TRACK B: Biopharmaceuticals & Drugs
Navigating Sustainability in the Lab: Developing ESG Practices
9:45 AM - 10:45 AM
Join us for a discussion on how to integrate environmental, social and governance (ESG) policies in a laboratory setting. Sustainability practices go beyond recycling single use items to a resource efficiency model and business imperative. ESG measures are increasingly critical to align with environmental accountability, organizational initiatives, and business longevity. Methods of imbedding sustainability in lab operations serve to build an environment for growth and efficiency, mitigate compliance risk, eliminate waste, and extend resources.
Managing Director, American Laboratory Trading
Jayson Bernstein joined American Laboratory Trading (ALT) in 2009 and served as its president from 2015 until the company was acquired by Heritage Global Partners (NASDAQ: HGBL) in August 2021. He now serves as Managing Director running the ongoing operations of ALT under the Heritage Global family of companies. Headquartered in East Lyme, CT, ALT provides two key services – as a leading supplier of premium refurbished lab equipment and as a prominent provider of surplus lab asset management solutions for labs around the world. Bernstein has leveraged the company’s access to early stage, small- to medium-sized biotech companies, and academia by securing key alliances with some of the most reputable names in the industry, including BIO, as a preferred vendor for their members, and Agilent Technologies, as a value-added reseller – two organizations that understand the benefit of reaching this important demographic.
Kevin Karem, PhD
Director, Southeast Food and Feed Laboratory, Office of Regulatory Affairs, Office of Regulatory Science, U.S. Food and Drug Administration
Dr. Kevin Karem is the Director for the Southeast Food and Feed Lab within the FDA that monitors food quality and safety for the nation. His leadership provides support for technical operations within three laboratory branches supporting analysis of microbiology, chemical and nutritional threats to the nation’s food supply. He spent 22 years at the CDC leading large technical teams for global disease control, has designed numerous laboratory tests, and provided leadership for the nations outbreak responses for decades, including coordination of response activities with global partners. Areas of expertise beyond operational leadership include process efficiency, technology assessment, implementation of innovations. Specific scientific expertise includes biomedical applications, disease ecology, epidemiology, immunology, vaccine efficacy, diagnostic test development and biosecurity applications. He maintains a passion for innovative technologies and personnel coaching for enhanced outcomes.
Sustainability Manager, Clean Harbors, Inc.
Daniel serves as corporate sustainability manager for Clean Harbors, Inc. a premier North American environmental and industrial services provider. Through its Safety-Kleen subsidiary Safety-Kleen, Clean harbors is also North America’s largest re-refiner and recycler of used oil and parts washing services. Additionally Clean Harbors has operations located in India. Mr. Liwicki has over a decade of experience as an environmental professional providing technical environmental management and engineering services for a wide range of industries both as a corporate representative and consultant. Daniel manages ESG and sustainability programs, initiatives, policies, and disclosures for Clean Harbors, Inc. globally. As part of Mr. Liwicki’ s responsibilities he provides solutions to Clean Harbors’ customers to meet their tailored sustainability goals and targets. Sustainability stewardship is at the core of the Clean Harbors business through balancing economic success with environmental, social, and governance considerations.
Business Development Manager, My Green Lab
Stephanie Millar works as the Business Development Manager for My Green Lab. In early 2022, she was appointed as the Pharma and Biotech Sector Lead on the UNFCCC Climate Champions team. In these dual roles, she combines her industry experience with her passion for sustainability to shape the sector’s strategy for achieving net zero carbon. Stephanie has a master’s degree in Chemistry from the University of Auckland, where she applied Green Chemistry principles to her work, sparking her passion for sustainable science. In addition to her accomplishments in science and sustainability, Stephanie led the development of a mentorship program for Women in Climate Tech, empowering women to pursue careers in STEM and sustainability. Using her knowledge of sustainable science and her enjoyment in connecting with people, Stephanie aims to accelerate climate action across all of the life sciences.
Americas Business Development Manager, Certified Pre-Owned Instruments, Agilent Technologies
Naomi Serillo works as the Americas Business Development Manager for Agilent’s award-winning Certified Pre-Owned Instruments Program. In her role, she has used her passion for sustainability to help shape waste reduction initiatives, including Agilent’s Trade-in & Buyback Program. Agilent has received numerous awards for its leadership in advancing environmental sustainability through customer partnerships and internal operations, committing to achieving net-zero emissions by 2050. Naomi has been with Agilent for 7 years working in several roles including directly supporting customers in Georgia. She holds a B.S. in Biochemistry from the University of Delaware.
