Tasty Topics: Addressing the potential impact of the BIOSECURE Act

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with: Tom Willson, Vice President of Contract Manufacturing at Pfizer CentreOne Hanna Lesch, Chief Technology Officer at Extothera  Stephen Grant, entrepreneurial advisor and angel investor Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Tom, Hanna, and Stephen, covering: Unraveling the potential seismic shift in the pharmaceutical outsourcing industry; the BIOSECURE Act and its implications Will the BIOSECURE Act accelerate a trend toward a more regionalized approach to drug development and manufacturing? How Biotechs/CDMOs are going to adapt their strategies post BIOSECURE Act What impacts BIOSECURE will have on the supply chain    The BIOSECURE Act has the potential to significantly restrict the ability of biotechnology companies to collaborate with certain Chinese companies without losing the ability to contract with the US government. Our guests provide insightful perspectives on the potential implications of this legislation on the supply chain of life-saving drugs across America.   Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating!   Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Mihaela Simianu, Vice President of R&D and Operations at Singota Solutions. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Mihaela, covering: How having physician parents in Romania motivated Mihaela into a career in the biopharmaceutical space What 17 years at Eli Lilly taught her about drug development and commercialization... and why she ultimately left for Amgen Why, after 25 years on the drug sponsor-side, she opted to move onto the CDMO side The rapid, complex, and fascinating experience of being part of a small CDMO that supports multiple sponsors to serve patients The advisory and execution role of a CDMO partner Dr. Simianu is a transformational leader in the biopharmaceutical industry, renowned for advancing technology and therapeutic products to enhance personalized medicine and public health. She has achieved significant outcomes for multi-billion-dollar organizations, leading to the approval of 20+ new therapeutic agents and the introduction of commercial processes at more than thirty manufacturing sites globally across her tenure with Eli Lilly, Amgen, and Merck. Her expertise spans multiple disease areas, and she excels in integrating raw material suppliers, facilities, and engineering equipment into pharmaceutical systems. Specializing in modern product development, quality, and manufacturing systems, she has played a pivotal role in injectable drug commercialization and market expansion. She advanced a portfolio of over thirty-five new pipeline products. Dr. Simianu holds a Ph.D. in Chemistry from Marquette University, an M.S./B.S. in Chemical Engineering from the Babes-Bolyai University of Cluj-Napoca, and a Jack Welch Management Institute certification. She is a recognized international industry expert and has actively volunteered for the Parenteral Drug Association for over 20 years. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Doctor Eric Edwards, Co-Founder and CEO at Phlow. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Eric, covering: How a life-threatening allergy for him and his identical twin brother led to a career in medicine and then an entrepreneurial journey in the pharma space The journey from inventors to becoming a commercial pharma company... followed by a $310m exit How a plan to support a shortage in critical medicines for children took a turn as the COVID-19 pandemic arrived The US Government awarded a $899m contract to help rebuild the domestic industrial base for Covid medicines and longer-term advanced manufacturing The paradox of innovative, specialty, expensive medicines vs. drug shortages for basic essential medicines that everyone should be able to access As CEO, Eric has assembled a world-class team committed to providing a solution to the broken essential medicines supply chain and the overreliance on foreign manufacturers for the US' highest priority medicines. He previously co-founded Kaléo, where he held several executive management positions, including Chief Science Officer, Chief Medical Officer, and Vice President. Dr. Edwards is the co-inventor of multiple marketed products for treating allergic emergencies (anaphylaxis), named on over 215 issued and patent-pending applications. As a Doctor of Medicine and a Biology Ph.D. in Pharmaceutical Sciences, Eric also continues to serve his community by volunteering on a local rescue squad. This includes responding to 911 calls and training paramedics in pre-hospital emergency care. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Andy Holt, CCO of Viralgen Vector Core. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Andy, covering: Growing a CDMO while dealmaking in a gene therapy company…at the same time Selling a revenue-generating therapy company to Bayer during the pandemic Faster failure or faster acceleration; the need to celebrate every gene therapy batch as it’s going to save lives The challenges of manufacturing AAV gene therapies and why the next generation of CGT CDMOs need a voice at the table  Andy has been working on the business side of cell and gene therapy for more than 15 years, focused on creatively connecting science and solutions, whether health care for whale sharks or supporting multi-billion dollar transactions between biotech and big pharma.  Along the way, he has held positions in business development and management for several large CDMOs like Lonza and MilliporeSigma, leadership positions in Askbio, Ncardia, and Cellistic, and his current role as Chief Commercial Officer for Viralgen, a pioneering AAV-focused CDMO leveraging Askbio’s manufacturing expertise for clients around the world. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital, and content agency that helps companies differentiate, get noticed, and grow in the life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Mark W. Womack, Chief Executive Officer at BioCina. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Mark, covering: How a tough upbringing in LA led him to the US Navy, and then onto a pathway into leadership Why he decided to end his own practice and jump into a senior role within a biopharma CDMO space The key factors that led him to relocate to Adelaide, Australia The reality that most biologics CDMOs frequently fail to deliver... and why winning requires operating with discipline, and consistently executing at a high level Mark W. Womack is BioCina’s Chief Executive Officer. Prior to BioCina, he was CEO of KBI Biopharma and Selexis SA, and previous to that, he was CEO and Managing Director of Stelis Biopharma, leading both to significant YOY growth. Preceding Stelis, as the CBO for AGC Biologics, one of the world’s leading global biopharma CDMOs, he led them to nearly a 300% increase in new sales in just two years. Prior to joining AGC Biologics, Mark served over 20 years as an international management consulting industry leader, guiding many of the world’s renowned companies to achieve record highs in revenue and profit. This included a $20B post-merger integration within General Motors and numerous transformations that generated more than $100M in certified client benefits. Mark began his professional journey by leading a succession of U.S. Navy units to unprecedented results, including while serving as a combat center leader on a destroyer class ship, and he received numerous of the Navy’s highest honors and awards. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.  

