Life Science Success

Send us a textIn this episode of Life Science Success, my guest is Mara Holinger.  Mara is the SVP and co-founder of Quantum Regulatory Solutions.  She has extensive experience in assisting pharmaceutical and biotech firms with preparing their regulatory pathway, providing regulatory input for clinical trial designs and clinical development plans, performing gap analyses for preclinical testing and writing regulatory applications.   Key points covered in this interview:  Background and Expertise: Mara Holinger has a strong background in Regulatory Affairs, with a Ph.D. in a related field. She also highlighted her co-founders' scientific expertise, making their team unique in the regulatory consulting field. Client Base: Quantum Regulatory Solutions primarily serves small to midsize pharmaceutical companies, offering a range of services beyond just regulatory strategy, including pre-meeting support and long-term pathway planning. Team Collaboration: Mara emphasized the importance of collaboration within her team, combining their diverse skill sets to provide comprehensive solutions to clients. This collaborative approach sets them apart from others in the field. Leadership and Empowerment: She mentioned the value of strong leadership and role models who encouraged her to speak up and not apologize for her opinions. This empowerment has been crucial in her career. Passion for Problem-Solving: What excites Mara is the opportunity to solve complex puzzles in the regulatory space, working closely with various stakeholders to ensure that innovative therapies can navigate the regulatory process successfully.

Send us a textIn this episode of Life Science Success, my guest is Cristian Massacesi MD.  Cristian is the Chief Medical Officer & Oncology Chief Development Officer at AstraZeneca.  In the interview, we will discuss his start in oncology, his career path, and current trends in oncology.    Guest Introduction: Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer at AstraZeneca. The discussion focuses on his career in oncology, his path in the medical field, and current trends in technology. Background and Career Path: Cristian Massacesi, originally from Italy, pursued a career in oncology due to its challenges and potential for impact. After training in Italy, the UK, and the USA, he transitioned from clinical practice to pharmaceutical research, realizing his passion for clinical research. Role at AstraZeneca: In his dual role at AstraZeneca, Massacesi focuses on prioritizing tasks and managing a busy schedule. He works in R&D, particularly in oncology, overseeing the development of safe and effective products, and engaging with various teams globally. Clinical Trials and Leadership: Massacesi emphasizes the importance of clinical trial diversity and the need for innovation in trial execution. He shares his perspective on leadership, highlighting the necessity of assembling strong teams and being accessible and human in management. Vision and Challenges: He is driven by the goal of defeating cancer and leading an organization towards this aim. Massacesi expresses concerns about the complexity of change management in drug development and the regulatory environment, while also finding excitement in the advancements and recognition in the field.

Send us a textIn this episode of Life Science Success, my guest is Bob Rochelle the Chief Commercial Officer at Cleveland Diagnostics.  Bob is a proven expert in launch, strategy, and marketing for novel healthcare products. His more than 30 years of experience ranges from start-ups such as Exact Sciences and Good Start Genetics to established multinationals such as Abbott Laboratories.   Introduction of Bob Rochelle: The episode of "Life Science Success" features Bob Rochelle, Chief Commercial Officer at Cleveland Diagnostics. Rochelle is recognized for his expertise in launch strategy and marketing for novel healthcare products. Bob Rochelle's Background: With 35 years in the healthcare industry, Rochelle has extensive experience, primarily in diagnostics, working with both pharmaceuticals and startups. His career includes roles in various therapeutic and diagnostic areas, from antibiotics and antihypertensive drugs to genetic disease diagnostics and cancer. Transition to Startups: Rochelle discusses his transition from large corporations like Abbott Laboratories to smaller startups. He emphasizes the appeal of being able to rapidly implement ideas and the challenges of limited resources compared to larger companies. Cleveland Diagnostics and Novel Technology: At Cleveland Diagnostics, Rochelle is involved with a novel platform technology for cancer diagnostics. He highlights the importance of innovative technology and a strong team in his career choices. Insights on Cancer Diagnostics and Career Lessons: Rochelle shares insights on the evolution of cancer diagnostics, emphasizing the importance of specificity and sensitivity in tests like isopsa for prostate cancer. He reflects on lessons learned throughout his career, including the significance of diverse perspectives in small companies and the challenges of navigating healthcare reimbursement systems.

