Roche
Technology and Innovation Leader
Alain Bindels is an experienced Design Thinking facilitator, who leads an Innovation task force at Roche, supporting different business units to adopt innovation. He is interested in patient centric design of the healthcare industry, using new available technologies. He is applying the Design Thinking methodology to conduct workshops to test new ways of working and new technologies. Alain Bindels is part of the Precision Medicine Group Basel Area, a local Swiss based network. He is working for more than 7 years at Roche in different roles. As Project Manager he was part of the Roche-Genentech Merger Integration team to harmonize and streamline processes across the company. Thereafter he moved into a project leadership role to build up 2 medical writing groups in China and India. He is responsible for strategic outsourcing activities in the clinical development area, for Safety, Regulatory and the Medical compliance office.
AMC
Member
Angela has over 30 years’ experience in biopharmaceutical and cell and gene therapy businesses, processes and facilities. Angela works closely with clients to guide and support them through new product expansion projects, starting from the strategic business review, ensuring the early definition of technical requirements is focused on the business benefits and that the final solution delivers these benefits.
Phlow Corp
Executive Vice President, Manufacturing, Science, and Technology
Andrew Carpenter, Ph.D., is EVP of Manufacturing, Science & Technology at Phlow Corp. He is a 20+ year veteran of the pharmaceutical industry, where he started his career in drug discovery with the goal of identifying life-saving medicines or medicines that impacted patient’s quality of life. That dream is near, as Andrew identified a candidate molecule that is currently on track to be launched in 2021 as a treatment for Alagille Syndrome, a rare genetic disorder affecting children. During his career, Andrew has led projects in multiple therapeutic areas (cardiovascular, obesity, diabetes) as well as different modalities (small molecule, peptide). He then carried his project leadership experience to the contract manufacturing industry, where he expanded his skill set into API and drug product manufacturing and found a new passion in continuous manufacturing. In 2020, Andrew joined Phlow™ to help build our world-class development capabilities in addition to using strategic partnerships to reliably supply affordable, high-quality essential medicines through US-based advanced manufacturing.
Pfizer
Director-Team Leader PPD Business Development
Bernd Schuemmelfeder is a pharmacist by training with more than 30 years of experience in pharmaceutical industry and holds a Ph.D. in Pharmaceutical Chemistry. He is a certified Six Sigma Black Belt and Lean Admin Expert.
In his current role he acts as Director PPD Business Development within Global Technology & Engineering Group and is based in Freiburg, Germany.
He is responsible for PPD’s contract services business interacting with external partners managing budgets, CRM and technical projects as well as various PPD Freiburg strategic initiatives, business process optimization and alliance projects.
As GT&E New Products Team Lead, he managed various matrix teams and gained expertise in global project management at Pfizer New York Headquarter.
His vast expertise is based on several years of leading commercial and pilot plant operations with focus on production, tech transfers, process development and new product introductions.
Bernd enjoys family life as well as road biking and fine dining.
Pharmatech Associates- A USP Company
CEO
Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe. Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative.
Takeda
Director, Supply Sustainability
Bridget is the Director of Supplier Sustainability at Takeda Pharmaceuticals. She’s been with Takeda for 5 years, responsible for development and implementation of Takeda’s Net Zero strategy for Scope 3 and Takeda’s supply chain. Bridget is also the co-lead for the PSCI Scope 3 Topic Team and has held various roles within PSCI since joining Takeda.
Bridget has over 20 years of experience in sourcing and supply chain management, with the past 10 years focused on supply chain sustainability. She graduated with her bachelors degree from Arizona State University, and an MBA with a Finance concentration from Bentley University and a masters in International Relations from Northeastern University.
Bridget lives north of Boston with her four kids and husband. When she’s not working on sustainability and climate change issues, she can be found running, volunteering at school or attending games/recitals on the weekends.
Partner
Edgewater Capital
Bob spends his time at Edgewater driving deal origination, transaction execution, and portfolio management. Prior to joining Edgewater in 2011 as an associate, he was an investment banker at Harris Williams & Co. and Candlewood Partners. While in investment banking, Bob completed a variety of corporate finance transactions, including M&A, leveraged financings, and other advisory services. Bob has served on the Boards of Edgewater portfolio companies Fiber Materials, FAR Chemical, TRITEC Performance Solutions, Callery, Pure Wafer, DanChem, and Haematologic Technologies. Bob has a BS in Corporate Finance from the University of Akron and an MBA from the Weatherhead School of Management at Case Western Reserve University.