Advances in Antimicrobial Innovation and National Action Plans
11:30 AM - 12:30 PM
Functioning antibiotics underpin our modern medical system, lowering the risk of surgeries and enabling treatments for a huge range of diseases and conditions. But their functionality is finite as pathogens evolve resistance. The newest data suggests resistant infections are already the third largest underlying cause of death globally, while the pipeline of new and novel antimicrobial treatments dwindles. The solutions to this conundrum will require multisectoral partnership across the human and animal health industry, academia, investors, and government. With this panel, we want to start a conversation about the future of antibiotics, where the challenges and opportunities are, our successes and failures, and make the case for hope.
CarriAyne Jones Parr, PhD
Head of UK Science and Innovation Network, Southeast US; Global Health and AMR Lead, British Consulate-General, Atlanta
Dr. CarriAyne Jones Parr has spent close to a decade working between government, academia, and industry on emerging areas of science and innovation. For the last 6 years, she has been Head of the UK Science and Innovation Network in the southeast US, part of a global team of science diplomats. CarriAyne champions the UK Science and Innovation Network’s bilateral global health and antimicrobial resistance efforts. She trained as a biogeochemist and earth systems scientist. She is also a wife, mother, potter, gardener, and cyclist.
Sheyda Azimi, PhD
Assistant Professor, Department of Biology, Georgia State University
My research is focused on understanding the role of intra-specific bacterial population heterogeneity, and investigating the impact of population heterogeneity on microbiogeography, antimicrobial resistance, and host-pathogen interactions.
Michael Craig, MPP
Director, Antibiotic Resistance Coordination and Strategy Unit, Centers for Disease Control and Prevention
Michael Craig leads the coordination of CDC’s cross-cutting antibiotic resistance activities by developing and guiding CDC’s strategic direction to address national goals to combat antibiotic resistance. Craig serves as one of the Ex Officio Members representing CDC on the President’s Advisory Committee for Combatting Antibiotic-Resistant Bacteria, and he works closely with leadership within the U.S. Department of Health and Human Services (HHS) to align public health activities related to antibiotic resistance across multiple federal agencies.
Prior to this role, Craig spent 12 years with CDC Washington, where he provided policy and strategy expertise to multiple centers within CDC, including advice related to healthcare-associated infections and antibiotic resistance for the National Center for Emerging and Zoonotic Infectious Diseases.
Elizabeth Hermsen, PharmD, MBA, FIDP, FIDSA
Global AMR & AMS Medical Affairs Lead, External Medical Engagement, Hospital Business Unit, Pfizer, Inc.
Dr. Hermsen is the Lead for Global Antimicrobial Resistance & Antimicrobial Stewardship Medical Affairs at Pfizer and an Adjunct Associate Professor at the University of Nebraska Medical Center, Colleges of Pharmacy and Medicine, in Omaha, Nebraska. Dr. Hermsen received her Doctor of Pharmacy degree from the University of Nebraska Medical Center followed by a pharmacy practice residency at The Nebraska Medical Center, a fellowship in Infectious Diseases Research at the University of Minnesota, College of Pharmacy, and a master’s degree in business administration at the University of Minnesota, Carlson School of Management. Following her fellowship, Dr. Hermsen developed and co-directed the antimicrobial stewardship program at The Nebraska Medical Center and then joined Cubist, where she held medical affairs and outcomes research roles and created and led the Antimicrobial Stewardship Outreach Group.
Henry Skinner, PhD
CEO, AMR Action Fund
Henry Skinner, PhD, is an experienced executive who is deeply versed in the commercial and scientific challenges of antimicrobial drug development. He was named CEO of the AMR Action Fund in 2021. Prior to joining the Fund, he held leadership positions across the pharmaceutical and venture capital sectors, including serving as Senior Vice President, Venture at Tekla Capital Management and as Deputy Head and Managing Director of the Novartis Venture Fund. In addition, Henry was the CEO of SelectX Pharmaceuticals, which focused on developing small-molecule antimicrobials, and NeoGenesis Pharmaceuticals, which developed a platform for identifying and optimizing new drug candidates that was acquired by Schering-Plough.
