Upcoming program speakers

Speakers who have been there, done that from both the sponsor and service side attend Outsourced Pharma to openly dialogue with you. In our sessions, authentic discussion between panelists is equaled by the energetic participation of attendees. True story: a panelist described the audience involvement as so boisterous, "it was like they were on the panel!"

Check out the top-shelf line-up.

Speakers by Show Speaker Bios

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Speakers by Show

San Francisco 2017

Confirmed speakers include:
Achaogen | Tina Larson, VP, Technical Operations
Achaogen | Amelia Milani, Senior Director, Supply Chain
Achaogen | JIm Kirchner, Senior Director, CMC
Achaogen | Kirin Jamison, Director, Antibody Process Development
ADC Therapeutics | Mike Mulkerrin, Head, CMC
Aequor, Inc. | Marilyn Bruno, CEO
Amunix Pharmaceuticals | Ulrich Ernst, SVP, Manufacturing & Quality Ops.
Assembly Biosciences | Jennifer Troia, SVP, HR & Organization Dev.
Boehringer Ingelheim | Jens Vogel, President & CEO, BI Fremont Inc.
Cell Design Labs | Peter Emtage, SVP, Research
Cyathlon Bioscience | Jason Carstens, Principal Consultant
Dermira | Sriram Naganathan, Sr. Dir., Chemical Development
FDA | Jane M. Kreis, Traning Officer
FibroGen | Wayne Frost, VP, Regulatory Affairs
Hayat Pharmaceuticals Consulting | Umar Hayat, Principal
Jaguar Animal Health | David Upchurch, VP, Supply Chain
Juno Therapeutics | Mary Mallaney, Senior Engineer
KO Pharma R&D| Sami Karabomi, Co-Founder
Nuredis | Thomas W. Sun, VP, Nonclinical Development
Outsourced Pharma | Louis Garguilo, Conference Chair & Chief Editor
PCT Cell Therapy Services (Hitachi Group) | Catherine McIntyre, Sr. Dir., Global MSAT
Pfizer | Ali Javadian, Dir., Biotherapeutics & Vaccines Outsourcing
PharmAssist | Jeff Evans, CEO, President
Pharmatech Associates | Bikash Chatterjee, President & CSO
Regulatory Pathfinders | Federico Goodsaid, Principal (former FDA official)
Rondaxe Pharma | Dave Perritt, Vice President
Universal Cells | Bryan Steadman, Chief Technology Officer
Validant | John McShane, Managing Partner
Valley Fever Solutions | David Larwood, CEO & President
Versartis | Vinita Kumar, VP, QA & QC
Wallowitz Associates | Sue Wallowitz, President

 

