Angie Santiago, BBA, CRCS, is the Medical Oncology Senior Business Manager at the Sidney Kimmel Cancer Center, Jefferson Health. She created and implemented the Oncology Patient Assistance Program that is utilized by the health system. The program was initiated to assist patients with the acquisition of supplemental financial coverage, over and beyond what has been traditionally provided by the hospital’s business office. She also oversees the Medical Oncology Billing Department with regards to the prior authorization process, coding, charge entry and denials. Santiago has worked in healthcare for almost 21 years within patient access, revenue cycle, and financial counseling. She is the past chair for the Association of Community Cancer Centers Financial Advocacy Network (2021-2022) and continues to be a on the network’s Advisory Committee. Santiago has also presented on financial toxicity and related topics at patient navigators’ networking meetings.

Marysia Cole, MPH – Manager of Market Insights, DKP

After working as a care coordinator for patients living with HIV in Indianapolis, Marysia was inspired to help get patients access to much-needed therapies on a larger scale. She has experience working directly with payers and providers to assess evolution in market access and potential barriers to care.

At DKP, she conducts and analyzes market research to identify important industry trends that impact how those living with cancer and rare disease access and experience care. She’s adept at sifting through complex information to find the “so what.”

Marysia also loves diving into the evolving science of cell and gene therapies. With a master’s in public health, she’s passionate about uncovering new market trends that impact key healthcare stakeholders and most of all, patients.

Nick Lynch is a Partner at FCS and is based in the Philadelphia area. He is experienced in providing Contracting Strategy, Gross to Net, Commercial and Government Pricing compliance, and Fair Market Value support with a focus on operational, strategic, regulatory, and financial risks for emerging small, mid-size, and top-ten pharmaceutical and biotechnology companies.

Prior to FCS, Nick led the Pricing & Contracting Solutions (PaCS) Advisory practice at Deloitte where he led a wide range of services around GP, Commercial Contract Strategy, GTN, Compliance and also was Deloitte’s life science FMV and BFSFs solution lead.

He has advised many life science companies ranging from emerging biotechnology manufacturers to Top 5 pharmaceutical manufacturers, on their distribution strategy and fair market value analyses for their fee-for-service arrangements with their trade partners which include distributors, specialty distributors, third party logistic providers, GPO’s, PBM’s, patient assistance program service providers, retail pharmacies, and specialty pharmacies.

Jake Keenan is a Senior Director at FCS with over twenty years of experience in the Life Sciences industry focused on compliance with government program regulations and excellence in contract operations.

Jake has consulted with all types of pharmaceutical manufacturers to help them achieve best practices in Medicaid, Dept of Veteran Affairs, and Medicare price calculation and reporting requirements. This includes building methodologies and initiating manufacturers into the government programs upon launch, as well as performing government price calculation assessments to identify gaps to improve compliance.

Prior to FCS, Jake has led service delivery teams at pharmaceutical service providers to ensure Life Science clients pay Managed Care and Medicaid rebates accurately and timely while avoiding revenue leakage. Jake also has experience with the 340B program in assisting manufacturer clients avoid duplicate discounts while adhering to program compliance requirements.

Reagan Klima brings 25 years of Pre-commercial Strategic Planning, Execution and Leadership to ensure commercial excellence. She is seen as a Strategic Growth Partner amongst CLT, providing Market Access and Go-to-Market Excellence with proven success in pre-approval market readiness, product launch and product growth throughout its lifecycle.

Throughout her career, Reagan has served in a variety of leadership roles, including Vice President, US Market Access at BioMarin, Vice President of Market Access & Government Affairs at Sobi North America, and Head of US Market Access at Kite Pharma, Inc. GILEAD, where she held roles in pre- approval, launch and on-going commercial execution for the first adult cell therapies to market: Yescarta™ (axicabtagene ciloleucel) and Tecartus™ (Brexucabtagene autoleucel). Prior to Kite Pharma, Reagan held a variety of roles with other biopharmaceutical companies such as Incyte Corporation and Algeta, leading Strategic Accounts & GPO Oncology team, National Accounts and Provider and Access Solutions through GPOs, VA/DOD, LPGs, and targeted IDNs.

Reagan’s leadership distinction includes being recognized as an excellent collaborator and driving innovation through forward thinking, strong analytics and identifying both potential barriers and solutions to access for first-in-class, novel, complex rare diseases, oncology, and cell & gene therapies.

Mindy Scharlin, MPH, has worked in the field of Managed Care Contracting for more than 35 years. She most recently worked for Stanford Hospital and Lucile Packard Children’s Hospital as the Director of Transplant Contracting. Mindy was responsible for transplant contracting as well as high-cost pharmaceutical and gene therapy contracting. As of May 2023, Mindy began a full time consulting practice including developing high-cost pharmaceuticals and gene therapy reimbursement strategies. During Mindy’s long career she was a national speaker on Transplant contracting.