IND Enabling Strategy from Mouse to Man
2:45 PM - 3:45 PM
The focus of our discussion will be on the strategic considerations taking a therapeutic through the clinical and regulatory path from pre-clinical to clinical trials. Our expert panel will share best practices, common pitfalls to avoid and how preclinical, CMC, and clinical work in parallel. We will discuss pre-clinical GLP/non-GLP, program management, CMC Regulatory submission and GMP requirements, Clinical development plan, protocol development, CRO partner selection, setting a budget and site and PI selection.
Art Spalding, MBA
President, TAMM Net, Inc.
Mr. Spalding has over 25 years’ experience in pharmaceuticals and medical devices directing various functions including: reimbursement, market research, clinical trial design and facility recruitment, distribution, business development, managed markets, hospital sales, forecasting, and sales operations. Mr. Spalding held management and director level positions at various companies including Parke-Davis, Pfizer, Solvay, Peer-Point Medical Education, and Columbia Laboratories. In 2009, Mr. Spalding started TAMM Net, Inc., a CRO servicing biomedical manufacturers. TAMM Net has helped manufacturers: conduct clinical trials; gain reimbursement; and gain governmental marketing approvals/clearances. Mr. Spalding holds a B.S. in Chemistry from Union College, Schenectady, NY and an MBA in Health Administration from Temple University in Philadelphia.
James Blackwell, PhD, MBA, MS
President and Principal Consultant, Windshire Group, LLC
As the Founder and a Principal Consultant for the Windshire Group, LLC, Dr. Blackwell is a leading consultant to the life science industry, with broad CMC and Manufacturing experience that spans early process development through commercial operations. He brings extensive product experience in antibodies, fusion proteins, peptides, oligonucleotides, gene and cell therapy, oral dosage forms, personalized medicines, and medical devices with clients ranging from virtual start-ups to leading multi-national companies. Through his consulting work, Dr. Blackwell delivers best-in-class services in Process and Product, Analytical, Formulation, Manufacturing and Technical Operations. His regulatory experience includes INDs, PAIs, DMFs, DMFs, and leading BLA CMC submissions. Blackwell also has extensive experience evaluating and selecting CDMOs and providing oversight and management of external operations. Dr. Blackwell has been on the formative management team for several start-ups.
Saundra Maass-Robinson, MD
Psychiatrist; Principal Investigator, iResearch Atlanta, LLC
Dr. Maass-Robinson is a board-certified psychiatrist with extensive experience in outpatient clinics, detention centers, and inpatient units. She brings a wealth of experience and a unique perspective to our research team; her research interests include the treatment of Mood Disorders, Anxiety Disorders, Attention Disorders, Psychotic Disorders (e.g., Trichotillomania, Bipolar disorder, Major Depression and Treatment Resistant Depression, Postpartum Depression, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder, Schizophrenia). She earned her undergraduate degree from Michigan State University, her master’s degree in political science from Atlanta University in Atlanta, GA, graduated Medical School from University of North Carolina, Chapel Hill, and completed her residency in psychiatry at Emory University School of Medicine. She was awarded “Psychiatrist of the Year” in 1997 by the Georgia Psychiatric Physicians Association (GPPA).
Marta New, PhD, MBA
Founder & CEO, Radyus Research
Dr. New is a founder and CEO of Radyus Research. She is an experienced drug developer with background in early-stage venture capital, large pharma R&D and university technology transfer. Dr. New received her PhD in immunology and microbiology from the University of Illinois at Chicago and postdoctoral fellowship at Northwestern University. She also earned an MBA in finance and marketing at Kellogg School of Management. Dr. New spent most of her career translating early academic research into differentiated therapeutics and draws her expertise from positions at Baxter, Baxalta and Agent Capital, among others. She participated in building several successful academic spinouts and invested in over 20 biotech companies. These days, Dr. New advises Radyus clients on strategies for successful product development, fundraising and commercialization.
Janan Van Osdell, MBA, MHSA
Director Clinical Research, TAMM Net, Inc.