Past Programs

We're proud of the speakers who've given their time and talent to our programs. Below are just a few of our past participants - bravo!
Achaogen | Tina Larson, VP Technical Operations
ADC Therapeutics | Michael Mulkerrin, VP, Head of CMC
Agensys | Brian Mendelsohn, Leader of ADC Chemistry Group
Allergan | Sesha Neervannan, SVP Pharmaceutical Development
Alnylam Pharmaceuticals | John Frenz, VP Manufacturing
Amunix Operating Inc. | Ulrich Ernst, SVP Manufacturing & Quality Operations
Arcturus Therapeutics | Joseph Payne, President and CEO
BalinBac Therapeutics | John Gregg, President and CEO
Biogen | Thomas Holmes, Sir. Dir. Global External Manufacturing
Capricor Therapeutics | Denise McDade, VP of Quality
Cerulean Pharma | Marc Wolfgang, VP Technical Operations
CytRx | Carrie Helland, VP Project Management and Manufacturing
Depomed | Gerd Kochendoerfer, VP Pharmaceutical Development
Eleven Biotherapeutics | Greg Zarbis-Papastoitsis, VP Process and Manufacturing Sciences
Endocyte | Michael Brinkley, VP Quality
EPRIUS Biopharmaceuticals | Charles Laranjeira, VP Supply Operations
FORMA Therapeutics | Mary Kachinsky, VP Strategic Sourcing & Operations
Genentech | Todd Mabe, Head of External Quality, Biologic Drug Substance
Genzyme | Piet Houwen, Head of External Manufacturing
Innovent Biologics | Claudia Lin, VP Quality
J&J | Courtney Billington, VP Global Pharmaceutical Supply Chain
Medivation | Thomas Templeman, SVP Pharmaceutical Operations
Merck | Bob Kanuga, VP External Manufacturing
Mirati Therapeutics | Dennis Hester, VP Product Development and Head of CMC
Moderna Therapeutics | Hari Pujar, VP Tech Development & Manufacturing
Nektar | Maninder Hora, SVP Pharmaceutical Development and Manufacturing Operations
Neurocrine Biosciences | Scott Zook, Vice President, CMC Development
Orexigen | Philip Roberts, VP Technical Operations
Pernix Therapeutics | Terry Novak, COO
Polynoma | Pat Mallon, COO
Retrophin | Nils Olsson, VP CMC
Revance Therapeutics | Azita Nejad, VP Quality
Shire | Charlene Banard, SVP Quality
Shire | Mani Sundararajan, VP & Head Global Pharmaceutical Technology
Stemline Therapeutics | Joan Connolly, VP Manufacturing
Sorrento Therapeutics | Jeffrey Su, EVP & COO
Sunovion | Vincent Kosewski, VP Supply Chain Operations
Theravance Biopharma | Junning Lee, SVP Technical Operations
Versartis | Patrick Murphy, VP Manufacturing
XenoPort | Sami Karaborni, VP Development Operations

 

Speaker Biographies

Marilyn Bruno

Marilyn Bruno

CEO | Aequor, Inc.
San Francisco | The geography of outsourcing: How important is your project’s location?

Marilyn Bruno has served as CEO of Aequor, Inc. since 2006, drawing on 30+ years’ experience in international business, finance and law. Aequor is a biotech start-up that is launching proprietary molecules that inhibit bacteria’s ability to contaminate and “foul” surfaces, and infect human and animal tissues. The Executive Director of the One Health Commission asked Dr. Bruno to help publicize and organize events for International One Health Day on November 3rd, an event launched by the United Nations’ World Health Organization, FAO and OIE to highlight that antimicrobial resistant pathogens are found on all surfaces and impact environmental, animal and human health. Dr. Bruno earned a B.A. from Mount Holyoke College, M.S. and Ph.D. from New York University, and J.D. from New York Law School. She is a member of the American Bar Association; Phi Alpha Delta Law Fraternity; Member of the Bars of: NY, NJ, FL, DC since 1992 and was certified to argue before the U.S. Supreme Court in 1998. Following work in academia in Europe and in finance on Wall Street, Dr. Bruno was honored in Business Week, and awarded “Woman Entrepreneur of the Year” for starting up a pre-Internet international trade database to support the coordination of non-traditional trade finance transactions (countertrade/barter) for developing countries during liquidity crises. She was a Clerk at the U.S. Federal Court of International Trade and then served 14 years in the U.S. State Department, specializing in economic affairs, food security and pandemic response.

Jason Carstens

Jason Carstens

Principal Consultant | Cyathlon Bioscience
San Francisco | Spotlight Technology: Outsourcing Assistance for Cell and Gene Therapies