Send us a textIn this episode of Life Science Success, my guest is Todd Druley PhD.  Todd is the Chief Medical Officer at Mission Bio.  His expertise lies in translational genomic and computational tools to improve clinical diagnostics and apply these tools to disease-specific questions in cancer.   Key Takeaways: Dr. Todd Druley is the Chief Medical Officer at Mission Bio, specializing in translational genomics and computational tools for clinical diagnostics, especially in cancer. Dr. Druley's career was influenced by a personal connection to pediatric leukemia, leading him to bridge medicine and genomics research. He transitioned from academia to industry, joining companies like Archer DX and Mission Bio to have a broader impact in diagnostics and treatment. Dr. Druley emphasizes the importance of single-cell multiomics in diagnostics and bridging the gap between technical advancements and clinical treatments in pediatric oncology.  

Send us a textIn this episode of Life Science Success, my guest is Kalyan Obalampalli.  Kalyan is a disruptor and technology innovator with over 20 years of experience in leadership positions in clinical operations and outsourcing at major pharma and biotechs. Kalyan is the founder and president of Clin.AI, a disruptive start-up that is revolutionizing the way vendor selection and management is conducted in the industry.   Introduction of Kalyan Obalampalli (KO): KO is a disruptor and technology innovator with over 20 years of experience in leadership positions in clinical operations and outsourcing at major pharmaceutical and biotech companies. He is the founder and president of Clin.AI, a startup revolutionizing vendor selection and management in the industry. KO's Background: KO's academic background includes a degree in electrical engineering and a master's in biomedical engineering. He started his career in pre-clinical animal work and transitioned to clinical operations in the pharmaceutical industry. The Problem Clin.AI Addresses: Clin.AI focuses on solving the problem of vendor selection and management, particularly for organizations with budgets in the range of $40-50 million. Traditional methods using Excel files can be time-consuming and inefficient. How Clin.AI Helps: Clin.AI provides a platform that streamlines vendor selection by quickly analyzing vendor proposals, facilitating negotiation, and aiding in the selection of the best vendor based on both price and quality. This platform can save organizations significant time and effort. KO's Philosophy: KO emphasizes the importance of spending time with people to understand their problems and potential solutions. He also highlights the significance of being forward-looking and adding value to clients' experiences.

Send us a text• Susan Stipa, with a diverse background in pharmaceuticals, biotechnology, and financial services, discusses the evolution of her career and her transition into marketing, emphasizing her passion for blending scientific understanding with creative communication. • She highlights the rapid and transformative advancements in biopharmaceuticals, touching on the challenges and excitement surrounding emerging therapies like cell and gene therapy and expressing concern about ensuring access to these innovations. • Susan mentions the importance of effective communication within the biotech industry, especially when engaging with journalists to accurately relay complex scientific concepts, showcasing CG Life’s role as a mediator to foster better understanding. • She reflects on valuable leadership advice received from her father about making a strong initial impression and the importance of human connection, opposing a rigid corporate mentality, to foster creativity and meaningful relationships. • Both Susan and the host, Don, share an appreciation for the relentless drive within the biotech industry and its potential to address global health challenges, emphasizing the fulfillment derived from their roles in this dynamic field.

Send us a textToday on the Life Science Success Podcast, we have a very special guest with us—David Hibbard, the Vice President of Engineering at Sunrise Labs. With over 25 years of experience in medical device development, David has been at the forefront of innovation in areas ranging from Stress Echocardiography to Robotics.   The interview features David Hibbard, VP of Engineering at Sunrise Labs, who has over 25 years of experience in medical device development. He holds a biomedical engineering degree from Boston University. Sunrise Labs specializes in Class II and Class III medical devices and focuses on end-to-end service, from software to hardware. The team size is just under 100 people, with approximately 70 to 80 engineers. David discusses the importance of strong project management, emphasizing the need to understand regulatory strategy and timelines, and advises that good client relationships are formed through transparency and integration, even in daily scrums. On the topic of leadership, David mentions the importance of good integrity and communication for long-term partnerships. He emphasizes that understanding the end user's needs is crucial for successful medical device development. Hibbard also talks about the use of AI to improve code robustness and mentions some of the challenges they are facing with remote work and maintaining a work-life balance in the current environment.

