CPHI Webinar Series
The HPAPI Boom: How Pharma is Rising to the Manufacturing Challenge
What will this webinar address?
As demand for novel therapies in the oncology, diabetic and autoimmune space continues to rise, so to does investment in High Potency APIs, which offer a myriad of benefits for patients, including fewer side effects, lower dosages and a more targeted therapeutic approach.
However, potency is not without its problems. Handling, containment and manufacture of these increasingly complex molecules provides a series of challenges for manufacturers, which has led to investment in new manufacturing sites and integrated technologies1, and a rising reliance on trusted outsourcing partners.
What is needed for the pharma industry to meet the rising demand for HPAPI molecules?
The webinar will bring together industry thought leaders to discuss the latest challenges and advancements in the HPAPI market, and what is needed to meet current production demands:
- Highlighting manufacturing challenges and opportunities in HPAPI production
- Evaluating the role of CDMOs in the HPAPI market, when should you outsource?
- Reviewing current site set ups and the infrastructure needed to meet demand
- Ongoing supply chain challenges affecting the HPAPI value chain
Bikash Chatterjee is CEO of Pharmatech Associates. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products. His work has guided the successful approval and commercialization of over a dozen new products in the U.S. and Europe.
William A. Hawkins BSc (Hons), MSc, CBiol, MRSB, ERT is a Managing Toxicologist for SafeBridge Regulatory and Life Sciences Group. He has spent over 21-years working in toxicology, practicing as an Occupational Toxicologist (OT) within the pharmaceutical industry for the last 11-years. As an experienced OT, specialties include worker and patient safety, hazard and risk assessments throughout the lifecycle of drug development, ICH M7, nitrosamine assessments, and worker safety incidents. Additional experience includes regulations such as REACH and GHS, SDS compilation, working as a non-clinical study director and a consumer safety toxicologist.
Martin Kohan is a managing toxicologist for SafeBridge Regulatory and Life Sciences Group. He has a BSc and MSc in biochemistry from La Plata National University, Argentina, as well as an MSc in pharmacology and PhD in medical sciences from the Hebrew University of Jerusalem, Israel.
Martin has over 11 years of industry experience in the field of toxicology conducting and managing over 1,000 hazard and risk assessments, including calculation of exposure limits and/or determination of exposure control bands for drug substances and isolated intermediates and quality deviations (impurities and extractables and leachables) for Teva (2010-18) and AstraZeneca (2018-22).
He's a Diplomate of the American Board of Toxicology (DABT), a European Registered Toxicologist (ERT), and a member of the UK Register of Toxicologists and the British Toxicology Society.
23rd February, 2023
4pm CET / 10am EST
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