Dr. Jason Carstens has over 20 years of cell therapy and biologics process development, GMP manufacturing, and CMC project management experience in the biotech industry. Dr. Carstens is currently a Principal Consultant at Cyathlon Bioscience, a consulting group that provides contract consulting services to clients in the cell therapy and biologics industry. Most recently, Dr. Carstens was VP of Manufacturing and Development at Nohla Therapeutics, a Seattle based cell therapy company. Previously he spent five years as the Director of Cell Therapy Process Development and Manufacturing at the Fred Hutchinson Cancer Research Center in Seattle. While at Fred Hutch, he worked on a variety of autologous and allogenic cell and gene therapy products including CAR T-cells, TIL, antigen specific T-cells, hematopoietic stem cells, and B-cells for use in human clinical trials. Dr. Carstens also spent 13 years at CMC Biologics, a contract development and manufacturing organization, where he was responsible for cell line and cell culture process development supporting manufacture, transfer, and scale-up of more than 50 unique recombinant proteins, antibodies, and biosimilars. Dr. Carstens has an appointment at the University of Washington as an Affiliate Associate Professor. He earned his PhD in Chemical Engineering from the University of California at Berkeley.

Bikash Chatterjee

Bikash Chatterjee

President & CSO | Pharmatech Associates
San Francisco | Teaming Up For Regulatory Advancements

Bikash has been involved in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years. Mr. Chatterjee has guided the successful approval of over a dozen new products within the U.S. and Europe and is a frequent speaker at industry and regulatory events. He has published and is a regular editorial contributor to several internationally recognized industry journals. Mr. Chatterjee has spoken and published extensively on the application of PAT, Lean Six Sigma, Quality by Design and Process Validation approaches within the regulated life sciences industry. He is an ISO 9000 certified Lead Assessor and Six Sigma and Lean Manufacturing Master Black Belt. Mr. Chatterjee has developed and transferred products and processes to satellite operations and Contract Manufacturing Organizations for much of his career. He has extensive experience with design and implementation of systems to satisfy the requirements for ICH Q8, Q9, and Q10 as well as e-pedigree and the application of risk based approaches in the area of validation. His experience in complex product and process development and technology transfer has resulted in the development of a six sigma based methodology to support the PAT initiative and has successfully tailored the principles of Lean and Six Sigma for application in the pharmaceutical R&D environment resulting in reduced program risk and reduced time to market. Mr. Chatterjee is a member of the USP National Advisory Board and is the Past-Chairman of the Golden Gate Chapter of the American Society of Quality. Mr. Chatterjee is a member of the Healthcare Information and Management System Society Technical Advisory Board and sits on several private Scientific Advisory Boards. He is a standing member of the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, a founding member of the CPhl Expert industry Advisory Board and writes a recurring column for several magazines on industry trends and challenges. He is a frequent industry speaker and has published over 70 articles. He is also the author of "Applying Lean Six Sigma in the Pharmaceutical Industry (ISBN: 978-0-566-09204-6), July 2014 published by Gower Publishing, Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego.

Peter Emtage

Peter Emtage

SVP, Research | Cell Design Labs
San Francisco | Spotlight technology: Outsourcing assistance for cell and gene therapies

Peter Emtage, Ph.D. is the SVP of Research at Cell Design Labs (CDL). Prior to joining CDL, Peter held senior positions at Intrexon, Medimmune and Femta Pharmaceuticals. Peter is an immunologist by training and over the past 20 years has focused on developing drugs to modulate the immune response in humans. His work in oncology, autoimmunity and infectious disease has included the utilization of viral and non-viral delivery systems, chimeric antigen receptor and TCR adoptive T cell modalities, and monoclonal antibody development. His career started with a post-doctoral fellowship at the National Institutes of Health followed by his role as Research Scientist at Aventis Pasteur and then Instructor in Medicine at Harvard Medical School.