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Bill Vincent, Founder and board chair at Genezen. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Bill, covering: The days when CGT therapies were viewed as just academic... then the events in 2012 that changed everything in the space How partnering with Indiana University for its vector capacity led to the creation of Genezen Building a team that had been trained really well... by his wife! Looking for a PE company that brings more than just a fat cheque What’s next for the CGT sector after an over-hyped few years of fundraises... and what areas could be hot in the future Bill is the board chair of Genezen, a biotech contract manufacturer of viral vectors, cell manufacturing, and testing services. He founded the company fourteen years ago and grew it from his one-person operation to its current 60 employees with an outside investment of $45 million. He has spent the last 35 years working in the consumer products, pharma, and biotech sectors. Prior to Genezen, Bill was President and CEO at Rimedion, a gene therapy company developing treatments for rare genetic disorders. He currently serves on the board of Cellular Engineering Technologies, a stem cell services company. Bill discovered a passion for entrepreneurship through his exposure to new business development opportunities in a corporate setting. Upon completing his MBA at the University of Texas, he participated in a two-year executive development program with Philip Morris. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Helen Shaw and Dan Henley, co-founders of VCTC. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Helen and Dan, covering: Exposing your team to everything, letting them feel the pressure... but always being there to help and guide The founding story of VCTC... and the fun and games of dividing responsibilities as co-founders How the frustrations of being a patient with an orphan disease shaped the ethos of VCTC The uptake of patient recruitment and retention in virtual and decentralized clinical trials Finding a powerful niche in the life sciences space to enable you to grow, globally Helen and Dan are co-founders of the VCTC, a UK clinical trial site that specializes in delivering virtual and decentralized clinical trials. Helen has fourteen years of clinical research experience spanning academia, clinical trial sites, biotech and CRO, with exposure across study management, medical writing, clinical science, and commercial roles. Dan is a senior executive bringing 15 plus years of comprehensive achievements in predominantly commercial roles supporting biotechnology, pharma and life sciences companies, through their non-clinical, clinical and commercial journeys. The VCTC is a UK-based clinical trial site that specializes in running patient-centric clinical trials. We bring virtual and decentralized clinical trials to participants in their own homes. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Bill Humphries, CEO at Alcami. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Bill, covering: The role managers, leaders, and mentors have played in shaping his illustrious career in dermatology The importance of ‘force multiply’ in getting results and accelerating growth Why, after a career spent on the drug sponsor side... he decided to switch to the CDMO services side How do the shifting sands in the sector provide a treasure trove of opportunities? Bill Humphries, Alcami CEO, is an experienced leader in the life sciences industry, previously serving as CEO at Isosceles Pharmaceuticals, President and Group Company Chairman of Ortho-Dermatologics, CEO of Merz North America, President of Stiefel, a GSK Company and Vice President of US Skincare at Allergan Pharmaceuticals.  Bill also served as Chairman of the Board at Clearside Biomedical, Executive Chairman of Strata Skin Sciences, and a member of the Board of Directors at Aclaris Therapeutics, PhaseBio Pharmaceuticals, SKNV, and Bryn Pharmaceuticals. Humphries’ academic credentials include a B.A. from Bucknell University and an MBA from Pepperdine University. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital, and content agency that helps companies differentiate, get noticed, and grow in the life sciences.

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector for part 2 of our conversation with Thomas Eldered, Executive Chairman at Flerie. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Thomas, covering: The story behind Recipharm’s decision to divest Cobra Biologics that led Thomas to become owner How ‘big faith’ and the gene therapy revolution changed the fortunes of the loss-making biologics CDMO After the third exit, why did he choose ‘passion rather than pension’? To fuel his love for creating things and building companies Flerie’s mission and its patient-centric investment strategy in life sciences. The story behind Thomas’ signature bowtie look… Thomas Eldered was co-founder of Recipharm AB in 1995, where he served as CEO from 2008 to 2021, growing Recipharm from a local Swedish pharmaceutical contract manufacturer to an international CDMO with more than 9000 employees in 10 countries. He was also the founder of Flerie Invest AB in 2011, where he is currently the executive chairman. Thomas is presently chairman of the board and a member of the board of several life science companies. He holds a Master of Science in Industrial Engineering and Management from Linköping University. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.  

In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with part 1 of our episode with Thomas Eldered, Executive Chairman at Flerie. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Thomas, covering: Where his entrepreneurial spark originated, and how they created a CMO (before that was even a thing) after several failed plans How did the timing of his first exit and having ‘cash during the crash’ fuel M&A to grow Recipharm into an international powerhouse? Why did he decide to go public? No one else in Sweden or in the CDMO space was getting an IPO A lifetime with Lars (his business partner) and the benefit of a partnership with aligned common interest Why he decided to sell Recipharm after 26 years and why leaving the company was the most difficult mental decision Thomas Eldered was co-founder of Recipharm AB in 1995, where he served as CEO from 2008 to 2021, growing Recipharm from a local Swedish pharmaceutical contract manufacturer to an international CDMO with more than 9000 employees in 10 countries. He also founded Flerie Invest AB in 2011, where he is currently Executive Chairman. Thomas is currently chairman of the board and a member of the board of several life science companies.  He holds a Master of Science in Industrial Engineering and Management from Linköping University. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We’d also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.