Ulrich Granzer

CEO, Granzer Regulatory Consulting & Services

Independent consultant, owner and CEO of Granzer Regulatory Consulting & Services GmbH with currently 50+ employees. Dr. Ulrich Granzer is focusing on global drug development and regulatory affairs with special considerations for orphan drugs. Dr. Granzer has major experience with biotech products (proteins, cell-based therapies, gene therapies, oligonucleotides, vaccines, phages) and small molecules. A mainstay of his work is dedicated to orphan drugs. He holds a PhD in pharmaceutical chemistry. Prior to being independent he held senior positions at Glaxo, BASF pharma Knoll, and Bayer. He has a track record of working on more than 300 new molecular entities (small molecules, proteins incl. antibodies, oligonucleotides, gene therapies, cell therapies). Recently he and his firm supported the first approval of a mRNA vaccine against Covid 19.

Marlene E. Haffner

CEO, Haffner Associates

Dr. Marlene Haffner, M.D., M.P.H., has been a Public Health and rare disease advocate throughout her entire professional career. A graduate of the George Washington School of Medicine with residencies in Internal Medicine, Dermatology and Hematology, she began working on the Navajo Reservation where she became the Medical Director of the Navajo Area Indian Health Service. After 10 years working with the Navajo People who lived mainly in austere circumstances, she was transferred to the FDA in the Washington, D.C. area. There she was requested by the FDA Commissioner to manage the fledgling Orphan Drug Program — the first such program in the US and in the world. The Orphan Act, passed in 1983, determines a product treating a disease of fewer than 200,000 in the US could be entitled to certain financial incentives on FDA full drug approval including tax credits for clinical development, and 7 years exclusive marketing for the drug for the disease. The program has been very successful with now more than 800 orphan drug products approved in the US. In addition, with Dr. Haffner’s advocacy and example, programs have been developed in many other countries including the EU, Japan, Philippines, Singapore and beyond. Many millions of people with rare diseases have received therapies as a result of the initial US Orphan Drug Act.

David H. Crean

Managing Partner, Cardiff Advisory

Dr. David H. Crean has carved a distinguished career over three decades, excelling in mergers & acquisitions, strategic partnerships, and investments across the life sciences and healthcare industries. His expertise spans executive roles within biopharmaceutical companies, investment banking, private equity, and venture capital. At the helm of Cardiff Advisory LLC as a Managing Partner, Dr. Crean specializes in mergers and acquisitions (M&A), corporate partnering, valuations, and strategic advisory services, focusing on the life science and healthcare sectors. His leadership extends to pivotal roles on the Boards of Directors for Paracrine, Cenna Biosciences, Almon Therapeutics, BIOCOM California, San Diego Connect, and the California Life Sciences Association, showcasing his influence and contribution to the industry's growth and innovation. His strategic foresight and understanding of the market dynamics have made him a trusted advisor to boards and executive teams seeking to navigate the complexities of the life sciences industry. Dr. Crean's accomplishments have earned him recognition as a thought leader and influencer, receiving accolades such as the 2023 Leaders of Influence in Life Sciences, consistent inclusion in San Diego’s 500 Most Influential People list from 2019 to 2023, the 2019 Investment Banker of the Year by M&A Advisors, and several awards for healthcare leadership and advisory excellence. Beyond his professional achievements, David H. Crean is committed to mentoring the next generation of leaders in the biotechnology and healthcare industries, emphasizing the importance of integrating scientific excellence with sound business strategies to drive sustainable growth and impact. Educationally, Dr. Crean's foundation in the field is robust, holding a Ph.D. in Biophysics and an MBA with a finance concentration from Pepperdine University Graziadio School of Management. His qualifications include FINRA Series 79 and Series 63 licenses, underscoring his credibility and expertise in investment banking​​​​​​.

Cornell Stamoran

Vice President, Strategy and Government Affairs, Catalent

Dr. Cornell Stamoran has more than thirty years’ experience across a broad range of disciplines, including accounting and finance, strategy, M&A, innovation, IT, advocacy (IR, PR, Gov’t), and sales and marketing. Dr. Stamoran began his career with five years in Arthur Andersen & Co.’s accounting and audit practice. He then joined drug delivery provider R.P. Scherer Corporation, first focusing on finance and IT, then migrating to strategy and innovation. Following Cardinal Health’s acquisition of Scherer, Dr. Stamoran continued his migration to growth-related functions, including building global business development and sales operations teams, establishing a strategic marketing function, and supporting M&A. Following Catalent’s spin-out in 2007, Dr. Stamoran has been accountable for branding and marketing; public, investor, and government relations; market intelligence and strategy; and innovation and regulatory policy, including as a member of the industry negotiating team for GDUFA reauthorization. Dr. Stamoran holds a B.S.A. with honors from the University of Michigan (accounting and finance), and a Ph.D. in history. He holds/has held a variety of professional certifications including Certified Public Accountant, Certified Management Accountant, Certified Information Systems Auditor, Certified Licensing Professional, Certified Systems Engineer, Lean-Six Sigma Green Belt, and is completing a RAPS regulatory affairs certificate.

Todd Stutzman

Senior Director Pharmaceutical Development, Clinical Development & Supplies, Catalent

Dr. Todd Stutzman is a highly experienced pharmaceutical executive who has spent a significant part of his career in the industry. He began his career at Sandoz Pharmaceuticals, where he worked on the formulation development of several OTC products, including liquids and solids. He then moved to Marion Merrell Dow, where he developed oral solid immediate and sustained-release formulations. For the past ten years, Dr. Stutzman has been working at Catalent, where he has overseen and worked on over 150 different compounds across a broad range of therapeutic areas. His work has involved developing formulations for various drug delivery systems, including oral and inhalation products. He has also been involved in scale-up and process development, ensuring that the manufacturing process is optimized for efficiency and quality. Dr. Stutzman is highly skilled in Good Manufacturing Practices (GMP), which are essential for ensuring that pharmaceutical products are manufactured consistently and meet the required quality standards. He also has extensive experience in managing research and development projects, as well as managing relationships with contract research organizations (CROs).

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Arsalan Arif

Founder & publisher, endpoints news

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.