Ulrich Ernst

Ulrich Ernst

SVP, Tech Operations | Amunix Pharmaceuticals
San Francisco | Putting It Together: Evaluating Your Provider Network

Dr. Ulrich Ernst is the Chief Operating Officer at Amunix. Dr. Ernst has previously held senior level positions with several global biopharmaceutical companies and brings over 20 years of experience in successfully moving products from clinical stage development to market approval. As VP/Site Head of Alexion’s commercial Rhode Island manufacturing facility, Dr. Ernst led the startup efforts to gain FDA, EMA and rest-of-world site approvals for SOLIRIS®. As Vice-President of Commercial Manufacturing at ZymoGenetics, Dr. Ernst helped create the infrastructure for the commercial manufacturing/medical device enterprise which launched the RECOTHROM® hemostasis franchise. Additionally, Dr. Ernst has held senior operations positions with JNJ and Baxter, where he contributed to the product development and global launches of NATRECOR® and ADVATE®, respectively. Dr. Ernst began his career at Regeneron and Somatogen where he contributed to development efforts on novel protein therapeutics. Dr. Ernst received a B.S. in Chemical Engineering from the University of Minnesota and a Ph.D. in Chemical Engineering from Lehigh University in Pennsylvania. Dr. Ernst is broadly published and is an inventor on several patents.

Jeff Evans

Jeff Evans

CEO, President | PharmAssist
San Francisco | Your Workforce: Challenges In Hiring New And Skilled Employees

Seasoned pharmaceutical industry thought leader with vision to identify creative solutions for pharmaceutical entities to bring new products to patients, while providing a significant financial return to investors. An innovative entrepreneur, with an international professional network, has enabled hundreds of companies achieve development goals

Wayne Frost

Wayne Frost

VP, Regulatory Affairs | FibroGen
San Francisco | Data integrity meets knowledge transfer | The geography of outsourcing: How important is your project’s location?

Wayne Frost has over 20 years of pharmaceutical industry experience, focused on regulatory affairs and drug development. He is responsible for several approved NDA's in the area of Inflammation, Respiratory, Local Anesthesia, and Cardiovascular. Frost's specialties include: Regulatory strategy and registration. labeling development and negotiations

Louis Garguilo

Louis Garguilo

Chief Editor & Conference Chair | Outsourced Pharma
San Francisco | Spotlight Leadership Company: Achaogen

Louis Garguilo is chief editor and conference chair for Outsourced Pharma, and a contributing editor to Life Science Leader magazine. He studied public relations and journalism at Syracuse University (and holds a Master’s in English), and has 30+ years of international experience in business communications and development positions. Louis spent a decade at a global pharmaceutical contract research, development and manufacturing organization; served under the governor of New York in the state’s economic development agency, as liaison to the pharmaceutical/biotechnology industry; was chief strategic officer for an e-learning software company; and spent most of the ‘80s and ‘90s in Japan as an educator, author, and business communications consultant, including for the Osaka Medical Center for Cancer and Cardiovascular Diseases.

Federico Goodsaid

Federico Goodsaid

Principal | Regulatory Pathfinders (former FDA official)
San Francisco | Spotlight Leadership Company: Achaogen

Regulatory and clinical product development executive with extensive FDA and pharmaceutical and medical device industry experience in the development of new precision medicine products and of novel regulatory strategies and policies and efficient regulatory pathways for product approval by regulatory agencies throughout the world.

Umar Hayat

Umar Hayat

Principal | Hayat Pharmaceuticals Consulting (former FDA official)
San Francisco | Teaming up for regulatory advancements

Biography coming soon.

Kirin Jamison

Kirin Jamison

Director, Antibody Process Development | Achaogen
San Francisco | Spotlight Leadership Company: Achaogen

Results oriented leader with a passion for motivating organizations to solve complex problems using a systematic, analytical, and pragmatic approach. An experienced cross-functional team leader and people manager, with a strong commitment to employee development. Passionate about improving the lives of patients in need of high quality health care.