Thermo Fisher Scientific
Global SME, Sterile Drug Product
KEY ROLES AND RESPONSIBILITIES
· Provide technical support, designs strategies, and supports new business opportunities for sterile manufacturing
· Evaluate potential parenteral programs and determine the best fit in the Thermo Fisher Scientific network
· Liaise with customers to align on project scope, technology and expectations
EDUCATION
· Bachelor’s degree in chemistry from Moravian College in Pennsylvania
SCIENTIFIC EXPERTISE
· Extensive experience in pre-clinical to early phase formulation development of sterile products
· Process engineering expertise to enable technology transfer and scale up of parenteral formulations
· High level knowledge of all phases from drug discovery to commercial manufacturing and commercial launch
· Extensive experience with both small and large molecules, including small molecule formulation for controlled release of poorly water soluble drugs
ProductLife Group
Head of Analytical Services
With over 30 years of industry experience, Mr. Byrne is our most senior Analytical Services expert at DSI. Colman is technically proficient in all aspects of analytical services having spent years managing both contract laboratories and AR&D groups at pharma and biopharma companies. This includes both biologic large and synthetic small molecules, raw material release testing, HPLC, GC, and TOC testing, protein/peptide sequencing, API manufacturing processes, lipid-based product testing, and various forms of drug product testing, and support of combination products. Colman provides oversight to other internal analytical team members, he directly supports clients in all the stages of development. Using his technical ability in conjunction with his knowledge of submission requirements, he not only supports an initial filing effort but also the technical defense of a submission (information requests, in person Regulatory Agency meetings, and annual report updates).
DoubleRainbow Biosciences
Senior Vice President, Global Business Groups
Cavan Farley is Vice-President, Global Business Groups at Double Rainbow. A nationally
recognized, award-winning senior executive, Cavan has 20 years of leadership
experience at global, research-based pharmaceutical companies. She has held critical
roles across varied business channels, including market access, sales and marketing, and planning and execution.
Considered an inspired leader and team motivator, Cavan employs a multi-dimensional
approach to competitive market opportunities to drive differential performance and
ensure successful launch. Experienced in solving complex business challenges, she is
skilled at people development and cross-functional collaboration; attributes honed in
commercial leadership positions at Gilead Sciences and GlaxoSmithKline.
Prior to joining Double Rainbow, Cavan held the position of Executive Director
Corporate Accounts, Market Access for Allergan (now AbbVie). In this role, she led a
team responsible for a broad set of market access customers including national and
regional payers, the Specialty Pharmacy and Federal Channels, as well as Kaiser, totaling
more than $1B in U.S. sales.
She successfully designed and implemented an innovative account strategy and
structure in 2019 for, optimizing access and portfolio performance of approximately
$250M, and leading her team to double-digit net sales growth year-over-year,
subsequently out-pacing the nation for the previous three years. In addition, she
successfully executed launch access strategies for UBREVLY, VRAYLAR, XEN, and
DURYSTA, including pre-approval engagement and post-approval reviews, negotiation,
and coverage.
Cavan’s career has informed her knowledge and expertise across varied disease states
and therapeutic areas, including infectious and rare diseases, neurology, and
immunology amongst others.
She has a B.A. in Journalism and Business from the University of Richmond.
Lonza
Senior Principal Engineer
Deanna Mudie is a Senior Principal Engineer in Research and Development at Lonza’s site in Bend, Oregon, USA. She earned her B.S.E. in Chemical Engineering and her Ph.D. in Pharmaceutical Sciences from the University of Michigan. Since joining Lonza in 2016, Deanna has focused on enabling bioavailability-enhancing amorphous solid dispersion (ASD) formulations by developing dosage form platforms and in vitro/in silico strategies for predicting ASD bioperformance. During her doctoral and post-doctoral work Deanna developed mechanistic in vitro and in vivo drug transport models to predict oral dosage form dissolution and intestinal absorption. Deanna began her career in the pharmaceutical field as an engineer at Pfizer and Merck characterizing, developing and manufacturing oral dosage forms from preclinical to commercial scales.
Successful, innovative, and entrepreneurial life sciences professional, with 19+ years of progressive global business experience in new business and market development, innovation, and R&D. Proven track record of delivering new and cutting-edge products, technology platforms, and services to a large and diverse customer base from ideation to product launch and market expansion.
Howard J Federoff, MD, PhD is co-founder, director and Chief Medical Officer of Ryne Bio, an allogeneic stem cell start-up company focused on neurologic disorders. He also co-founded in 2022 Kaleibe a gene therapy focused on rare neurodegenerative diseases. He is the former CEO, President and director of Brooklyn ImmunoTherapeutics. He was receently a distinguished professor of neurology at the University of California, Irvine. He is the former CEO of UCI Health, vice chancellor for Health Affairs and dean of the UCI School of Medicine.