Ms. Van Osdell has over 20 years’ experience in various aspects of health care and the pharmaceutical industry resulting in a unique blend of business and science. She has been associated with TAMM Net, Inc. for over 12 years. Before affiliating with TAMM Net, Inc., she was in Medical Affairs as Manager of Continuing Medical Education grants at Solvay Pharmaceuticals, Inc. where she was responsible for regulatory compliance, processes, budgeting, and grant review. Her career includes 15 years with Procter & Gamble Pharmaceuticals where she worked in Clinical Research, Professional Relations, Health Economics, and Educational Marketing. Her achievements at Procter & Gamble Pharmaceuticals include Clinical Research Trial Manager for bringing naproxyn sodium from RX to OTC as the branded OTC analgesic, Aleve®; and she worked seven years with inflammatory bowel disease physicians and patients with the branded mesalamine, Asacol®.
Maximizing Value in Partnering Deals
4:30 PM - 5:30 PM
This session will discuss the deal process, how to avoid mistakes, and address key issue areas all towards maximizing deal value. Geared towards C-level executives, business development leaders and company deal teams, join us to create and implement best practices for conducting licensing deals and major collaboration deals that will ultimately develop and commercialize technology within the life sciences industry.
Shareholder and Co-Chair Global Life Sciences and Medical Technology, Greenberg Traurig LLP
Wayne H. Elowe is Co-Chair of Greenberg Traurig’s global Life Sciences and Medical Technology Group and Co-Chair of the Corporate Practice in Atlanta. He concentrates his practice on corporate counseling, international business and complex commercial transactions, with an emphasis on mergers and acquisitions, joint ventures, strategic investments and alliances, licensing, and technology transactions. He represents publicly traded and privately held multinational corporations, private equity funds and other investors in various industries, including pharmaceuticals, biotechnology, medical devices, information technology, media, manufacturing, real estate, telecommunications, outsourcing, chemicals and food. Wayne is regularly involved with complex relationships involving the acquisition, licensing, sharing, development and monetization of various technology-driven assets. He is frequently called upon to work with clients to ensure that strategic goals are consistently implemented in their transactions and partnering relationships and across multiple jurisdictions.
Shareholder and Co-Chair Global Life Sciences and Medical Technology, Greenberg Traurig LLP
David Dykeman, who serves as Co-Managing Shareholder of Greenberg Traurig's Boston office and co-chairs the firm's global Life Sciences & Medical Technology Group, is a registered patent attorney with 25 years of experience in patent and intellectual property law. David's practice focuses on securing worldwide intellectual property protection and related business strategy for high tech clients, with particular experience in life sciences, medical devices, robotics, materials, and information technology. David provides strategic patent portfolio development and intellectual property advice for clients including major research institutions, multi-national corporations, and start-up companies. He also performs patent due diligence to assess patent portfolios for venture capital investment, mergers and acquisitions, and licensing opportunities.
Vice President Innovation & Impact Investing, American Cancer Society; Managing Director, BrightEdge, LLC
Vice President of Innovation and Impact Investing at American Cancer Society and Managing Director of BrightEdge — ACS’s mission-driven venture capital and impact investment arm. Alice is an impact investor, social innovation entrepreneur, and patient advocate with extensive experience in life sciences and business, coupled with her passion for the American Cancer Society’s lifesaving mission.
Her American Cancer Society volunteer leadership includes past Chair Eastern New England Board of Directors and National Board Member of American Cancer Society Cancer Action Network. She is on faculty at Harvard-MIT HST Sloan Healthcare Ventures where she teaches biomedical innovation and healthcare entrepreneurship. Before joining BrightEdge, Alice was an advisor at Red Sky Partners advising high-growth life sciences and health tech startup companies on business development and go-to-market strategies.
Paul Thompson, PhD, JD
Vice President Legal Affairs – Global Business Development and M&A, UCB, Inc.
Paul Thompson is Vice President Legal - Business Development and M&A at UCB, a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 38 years of experience in the biopharmaceutical industry, his current responsibilities include structuring and negotiating mergers & acquisitions, license agreements, joint ventures, collaborations, strategic alliances and other business transactions.
Managing Director, LYFE Capital
Derek Yuan is a Managing Director at LYFE Capital, based in the Menlo Park office. He is responsible for innovation investment from US and China. Prior to joining LYFE, Derek was working at Credit Suisse Equity research covering biotechnology companies and before that LYFE science specialist at LEK consulting. Derek obtained his PhD in biology from the Rockefeller University and bachelor degree from Tsinghua University.