Ali Javadian

Ali Javadian

Director, Biotherapeutics & Vaccines Outsourcing | Pfizer
San Francisco | Spotlight Technology: Outsourcing Assistance For Cell and Gene Therapies

Ali Javadian serves as director at Pfizer Bio-Therapeutics Pharmaceutical Sciences Outsourcing. Ali provides scientific and managerial services to assure the success of clinical manufacturing, compliance with applicable regulations, and testing operations for production, leading to clinical trials. Ali is also responsible for externaIization and outsourcing of the Bio-Therapeutics portfolio including vaccines, adjuvants, cytotoxic antibody drug conjugates, monoclonal antibodies and protein therapeutics for pre-clinical and clinical trials. Ali's specialties include project management, technology transfer, budget design and implementation of projects, leadership & team building, communication and interpersonal skills.

Sami Karaborni

Sami Karaborni

Co-Founder | KO Pharma R&D
San Francisco | Aligning Motivations For Sponsor And Supplier Innovation

Sami is an independent consultant in Pharmaceutical Development and Supply Chain management. He has more than 25 years of industrial experience In API and drug product development.

Jim Kirchner

Jim Kirchner

Senior Director, CMC | Achaogen
San Francisco | Spotlight Leadership Company: Achaogen

Jim Kirchner is a pharmaceutical development leader and Ph.D. scientist with 15 years of broad-based pharmaceutical experience including API and drug product process development, analytical development and clinical manufacturing expertise. He is an effective leader and team builder with a collaborative and energetic management style, with proven success in expanding his technical expertise into new arenas. Jim has proven success in strategic development of initiating, qualifying, and managing outsourced preclinical and clinical development drug supply needs balancing internal and external resources in process development and analytical development. He is able to develop and manage to budgets and balance technical and business requirements. Jim's specialties include: Strategic and Tactical Drug Development, Strategic and Tactical Process and Analytical Development, CMO Oversite and Contract Negotiation, CMC Team Leader, International Experience in Pharmaceutical Development, Pharmaceutical Product Leader, Manufacturing Scale Ups, IND and CTD Preparation, Cross-Functional Team Leadership, Manufacturing Site Selection, US and ex-US Clinical Drug.

Jane M. Kreis

Jane M. Kreis

Training Officer | FDA
San Francisco | Teaming up for regulatory advancements

Biography coming soon.

Vinita Kumar

Vinita Kumar

VP, QA & QC | Versartis
San Francisco | Data Integrity Meets Knowledge Transfer

Vinita has 25 years of industry experience in pharmaceutical development at both start-up and large companies. Her experience encompasses working from early phase development to full-scale commercial production both in an in-house and out-sourced environment. She has worked with several contract service organizations and contract laboratories where she has ensured compliance with FDA and EMA standards. Prior to joining Versartis, Vinita most recently served as Vice President of Quality at Relypsa where she built and led the quality organization from early development phase through FDA approval and commercial phase. Her career began as a pre-formulation Scientist at Syntex, followed by 23 years working at Roche, Oread, Telik, Ilypsa (Amgen) and Relypsa. Vinita has provided leadership to the quality organization primarily in small molecule and polymeric drugs. She has hosted several Regulatory Authority Inspections and has been successful in obtaining positive outcomes. She has been involved in marketed drugs such as Naprosyn®, Cellcept®, Toradol® and Veltassa®. Vinita is responsible for the overall quality operations and quality control, including quality management of all GxP Compliance, Validation, QC GMP, QC Clinical and QC Research. She holds two MS degrees: one in Physical Organic Chemistry from Southern Illinois University and another in Organic Chemistry from Patna University.

Tina Larson

Tina Larson

VP, Technical Operatipons | Achaogen
San Francisco | Spotlight Leadership Company: Achaogen

Tina M. Larson is Vice President of Technical Operations at Achaogen, a biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. Ms. Larson is accountable for CMC Development, Manufacturing, Supply Chain, Quality Assurance and In Vitro Diagnostic Devices. Prior to Achaogen, she was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science, CMC Development, and Global Business Operations. Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe. She was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star. Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.