Jessica is the Senior Director of Clinical and Regulatory Affairs for Mydecine Innovations Group. She has spent the last ten years in the clinical research industry and has worked closely with cross-functional teams to develop clinical evidence generation strategies for global indication submissions. Jessica has supported and published research in robotics, orthopaedics, trauma, biologics, transcranial magnetic stimulation, and now psychedelic-assisted psychotherapy. She is enthusiastic about the future of integrative healing models in the United States healthcare system. Jessica received her graduate degree in Clinical Research Administration from the George Washington University and resides in the Greater Philadelphia area in the United States.
Jim Fries is a success-based executive with more than 25 years of experience building medical device and diagnostic companies across all pathways, including growth-oriented commercial initiatives, regulatory, and market access. Jim has been involved in driving thought-leader panels and committees within the areas of vascular intervention, cardiometabolics, diabetes, orthopedics, and pharmaceutical quality, which has resulted in numerous guidelines and consensus papers. Jim became CEO of Rx-360 in February of 2018, as a way of fulfilling his personal lifelong commitment to patient safety.
Lonza
Bioavailability Enhancement and PBPK Lead Scientist
Josh Marsh is a member of the Advanced Drug Delivery Technologies team at Lonza’s site in Bend, Oregon, USA. He started his career at the Bend site in 2016. Josh has focused on the design of amorphous solid dispersion formulations and informative dissolution testing with the goal of improved bio-availability. He is passionate about utilizing PBPK modeling to further the understanding of in vivo drug absorption, and the design of better drug products for clients and patients. Josh earned his B.S. in Chemistry from Oregon State University.
Mr. Michailaros provides over 21 years of drug product expertise with both oral and solid processes, and product development and manufacturing. He specializes in difficult technical formulation and manufacturing challenges and products with unique requirements, including controlled release, zero-order release, abuse deterrence, pediatric formulations, oral disintegration. In addition, he has developed, and optimized products including controlled release tablets, abuse deterred capsules, pediatric formulations, solid and liquid filled capsules, suspensions, inhaled products, and transdermals. Mr. Michailaros has helped author regulatory submissions in the EU as well as in the US and has worked extensively with international vendors. He has extensive experience in project management, scale-up, tech transfer and validation, lean manufacturing, six sigma/process excellence, design of experiments (DOE), chemistry manufacturing and controls (CMC) regulatory submission authoring, capital projects and third-party manufacturing management.
Marisa is an Award-winning communications and public relations executive with proven experience leading organization-wide, integrated internal and external communications strategy development and execution, and managing direct reports. Corporate and consultancy background, with leadership team experience. Keen intuition and ability to cultivate relationships and influence colleagues and stakeholders in highly matrixed environments. Lean Six Sigma Yellow Belt, Certified Executive/Professional Coach and Accredited in Public Relations.
Modestus Obochi (he goes by Modi) is an accomplished senior executive with over 25 years of diverse experiences growing revenues and shareholder values across biotech and pharma companies. A visionary leader, team builder, and patient-centric innovator, Modi’s collaborative leadership style and operational expertise enable individuals and teams to consistently exceed their potentials and deliver superior, sustainable results.
Modi has successfully structured and closed multiple strategic transactions worth over $5B while holding leadership positions across marketing, portfolio strategy and management, and business development, including Global Head of Strategic Marketing and Global Expansion for Hospira’s $3.5B specialty injectable pharmaceutical business; Head of Commercial Development for Pfizer’s $7B injectable portfolio and Global Vice President for Baxter’s $1B pharmaceutical business unit.
Michael Frank is the Digital Ventures Lead in Memorial Sloan Kettering’s Office of Technology Development. He is a member of the Digital Health team in OTD’s Technology Management and Commercialization group.
Before joining MSK in 2021, Michael spent more than 15 years in life sciences and digital venture roles in the biopharmaceutical and management consulting industries. Most recently, he worked at Pfizer, Inc. as Senior Director, Breakthrough Change in the CEO’s Transformation/Innovation function. Earlier, Michael worked as a strategy consultant at Booz & Co (a PWC Company) and PA Consulting. He was also VP of technology at Phosplatin Therapeutics, a NYC biotech startup, and Director of BD and Commercial Operations at CombinatoRx.