Ms. Scharlin is a contributing author to the book Transplant Administration where she wrote the chapter on Managed Care Contracting.

Ms. Scharlin holds a Master of Public Health from the University of California at Berkeley.

Samantha Williams – Manager of Payer Business Intelligence, DKP

Samantha’s deepest industry knowledge spans pharmacy, medical, pricing, and operational aspects of Medicaid. She’s driven most by connecting the dots, solving problems, and breaking down barriers for patients.

As part of DKP’s payer intelligence team, Samantha has developed long-standing relationships with Medicaid agencies around the country. These relationships, combined with her expertise in policy research, claims issues, and prior authorization criteria, allow Samantha to increase uptake for manufacturers, increasing access for patients in need of life-changing treatments.

Joe DePinto has spent the past 30 years focused on bringing life-saving specialty drugs to market, helping patients with complex diseases to access advanced care, and helping to develop future leaders in the pharmaceutical industry. His experience includes operations globally for multiple biotech, pharma and technology companies. He is recognized for consistently delivering multi-million dollar revenue gains in highly competitive marketplaces. Joe is a passionate leader with a commitment to mentorship and building strong, diverse teams. Joe was the first male National Board member of the Healthcare Businesswomen’s Association.

Currently Joe is the Head of Cell Gene and Advanced Therapies at McKesson. In Joe’s role he is responsible for building out the CGT strategy and vertical at McKesson. His role includes providing solutions and services to support the biopharma, providers, and payors as they navigate the CGT value chain.

During his tenure at Vineti, a venture based start up company, he developed the commercial infrastructure to support ongoing commercial operations and new customer acquisition in the cell and gene therapy space. As President of Cardinal Health Specialty Solutions, DePinto led one of the fastest growing businesses within the Fortune 14-ranked Cardinal Health. Established just six years prior, Specialty Solutions grew from $5 billion in revenues in 2015 to more than $20+ billion in 2020 under DePinto’s leadership. In his tenure, he directed two key acquisitions; oversaw the company’s expansion into Nashville, Dallas, and Boston and led critical operational expansions.

DePinto’s past roles have included leadership positions at top pharmaceutical companies including Johnson & Johnson and Lilly. His core leadership competencies include leading all aspects of strategy, drug development, investor relations, and commercialization with multiple global launches. He also previously served as the EVP Chief Commercial Officer at Sunesis Pharmaceuticals, EVP Global Commercial Operations at Dendreon, VP Global Commercial Operations at ImClone, and VP at Abraxis Oncology.

Joe’s academic credentials include a BS in Marketing and an MBA, with an emphasis on Pharmaceutical/Chemical Studies.

Robb Richards has over 20 years of experience in oncology, first with a private practice in Southern New Jersey and more recently the University of Pennsylvania Health System. He has served in different roles throughout his career: IT Manager for the Center for Cancer and Hematologic Disease in Cherry Hill, Division Chief Operating Officer of Regional Cancer Care Associates (RCCA) in Cherry Hill, New Jersey, and RCCA corporate VP and Chief Information Officer. He unofficially joined Penn’s Cell Therapy and Transplant program (CTT) in 2016 and was the lead in overseeing operationalizing/implementation of CAR T cell therapy for commercial use. He is currently the Corporate Director of The Center for Cell Therapy and Transplant program at Penn Medicine, with oversight of both commercial and research work and its expansion into community hospitals within the Penn system.

Robb received his BS in Information Technology from Drexel University and both his MS in Informatics and MBA from St Joseph’s University.

Dr. Mahmoudjafari is board certified oncology pharmacist and a Clinical Pharmacy Manager in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Cancer Center, the only NCI-comprehensive Cancer Center in the state of Kansas. She earned her PharmD and MBA from the UMKC School of Pharmacy and the Henry W. Bloch School of Management. She is an experienced practitioner with a focus on clinical management, drug formulary management, and operationalization of cell and gene therapies. She currently has oversight of both commercial and research work in the cell and gene therapy space and actively works on developing the appropriate infrastructure to support these new and innovative treatment modalities.

Dr. Mahmoudjafari maintains active organizational involvement with HOPA, ATOPP and ASTCT. In 2022, she was the recipient of the ASTCT Pharmacy Special Interest Group Lifetime Achievement Award and ASCO’s 40 Under 40 in Cancer award.

Tim Miller, MHA, CHFP – Director of Market Insights, DKP

Tim’s experience stems from his years working with managed care health plans with a focus on government payers. He worked closely with health systems and provider practices both on the payer side building relationships and on the facility side in-house at the VA.

As the leader of market insights at DKP, Tim drives knowledge and actionable insights for the company’s clients and team. A day in his world involves not only capturing the pulse of healthcare trends but also wielding his analytical skills to interpret and deliver tailored intel to the right people at the right time. He is fascinated by the dynamic nature of biopharma research and the financial intricacies of the healthcare system.