David Larwood

David Larwood

CEO & President | Valley Fever Solutions
San Francisco | Aligning Motivations For Sponsor And Supplier Innovation

David has been CEO since the founding of Valley Fever Solutions in 2007. He has been leading the manufacturing process development, now in increasing scale GMP manufacturing. In his PhD studies in Pharmaceutical Chemistry at the University of California San Francisco he helped invent a successful drug delivery system (PEG liposomes, used in Doxil and other products). Earlier, he was first to synthesize Iotrolan, a commercially important contrast agent still in use 35 years later. David is an experienced business executive with 19 years experience as VP or CEO. For 3 years he was VP and primary attorney of FormFactor, a startup company that has been successfully public sine 2003. In 2001, he took Verisity Ltd. public as its General Counsel and remained in that role until the company was acquired in 2005.

Mary Mallaney

Mary Mallaney

Senior Engineer | Juno Therapeutics
San Francisco | Spotlight Technology: Outsourcing Assistance for Cell and Gene Therapies | Your Workforce: Challenges In Hiring New And Skilled Employees

Mary Mallaney has been working as a Chemical Engineer in biotechnology for 8 years. She started her career at Genentech working on both drug substance and drug product manufacturing process development for large molecule products in various groups in technical operations. Building on the late stage experience she gained from her time at Genentech, Mary moved up to Seattle to take a role at Juno Therapeutics just over 2 years ago to lead CMC strategy for process characterization and validation in the emerging field of autologous cell therapy. In her free time she enjoys traveling and getting outside to explore all that the pacific northwest has to offer.

Catherine McIntyre

Catherine McIntyre

Sr. Director, Global MSAT | PCT Cell Therapy Services (Hitachi Group)
San Francisco | Spotlight Technology: Outsourcing Assistance for Cell and Gene Therapies

As Interim Site Head at PCT, a Caladrius Company, Catherine is accountable for the daily management of the Mountain View Site, providing clinical manufacturing for ongoing cell therapy clinical trials, product development and technology transfer services for a variety of clients. In her permanent role as Senior Director, Global MSAT Operations, Catherine is accountable for the technology transfer of cell therapy manufacturing and associated processes from client to PCT to support clinical trials, ongoing support of established manufacturing processes. Catherine has 17 years of biotech experience in cell therapy manufacturing (cGMP), tech transfer, program management, product development, functional management, and Systems Validation. She has a PhD in Virology (1990) and nine years of academic research experience in tumor immunology, cancer vaccine development and dendritic cells.

John McShane

John McShane

Managing Partner | Validant
San Francisco | The Geography Of Outsourcing: How Important Is Your Project’s Location?

John McShane is a results oriented Pharmaceutical Quality and Operations leader with 35 years of progressively increasing responsibility in quality, manufacturing, validation and technical support. He has demonstrated expertise in critical Quality remediation and Quality System implementation, manufacturing operations, pharmaceutical validation and business process improvement. John has been successful in leading and directing cross-functional teams to accomplish critical strategies in compressed frames. He is recognized as a member of management who delivers results by building teams and relationships at all levels of the organization, demonstrating versatility and facilitating innovation.

Amelia Milani

Amelia Milani

Sr. Director, Supply Chain | Achaogen
San Francisco | Spotlight Leadership Company: Achaogen

Amelia Milani is a calculated risk taker who enjoys tackling challenging situations in a fast-paced environment. Milania works collaboratively with others to solve large problems and managing change to deliver results. She is passionate about leading and inspiring people to do their best and working in an industry that is focused on improving and saving lives..