Marisa is an Award-winning communications and public relations executive with proven experience leading organization-wide, integrated internal and external communications strategy development and execution, and managing direct reports. Corporate and consultancy background, with leadership team experience. Keen intuition and ability to cultivate relationships and influence colleagues and stakeholders in highly matrixed environments. Lean Six Sigma Yellow Belt, Certified Executive/Professional Coach and Accredited in Public Relations.
Peter is the President of xCell Strategic Consulting, a consulting firm to the Pharmaceutical Industry. xCell provides consulting services in the areas of Drug Development, Outsourcing, and Supply Chain. In addition, xCell Provides advice and support for M&A in the Pharmaceutical Services Industry. Prior to founding xCell, Peter served as Division President of Qualitest, Endo Pharmaceutical’s Generic Drug Division. He also served as the President of North America Commercial Operations and CEO at Patheon Pharmaceuticals. Patheon is a leading Contract Manufacturing and Contract Research Organization which at the time was Publicly Traded and had $700 million in revenues and 5000 employees.
Prior to joining Patheon, Peter spent 14 years with Wyeth Pharmaceuticals. While at Wyeth, he oversaw a significant portion of the Manufacturing and Supply Chain organization including Consumer Products such as Advil and Centrum Vitamins, Branded Drug Products and Vaccines such as Prevnar. He also oversaw Global Engineering and expansion programs to support drug manufacturing and Research and Development. .Peter also spent 14 years at SmithKline Beecham (now GlaxoSmithKline) before joining Wyeth. His assignments included significant international project work in Europe and Asia and operations experience with injectable product manufacturing.
Peter is a member of the Global Pharmaceutical Manufacturing Leadership Forum of the ISPE and is a frequent speaker at Industry events. He serves on the Board of Abzena, a Biopharmaceutical Company and as the Chairman of the Board of Trustees of the Pharma, Biopharma Outsourcing Association (PBOA); a non-profit trade association that represents the needs and interests of Pharmaceutical Contract Development & Manufacturing Organizations (CDMOs).
Peter previously served on the Board of IPS – a Global Healthcare Engineering Company, the Board of Frontida Laboratories and the Board of CASA Youth Services – a non-profit organization serving the needs of Children in the Foster Care environment. He has a BS in Mechanical Engineering from Villanova University and an MBA from Philadelphia University. Peter and his wife Lynn reside in Valley Forge, Pennsylvania.
Mr. Peter Stevenson is a leader in the pharmaceutical industry with extensive manufacturing and commercial experience. He was a member of Pfizer’s Global Manufacturing Leadership Team with responsibilities for global procurement, global external supply and a portfolio of Pfizer internal manufacturing sites in North America, Europe and Asia.
Later, he served as General Manager of Pfizer’s contract manufacturing business and as Value Stream Leader for the Injectables and Hospital Products Value Stream. Mr. Stevenson recently retired from Pfizer and currently serves as the Board Vice-Chair for Uniting to Combat Neglected Tropical Diseases and Chair of the Governance Committee.
Earlier in his career, Mr. Stevenson held positions at Rhone Poulenc and Celanese including a 3-year expatriate assignment in France.
He holds a Bachelor’s degree in Arts from Gettysburg College, Pennsylvania
Rick L. Knight is the Global Head Strategic Account Management at Pfizer CentreOne. Rick is a high-impact healthcare executive with extensive experience in global pharmaceutical and medical device businesses. Rick began his career in sales and marketing and has held leadership roles at AmerisourceBergen, Honeywell, and Becton Dickinson.
Prior to joining Pfizer CentreOne Rick was Vice President and General Manager at Cardinal Health where he grew a suite of 3-businesses into one of the largest suppliers of multi-source prescription and over-the-counter products in the industry, with a portfolio spanning nearly 50 therapeutic categories.
He has also led patient care efforts as a Director of Hospital Pharmacy and Supervising Retail Pharmacist.
Rick holds an undergraduate degree from Albany College of Pharmacy and Health Sciences and an MBA from the University of Rochester’s Simon Business School.
Rick is a technical operation professional, driven to develop and lead high-performing organizations and committed to the success of my teams and my colleagues. Rick is strongly committed to collaborating acrossfunctional lines and drive a vision for success. His diverse background and experience has enabled him to play a leading role in all aspects of the External Supply site and its development to its current state, as well as creating the vision for the future.
Sheila currently is an Executive Director of Global Supply Planning & Transformation at Amgen. She has a long career in the pharmaceutical and industrial manufacturing companies in supply chain and has worked for companies like GSK, Honeywell, Merck and BMS in roles of increasing responsibility. Her experience spans Information Technology, Supply Planning, Product and Network Strategy and finally End to End SC transformation.