Send us a textIn this episode of the Life Science Success Podcast my guest is Dr. Vibhor Gupta.  Dr. Gupta is the Director and Founder at PangaeaData.AI. He trained in oncology research and has a breadth of experience in life sciences through his work in industry and academia over the last two decades.   Dr. Vibhor Gupta is the Director and Founder of PangaeaData.AI. He has a background in oncology research and a breadth of experience in life sciences. Dr. Gupta's journey in the Life Sciences industry began when he realized the importance of combining scientific knowledge with computer programming skills to make sense of medical data, especially in the context of improving patient outcomes and advancing scientific research. He emphasized the importance of motivation in pursuing a career in life sciences and how it helps individuals weather challenges and stay focused on their goals. Dr. Gupta discussed his experience working in Silicon Valley with Quantum Secure, where he gained valuable insights into product development, customer behavior, and innovation in the tech industry. Pangaea Data's focus is on leveraging artificial intelligence to connect undiagnosed patients with appropriate treatments and clinical trials, benefiting patients, clinicians, and pharmaceutical companies. They have demonstrated success in finding previously undiagnosed patients and reducing treatment costs.

Send us a textIn this episode of the Life Science Success Podcast, we're honored to have Dr. Alan Trounson, the CEO of Cartherics Pty Ltd, a company at the forefront of redefining cancer treatment through immunotherapy. Tune in as we discuss the future of cancer treatment, and much more!"   Dr. Alan Trounson, CEO of Cartherics Pty Ltd, has a rich background in reproductive sciences and stem cell research. He has been instrumental in the development of human IVF and embryonic stem cells, and has also led the California Institute for Regenerative Medicine with a $3 billion budget. Cartherics aims to redefine cancer treatment through immunotherapy. The company is working on off-the-shelf CAR-T therapies that are designed to be low-cost and widely accessible, aiming to make cancer a manageable condition rather than a terminal one. The company differentiates itself by focusing on overcoming immune inhibitors in solid tumors and recruiting the patient's own immune system for a more effective treatment. They are also involved in gene editing to extend the life of CAR-T cells and make them more effective. Cartherics is in discussions with the FDA and plans to enter clinical trials by 2025. They are also collaborating with various international partners, including companies in Korea, China, Malaysia, and Australia, to bring in innovative ideas and technologies. Dr. Trounson is enthusiastic about the science and the potential impact of their work. He believes that getting the science right is crucial for achieving the expected outcomes and is excited about the broader scientific developments in the field.

Send us a textIn this episode of Life Science Success, my guest is Gaurav Kapoor.  Gaurav is a co-founder of Indegene, a digital-first life sciences commercialization company with 19 of the world's top 20 biopharma companies as clients. Gaurav is an expert in life sciences commercialization, having pioneered the co-commercialization model at Indegene. He has close to 25 years of experience in the technology-led healthcare solutions space.   Part 1: Introduction and Background Don Davis: Host of the Life Science Success Podcast, focuses on strategy, people, process, and technology in life sciences. He also has a weekly series on LinkedIn Live about scaling organizations. Gaurav Kapoor: Co-founder of Indegene, a digital-first life sciences commercialization company. They work with 19 of the world's top 20 biopharma companies. Part 2: Journey and Motivation Gaurav Kapoor: Shares his 25-year journey with Indegene. Initially focused on bridging the knowledge gap between doctors and the pharma industry using data and technology. They digitized thousands of hours of content from medical conferences. Part 3: Business Model and Shifts Indegene initially focused on B2C but shifted to a B2B model. They also moved their focus to the U.S. market due to its innovation and concentration of pharma companies. Part 4: Industry Changes and Adaptation Significant industry changes around 2010 due to the patent cliff led to a focus on centralization and compliance. Indegene started reimagining the sales and marketing model around 2015, predicting a shift towards an omni-channel approach. Part 5: Co-Commercialization Indegene pioneered co-commercialization, focusing on an omni-channel sales model and a "launch in a box" platform for mid-pharma and biotech companies. This allows for leaner, more efficient launches and operations. Part 6: Future Outlook Both Don and Gaurav discuss the need for the industry to continue evolving, especially in the wake of the COVID-19 pandemic. They express hope that the new efficiencies and approaches adopted during the pandemic will become the new normal.