Mike Mulkerrin

Mike Mulkerrin

Head, CMC | ADC Therapeutics
San Francisco | Data Integrity Meets Knowledge Transfer

Dr. Michael Mulkerrin is Vice President, Head of CMC (Chemistry Manufacturing and Control) of at ADC Therapeutics. Dr. Mulkerrin has extensive industry experience in biologics manufacturing. Prior to joining ADC Therapeutics, he held the position of Vice President, Process Development and Manufacturing at OncoMed Pharmaceuticals. Prior to OncoMed, Dr. Mulkerrin was the Senior Director in Process Sciences at Amgen heading Analytical Biochemistry. He also served in leadership positions in the development of therapeutic monoclonal antibody projects at Genentech and Abgenix. In 2010, Dr. Mulkerrin was elected to the USP Council of Experts, and is Chairman of the Biologics Monographs – Proteins Expert Committee. Dr. Mulkerrin has a B.S. in Biochemistry from the University of Massachusetts, Amherst, and a Ph.D. in Biochemistry from the University of Georgia, Athens.

Sriram Naganathan

Sriram Naganathan

Sr. Director, Chemical Development | Dermira
San Francisco | The Geography Of Outsourcing: How Important Is Your Project’s Location? | Aligning Motivations For Sponsor And Supplier Innovation

Sriram is a chemical process-development and CMC professional offering 23 years of experience from preclinical development through commercialization of small molecules and peptides. He has hands-on experience in multi-step synthesis, route-scouting, process development, scale-up, tech transfer to CRO/CMO, including manufacture under cGMP and process validation. Sriram also has extensive knowledge of CMC regulatory landscape (FDA, EMEA) including preparation of CMC sections of IND, IMPD, NDA and MAA.

Dave Perritt

Dave Perritt

Vice President | Rondaxe Pharma
San Francisco | Your Workforce: Challenges In Hiring New And Skilled Employees

Dave is an entrepreneurial sales and business leader with experience in solution based sales and over 10 years of sales experience. His specialties include: Business Development, Account Management, Channel Management, Organic Growth, Market and Business Analysis, Product Demonstrations, Contract Negotiations, Sales Leadership, Project Launches, Territory Sales Management, Strategic Planning, Lead Qualification, UAT Experience, CRM Experience, Import/Export Regulatory Experience. Software related to: Drug Discovery, Regulatory Affairs, R & D, Quality Assurance, and Manufacturing.

Bryan Steadman

Bryan Steadman

Chief Technology Officer | Universal Cells
San Francisco | Spotlight technology: Outsourcing assistance for cell and gene therapies

Dr. Bryan Steadman is the Chief Technology Officer at Universal Cells Inc. responsible for the translation of R&D to GMP activities and leadership of the Quality, Regulatory, Process Development and Manufacturing Operations. Most recently, Bryan was the Executive Director Process Development at Amgen helping transform biotechnology manufacturing by leveraging internal and external technology development into an integrated facility design. Prior to Amgen, Bryan was VP CMC Operations for LigoCyte, a VC funded biotechnology firm in Bozeman MT that was acquired by Takeda. In total, he has more than 25 years of technical experience having also worked at Merck, Bristol-Meyers Squibb and Allergan in technical and management roles. Bryan has a PhD in Environmental Toxicology and BS in Microbiology, both from the University of Wyoming.

Thomas W. Sun

Thomas W. Sun

Vice President, Nonclinical Development | Nuredis
San Francisco | The Geography Of Outsourcing: How Important Is Your Project’s Location? | Putting It Together: Evaluating Your Provider Network

Tom Sun is the Vice President of Nonclinical Development at Nuredis. He is responsible for medicinal chemistry, CMC and other aspects of nonclinical development. Prior to joining Nuredis, Tom was Vice President of Pharmaceutics and Manufacturing at Rigel Pharmaceuticals, Inc. He was a co-inventor of fostamatinib and played a key role in establishing the CMC strategy, the product development and manufacturing, and the NDA of fostamatinib. Tom and his team developed oral solid and liquid products, nasal spray, ophthalmic solution and topical ointment and contributed to the advancement of nine new chemical entities to clinical studies. Tom began his industry career at Roche Nutley and then moved to Roche Palo Alto. He worked at Roche for 6 years in the areas of process development, pharmaceutical chemistry and product development. Tom received his B.S. degree in Chemical Engineering and his M.S. degree in Chemistry from Dalian University of Technology, and his Ph.D. in Organic Chemistry from the University of California, Santa Cruz.

Jennifer Troia

Jennifer Troia

SVP, HR & Organizational Development | Assembly Biosciences
San Francisco | Your Workforce: Challenges In Hiring New And Skilled Employees

Jennifer Troia recently joined Assembly Biosciences in 2017 as Senior Vice President, Human Resources and Organization Development. Previously, she had re-joined Sunesis Pharmaceuticals in December 2013, after spending over four years consulting within the life sciences industry. Prior to that, Ms. Troia spent a year as Vice President, Human Resources, at CoMentis, Inc. She served as Vice President, Human Resources and Corporate Operations at Sunesis Pharmaceuticals, Inc. between January 2001 and August 2008, where she held leadership positions of increasing responsibility. She worked with COR Therapeutics between 1996 and 2001, playing a pivotal role in hiring a national sales force of more than 100 employees. With over 25 years of experience in Human Resources, she has also held positions at Gilead Sciences as well as in the high technology and investment banking industries. She was employed at 3M for seven years before then. Ms. Troia has been serving on the Board of Directors of the Bay Area Human Resource Executives Council since 2004. She is a certified member of the Society for Human Resource Management (SHRM-SCP). She is also a member of the Northern California Human Resource Association. Ms. Troia holds a Masters in Human Resources and Organization Development from the University of San Francisco.

David UpChurch

David Upchurch

Vice President, Supply Chain | Jaguar Animal Health
San Francisco | Aligning Motivations For Sponsor And Supplier Innovation | Putting It Together: Evaluating Your Provider Network

David Upchurch is an experienced pharmaceutical executive with over 25 years in the industry, and joined Jaguar’s team in 2016. Prior to Jaguar, Mr. Upchurch held positions of increasing seniority in pharmaceutical manufacturing and supply chain management for Agouron Pharmaceuticals and Gilead Sciences. Mr. Upchurch served key roles in authoring global marketing submissions, securing approvals, launch, and lifecycle management for over a dozen novel pharmaceutical products, and managed international health authority site inspections on a regular basis. Mr. Upchurch holds a BS from The University of the South, an MS from the University of Alabama-Birmingham, and an MBA from the University of San Diego.

Jens Vogel

Jens Vogel

President & CEO, BI Fremont Inc | Boehringer Ingelheim
San Francisco | Aligning Motivations For Sponsor And Supplier Innovation

Dr. Jens Vogel serves as President and CEO of Boehringer Ingelheim Fremont Inc. Jens has 20 years of experience in all aspects of biopharmaceutical development and manufacturing, through senior leadership roles in process & technology development, GMP manufacturing and global project leadership in the US, Germany and the UK. Prior to his current role, Jens was Global Head of CMC Strategy & TechRA, covering CMC development & global regulatory strategy for the entire portfolio of innovative BI biologics, Biosimilars, as well as, all contract development & manufacturing projects. Before he joined Boehringer Ingelheim, Jens was part of Bayer’s Global Biologics Development Leadership Team in Berkeley. To date, Jens and his teams contributed to the successful licensure and post launch support of multiple commercial biologics, as well as, more than 60 INDs/IMPDs. Jens’ interests include reliable supply of biologic therapies to patients, disruptive innovation in technology and business models, and strategic collaborations to maximize value generation for all stakeholders. He is very active in the industry community and was voted as one of the 100 most influential people in drug development and manufacture (The Medicine Maker Power List 2015).

Sue Wollowitz

Sue Wollowitz

President | Wollowitz Associates
San Francisco | Data Integrity Meets Knowledge Transfer

Sue Wollowitz is a consultant in drug development CMC issues, scale-up, outsourcing, analytical, regulatory requirements. Her strengths include creating an effective CMC presence in a demanding cross-functional environment and finding collaborative solutions to intra- and inter-company drug development challenges.